[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25443]


[[Page Unknown]]

[Federal Register: October 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0357]

 

Surveillance System for Antimicrobial Resistance; Public Hearing

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing regarding approaches to surveillance for the development of 
bacterial resistance to human and animal antimicrobial drugs. The 
purpose of the hearing is 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.

DATES: The public hearing will be held on November 9 and 10, 1994, from 
8:30 a.m. to 5 p.m. Submit written notices of participation and 
comments by November 1, 1994. Written comments will be accepted until 
February 1, 1995.

ADDRESSES: The hearing will be held at the Rockville Civic Center, F. 
Scott Fitzgerald Theater, 603 Edmonston Dr., Rockville, MD. For 
recorded directions to the Civic Center call 301-309-3007. Submit 
written notices of participation and 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 the docket number found in brackets in the heading 
of this document. Transcripts of the hearing will be available for 
review at the Dockets Management Branch (address above).

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

SUPPLEMENTARY INFORMATION:

I. Background

    On May 11 and 12, 1994, FDA's Anti-Infective Drugs Advisory 
Committee and the Veterinary Medicine Advisory Committee were jointly 
convened to discuss the use of fluoroquinolone drug products in animal 
husbandry, in terms of both the therapeutic benefits of these drugs to 
animals and the potential risks to humans with respect to the use of 
these drugs in animals, inducing further antimicrobial resistance in 
human pathogens. One of the recommendations of the joint advisory 
committee was for improved surveillance for the development of 
antimicrobial resistance in both animals and humans. A cooperative 
surveillance effort, involving Government, academia, and industry, was 
recommended.

II. Scope of The Hearing

    In light of the significant public health impact of increasing 
bacterial resistance on the future utility of antibacterial agents in 
animals and humans, FDA is soliciting broad public participation and 
comment on how best to implement an animal and human bacterial 
resistance monitoring system for regulatory purposes. The agency 
encourages investigators with information relevant to bacterial 
resistance monitoring, as well as other interested persons, to respond 
to this notice. Examples of issues that are of interest to the agency 
include the following: (1) FDA's role in using data from a surveillance 
system to regulate antibacterial agents in humans and animals in order 
to minimize the emergence of antibacterial resistance; (2) the 
objectives of a surveillance system for regulatory purposes; (3) the 
populations of animal and human pathogens to be tested; (4) the 
surveillance information to be collected; (5) whether current systems 
are adequate to provide unbiased, timely information to FDA; and (6) 
funding and maintenance options for a surveillance system if current 
systems are not adequate. 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.

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
presiding officer will be the Commissioner of Food and Drugs or his 
designee. The presiding officer will be accompanied by a panel of 
Public Health Service employees with the relevant expertise.
    Persons who wish to participate in the part 15 hearing must file a 
notice of participation with the Dockets Management Branch (address 
above) by November 1, 1994. To ensure timely handling, any outer 
envelope should be clearly marked with the docket number found in 
brackets in the heading of this document and the statement 
``Surveillance System for Antimicrobial Resistance Hearing.'' Groups 
should submit two copies. The notice of participation should contain 
the person's name, address, telephone number, affiliation if any, brief 
summary of the presentation, and approximate amount of time requested 
for the presentation. The agency asks that interested persons and 
groups having similar interests consolidate their comments and present 
them through a single representative. FDA will allocate the time 
available for the hearing among the persons who file notices of 
participation as described above. If time permits, FDA may allow 
interested persons attending the hearing who did not submit a written 
notice of participation, in advance, to make an oral presentation at 
the conclusion of the hearing.
    After reviewing the notices of participation and accompanying 
information, FDA will schedule each appearance and notify each 
participant by telephone of the time allotted to the person and the 
approximate time the person's oral presentation is scheduled to begin. 
The hearing schedule will be available at the hearing. After the 
hearing, it will be placed on file in the Dockets Management Branch 
under the docket number found in brackets in the heading of this 
document.
    Under Sec. 15.30 the hearing is informal, and the rules of evidence 
do not apply. No participant may interrupt the presentation of another 
participant. Only the presiding officer and panel members may question 
any person during or at the conclusion of their presentation.
    Public hearings, including hearings under part 15, are subject to 
FDA's guideline (21 CFR part 10, Subpart C) concerning the policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings. Under Sec.  10.205, representatives of the electronic 
media may be permitted, subject to certain limitations, to videotape, 
film, or otherwise record FDA's public administrative proceedings, 
including presentations by participants. The hearing will be 
transcribed as stipulated in Sec. 15.30(b). Orders for copies of the 
transcript can be placed at the meeting or through the Dockets 
Management Branch (address above).
    Any handicapped persons requiring special accommodations in order 
to attend the hearing should direct those needs to the contact person 
listed above.
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in 
Sec. 15.30(h).
    To permit time for all interested persons to submit data, 
information, or views on this subject, the administrative record of the 
hearing will remain open following the hearing until February 1, 1995. 
Persons who wish to provide additional materials for consideration 
should file these materials with the Dockets Management Branch (address 
above) by February 1, 1995.

    Dated: October 7, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-25443 Filed 10-13-94; 8:45 am]
BILLING CODE 4160-01-F