Notice2023-28291
Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry; Availability
Primary source
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Published
December 22, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Data Standards for Drug and Biological Product Submissions Containing Real- World Data." This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog. FDA is publishing this guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 22, 2021.
Full Text
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<title>Federal Register, Volume 88 Issue 245 (Friday, December 22, 2023)</title>
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[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88633-88634]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0548]
Data Standards for Drug and Biological Product Submissions
Containing Real-World Data; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Data
Standards for Drug and Biological Product Submissions Containing Real-
World Data.'' This guidance provides recommendations to sponsors to
help support compliance with the Federal Food, Drug, and Cosmetic Act
(FD&C Act) when submitting study data derived from real-world data
(RWD) sources in applicable regulatory submissions using standards
specified in the Data Standards Catalog. FDA is publishing this
guidance as part of a series of guidance documents under its program to
evaluate the use of real-world evidence (RWE) in regulatory decision
making. This guidance finalizes the draft guidance of the same title
issued on October 22, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on December 22, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2021-D-0548 for ``Data Standards for Drug and Biological Product
Submissions Containing Real-World Data.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-
796-3161; or James Myers, 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:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Data Standards for Drug and Biological Product Submissions
Containing Real-World Data.'' Section 3022 of the 21st Century Cures
Act (Cures Act) amended the FD&C Act to add section 505F, Utilizing
Real World Evidence (21 U.S.C. 355g). In addition, under the
Prescription Drug User Fee Amendments of 2017 (PDUFA VI), FDA committed
to publishing draft guidance on how RWE can contribute to the
assessment of safety and effectiveness in
[[Page 88634]]
regulatory submissions. In 2018, FDA created an RWE Framework and
Program (Program) to evaluate the potential use of RWE to help support
the approval of a new indication for a drug already approved under the
FD&C Act or to help to support or satisfy postapproval study
requirements. In late 2021, FDA utilized the Program to issue draft
guidances outlining considerations for the use of RWD and RWE in
regulatory decision-making to help satisfy the Cures Act mandate and
the PDUFA VI commitment.
This guidance finalizes the draft guidance entitled ``Data
Standards for Drug and Biological Product Submissions Containing Real-
World Data'' issued on October 22, 2021 (86 FR 58672). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include clarification of
FDA's understanding of challenges when using currently supported data
standards for RWD sources and elaboration of available FDA resources
for consultation about the use of data standards for study data
submitted to FDA. In addition, editorial changes were made to improve
clarity, including the movement of concepts from glossary entries to
footnotes to the main document text.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Data Standards for Drug and Biological
Product Submissions Containing Real-World Data.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 314 (Applications for FDA Approval to Market a New Drug) have
been approved under OMB control number 0910-0001; the collections of
information in 21 CFR part 312 (Investigational New Drug Regulations)
have been approved under OMB control number 0910-0014; the collections
of information in 21 CFR part 58 (Good Laboratory Practice Regulations
for Nonclinical Laboratory Studies) have been approved under OMB
control number 0910-0119; and the collections of information in 21 CFR
part 601 (General Licensing Provisions: Biologics License Application,
Changes to an Approved Application, Labeling, Revocation and
Suspension) have been approved under OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28291 Filed 12-21-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 22, 2023.
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