[Federal Register Volume 67, Number 72 (Monday, April 15, 2002)]
[Rules and Regulations]
[Page 18085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9015]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 67, No. 72 / Monday, April 15, 2002 / Rules
and Regulations
[[Page 18085]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Sometribove Zinc Suspension
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 supplemental new animal drug
application (NADA) filed by Monsanto Co. which provides for
subcutaneous injection of sometribove zinc suspension in healthy
lactating dairy cows to increase the production of marketable milk with
no restriction on injection site. Three injection sites are
recommended.
DATES: This rule is effective April 15, 2002.
FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0221, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Monsanto Co., 800 North Lindbergh Blvd., St.
Louis, MO 63167, filed a supplement to NADA 140-872 that provides for
the use of POSILAC 1 STEP (sometribove zinc suspension) in healthy
lactating dairy cows to increase the production of marketable milk. The
supplemental NADA provides for subcutaneous injection with no
restriction on injection site. Three injection sites are recommended:
The neck area, the postscapular region, or the depression on either
side of the tailhead. The application is approved as of December 27,
2001, and the regulations are amended in Sec. 522.2112 (21 CFR
522.2112) to reflect the approval. The basis of approval is discussed
in the freedom of information summary.
Section 522.2112 is also being amended to provide for changes to
the conditions of use approved November 4, 1997. These changes included
the use of sometribove zinc suspension beginning during the 9th or 10th
week after calving, and the removal of, or changes in, precautionary
statements from labeling pertaining to certain reproductive disorders.
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)(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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 522
Animal drugs.
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 522.2112 is amended by revising the section heading and
paragraph (a), by removing paragraph (c), by redesignating paragraph
(d) as paragraph (c), and by revising newly redesignated paragraphs
(c)(1) and (c)(3) to read as follows:
Sec. 522.2112 Sometribove zinc suspension.
(a) Specifications. Each single-dose syringe contains 500
milligrams (mg) sometribove zinc in a prolonged-release suspension.
* * * * *
(c) Conditions of use--(1) Amount. Inject 500 mg every 14 days
beginning during the 9th or 10th week (57 to 70 days) after calving and
continue until the end of lactation.
* * * * *
(3) Limitations. For use in lactating dairy cows only. Safety to
replacement bulls born to treated dairy cows has not been established.
Administer subcutaneously. To minimize injection site blemishes on
carcass at time of slaughter, avoid injections within 2 weeks of
expected slaughter. No milk discard or preslaughter withdrawal period
is required. Use may result in reduced pregnancy rates and, in first
calf heifers, an increase in days open. The incidence of retained
placenta may be higher. Treated cows are at an increased risk for
clinical mastitis and subclinical mastitis. In some herds, use has been
associated with increases in somatic cell counts in milk. Care should
be taken to differentiate increased body temperature due to use of this
product from an increased body temperature that may occur due to
illness. Use may result in an increase in digestive disorders such as
indigestion, bloat, and diarrhea. There may be an increase in the
number of cows experiencing periods of ``off-feed'' (reduced feed
intake) during treatment. Cows treated with this product may have
increased numbers of enlarged hocks and lesions of the knee (carpal
region), and second lactation or older cows may have more disorders of
the foot region. Use has been associated with reductions in hemoglobin
and hematocrit values during treatment. Human warning: Avoid prolonged
or repeated contact with eyes and skin.
Dated: March 21, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Vetrinary Medicine.
[FR Doc. 02-9015 Filed 4-12-02; 8:45 am]
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