[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Draft Guidance for Industry on Format and Content of Proposed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availability of a draft guidance for industry entitled ``Format and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 The draft guidance describes the format and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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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draft guidance may also be obtained by mail by calling CBER at 1-800-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on the draft guidance to the Division of Dockets Management (HFA-305),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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