[Federal Register Volume 60, Number 34 (Tuesday, February 21, 1995)]
[Notices]
[Page 9691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4213]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0357]


Surveillance System for Antimicrobial Resistance; Public Hearing; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening to April 
1, 1995, the comment period for the notice of public hearing regarding 
approaches to surveillance for the development of bacterial resistance 
to human and animal antimicrobial drugs, which published in the Federal 
Register of October 14, 1994 (59 FR 52168). Interested persons were 
given until February 1, 1995, to submit comments. FDA is taking this 
action to provide interested persons with an opportunity to comment on 
submissions received after the public hearing.

DATES: Submit written comments by April 1, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with docket number found in brackets in the heading of this 
document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday. Transcripts of 
the November 9 and 10, 1994, hearing are available for review at the 
Dockets Management Branch (address above).

FOR FURTHER INFORMATION CONTACT: Ermona McGoodwin, Center for Drug 
Evaluation and Research (HFD-9), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5455.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 14, 1994 
(59 FR 52168), FDA announced that it would be holding a public hearing 
November 9 and 10, 1994, on surveillance systems for antimicrobial 
resistance. Interested persons were given until February 1, 1995, to 
submit comments. The purpose of the hearing was to solicit information 
from, and the views of, interested persons, including scientists, 
professional groups, and consumers, on the issues and concerns relating 
to approaches for regulatory purposes to surveillance for the 
development of bacterial resistance to antibacterial agents used in 
humans and in animals. This hearing was held in response to a 
recommendation for improved surveillance for the development of 
antimicrobial resistance in both animals and humans as discussed at the 
May 11 and 12, 1994, joint meeting of FDA's Anti-Infective Drugs 
Advisory Committee and the Veterinary Medicine Advisory Committee (see 
the Federal Register of April 15, 1994, (59 FR 18136 at 18137)).
    FDA is actively seeking the views of professional and consumer 
groups regarding the implications of an animal and human bacterial 
resistance monitoring system for regulatory purposes on their 
constituent populations. To permit time for all interested persons to 
comment on submissions received after the public hearing, the 
administrative record of the hearing will remain open until April 1, 
1995. Persons who wish to provide additional materials for 
consideration should file these materials with the Dockets Management 
Branch (address above) by April 1, 1995.

    Dated: February 14, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-4213 Filed 2-17-95; 8:45 am]
BILLING CODE 4160-01-F