Reports and guidance documents; availability, etc.: Federal Food, Drug, and Cosmetic Act; section 507 repeal; industry and reviewer guidance,

[Federal Register: June 15, 1998 (Volume 63, Number 114)]

[Notices]

[Page 32673-32674]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr15jn98-58]

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.

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. 98-15769Filed6-12-98; 8:45 am]

BILLING CODE 4160-01-F