[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Notices]
[Pages 72083-72084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32324]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0969]
Guidance for Industry: Consideration of the Human Health Impact
of the Microbial Effects of Antimicrobial New Animal Drugs Intended for
Use in Food-Producing Animals (GFI #78); Availability; Republication
Editorial Note: FR Doc. 99-32324 was originally published at
page 70716 in the Federal Register of Friday, December 17, 1999. The
companion Framework document was inadvertently not published. At the
request of the agency, FR Doc. 99-32324 is republished below in its
entirety together with the companion Framework document.
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance document entitled ``Guidance for
Industry: Consideration of the Human Health Impact of the Microbial
Effects of Antimicrobial New Animal Drugs Intended for Use in Food-
Producing Animals'' (GFI #78). After the agency considered public
comments on a draft of this guidance, announced in the Federal Register
of November 18, 1998, it determined that revision of the draft guidance
was necessary. GFI #78 addresses how under section 512 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b) FDA intends to
consider the potential human health impact of the microbial effects
associated with all uses of all classes of antimicrobial new animal
drugs intended for use in food-producing animals when approving such
drugs. For additional information regarding the subject matter dealt
with in GFI #78, see the notice of availability of the document
entitled ``FDA Response to Comments on a Proposed Framework for
Evaluating and Assuring the Human Food Safety of the Microbial Effects
of Antimicrobial New Animal Drugs Intended for Use in Food-Producing
Animals'' that appears elsewhere in this issue of the Federal Register.
DATES: Submit comments at any time.
ADDRESSES: Submit written comments on GFI #78 to the Dockets Management
Branch (HFA-305), Food and Drug Administration, rm. 1061, 5630 Fishers
Lane, Rockville, MD 20852.
FDA will also accept electronic comments. Persons who wish to
submit electronic comments should go to the FDA home page at
www.fda.gov and select ``Dockets'' and follow the instructions.
Submit written requests for single copies of the document entitled
``Guidance for Industry: Consideration of the Human Health Impact of
the Microbial Effects of Antimicrobial New Animal Drugs Intended for
Use in Food-Producing Animals'' (GFI #78) to the Communications Staff
(HFV-12), Center for Veterinary Medicine, Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855. Send one self-addressed
adhesive label to assist that office in processing your requests. See
section III. Electronic Access of this document for information on
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Sharon Thompson, Center for Veterinary
Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1798, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 18, 1998 (63 FR 64094), FDA
announced the availability of a draft guidance entitled ``Guidance for
Industry: Evaluation of the Human Health Impact of the Microbial
Effects of Antimicrobial New Animal Drugs Intended for Use in Food-
Producing Animals'' (GFI #78). This draft guidance announced that FDA
believed that it is necessary to evaluate the human health impact of
the microbial effects associated with all uses of all classes of
antimicrobial new animal drugs intended for use in food-producing
animals when approving such drugs. The publication of the draft of GFI
#78 was the first step in the agency's consideration of the issues
related to the use of antimicrobial new animal drugs in food-producing
animals. The draft of GFI #78 laid out the agency's rationale for its
current thinking about its authority under section 512 of the act to
consider the human health impact of the microbial effects associated
with the use of antimicrobial new animal drugs in food-producing
animals.
In the Federal Register of January 6, 1999 (64 FR 887), FDA
announced the availability of a discussion paper entitled ``A Proposed
Framework for Evaluating and Assuring the Human Safety of the Microbial
Effects of Antimicrobial New Animal Drugs Intended for Use in Food-
Producing Animals'' (Framework Document). The Framework Document was
the second step in the agency's consideration of issues related to the
use of antimicrobial new animal drugs in food-producing animals. FDA
made the Framework Document available to the public to initiate
discussions with the scientific community and other interested parties
on the agency's thinking about appropriate underlying concepts to be
used to develop microbial safety policies protective of the public
health. The Framework Document is related to GFI #78 in that it sets
out a conceptual risk-based framework for evaluating the microbial
safety (related to human health impact) of antimicrobial new animal
drugs intended for use in food-producing animals.
After considering comments received by the public for both the
draft of GFI #78 and the Framework Document, FDA determined that it was
necessary to make some revisions to GFI #78. The revisions are intended
to make GFI #78
[[Page 72084]]
more clearly reflect the agency's intentions regarding this issue. For
example, the words ``evaluate'' and ``evaluation'' have been changed to
``consider'' and ``consideration,'' and other changes have been made to
indicate that additional testing would not always be needed to
determine the potential human health impact of the microbial effects
associated with antimicrobial new animal drugs intended for use in
food-producing animals.
GFI #78 represents the agency's current thinking on how under
section 512 of the act it intends to consider the potential human
health impact of the microbial effects associated with all uses of all
classes of antimicrobial new animal drugs intended for use in food-
producing animals when approving such drugs. It does not create or
confer any right for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute, regulations, or
both.
II. Comments
Interested persons may, at any time, submit written or electronic
comments on GFI #78 to the Dockets Management Branch (address above).
Two copies of written comments are to be submitted, except that
individuals may submit one copy. All comments are to be identified with
the docket number found in brackets in the heading of this document.
GFI #78 and written and electronic comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain copies of ``Guidance
for Industry: Consideration of the Human Health Impact of the Microbial
Effects of Antimicrobial New Animal Drugs Intended for Use in Food-
Producing Animals'' (GFI #78) at http://www.fda.gov/cvm.
Dated: December 8, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
Editorial Note: FR Doc. 99-32324 was originally published at
page 70716 in the Federal Register of Friday, December 17, 1999. The
companion Framework document was inadvertently not published. At the
request of the agency, FR Doc. 99-32324 is republished in its
entirety together with the companion Framework document.
[FR Doc. 99-32324 Filed 12-14-99; 4:09 pm]
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