Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices 77223 

dependent DDI studies, alternative 

approaches for evaluating pHdependent DDIs, and extrapolating 

clinical DDI study results with drug 

classes of ARAs. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Evaluation of Gastric pH-Dependent 

Drug Interactions With Acid-Reducing 

Agents: Study Design, Data Analysis, 

and Clinical Implications.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information for submissions of 

investigational new drug applications, 

new drug applications, and biologic 

license applications in 21 CFR parts 

312, 314, and 601 have been approved 

under OMB control numbers 0910– 

0014; 0910–0001; and 0910–0338, 

respectively. In addition, the 

submission of prescription drug labeling 

under 21 CFR 201.56 and 201.57 has 

been approved under OMB control 

number 0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs or https://

www.regulations.gov. 

Dated: November 25, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26510 Filed 11–30–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0076] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Electronic 

Records; Electronic Signatures 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by December 

31, 2020. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0303. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Electronic Records; Electronic 

Signatures—21 CFR Part 11 

OMB Control Number 0910–0303— 

Extension 

This information collection supports 

FDA regulations in part 11 (21 CFR part 

11), which govern criteria for 

acceptance of electronic records, 

electronic signatures, and handwritten 

signatures executed to electronic 

records as equivalent to paper records. 

Under these regulations, records and 

reports may be submitted to us 

electronically provided that we have 

stated our ability to accept the records 

electronically in an Agency-established 

public docket and that the other 

requirements of part 11 are met. 

The recordkeeping provisions in 

§§ 11.10, 11.30, 11.50, and 11.300 (21 

CFR 11.10, 11.30, 11.50, and 11.300) 

require the following standard operating 

procedures to ensure appropriate use of 

and precautions for systems using 

electronic records and signatures: (1) 

§ 11.10 specifies procedures and 

controls for persons who use closed 

systems to create, modify, maintain, or 

transmit electronic records; (2) § 11.30 

specifies procedures and controls for 

persons who use open systems to create, 

modify, maintain, or transmit electronic 

records; (3) § 11.50 specifies procedures 

and controls for persons who use 

electronic signatures; and (4) § 11.300 

specifies controls to ensure the security 

and integrity of electronic signatures 

based upon use of identification codes 

in combination with passwords. The 

reporting provision (§ 11.100) requires 

persons to certify to us in writing that 

they will regard electronic signatures 

used in their systems as the legally 

binding equivalent of traditional 

handwritten signatures. 

The burden created by the 

information collection provision of this 

regulation is a one-time burden 

associated with the creation of standard 

operating procedures, validation, and 

certification. We anticipate that the use 

of electronic media will substantially 

reduce the paperwork burden associated 

with maintaining FDA-required records. 

The respondents are businesses and 

other for-profit organizations, State or 

local governments, Federal Agencies, 

and nonprofit institutions. 

To assist respondents with the 

information collection we have 

developed the guidance document 

entitled ‘‘Guidance for Industry: Part 11, 

Electronic Records; Electronic 

Signatures—Scope and Application,’’ 

available on our website at https://

www.fda.gov/media/75414/download. 

While we do not believe the guidance 

creates any attendant burden, it 

describes the Agency’s thinking 

regarding persons who, in fulfillment of 

a requirement in a statute or another 

part of FDA’s regulations to maintain 

records or submit information to FDA, 

have chosen to maintain the records or 

submit designated information 

electronically and, as a result, have 

become subject to part 11. Part 11 

applies to records in electronic form 

that are created, modified, maintained, 

archived, retrieved, or transmitted 

under any records requirements set 

forth in Agency regulations. Part 11 also 


khammond on DSKJM1Z7X2PROD with NOTICES4
77224 Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices 

applies to electronic records submitted 

to the Agency under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, even if such records 

are not specifically identified in Agency 

regulations (§ 11.1). 

In the Federal Register of August 13, 

2020 (85 FR 49381), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. One comment was received 

but was not responsive to the 

information collection topics solicited. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

§ 11.100 ................................................................................ 4,500 1 4,500 1 4,500 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

record per 

recordkeepers 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

§ 11.10 .................................................................................. 2,500 1 2,500 20 50,000 

§ 11.30 .................................................................................. 2,500 1 2,500 20 50,000 

§ 11.50 .................................................................................. 4,500 1 4,500 20 90,000 

§ 11.300 ................................................................................ 4,500 1 4,500 20 90,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 280,000 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26487 Filed 11–30–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of NIGMS SCORE 

Applications. 

Date: December 17, 2020. 

Time: 4:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, Bethesda, 

MD 20892 (Video Meeting). 

Contact Person: John J. Laffan, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN18J, Bethesda, 

MD 20892, (301) 594–2773, laffanjo@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.859, 

Biomedical Research and Research Training, 

National Institutes of Health, HHS) 

Dated: November 24, 2020. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–26431 Filed 11–30–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; Microbiome 

and Aging 1. 

Date: January 7, 2021. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Video Meeting). 

Contact Person: Bita Nakhai, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute on Aging, National 

Institutes of Health, Gateway Bldg., 2C212, 

7201 Wisconsin Avenue, Bethesda, MD 

20892, (301) 402–7701, nakhaib@nia.nih.gov. 


khammond on DSKJM1Z7X2PROD with NOTICES4