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, 30960 [2021-12198]

Download as PDF 30960 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 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. 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. khammond on DSKJM1Z7X2PROD with NOTICES 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.’’ SUMMARY 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. SUPPLEMENTARY INFORMATION: ACTION: Correction SUMMARY: 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 VerDate Sep<11>2014 17:15 Jun 09, 2021 Jkt 253001 Notice. The Food and Drug Administration (FDA or we) is 1 The 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). PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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 E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12198]


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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: [email protected].

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.''
---------------------------------------------------------------------------

    \1\ The 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 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