Can you buy over the counter viagra

The FDA took the unusual step Thursday in opening to the public a routine meeting with an advisory group that's weighing in on approving the erectile dysfunction treatment as the agency battles can you buy over the counter viagra public concerns about its safety as well as political pressure from President Donald Trump to approve it before the Nov. 3 election.The treatments and Related Biological Products Advisory Committee, an outside group of researchers and physicians who are advising the Food and Drug Administration on whether to approve a erectile dysfunction treatment, debated the standards needed to ensure a erectile dysfunction treatment is safe and effective in a meeting broadcast on YouTube and can you buy over the counter viagra C-SPAN. Those are key questions among medical experts who worry the U.S. Will approve a can you buy over the counter viagra treatment before it has been adequately tested. Officials at the meeting Thursday said the public forum was "critical" to build public trust and confidence in the development of potential treatments, which are being developed in record time.

FDA officials can you buy over the counter viagra promised that any treatment would undergo rigorous testing before being distributed to the public."treatment development can be expedited. However, I want to stress that it cannot, and must not, be rushed," Dr. Marion Gruber, director of FDA's Office of treatments Research and Review, said, adding the can you buy over the counter viagra agency would not reduce its standards.Trump has pushed the FDA to approve a drug in time to distribute by the Nov. 3 election — a daunting task even his closest advisors have said is near impossible. "I think we should have it before the election, but frankly the politics gets involved can you buy over the counter viagra and that's okay.

They want to play their games, it's going to be right after the election," Trump said in a video he posted on Twitter Oct. 7. "The FDA has acted as quickly as they've ever acted in history. There's never been a time, and no president's ever pushed them like I've pushed them either, to be honest." The agency is approving drugs "in a matter of weeks" that used to take years, he added.Four drugmakers backed by the U.S. Are still conducting their late-stage trials, and medical experts don't expect to see trial data needed for FDA authorization until later this month at the earliest.Because of the viagra, U.S.

Health officials and researchers have been accelerating the development of treatment candidates by investing in multiple stages of research even though doing so could be for naught if the treatment ends up not being effective or safe.The FDA, under pressure from the White House, has faced skepticism from medical experts that the treatment approval process could be influenced by politics, not science.Earlier this month, the FDA laid out updated safety standards for erectile dysfunction treatment makers. The standards, posted in a document on the FDA's website, would almost certainly prevent the introduction of a treatment before the presidential election on Nov. 3.The FDA had indicated it would approve a treatment that's safe and at least 50% effective. The flu treatment, by comparison, generally reduces people's risk of getting influenza by 40% to 60% compared with people who aren't inoculated, according to the Centers for Disease Control and Prevention. FDA Commissioner Dr.

Stephen Hahn has previously said the agency wouldn't authorize a treatment that's not safe, even if it is fairly effective.The FDA has also said it would track treatments for years after they are authorized.Dr. Doran Fink, deputy director of the FDA's Division of treatments, said at the meeting Thursday afternoon that widespread deployment of a weak erectile dysfunction treatment could result in more harm than good. He said the potential treatment could end up providing a "false sense of security" that interferes with measures to reduce transmission.It could also "interfere with the development and evaluation of potentially better treatments that could have a greater impact on the erectile dysfunction treatment viagra," he warned. "Without sufficiently stringent criteria, a erectile dysfunction treatment candidate could be declared effective just by chance. And the risk of declaring a weakly effective treatment and deploying a weakly effective treatment increases as the number of treatments being evaluated in phase three trials increases."Dr.

Hilary Marston, medical officer and policy adviser for viagra preparedness at the National Institutes of Health, said Thursday that the regulatory hold for AstraZeneca and pause for Johnson &. Johnson are signs that safety measures put in place are working. "Adverse events are expected to happen in these treatment trials, both in the treatment and placebo group," she said. "We are finding these events because we are specifically looking for them.".

Mom accidentally gives son viagra

Viagra
Cialis professional
Levitra with dapoxetine
Viagra soft tabs
Best way to use
18h
16h
10h
13h
Duration of action
Online Drugstore
At cvs
At cvs
RX pharmacy
Does medicare pay
Canadian Pharmacy
Online Pharmacy
At walmart
On the market
Best price for generic
150mg 20 tablet $69.95
20mg 60 tablet $257.95
$
$
Male dosage
No more than once a day
Once a day
Twice a day
Once a day
Take with high blood pressure
Yes
Online
Online
Online

Start Preamble mom accidentally gives son viagra U.S http://msalbasclass.com/2017/09/english-3p-honors-friday-in-class/. Small Business Administration. Interim final mom accidentally gives son viagra rule. This interim final rule announces the implementation of section 311 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the Economic Aid Act).

The Economic Aid Act authorizes the U.S. Small Business Administration to guarantee additional loans under the temporary Paycheck Protection Program, which was originally established under the erectile dysfunction Aid, Relief, and Economic Security mom accidentally gives son viagra Act to provide economic relief to small businesses nationwide adversely impacted under the erectile dysfunction Disease 2019 (erectile dysfunction treatment) Emergency Declaration (erectile dysfunction treatment Emergency Declaration) issued by President Trump on March 13, 2020. Section 311 of the Economic Aid Act adds a second temporary program to SBA's 7(a) Loan Program titled, “Paycheck Protection Program Second Draw Loans.” This interim final rule implements the key provisions of section 311 of the Economic Aid Act and requests public comment. Effective Date.

This interim final rule is effective January mom accidentally gives son viagra 12, 2021. Applicability Date. This interim final rule applies to loan applications and applications for loan forgiveness submitted for Paycheck Protection Program Second Draw Loans. Comment mom accidentally gives son viagra Date.

Comments must be received on or before February 16, 2021. You may submit comments, identified by number SBA-2021-0002 through the Federal eRulemaking Portal. Http://www.regulations.gov. Follow the instructions for submitting comments.

SBA will post all comments on www.regulations.gov. If you wish to submit confidential business information (CBI) as defined in the User Notice at www.regulations.gov, please send an email to ppp-ifr@sba.gov. All other comments must be submitted through the Federal eRulemaking Portal described above. Highlight the information that you consider to be CBI and explain why you believe SBA should hold this information as confidential.

SBA will review the information and make the final determination whether it will publish the information. Start Further Info Call Center Representative at 833-572-0502, or the local SBA Field Office. The list of offices can be found at https://www.sba.gov/​tools/​local-assistance/​districtoffices. End Further Info End Preamble Start Supplemental Information I.

Background Information On December 27, 2020, President Trump signed the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the Economic Aid Act) (Pub. L. 116-260) into law to provide continued assistance to individuals and businesses that have been financially impacted by the ongoing erectile dysfunction viagra. Section 311 of the Economic Aid Act added a new temporary section 7(a)(37) to the Small Business Act (15 U.S.C.

636(a)(37)). This new section authorizes the U.S. Small Business Administration (SBA or the Administration) to guarantee Paycheck Protection Program Second Draw Loans (PPP Second Draw Program), under generally the same terms and conditions available under the Paycheck Protection Program (PPP) established under section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)).

Under section 311, SBA may guarantee loans under the PPP Second Draw Program through March 31, 2021 (“Second Draw PPP Loans”) to borrowers that previously received a PPP loan under section 7(a)(36) of the Small Business Act (“First Draw PPP Loans”) and have used or will use the full amount of the initial PPP loan for authorized purposes on or before the expected date of disbursement of the Second Draw PPP Loan. Like First Draw PPP Loans, Second Draw PPP Loans are intended to provide expeditious relief to America's small Start Printed Page 3713businesses. Second Draw PPP Loans generally are guaranteed by SBA under the same terms, conditions, and processes as First Draw PPP Loans. SBA guarantees 100 percent of Second Draw PPP Loans and SBA may forgive up to the full principal loan amount.

Second Draw PPP Loans are subject to SBA's and the Department of the Treasury's (Treasury's) consolidated interim final rules implementing updates to the Paycheck Protection Program for First Draw PPP Loans (“Consolidated First Draw PPP IFR”) issued concurrently with this interim final rule (IFR) [] and all PPP loan program requirements, except as specified in this IFR. The key differences between First Draw PPP Loans and Second Draw PPP Loans are described in this IFR, which explains the loan terms, eligibility requirements, and application process for Second Draw PPP Loans. II. Comments and Immediate Effective Date This interim final rule is being issued without advance notice and public comment because section 303 of the Economic Aid Act authorizes SBA to issue regulations to implement the Economic Aid Act without regard to notice requirements.

In addition, this rule is being issued to allow for immediate implementation of this program. The intent of the Economic Aid Act is that SBA provide relief to America's small businesses expeditiously. The last day to apply for and receive a PPP loan is March 31, 2021. Given the short duration of this program, and the urgent need to issue loans quickly, the Administrator in consultation with the Secretary has determined that it is impractical and not in the public interest to provide a 30-day delayed effective date.

An immediate effective date will give small businesses the maximum amount of time to apply for loans and lenders the maximum amount of time to process applications before the program ends. This good cause justification also supports waiver of the 60-day delayed effective date for major rules under the Congressional Review Act at 5 U.S.C. 808(2). Although this IFR is effective immediately, comments are solicited from interested members of the public on all aspects of the interim final rule.

These comments must be submitted on or before February 16, 2021. SBA will consider these comments and the need for making any revisions as a result of these comments. III. Summary of Key Terms of PPP Second Draw Loans The rules applicable to Second Draw PPP Loans are published in section IV of this IFR.

This summary provides additional information and explains the key terms in the IFR. All references to subsections refer to section IV. Second Draw PPP Loans are generally subject to the same terms, conditions and requirements as First Draw PPP Loans. These include, but are not limited to the following terms.

The guarantee percentage is 100 percent. No collateral will be required. No personal guarantees will be required. The interest rate will be 100 basis points or one percent, calculated on a non-compounding, non-adjustable basis.[] The maturity is five years.

All loans will be processed by all lenders under delegated authority and lenders will be permitted to rely on certifications of the borrower to determine the borrower's eligibility and use of loan proceeds. Subsection (b) of this IFR confirms that these terms apply to Second Draw PPP Loans. Subsection (b) also confirms that SBA's Consolidated First Draw PPP IFR, Frequently Asked Questions (FAQs), and other guidance about PPP loans under section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)) apply to Second Draw PPP Loans, except as specified in this IFR.[] The Economic Aid Act includes terms and conditions, including but not limited to terms relating to eligibility and a borrower's maximum loan amount, that apply only to Second Draw PPP Loans and do not apply to First Draw PPP Loans, regardless of when the First Draw PPP Loan is made.

These terms and conditions specific to Second Draw PPP Loans are summarized below. A. Eligibility Requirements 1. General Eligibility Requirements In general, the Economic Aid Act made the eligibility requirements for Second Draw PPP Loans narrower than the eligibility requirements for First Draw PPP Loans.

The Economic Aid Act generally provides that a borrower is eligible for a Second Draw PPP Loan only if it has 300 or fewer employees and experienced a revenue reduction in 2020 relative to 2019 (described further below).[] In addition, the Economic Aid Act provides that a Second Draw PPP Loan may only be made to an eligible borrower that (i) has received a First Draw PPP Loan, and (ii) has used, or will use, the full amount of the First Draw PPP Loan on or before the expected date on which the Second Draw PPP Loan is disbursed to the borrower.[] Accordingly, subsections (c)(1)(i) through (c)(1)(iv) of this IFR implement these criteria. Subsection (c)(1)(ii) of the IFR clarifies that “the full amount” of the borrower's First Draw PPP Loan includes the amount of any increase on such First Draw PPP Loan made pursuant to the Economic Aid Act. In addition, subsection (c)(1)(ii) of the IFR clarifies that the borrower must have spent the full amount of its First Draw PPP Loan on eligible expenses under the PPP rules to be eligible for a Second Draw PPP Loan. This clarification will help ensure program integrity by preventing a borrower from receiving a Second Draw PPP Loan if the borrower has not complied with PPP loan program requirements.[] 2.

Revenue Reduction Requirement The Economic Aid Act provides that, to be eligible for a Second Draw PPP Loan, the borrower must have experienced a revenue reduction of 25% or greater in 2020 relative to 2019.[] A borrower must calculate this revenue reduction by comparing the borrower's quarterly gross receipts for one quarter in 2020 with the borrower's gross receipts for the corresponding quarter of 2019. For example, a borrower with gross receipts of $50,000 in the second quarter of 2019 and gross receipts of $30,000 in the second quarter of 2020 has experienced a revenue reduction of 40 percent between the quarters, and is therefore eligible for a Second Draw PPP loan (assuming all other eligibility criteria are met). Subsection (c)(1)(iv)(A) of the IFR reflects this methodology. Subsection (c)(1)(iv)(B) of the IFR provides that a borrower that was in operation in all four quarters of 2019 is deemed to have experienced the required revenue reduction if it Start Printed Page 3714experienced a reduction in annual receipts of 25 percent or greater in 2020 compared to 2019 and the borrower submits copies of its annual tax forms substantiating the revenue decline.

This provision will allow a borrower to provide annual tax return forms to substantiate its revenue reduction. The Administrator, in consultation with the Secretary of the Treasury (Secretary), has determined that this is necessary to improve administrability of Second Draw PPP Loans by providing borrowers an additional verifiable method for substantiating their revenue reduction. This method will be particularly important for small borrowers that may not have quarterly revenue information readily available. Moreover, this approach is appropriate because, if annual filings show a 25 percent revenue reduction, then at least one quarter in 2020 would have had at least a 25 percent revenue reduction.

A borrower that did not experience a 25 percent annual decline in revenues, or that was not in operation in all four quarters of 2019, may still meet the revenue reduction requirement under one of the quarterly measurements described above. The Economic Aid Act does not include a general definition of gross receipts for purposes of determining a borrower's revenue reduction.[] Subsection (c)(2) of the IFR defines gross receipts consistent with the definition of receipts in 13 CFR 121.104 of SBA's size regulations because this definition appropriately captures the type of income that is typically included in a small business's gross receipts.[] Moreover, this definition will enhance the administrability of Second Draw PPP Loans because it is a definition already used by the Administration and many small businesses. The IFR specifies that any forgiveness amount of a First Draw PPP Loan that a borrower received in calendar year 2020 is excluded from a borrower's gross receipts. Excluding the forgiveness amount from a borrower's gross receipts is consistent with section 7A(i) of the Small Business Act, which expressly excludes PPP forgiveness amounts from being taxed as income.[] This clarification ensures the effectiveness of the second draw loan program by ensuring that a borrower is not disqualified from receiving a Second Draw PPP Loan because it received forgiveness on a First Draw PPP Loan.

This furthers the purpose of the second draw loan provisions, which is to deliver additional aid to small businesses that previously received a First Draw PPP Loan. 3. Business Concerns With More Than One Physical Location Under the CARES Act, any single business entity that is assigned a NAICS code beginning with 72 (including hotels and restaurants) and employs not more than 500 employees per physical location is eligible to receive a First Draw PPP Loan.[] In addition, as discussed below, under the Consolidated First Draw PPP IFR, SBA's affiliation rules (13 CFR 121.301) do not apply to any business entity that is assigned a NAICS code beginning with 72 and that employs not more than a total of 500 employees.[] As a result, if each hotel or restaurant location owned by a parent business is a separate legal business entity and employs not more than 500 employees, each hotel or restaurant location is permitted to apply for a separate PPP loan provided it uses its unique EIN. Section 317 of the Economic Aid Act modified this provision for Second Draw PPP Loans by reducing the limit on employees per physical location to 300.

Accordingly, a single business entity that is assigned a NAICS code beginning with 72 is eligible to receive a Second Draw PPP Loan if it employs no more than 300 employees per physical location and meets the revenue reduction requirements and otherwise satisfies the eligibility criteria described in this IFR.[] Under section 317 of the Economic Aid Act, the same standard applies to certain news organizations.[] Subsections (c)(3) and (c)(4) of the IFR implement these statutory provisions. Borrowers may consult PPP Frequently Asked Question (FAQ) 24 [] for guidance on these standards for business concerns with more than one physical location, except that, for Second Draw PPP Loans, the number of employees per physical location is limited to 300 rather than 500. B. Affiliation Rules The same affiliation rules that apply to First Draw PPP Loans apply to Second Draw PPP Loans, except as provided in this IFR.

As with First Draw PPP Loans, in most cases, a borrower is considered together with its affiliates to determine eligibility for the PPP.[] However, the CARES Act waived the affiliation rules for certain categories of borrowers.[] Paragraph 7(a)(37)(E) of the Small Business Act, as amended by the Economic Aid Act, applies the same Start Printed Page 3715waivers to Second Draw PPP Loans, adds a waiver for certain eligible news organizations, and makes adjustments to reflect the reduced size requirement for Second Draw PPP Loans. Specifically, business concerns with a NAICS code beginning with 72 qualify for the affiliation waiver for Second Draw PPP Loans if they employ 300 or fewer employees. Eligible news organizations with a NAICS code beginning with 511110 or 5151 (or majority-owned or controlled by a business concern with those NAICS codes) may qualify for the affiliation waiver for Second Draw PPP Loans only if they employ 300 or fewer employees per physical location.[] Subsection (d)(2) implements these revised affiliation waivers. SBA also adopted a religious exemption to the affiliation rules by regulation,[] which applies to Second Draw PPP loans.

C. Excluded Entities An entity that is ineligible to receive a First Draw PPP Loan under the CARES Act or Consolidated First Draw PPP IFR is also ineligible for a Second Draw PPP Loan.[] Subsection (e)(1) of the IFR implements this restriction. Subsection (e)(1) ensures that a borrower that received a First Draw PPP Loan despite being ineligible to receive the loan is not eligible to receive a Second Draw PPP Loan. The Economic Aid Act also prohibits several additional categories of borrowers from receiving a Second Draw PPP Loan under section 7(a)(37) of the Small Business Act.

These categories of prohibited borrowers are listed in subsection (e) of the IFR. A business concern or entity primarily engaged in political activities or lobbying activities, including any entity that is organized for research or for engaging in advocacy in areas such as public policy or political strategy or that describes itself as a think tank in any public documents; [] certain entities organized under the laws of the People's Republic of China or the Special Administrative Region of Hong Kong, or with other specified ties to the People's Republic of China or the Special Administrative Region of Hong Kong; [] any person required to submit a registration statement under section 2 of the Foreign Agents Registration Act of 1938 (22 U.S.C. 612); [] a person or entity that receives a grant for shuttered venue operators under section 324 of the Economic Aid Act; [] entities in which the President, the Vice President, the head of an Executive department, or a Member of Congress, or the spouse of such person owns, controls, or holds at least 20 percent of any class of equity; [] or a publicly traded company, defined as an issuer, the securities of which are listed on an exchange registered as a national securities exchange under section 6 of the Securities Exchange Act of 1934 (15 U.S.C. 78f).[] In addition, subsection (e)(9) of this IFR provides that an entity that has previously received a Second Draw PPP Loan may not receive another Second Draw PPP Loan, as required by the Economic Aid Act.[] Subsection (e)(9) also prohibits an entity that has permanently closed from receiving a Second Draw PPP Loan because paragraph 7(a)(37)(A)(iv) of the Small Business Act is best understood to describe existing businesses.

The Administrator, in consultation with the Secretary, has determined this provision is also necessary to maintain program integrity, prevent abuse, and preserve the availability of Second Draw PPP Loan funds for businesses still in operation. Preserving funds for such businesses is necessary because only businesses that are still in operation will retain employees, which is a primary purpose of the PPP. A borrower that has temporarily closed or temporarily suspended its business remains eligible for a Second Draw PPP Loan. D.

Payroll Cost Calculation In general, section 307 of the Economic Aid Act provides that the maximum loan amount for a Second Draw PPP Loan is equal to the lesser of two and half months of the borrower's average monthly payroll costs or $2 million. Relative to First Draw PPP loans, the Economic Aid Act adjusted the methodology for calculating a borrower's payroll costs. Unlike First Draw PPP Loans, the Economic Aid Act provides that the relevant time period for calculating a borrower's payroll costs for a Second Draw PPP Loan is either the twelve-month period prior to when the loan is made or calendar year 2019. The Act also provided tailored methodologies for certain categories of borrowers.

