[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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  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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-P