[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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