[Federal Register Volume 59, Number 85 (Wednesday, May 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10606]


[[Page Unknown]]

[Federal Register: May 4, 1994]


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

 

Public Workshop on Improvements in the Drug Master File System; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until June 
3, 1994 the comment period for a notice that appeared in the Federal 
Register of January 14, 1994 (59 FR 2413). The document announced a 
public workshop on possible improvements in the drug master file (DMF) 
system. This action is based on a request for an extension of the 
comment period.

DATES: Written comments by June 3, 1994.

ADDRESSES: Submit written comments regarding the workshop to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857. Transcripts and 
summaries of the workshop are available 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: In the Federal Register of January 14, 1994 
(59 FR 2413), FDA announced that on January 31, 1994, the agency would 
be holding a public workshop on possible improvements in the DMF 
system, especially Type II DMF's, which concern drug substances, drug 
substance intermediates, and materials used in their preparation, or 
drug products. The workshop focused on alternative ways for the Center 
for Drug Evaluation and Research (CDER) to review Type II DMF's for 
drug substances and intermediates. The agency announced that it would 
accept data, information, or views on this subject until March 14, 
1994.
    The International Pharmaceutical Excipients Council (IPEC) 
requested that FDA extend the comment period for an additional 60 days. 
IPEC explained that several of its members could not attend the public 
workshop because of a scheduling conflict with the U.S. Pharmacopeia's 
Second Open Conference on Excipient Harmonization and that the members 
are reviewing the transcript and summary of the workshop.
    The purpose of reopening the comment period is to provide an 
opportunity for interested persons to submit comments for review by 
CDER in considering possible improvements in the DMF system. FDA 
believes that reopening the comment period until June 3, 1994, provides 
sufficient opportunity to comment on the workshop transcript and 
summary.
    Interested persons may, on or before June 3, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
this notice. 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.

    Dated: April 26, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-10606 Filed 5-3-94; 8:45 am]
BILLING CODE 4160-01-F