[Federal Register Volume 76, Number 63 (Friday, April 1, 2011)]
[Notices]
[Pages 18226-18227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7707]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0283]
Guidance for Industry on Postmarketing Studies and Clinical
Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug,
and Cosmetic Act; 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 ``Postmarketing
Studies and Clinical Trials--Implementation of Section 505(o)(3) of the
Federal Food, Drug, and Cosmetic Act.'' The Food and Drug
Administration Amendments Act of 2007 (FDAAA) added new provisions to
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA
to require certain postmarketing studies and clinical trials for
prescription drugs approved under the FD&C Act and biological products
approved under the Public Health Service Act (the PHS Act). This
guidance provides information on the implementation of the new
provisions and a description of the types of postmarketing studies and
clinical trials that will generally be required under the new
legislation (postmarketing requirements (PMRs)) and the types that will
generally be agreed-upon commitments (postmarketing commitments (PMCs))
because they do not meet the new statutory criteria for required
postmarketing studies and clinical trials.
DATES: Submit either electronic or written 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 the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist the office in
processing your requests.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT:
Nancy Dickinson, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6226, Silver
Spring, MD 20993-0002, 301-796-5400; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Postmarketing Studies and Clinical Trials--Implementation of
Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' In the
past, FDA has used the term ``PMC'' to refer to studies (including
clinical trials), conducted by an applicant after FDA has approved a
drug for marketing or licensing, that were intended to further refine
the safety, efficacy, or optimal use of a product, or to ensure
consistency and reliability of product quality. These commitments were
either agreed upon by FDA and the applicant or, in certain
circumstances, required by FDA. Prior to the passage of FDAAA, FDA
required PMCs in the following situations:
Subpart H and subpart E accelerated approvals, which
require postmarketing studies to demonstrate clinical benefit (21 CFR
314.510 and 601.41);
Deferred pediatric studies, where studies are required
under the Pediatric Research Equity Act (section 505, FD&C Act); and
Animal Efficacy Rule approvals, where studies to
demonstrate safety and efficacy in humans are required at the time of
use (21 CFR 314.610(b)(1) and 601.91(b)(1)).
Title IX, section 901 of FDAAA (Pub. L. 110-85) amended the FD&C
Act by adding new section 505(o) (21 U.S.C. 355(o)). Section 505(o)(3)
of the FD&C Act authorizes FDA to require certain postmarketing studies
or clinical trials for prescription drugs approved under section 505(b)
of the FD&C Act and biological products approved under section 351 of
the PHS Act (42 U.S.C. 262). Section 505(o)(3)(B) of the FD&C Act
states that postmarketing studies and clinical trials may be required
for one of three purposes:
To assess a known serious risk related to the use of the
drug;
[[Page 18227]]
To assess signals of serious risk related to the use of
the drug; or
To identify an unexpected serious risk when available data
indicates the potential for a serious risk.
This guidance provides information on the implementation of new
section 505(o)(3) of the FD&C Act. The guidance also describes which
types of postmarketing studies and clinical trials will be required
(PMRs) under section 505(o)(3) and which types will be agreed-upon
commitments because they do not meet the statutory criteria for
required studies and trials (PMCs).
In the Federal Register of July 15, 2009 (74 FR 34358), FDA
announced the availability of a draft guidance for industry entitled
``Postmarketing Studies and Clinical Trials--Implementation of Section
505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' The notice
gave interested persons the opportunity to comment by October 13, 2009.
The draft guidance was revised in response to comments submitted to the
docket requesting that the guidance clearly distinguish PMRs required
under section 505(o)(3) of the FD&C Act from risk evaluation and
mitigation strategies. The revisions also provide additional detail in
the examples of PMRs and PMCs and clarify reporting requirements.
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 implementation of section 901 of FDAAA
on postmarketing studies and 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
III. Paperwork Reduction Act of 1995
This guidance provides information on the implementation of section
901 of FDAAA. The collections of information requested in the draft
guidance would be submitted under 21 CFR 314.80, 314.81, and 601.70.
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) and are approved under OMB control numbers 0910-
0230, 0910-0001, and 0910-0338. Section VI of the guidance refers to
procedures in the guidance entitled ``Formal Dispute Resolution:
Appeals Above the Division Level,'' which contains collections of
information approved under OMB control number 0910-0430.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.
Dated: March 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7707 Filed 3-31-11; 8:45 am]
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