[Federal Register Volume 68, Number 211 (Friday, October 31, 2003)]
[Rules and Regulations]
[Pages 62005-62006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Sometribove Zinc Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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. The supplemental NADA provides 
for revised wording of the indication and precautionary labeling for 
sometribove zinc suspension used to increase the production of 
marketable milk in healthy lactating dairy cows. The regulations are 
also being amended to reflect a different drug labeler code (DLC) for 
Monsanto Co.

DATES: This rule is effective October 31, 2003.

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 (sometribove zinc suspension) to increase the 
production of marketable milk in healthy lactating dairy cows. The 
supplemental NADA provides for revised precautionary labeling. The 
application is approved as of September 11, 2003, and the regulations 
are amended in 21 CFR 522.2112 to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    In addition, Monsanto Co. has changed their DLC. At this time, 21 
CFR 510.600(c) is being amended to reflect this DLC change.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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

[[Page 62006]]

congressional review requirements in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

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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 parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

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2. Section 510.600 Names, addresses, and drug labeler codes of sponsors 
of approved applications is amended in the table in paragraph (c)(1) in 
the entry for ``Monsanto Co.'' by removing ``059945'' and by adding in 
its place ``000911''; and in the table in paragraph (c)(2) by removing 
the entry for ``059945'' and by numerically adding an entry for 
``000911'' to read ``Monsanto Co., 800 North Lindbergh Blvd., St. 
Louis, MO 63167''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


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4. Section 522.2112 is amended in paragraph (b) by removing ``059945'' 
and by adding in its place ``000911''; in paragraph (c)(1) by removing 
``beginning'' and by adding in its place ``starting''; and by revising 
paragraphs (c)(2) and (c)(3) to read as follows:


Sec.  522.2112  Sometribove zinc suspension.

* * * * *
    (c) * * *
    (2) Indications for use. To increase production of marketable milk 
in healthy lactating dairy cows.
    (3) Limitations. Use in lactating dairy cows only. Safety to 
replacement bulls born to treated dairy cows has not been established. 
Inject subcutaneously. Avoid injections within 2 weeks of expected 
slaughter to minimize injection site blemishes on carcass. There is no 
milk discard or preslaughter withdrawal period. Use may reduce 
pregnancy rates and increase days open. Treated cows are at an 
increased risk for mastitis and higher milk somatic cell counts. Use 
care to differentiate increased body temperature due to use of this 
product from an increased body temperature that may occur due to 
illness. Cows treated with this product may have more enlarged hocks 
and disorders of the foot region. Use may reduce hemoglobin and 
hematocrit values during treatment. Human warning: Avoid prolonged or 
repeated contact with eyes and skin.

    Dated: October 10, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-27395 Filed 10-30-03; 8:45 am]
BILLING CODE 4160-01-S