[Federal Register Volume 74, Number 189 (Thursday, October 1, 2009)]
[Notices]
[Pages 50801-50802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0461]


Draft Guidance for Industry on Format and Content of Proposed 
Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and 
Proposed REMS Modifications; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 50802]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Format and 
Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), 
REMS Assessments, and Proposed REMS Modifications.'' The Food and Drug 
Administration Amendments Act of 2007 (FDAAA) added new provisions to 
the Federal Food, Drug, and Cosmetic Act (the act) giving FDA the 
authority to require REMS. The draft guidance describes the format and 
content of a proposed risk evaluation and mitigation strategy, 
including REMS supporting documentation, the content of assessments and 
proposed modifications of approved REMS, what identifiers to use on 
REMS documents, and how to communicate with FDA about a REMS.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 December 30, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 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draft guidance may also be obtained by mail by calling CBER at 1-800-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 that 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on the draft guidance to the Division of Dockets Management (HFA-305), 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:
    Regarding questions for the Center for Drug Evaluation and 
Research: Kathleen Frost, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4316, 
Silver Spring, MD 20993-0002, 301-796-2380.
    Regarding questions for the Center for Biologics Evaluation and 
Research: Stephen Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Format and Content of Proposed Risk Evaluation and 
Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS 
Modifications.'' On September 27, 2007, the President signed into law 
FDAAA (Public Law 110-85). Title IX, Subtitle A, section 901 of FDAAA 
created new section 505-1 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 355-1). Section 505-1(a) of the act authorizes FDA 
to require persons who submit certain applications or hold certain 
approved applications\1\ to submit a proposed REMS if FDA determines 
that a REMS is necessary to ensure that the benefits of a drug outweigh 
the risks of the drug and informs the holder of the application for the 
drug of the determination. Sections 505-1(c) through (f) describe the 
content of a required strategy. Section 505-1(g) describes assessments 
and modifications of an approved strategy.
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    \1\ Section 505-1(b)(2) of the act (21 U.S.C. 355(p)(1)) 
provides that section 505-1 of the act applies to applications for 
prescription drugs approved under section 505(b) or (j) of the act 
and applications approved under section 351 of the Public Health 
Service Act (42 U.S.C. 262). See Section 505(p)(1).
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    The draft guidance provides information regarding FDA's current 
thinking on the format and content that should be used for submissions 
of proposed REMS, including a description of REMS supporting 
documentation. It also includes preliminary information on the content 
of assessments and proposed modifications of approved REMS, information 
on identifiers that should be included on the first page of REMS 
submissions, and information on whom to contact to communicate with FDA 
about a REMS.
    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 format 
and content of proposed REMS, REMS assessments, and proposed REMS 
modifications. 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 guidance contains information collection provisions that 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 
collection of information in the guidance was approved under OMB 
control numbers 0910-0001 and 0910-0338.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: September 25, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23616 Filed 9-30-09; 8:45 am]
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