[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of November 18, 1998, it determined that revision of the draft guidance 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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