[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Notices]
[Pages 34358-34359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16867]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0283]


Draft Guidance for Industry on Postmarketing Studies and Clinical 
Trials; Implementation 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availability of a draft guidance for industry entitled ``Postmarketing 
Studies and Clinical Trials--Implementation of Section 505(o) 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 act) authorizing FDA to 
require certain postmarketing studies and clinical trials for 
prescription drugs and biological products approved under the act or 
the Public Health Service Act (the PHS Act). This draft guidance 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by October 13, 2009.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 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 The draft guidance may also be obtained by mail by calling CBER 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 written 
comments on the draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Nancy Clark, Center for Drug 
Evaluation and Research, Food and Drug

[[Page 34359]]

Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6144, 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 draft guidance for industry 
entitled ``Postmarketing Studies and Clinical Trials--Implementation of 
Section 505(o) 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:
    <bullet> Subpart H and subpart E accelerated approvals, which 
require postmarketing studies to demonstrate clinical benefit (21 CFR 
314.510 and 601.41);
    <bullet> Deferred pediatric studies, where studies are required 
under the Pediatric Research Equity Act (PREA) (21 CFR 314.55(b) and 
601.27(b)); and
    <bullet> 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 (Public Law 110-85) amended the act 
by adding new section 505(o) (21 U.S.C. 355(o)). Section 505(o) of the 
act authorizes FDA to require certain postmarketing studies or clinical 
trials for prescription drug and biological products approved under 
section 505 of the act or section 351 of the PHS Act (42 U.S.C. 262). 
Section 505(o)(3)(B) of the act states that postmarketing studies and 
clinical trials may be required for one of three purposes:
    <bullet> To assess a known serious risk related to the use of the 
drug;
    <bullet> To assess signals of serious risk related to the use of 
the drug; or
    <bullet> To identify an unexpected serious risk when available data 
indicates the potential for a serious risk.
    This draft guidance provides information on the implementation of 
new section 505(o) of the act. The draft guidance also describes which 
types of postmarketing studies and clinical trials will be required 
(PMRs) under section 505(o) of the act and which types will be agreed-
upon commitments because they do not meet the statutory criteria for 
required studies and trials (PMCs).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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) 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.

III. Paperwork Reduction Act of 1995

    This draft 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 draft 
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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: July 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16867 Filed 7-14-09; 8:45 am]
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