[Federal Register: November 29, 1999 (Volume 64, Number 228)]
[Notices]               
[Page 66638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no99-79]                         

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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.

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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