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
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Abstract
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.
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<title>Federal Register, Volume 86 Issue 110 (Thursday, June 10, 2021)</title>
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[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30960]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="/cdn-cgi/l/email-protection#9af9feffe8fefbeefbe9eefbf4fefbe8fee9dafcfefbb4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="2142454453454055405255404f4540534552614745400f4949520f464e57">[email protected]</span></a>.
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]
BILLING CODE 4164-01-P
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