[Federal Register Volume 62, Number 205 (Thursday, October 23, 1997)]
[Rules and Regulations]
[Pages 55161-55162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28015]
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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; Bacitracin Zinc
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 a hybrid abbreviated new animal
drug application (ANADA) filed by ALPHARMA, Inc. The hybrid ANADA
provides for the use of bacitracin zinc Type A medicated articles to
make Type C medicated feeds for cattle, broiler chickens, turkeys,
pheasants, growing quail, and growing and finishing swine, for
increased rate of weight gain and improved feed efficiency, and for
laying chickens for improved feed efficiency and increased egg
production.
EFFECTIVE DATE: October 15, 1997.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: ALPHARMA, Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, is sponsor of hybrid ANADA 200-223 that
provides for use of bacitracin zinc Type A medicated articles
(bacitracin zinc equivalent to 50 grams (g) of bacitracin per pound) to
make Type C medicated feeds for cattle when fed at 35 to 70 milligrams
per head per day, for growing broiler chickens, turkeys, and pheasants
fed at 4 to 50 g per ton (g/t), for growing quail up to 5 weeks of age
fed at 5 to 20 g/t, for growing and finishing swine fed at 10 to 50 g/
t, for increased rate of weight gain and improved feed efficiency, and
for laying chickens fed at 10 to 25 g/t for improved
[[Page 55162]]
feed efficiency and increased egg production.
The data submitted in support of this hybrid ANADA satisfy the
requirements of section 512(b)(1) and (b)(2) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 360b(b)(1) and (b)(2)) and the
regulations in 21 CFR part 514. The hybrid ANADA has been defined in
the Center's Seventh Generic Animal Drug Policy letter dated March 20,
1991. The hybrid ANADA relies on the approval of a listed (pioneer)
animal drug and contains additional data needed to support the change
in the generic product. The hybrid ANADA is thus relying on the
approval of the listed animal drug to the extent that such reliance is
allowed under section 512(n) of the act, to establish the safety and
effectiveness of the underlying animal drug. An application that relies
in part on the approval of a listed animal drug for this purpose is
considered an application described in section 512(b)(2) of the act.
ALPHARMA, Inc.'s, hybrid ANADA 200-223 for bacitracin zinc is
approved as a generic copy of Hoffmann-LaRoche's NADA 46-920. The
hybrid ANADA is approved as of August 20, 1997, and the regulations are
amended in 21 CFR 558.78 by revising paragraph (a)(1) to indicate
additional approvals and in paragraph (d)(1) by removing the footnote
to the table to reflect the approval. The basis of 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) 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
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 558.78 is amended by revising paragraph (a), and in
paragraph (d)(1) by removing the footnote to the table to read as
follows:
Sec. 558.78 Bacitracin zinc.
(a) Approvals. To sponsors listed in Sec. 510.600(c) of this
chapter for use as in paragraph (d) of this section as follows:
(1) To 046573: 50 grams per pound as in paragraphs (d)(1)(i),
(d)(1)(ii), (d)(1)(iii), (d)(1)(iv), and (d)(2) of this section.
(2) To 000004: 10, 25, 40, and 50 grams per pound as in paragraphs
(d)(1)(i), (d)(1)(ii), (d)(1)(v), (d)(1)(vi), (d)(2), and (d)(3) of
this section.
(3) To 000010: 5 and 50 grams per pound as in paragraph (d)(1)(i)
of this section.
* * * * *
Dated: September 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-28015 Filed 10-22-97; 8:45 am]
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