These calculations are reflected in subsection (f) of this IFR. Subsection (f) of the IFR uses “calendar year 2020” to refer to “the twelve-month period prior to when the loan is made.” Calculating payroll costs based on calendar year 2020 rather than the twelve months preceding the date the loan is made will simplify the calculations and documentation requirements for borrowers because payroll records are more commonly created and retained on a calendar-year basis. Allowing borrowers to calculate payroll costs based on calendar year 2020 is also not expected to result in a significant difference in payroll costs compared to the twelve months preceding the date the loan is made because all Second Draw PPP Loans will be made in the first quarter of 2021. However, the rule notes that Second Draw PPP Loan borrowers who are not self-employed (including sole proprietorships and independent contractors) are also permitted to use the precise 1-year period before the date on which the loan is made to calculate payroll costs if they choose not to use 2019 or 2020 to calculate payroll costs.

Consistent with the Economic Aid Act, subsections (f)(3) and (f)(4) of the IFR include tailored calculation methodologies for seasonal businesses, new entities that did not exist for the full twelve-month period preceding the Second Draw PPP Loan, and borrowers assigned a NAICS code beginning with 72 at the time of disbursement. For borrowers assigned a NAICS code beginning with 72 at the time of disbursement, the Economic Aid Act provides that the maximum loan amount is equal to three-and-a-half (3.5) months of payroll costs rather than two-and-a-half (2.5) months.[] These subsections also provide that, for a borrower with a NAICS code beginning with 72 that would fall into more than one category listed in subsection (f) (for example, a business with a NAICS code beginning with 72 that is also a seasonal business or is also a new entity without 12 months of payroll costs), the borrower may calculate its average monthly payroll costs based on the methodology that applies to the entity but may use the 3.5 multiplier Start Printed Page 3716applicable to businesses with a NAICS code beginning with 72. The Administrator, in consultation with the Secretary, has determined that this methodology is necessary to provide small businesses in the accommodation and food services sector the full amount of relief provided in the Economic Aid Act while allowing these borrowers to calculate their average monthly payroll costs accurately. The Economic Aid Act included a new payroll cost calculation for farmers and ranchers receiving First Draw PPP Loans.

However, it did not specify how payroll costs should be calculated for Second Draw PPP Loans to farmers and ranchers. This IFR clarifies that the same general calculation for farmers and ranchers applicable to First Draw PPP Loans applies to Second Draw PPP Loans, with adjustments that (i) eliminate the provision for refinancing of an Economic Injury Disaster Loan (EIDL), which does not apply to Second Draw PPP Loans, and (ii) apply the choice of time period for calculating a farmer's or rancher's payroll costs for Second Draw PPP Loans, consistent with other Second Draw PPP Loans. This IFR also specifies that, in calculating a farmer's or rancher's maximum loan amount, any employee payroll costs should be subtracted from the farmer's or rancher's gross income to avoid double-counting amounts that represent pay to the employees of the farmer or rancher. Subsections (f)(7) and (f)(8) of the IFR include tailored calculation methodologies for self-employed individuals and partnerships.

These methodologies are based on the corresponding methodologies for self-employed individuals and partnerships that are used for First Draw PPP Loans.[] These methodologies have been adjusted to eliminate the provision for refinancing of an EIDL loan, which does not apply to Second Draw PPP loans and to apply the choice of time period for calculating payroll costs, consistent with other Second Draw PPP loans. Finally, subsection (f)(9) provides that businesses that are part of a single corporate group shall in no event receive more than $4,000,000 of Second Draw PPP Loans in the aggregate. The Administrator, in consultation with the Secretary, determined that limiting the amount of Second Draw PPP Loans that a single corporate group may receive will promote the availability of PPP loans to the largest possible number of borrowers, consistent with the CARES and Economic Aid Act. The Administrator has concluded that a limitation of $4,000,000 is appropriate because it is proportional to the $20,000,000 maximum amount for corporate groups that is provided under the Consolidated First Draw PPP IFR when the maximum loan amount for a single PPP loan is $10,000,000.

E. Second Draw PPP Loan Application and Documentation Requirements Subsection (g) of this IFR includes the application and documentation requirements for Second Draw PPP Loans. The documentation required to substantiate an applicant's payroll cost calculations is generally the same as documentation required for First Draw PPP Loans. However, no additional documentation to substantiate payroll costs will be required if the applicant (i) used calendar year 2019 figures to determine its First Draw PPP Loan amount, (ii) used calendar year 2019 figures to determine its Second Draw PPP Loan amount (instead of calendar year 2020), and (iii) the lender for the applicant's Second Draw PPP Loan is the same as the lender that made the applicant's First Draw PPP Loan.

In such cases, additional documentation is not required because the lender already has the relevant documentation supporting the borrower's payroll costs. The lender may request additional documentation, however, if on further review the lender concludes that it would be useful in conducting the lender's good-faith review of the borrower's loan amount calculation. For loans with a principal amount greater than $150,000, the applicant must also submit documentation adequate to establish that the applicant experienced a revenue reduction of 25% or greater in 2020 relative to 2019. (The revenue reduction requirement is addressed in subsection (c)(1)(iv) of this IFR.) Such documentation may include relevant tax forms, including annual tax forms, or, if relevant tax forms are not available, quarterly financial statements or bank statements.

For loans with a principal amount of $150,000 or less, such documentation is not required at the time the borrower submits its application for a loan, but must be submitted on or before the date the borrower applies for loan forgiveness, as required under the Economic Aid Act.[] If a borrower does not submit an application for loan forgiveness, such documentation must be provided upon SBA's request. F. Lender Requirements Subsection (g) of this IFR contains the provisions specific to lenders for Second Draw PPP Loans. Paragraph 7(a)(37)(K) of the Small Business Act, added by the Economic Aid Act, states that a lender approved to make First Draw PPP loans may make Second Draw PPP Loans under the same terms and conditions as new First Draw PPP Loans.

Subsection (g)(2) of this IFR provides that lenders are subject to the same requirements when making Second Draw PPP Loans as when they are making First Draw PPP Loans. These provisions allow a lender approved to make Second Draw PPP Loans to use existing program guidance and standard operating procedures to the maximum extent practicable.[] The requirements applicable to PPP lenders are in sections (C) and (D) of the Consolidated First Draw PPP IFR. If a borrower has not submitted new payroll documentation with its Second Draw PPP Loan application because it previously submitted 2019 payroll information to the same lender when it applied for its First Draw PPP Loan, then the lender must confirm the borrower's average monthly payroll costs based on that prior documentation. In addition, for a Second Draw PPP Loan greater than $150,000, the lender must confirm the dollar amount and percentage of the borrower's revenue reduction by performing a good faith review, in a reasonable time, of the borrower's calculations and supporting documents concerning the borrower's revenue reduction.

If the lender identifies errors in the borrower's calculation or a material lack of substantiation in the borrower's supporting documents, the lender should work with the borrower to remedy the issue. G. Loans to Borrowers With Unresolved First Draw PPP Loans As described in SBA's interim final rule on SBA Loan Review Procedures and Related Borrower and Lender Responsibilities, SBA may review any PPP loan, as the Administrator deems appropriate.[] Subsection (i) of the IFR establishes procedures relating to the handling of a Second Draw PPP Loan application by a borrower whose First Draw PPP Loan is under review by SBA (“unresolved borrower”). If a borrower's First Draw PPP loan is under review by SBA and/or information in SBA's possession indicates that the borrower may have been ineligible for the First Start Printed Page 3717Draw PPP Loan it received or for the loan amount it received, the lender will receive notification from SBA when the lender submits an application for a guaranty of a Second Draw PPP Loan and will not receive an SBA loan number until the issue related to the unresolved borrower's First Draw PPP Loan is resolved.

SBA will resolve issues related to unresolved borrowers expeditiously. These procedures are designed to promote compliance with the eligibility requirements for Second Draw PPP Loans by preventing additional loans from being made to borrowers that were not eligible for a First Draw PPP Loan or received an impermissible loan amount. At the same time, these procedures do not disqualify an eligible unresolved borrower from receiving a Second Draw PPP Loan, in recognition that many flags will be resolved in the borrower's favor. The Administrator, in consultation with the Secretary, has determined that these procedures strike an appropriate balance between promoting program integrity and preventing abuse, while making Second Draw PPP Loans available to all eligible borrowers as expeditiously as possible.

SBA will set aside available appropriations to fund Second Draw PPP Loans applied for by unresolved borrowers in the event they are approved. H. Loan Forgiveness Loan forgiveness of Second Draw PPP Loans and the loan review process for Second Draw PPP Loans are generally subject to the interim final rules regarding Loan Forgiveness and SBA Loan Review Procedures and Related Borrower and Lender Responsibilities, as modified to conform to the Economic Aid Act by the Consolidated First Draw PPP IFR, which is being published concurrently with this IFR. Subsection (j) contains forgiveness provisions specific to Second Draw PPP loans.

Table of Contents (a) Second Draw PPP Loan Program (b) What requirements apply to Second Draw PPP Loans?. (c) Who is eligible for a Second Draw PPP Loan?. (d) How do SBA's affiliation rules affect an applicant's eligibility for a Second Draw PPP Loan?. (e) Who is not eligible for a Second Draw PPP Loan?.

(f) What is the maximum loan amount for a Second Draw PPP Loan?. (g) How do I submit an application for a Second Draw PPP Loan and what documentation must I provide to demonstrate eligibility?. (h) What do lenders need to know and do?. (i) Will an applicant's Second Draw PPP Loan application be affected if there are unresolved issues regarding the applicant's First Draw PPP Loan?.

(j) Are Second Draw PPP Loans eligible for loan forgiveness?. IV. Paycheck Protection Program Second Draw Loans (a) Second Draw PPP Loan Program Under section 7(a)(37) of the Small Business Act (15 U.S.C. 636(a)(37)), SBA is authorized to guarantee Paycheck Protection Program Second Draw Loans (“Second Draw PPP Loans”).

(b) What requirements apply to Second Draw PPP Loans?. (1) Second Draw PPP Loans are subject to SBA's and the Department of the Treasury's (“Treasury's”) consolidated interim final rule implementing the Paycheck Protection Program (“Consolidated First Draw PPP IFR”) and all PPP loan program requirements, except as otherwise provided in this section, including but not limited to the following terms. (i) The guarantee percentage is 100 percent. (ii) No collateral will be required.

(iii) No personal guarantees will be required. (iv) The interest rate will be 100 basis points or one percent, calculated on a non-compounding, non-adjustable basis. (v) The maturity is five years. (vi) All loans will be processed by all lenders under delegated authority and lenders will be permitted to rely on certifications of the borrower in order to determine eligibility of the borrower and the use of loan proceeds.

(2) Frequently Asked Questions and other guidance issued by SBA or by SBA in consultation with the Department of the Treasury with respect to PPP loans under section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)) (“First Draw PPP Loans”) apply to Second Draw PPP Loans, except as otherwise provided in this section. (c) Who is eligible for a Second Draw PPP Loan?. Subject to subsection (e) of this section, below, the following applicants are eligible for Second Draw PPP Loans.

(1) An applicant is eligible for a Second Draw PPP Loan if it is a business concern, independent contractor, eligible self-employed individual, sole proprietor, nonprofit organization eligible for a First Draw PPP Loan, veterans organization, Tribal business concern, housing cooperative, small agricultural cooperative, eligible 501(c)(6) organization or destination marketing organization, or an eligible nonprofit news organization [] that. (i) Previously received a First Draw PPP loan in accordance with the eligibility criteria in the Consolidated First Draw PPP IFR. (ii) has used, or will use, the full amount of its First Draw PPP Loan (including the amount of any increase on such First Draw PPP Loan) on authorized uses under subsection (B)(11) of the Consolidated First Draw PPP IFR on or before the expected date on which the Second Draw PPP Loan will be disbursed; [] (iii) employs not more than 300 employees, unless it satisfies the alternative criteria for businesses with a North American Industry Classification System (“NAICS”) code beginning with 72 and eligible news organizations with more than one physical location described in subsection (c)(3) or (c)(4) of this section. And (iv) (A) experienced a reduction in revenue in calendar year 2020, measured as follows.

(1) the applicant had gross receipts during the first, second, third, or fourth quarter in 2020 that demonstrate at least a 25 percent reduction from the applicant's gross receipts during the same quarter in 2019 (for example, an applicant that had gross receipts of $50,000 in the second quarter of 2019 and had gross receipts of $30,000 in the second quarter of 2020 experienced a 40 percent revenue reduction between these two quarters). (2) if the applicant was not in business during the first or second quarter of 2019, but was in business during the third and fourth quarters of 2019, the applicant had gross receipts during the first, second, third, or fourth quarter of 2020 that demonstrate at least a 25 percent reduction from the applicant's gross receipts during the third or fourth quarter of 2019 (for example, an applicant that had gross receipts of $50,000 in the third quarter of 2019 and had gross receipts of $30,000 in the third quarter of 2020-demonstrating a reduction of 40 percent from the applicant's gross receipts during the third quarter in 2019). (3) if the applicant was not in business during the first, second, or third quarter of 2019, but was in business during the fourth quarter of 2019, the applicant had gross receipts Start Printed Page 3718during the first, second, third, or fourth quarter of 2020 that demonstrate at least a 25 percent reduction from the fourth quarter of 2019 (for example, an applicant that had gross receipts of $50,000 in the fourth quarter of 2019 and had gross receipts of $30,000 in the fourth quarter of 2020-demonstrating a reduction of 40 percent from the applicant's gross receipts during the fourth quarter in 2019). Or (4) if the applicant was not in business during 2019, but was in operation on February 15, 2020, the applicant had gross receipts during the second, third, or fourth quarter of 2020 that demonstrate at least a 25 percent reduction from the gross receipts of the entity during the first quarter of 2020 (for example, an applicant that had gross receipts of $50,000 in the first quarter of 2020 and had gross receipts of $30,000 in the fourth quarter of 2020—demonstrating a reduction of 40 percent from the applicant's gross receipts during the first quarter in 2020).

(B) An applicant that was in operation in all four quarters of 2019 is deemed to have experienced the revenue reduction in subsection (c)(1)(iv)(A)(1) if it experienced a reduction in annual receipts of 25 percent or greater in 2020 compared to 2019 and the borrower submits copies of its annual tax forms substantiating the revenue decline. (2)(i) Gross receipts includes all revenue in whatever form received or accrued (in accordance with the entity's accounting method) from whatever source, including from the sales of products or services, interest, dividends, rents, royalties, fees, or commissions, reduced by returns and allowances. Generally, receipts are considered “total income” (or in the case of a sole proprietorship, independent contractor, or self-employed individual “gross income”) plus “cost of goods sold,” and excludes net capital gains or losses as these terms are defined and reported on IRS tax return forms. Gross receipts do not include the following.

Taxes collected for and remitted to a taxing authority if included in gross or total income (such as sales or other taxes collected from customers and excluding taxes levied on the concern or its employees). Proceeds from transactions between a concern and its domestic or foreign affiliates. And amounts collected for another by a travel agent, real estate agent, advertising agent, conference management service provider, freight forwarder or customs broker. All other items, such as subcontractor costs, reimbursements for purchases a contractor makes at a customer's request, investment income, and employee-based costs such as payroll taxes, may not be excluded from gross receipts.

(ii) Gross receipts of affiliates are calculated as follows. (A) Gross receipts of a borrower with affiliates is calculated by adding the gross receipts of the business concern with the gross receipts of each affiliate. (B) If a borrower has acquired an affiliate or been acquired as an affiliate during 2020, gross receipts includes the receipts of the acquired or acquiring concern. This aggregation applies for the entire period of measurement, not just the period after the affiliation arose.

However, if a concern acquired a segregable division of another business concern during 2020, gross receipts do not include the receipts of the acquired division prior to the acquisition. (C) The gross receipts of a former affiliate are not included. This exclusion of gross receipts of such former affiliate applies during the entire period of measurement, rather than only for the period after which affiliation ceased. However, if a borrower sold a segregable division during 2020, the gross receipts will continue to include the receipts of the division that was sold.

(D) All terms in this subsection shall have the meaning attributed to them by the IRS. (iii) For an eligible nonprofit organization, a veterans organization, an eligible nonprofit news organization, an eligible 501(c)(6) organization, or eligible destination marketing organization, gross receipts means gross receipts within the meaning of section 6033 of the Internal Revenue Code of 1986. (iv) The amount of any forgiven First Draw PPP Loan shall not be included toward any borrower's gross receipts. (3) Any business concern that has more than one physical location and that employs not more than 300 employees per physical location is eligible to receive a Second Draw PPP Loan if it is assigned a NAICS code beginning with 72 at the time of loan disbursement and otherwise meets the eligibility criteria in subsection (c)(1).

(4) Any business concern, or any station which broadcasts pursuant to a license granted by the Federal Communications Commission under title III of the Communications Act of 1934 (47 U.S.C. 301 et seq.), that has more http://www.soilplus.ro/member/mark-rupert-3/ than one physical location and that employs not more than 300 employees per physical location is eligible to receive a Second Draw PPP Loan if it meets the eligibility criteria in subsection (c)(1) and. (1) Is majority owned or controlled by a business concern that is assigned a NAICS code beginning with 511110 or 5151 or, with respect to a public broadcasting entity (as defined in section 397(11) of the Communications Act of 1934 (47 U.S.C. 397(11))), has a trade or business that falls under such a code.

And (2) makes a good faith certification that proceeds of the loan will be used to support expenses at the component of the organization that produces or distributes locally focused or emergency information. (d) How do SBA's affiliation rules affect an applicant's eligibility for a Second Draw PPP Loan?. (1) Eligibility for Second Draw PPP Loans is governed by the same affiliations rules (and waivers) as First Draw PPP Loans, except as described in subsection (d)(2). (2) The affiliation rules under 13 CFR 121.301(f) are waived with respect to eligibility for a Second Draw PPP Loan for.

(i) Any business concern with not more than 300 employees that, as of the date on which the covered loan is disbursed, is assigned a NAICS code beginning with 72. And (ii) (A) any business concern (including any station which broadcasts pursuant to a license granted by the Federal Communications Commission under title III of the Communications Act of 1934 (47 U.S.C. 301 et seq.) without regard for whether such a station is a concern as defined in 13 CFR 121.105, or any successor thereto) that employs not more than 300 employees, per physical location of such business concern and is majority owned or controlled by a business concern that is assigned a NAICS code beginning with 511110 or 5151. Or (B) any nonprofit organization that is assigned a NAICS code beginning with 5151.

(e) Who is not eligible for a Second Draw PPP Loan?. An applicant is not eligible for a Second Draw PPP Loan, even if it meets the eligibility requirements of subsection (c) of this section, if the applicant is. (1) Excluded from eligibility under the Consolidated First Draw PPP IFR; [] (2) a business concern or entity primarily engaged in political activities or lobbying activities, as defined in section 3 of the Lobbying Disclosure Act of 1995 (2 U.S.C. 1602), including any entity that is organized for research or for engaging in advocacy in areas such as public policy or political strategy or Start Printed Page 3719otherwise describes itself as a think tank in any public documents.

(3) any business concern or entity. (i) For which an entity created in or organized under the laws of the People's Republic of China or the Special Administrative Region of Hong Kong, or that has significant operations in the People's Republic of China or the Special Administrative Region of Hong Kong, owns or holds, directly or indirectly, not less than 20 percent of the economic interest of the business concern or entity, including as equity shares or a capital or profit interest in a limited liability company or partnership. Or (ii) that retains, as a member of the board of directors of the business concern, a person who is a resident of the People's Republic of China. (4) any person required to submit a registration statement under section 2 of the Foreign Agents Registration Act of 1938 (22 U.S.C.

612). (5) any person or entity that receives a grant for shuttered venue operators under section 324 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act. (6) any entity in which the President, the Vice President, the head of an Executive department, or a Member of Congress, or the spouse of such person as determined under applicable common law, directly or indirectly holds a controlling interest in the entity, where. (i) “controlling interest” means owning, controlling, or holding not less than 20 percent, by vote or value, of the outstanding amount of any class of equity interest in an entity.

(ii) “equity interest” means. (A) A share in an entity, without regard to whether the share is transferable or classified as stock or anything similar. (B) a capital or profit interest in a limited liability company or partnership. Or (C) a warrant or right, other than a right to convert, to purchase, sell, or subscribe to a share or interest described in (A) or (B), respectively.

(iii) “Executive department” has the meaning given the term in section 101 of title 5, United States Code. (iv) “Member of Congress” means a Member of the Senate or House of Representatives, a Delegate to the House of Representatives, and the Resident Commissioner from Puerto Rico. And (v) For the purpose of determining whether a person has a controlling interest in the entity, the securities owned, controlled, or held by the President, the Vice President, the head of an Executive department, or a Member of Congress, shall be aggregated with the securities held by his or her spouse as determined under applicable common law. (7) any issuer, the securities of which are listed on an exchange registered as a national securities exchange under section 6 of the Securities Exchange Act of 1934 (15 U.S.C.

