Guidance for Industry on Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements; Availability

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