[Federal Register: April 19, 2007 (Volume 72, Number 75)]
[Rules and Regulations]
[Page 19665]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap07-2]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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Register, FDA has withdrawn approval of the NADAs.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:
pamela.esposito@fda.hhs.gov.
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041 and all supplements and amendments thereto, were withdrawn, as of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