[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.

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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.''
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    \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]
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