78f), where the terms “exchange,” “issuer,” and “security” have the meanings given those terms in section 3(a) of the Securities Exchange Act of 1934 (15 U.S.C. 78c(a)) (except SBA will not consider whether a news organization that is eligible under subsection (c)(4) is affiliated with an entity, which includes any entity that owns or controls such news organization, that is an issuer). (8) an entity that has previously received a Second Draw PPP Loan. Or (9) an entity that has permanently closed.

(f) What is the maximum loan amount for a Second Draw PPP Loan?. (1) In general, the maximum loan amount for a Second Draw PPP Loan is equal to the lesser of two and half months of the borrower's average monthly payroll costs or $2 million, except as otherwise specified in this subsection (e). A borrower's average monthly payroll costs may be based on calendar year 2020, calendar year 2019,[] or as otherwise specified in subsections (f)(2) through (f)(9) of this section. €œPayroll costs” has the same meaning as in subsections (B)(4)(g) and (B)(4)(h) of the Consolidated First Draw PPP IFR and is calculated in the same manner.

In calculating a borrower's payroll costs, the borrower must subtract any compensation paid to an employee in excess of $100,000 on an annualized basis, as prorated for the time period during which the payments are made or the obligation to make the payments is incurred. (2) Except as otherwise provided in subsection (f)(3) through (f)(7), the maximum amount of a Second Draw PPP Loan is calculated as the lesser of. (i) The product obtained by multiplying. (A) The average total monthly payment for payroll costs incurred or paid by the borrower during 2019 or 2020 (at the election of the borrower).

By (B) 2.5. Or (ii) $2,000,000. (3) The maximum amount of a Second Draw PPP Loan to a borrower that is a seasonal employer (meaning an employer that does not operate for more than 7 months in any calendar year or that during the preceding calendar year, had gross receipts for any 6 months of that year that were not more than 33.33 percent of the gross receipts of the employer for the other 6 months of that year) is calculated as the lesser of. (i) The product obtained by multiplying.

(A) At the election of the borrower, the average total monthly payments for payroll costs incurred or paid by the borrower for any 12-week period between February 15, 2019 and February 15, 2020. By (B) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10), 3.5). Or (ii) $2,000,000. (4) The maximum amount of a Second Draw PPP Loan to a borrower that did not exist during the 1-year period preceding February 15, 2020, but was in operation on February 15, 2020 (“new entity”), is calculated as the lesser of.

(i) The product obtained by multiplying. (A) The quotient obtained by dividing. (1) The sum of the total monthly payments by the borrower for payroll costs paid or incurred by the borrower as of the date on which the borrower applies for the Second Draw PPP Loan. By (2) the number of months in which those payroll costs were paid or incurred.

By (B) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10), 3.5). Or (ii) $2,000,000. (5) The maximum amount of a Second Draw PPP Loan made to a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10) (that is not a seasonal employer or new entity addressed in subsection (f)(3) or (f)(4) or a borrower with self-employment income or a partnership addressed in subsection (f)(7) or (f)(8) of this section) is calculated as the lesser of. (i) The product obtained by multiplying.

(A) The average total monthly payment for payroll costs incurred or paid by the borrower during either 2019 or 2020 (at the borrower's election) by (B) 3.5. Or (ii) $2,000,000. (6) (i) The maximum amount of a Second Draw PPP Loan to a farmer or rancher that:Start Printed Page 3720 (A) Operates as a sole proprietorship or as an independent contractor, or is an eligible self-employed individual. (B) reports farm income or expenses on a Schedule F (IRS Form 1040).

And (C) was in business as of February 15, 2020. Is calculated according to (ii) or (iii) of this subsection(e)(6), depending on whether the borrower has employees. (ii) If a borrower meeting the criteria in subsection (6)(i) of this section does not have any employees, the maximum loan amount is the product obtained by multiplying. (A) The gross income of the borrower in 2019 or 2020, as reported on a Schedule F (IRS Form 1040), that is not more than $100,000, divided by 12.

And (B) 2.5. (iii) If a borrower meeting the criteria in subsection (6)(i) of this section has employees, the maximum loan amount is calculated as the lesser of. (A) The product obtained by multiplying. (1) The sum of (i) the difference between gross income and employee payroll costs of the borrower in 2019 or 2020 (at the election of the borrower), as reported on a Schedule F (IRS Form 1040), that is not more than $100,000, divided by 12, and (ii) the average total monthly payment for employee payroll costs incurred or paid by the borrower during the same year elected by the borrower.

By (2) 2.5. Or (B) $2,000,000. (7) The maximum amount of a Second Draw PPP Loan to a borrower that has income from self-employment and files a Form 1040, Schedule C, is calculated as follows, depending on whether the borrower has employees. (i) For a borrower that has income from self-employment and does not have any employees, the maximum loan amount is the lesser of.

(A) The product obtained by multiplying. (1) The net profit of the borrower in 2019 or 2020, as reported on IRS Form 1040 Schedule C, that is not more than $100,000, divided by 12. And (2) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 as defined in subsection (f)(10) at the time of disbursement, 3.5). (ii) For a borrower that has income from self-employment and has employees, the maximum loan amount is the lesser of.

(A) The product obtained by multiplying. (1) The sum of (i) the net profit of the borrower in 2019 or 2020 (at the election of the borrower), as reported on IRS Form 1040 Schedule C, that is not more than $100,000, divided by 12. (ii) the average total monthly payment for employee payroll costs incurred or paid by the borrower during the same year elected by the borrower. By (2) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10), 3.5).

Or (B) $2,000,000. (8) The maximum amount of a Second Draw PPP Loan to a borrower that files taxes as a partnership is calculated as the lesser of. (i) The product obtained by multiplying. (A) The sum of (1) net earnings from self-employment of individual general partners in 2019 or 2020 (at the election of the borrower), as reported on IRS Form 1065 K-1, reduced by section 179 expense deduction claimed, unreimbursed partnership expenses claimed, and depletion claimed on oil and gas properties, multiplied by 0.9235,[] that is not more than $100,000, divided by 12.

(2) the average total monthly payment for employee payroll costs incurred or paid by the borrower during the same year elected by the borrower. By (B) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 as defined in subsection (f)(10) at the time of disbursal, 3.5). Or (ii) $2,000,000. (9) Businesses that are part of a single corporate group shall in no event receive more than $4,000,000 of Second Draw PPP Loans in the aggregate.

Corporate group has the same meaning as in subsection (B)(4)(f) of the Consolidated First Draw PPP IFR. (10) For purposes of calculating a borrower's maximum payroll costs, a borrower may multiply its average monthly payroll costs by 3.5 only if the borrower is in the Accommodation and Food Services sector and has reported a NAICS code beginning with 72 as its business activity code on its most recent IRS income tax return. (g) How do I submit an application for a Second Draw PPP Loan and what documentation must I provide to demonstrate eligibility?. (1) The applicant must submit to the lender SBA Form 2483-SD (Paycheck Protection Program Second Draw Borrower Application Form) or the lender's equivalent form including the required certifications and the documentation in subsection (g)(2).

(2) At the time an applicant submits its loan application form, it must submit the following unless the documentation was submitted to the lender for the First Draw PPP Loan (i.e., the applicant used calendar year 2019 figures to determine both its First Draw PPP Loan amount and its Second Draw PPP Loan amount, and the lender for the applicant's Second Draw PPP Loan is the same as the lender that made the applicant's First Draw PPP Loan). (i) If the applicant is not self-employed, the applicant's Form 941 (or other tax forms containing similar information) and state quarterly wage unemployment insurance tax reporting forms from each quarter in 2019 or 2020 (whichever was used to calculate payroll), as applicable, or equivalent payroll processor records, along with evidence of any retirement and employee group health, life, disability, vision and dental insurance contributions, must be provided. A partnership must also include its IRS Form 1065 K-1s. (ii) If the applicant is self-employed and has employees, the applicant's 2019 or 2020 (whichever was used to calculate loan amount) IRS Form 1040 Schedule C, Form 941 (or other tax forms or equivalent payroll processor records containing similar information) and state quarterly wage unemployment insurance tax reporting forms from each quarter in 2019 or 2020 (whichever was used to calculate loan amount), as applicable, or equivalent payroll processor records, along with evidence of any retirement and employee group health, life, disability, vision and dental insurance contributions, if applicable, must be provided.

A payroll statement or similar documentation from the pay period that covered February 15, 2020 must be provided to establish the applicant was in operation on February 15, 2020. (iii) If the applicant is self-employed and does not have employees, the applicant must provide (a) its 2019 or 2020 (whichever was used to calculate loan amount) Form 1040 Schedule C, (b) a 2019 or 2020 (whichever was used to calculate loan amount) IRS Form 1099-MISC detailing nonemployee compensation received (box 7), invoice, bank statement, or book of record that establishes that the applicant is self-employed. And (c) a 2020 invoice, bank statement, or book of record to establish that the applicant was in operation on or around February 15, 2020. (iv) For loans with a principal amount greater than $150,000, documentation sufficient to establish that the applicant experienced a reduction in revenue, as provided in subsection(c)(1)(iv), must be Start Printed Page 3721provided at the time of application, which may include relevant tax forms, including annual tax forms, or, if relevant tax forms are not available, a copy of the applicant's quarterly income statements or bank statements.

(v) For loans with a principal amount of $150,000 or less, the applicant must submit documentation sufficient to establish that the applicant experienced a reduction in revenue as provided in subsection (c)(1)(i) of this section at the time of application, on or before the date the borrower submits an application for loan forgiveness, or, if the borrower does not apply for loan forgiveness, at SBA's request. Such documentation may include relevant tax forms, including annual tax forms, or, if relevant tax forms are not available, a copy of the applicant's quarterly income statements or bank statements. (3) On the Second Draw PPP Loan borrower application, an authorized representative of the applicant [] must make the certifications listed in subsection (B)(12) of the Consolidated First Draw PPP IFR, except. (i) Instead of the certification in subsection (B)(12)(v) of the Consolidated First Draw PPP IFR, the applicant must certify that the applicant has not and will not receive another Second Draw Paycheck Protection Program Loan.

And (ii) an authorized representative of the applicant must also certify. (A) The Applicant has realized a reduction in gross receipts in excess of 25% relative to the relevant comparison time period. For loans greater than $150,000, Applicant has provided documentation to the lender substantiating the decline in gross receipts. For loans of $150,000 or less, Applicant will provide documentation substantiating the decline in gross receipts upon or before seeking loan forgiveness for the Second Draw Paycheck Protection Program Loan or upon SBA request.

(B) The Applicant received a First Draw Paycheck Protection Program Loan and, before the Second Draw Paycheck Protection Program Loan is disbursed, will have used the full loan amount (including any increase) of the First Draw Paycheck Protection Program Loan only for eligible expenses. (C) The Applicant is not a business concern or entity (a) for which an entity created in or organized under the laws of the People's Republic of China or the Special Administrative Region of Hong Kong, or that has significant operations in the People's Republic of China or the Special Administrative Region of Hong Kong, owns or holds, directly or indirectly, not less than 20 percent of the economic interest of the business concern or entity, including as equity shares or a capital or profit interest in a limited liability company or partnership. Or (b) that retains, as a member of the board of directors of the business concern, a person who is a resident of the People's Republic of China. (D) The Applicant is not required to submit a registration statement under section 2 of the Foreign Agents Registration Act of 1938 (22 U.S.C.

612). (E) The Applicant is not a business concern or entity primarily engaged in political or lobbying activities, including any entity that is organized for research or for engaging in advocacy in areas such as public policy or political strategy or otherwise describes itself as a think tank in any public documents. (4) A lender must submit SBA Form 2484-SD (Paycheck Protection Program Lender's Application—Second Draw Loan Guaranty) electronically in accordance with program requirements and maintain the forms and supporting documentation in its files. (h) What do lenders need to know and do?.

(1) A lender approved to make First Draw PPP Loans may make Second Draw PPP Loans under the same terms and conditions applicable to First Draw PPP Loans, including all requirements under sections (C) and (D) of the Consolidated First Draw PPP IFR, except as otherwise provided in this section. (2) What do lenders have to do in terms of loan underwriting?. (i) Each lender shall. (A) Confirm receipt of borrower certifications contained in Paycheck Protection Program Second Draw Borrower Application Form (SBA Form 2483-SD) or lender's equivalent.

(B) Confirm receipt of information demonstrating that a borrower was either an eligible self-employed individual, independent contractor, or sole proprietorship with no employees or had employees for whom the borrower paid salaries and payroll taxes on or around February 15, 2020. (C) Confirm the dollar amount of average monthly payroll costs for 2019 or 2020 (whichever was used to calculate loan amount) by reviewing the payroll documentation submitted with the borrower's application. (D) For a Second Draw PPP Loan greater than $150,000 or a loan of $150,000 or less where the borrower provides documentation of revenue reduction, confirm the dollar amount and percentage of the borrower's revenue reduction by performing a good faith review, in a reasonable time, of the borrower's calculations and supporting documents concerning the borrower's revenue reduction. For a loan of $150,000 or less where the borrower does not provide documentation of revenue reduction with its application, the lender shall perform this review when the borrower provides such documentation.

If the lender identifies errors in the borrower's calculation or material lack of substantiation in the borrower's supporting documents, the lender should work with the borrower to remedy the issue. (E) Follow applicable BSA requirements (listed in subsection (C)(3)(d) of the Consolidated First Draw PPP IFR). And (ii) Each lender's underwriting obligation under the Second Draw PPP is limited to the items above and reviewing the “Paycheck Protection Program Second Draw Borrower Application Form” (SBA Form 2483-SD) or lender's equivalent form. (iii) A lender may rely on any certification or documentation submitted by an applicant for a PPP loan or an eligible recipient or eligible entity that (A) is submitted pursuant to all applicable statutory requirements, regulations, and guidance related to a PPP loan, including under sections 7(a)(36) or (37) of the Small Business Act (15 U.S.C.

636(a)(36) and (37)). And (B) attests that the applicant, eligible recipient, or eligible entity, as applicable, has accurately provided the certification or documentation to the lender in accordance with the statutory requirements, regulations, and guidance related to PPP loans. With respect to a lender that relies on such a certification or documentation related to a Second Draw PPP Loan, an enforcement action may not be taken against the lender, and the lender shall not be subject to any penalties relating to loan origination or forgiveness of the Second Draw PPP Loan, if—(A) the lender acts in good faith relating to loan origination or forgiveness of the Second Draw PPP Loan based on that reliance. And (B) all other relevant Federal, State, local, and other statutory and regulatory requirements applicable to the lender are satisfied with respect to the Second Draw PPP Loan.

(3) SBA will pay lenders fees for processing Second Draw PPP Loans in the following amounts:Start Printed Page 3722 (i) for a Second Draw PPP Loan of up to (and including) $50,000, in an amount equal to the lesser of. (A) 50 percent of the balance of the financing outstanding at the time of disbursement of the loan. Or (B) $2,500. And (ii) for a Second Draw PPP Loan of more than $50,000, in an amount that is.

(A) 5 percent of the balance of the financing outstanding at the time of disbursement of the loan for a loan up to (and including) $350,000. And (B) 3 percent of the balance of the financing outstanding at the time of disbursement of the loan for a loan above $350,000. (i) Will an applicant's Second Draw PPP Loan application be affected if there are unresolved issues regarding the applicant's First Draw PPP Loan?. (1) If a First Draw PPP Loan is under review pursuant to PPP rules and/or information in SBA's possession indicates that the borrower may have been ineligible for the First Draw PPP Loan it received or for the loan amount received by the borrower, the lender will receive notification from SBA when the lender submits an application for guaranty of a Second Draw PPP Loan (“unresolved borrower”).

(2) If the lender receives notification that the Applicant for a Second Draw PPP Loan is an unresolved borrower, the lender will not receive an SBA loan number. SBA will resolve the issue related to the unresolved borrower expeditiously and will notify the lender of the process to obtain an SBA loan number for the Second Draw PPP Loan, if appropriate. (j) Are Second Draw PPP Loans eligible for loan forgiveness?. Second Draw PPP Loans are eligible for loan forgiveness on the same terms and conditions as First Draw PPP Loans, except that Second Draw PPP Loan borrowers with a principal amount of $150,000 or less are required to provide documentation of revenue reduction if such documentation was not provided at the time of the loan application as specified in subsections (g)(2)(iv) and (v) of this section.

V. Additional Information SBA may provide further guidance, if needed, through SBA notices and a program guide which will be posted on SBA's website at www.sba.gov. Questions on the Paycheck Protection Program 7(a) Loans (First Draw PPP Loans and Second Draw PPP Loans) may be directed to the Lender Relations Specialist in the local SBA Field Office. The local SBA Field Office may be found at https://www.sba.gov/​tools/​local-assistance/​districtoffices.

Compliance With Executive Orders 12866, 12988, 13132, 13563, and 13771, the Paperwork Reduction Act (44 U.S.C. Ch. 35), and the Regulatory Flexibility Act (5 U.S.C. 601-612) Executive Orders 12866, 13563, and 13771 This interim final rule is economically significant for the purposes of Executive Orders 12866 and 13563, and the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) had determined that this is a major rule under the Congressional Review Act (5 U.S.C.

804(2)). SBA, however, is proceeding under the emergency provision at Executive Order 12866 section 6(a)(3)(D) based on the need to move expeditiously to mitigate the current economic conditions arising from the erectile dysfunction treatment emergency. This rule's designation under Executive Order 13771 will be informed by public comment. This rule is necessary to implement the Economic Aid Act in order to provide economic relief to small businesses nationwide adversely impacted under the erectile dysfunction treatment Emergency Declaration.

We anticipate that this rule will result in substantial benefits to small businesses, their employees, and the communities they serve. However, we lack data to estimate the effects of this rule. The Administrator of OIRA has determined that this is a major rule for purposes of the Congressional Review Act (5 U.S.C. 801 et seq.) (CRA).

Under section 801(3) of the CRA, a major rule takes effect 60 days after the rule is published in the Federal Register. Notwithstanding this requirement, section 808(2) of the CRA allows agencies to dispense with the requirements of section 801 when the agency for good cause finds that such procedure would be impracticable, unnecessary, or contrary to the public interest and the rule shall take effect at such time as the agency promulgating the rule determines. Pursuant to section 808(2) of the CRA, SBA finds, for good cause, that a 60-day delay in the effective date is unnecessary and contrary to the public interest. As discussed elsewhere in this interim final rule, the last day to apply for and receive a PPP loan is March 31, 2021.

Given the short duration of this program, and the urgent need to issue loans quickly, the Administrator in consultation with the Secretary has determined that it is impractical and not in the public interest to provide a delayed effective date. An immediate effective date will give small businesses the maximum amount of time to apply for loans and lenders the maximum amount of time to process applications before the program ends. Executive Order 12988 SBA has drafted this rule, to the extent practicable, in accordance with the standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, to minimize litigation, eliminate ambiguity, and reduce burden. The rule has no preemptive or retroactive effect.

Executive Order 13132 SBA has determined that this rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various layers of government. Therefore, SBA has determined that this rule has no federalism implications warranting preparation of a federalism assessment. Paperwork Reduction Act, 44 U.S.C. Chapter 35 SBA has determined that this rule will impose new recordkeeping or reporting requirements under the Paperwork Reduction Act (“PRA”).

This information collection (IC) consists of SBA Form 2483-SD (Paycheck Protection Program Second Draw Application Form) and SBA Form 2484-SD (Paycheck Protection Program Lender's Application—Second Draw Loan Guaranty. SBA has requested emergency approval for the IC required to implement the Second Draw PPP Program described above. Regulatory Flexibility Act (RFA) The Regulatory Flexibility Act (RFA) generally requires that when an agency issues a proposed rule, or a final rule pursuant to section 553(b) of the APA or another law, the agency must prepare a regulatory flexibility analysis that meets the requirements of the RFA and publish such analysis in the Federal Register. 5 U.S.C.

603, 604. Specifically, the RFA normally requires agencies to describe the impact of a rulemaking on small entities by providing a regulatory impact analysis. Such analysis must address the consideration of regulatory options that would lessen the economic effect of the rule on small entities. The RFA defines a “small entity” as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA).

