[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Notices]
[Pages 64094-64096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30747]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0969]
``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''; Availability
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availability of a draft guidance entitled ``Guidance for Industry: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.'' This draft guidance announces that FDA now believes it is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.
DATES: Written comments should be submitted by December 18, 1998.
ADDRESSES: Submit written requests for single copies of this draft
guidance to
[[Page 64095]]
the Communications Staff (HFV-12), Center for Veterinary Medicine
(CVM), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855. Send one self-addressed adhesive label to assist the office in
processing your requests.
Submit written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville MD
20852. Comments should be identified with the full title of the draft
guidance and the docket number found in brackets in the heading of this
document. See the SUPPLEMENTARY INFORMATION section of this document
for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Margaret A. Miller, Office of New
Animal Drug Evaluation (HFV-100), Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
594-1620.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's ``Good Guidance Practices'' (GGP's) require the agency to
publish, as Level 1 guidance, a change in interpretation or policy that
is of more than a minor nature (62 FR 8961, February 27, 1997).
Therefore, FDA is announcing the availability of a draft guidance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.'' The draft guidance describes the
agency's current thinking on this subject.
Since the 1970's, FDA has evaluated the effects of an antimicrobial
drug product on enteric bacteria of food-producing animals in
determining whether certain feed uses of an antimicrobial new animal
drug are safe under section 512 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360b). Under section 512 of the act, an
application for approval of a new animal drug must ``include adequate
tests by all methods reasonably applicable to show whether or not such
drug is safe for use * * *'' (21 U.S.C. 360b(d)(1)(A)) . Section 201(u)
of the act (21 U.S.C. 321(u)) states that when ``safe' is used in
section 512, the term ``has reference to the health of man or animal''.
In addition, section 512(d)(2) of the act states that, when determining
the safety of a new animal drug, the agency ``shall consider, among
other relevant factors, (A) the probable consumption of such drug and
of any substance formed in or on food because of the use of such drug,
[and] (B) the cumulative effect on man * * * of such drug, taking into
account any chemically or pharmacologically related substance * * *''
(21 U.S.C. 360b(d)(2)).
In the past, FDA evaluated the human health impact of the microbial
effects of only certain uses of antimicrobial new animal drugs in
animal feeds (Ref. 1). However, based on scientific evidence referenced
in the draft guidance, the agency now believes that sponsors of all
antimicrobial new animal drugs intended for use in food-producing
animals should provide information that will allow the agency to
evaluate the human health impact of the intended use.
To assess the human health impact, the following two separate, but
related aspects, should be evaluated: (1) The quantity of resistant
enteric bacteria formed in the animal's intestinal tract following
exposure to the antimicrobial new animal drug (resistance) and (2)
changes in the number of enteric bacteria in the animal's intestinal
tract that can cause human illness (pathogen load). In some cases, a
preapproval study or studies may be needed. FDA recognizes that there
is no standardized protocol established for determining the human
health impact of the microbial effect(s) of an antimicrobial product,
and that one standard study is likely to be inappropriate for all
intended uses.
This draft guidance represents the agency's current thinking only
about its authority under the act to consider 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. It does not provide technical guidance regarding the design of
studies or types of information required to satisfy the requirements to
demonstrate safety. The agency intends to solicit public comments on
this issue at a meeting of the Veterinary Medicine Advisory Committee
in Rockville, MD, on December 10 and 11, 1998, and possibly later at
other public meetings that involve experts in public health.
The draft document does not create or confer any rights 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
requirement of the applicable statute, regulations, or both.
References that are cited in the draft guidance have been placed on
display in the Dockets Management Branch (address above), and may be
seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.
II. Comment
Interested persons may, on or before December 18, 1998, submit to
the Dockets Management Branch (address above) written comments
regarding this draft guidance. 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. A copy of the draft guidance and received comments
may be seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
using the World Wide Web (WWW). For WWW access, connect to CVM at
``http://www.fda.gov/cvm''.
IV. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. U.S. Food and Drug Administration, ``Human Health Safety
Criteria,'' Center for Veterinary Medicine, Guideline 18.
2. Food and Drug Administration, ``Penicillin Use in Animal
Feeds,'' 42 FR 43769-43793, August 30, 1977.
3. Endtz, H., G. Ruiijs, et. al., ``Quinolone Resistance in
Campylobacter Isolated From Man and Poultry Following the
Introduction of Fluoroquinolones in Veterinary Medicine,'' Journal
of Antimicrobial Chemotherapy, 27, 199-208, 1991.
4. Aserkoff, B., and J. V. Bennett, ``Effect of Antibiotic
Therapy in Acute Salmonellosis on the Fecal Excretion of
Salmonella,''New England Journal of Medicine, 281, 636-640, 1969.
5. Seyfarth, A. M., H. C. Wegener, and N. Frimodt-Moller,
``Antimicrobial Resistance in Salmonella enterica subsp. enterica
serovar typhimurium from Humans and Production Animals,'' Journal of
Antimicrobial Chemotherapy, 40, 67-75, 1997.
6. D'Aoust, J-Y., Salmonella Species, In: Food Microbiology
Fundamentals and Frontiers, edited by Doyle, M. P., L. R. Beuchat,
and T. J. Montville, ASM Press, Washington, DC, pp. 129-158, 1997.
7. Nachamkin, I., Campylobacter jejuni, In: Food Microbiology
Fundamentals and Frontiers, edited by Doyle, M. P., L. R. Beuchat,
T. J. Montville, ASM Press, Washington, DC, pp. 159-170, 1997.
8. Bates, J., J. Z. Jordens, and D. T. Griffiths, ``Farm Animals
as a Putative Reservoir for Vancomycin-resistant Enterococcal
Infection in Man,'' Journal of Antimicrobial Chemotherapy, 34, 507-
514, 1994.
9. Department of Agriculture, Food Safety Inspection Service,
``Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems; Final Rule,'' 61 FR 38805-38989, July 25, 1996.
[[Page 64096]]
10. Department of Agriculture, ``Nationwide Beef Microbiological
Baseline: Steers and Heifers,'' October 1992-September 1993;
``Nationwide Broiler Chicken Microbiological Baseline,'' July 1994-
June 1995; and ``Nationwide Pork Microbiological Baseline: Market
Hogs,'' April 1995-March 1996: Food Safety Inspection Service, Data
Collection Programs, Microbiology Division.
11. U.S. Food and Drug Administration, ``Microbiological Testing
of Antimicrobial Drug Residues in Food,'' Center for Veterinary
Medicine, Guideline 52.
Dated: November 10, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-30747 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F
