[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE 4160-01-F