[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
