12466 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

Approval Under OMB Delegated 

Authority of the Temporary Revision of 

the Following Information Collection 

Report title: Reporting and Disclosure 

Requirements Associated with 

Emergency Lending Under Section 

13(3). 

Agency form number: FR A. 

OMB control number: 7100–0373. 

Frequency: Event-generated. 

Respondents: Entities or persons 

borrowing under an emergency lending 

program or facility established pursuant 

to section 13(3) of the Federal Reserve 

Act. 

Estimated number of respondents: FR 

A–1: 4,914; FR A–2: 3,073; FR A–3: 

12,150; FR A–4: 5. 

Estimated average hours per response: 

FR A–1: 8; FR A–2: 40; FR A–3, Lender 

per-loan certifications: 2; FR A–3, 

Borrower certifications: 8; FR A–4: 1. 

Estimated annual burden hours: 

257,305. 

General description of report: The 

Board’s Regulation A (12 CFR part 201) 

establishes policies and procedures with 

respect to emergency lending under 

section 13(3) of the Federal Reserve Act, 

as required by sections 1101 and 1103 

of the Dodd-Frank Wall Street Reform 

and Consumer Protection Act. 

Regulation A requires that borrowers 

make two certifications in order to 

participate in any emergency lending 

authorized under section 13(3). These 

certifications, designated in this 

information collection as FR A–1, 

include that the borrowers are not 

insolvent and that they cannot obtain 

adequate credit accommodation. 

In addition to these certifications, the 

Board may establish additional 

certification requirements for an 

individual emergency lending facility. 

The second part of the FR A information 

collection, the FR A–2, pertains to 

reporting requirements associated with 

individual facilities that are related to 

requirements of the Coronavirus Aid, 

Relief, and Economic Security Act 

(CARES Act). The third part of FR A, 

designated as the FR A–3, pertains to 

reporting requirements specific to the 

Main Street Expanded Loan Facility, the 

Main Street New Loan Facility, the 

Main Street Priority Loan Facility, the 

Nonprofit Organization Expanded Loan 

Facility, and the Nonprofit Organization 

New Loan Facility (collectively, the 

‘‘Main Street Lending Program’’). The 

fourth part of FR A, designated as the 

FR A–4, pertains to a disclosure 

requirement for Paycheck Protection 

Program (PPP) borrowers seeking to 

reduce the calculation of existing 

outstanding and undrawn available debt 

to participate in the Main Street 

Lending Program. 

Legal authorization and 

confidentiality: The FR A is authorized 

pursuant to section 13(3) of the Federal 

Reserve Act, which sets out 

requirements for emergency lending. 

The obligation to respond is required to 

obtain a benefit. 

The information collected under the 

FR A may be kept confidential under 

exemption 4 of the Freedom of 

Information Act, which protects 

commercial or financial information 

obtained from a person that is privileged 

or confidential. 

Current actions: The Board is revising 

the FR A information collection to 

address information collection 

requirements related to borrowers under 

the Main Street Lending Program, who 

participate in the PPP. Participating 

borrowers seeking to reduce the 

calculation of ‘‘existing outstanding and 

undrawn available debt’’ for purposes of 

determining the maximum allowable 

loan amount under the Main Street 

Lending Program must provide its 

eligible lender either with the Small 

Business Administration form it has 

already completed and submitted to its 

PPP lender (which may be the same 

lender), or must complete and submit a 

Board form to its Main Street lender 

during the Main Street loan 

underwriting process, as applicable. The 

FR A respondent counts for all parts of 

the information collection are being 

revised to reflect updated estimates of 

lender participation in the Main Street 

Lending Program. 

Detailed Discussion of Public 

Comments: On March 2, 2020, the Board 

published a notice in the Federal 

Register (85 FR 12295) requesting 

public comment for 60 days on the 

extension, without revision, of the FR A. 

One comment was received; it did not 

address aspects of the information 

collection as described in 5 CFR 

1320.8(d). On May 15, 2020, following 

the temporary approval of a first set of 

revisions to the FR A, the Board 

published a Federal Register notice (85 

FR 29447) requesting public comment 

for 60 days on those temporary 

revisions. On June 4, 2020, following 

the temporary approval of a second set 

of revisions to the FR A, the Board 

published a Federal Register notice (85 

FR 34448) requesting public comment 

for 60 days on those temporary 

revisions. On August 21, 2020, 

following the temporary approval of a 

third set of revisions to the FR A, the 

Board published a Federal Register 

notice (85 FR 51715) requesting public 

comment for 60 days on those 

temporary revisions. Comments in 

response to all of those requests for 

comment are expected to be considered, 

along with any comments received in 

response to this request for comment. 

