Document ID: FDA-2022-D-1385-0003
Agency: fda
Document Type: Notice
Title: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome
Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability; Correction
Posted Date: 2022-07-11T04:00Z

[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Page 41135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14677]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1385]

Patient-Focused Drug Development: Selecting, Developing, or 
Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance 
for Industry, Food and Drug Administration Staff, and Other 
Stakeholders; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
entitled ``Patient-Focused Drug Development: Selecting, Developing, or 
Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance 
for Industry, Food and Drug Administration Staff, and Other 
Stakeholders; Availability'' that appeared in the Federal Register of 
June 30, 2022. The document announced the publication of a draft 
guidance, the third in a series of four methodological patient-focused 
drug development guidance documents that describe how stakeholders 
(patients, researchers, medical product developers, and others) can 
collect and submit patient experience data and other relevant 
information from patients and caregivers to be used for medical product 
development and regulatory decision-making. The document was published 
with the incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, 
Planning, Legislation and International Affairs, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver 
Spring, MD 20993-0002, 301-796-9115, email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 30, 
2022 (87 FR 39101), in FR Doc. 2022-13952, the following corrections 
are made:
    1. On page 39101, in the third column in the header of the 
document, ``Docket No. FDA-2018-N-2455'' is corrected to read ``Docket 
No. FDA-2022-D-1385.''
    2. On page 39102, in first column in ``Instructions,'' ``Docket No. 
FDA-2018-N-2455'' is corrected to read ``Docket No. FDA-2022-D-1385.''

    Dated: July 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14677 Filed 7-8-22; 8:45 am]
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