[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Rules and Regulations]
[Page 62005-62006]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-3]
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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: ssechen@cvm.fda.gov.
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.
0
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]
0
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
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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