Board of Governors of the Federal Reserve 

System, February 26, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–04362 Filed 3–2–21; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0362] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practice for 

Manufacturing, Processing, Packing, 

and Holding of Finished 

Pharmaceuticals, Including Medical 

Gases, and Active Pharmaceutical 

Ingredients 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed extension of an existing 

collection of information, and to allow 

60 days for public comment in response 

to the notice. This notice solicits 

comments on the information collection 

associated with current good 

manufacturing practice (CGMP) for 

drugs, finished pharmaceuticals, 

including medical gases, and active 

pharmaceutical ingredients (APIs). 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 3, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before May 3, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 3, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 


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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 12467 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2011–N–0362 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Current 

Good Manufacturing Practice 

Regulations for Manufacturing, 

Processing, Packing, and Holding of 

Finished Pharmaceuticals, Including 

Medical Gases, and Active 

Pharmaceutical Ingredients.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Current Good Manufacturing Practice 

for Finished Pharmaceuticals, Including 

Medical Gases, and Active 

Pharmaceutical Ingredients—21 CFR 

parts 210 and 211 and 21 U.S.C 

351(a)(2)(B). 

OMB Control Number 0910–0139— 

Extension 

This information collection supports 

FDA regulations that govern the 

manufacture, processing, packing, or 

holding of finished pharmaceuticals, 

including medical gases, and APIs. 

Under section 501(a)(2)(B) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C 351(a)(2)(B)), a 

drug is adulterated if the methods used 

in, or the facilities or controls used for 

its manufacture, processing, packing, or 

holding do not conform to or are not 

operated or administered in conformity 

with CGMP regulations. FDA is 

responsible for enforcing the FD&C Act 

as well as related statutes, including the 

Public Health Service Act. Congress 

enacted these laws to ensure that 

covered products meet applicable 

requirements regarding the safety, 

identity and strength, and the quality 

and purity characteristics they purport 

or are represented to possess, and are 

labeled with adequate warnings and 

instructions for use. 

The pharmaceutical or drug qualityrelated regulations appear in several 

parts of Title 21 Code of Federal 

Regulations (CFR) (Food and Drugs), 

including sections in parts 1 through 99, 

200 through 299, 300 through 499, 600 

through 799, and 800 through 1299. The 


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12468 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

regulations enable a common 

understanding of the regulatory process 

by describing requirements to be 

followed by drug manufacturers, 

applicants, and FDA. Under part 211 (21 

CFR part 211; see 21 CFR 211.94(e)(1)), 

specific requirements for medical gas 

containers and closures are also found 

in the regulations. Finally, the 

information collection also supports 

regulations codified under parts 610 and 

680 (21 CFR parts 610 and 680), which 

reference certain CGMP regulations in 

part 211 (see §§ 610.12(g), 610.13(a)(2), 

610.18(d), 680.2(f), and 680.3(f)). 

These regulations set forth 

information collection requirements that 

allow FDA to meet its public health 

protection responsibilities. Products 

that fail to comply with CGMP 

requirements may be rendered 

adulterated under section 501(a)(2)(B) of 

the FD&C Act. To demonstrate that their 

products comply with the requirements 

of section 501(a)(2)(B), API 

manufacturers must maintain CGMP 

records; therefore, we have counted 

them among respondents who incur 

burden for the information collection. In 

the table below, we have included an 

additional 1,260 respondents to reflect 

API manufacturers not included in our 

previous submission for renewal. 

To assist respondents with the 

information collection requirements for 

medical gases, we developed a draft 

guidance for industry entitled ‘‘Current 

Good Manufacturing Practice for 

Medical Gases.’’ This guidance, when 

finalized will discuss our 

recommendations regarding compliance 

with applicable requirements found in 

the regulations as they apply to these 

products. The guidance is available for 

download from our internet site at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/current-goodmanufacturing-practice-medical-gases. 

We believe the recommendations, if 

followed, will help respondents focus 

their information collection activities 

most efficiently with regard to 

demonstrating regulatory compliance. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN—APIS, FINISHED PHARMACEUTICALS, AND MEDICAL GASES 1 2

Section 501(a)(2)(B) of the FD&C 

Act; parts 210 and 211 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records Average burden per recordkeeping Total hours 

CGMP API Manufacturers ................ 1,260 256 322,560 0.82 (49.2 minutes) .......................... 264,499 

CGMP Finished Pharmaceuticals 

Manufacturers (excludes medical 

gases).

3,270 299 977,730 0.64 (38 minutes) ............................. 625,747 

CGMP Medical Gases Manufacturers.2,284 280 639,520 0.62 (37 minutes) ............................. 396,502 

Total ........................................... ........................ ........................ 1,939,810 ........................................................... 1,286,748 

1There are no capital or operating and maintenance costs associated with the information collection. 

2 Records and burden per activity have been averaged and rounded. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 29,073 hours and 

1,762 records annually for CGMP for 

finished pharmaceutical manufacturers, 

excluding those manufacturers of 

medical gases. Our estimated burden for 

the information collection also reflects 

an overall decrease of 486 hours and 

1,574 records annually for medical gas 

manufacturers. Our inclusion of API 

manufacturers in this collection 

represents an addition of 264,499 hours 

and 322,560 records prepared. 

Dated: February 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04380 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0132] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and Drug 

Administration’s Study of How 

Consumers Use Flavors To Make 

Inferences About Electronic Nicotine 

Delivery System Product Qualities and 

Intentions To Use (Phase 2) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on FDA’s 

investigation of how consumers use 

flavors to make inferences about 

Electronic Nicotine Delivery System 

(ENDS) product qualities and intentions 

to use. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 3, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before May 3, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 3, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https:// 


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