(2) a nonprofit organization that is not dominant in its field. Or (3) a small government Start Printed Page 3723jurisdiction with a population of less than 50,000. 5 U.S.C. 601(3)-(6).

Except for small government jurisdictions with a population of less than 50,000, neither State nor local governments are “small entities.” The requirement to conduct a regulatory impact analysis does not apply if the head of the agency “certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” 5 U.S.C. 605(b). The agency must, however, publish the certification in the Federal Register at the time of publication of the rule, “along with a statement providing the factual basis for such certification.” If the agency head has not waived the requirements for a regulatory flexibility analysis in accordance with the RFA's waiver provision, and no other RFA exception applies, the agency must prepare the regulatory flexibility analysis and publish it in the Federal Register at the time of promulgation or, if the rule is promulgated in response to an emergency that makes timely compliance impracticable, within 180 days of publication of the final rule. 5 U.S.C.

604(a), 608(b). Rules that are exempt from notice and comment are also exempt from the RFA requirements, including conducting a regulatory flexibility analysis, when among other things the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. Small Business Administration's Office of Advocacy guide. How to Comply with the Regulatory Flexibility Ac.

Ch.1. P.9. Since this rule is exempt from notice and comment, SBA is not required to conduct a regulatory flexibility analysis. Start Authority 15 U.S.C.

636(a)(36). erectile dysfunction Aid, Relief, and Economic Security Act, Pub. L. 116-136, section 1114.

And Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act, Pub. L. 116-260, section 303. End Authority Start Signature Jovita Carranza, Administrator.

End Signature End Supplemental Information [FR Doc. 2021-00452 Filed 1-12-21. 4:15 pm]BILLING CODE 8026-03-P.

Start Preamble can you buy over the counter viagra U.S. Small Business Administration. Interim final can you buy over the counter viagra rule. This interim final rule announces the implementation of section 311 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the Economic Aid Act).

The Economic Aid Act authorizes the U.S. Small Business Administration to guarantee additional loans under the temporary Paycheck Protection Program, which was originally established under the can you buy over the counter viagra erectile dysfunction Aid, Relief, and Economic Security Act to provide economic relief to small businesses nationwide adversely impacted under the erectile dysfunction Disease 2019 (erectile dysfunction treatment) Emergency Declaration (erectile dysfunction treatment Emergency Declaration) issued by President Trump on March 13, 2020. Section 311 of the Economic Aid Act adds a second temporary program to SBA's 7(a) Loan Program titled, “Paycheck Protection Program Second Draw Loans.” This interim final rule implements the key provisions of section 311 of the Economic Aid Act and requests public comment. Effective Date.

This interim can you buy over the counter viagra final rule is effective January 12, 2021. Applicability Date. This interim final rule applies to loan applications and applications for loan forgiveness submitted for Paycheck Protection Program Second Draw Loans. Comment can you buy over the counter viagra Date.

Comments must be received on or before February 16, 2021. You may submit comments, identified by number SBA-2021-0002 through the Federal eRulemaking Portal. Http://www.regulations.gov. Follow the instructions for submitting comments.

SBA will post all comments on www.regulations.gov. If you wish to submit confidential business information (CBI) as defined in the User Notice at www.regulations.gov, please send an email to ppp-ifr@sba.gov. All other comments must be submitted through the Federal eRulemaking Portal described above. Highlight the information that you consider to be CBI and explain why you believe SBA should hold this information as confidential.

SBA will review the information and make the final determination whether it will publish the information. Start Further Info Call Center Representative at 833-572-0502, or the local SBA Field Office. The list of offices can be found at https://www.sba.gov/​tools/​local-assistance/​districtoffices. End Further Info End Preamble Start Supplemental Information I.

Background Information On December 27, 2020, President Trump signed the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the Economic Aid Act) (Pub. L. 116-260) into law to provide continued assistance to individuals and businesses that have been financially impacted by the ongoing erectile dysfunction viagra. Section 311 of the Economic Aid Act added a new temporary section 7(a)(37) to the Small Business Act (15 U.S.C.

636(a)(37)). This new section authorizes the U.S. Small Business Administration (SBA or the Administration) to guarantee Paycheck Protection Program Second Draw Loans (PPP Second Draw Program), under generally the same terms and conditions available under the Paycheck Protection Program (PPP) established under section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)).

Under section 311, SBA may guarantee loans under the PPP Second Draw Program through March 31, 2021 (“Second Draw PPP Loans”) to borrowers that previously received a PPP loan under section 7(a)(36) of the Small Business Act (“First Draw PPP Loans”) and have used or will use the full amount of the initial PPP loan for authorized purposes on or before the expected date of disbursement of the Second Draw PPP Loan. Like First Draw PPP Loans, Second Draw PPP Loans are intended to provide expeditious relief to America's small Start Printed Page 3713businesses. Second Draw PPP Loans generally are guaranteed by SBA under the same terms, conditions, and processes as First Draw PPP Loans. SBA guarantees 100 percent of Second Draw PPP Loans and SBA may forgive up to the full principal loan amount.

Second Draw PPP Loans are subject to SBA's and the Department of the Treasury's (Treasury's) consolidated interim final rules implementing updates to the Paycheck Protection Program for First Draw PPP Loans (“Consolidated First Draw PPP IFR”) issued concurrently with this interim final rule (IFR) [] and all PPP loan program requirements, except as specified in this IFR. The key differences between First Draw PPP Loans and Second Draw PPP Loans are described in this IFR, which explains the loan terms, eligibility requirements, and application process for Second Draw PPP Loans. II. Comments and Immediate Effective Date This interim final rule is being issued without advance notice and public comment because section 303 of the Economic Aid Act authorizes SBA to issue regulations to implement the Economic Aid Act without regard to notice requirements.

In addition, this rule is being issued to allow for immediate implementation of this program. The intent of the Economic Aid Act is that SBA provide relief to America's small businesses expeditiously. The last day to apply for and receive a PPP loan is March 31, 2021. Given the short duration of this program, and the urgent need to issue loans quickly, the Administrator in consultation with the Secretary has determined that it is impractical and not in the public interest to provide a 30-day delayed effective date.

An immediate effective date will give small businesses the maximum amount of time to apply for loans and lenders the maximum amount of time to process applications before the program ends. This good cause justification also supports waiver of the 60-day delayed effective date for major rules under the Congressional Review Act at 5 U.S.C. 808(2). Although this IFR is effective immediately, comments are solicited from interested members of the public on all aspects of the interim final rule.

These comments must be submitted on or before February 16, 2021. SBA will consider these comments and the need for making any revisions as a result of these comments. III. Summary of Key Terms of PPP Second Draw Loans The rules applicable to Second Draw PPP Loans are published in section IV of this IFR.

This summary provides additional information and explains the key terms in the IFR. All references to subsections refer to section IV. Second Draw PPP Loans are generally subject to the same terms, conditions and requirements as First Draw PPP Loans. These include, but are not limited to the following terms.

The guarantee percentage is 100 percent. No collateral will be required. No personal guarantees will be required. The interest rate will be 100 basis points or one percent, calculated on a non-compounding, non-adjustable basis.[] The maturity is five years.

All loans will be processed by all lenders under delegated authority and lenders will be permitted to rely on certifications of the borrower to determine the borrower's eligibility and use of loan proceeds. Subsection (b) of this IFR confirms that these terms apply to Second Draw PPP Loans. Subsection (b) also confirms that SBA's Consolidated First Draw PPP IFR, Frequently Asked Questions (FAQs), and other guidance about PPP loans under section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)) apply to Second Draw PPP Loans, except as specified in this IFR.[] The Economic Aid Act includes terms and conditions, including but not limited to terms relating to eligibility and a borrower's maximum loan amount, that apply only to Second Draw PPP Loans and do not apply to First Draw PPP Loans, regardless of when the First Draw PPP Loan is made.

These terms and conditions specific to Second Draw PPP Loans are summarized below. A. Eligibility Requirements 1. General Eligibility Requirements In general, the Economic Aid Act made the eligibility requirements for Second Draw PPP Loans narrower than the eligibility requirements for First Draw PPP Loans.

The Economic Aid Act generally provides that a borrower is eligible for a Second Draw PPP Loan only if it has 300 or fewer employees and experienced a revenue reduction in 2020 relative to 2019 (described further below).[] In addition, the Economic Aid Act provides that a Second Draw PPP Loan may only be made to an eligible borrower that (i) has received a First Draw PPP Loan, and (ii) has used, or will use, the full amount of the First Draw PPP Loan on or before the expected date on which the Second Draw PPP Loan is disbursed to the borrower.[] Accordingly, subsections (c)(1)(i) through (c)(1)(iv) of this IFR implement these criteria. Subsection (c)(1)(ii) of the IFR clarifies that “the full amount” of the borrower's First Draw PPP Loan includes the amount of any increase on such First Draw PPP Loan made pursuant to the Economic Aid Act. In addition, subsection (c)(1)(ii) of the IFR clarifies that the borrower must have spent the full amount of its First Draw PPP Loan on eligible expenses under the PPP rules to be eligible for a Second Draw PPP Loan. This clarification will help ensure program integrity by preventing a borrower from receiving a Second Draw PPP Loan if the borrower has not complied with PPP loan program requirements.[] 2.

Revenue Reduction Requirement The Economic Aid Act provides that, to be eligible for a Second Draw PPP Loan, the borrower must have experienced a revenue reduction of 25% or greater in 2020 relative to 2019.[] A borrower must calculate this revenue reduction by comparing the borrower's quarterly gross receipts for one quarter in 2020 with the borrower's gross receipts for the corresponding quarter of 2019. For example, a borrower with gross receipts of $50,000 in the second quarter of 2019 and gross receipts of $30,000 in the second quarter of 2020 has experienced a revenue reduction of 40 percent between the quarters, and is therefore eligible for a Second Draw PPP loan (assuming all other eligibility criteria are met). Subsection (c)(1)(iv)(A) of the IFR reflects this methodology. Subsection (c)(1)(iv)(B) of the IFR provides that a borrower that was in operation in all four quarters of 2019 is deemed to have experienced the required revenue reduction if it Start Printed Page 3714experienced a reduction in annual receipts of 25 percent or greater in 2020 compared to 2019 and the borrower submits copies of its annual tax forms substantiating the revenue decline.

This provision will allow a borrower to provide annual tax return forms to substantiate its revenue reduction. The Administrator, in consultation with the Secretary of the Treasury (Secretary), has determined that this is necessary to improve administrability of Second Draw PPP Loans by providing borrowers an additional verifiable method for substantiating their revenue reduction. This method will be particularly important for small borrowers that may not have quarterly revenue information readily available. Moreover, this approach is appropriate because, if annual filings show a 25 percent revenue reduction, then at least one quarter in 2020 would have had at least a 25 percent revenue reduction.

A borrower that did not experience a 25 percent annual decline in revenues, or that was not in operation in all four quarters of 2019, may still meet the revenue reduction requirement under one of the quarterly measurements described above. The Economic Aid Act does not include a general definition of gross receipts for purposes of determining a borrower's revenue reduction.[] Subsection (c)(2) of the IFR defines gross receipts consistent with the definition of receipts in 13 CFR 121.104 of SBA's size regulations because this definition appropriately captures the type of income that is typically included in a small business's gross receipts.[] Moreover, this definition will enhance the administrability of Second Draw PPP Loans because it is a definition already used by the Administration and many small businesses. The IFR specifies that any forgiveness amount of a First Draw PPP Loan that a borrower received in calendar year 2020 is excluded from a borrower's gross receipts. Excluding the forgiveness amount from a borrower's gross receipts is consistent with section 7A(i) of the Small Business Act, which expressly excludes PPP forgiveness amounts from being taxed as income.[] This clarification ensures the effectiveness of the second draw loan program by ensuring that a borrower is not disqualified from receiving a Second Draw PPP Loan because it received forgiveness on a First Draw PPP Loan.

This furthers the purpose of the second draw loan provisions, which is to deliver additional aid to small businesses that previously received a First Draw PPP Loan. 3. Business Concerns With More Than One Physical Location Under the CARES Act, any single business entity that is assigned a NAICS code beginning with 72 (including hotels and restaurants) and employs not more than 500 employees per physical location is eligible to receive a First Draw PPP Loan.[] In addition, as discussed below, under the Consolidated First Draw PPP IFR, SBA's affiliation rules (13 CFR 121.301) do not apply to any business entity that is assigned a NAICS code beginning with 72 and that employs not more than a total of 500 employees.[] As a result, if each hotel or restaurant location owned by a parent business is a separate legal business entity and employs not more than 500 employees, each hotel or restaurant location is permitted to apply for a separate PPP loan provided it uses its unique EIN. Section 317 of the Economic Aid Act modified this provision for Second Draw PPP Loans by reducing the limit on employees per physical location to 300.

Accordingly, a single business entity that is assigned a NAICS code beginning with 72 is eligible to receive a Second Draw PPP Loan if it employs no more than 300 employees per physical location and meets the revenue reduction requirements and otherwise satisfies the eligibility criteria described in this IFR.[] Under section 317 of the Economic Aid Act, the same standard applies to certain news organizations.[] Subsections (c)(3) and (c)(4) of the IFR implement these statutory provisions. Borrowers may consult PPP Frequently Asked Question (FAQ) 24 [] for guidance on these standards for business concerns with more than one physical location, except that, for Second Draw PPP Loans, the number of employees per physical location is limited to 300 rather than 500. B. Affiliation Rules The same affiliation rules that apply to First Draw PPP Loans apply to Second Draw PPP Loans, except as provided in this IFR.

As with First Draw PPP Loans, in most cases, a borrower is considered together with its affiliates to determine eligibility for the PPP.[] However, the CARES Act waived the affiliation rules for certain categories of borrowers.[] Paragraph 7(a)(37)(E) of the Small Business Act, as amended by the Economic Aid Act, applies the same Start Printed Page 3715waivers to Second Draw PPP Loans, adds a waiver for certain eligible news organizations, and makes adjustments to reflect the reduced size requirement for Second Draw PPP Loans. Specifically, business concerns with a NAICS code beginning with 72 qualify for the affiliation waiver for Second Draw PPP Loans if they employ 300 or fewer employees. Eligible news organizations with a NAICS code beginning with 511110 or 5151 (or majority-owned or controlled by a business concern with those NAICS codes) may qualify for the affiliation waiver for Second Draw PPP Loans only if they employ 300 or fewer employees per physical location.[] Subsection (d)(2) implements these revised affiliation waivers. SBA also adopted a religious exemption to the affiliation rules by regulation,[] which applies to Second Draw PPP loans.

C. Excluded Entities An entity that is ineligible to receive a First Draw PPP Loan under the CARES Act or Consolidated First Draw PPP IFR is also ineligible for a Second Draw PPP Loan.[] Subsection (e)(1) of the IFR implements this restriction. Subsection (e)(1) ensures that a borrower that received a First Draw PPP Loan despite being ineligible to receive the loan is not eligible to receive a Second Draw PPP Loan. The Economic Aid Act also prohibits several additional categories of borrowers from receiving a Second Draw PPP Loan under section 7(a)(37) of the Small Business Act.

These categories of prohibited borrowers are listed in subsection (e) of the IFR. A business concern or entity primarily engaged in political activities or lobbying activities, including any entity that is organized for research or for engaging in advocacy in areas such as public policy or political strategy or that describes itself as a think tank in any public documents; [] certain entities organized under the laws of the People's Republic of China or the Special Administrative Region of Hong Kong, or with other specified ties to the People's Republic of China or the Special Administrative Region of Hong Kong; [] any person required to submit a registration statement under section 2 of the Foreign Agents Registration Act of 1938 (22 U.S.C. 612); [] a person or entity that receives a grant for shuttered venue operators under section 324 of the Economic Aid Act; [] entities in which the President, the Vice President, the head of an Executive department, or a Member of Congress, or the spouse of such person owns, controls, or holds at least 20 percent of any class of equity; [] or a publicly traded company, defined as an issuer, the securities of which are listed on an exchange registered as a national securities exchange under section 6 of the Securities Exchange Act of 1934 (15 U.S.C. 78f).[] In addition, subsection (e)(9) of this IFR provides that an entity that has previously received a Second Draw PPP Loan may not receive another Second Draw PPP Loan, as required by the Economic Aid Act.[] Subsection (e)(9) also prohibits an entity that has permanently closed from receiving a Second Draw PPP Loan because paragraph 7(a)(37)(A)(iv) of the Small Business Act is best understood to describe existing businesses.

The Administrator, in consultation with the Secretary, has determined this provision is also necessary to maintain program integrity, prevent abuse, and preserve the availability of Second Draw PPP Loan funds for businesses still in operation. Preserving funds for such businesses is necessary because only businesses that are still in operation will retain employees, which is a primary purpose of the PPP. A borrower that has temporarily closed or temporarily suspended its business remains eligible for a Second Draw PPP Loan. D.

Payroll Cost Calculation In general, section 307 of the Economic Aid Act provides that the maximum loan amount for a Second Draw PPP Loan is equal to the lesser of two and half months of the borrower's average monthly payroll costs or $2 million. Relative to First Draw PPP loans, the Economic Aid Act adjusted the methodology for calculating a borrower's payroll costs. Unlike First Draw PPP Loans, the Economic Aid Act provides that the relevant time period for calculating a borrower's payroll costs for a Second Draw PPP Loan is either the twelve-month period prior to when the loan is made or calendar year 2019. The Act also provided tailored methodologies for certain categories of borrowers.

These calculations are reflected in subsection (f) of this IFR. Subsection (f) of the IFR uses “calendar year 2020” to refer to “the twelve-month period prior to when the loan is made.” Calculating payroll costs based on calendar year 2020 rather than the twelve months preceding the date the loan is made will simplify the calculations and documentation requirements for borrowers because payroll records are more commonly created and retained on a calendar-year basis. Allowing borrowers to calculate payroll costs based on calendar year 2020 is also not expected to result in a significant difference in payroll costs compared to the twelve months preceding the date the loan is made because all Second Draw PPP Loans will be made in the first quarter of 2021. However, the rule notes that Second Draw PPP Loan borrowers who are not self-employed (including sole proprietorships and independent contractors) are also permitted to use the precise 1-year period before the date on which the loan is made to calculate payroll costs if they choose not to use 2019 or 2020 to calculate payroll costs.

Consistent with the Economic Aid Act, subsections (f)(3) and (f)(4) of the IFR include tailored calculation methodologies for seasonal businesses, new entities that did not exist for the full twelve-month period preceding the Second Draw PPP Loan, and borrowers assigned a NAICS code beginning with 72 at the time of disbursement. For borrowers assigned a NAICS code beginning with 72 at the time of disbursement, the Economic Aid Act provides that the maximum loan amount is equal to three-and-a-half (3.5) months of payroll costs rather than two-and-a-half (2.5) months.[] These subsections also provide that, for a borrower with a NAICS code beginning with 72 that would fall into more than one category listed in subsection (f) (for example, a business with a NAICS code beginning with 72 that is also a seasonal business or is also a new entity without 12 months of payroll costs), the borrower may calculate its average monthly payroll costs based on the methodology that applies to the entity but may use the 3.5 multiplier Start Printed Page 3716applicable to businesses with a NAICS code beginning with 72. The Administrator, in consultation with the Secretary, has determined that this methodology is necessary to provide small businesses in the accommodation and food services sector the full amount of relief provided in the Economic Aid Act while allowing these borrowers to calculate their average monthly payroll costs accurately. The Economic Aid Act included a new payroll cost calculation for farmers and ranchers receiving First Draw PPP Loans.

However, it did not specify how payroll costs should be calculated for Second Draw PPP Loans to farmers and ranchers. This IFR clarifies that the same general calculation for farmers and ranchers applicable to First Draw PPP Loans applies to Second Draw PPP Loans, with adjustments that (i) eliminate the provision for refinancing of an Economic Injury Disaster Loan (EIDL), which does not apply to Second Draw PPP Loans, and (ii) apply the choice of time period for calculating a farmer's or rancher's payroll costs for Second Draw PPP Loans, consistent with other Second Draw PPP Loans. This IFR also specifies that, in calculating a farmer's or rancher's maximum loan amount, any employee payroll costs should be subtracted from the farmer's or rancher's gross income to avoid double-counting amounts that represent pay to the employees of the farmer or rancher. Subsections (f)(7) and (f)(8) of the IFR include tailored calculation methodologies for self-employed individuals and partnerships.

