[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 20987-20988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1221]


Electronic Submissions: Data Standards; Support and Requirement 
for the Clinical Data Interchange Standards Consortium Standard for 
Exchange of Nonclinical Data Implementation Guide--Animal Rule Version 
1.0

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Biologics Evaluation and Research (CBER) is announcing support for the 
Clinical Data Interchange Standards Consortium (CDISC) Standard for 
Exchange of Nonclinical Data Implementation Guide--Animal Rule Version 
1.0 (SENDIG-AR v1.0) on March 26, 2024, and this standard will be 
required in submissions to CBER for studies that start after March 15, 
2027. The Agency will update the FDA Data Standards Catalog (Catalog) 
to reflect this change.

DATES: Support for version CDISC SENDIG-AR v1.0 begins March 26, 2024. 
The requirement for electronic submissions using CDISC SENDIG-AR v1.0 
begins for studies that start after March 15, 2027, for new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), certain 
biologics license applications (BLAs), and certain investigational new 
drug applications (INDs). Submit either electronic or written comments 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-N-1221 for ``Data Standards; Support and Requirement Begins 
for the Clinical Data Interchange Standards Consortium (CDISC) Standard 
for Exchange of Nonclinical Data Implementation Guide--Animal Rule 
Version 1.0 (SENDIG-AR v1.0).'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Victoria Wagman, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: FDA's CBER is issuing this Federal Register 
notice to announce the date that support and requirement begins for 
CDISC SENDIG-AR v1.0. The guidance for industry entitled ``Providing 
Regulatory Submissions In Electronic Format--Standardized Study Data,'' 
published June 2021 (eStudy Data guidance) (available at: https://www.fda.gov/media/82716/download), implements the electronic submission 
requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379k-1(a)) for study data contained in NDAs, ANDAs, 
certain BLAs, and certain INDs submitted to CBER or the Center for Drug 
Evaluation and Research by specifying the format for electronic 
submissions. The eStudy Data guidance states that a Federal Register 
notice will specify any new standards and version

[[Page 20988]]

updates to FDA-supported study data standards that will be added to the 
Catalog, when the support for such standards and version updates begins 
or ends, and when the requirement to use such standards and version 
updates in submissions begins or ends.
    Support for CDISC SENDIG-AR v1.0 begins March 26, 2024. The 
requirement for electronic submissions to be submitted using CDISC 
SENDIG-AR v1.0 begins for studies that start after March 15, 2027, for 
NDAs, ANDAs, certain BLAs, and certain INDs.

    Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06294 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P