[Federal Register Volume 71, Number 32 (Thursday, February 16, 2006)]
[Notices]
[Pages 8307-8308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2184]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999N-1852] (formerly 99N-1852)


Guidance for Industry on Reports on the Status of Postmarketing 
Study Commitments--Implementation of Section 130 of the Food and Drug 
Administration Modernization Act of 1997; 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 ``Reports on the 
Status of Postmarketing Study Commitments--Implementation of Section 
130 of the Food and Drug Administration Modernization Act of 1997.'' 
This guidance provides recommendations on procedures, content, and 
format for submitting a postmarketing study status report for an 
approved human drug or licensed biological product; timeframes for 
FDA's review of postmarketing study commitments; and information about 
postmarketing study commitments that will be available to the public. 
The guidance is intended to assist applicants in meeting the 
requirements of section 130 of the Food and Drug Administration 
Modernization Act of 1997.

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 (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. The 
document may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800.
    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.fda.gov/dockets/ecomments. See

[[Page 8308]]

the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT:
    Beth Duvall-Miller (CDER), Center for Drug Evaluation and Research 
(6411), Food and Drug Administration, 10903 New Hampshire Ave., bldg. 
22, rm. 6466, Silver Spring, MD 20993, 301-796-0700; or
    Robert Yetter (CBER), Center for Biologics Evaluation and Research 
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Reports on the Status of Postmarketing Study Commitments--
Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997.'' Section 506B (``Reports of Postmarketing 
Studies'') of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 356b) provides FDA with additional authority for monitoring the 
progress of postmarketing studies that drug and biological applicants 
have made a commitment to conduct. Postmarketing studies are those 
studies conducted after approval to gather additional information about 
the safety, efficacy, or optimal use of the approved drug or biological 
product.
    Under section 506B(a) of the act, an applicant who has entered into 
an agreement with FDA to conduct a postmarketing study is required to 
provide the agency with an annual report on the status of the study 
until FDA notifies the applicant, in writing, that all postmarketing 
study commitments established under the application(s) have either been 
fulfilled or have been released. The annual report must address the 
progress of the study or the reasons for the failure of the applicant 
to conduct the study. Section 506B(c) of the act directs FDA to develop 
and publish annually in the Federal Register a report on the status of 
postmarketing studies that applicants have made a commitment to conduct 
and for which status reports have been submitted. In the Federal 
Register of October 30, 2000 (65 FR 64607), the agency published a 
final rule to implement section 506B of the act. The final rule makes 
several changes to the existing regulations for approved human drugs 
and licensed biological products.
    In the Federal Register of April 4, 2001 (66 FR 17912), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Reports on the Status of Postmarketing Studies--
Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997.'' The notice gave interested persons an 
opportunity to submit comments by July 3, 2001. A number of comments 
were received in the docket for the 2001 draft guidance. After careful 
consideration of the comments, the draft guidance was revised. In 
addition to edits to improve clarity, the substantive changes made to 
the draft guidance included an update of the types of postmarketing 
studies currently required by FDA and an improved explanation of the 
procedures for establishing and revising study schedules.
    This guidance is intended to provide information on the following: 
(1) Procedures concerning the submission of postmarketing study 
commitment status reports; (2) the content and format of a 
postmarketing study commitment status report; (3) timeframes for FDA's 
review of postmarketing study commitment final study reports; and (4) 
information about postmarketing study commitments that will be 
available to the public. This guidance applies to postmarketing study 
commitments for approved human drug products and licensed biological 
products that meet the definition of ``drug'' under the act. It does 
not apply to biological products that meet the definition of medical 
``device'' under the act; or to veterinary drug products, which will be 
addressed separately.
    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 submission of postmarketing study 
commitment reports for approved human drug or licensed biological 
products. 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These 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. 3501-3520). The 
collections of information in 21 CFR 314.81 and 601.70 have been 
approved under OMB control numbers 0910-0001 and 0910-0433.

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 
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. The guidance and 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 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-2184 Filed 2-15-06; 8:45 am]
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