These methodologies are based on the corresponding methodologies for self-employed individuals and partnerships that are used for First Draw PPP Loans.[] These methodologies have been adjusted to eliminate the provision for refinancing of an EIDL loan, which does not apply to Second Draw PPP loans and to apply the choice of time period for calculating payroll costs, consistent with other Second Draw PPP loans. Finally, subsection (f)(9) provides that businesses that are part of a single corporate group shall in no event receive more than $4,000,000 of Second Draw PPP Loans in the aggregate. The Administrator, in consultation with the Secretary, determined that limiting the amount of Second Draw PPP Loans that a single corporate group may receive will promote the availability of PPP loans to the largest possible number of borrowers, consistent with the CARES and Economic Aid Act. The Administrator has concluded that a limitation of $4,000,000 is appropriate because it is proportional to the $20,000,000 maximum amount for corporate groups that is provided under the Consolidated First Draw PPP IFR when the maximum loan amount for a single PPP loan is $10,000,000.

E. Second Draw PPP Loan Application and Documentation Requirements Subsection (g) of this IFR includes the application and documentation requirements for Second Draw PPP Loans. The documentation required to substantiate an applicant's payroll cost calculations is generally the same as documentation required for First Draw PPP Loans. However, no additional documentation to substantiate payroll costs will be required if the applicant (i) used calendar year 2019 figures to determine its First Draw PPP Loan amount, (ii) used calendar year 2019 figures to determine its Second Draw PPP Loan amount (instead of calendar year 2020), and (iii) the lender for the applicant's Second Draw PPP Loan is the same as the lender that made the applicant's First Draw PPP Loan.

In such cases, additional documentation is not required because the lender already has the relevant documentation supporting the borrower's payroll costs. The lender may request additional documentation, however, if on further review the lender concludes that it would be useful in conducting the lender's good-faith review of the borrower's loan amount calculation. For loans with a principal amount greater than $150,000, the applicant must also submit documentation adequate to establish that the applicant experienced a revenue reduction of 25% or greater in 2020 relative to 2019. (The revenue reduction requirement is addressed in subsection (c)(1)(iv) of this IFR.) Such documentation may include relevant tax forms, including annual tax forms, or, if relevant tax forms are not available, quarterly financial statements or bank statements.

For loans with a principal amount of $150,000 or less, such documentation is not required at the time the borrower submits its application for a loan, but must be submitted on or before the date the borrower applies for loan forgiveness, as required under the Economic Aid Act.[] If a borrower does not submit an application for loan forgiveness, such documentation must be provided upon SBA's request. F. Lender Requirements Subsection (g) of this IFR contains the provisions specific to lenders for Second Draw PPP Loans. Paragraph 7(a)(37)(K) of the Small Business Act, added by the Economic Aid Act, states that a lender approved to make First Draw PPP loans may make Second Draw PPP Loans under the same terms and conditions as new First Draw PPP Loans.

Subsection (g)(2) of this IFR provides that lenders are subject to the same requirements when making Second Draw PPP Loans as when they are making First Draw PPP Loans. These provisions allow a lender approved to make Second Draw PPP Loans to use existing program guidance and standard operating procedures to the maximum extent practicable.[] The requirements applicable to PPP lenders are in sections (C) and (D) of the Consolidated First Draw PPP IFR. If a borrower has not submitted new payroll documentation with its Second Draw PPP Loan application because it previously submitted 2019 payroll information to the same lender when it applied for its First Draw PPP Loan, then the lender must confirm the borrower's average monthly payroll costs based on that prior documentation. In addition, for a Second Draw PPP Loan greater than $150,000, the lender must confirm the dollar amount and percentage of the borrower's revenue reduction by performing a good faith review, in a reasonable time, of the borrower's calculations and supporting documents concerning the borrower's revenue reduction.

If the lender identifies errors in the borrower's calculation or a material lack of substantiation in the borrower's supporting documents, the lender should work with the borrower to remedy the issue. G. Loans to Borrowers With Unresolved First Draw PPP Loans As described in SBA's interim final rule on SBA Loan Review Procedures and Related Borrower and Lender Responsibilities, SBA may review any PPP loan, as the Administrator deems appropriate.[] Subsection (i) of the IFR establishes procedures relating to the handling of a Second Draw PPP Loan application by a borrower whose First Draw PPP Loan is under review by SBA (“unresolved borrower”). If a borrower's First Draw PPP loan is under review by SBA and/or information in SBA's possession indicates that the borrower may have been ineligible for the First Start Printed Page 3717Draw PPP Loan it received or for the loan amount it received, the lender will receive notification from SBA when the lender submits an application for a guaranty of a Second Draw PPP Loan and will not receive an SBA loan number until the issue related to the unresolved borrower's First Draw PPP Loan is resolved.

SBA will resolve issues related to unresolved borrowers expeditiously. These procedures are designed to promote compliance with the eligibility requirements for Second Draw PPP Loans by preventing additional loans from being made to borrowers that were not eligible for a First Draw PPP Loan or received an impermissible loan amount. At the same time, these procedures do not disqualify an eligible unresolved borrower from receiving a Second Draw PPP Loan, in recognition that many flags will be resolved in the borrower's favor. The Administrator, in consultation with the Secretary, has determined that these procedures strike an appropriate balance between promoting program integrity and preventing abuse, while making Second Draw PPP Loans available to all eligible borrowers as expeditiously as possible.

SBA will set aside available appropriations to fund Second Draw PPP Loans applied for by unresolved borrowers in the event they are approved. H. Loan Forgiveness Loan forgiveness of Second Draw PPP Loans and the loan review process for Second Draw PPP Loans are generally subject to the interim final rules regarding Loan Forgiveness and SBA Loan Review Procedures and Related Borrower and Lender Responsibilities, as modified to conform to the Economic Aid Act by the Consolidated First Draw PPP IFR, which is being published concurrently with this IFR. Subsection (j) contains forgiveness provisions specific to Second Draw PPP loans.

Table of Contents (a) Second Draw PPP Loan Program (b) What requirements apply to Second Draw PPP Loans?. (c) Who is eligible for a Second Draw PPP Loan?. (d) How do SBA's affiliation rules affect an applicant's eligibility for a Second Draw PPP Loan?. (e) Who is not eligible for a Second Draw PPP Loan?.

(f) What is the maximum loan amount for a Second Draw PPP Loan?. (g) How do I submit an application for a Second Draw PPP Loan and what documentation must I provide to demonstrate eligibility?. (h) What do lenders need to know and do?. (i) Will an applicant's Second Draw PPP Loan application be affected if there are unresolved issues regarding the applicant's First Draw PPP Loan?.

(j) Are Second Draw PPP Loans eligible for loan forgiveness?. IV. Paycheck Protection Program Second Draw Loans (a) Second Draw PPP Loan Program Under section 7(a)(37) of the Small Business Act (15 U.S.C. 636(a)(37)), SBA is authorized to guarantee Paycheck Protection Program Second Draw Loans (“Second Draw PPP Loans”).

(b) What requirements apply to Second Draw PPP Loans?. (1) Second Draw PPP Loans are subject to SBA's and the Department of the Treasury's (“Treasury's”) consolidated interim final rule implementing the Paycheck Protection Program (“Consolidated First Draw PPP IFR”) and all PPP loan program requirements, except as otherwise provided in this section, including but not limited to the following terms. (i) The guarantee percentage is 100 percent. (ii) No collateral will be required.

(iii) No personal guarantees will be required. (iv) The interest rate will be 100 basis points or one percent, calculated on a non-compounding, non-adjustable basis. (v) The maturity is five years. (vi) All loans will be processed by all lenders under delegated authority and lenders will be permitted to rely on certifications of the borrower in order to determine eligibility of the borrower and the use of loan proceeds.

(2) Frequently Asked Questions and other guidance issued by SBA or by SBA in consultation with the Department of the Treasury with respect to PPP loans under section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)) (“First Draw PPP Loans”) apply to Second Draw PPP Loans, except as otherwise provided in this section. (c) Who is eligible for a Second Draw PPP Loan?. Subject to subsection (e) of this section, below, the following applicants are eligible for Second Draw PPP Loans.

(1) An applicant is eligible for a Second Draw PPP Loan if it is a business concern, independent contractor, eligible self-employed individual, sole proprietor, nonprofit organization eligible for a First Draw PPP Loan, veterans organization, Tribal business concern, housing cooperative, small agricultural cooperative, eligible 501(c)(6) organization or destination marketing organization, or an eligible nonprofit news organization [] that. (i) Previously received a First Draw PPP loan in accordance with the eligibility criteria in the Consolidated First Draw PPP IFR. (ii) has used, or will use, the full amount of its First Draw PPP Loan (including the amount of any increase on such First Draw PPP Loan) on authorized uses under subsection (B)(11) of the Consolidated First Draw PPP IFR on or before the expected date on which the Second Draw PPP Loan will be disbursed; [] (iii) employs not more than 300 employees, unless it satisfies the alternative criteria for businesses with a North American Industry Classification System (“NAICS”) code beginning with 72 and eligible news organizations with more than one physical location described in subsection (c)(3) or (c)(4) of this section. And (iv) (A) experienced a reduction in revenue in calendar year 2020, measured as follows.

(1) the applicant had gross receipts during the first, second, third, or fourth quarter in 2020 that demonstrate at least a 25 percent reduction from the applicant's gross receipts during the same quarter in 2019 (for example, an applicant that had gross receipts of $50,000 in the second quarter of 2019 and had gross receipts of $30,000 in the second quarter of 2020 experienced a 40 percent revenue reduction between these two quarters). (2) if the applicant was not in business during the first or second quarter of 2019, but was in business during the third and fourth quarters of 2019, the applicant had gross receipts during the first, second, third, or fourth quarter of 2020 that demonstrate at least a 25 percent reduction from the applicant's gross receipts during the third or fourth quarter of 2019 (for example, an applicant that had gross receipts of $50,000 in the third quarter of 2019 and had gross receipts of $30,000 in the third quarter of 2020-demonstrating a reduction of 40 percent from the applicant's gross receipts during the third quarter in 2019). (3) if the applicant was not in business during the first, second, or third quarter of 2019, but was in business during the fourth quarter of 2019, the applicant had gross receipts Start Printed Page 3718during the first, second, third, or fourth quarter of 2020 that demonstrate at least a 25 percent reduction from the fourth quarter of 2019 (for example, an applicant that had gross receipts of $50,000 in the fourth quarter of 2019 and had gross receipts of $30,000 in the fourth quarter of 2020-demonstrating a reduction of 40 percent from the applicant's gross receipts during the fourth quarter in 2019). Or (4) if the applicant was not in business during 2019, but was in operation on February 15, 2020, the applicant had gross receipts during the second, third, or fourth quarter of 2020 that demonstrate at least a 25 percent reduction from the gross receipts of the entity during the first quarter of 2020 (for example, an applicant that had gross receipts of $50,000 in the first quarter of 2020 and had gross receipts of $30,000 in the fourth quarter of 2020—demonstrating a reduction of 40 percent from the applicant's gross receipts during the first quarter in 2020).

(B) An applicant that was in operation in all four quarters of 2019 is deemed to have experienced the revenue reduction in subsection (c)(1)(iv)(A)(1) if it experienced a reduction in annual receipts of 25 percent or greater in 2020 compared to 2019 and the borrower submits copies of its annual tax forms substantiating the revenue decline. (2)(i) Gross receipts includes all revenue in whatever form received or accrued (in accordance with the entity's accounting method) from whatever source, including from the sales of products or services, interest, dividends, rents, royalties, fees, or commissions, reduced by returns and allowances. Generally, receipts are considered “total income” (or in the case of a sole proprietorship, independent contractor, or self-employed individual “gross income”) plus “cost of goods sold,” and excludes net capital gains or losses as these terms are defined and reported on IRS tax return forms. Gross receipts do not include the following.

Taxes collected for and remitted to a taxing authority if included in gross or total income (such as sales or other taxes collected from customers and excluding taxes levied on the concern or its employees). Proceeds from transactions between a concern and its domestic or foreign affiliates. And amounts collected for another by a travel agent, real estate agent, advertising agent, conference management service provider, freight forwarder or customs broker. All other items, such as subcontractor costs, reimbursements for purchases a contractor makes at a customer's request, investment income, and employee-based costs such as payroll taxes, may not be excluded from gross receipts.

(ii) Gross receipts of affiliates are calculated as follows. (A) Gross receipts of a borrower with affiliates is calculated by adding the gross receipts of the business concern with the gross receipts of each affiliate. (B) If a borrower has acquired an affiliate or been acquired as an affiliate during 2020, gross receipts includes the receipts of the acquired or acquiring concern. This aggregation applies for the entire period of measurement, not just the period after the affiliation arose.

However, if a concern acquired a segregable division of another business concern during 2020, gross receipts do not include the receipts of the acquired division prior to the acquisition. (C) The gross receipts of a former affiliate are not included. This exclusion of gross receipts of such former affiliate applies during the entire period of measurement, rather than only for the period after which affiliation ceased. However, if a borrower sold a segregable division during 2020, the gross receipts will continue to include the receipts of the division that was sold.

(D) All terms in this subsection shall have the meaning attributed to them by the IRS. (iii) For an eligible nonprofit organization, a veterans organization, an eligible nonprofit news organization, an eligible 501(c)(6) organization, or eligible destination marketing organization, gross receipts means gross receipts within the meaning of section 6033 of the Internal Revenue Code of 1986. (iv) The amount of any forgiven First Draw PPP Loan shall not be included toward any borrower's gross receipts. (3) Any business concern that has more than one physical location and that employs not more than 300 employees per physical location is eligible to receive a Second Draw PPP Loan if it is assigned a NAICS code beginning with 72 at the time of loan disbursement and otherwise meets the eligibility criteria in subsection (c)(1).

(4) Any business concern, or any station which broadcasts pursuant to a license granted by the Federal Communications Commission under title III of the Communications Act of 1934 (47 U.S.C. 301 et seq.), that has more than one physical location and that employs not more than 300 employees per physical location is eligible to receive a Second Draw PPP Loan if it meets the eligibility criteria in subsection (c)(1) and. (1) Is majority owned or controlled by a business concern that is assigned a NAICS code beginning with 511110 or 5151 or, with respect to a public broadcasting entity (as defined in section 397(11) of the Communications Act of 1934 (47 U.S.C. 397(11))), has a trade or business that falls under such a code.

And (2) makes a good faith certification that proceeds of the loan will be used to support expenses at the component of the organization that produces or distributes locally focused or emergency information. (d) How do SBA's affiliation rules affect an applicant's eligibility for a Second Draw PPP Loan?. (1) Eligibility for Second Draw PPP Loans is governed by the same affiliations rules (and waivers) as First Draw PPP Loans, except as described in subsection (d)(2). (2) The affiliation rules under 13 CFR 121.301(f) are waived with respect to eligibility for a Second Draw PPP Loan for.

(i) Any business concern with not more than 300 employees that, as of the date on which the covered loan is disbursed, is assigned a NAICS code beginning with 72. And (ii) (A) any business concern (including any station which broadcasts pursuant to a license granted by the Federal Communications Commission under title III of the Communications Act of 1934 (47 U.S.C. 301 et seq.) without regard for whether such a station is a concern as defined in 13 CFR 121.105, or any successor thereto) that employs not more than 300 employees, per physical location of such business concern and is majority owned or controlled by a business concern that is assigned a NAICS code beginning with 511110 or 5151. Or (B) any nonprofit organization that is assigned a NAICS code beginning with 5151.

(e) Who is not eligible for a Second Draw PPP Loan?. An applicant is not eligible for a Second Draw PPP Loan, even if it meets the eligibility requirements of subsection (c) of this section, if the applicant is. (1) Excluded from eligibility under the Consolidated First Draw PPP IFR; [] (2) a business concern or entity primarily engaged in political activities or lobbying activities, as defined in section 3 of the Lobbying Disclosure Act of 1995 (2 U.S.C. 1602), including any entity that is organized for research or for engaging in advocacy in areas such as public policy or political strategy or Start Printed Page 3719otherwise describes itself as a think tank in any public documents.

(3) any business concern or entity. (i) For which an entity created in or organized under the laws of the People's Republic of China or the Special Administrative Region of Hong Kong, or that has significant operations in the People's Republic of China or the Special Administrative Region of Hong Kong, owns or holds, directly or indirectly, not less than 20 percent of the economic interest of the business concern or entity, including as equity shares or a capital or profit interest in a limited liability company or partnership. Or (ii) that retains, as a member of the board of directors of the business concern, a person who is a resident of the People's Republic of China. (4) any person required to submit a registration statement under section 2 of the Foreign Agents Registration Act of 1938 (22 U.S.C.

612). (5) any person or entity that receives a grant for shuttered venue operators under section 324 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act. (6) any entity in which the President, the Vice President, the head of an Executive department, or a Member of Congress, or the spouse of such person as determined under applicable common law, directly or indirectly holds a controlling interest in the entity, where. (i) “controlling interest” means owning, controlling, or holding not less than 20 percent, by vote or value, of the outstanding amount of any class of equity interest in an entity.

(ii) “equity interest” means. (A) A share in an entity, without regard to whether the share is transferable or classified as stock or anything similar. (B) a capital or profit interest in a limited liability company or partnership. Or (C) a warrant or right, other than a right to convert, to purchase, sell, or subscribe to a share or interest described in (A) or (B), respectively.

(iii) “Executive department” has the meaning given the term in section 101 of title 5, United States Code. (iv) “Member of Congress” means a Member of the Senate or House of Representatives, a Delegate to the House of Representatives, and the Resident Commissioner from Puerto Rico. And (v) For the purpose of determining whether a person has a controlling interest in the entity, the securities owned, controlled, or held by the President, the Vice President, the head of an Executive department, or a Member of Congress, shall be aggregated with the securities held by his or her spouse as determined under applicable common law. (7) any issuer, the securities of which are listed on an exchange registered as a national securities exchange under section 6 of the Securities Exchange Act of 1934 (15 U.S.C.

78f), where the terms “exchange,” “issuer,” and “security” have the meanings given those terms in section 3(a) of the Securities Exchange Act of 1934 (15 U.S.C. 78c(a)) (except SBA will not consider whether a news organization that is eligible under subsection (c)(4) is affiliated with an entity, which includes any entity that owns or controls such news organization, that is an issuer). (8) an entity that has previously received a Second Draw PPP Loan. Or (9) an entity that has permanently closed.

(f) What is the maximum loan amount for a Second Draw PPP Loan?. (1) In general, the maximum loan amount for a Second Draw PPP Loan is equal to the lesser of two and half months of the borrower's average monthly payroll costs or $2 million, except as otherwise specified in this subsection (e). A borrower's average monthly payroll costs may be based on calendar year 2020, calendar year 2019,[] or as otherwise specified in subsections (f)(2) through (f)(9) of this section. €œPayroll costs” has the same meaning as in subsections (B)(4)(g) and (B)(4)(h) of the Consolidated First Draw PPP IFR and is calculated in the same manner.

In calculating a borrower's payroll costs, the borrower must subtract any compensation paid to an employee in excess of $100,000 on an annualized basis, as prorated for the time period during which the payments are made or the obligation to make the payments is incurred. (2) Except as otherwise provided in subsection (f)(3) through (f)(7), the maximum amount of a Second Draw PPP Loan is calculated as the lesser of. (i) The product obtained by multiplying. (A) The average total monthly payment for payroll costs incurred or paid by the borrower during 2019 or 2020 (at the election of the borrower).

By (B) 2.5. Or (ii) $2,000,000. (3) The maximum amount of a Second Draw PPP Loan to a borrower that is a seasonal employer (meaning an employer that does not operate for more than 7 months in any calendar year or that during the preceding calendar year, had gross receipts for any 6 months of that year that were not more than 33.33 percent of the gross receipts of the employer for the other 6 months of that year) is calculated as the lesser of. (i) The product obtained by multiplying.

(A) At the election of the borrower, the average total monthly payments for payroll costs incurred or paid by the borrower for any 12-week period between February 15, 2019 and February 15, 2020. By (B) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10), 3.5). Or (ii) $2,000,000. (4) The maximum amount of a Second Draw PPP Loan to a borrower that did not exist during the 1-year period preceding February 15, 2020, but was in operation on February 15, 2020 (“new entity”), is calculated as the lesser of.

(i) The product obtained by multiplying. (A) The quotient obtained by dividing. (1) The sum of the total monthly payments by the borrower for payroll costs paid or incurred by the borrower as of the date on which the borrower applies for the Second Draw PPP Loan. By (2) the number of months in which those payroll costs were paid or incurred.

