[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Notices]
[Pages 27092-27093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12900]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0276]
Guidance for Industry on Standards for the Prompt Review of
Efficacy Supplements, Including Priority Efficacy Supplements;
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 ``Standards for the
Prompt Review of Efficacy Supplements, Including Priority Efficacy
Supplements.'' As required by the Food and Drug Administration
Modernization Act of 1997 (Modernization Act), this guidance for
industry describes the standards for the prompt review of efficacy
supplements. It also is intended to define those efficacy supplements
that are eligible for priority review.
DATES: Written comments may be submitted on the guidance document by
August 13, 1998. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of this guidance for industry are available on the
Internet at http://www.fda.gov/cder/guidance/index.htm, or http://
www.fda.gov/cber/guidelines.htm. Submit written comments on this
guidance to the Dockets Management Branch (HFD-305), Food and Drug
Administration,
[[Page 27093]]
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments are to be
identified with the docket number found in brackets in the heading of
this document. After the comment period, comments may be submitted to
one of the centers at the addresses below.
FOR FURTHER INFORMATION CONTACT:
Joseph P. Griffin, Center for Drug Evaluation and Research (HFD-7),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-594-2041, or
Robert A. Yetter, Center for Biologics Evaluation and Research
(HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448, 301-827-0373.
SUPPLEMENTARY INFORMATION: Section 403(a) of the Modernization Act
requires that FDA publish in the Federal Register standards for the
``prompt review of supplemental applications submitted for approved
articles * * *.'' The legislative history indicates that this provision
was directed at certain types of efficacy supplements, i.e.,
supplemental applications proposing to add a new use of an approved
drug to the product labeling.\1\ Section 403(b)(3) of the Modernization
Act requires that FDA provide guidance to define supplemental
applications that are eligible for priority review. This guidance
document fulfills both Modernization Act requirements.
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\1\ See U.S. Congress, Senate Committee on Labor and Human
Resources, ``Food and Drug Administration Modernization Act of
1997,'' S. Rept. 105-43 on S. 830, pp. 41-42, 105th Cong., 1st
sess., 1 July 1997; and House Committee on Commerce, ``Prescription
Drug User Fee Authorization and Drug Regulation Act of 1997,'' H.
Rept. 105-310 on H.R. 1411, pp. 63-64, 105th Cong., 1st sess., 7
October 1997.
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Section 101 of the Modernization Act reauthorized for an additional
5 years, with certain technical changes, the user fee program described
in the Prescription Drug User Fee Act of 1992. Section 101 of the
Modernization Act directed that the user fees authorized by the
amendments in that subtitle be dedicated toward expediting the drug
development process and the review of human drug applications as set
forth in the performance goals identified in letters from the Secretary
of Health and Human Services to the chairman of the Committee on
Commerce of the House of Representatives and the chairman of the
Committee on Labor and Human Resources of the Senate, as set forth in
the Congressional Record. The referenced performance goals include
standards for the review of efficacy supplements and distinguish
between priority and standard supplements. The guidance also defines
``priority'' for purposes of applying the performance goals.
The guidance document is being issued as a Level 1 guidance
consistent with FDA's good guidance practices (62 FR 8961, February 27,
1997). It is being implemented without prior public comment because the
guidance is needed to implement the Modernization Act. However, the
agency wishes to solicit comment from the public and is providing a 90-
day comment period and establishing a docket for the receipt of
comments.
This guidance document represents the agency's current thinking on
the standards for the prompt review of efficacy supplements. 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 statute,
regulations, or both.
Interested persons may, at any time, submit written comments on the
guidance document to the Dockets Management Branch (address above). Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. The guidance
document and received comments are available for public examination in
the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 8, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-12900 Filed 5-14-98; 8:45 am]
BILLING CODE 4160-01-F