[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Rules and Regulations]
[Page 19665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7458]


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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; 
Withdrawal of Approval of NADAs; Estradiol Benzoate

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 that reflect approval of two new animal drug 
applications (NADAs) for a suspension implant of estradiol benzoate 
microspheres used in steers and heifers fed in confinement for 
slaughter for increased rate of weight gain and improved feed 
efficiency, and in suckling beef calves for increased rate of weight 
gain. In a notice published elsewhere in this issue of the Federal 
Register, FDA has withdrawn approval of the NADAs.

DATES: This rule is effective April 19, 2007.

FOR FURTHER INFORMATION CONTACT:  Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail: 
<a href="/cdn-cgi/l/email-protection#deaebfb3bbb2bff0bbadaeb1adb7aab19eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="fb8b9a969e979ad59e888b9488928f94bb9d9f9ad5939388d59c948d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., 
Fort Collins, CO 80524, has requested that FDA withdraw approval of 
NADA 141-040 for DURALEASE (estradiol benzoate), a suspension implant 
of estradiol benzoate microspheres used in steers and heifers fed in 
confinement for slaughter for increased rate of weight gain and 
improved feed efficiency and NADA 141-041 for CELERIN-C (estradiol 
benzoate), a similar product used in suckling beef calves for increased 
rate of weight gain. This action is requested because the products are 
no longer manufactured or marketed.
    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADA 141-040 and NADA 141-
041 and all supplements and amendments thereto, were withdrawn, as of 
September 29, 2006.
    Following the withdrawal of approval of these NADAs, PR 
Pharmaceuticals, Inc., is no longer a sponsor of an approved 
application. Therefore, 21 CFR 510.600(c) is amended to remove entries 
for this firm. As provided in the regulatory text of this document, the 
animal drug regulations are amended to reflect the withdrawal of 
approval.
    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

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

0
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. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``PR Pharmaceuticals, Inc.''; and in the table in paragraph (c)(2) 
remove the entry for ``067210''.

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.


Sec.  522.841  [Removed]

0
4. Remove Sec.  522.841.

    Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7458 Filed 4-18-07; 8:45 am]
BILLING CODE 4160-01-S


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