[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
