[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