30960 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 

1The Animal Rule refers to FDA’s regulations for 

the approval of new drugs and biological products 

when human efficacy studies are not ethical or 

feasible (see 21 CFR 314.600–650 for drugs and 21 

CFR 601.90–95 for biologics). 

Dated: June 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12191 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0315] 

Electronic Study Data Submission; 

Data Standards; Support and 

Requirement Begin for Study Data 

Tabulation Model Version 1.8 With 

Standard for Exchange of Nonclinical 

Data Implementation Guide—Animal 

Rule Version 1.0; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document that appeared in the Federal 

Register on March 11, 2020. The 

document announced that FDA will 

begin supporting the Clinical Data 

Interchange Standards Consortium 

(CDISC) for Study Data Tabulation 

Model version 1.8 (SDTM v1.8), and 

CDISC Standard for Exchange of 

Nonclinical Data Implementation 

Guide—Animal Rule version 1.0 

(SENDIG–AR v1.0) on March 15, 2020, 

and that these new standards will be 

required in submissions to FDA 

effective March 15, 2022. The document 

omitted the 36-month implementation 

period for certain investigational new 

drugs applications (INDs) as required by 

the guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data’’ which is referenced in that 

document. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Chenoa Conley, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1117, 

Silver Spring, MD 20993–0002, 301– 

796–0035, email: cderdatastandards@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of March 11, 

2020 (85 FR 14205), in FR Doc. 2020– 

04898, the following corrections are 

made: 

1. On page 14205, in the second 

column, the first sentence of the 

SUMMARY is corrected to read: ‘‘The Food 

and Drug Administration (FDA or 

Agency) Center for Drug Evaluation and 

Research (CDER) is announcing that 

FDA will begin supporting the Clinical 

Data Interchange Standards Consortium 

(CDISC) for Study Data Tabulation 

Model version 1.8 (SDTM v1.8), and 

CDISC Standard for Exchange of 

Nonclinical Data Implementation 

Guide—Animal Rule version 1.0 

(SENDIG–AR v1.0) on March 15, 2020, 

and that these new standards will be 

required in submissions for studies that 

start after March 15, 2022 (for new drug 

applications (NDAs), abbreviated new 

drug applications (ANDAs), and 

biologics license applications (BLAs)), 

and in submissions for studies that start 

after March 15, 2023 (for certain 

investigational new drug applications 

(INDs)), that are submitted to CDER.’’ 

2. On page 14206, in the first column, 

the last sentence of the document is 

corrected to read as follows: ‘‘FDA will 

begin supporting SDTM v1.8 and 

SENDIG–AR v1.0 on March 15, 2020, 

and the use of these new standards will 

be required in Animal Rule 1

submissions for studies that start after 

March 15, 2022 (for NDAs, ANDAs, and 

BLAs), and in Animal Rule submissions 

for studies that start after March 15, 

2023 (for certain INDs), that are 

submitted to CDER.’’ 

Dated: June 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12198 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0362] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice for Finished 

Pharmaceuticals, Including Medical 

Gases, and Active Pharmaceutical 

Ingredients 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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 July 12, 

2021. 

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 0910–0139. 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. 

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 active 

pharmaceutical ingredients (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 current good manufacturing 

practice (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 


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