By (B) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10), 3.5). Or (ii) $2,000,000. (5) The maximum amount of a Second Draw PPP Loan made to a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10) (that is not a seasonal employer or new entity addressed in subsection (f)(3) or (f)(4) or a borrower with self-employment income or a partnership addressed in subsection (f)(7) or (f)(8) of this section) is calculated as the lesser of. (i) The product obtained by multiplying.

(A) The average total monthly payment for payroll costs incurred or paid by the borrower during either 2019 or 2020 (at the borrower's election) by (B) 3.5. Or (ii) $2,000,000. (6) (i) The maximum amount of a Second Draw PPP Loan to a farmer or rancher that:Start Printed Page 3720 (A) Operates as a sole proprietorship or as an independent contractor, or is an eligible self-employed individual. (B) reports farm income or expenses on a Schedule F (IRS Form 1040).

And (C) was in business as of February 15, 2020. Is calculated according to (ii) or (iii) of this subsection(e)(6), depending on whether the borrower has employees. (ii) If a borrower meeting the criteria in subsection (6)(i) of this section does not have any employees, the maximum loan amount is the product obtained by multiplying. (A) The gross income of the borrower in 2019 or 2020, as reported on a Schedule F (IRS Form 1040), that is not more than $100,000, divided by 12.

And (B) 2.5. (iii) If a borrower meeting the criteria in subsection (6)(i) of this section has employees, the maximum loan amount is calculated as the lesser of. (A) The product obtained by multiplying. (1) The sum of (i) the difference between gross income and employee payroll costs of the borrower in 2019 or 2020 (at the election of the borrower), as reported on a Schedule F (IRS Form 1040), that is not more than $100,000, divided by 12, and (ii) the average total monthly payment for employee payroll costs incurred or paid by the borrower during the same year elected by the borrower.

By (2) 2.5. Or (B) $2,000,000. (7) The maximum amount of a Second Draw PPP Loan to a borrower that has income from self-employment and files a Form 1040, Schedule C, is calculated as follows, depending on whether the borrower has employees. (i) For a borrower that has income from self-employment and does not have any employees, the maximum loan amount is the lesser of.

(A) The product obtained by multiplying. (1) The net profit of the borrower in 2019 or 2020, as reported on IRS Form 1040 Schedule C, that is not more than $100,000, divided by 12. And (2) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 as defined in subsection (f)(10) at the time of disbursement, 3.5). (ii) For a borrower that has income from self-employment and has employees, the maximum loan amount is the lesser of.

(A) The product obtained by multiplying. (1) The sum of (i) the net profit of the borrower in 2019 or 2020 (at the election of the borrower), as reported on IRS Form 1040 Schedule C, that is not more than $100,000, divided by 12. (ii) the average total monthly payment for employee payroll costs incurred or paid by the borrower during the same year elected by the borrower. By (2) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 at the time of disbursement as defined in subsection (f)(10), 3.5).

Or (B) $2,000,000. (8) The maximum amount of a Second Draw PPP Loan to a borrower that files taxes as a partnership is calculated as the lesser of. (i) The product obtained by multiplying. (A) The sum of (1) net earnings from self-employment of individual general partners in 2019 or 2020 (at the election of the borrower), as reported on IRS Form 1065 K-1, reduced by section 179 expense deduction claimed, unreimbursed partnership expenses claimed, and depletion claimed on oil and gas properties, multiplied by 0.9235,[] that is not more than $100,000, divided by 12.

(2) the average total monthly payment for employee payroll costs incurred or paid by the borrower during the same year elected by the borrower. By (B) 2.5 (or, only for a borrower assigned a NAICS code beginning with 72 as defined in subsection (f)(10) at the time of disbursal, 3.5). Or (ii) $2,000,000. (9) Businesses that are part of a single corporate group shall in no event receive more than $4,000,000 of Second Draw PPP Loans in the aggregate.

Corporate group has the same meaning as in subsection (B)(4)(f) of the Consolidated First Draw PPP IFR. (10) For purposes of calculating a borrower's maximum payroll costs, a borrower may multiply its average monthly payroll costs by 3.5 only if the borrower is in the Accommodation and Food Services sector and has reported a NAICS code beginning with 72 as its business activity code on its most recent IRS income tax return. (g) How do I submit an application for a Second Draw PPP Loan and what documentation must I provide to demonstrate eligibility?. (1) The applicant must submit to the lender SBA Form 2483-SD (Paycheck Protection Program Second Draw Borrower Application Form) or the lender's equivalent form including the required certifications and the documentation in subsection (g)(2).

(2) At the time an applicant submits its loan application form, it must submit the following unless the documentation was submitted to the lender for the First Draw PPP Loan (i.e., the applicant used calendar year 2019 figures to determine both its First Draw PPP Loan amount and its Second Draw PPP Loan amount, and the lender for the applicant's Second Draw PPP Loan is the same as the lender that made the applicant's First Draw PPP Loan). (i) If the applicant is not self-employed, the applicant's Form 941 (or other tax forms containing similar information) and state quarterly wage unemployment insurance tax reporting forms from each quarter in 2019 or 2020 (whichever was used to calculate payroll), as applicable, or equivalent payroll processor records, along with evidence of any retirement and employee group health, life, disability, vision and dental insurance contributions, must be provided. A partnership must also include its IRS Form 1065 K-1s. (ii) If the applicant is self-employed and has employees, the applicant's 2019 or 2020 (whichever was used to calculate loan amount) IRS Form 1040 Schedule C, Form 941 (or other tax forms or equivalent payroll processor records containing similar information) and state quarterly wage unemployment insurance tax reporting forms from each quarter in 2019 or 2020 (whichever was used to calculate loan amount), as applicable, or equivalent payroll processor records, along with evidence of any retirement and employee group health, life, disability, vision and dental insurance contributions, if applicable, must be provided.

A payroll statement or similar documentation from the pay period that covered February 15, 2020 must be provided to establish the applicant was in operation on February 15, 2020. (iii) If the applicant is self-employed and does not have employees, the applicant must provide (a) its 2019 or 2020 (whichever was used to calculate loan amount) Form 1040 Schedule C, (b) a 2019 or 2020 (whichever was used to calculate loan amount) IRS Form 1099-MISC detailing nonemployee compensation received (box 7), invoice, bank statement, or book of record that establishes that the applicant is self-employed. And (c) a 2020 invoice, bank statement, or book of record to establish that the applicant was in operation on or around February 15, 2020. (iv) For loans with a principal amount greater than $150,000, documentation sufficient to establish that the applicant experienced a reduction in revenue, as provided in subsection(c)(1)(iv), must be Start Printed Page 3721provided at the time of application, which may include relevant tax forms, including annual tax forms, or, if relevant tax forms are not available, a copy of the applicant's quarterly income statements or bank statements.

(v) For loans with a principal amount of $150,000 or less, the applicant must submit documentation sufficient to establish that the applicant experienced a reduction in revenue as provided in subsection (c)(1)(i) of this section at the time of application, on or before the date the borrower submits an application for loan forgiveness, or, if the borrower does not apply for loan forgiveness, at SBA's request. Such documentation may include relevant tax forms, including annual tax forms, or, if relevant tax forms are not available, a copy of the applicant's quarterly income statements or bank statements. (3) On the Second Draw PPP Loan borrower application, an authorized representative of the applicant [] must make the certifications listed in subsection (B)(12) of the Consolidated First Draw PPP IFR, except. (i) Instead of the certification in subsection (B)(12)(v) of the Consolidated First Draw PPP IFR, the applicant must certify that the applicant has not and will not receive another Second Draw Paycheck Protection Program Loan.

And (ii) an authorized representative of the applicant must also certify. (A) The Applicant has realized a reduction in gross receipts in excess of 25% relative to the relevant comparison time period. For loans greater than $150,000, Applicant has provided documentation to the lender substantiating the decline in gross receipts. For loans of $150,000 or less, Applicant will provide documentation substantiating the decline in gross receipts upon or before seeking loan forgiveness for the Second Draw Paycheck Protection Program Loan or upon SBA request.

(B) The Applicant received a First Draw Paycheck Protection Program Loan and, before the Second Draw Paycheck Protection Program Loan is disbursed, will have used the full loan amount (including any increase) of the First Draw Paycheck Protection Program Loan only for eligible expenses. (C) The Applicant is not a business concern or entity (a) for which an entity created in or organized under the laws of the People's Republic of China or the Special Administrative Region of Hong Kong, or that has significant operations in the People's Republic of China or the Special Administrative Region of Hong Kong, owns or holds, directly or indirectly, not less than 20 percent of the economic interest of the business concern or entity, including as equity shares or a capital or profit interest in a limited liability company or partnership. Or (b) that retains, as a member of the board of directors of the business concern, a person who is a resident of the People's Republic of China. (D) The Applicant is not required to submit a registration statement under section 2 of the Foreign Agents Registration Act of 1938 (22 U.S.C.

612). (E) The Applicant is not a business concern or entity primarily engaged in political or lobbying activities, including any entity that is organized for research or for engaging in advocacy in areas such as public policy or political strategy or otherwise describes itself as a think tank in any public documents. (4) A lender must submit SBA Form 2484-SD (Paycheck Protection Program Lender's Application—Second Draw Loan Guaranty) electronically in accordance with program requirements and maintain the forms and supporting documentation in its files. (h) What do lenders need to know and do?.

(1) A lender approved to make First Draw PPP Loans may make Second Draw PPP Loans under the same terms and conditions applicable to First Draw PPP Loans, including all requirements under sections (C) and (D) of the Consolidated First Draw PPP IFR, except as otherwise provided in this section. (2) What do lenders have to do in terms of loan underwriting?. (i) Each lender shall. (A) Confirm receipt of borrower certifications contained in Paycheck Protection Program Second Draw Borrower Application Form (SBA Form 2483-SD) or lender's equivalent.

(B) Confirm receipt of information demonstrating that a borrower was either an eligible self-employed individual, independent contractor, or sole proprietorship with no employees or had employees for whom the borrower paid salaries and payroll taxes on or around February 15, 2020. (C) Confirm the dollar amount of average monthly payroll costs for 2019 or 2020 (whichever was used to calculate loan amount) by reviewing the payroll documentation submitted with the borrower's application. (D) For a Second Draw PPP Loan greater than $150,000 or a loan of $150,000 or less where the borrower provides documentation of revenue reduction, confirm the dollar amount and percentage of the borrower's revenue reduction by performing a good faith review, in a reasonable time, of the borrower's calculations and supporting documents concerning the borrower's revenue reduction. For a loan of $150,000 or less where the borrower does not provide documentation of revenue reduction with its application, the lender shall perform this review when the borrower provides such documentation.

If the lender identifies errors in the borrower's calculation or material lack of substantiation in the borrower's supporting documents, the lender should work with the borrower to remedy the issue. (E) Follow applicable BSA requirements (listed in subsection (C)(3)(d) of the Consolidated First Draw PPP IFR). And (ii) Each lender's underwriting obligation under the Second Draw PPP is limited to the items above and reviewing the “Paycheck Protection Program Second Draw Borrower Application Form” (SBA Form 2483-SD) or lender's equivalent form. (iii) A lender may rely on any certification or documentation submitted by an applicant for a PPP loan or an eligible recipient or eligible entity that (A) is submitted pursuant to all applicable statutory requirements, regulations, and guidance related to a PPP loan, including under sections 7(a)(36) or (37) of the Small Business Act (15 U.S.C.

636(a)(36) and (37)). And (B) attests that the applicant, eligible recipient, or eligible entity, as applicable, has accurately provided the certification or documentation to the lender in accordance with the statutory requirements, regulations, and guidance related to PPP loans. With respect to a lender that relies on such a certification or documentation related to a Second Draw PPP Loan, an enforcement action may not be taken against the lender, and the lender shall not be subject to any penalties relating to loan origination or forgiveness of the Second Draw PPP Loan, if—(A) the lender acts in good faith relating to loan origination or forgiveness of the Second Draw PPP Loan based on that reliance. And (B) all other relevant Federal, State, local, and other statutory and regulatory requirements applicable to the lender are satisfied with respect to the Second Draw PPP Loan.

(3) SBA will pay lenders fees for processing Second Draw PPP Loans in the following amounts:Start Printed Page 3722 (i) for a Second Draw PPP Loan of up to (and including) $50,000, in an amount equal to the lesser of. (A) 50 percent of the balance of the financing outstanding at the time of disbursement of the loan. Or (B) $2,500. And (ii) for a Second Draw PPP Loan of more than $50,000, in an amount that is.

(A) 5 percent of the balance of the financing outstanding at the time of disbursement of the loan for a loan up to (and including) $350,000. And (B) 3 percent of the balance of the financing outstanding at the time of disbursement of the loan for a loan above $350,000. (i) Will an applicant's Second Draw PPP Loan application be affected if there are unresolved issues regarding the applicant's First Draw PPP Loan?. (1) If a First Draw PPP Loan is under review pursuant to PPP rules and/or information in SBA's possession indicates that the borrower may have been ineligible for the First Draw PPP Loan it received or for the loan amount received by the borrower, the lender will receive notification from SBA when the lender submits an application for guaranty of a Second Draw PPP Loan (“unresolved borrower”).

(2) If the lender receives notification that the Applicant for a Second Draw PPP Loan is an unresolved borrower, the lender will not receive an SBA loan number. SBA will resolve the issue related to the unresolved borrower expeditiously and will notify the lender of the process to obtain an SBA loan number for the Second Draw PPP Loan, if appropriate. (j) Are Second Draw PPP Loans eligible for loan forgiveness?. Second Draw PPP Loans are eligible for loan forgiveness on the same terms and conditions as First Draw PPP Loans, except that Second Draw PPP Loan borrowers with a principal amount of $150,000 or less are required to provide documentation of revenue reduction if such documentation was not provided at the time of the loan application as specified in subsections (g)(2)(iv) and (v) of this section.

V. Additional Information SBA may provide further guidance, if needed, through SBA notices and a program guide which will be posted on SBA's website at www.sba.gov. Questions on the Paycheck Protection Program 7(a) Loans (First Draw PPP Loans and Second Draw PPP Loans) may be directed to the Lender Relations Specialist in the local SBA Field Office. The local SBA Field Office may be found at https://www.sba.gov/​tools/​local-assistance/​districtoffices.

Compliance With Executive Orders 12866, 12988, 13132, 13563, and 13771, the Paperwork Reduction Act (44 U.S.C. Ch. 35), and the Regulatory Flexibility Act (5 U.S.C. 601-612) Executive Orders 12866, 13563, and 13771 This interim final rule is economically significant for the purposes of Executive Orders 12866 and 13563, and the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) had determined that this is a major rule under the Congressional Review Act (5 U.S.C.

804(2)). SBA, however, is proceeding under the emergency provision at Executive Order 12866 section 6(a)(3)(D) based on the need to move expeditiously to mitigate the current economic conditions arising from the erectile dysfunction treatment emergency. This rule's designation under Executive Order 13771 will be informed by public comment. This rule is necessary to implement the Economic Aid Act in order to provide economic relief to small businesses nationwide adversely impacted under the erectile dysfunction treatment Emergency Declaration.

We anticipate that this rule will result in substantial benefits to small businesses, their employees, and the communities they serve. However, we lack data to estimate the effects of this rule. The Administrator of OIRA has determined that this is a major rule for purposes of the Congressional Review Act (5 U.S.C. 801 et seq.) (CRA).

Under section 801(3) of the CRA, a major rule takes effect 60 days after the rule is published in the Federal Register. Notwithstanding this requirement, section 808(2) of the CRA allows agencies to dispense with the requirements of section 801 when the agency for good cause finds that such procedure would be impracticable, unnecessary, or contrary to the public interest and the rule shall take effect at such time as the agency promulgating the rule determines. Pursuant to section 808(2) of the CRA, SBA finds, for good cause, that a 60-day delay in the effective date is unnecessary and contrary to the public interest. As discussed elsewhere in this interim final rule, the last day to apply for and receive a PPP loan is March 31, 2021.

Given the short duration of this program, and the urgent need to issue loans quickly, the Administrator in consultation with the Secretary has determined that it is impractical and not in the public interest to provide a delayed effective date. An immediate effective date will give small businesses the maximum amount of time to apply for loans and lenders the maximum amount of time to process applications before the program ends. Executive Order 12988 SBA has drafted this rule, to the extent practicable, in accordance with the standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, to minimize litigation, eliminate ambiguity, and reduce burden. The rule has no preemptive or retroactive effect.

Executive Order 13132 SBA has determined that this rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various layers of government. Therefore, SBA has determined that this rule has no federalism implications warranting preparation of a federalism assessment. Paperwork Reduction Act, 44 U.S.C. Chapter 35 SBA has determined that this rule will impose new recordkeeping or reporting requirements under the Paperwork Reduction Act (“PRA”).

This information collection (IC) consists of SBA Form 2483-SD (Paycheck Protection Program Second Draw Application Form) and SBA Form 2484-SD (Paycheck Protection Program Lender's Application—Second Draw Loan Guaranty. SBA has requested emergency approval for the IC required to implement the Second Draw PPP Program described above. Regulatory Flexibility Act (RFA) The Regulatory Flexibility Act (RFA) generally requires that when an agency issues a proposed rule, or a final rule pursuant to section 553(b) of the APA or another law, the agency must prepare a regulatory flexibility analysis that meets the requirements of the RFA and publish such analysis in the Federal Register. 5 U.S.C.

603, 604. Specifically, the RFA normally requires agencies to describe the impact of a rulemaking on small entities by providing a regulatory impact analysis. Such analysis must address the consideration of regulatory options that would lessen the economic effect of the rule on small entities. The RFA defines a “small entity” as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA).

(2) a nonprofit organization that is not dominant in its field. Or (3) a small government Start Printed Page 3723jurisdiction with a population of less than 50,000. 5 U.S.C. 601(3)-(6).

Except for small government jurisdictions with a population of less than 50,000, neither State nor local governments are “small entities.” The requirement to conduct a regulatory impact analysis does not apply if the head of the agency “certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” 5 U.S.C. 605(b). The agency must, however, publish the certification in the Federal Register at the time of publication of the rule, “along with a statement providing the factual basis for such certification.” If the agency head has not waived the requirements for a regulatory flexibility analysis in accordance with the RFA's waiver provision, and no other RFA exception applies, the agency must prepare the regulatory flexibility analysis and publish it in the Federal Register at the time of promulgation or, if the rule is promulgated in response to an emergency that makes timely compliance impracticable, within 180 days of publication of the final rule. 5 U.S.C.

604(a), 608(b). Rules that are exempt from notice and comment are also exempt from the RFA requirements, including conducting a regulatory flexibility analysis, when among other things the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. Small Business Administration's Office of Advocacy guide. How to Comply with the Regulatory Flexibility Ac.

Ch.1. P.9. Since this rule is exempt from notice and comment, SBA is not required to conduct a regulatory flexibility analysis. Start Authority 15 U.S.C.

636(a)(36). erectile dysfunction Aid, Relief, and Economic Security Act, Pub. L. 116-136, section 1114.

And Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act, Pub. L. 116-260, section 303. End Authority Start Signature Jovita Carranza, Administrator.

End Signature End Supplemental Information [FR Doc. 2021-00452 Filed 1-12-21. 4:15 pm]BILLING CODE 8026-03-P.

How should I take Viagra?

Take Viagra by mouth with a glass of water. The dose is usually taken 1 hour before sexual activity. You should not take the dose more than once per day. Do not take your medicine more often than directed. Overdosage: If you think you have taken too much of Viagra contact a poison control center or emergency room at once. NOTE: Viagra is only for you. Do not share Viagra with others.

Viagra sex videos

(SACRAMENTO) October is Breast Cancer Awareness Month viagra sex videos and this year it brings new meaning for the newly appointed Chair of the UC Davis Department of Radiology.Elizabeth Morris has an impressive résumé as a pioneer in high-risk breast cancer screening. She also gained international prominence as coauthor of the book “Breast MRI viagra sex videos. Diagnosis and Intervention.”The new UC Davis radiology chair has conducted research on imaging biomarkers to assess risk and treatment response. She also advocates for getting women at risk for breast cancer the screenings they need to detect cancer when it is most responsive to treatment.And, now, she is a breast cancer survivor herself.“For me, the viagra sex videos whole experience of being a cancer patient felt like a confluence of my personal and professional lives,” said Morris. €œI’ve been viagra sex videos on a mission to detect breast cancer early in women so it can be found in time, and then suddenly I was facing my own breast cancer diagnosis.”Morris comes to UC Davis from New York’s Memorial Sloan Kettering Cancer Center, where she was chief of Breast Imaging Services.

