Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of NADAs; Estradiol Benzoate, 19665 [E7-7458]

Download as PDF Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Rules and Regulations paragraph (1)(i), redesignating (1)(ii) and (1)(iii) as (1)(i) and (1)(ii), respectively, and revising paragraph (12) to read as follows: § 1.1 General definitions. * * * * * Light-sport aircraft * * * * * * * * (12) Fixed or retractable landing gear, or a hull, for an aircraft intended for operation on water. * * * * * Issued in Washington, DC, on April 9, 2007. Marion C. Blakey, Administrator. [FR Doc. E7–7453 Filed 4–18–07; 8:45 am] BILLING CODE 4910–13–P 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. cprice-sewell on PROD1PC66 with RULES ACTION: List of Subjects 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 In a notice published elsewhere in this issue of the Federal Register, FDA has withdrawn approval of the NADAs.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 VerDate Aug<31>2005 15:04 Apr 18, 2007 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. Jkt 211001 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 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 parts 510 and 522 are amended as follows: I PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 [Amended] 2. In § 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’’. I PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 19665 PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. § 522.841 I [Removed] 4. Remove § 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 558 New Animal Drugs For Use in Animal Feed; Withdrawal of Approval of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for intermediate premixes used to manufacture Type C medicated feeds. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs. DATES: This rule is effective April 30, 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: Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 68701, has requested that FDA withdraw approval of NADA 121– 200 for Tylosin 10 Premix (tylosin), NADA 129–159 for TYLAN 40 Sulfa-G (tylosin and sulfamethazine), and NADA 137–484 for Swine Guard-BN (pyrantel). All are intermediate premixes used to manufacture Type C medicated feeds. This action is requested because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA gives notice that approval of NADA E:\FR\FM\19APR1.SGM 19APR1

Agencies

[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Rules and Regulations]
[Page 19665]
From the Federal Register Online via the Government Printing 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.

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

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

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