[Federal Register: December 9, 2009 (Volume 74, Number 235)] [Notices] [Page 65132-65133] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09de09-66]
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.
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This guidance finalizes the draft guidance published on February 3,
DATES: Submit written or electronic comments on agency guidances at any
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
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.
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
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).
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
IV. Electronic Access
Persons with access to the Internet may obtain the document at
GuidanceDocuments/default.htm, or http://www.regulations.gov.
Dated: December 3, 2009.
Assistant Commissioner for Policy.
[FR Doc. E9-29273 Filed 12-8-09; 8:45 am]
BILLING CODE 4160-01-S