[Federal Register Volume 63, Number 24 (Thursday, February 5, 1998)]
[Notices]
[Pages 5957-5958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0004]


Guidance for Reviewers on Repeal of Section 507 of the Federal 
Food, Drug, and Cosmetic Act; 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 document for reviewers entitled ``Repeal of 
Section 507 of the Federal Food, Drug, and Cosmetic Act.'' The guidance 
is intended to clarify the administrative processes that will be 
followed in implementing the Food and Drug Administration Modernization 
Act of 1997 (the FDAMA).

DATES: General comments on the agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of this guidance 
document entitled ``Repeal of Section 507 of the Federal Food, Drug, 
and Cosmetic Act'' to the Drug Information Branch (HFD-210), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your requests. Submit written 
comments on the guidance to the Dockets Management Branch (HFD-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT:  Murray M. Lumpkin, Center for Drug 
Evaluation and Research (HFD-20), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5400.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance document for reviewers entitled ``Repeal of Section 507 of the 
Federal Food, Drug, and Cosmetic Act.'' Section 125 of title I of the 
FDAMA (Pub. L. 105-115), signed into law by President Clinton on 
November 21, 1997, repealed section 507 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 357). As a result of the repeal of 
section 507 of the act, which took effect immediately, several of the 
agency's administrative processes for reviewing and approving 
antibiotic drug applications must be changed. This guidance document is 
intended to clarify several of the administrative processes that will 
be followed in implementing section 125 of the FDAMA.
    This guidance document represents the agency's current thinking on 
the implementation of the repeal of section 507 of the act. 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 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 may be seen in the office above between 9

[[Page 5958]]

a.m. and 4 p.m., Monday through Friday.
    Copies of this guidance document are available on the Internet at 
``http://www.fda.gov/cder/guidance/index.htm.''

    Dated: January 28, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-2754 Filed 2-4-98; 8:45 am]
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