[Federal Register Volume 64, Number 228 (Monday, November 29, 1999)]
[Notices]
[Page 66638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30819]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4808]
Guidance for Industry on Drug Master Files for Bulk Antibiotic
Drug Substances; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Drug Master Files
for Bulk Antibiotic Drug Substances.'' This guidance is intended to
assist those in industry whose approved applications for bulk
antibiotic drug substances were converted to Type II drug master files
(DMF's) as a result of the repeal of the statutory provision in the
Federal Food, Drug, and Cosmetic Act (the act) under which the agency
certified antibiotic drugs.
DATES: Written comments may be submitted 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 for industry 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 the office in processing your
requests. Submit written comments on the guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Susan M. Rosencrance, Center for Drug
Evaluation and Research (HFD-643), Food and Drug Administration, Office
of Generic Drugs, 7500 Standish Pl., Rockville, MD 20855, 301-827-5779.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Drug Master Files for Bulk Antibiotic
Drug Substances.'' The purpose of this guidance is to provide
recommendations to those in industry whose approved applications for
bulk antibiotic drug substances were administratively converted, by
FDA, to Type II DMF's as a result of the repeal of section 507 of the
act (see section 125(b) of the Food and Drug Administration
Modernization Act of 1997). This guidance describes the purpose of
DMF's, discusses the type of information expected in a Type II DMF,
explains the administrative procedures governing review of DMF's, and
clarifies the responsibilities of a DMF holder. FDA is issuing this
guidance because of a possible misunderstanding by some DMF holders
about the need to inform FDA of manufacturing changes to bulk
antibiotic drug substances that are covered under a DMF. The
information included in the guidance is a compilation of previously
published information.
This Level 2 guidance is being issued consistent with FDA's good
guidance practices (62 FR 8961, February 27, 1997). FDA is issuing a
notice of availability for this Level 2 guidance to ensure that
industry is aware of the importance of updating DMF's when changes are
made.
The guidance represents the agency's current thinking on DMF's for
bulk antibiotic drug substances. 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 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 are available for public examination in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 17, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-30819 Filed 11-26-99; 8:45 am]
BILLING CODE 4160-01-F
