[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:
    <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 (section 505, FD&C Act); 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 (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:
    <bullet> To assess a known serious risk related to the use of the 
drug;

[[Page 18227]]

    <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 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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