[Federal Register Volume 59, Number 10 (Friday, January 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1048]


[[Page Unknown]]

[Federal Register: January 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0490]

 

Improvements in the Drug Master File System; Notice of a Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop on possible improvements in the drug master file (DMF) system. 
The purpose of this workshop is to exchange ideas with interested 
persons about ways of improving the drug substance and drug substance 
intermediate Type II DMF review process.

DATES: The public workshop will be held on January 31, 1994, 8:30 a.m. 
to 5 p.m. Registration will be between 8 a.m. and 8:30 a.m. Interested 
persons are encouraged to preregister before January 21, 1994, by 
telephoning the contact person. Space for the workshop is limited.

ADDRESSES: The public workshop will be held at the Parklawn Bldg., 
conference rms. D and E, 5600 Fishers Lane, Rockville, MD 20857. 
Written comments regarding the workshop may be submitted to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Copies of a report entitled 
``Recommendations for Improvement in FDA's Drug Master File System'' 
may be obtained from the Freedom of Information Office (HFI-35), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Eric P. Duffy, Center for Drug 
Evaluation and Research (HFD-635), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0360.

SUPPLEMENTARY INFORMATION: A DMF is a submission to FDA that may be 
used to provide confidential, detailed information about facilities, 
processes, or articles used in the manufacturing, processing, 
packaging, and storing of one or more human drugs (see 21 CFR 314.420). 
The submission of a DMF is not required by law or FDA regulation. A DMF 
is submitted solely at the discretion of the holder. The information 
contained in the DMF may be used to support an investigational new drug 
application, a new drug application, an abbreviated new drug 
application, another DMF, an export application, or amendments and 
supplements to any of these. FDA's Center for Drug Evaluation and 
Research (CDER) reviews the DMF only when it is referenced in such 
submissions.
    Five types of DMF's exist regarding the following topics: Type I-- 
manufacturing site, facilities, operating procedures, and personnel; 
Type II--drug substance, drug substance intermediate, and material used 
in their preparation, or drug product; Type III--packaging material; 
Type IV--excipient, colorant, flavor, essence, or material used in 
their preparation; and Type V--FDA-accepted reference information.
    CDER is considering ways to improve the DMF system, especially Type 
II DMF's, which often constitute a critical part of a submission. The 
workshop will focus on alternative ways for CDER to review Type II 
DMF's for drug substances and intermediates. CDER's Chemistry, 
Manufacturing and Controls Coordinating Committee has recommended 
changes to the DMF review process in a report entitled 
``Recommendations for Improvement in FDA's Drug Master File System,'' 
dated November 2, 1993. The report is available from the Freedom of 
Information Office (address above) or may be viewed at the Dockets 
Management Branch (address above) [Docket No. 90S-0308 (document #M-
203)].
    A tentative agenda for the public workshop is as follows:
     Morning session, 8:30 a.m. to 12:30 p.m.
    1. FDA presentations:
Recommended review processes for Type II DMF's (drug substances and 
intermediates)
    a. existing DMF system;
    b. suggested improvements to the existing DMF system;
    c. abbreviated antibiotic application model--approval; and
    d. Type II DMF ``authorization.''
    2. Presentations by industry representatives:
Perspectives on the Type II DMF review process and proposals.
    3. Presentations by other interested persons/Questions for 
presenters/ Open discussion
Approvals/nonapprovals/other--pros/cons.
    Afternoon session, 1:30 p.m. to 5 p.m.
    1. Overview--Other DMF systems for drug substances and 
intermediates--foreign models.
    a. European Community Drug Substance DMF Format and Content; and
    b. Canadian Drug Substance DMF Format and Content.
    2. Presentations by other interested persons/Questions for 
presenters/Open discussion.
    A transcript and summary of the workshop will be available from the 
Freedom of Information Office (address above) approximately 10 days 
after the workshop at a cost of 10 cents per page.
    Interested persons may submit comments on the workshop 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. Received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.



    To permit time for all interested persons to submit data, 
information, or views on this subject, the docket for the workshop will 
remain open until March 14, 1994. Persons who wish to provide 
additional materials for consideration should file these materials with 
the Dockets Management Branch (address above).

    Dated: January 10, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-1048 Filed 1-12-94; 11:29 am]
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