[Federal Register Volume 74, Number 235 (Wednesday, December 9, 2009)]
[Notices]
[Pages 65132-65133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29273]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0362] (Formerly Docket No. 2006-D-0044)


Guidance for Industry on Patient-Reported Outcome Measures: Use 
in Medical Product Development to Support Labeling Claims; Availability

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 guidance for industry entitled ``Patient-Reported 
Outcome Measures: Use in Medical Product Development to Support 
Labeling Claims.'' This guidance describes how FDA reviews and 
evaluates patient-reported outcome (PRO) instruments used to measure 
treatment benefit in medical product clinical trials. It also provides 
recommendations on how sponsors can use study results measured by PRO 
instruments to support claims in approved medical product labeling. 
This guidance finalizes the draft guidance published on February 3, 
2006.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: 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, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448; or Office of Communication, Education, 
and Radiation Programs, Division of Small Manufacturers, International 
and Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850-4307. Send one self-addressed adhesive label to assist in 
processing your requests. Submit written comments on the guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for

[[Page 65133]]

electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Laurie B. Burke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6462, Silver Spring, MD 20993-0002, 301-
796-0900; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-6210; or Sahar Dawisha, Center 
for Devices and Radiological Health (HFZ-440), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0717.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Patient-Reported Outcome Measures: Use in Medical Product 
Development to Support Labeling Claims.'' This guidance describes how 
FDA reviews and evaluates PRO instruments used to measure treatment 
benefit in medical product clinical trials. A PRO instrument (e.g., 
questionnaire, diary, plus all the information and documentation that 
support its use) is a means to capture PRO data. This guidance also 
describes FDA's current thinking on how sponsors can use study results 
measured by PRO instruments to support claims in approved medical 
product labeling. It does not address the use of PRO instruments for 
purposes beyond evaluation of treatment benefit claims made about a 
drug or medical product in labeling.
    By explicitly addressing the review issues identified in this 
guidance, sponsors can increase the efficiency of their discussions 
with FDA during the medical product development process, streamline 
FDA's review of PRO instrument adequacy, and provide optimal 
information about the patient's perspective for use in making 
conclusions about treatment benefit at the time of medical product 
approval.
    A draft version of this guidance was made available for public 
comment in the Federal Register of February 3, 2006 (71 FR 5862). All 
of the public comments we received have been considered and the 
guidance has been revised as appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the use of PRO measures in medical product 
clinical trials. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance contains information collection that is subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The information collection 
has been approved under OMB Control Numbers 0910-0001, 0910-0338, and 
0910-0231. The information requested in the guidance is currently 
submitted to FDA to support the medical product's effectiveness and to 
support claims in approved medical product labeling (see 21 CFR 
314.50(d)(5), 314.126(b)(6), 601.2, and part 814).

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29273 Filed 12-8-09; 8:45 am]
BILLING CODE 4160-01-S