Her cancer was caught as she was getting elective breast reduction surgery before leaving for California to accept her new post at UC Davis Health.Never did Morris think she would start radiation therapy at the UC Davis Comprehensive Cancer Center the same month she started her new position across campus.Risk factors low“I didn’t have any family history of breast cancer, and my only risk factors were being a female over 50 with extremely dense breasts,” said Morris as she openly shared her story to benefit other women who wonder if they might contract breast cancer.Tissue removed during the breast cancer reduction surgery was sent to pathology, which is routine during such procedures. Morris is highly appreciative of the attentive pathologist viagra sex videos who picked up her cancer, demonstrating how cancer detection is often a team effort. “My 3D mammogram and viagra sex videos screening uasound were negative, so I didn’t wait apprehensively for my pathology results,” said Morris. €œI was surprised when my doctor told me they discovered a four-millimeter tumor called invasive lobular carcinoma, named for the way it grows in a single–file linear pattern. The shape of the tumor makes it difficult to spot in a traditional mammogram and uasound.”Advanced screening technology key to early detectionLobular cancers are the second most common type of viagra sex videos invasive breast cancer, meaning cancer that has spread to surrounding tissue.

€œIt just goes to show that mammograms don’t detect all cancers, and that’s why we need to make contrast-based imaging such as MRI or contrast-enhanced mammography available to women — perhaps not annually but at least every few years,” said Morris.Tests using an injection of contrast dye, such as MRI and contrast-enhanced mammography, are better at detecting all types of cancer compared with traditional mammograms.“If I had to take on cancer, I’m glad I was at UC Davis,” said Morris who is from Davis and obtained her undergraduate degree from viagra sex videos UC Davis.“My own personal journey has only strengthened my resolve to give women the best possible chance of surviving breast cancer by getting them access to the best possible screening technology,” said Morris. €œI’m so excited to contribute to UC Davis’ world-class reputation as a leader in imaging technology and contemporary research programs as it continues to serve a large and diverse community.” If I had to take on cancer, I’m glad I was at UC Davis Health.—Elizabeth Morris, Chair, Department of RadiologyFormidable cancer fighters forming a strong bondMegan Daly and Elizabeth Morris have more than a couple of things in common. They are viagra sex videos female physicians at UC Davis Health, both in the radiology field, and both determined to cure Morris’ breast cancer.Elizabeth Morris started her new position as chair of the Dept. Of Radiology the same time she started breast cancer treatment.“As a breast imaging expert, with an extensive background in diagnostic radiology, Liz had a very thorough understanding of our radiation treatment plan before we viagra sex videos even spoke. So, if anything, she asked fewer questions than many patients who don’t understand the concept of radiation or why we use it,” said Daly, a radiation oncologist.

She treated Morris with 16 fractions, or small doses, of radiation starting the first month of her tenure as chair of radiology at UC Davis.Radiology is used in diagnosing cancer through imaging radiation, and radiation oncology deploys radiation to target and destroy tumors after they are discovered.Daly and Morris share a doctor-patient relationship and have also become peers and personal friends as they took an aggressive approach to treating Morris’ breast cancer.“Megan has such a personable style with her patients and is so effective at explaining the advances in radiation oncology now available to breast cancer patients treated at the UC Davis Comprehensive Cancer Center,” Morris said.Daly specializes in a variety of radiotherapy techniques, including viagra sex videos the image-guided radiation therapy used to treat Morris.“Liz was a great patient and, now as a breast cancer survivor, is in a unique position to understand the journey our patients take as they bravely face and conquer cancer,” Daly said. UC Davis Comprehensive Cancer CenterUC Davis Comprehensive Cancer Center is the viagra sex videos only National Cancer Institute-designated center serving the Central Valley and inland Northern California, a region of more than 6 million people. Its specialists provide compassionate, comprehensive care for more than 100,000 adults and children every year and access to more than 200 active clinical trials at any given time. Its innovative research program engages more than 240 scientists at UC Davis who work collaboratively to advance discovery of new tools viagra sex videos to diagnose and treat cancer. Patients have viagra sex videos access to leading-edge care, including immunotherapy and other targeted treatments.

Its Office of Community Outreach and Engagement addresses disparities in cancer outcomes across diverse populations, and the cancer center provides comprehensive education and workforce development programs for the next generation of clinicians and scientists. For more information, visit cancer.ucdavis.edu.(SACRAMENTO) The National Institute on Aging (NIA) is funding a viagra sex videos UC Davis Health study designed to understand how early life health and behavior impact the risk of cognitive decline, Alzheimer’s disease and related dementias. The $18 million, five-year grant from NIA is a renewal of funding for KHANDLE (Kaiser Healthy Aging and Diverse viagra sex videos Life Experiences Study).The groundbreaking study looks at the whole spectrum of factors that may affect brain health.“The KHANDLE study is the largest diverse cohort set up to answer questions about life course risk for late life brain outcomes, such as dementia, Alzheimer’s disease, cognitive decline, neurodegeneration and other brain diseases,” said Professor Rachel Whitmer, principal investigator on this grant and leader on KHANDLE. She is the chief of the division of epidemiology at the Department of Public Health Sciences and associate director of the Alzheimer’s Disease Research Center at UC Davis.A life course approach to studying dementiaKHANDLE researchers use a life course approach to study health and behavioral risks and protective factors associated with brain health outcomes. This approach assesses the physical and social hazards from gestation viagra sex videos to midlife that may affect chronic disease risk and health outcomes in later life.Rachel Whitmer is the associate director of Alzheimer’s Disease Research Center at UC Davis.“Aging is a lifelong process with earlier life experiences shaping adult and elderly health,” Whitmer said.

€œOur study allows us to do time travel in a sense, as we can leverage decades of information from medical records and health viagra sex videos checkups, starting from the 1960 and 1970s.”The study reaches out to communities underrepresented in research on dementia and related diseases. In its first cycle, it recruited 1712 elderly participants from Davis, Sacramento and the Bay Area. The new viagra sex videos grant will support the recruitment of an additional 500 new participants.“What is particularly unique about our study is the diversity of the participants recruited. We are proud to have equal representation of Asian, Black, Latino and white viagra sex videos participants,” Whitmer said.While around 6 million people in the U.S. Are living with Alzheimer’s, there are huge disparities in rates of the disease and cognitive impairments across ethno-racial groups.

According to the Alzheimer’s Association, older Black Americans are about twice viagra sex videos as likely to have Alzheimer's or other dementias as older whites. Older Hispanics are about 1.5 times as likely.This study is set up to uncover how and why viagra sex videos that happens.The grant will also allow for a brain donation program run by Prof. Brittany Dugger, an assistant professor within the Department of Pathology and Laboratory Medicine and the UC Davis Alzheimer’s Disease Center.Prof. Brittany Dugger runs brain donation program at UC Davis Alzheimer’s Disease Center.“Brain donation is a very important part of dementia viagra sex videos studies. One brain can have viagra sex videos a huge impact, providing a plethora of information to advance scientific research and the potential to improve treatments for future generations,” Dugger said.

€œBrains are especially needed from diverse populations to help researchers improve diagnosis, treatments and prognosis of diseases for ALL individuals.”“The erectile dysfunction treatment epidemic has demonstrated the enormous disparities plaguing the U.S. Understanding drivers of health disparities is one of the greatest public health needs of our time,” Whitmer viagra sex videos said. €œThe continuation of KHANDLE will help redress disparities in brain aging and provide needed public health information on reducing the risk of Alzheimer’s disease and related dementia.”Research from the Alzheimer’s Disease Research Center$16 million NIH award marks 30 years of Alzheimer’s disease research and careMapping the brain landscape for Alzheimer's disease using artificial intelligenceDementia looks different in brains of HispanicsHospital visits for extreme blood sugar highs and lows increase chance of dementia.

(SACRAMENTO) October is Breast Cancer Awareness Month and this year it brings new meaning for the newly appointed Chair of the UC Davis Department of Radiology.Elizabeth Morris has an impressive résumé as a can you buy over the counter viagra pioneer in high-risk breast cancer screening. She also gained international prominence as coauthor of the book “Breast can you buy over the counter viagra MRI. Diagnosis and Intervention.”The new UC Davis radiology chair has conducted research on imaging biomarkers to assess risk and treatment response.

She also advocates for getting women at risk for breast cancer the screenings they need to detect cancer when it is most responsive to treatment.And, now, she is a breast cancer survivor herself.“For me, the whole experience of being a cancer patient can you buy over the counter viagra felt like a confluence of my personal and professional lives,” said Morris. €œI’ve been on a mission to detect breast cancer early can you buy over the counter viagra in women so it can be found in time, and then suddenly I was facing my own breast cancer diagnosis.”Morris comes to UC Davis from New York’s Memorial Sloan Kettering Cancer Center, where she was chief of Breast Imaging Services. Her cancer was caught as she was getting elective breast reduction surgery before leaving for California to accept her new post at UC Davis Health.Never did Morris think she would start radiation therapy at the UC Davis Comprehensive Cancer Center the same month she started her new position across campus.Risk factors low“I didn’t have any family history of breast cancer, and my only risk factors were being a female over 50 with extremely dense breasts,” said Morris as she openly shared her story to benefit other women who wonder if they might contract breast cancer.Tissue removed during the breast cancer reduction surgery was sent to pathology, which is routine during such procedures.

Morris is highly appreciative of the attentive pathologist can you buy over the counter viagra who picked up her cancer, demonstrating how cancer detection is often a team effort. “My 3D mammogram and screening uasound were negative, so I can you buy over the counter viagra didn’t wait apprehensively for my pathology results,” said Morris. €œI was surprised when my doctor told me they discovered a four-millimeter tumor called invasive lobular carcinoma, named for the way it grows in a single–file linear pattern.

The shape of can you buy over the counter viagra the tumor makes it difficult to spot in a traditional mammogram and uasound.”Advanced screening technology key to early detectionLobular cancers are the second most common type of invasive breast cancer, meaning cancer that has spread to surrounding tissue. €œIt just goes to show that mammograms don’t detect all cancers, and that’s why we need to make contrast-based imaging such as MRI or contrast-enhanced mammography available to women — perhaps not annually but at least every few can you buy over the counter viagra years,” said Morris.Tests using an injection of contrast dye, such as MRI and contrast-enhanced mammography, are better at detecting all types of cancer compared with traditional mammograms.“If I had to take on cancer, I’m glad I was at UC Davis,” said Morris who is from Davis and obtained her undergraduate degree from UC Davis.“My own personal journey has only strengthened my resolve to give women the best possible chance of surviving breast cancer by getting them access to the best possible screening technology,” said Morris. €œI’m so excited to contribute to UC Davis’ world-class reputation as a leader in imaging technology and contemporary research programs as it continues to serve a large and diverse community.” If I had to take on cancer, I’m glad I was at UC Davis Health.—Elizabeth Morris, Chair, Department of RadiologyFormidable cancer fighters forming a strong bondMegan Daly and Elizabeth Morris have more than a couple of things in common.

They are female physicians at can you buy over the counter viagra UC Davis Health, both in the radiology field, and both determined to cure Morris’ breast cancer.Elizabeth Morris started her new position as chair of the Dept. Of Radiology the same time she started breast cancer treatment.“As a breast imaging expert, with an extensive background in diagnostic radiology, Liz can you buy over the counter viagra had a very thorough understanding of our radiation treatment plan before we even spoke. So, if anything, she asked fewer questions than many patients who don’t understand the concept of radiation or why we use it,” said Daly, a radiation oncologist.

She treated Morris with 16 fractions, or small doses, of radiation starting the first month of her tenure as chair of radiology at UC Davis.Radiology is used in diagnosing cancer through imaging radiation, and radiation oncology deploys radiation to target and destroy tumors after they are discovered.Daly and Morris share a doctor-patient relationship and have also become peers and personal friends as they took an aggressive approach to treating Morris’ breast cancer.“Megan has such a personable style with her patients and is so effective at explaining the advances in radiation oncology now available to breast cancer patients treated at the UC Davis Comprehensive Cancer Center,” Morris said.Daly specializes in a variety of radiotherapy techniques, including the image-guided radiation therapy used to treat Morris.“Liz was a great patient and, now as a breast cancer survivor, is in a unique position to understand the journey our patients take as they can you buy over the counter viagra bravely face and conquer cancer,” Daly said. UC Davis Comprehensive Cancer CenterUC Davis Comprehensive Cancer Center is the only National Cancer Institute-designated center serving the Central Valley and inland Northern California, a region of more than 6 million people can you buy over the counter viagra. Its specialists provide compassionate, comprehensive care for more than 100,000 adults and children every year and access to more than 200 active clinical trials at any given time.

Its innovative research program engages more than 240 scientists at UC Davis who work collaboratively to advance discovery of new tools to can you buy over the counter viagra diagnose and treat cancer. Patients have can you buy over the counter viagra access to leading-edge care, including immunotherapy and other targeted treatments. Its Office of Community Outreach and Engagement addresses disparities in cancer outcomes across diverse populations, and the cancer center provides comprehensive education and workforce development programs for the next generation of clinicians and scientists.

For more information, visit cancer.ucdavis.edu.(SACRAMENTO) The National Institute on Aging (NIA) is funding a UC Davis Health study designed to understand how early life health and behavior impact the can you buy over the counter viagra risk of cognitive decline, Alzheimer’s disease and related dementias. The $18 million, five-year grant from NIA is a renewal of funding for KHANDLE (Kaiser Healthy Aging and Diverse Life Experiences Study).The groundbreaking study looks at the whole spectrum of factors that may affect brain health.“The can you buy over the counter viagra KHANDLE study is the largest diverse cohort set up to answer questions about life course risk for late life brain outcomes, such as dementia, Alzheimer’s disease, cognitive decline, neurodegeneration and other brain diseases,” said Professor Rachel Whitmer, principal investigator on this grant and leader on KHANDLE. She is the chief of the division of epidemiology at the Department of Public Health Sciences and associate director of the Alzheimer’s Disease Research Center at UC Davis.A life course approach to studying dementiaKHANDLE researchers use a life course approach to study health and behavioral risks and protective factors associated with brain health outcomes.

This approach assesses the physical and social hazards from gestation can you buy over the counter viagra to midlife that may affect chronic disease risk and health outcomes in later life.Rachel Whitmer is the associate director of Alzheimer’s Disease Research Center at UC Davis.“Aging is a lifelong process with earlier life experiences shaping adult and elderly health,” Whitmer said. €œOur study allows us to do time travel in a sense, as we can leverage decades of information from medical records and health checkups, starting from the 1960 and 1970s.”The study reaches out to communities underrepresented in can you buy over the counter viagra research on dementia and related diseases. In its first cycle, it recruited 1712 elderly participants from Davis, Sacramento and the Bay Area.

The new grant will support the recruitment can you buy over the counter viagra of an additional 500 new participants.“What is particularly unique about our study is the diversity of the participants recruited. We are proud to have equal representation of Asian, Black, Latino and can you buy over the counter viagra white participants,” Whitmer said.While around 6 million people in the U.S. Are living with Alzheimer’s, there are huge disparities in rates of the disease and cognitive impairments across ethno-racial groups.

According to the Alzheimer’s Association, older Black Americans are about can you buy over the counter viagra twice as likely to have Alzheimer's or other dementias as older whites. Older Hispanics are can you buy over the counter viagra about 1.5 times as likely.This study is set up to uncover how and why that happens.The grant will also allow for a brain donation program run by Prof. Brittany Dugger, an assistant professor within the Department of Pathology and Laboratory Medicine and the UC Davis Alzheimer’s Disease Center.Prof.

Brittany Dugger runs brain donation program at can you buy over the counter viagra UC Davis Alzheimer’s Disease Center.“Brain donation is a very important part of dementia studies. One brain can have a huge impact, providing a plethora of information to advance scientific can you buy over the counter viagra research and the potential to improve treatments for future generations,” Dugger said. €œBrains are especially needed from diverse populations to help researchers improve diagnosis, treatments and prognosis of diseases for ALL individuals.”“The erectile dysfunction treatment epidemic has demonstrated the enormous disparities plaguing the U.S.

Understanding drivers of health disparities is one of the can you buy over the counter viagra greatest public health needs of our time,” Whitmer said. €œThe continuation of KHANDLE will help redress disparities in brain aging and provide needed public health information on reducing the risk of Alzheimer’s disease and related dementia.”Research from the Alzheimer’s Disease Research Center$16 million NIH award marks 30 years of Alzheimer’s disease research and careMapping the brain landscape for Alzheimer's disease using artificial intelligenceDementia looks different in brains of HispanicsHospital visits for extreme blood sugar highs and lows increase chance of dementia.

How to tell if a man is taking viagra

Funding will redirect people who use drugs from the criminal justice system August 26, 2020 - Peterborough, Ontario - Health buy viagra online with free samples Canada Problematic substance use has devastating impacts on how to tell if a man is taking viagra people, families and communities across Canada. Tragically, the erectile dysfunction treatment outbreak has worsened the situation for many Canadians struggling with substance use. The Government of Canada continues to address this serious public health issue by focusing on increasing access to quality treatment and harm reduction services how to tell if a man is taking viagra nationwide. Today, on behalf of the Honourable Patty Hajdu, Minister of Health, the Honourable Maryam Monsef, Minister for Women and Gender Equality and Rural Economic Development, announced more than $1.9 million in funding over the next three years to the Peterborough Police Service.

Through this funding, people who use drugs and experience mental health issues will how to tell if a man is taking viagra be connected to newly-created community-based outreach and support services. As part of this project, the Peterborough Police Service is working with local partners to create a community-based outreach team to increase the capacity for front-line community services to help people at risk who are referred by police. With the help of this new team, people who use drugs or experience mental health Read Full Article issues will be redirected from the criminal justice system how to tell if a man is taking viagra to harm reduction, peer support, health and social services. Additionally, this initiative will increase access to culturally appropriate services for Indigenous Peoples, LGBTQ2+ populations, youth, women, and those living with HIV through partnerships with other organizations such as Nogojiwanong Friendship Centre and Peterborough AIDS Research Network.

The Government of Canada is committed to working with partners, peer workers, people with lived and living experience and other stakeholders to ensure Canadians receive how to tell if a man is taking viagra the support they need to reduce the harms related to substance use.From. Health Canada Media advisory Government of Canada to announce funding for community-based, multi-sector outreach and support services in Peterborough PETERBOROUGH, August 25, 2020 — On behalf of the Federal Minister of Health, Patty Hajdu, the Honourable Maryam Monsef, Minister for Women and Gender Equality and Rural Economic Development, will announce federal funding to help connect people at risk of experiencing opioid-related overdoses to community-based outreach and support services in Peterborough.There will be a media availability immediately following the announcement.DateWednesday, August 26, 2020Time10:00 AM (EDT)LocationThe media availability will be held on Zoom.Zoom link. Https://us02web.zoom.us/j/89698543218Meeting ID how to tell if a man is taking viagra. 896 9854 3218 Contacts Media Inquiries:Cole DavidsonOffice of the Honourable Patty HajduMinister of Health613-957-0200Media RelationsHealth Canada613-957-2983hc.media.sc@canada.ca.

Funding will http://fieldrecordings.tv/archives/453 redirect people who use drugs from the criminal justice system August 26, 2020 - Peterborough, Ontario - Health Canada Problematic substance use has devastating impacts on people, families and can you buy over the counter viagra communities across Canada. Tragically, the erectile dysfunction treatment outbreak has worsened the situation for many Canadians struggling with substance use. The Government of Canada continues to address this serious public health issue by focusing on increasing access to quality treatment and harm can you buy over the counter viagra reduction services nationwide. Today, on behalf of the Honourable Patty Hajdu, Minister of Health, the Honourable Maryam Monsef, Minister for Women and Gender Equality and Rural Economic Development, announced more than $1.9 million in funding over the next three years to the Peterborough Police Service. Through this funding, people who use drugs and experience mental health issues will be connected to newly-created community-based outreach and support services can you buy over the counter viagra.

