Document ID: FDA-2023-N-1506-0012
Agency: fda
Document Type: Notice
Title: Methodological Challenges Related to Patient Experience Data; Summary of Received Comments
Posted Date: 2023-12-13T05:00Z

[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86343-86344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27312]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1506]

Methodological Challenges Related to Patient Experience Data; 
Summary of Received Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a summary on the comments received for the 
``Methodological Challenges Related to

[[Page 86344]]

Patient Experience Data; Request for Information and Comments'' notice 
published on May 2, 2023. The input received in response to the Request 
for Information will help FDA plan two public workshops focused on 
methodological challenges and will help FDA identify priorities for 
future work.

FOR FURTHER INFORMATION CONTACT: Ethan Gabbour, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993, 301-796-
8112, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under the seventh iteration of the Prescription Drug User Fee Act, 
incorporated as part of the FDA User Fee Reauthorization Act of 2022, 
FDA committed to facilitate the advancement and use of systematic 
approaches to collect and utilize robust and meaningful patient and 
caregiver input that can more consistently inform drug development and, 
as appropriate, regulatory decision making. This included issuing a 
Request for Information (RFI) available at https://www.federalregister.gov/documents/2023/05/02/2023-09265/methodological-challenges-related-to-patient-experience-data-request-for-information-and-comments to elicit public input on methodologic challenges related 
to patient experience data encountered by stakeholders, and other areas 
of greatest interest or concern to public stakeholders.\1\ The RFI was 
published on May 2, 2023, and the public comment period was open until 
July 3, 2023. A summary of the comments received can be found in the in 
the public docket or by going to https://www.regulations.gov and 
entering the following docket number: FDA-2023-N-1506.
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    \1\ The Federal Food, Drug, and Cosmetic Act, as amended by the 
21st Century Cures Act (Pub. L. 114-255) and the FDA Reauthorization 
Act of 2017 (FDARA) (Pub. L. 115-52), defines patient experience 
data as data that are collected by any persons (including patients, 
family members and caregivers of patients, patient advocacy 
organizations, disease research foundations, researchers and drug 
manufacturers) and are intended to provide information about 
patients' experiences with a disease or condition, including the 
impact (including physical and psychosocial impacts) of such disease 
or condition or a related therapy or clinical investigation and 
patient preferences with respect to treatment of the disease or 
condition.
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II. Electronic Access

    Persons with access to internet may obtain the summary within the 
public docket at https://www.regulations.gov/docket/FDA-2023-N-1506.

    Dated: December 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27312 Filed 12-12-23; 8:45 am]
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