[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36179-36180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17546]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use In Animal Feeds; Penicillin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of two supplemental new animal
drug applications (NADA's), one filed by Alpharma Inc., the other by
Pfizer, Inc. The supplemental NADA's provide for using approved
penicillin G procaine Type A medicated articles to make Type C
medicated chicken, turkey, pheasant, quail, and swine feeds used for
increased rate of weight gain and improved feed efficiency.
EFFECTIVE DATE: July 2, 1998.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, is sponsor of NADA 46-666. Pfizer, Inc., 235
East 42d St., New York, NY 10017, is sponsor of NADA 46-668. The
sponsors filed supplemental NADA's that provide for amending the
regulations concerning use of penicillin Type A medicated articles to
make Type B and C medicated feeds for chickens, turkeys, pheasants,
quail, and swine for increased rate of weight gain and improved feed
efficiency. The supplemental NADA's reflect the results of the National
Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy
Study Implementation (DESI) review of the products' effectiveness and
FDA's conclusions based on that review (35 FR 11533, July 17, 1970).
NAS/NRC evaluated these products as probably effective for faster
gain and/or feed efficiency. FDA concurred with these findings and
concluded that the appropriate claim should be ``for increased rate of
weight gain and improved feed efficiency for (under appropriate
conditions of use).'' The evaluation concerned only the drug's
effectiveness and safety to the animal to which administered, and it
did not take into account the safety for food use of food derived from
drug-treated animals. Nothing herein will constitute a bar to further
proceedings with respect to questions of safety of the drugs or their
metabolites as residues in food products derived from treated animals.
In the Federal Register of August 30, 1977 (42 FR 43772), the then
Bureau of Veterinary Medicine issued a notice of opportunity for
hearing (NOOH) on a proposal to withdraw approval of NADA's for all
penicillin-containing premixes (Type A medicated articles) intended for
subtherapeutic use in animal feeds. The NOOH was issued in response to
scientific research suggesting that subtherapeutic use of such drugs
has contributed to the pool of antibiotic-resistant pathogenic
microorganisms in food animals. Furthermore, research indicated that
the drug resistance could be transferred to pathogenic organisms in
humans. The NOOH is still pending and approval of these supplements to
finalize the DESI review process for penicillin-containing Type A
medicated articles does not constitute a bar to subsequent action to
withdraw approval on the grounds cited in the outstanding NOOH.
The supplemental NADA's are approved as of April 10, 1998. The
regulations are amended in 21 CFR 558.460 by redesignating paragraphs
(b) and (c) as paragraphs (c) and (d), by adding new paragraph (b), and
by revising the table in paragraph (d) to reflect the approval. The
basis for approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this application
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
2. Section 558.460 is amended by redesignating paragraphs (b) and
(c) as paragraphs (c) and (d), by adding paragraph (b), and by revising
the table in paragraph (d)(1) to read as follows:
Sec. 558.460 Penicillin.
* * * * *
(b) Sponsors. Type A medicated articles: To 000069, 100 grams per
pound. To 046573, 100 and 227 grams per pound.
* * * * *
(d) * * *
(1) * * *
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Combination
Penicillin in in grams per Indications Limitations Sponsor
grams per ton ton for use
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(i) 2.4 to 50 Chickens, Do not feed 000069,
turkeys, and to poultry 046573.
pheasants; producing
for eggs for
increased human
rate of consumption
weight gain .
and improved
feed
efficiency.
(ii) 5 to 20 Quail; for Quail; not Do.
increased over 5
rate of weeks of
weight gain age.
and improved
feed
efficiency.
[[Page 36180]]
(iii) 10 to 50 Swine; for ............ Do.
increased
rate of
weight gain
and improved
feed
efficiency.
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* * * * *
Dated: June 22, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-17546 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F
