[Federal Register: February 16, 2006 (Volume 71, Number 32)]
[Notices]
[Page 8307-8308]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe06-75]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
ms/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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