As part of this project, the Peterborough Police Service is working with local partners to create a community-based outreach team to increase the capacity for front-line community services to help people at risk who are referred by police. With the help of this new team, people who use drugs or experience mental health issues will be redirected from the criminal justice system to harm reduction, peer support, health can you buy over the counter viagra and social services. Additionally, this initiative will increase access to culturally appropriate services for Indigenous Peoples, LGBTQ2+ populations, youth, women, and those living with HIV through partnerships with other organizations such as Nogojiwanong Friendship Centre and Peterborough AIDS Research Network. The Government of Canada is committed to working with partners, peer workers, people with lived and living experience and can you buy over the counter viagra other stakeholders to ensure Canadians receive the support they need to reduce the harms related to substance use.From. Health Canada Media advisory Government of Canada to announce funding for community-based, multi-sector outreach and support services in Peterborough PETERBOROUGH, August 25, 2020 — On behalf of the Federal Minister of Health, Patty Hajdu, the Honourable Maryam Monsef, Minister for Women and Gender Equality and Rural Economic Development, will announce federal funding to help connect people at risk of experiencing opioid-related overdoses to community-based outreach and support services in Peterborough.There will be a media availability immediately following the announcement.DateWednesday, August 26, 2020Time10:00 AM (EDT)LocationThe media availability will be held on Zoom.Zoom link.

Https://us02web.zoom.us/j/89698543218Meeting ID can you buy over the counter viagra. 896 9854 3218 Contacts Media Inquiries:Cole DavidsonOffice of the Honourable Patty HajduMinister of Health613-957-0200Media RelationsHealth Canada613-957-2983hc.media.sc@canada.ca.

Dog viagra

In implementing dog viagra the ICH M9 guideline, it replaces the Health Canada guidance document. Biopharmaceutics Classification System Based Biowaiver. It is recommended that the Health Canada BCS Based Biowaiver Evaluation Template be completed for drug submissions that include a biowaiver request. As per its dog viagra commitment to ICH as a standing member, Health Canada is implementing this guidance with no modifications.

In implementing this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other Guidance documents are available dog viagra on the ICH Website. Please note that the ICH website is only available in English.

If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox. Should you have any questions or dog viagra comments regarding the content of the guidance, please contact. Health Canada - ICH CoordinatorE-mail. HPFB_ICH_DGPSA@hc-sc.gc.caUntitled Document August 26, 2020Our file number.

20-109235-116 Health Canada is pleased to announce the implementation of dog viagra International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9 Questions &. Answers. Biopharmaceutics Classification System (BCS) Based Biowaivers. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance dog viagra with the ICH Process.

The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. As per its commitment to ICH as a standing member, Health Canada is implementing this guidance with no modifications. In implementing this ICH guidance, Health Canada endorses the principles and practices dog viagra described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances.

This and other Guidance documents are available on the ICH Website. Please note that the ICH website is only dog viagra available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox. Should you have any questions or comments regarding the content of the guidance, please contact.

Biopharmaceutics Classification can you buy over the counter viagra System (BCS) Based Biowaivers August 26, How much zithromax cost 2020Our file number. 20-109235-116 Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9. Biopharmaceutics Classification System (BCS) Based Biowaivers. This guidance can you buy over the counter viagra has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.

The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. In implementing the ICH M9 guideline, it replaces the Health Canada guidance document. Biopharmaceutics Classification System can you buy over the counter viagra Based Biowaiver. It is recommended that the Health Canada BCS Based Biowaiver Evaluation Template be completed for drug submissions that include a biowaiver request.

As per its commitment to ICH as a standing member, Health Canada is implementing this guidance with no modifications. In implementing this ICH guidance, Health Canada can you buy over the counter viagra endorses the principles and practices described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other Guidance documents are available on the ICH Website.

Please note that the ICH website is only available can you buy over the counter viagra in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox. Should you have any questions or comments regarding the content of the guidance, please contact. Health Canada can you buy over the counter viagra - ICH CoordinatorE-mail.

HPFB_ICH_DGPSA@hc-sc.gc.caUntitled Document August 26, 2020Our file number. 20-109235-116 Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9 Questions &. Answers. Biopharmaceutics Classification System (BCS) Based Biowaivers.

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. As per its commitment to ICH as a standing member, Health Canada is implementing this guidance with no modifications. In implementing this ICH guidance, Health Canada endorses the principles and practices described therein.

This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances.

Viagra for women price

Although their viagra for women price satisfaction rate among users is more than 70 percent, and they are credited for providing their users with a greater quality of life, they remain among the most misunderstood–and stigmatized – devices in the medical world today. Even though they successfully amplify sound for millions of Americans, there are approximately 25 million more who would benefit from their use, but won’t wear them. Hearing aids come in a variety of stylesand colors.

They generally either viagra for women price fitin the ear (top) or behind the ear (bottom). Why?. Some are afraid the devices make them look old.

Others refuse to believe they have a hearing viagra for women price problem. Others don’t believe they will improve their ability to hear because of an experience a friend or family member shared. Sound familiar?.

Maybe it’s time to familiarize viagra for women price yourself with a few FAQs about hearing aids. What is a hearing aid?. A hearing aid is a small electronic device worn behind the ear or in the ear canal.

It amplifies sound so that a person viagra for women price with hearing loss can hear sound better. Hearing devices have three components. A microphone, amplifier and speaker.

Sound comes through the microphone and is viagra for women price converted into an electrical signal and sent to the amplifier. The amplifier increases the power of the signals and sends them to the ear through the speaker. Today’s hearing aid is much smaller and more powerful than the hearing devices our parents and grandparents wore even 10 years ago.

Advances in digital viagra for women price technology make them better able to distinguish conversation in noisy environments. Many are Bluetooth capable and connect with smartphones and other personal electronic devices we now use on a daily basis. More.

See the different types and styles of hearing aids Can hearing viagra for women price aids improve my hearing?. That depends on what type of hearing loss you have. Sensorineural hearing loss is caused by damage to the sensory hair cells of the inner ear.

This damage can be caused by exposure to loud noise, illness, viagra for women price medication, injury or age. If your hearing healthcare professional determines you have sensorineural hearing loss, you will probably benefit from wearing a hearing aid. Age-related hearing loss, generally a subset of sensorineural, is the loss of hearing that occurs in most people as they age.

This condition, known viagra for women price medically as presbycusis, is common and can often be improved with hearing aids. Conductive hearing loss, however is usually caused by an obstruction in the ear canal, such as swelling due to an ear or a benign tumor. If your hearing healthcare professional determines your hearing loss is conductive, your hearing may return to normal once the obstruction has been removed.

If your hearing does not return to normal, you may benefit from wearing a hearing aid, viagra for women price cochlear implant or bone-anchored hearing system. What should I look for when choosing a hearing aid?. That depends on your lifestyle and your budget.

An active person who enjoys traveling and athletic activities will most likely need a different viagra for women price model of hearing aid than someone who spends most of their time at home watching television. Your hearing healthcare professional will ask a variety of questions to help you determine what type of amplification you need, then work with you to make sure your hearing device works properly to help you hear the sounds that are most important to you. Remember that friend who told you they keep their hearing aids in the dresser drawer?.

That just might be because they weren’t honest with their hearing healthcare professional about viagra for women price their expectations and lifestyle, or didn’t schedule follow-up visits as requested. How long will it take for me to adjust to wearing hearing aids?. Wondering what to expect from new hearing aids?.

Adjusting to hearing aids varies from person to person and depends upon how long you waited to treat viagra for women price your hearing loss as well as its severity. Although our ears collect noise from our environment, it’s actually our brain that translates it into recognizable sound. If hearing loss is left untreated, the auditory part of your brain can actually atrophy, in which case your rehabilitation may take a while longer.

You’ll also want to wear them as recommended viagra for women price. Following your doctor’s orders improves your chances for success. More.

7 tips for getting used to hearing aids How long do viagra for women price hearing aids last?. With proper use and maintenance, hearing aids typically last between three and five years. Can I return my hearing aids if I’m not satisfied?.

Many hearing viagra for women price centers offer a trial period to ensure you are satisfied. Be sure to ask your hearing healthcare professional about their policies before you purchase any hearing device. How can I find out if I need a hearing aid?.

The best way to find out if you need a hearing aid viagra for women price is to have your hearing tested by a hearing healthcare professional. A thorough hearing test will take approximately an hour of your time during which you will most likely be asked to provide your health history, undergo a series of hearing assessments, and discuss your lifestyle and expectations for better hearing. Afterward, a hearing healthcare professional will discuss the results of your test with you and, if its determined that your hearing can benefit from amplification, discuss next steps.

If your hearing has changed recently or you suspect you have hearing loss, make an appointment to see a hearing viagra for women price healthcare professional in your community as soon as possible. There’s a lot to hear in this world – laughing children, music, the sound of someone you love calling your name – and hearing aids may be able to help you hear them.When deciding on a new pair of hearing aids, you should consider how long they will last. Just like buying a car, the actual mileage may vary.Most modern high-quality hearing aids have a life expectancy on average between three and seven years.

However, keep in mind that two viagra for women price people can buy exactly the same hearing aids and have them last vastly different amounts of time. Here's why. New hearing aids generally last aroundfive years, but this depends on a lotof different factors.

Factors impacting how viagra for women price long hearing aids will last There are at least nine factors that impact the average lifespan of a hearing aid. Materials used to make hearing aids Frequency of cleaning Where hearing aids are worn How hearing aids are stored Hearing aid style A person's body physiology Frequency of maintenance Technological advancements Unique hearing needs 1. Materials used to make hearing aids Although they are designed to be durable, hearing aids are made of plastic, metal, silicon, polymers and other materials that may be subject to some degree of structural degradation over time.

Most hearing aids sold today have a protective nanocoating on them to resist water, dust and moisture, but you should still treat viagra for women price them gently to protect them from shock and impacts. 2. Frequency of cleaning Most people would never dream of going months without washing their hair, face or body.

However, they forget their hearing aids are exposed to the same viagra for women price environment—moisture, dust, skin oils and sweat, extreme temperatures and sunlight. All this occurs in addition to the earwax generated by your ear canal in its natural cleaning process. Some wearers only have their hearing aids professionally cleaned twice a year or so.

This takes a toll on hearing aids viagra for women price and can significantly reduce their life expectancy. To help your hearing aids life expectancy, clean them daily as directed by your hearing care practitioner and have them professionally cleaned in the hearing clinic every three to four months. 3.

Where hearing aids are worn viagra for women price Hearing aids that are consistently in damp or dusty environments often have more performance issues than other hearing aids. If you’re concerned about the environments in which you wear your hearing aids, consult your hearing care professional for ideas about protective measures. You may need to use protective sleeves or schedule more frequent professional cleanings to extend the life of your hearing aids.

4. How hearing aids are stored The way hearing aids are stored when you’re not wearing them can also be a factor in hearing aid life expectancy. For hearing aids with disposable batteries, storing hearing aids with the battery door open will keep them safer.

A case with a dehumidifier will keep them drier as well, which will also help them last longer. Ask your hearing care practitioner what type of storage case or dehumidifier options would work best for your hearing aids. For rechargeable hearing aids, lithium batteries last about four to five years.

Just like with smartphones, the battery lifespan gets shorter the longer you own the device. If you notice your battery draining faster than usual, speak to your hearing care provider about whether new rechargeable batteries will help, or if you should get new devices. 5.

Style of hearing aids Conventional wisdom in the hearing aid industry is that behind-the-ear (BTE) styles tend to have a long lifespan than in-the-ear (ITE) styles. The reason behind this wisdom is more of the electronic components sit in the damp environment of the ear canal with ITE styles. However, recent technical advancements in nanocoatings on internal and external components may soon make this durability difference a thing of the past.

6. Your body’s physiology Some body chemistries are harder on the plastic and metal components of hearing aids and tend to discolor or degrade parts much faster than others. Some people have very oily skin, produce a lot of earwax or sweat profusely–all of these factors can impact hearing aid life, too.

You can’t control these things, of course, but if you have any of these issues you should discuss them with your hearing care practitioner when you’re selecting hearing aids. 7. Frequency of maintenance Most hearing aids have some readily-replaceable parts, such as wax guards, earmold tubing and silicone dome earpiece tips.

These parts are regularly replaced during routine maintenance visits with your hearing care practitioner. There are other parts which can usually be replaced or repaired in the clinic if they become damaged or nonfunctional, like battery doors, earmolds, external speakers and microphone covers. These types of maintenance activities are very important for making your hearing aids last as long as possible.

8. Technological advancements Hearing aid technology changes often.Many new hearing aids can connectto phones via Bluetooth, for example. Obsolescence can become an issue for very old hearing aids.

After several years (usually between five and 10), hearing aid manufacturers may stop making replacement parts for a particular aid, which may make repairs on old hearing aids difficult or impossible.

Even though they successfully amplify sound for millions of http://imlja.net/pf/property-for-sale-6/ Americans, there are approximately 25 million more who would benefit from their use, but won’t wear them can you buy over the counter viagra. Hearing aids come in a variety of stylesand colors. They generally either fitin the ear (top) or behind the ear (bottom). Why?. Some are afraid the devices make them look old.

Others refuse to believe they have a hearing problem. Others don’t believe they will improve their ability to hear because of an experience a friend or family member shared. Sound familiar?. Maybe it’s time to familiarize yourself with a few FAQs about hearing aids. What is a hearing aid?.

A hearing aid is a small electronic device worn behind the ear or in the ear canal. It amplifies sound so that a person with hearing loss can hear sound better. Hearing devices have three components. A microphone, amplifier and speaker. Sound comes through the microphone and is converted into an electrical signal and sent to the amplifier.

The amplifier increases the power of the signals and sends them to the ear through the speaker. Today’s hearing aid is much smaller and more powerful than the hearing devices our parents and grandparents wore even 10 years ago. Advances in digital technology make them better able to distinguish conversation in noisy environments. Many are Bluetooth capable and connect with smartphones and other personal electronic devices we now use on a daily basis. More.

See the different types and styles of hearing aids Can hearing aids improve my hearing?. That depends on what type of hearing loss you have. Sensorineural hearing loss is caused by damage to the sensory hair cells of the inner ear. This damage can be caused by exposure to loud noise, illness, medication, injury or age. If your hearing healthcare professional determines you have sensorineural hearing loss, you will probably benefit from wearing a hearing aid.

Age-related hearing loss, generally a subset of sensorineural, is the loss of hearing that occurs in most people as they age. This condition, known medically as presbycusis, is common and can often be improved with hearing aids. Conductive hearing loss, however is usually caused by an obstruction in the ear canal, such as swelling due to an ear or a benign tumor. If your hearing healthcare professional determines your hearing loss is conductive, your hearing may return to normal once the obstruction has been removed. If your hearing does not return to normal, you may benefit from wearing a hearing aid, cochlear implant or bone-anchored hearing system.

What should I look for when choosing a hearing aid?. That depends on your lifestyle and your budget. An active person who enjoys traveling and athletic activities will most likely need a different model of hearing aid than someone who spends most of their time at home watching television. Your hearing healthcare professional will ask a variety of questions to help you determine what type of amplification you need, then work with you to make sure your hearing device works properly to help you hear the sounds that are most important to you. Remember that friend who told you they keep their hearing aids in the dresser drawer?.

That just might be because they weren’t honest with their hearing healthcare professional about their expectations and lifestyle, or didn’t schedule follow-up visits as requested. How long will it take for me to adjust to wearing hearing aids?. Wondering what to expect from new hearing aids?. Adjusting to hearing aids varies from person to person and depends upon how long you waited to treat your hearing loss as well as its severity. Although our ears collect noise from our environment, it’s actually our brain that translates it into recognizable sound.

If hearing loss is left untreated, the auditory part of your brain can actually atrophy, in which case your rehabilitation may take a while longer. You’ll also want to wear them as recommended. Following your doctor’s orders improves your chances for success. More. 7 tips for getting used to hearing aids How long do hearing aids last?.

With proper use and maintenance, hearing aids typically last between three and five years. Can I return my hearing aids if I’m not satisfied?. Many hearing centers offer a trial period to ensure you are satisfied. Be sure to ask your hearing healthcare professional about their policies before you purchase any hearing device. How can I find out if I need a hearing aid?.

The best way to find out if you need a hearing aid is to have your hearing tested by a hearing healthcare professional. A thorough hearing test will take approximately an hour of your time during which you will most likely be asked to provide your health history, undergo a series of hearing assessments, and discuss your lifestyle and expectations for better hearing. Afterward, a hearing healthcare professional will discuss the results of your test with you and, if its determined that your hearing can benefit from amplification, discuss next steps. If your hearing has changed recently or you suspect you have hearing loss, make an appointment to see a hearing healthcare professional in your community as soon as possible. There’s a lot to hear in this world – laughing children, music, the sound of someone you love calling your name – and hearing aids may be able to help you hear them.When deciding on a new pair of hearing aids, you should consider how long they will last.

Just like buying a car, the actual mileage may vary.Most modern high-quality hearing aids have a life expectancy on average between three and seven years. However, keep in mind that two people can buy exactly the same hearing aids and have them last vastly different amounts of time. Here's why. New hearing aids generally last aroundfive years, but this depends on a lotof different factors. Factors impacting how long hearing aids will last There are at least nine factors that impact the average lifespan of a hearing aid.

Materials used to make hearing aids Frequency of cleaning Where hearing aids are worn How hearing aids are stored Hearing aid style A person's body physiology Frequency of maintenance Technological advancements Unique hearing needs 1. Materials used to make hearing aids Although they are designed to be durable, hearing aids are made of plastic, metal, silicon, polymers and other materials that may be subject to some degree of structural degradation over time. Most hearing aids sold today have a protective nanocoating on them to resist water, dust and moisture, but you should still treat them gently to protect them from shock and impacts. 2. Frequency of cleaning Most people would never dream of going months without washing their hair, face or body.

However, they forget their hearing aids are exposed to the same environment—moisture, dust, skin oils and sweat, extreme temperatures and sunlight. All this occurs in addition to the earwax generated by your ear canal in its natural cleaning process. Some wearers only have their hearing aids professionally cleaned twice a year or so. This takes a toll on hearing aids and can significantly reduce their life expectancy. To help your hearing aids life expectancy, clean them daily as directed by your hearing care practitioner and have them professionally cleaned in the hearing clinic every three to four months.

3. Where hearing aids are worn Hearing aids that are consistently in damp or dusty environments often have more performance issues than other hearing aids. If you’re concerned about the environments in which you wear your hearing aids, consult your hearing care professional for ideas about protective measures. You may need to use protective sleeves or schedule more frequent professional cleanings to extend the life of your hearing aids. 4.

How hearing aids are stored The way hearing aids are stored when you’re not wearing them can also be a factor in hearing aid life expectancy. For hearing aids with disposable batteries, storing hearing aids with the battery door open will keep them safer. A case with a dehumidifier will keep them drier as well, which will also help them last longer. Ask your hearing care practitioner what type of storage case or dehumidifier options would work best for your hearing aids. For rechargeable hearing aids, lithium batteries last about four to five years.

Just like with smartphones, the battery lifespan gets shorter the longer you own the device. If you notice your battery draining faster than usual, speak to your hearing care provider about whether new rechargeable batteries will help, or if you should get new devices. 5. Style of hearing aids Conventional wisdom in the hearing aid industry is that behind-the-ear (BTE) styles tend to have a long lifespan than in-the-ear (ITE) styles. The reason behind this wisdom is more of the electronic components sit in the damp environment of the ear canal with ITE styles.

However, recent technical advancements in nanocoatings on internal and external components may soon make this durability difference a thing of the past. 6. Your body’s physiology Some body chemistries are harder on the plastic and metal components of hearing aids and tend to discolor or degrade parts much faster than others. Some people have very oily skin, produce a lot of earwax or sweat profusely–all of these factors can impact hearing aid life, too. You can’t control these things, of course, but if you have any of these issues you should discuss them with your hearing care practitioner when you’re selecting hearing aids.

7. Frequency of maintenance Most hearing aids have some readily-replaceable parts, such as wax guards, earmold tubing and silicone dome earpiece tips. These parts are regularly replaced during routine maintenance visits with your hearing care practitioner. There are other parts which can usually be replaced or repaired in the clinic if they become damaged or nonfunctional, like battery doors, earmolds, external speakers and microphone covers. These types of maintenance activities are very important for making your hearing aids last as long as possible.

8. Technological advancements Hearing aid technology changes often.Many new hearing aids can connectto phones via Bluetooth, for example. Obsolescence can become an issue for very old hearing aids. After several years (usually between five and 10), hearing aid manufacturers may stop making replacement parts for a particular aid, which may make repairs on old hearing aids difficult or impossible. Software used to program hearing aids also changes over time and eventually becomes obsolete.