[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88633-88634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 This guidance finalizes the draft guidance of the same title 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: 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.
    <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 https://www.regulations.gov 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 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.
    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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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