[Federal Register Volume 63, Number 114 (Monday, June 15, 1998)]
[Notices]
[Pages 32673-32674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15769]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0365]


Revised Guidance for Industry and Reviewers on Repeal of Section 
507 of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.


[[Page 32674]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry and reviewers entitled 
``Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act.'' 
The guidance clarifies the processes that will be followed in 
implementing this section of the Food and Drug Administration 
Modernization Act of 1997 (Modernization Act). This revision includes 
clarification of the procedures applicable to bulk drug substances for 
products previously regulated under the Federal Food, Drug, and 
Cosmetic Act (the act).

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

ADDRESSES: Copies of this guidance are available on the Internet at 
http://www.fda.gov/cder/guidance/index.htm. Submit written requests for 
single copies of this guidance 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 (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: 
    For general information regarding this notice: Murray M. Lumpkin, 
Center for Drug Evaluation and Research (HFD-20), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5400.
    For issues on bulk drug substance procedures: Gordon R. Johnston, 
Center for Drug Evaluation and Research (HFD-601), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5845.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
revised guidance for industry and reviewers entitled ``Repeal of 
Section 507 of the Federal Food, Drug, and Cosmetic Act.'' Section 125 
of title I of the Modernization Act (Pub. L. 105-115), signed into law 
by President Clinton on November 21, 1997, repealed section 507 of 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 had to be changed. This guidance document, intended to 
clarify several of the administrative processes that will be followed 
in implementing section 125 of the Modernization Act, has now been 
revised to include the procedures applicable to bulk drug substances 
for products previously marketed under section 507 of the act.
    This revised guidance document is a level 1 guidance document 
consistent with FDA's good guidance practices (62 FR 8961, February 27, 
1997). It 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, at any time, submit comments on the 
guidance 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 and received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: June 8, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-15769 Filed 6-12-98; 8:45 am]
BILLING CODE 4160-01-F