Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate, 19716 [07-1941]

Download as PDF 19716 Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices & Information, Mail Stop C3–19–26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244–1849. ACTION: NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, employee identification number, tax identification number, national provider number, and for verification purposes, the subject individual’s name (woman’s maiden name, if applicable), HICN, and/or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5 (a)(2)). CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Data will be collected from Medicare administrative and claims records (Outcome and Assessment Information Set, Inpatient Rehabilitation Facilities Patient Assessment Instrument, Long Term Care Minimum Data Set), postacute care site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7–7404 Filed 4–18–07; 8:45 am] BILLING CODE 4120–03–P Notice. ACTION: 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 final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs. 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. Therefore, under authority delegated to the Commissioner of Food and Drugs, redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.115 Withdrawal of approval of applications, notice is given that approval of NADA 121–200, NADA 129–159, and NADA 137–484, and all supplements and amendments thereto, are hereby withdrawn, effective April 30, 2007. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–7461 Filed 4–18–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES cprice-sewell on PROD1PC66 with NOTICES Food and Drug Administration Food and Drug Administration [Docket No. 2007N–0077] [Docket No. 2007N–0078] Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine AGENCY: Food and Drug Administration, AGENCY: SUMMARY: The Food and Drug Administration (FDA) has withdrawn 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 final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs. 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. 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. Therefore, under authority delegated to the Commissioner of Food and Drugs, redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.115, notice is given that approval of NADA 141–040 and NADA 141–041 and all supplements and amendments thereto, were withdrawn as of September 29, 2006. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. SUPPLEMENTARY INFORMATION: Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. 07–1941 Filed 4–18–07; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration, HHS. HHS. VerDate Aug<31>2005 Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate Notice. 15:39 Apr 18, 2007 Jkt 211001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\19APN1.SGM 19APN1

Agencies

[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Notices]
[Page 19716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0078]


Withdrawal of Approval of New Animal Drug Applications; Estradiol 
Benzoate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has withdrawn 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 final rule published elsewhere in this issue 
of the Federal Register, FDA is amending the animal drug regulations to 
remove portions reflecting approval of these NADAs.

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.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs, redelegated to the Center for Veterinary Medicine, and in 
accordance with 21 CFR 514.115, notice is given that approval of NADA 
141-040 and NADA 141-041 and all supplements and amendments thereto, 
were withdrawn as of September 29, 2006.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending the animal drug regulations to reflect the 
withdrawal of approval of these NADAs.

    Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 07-1941 Filed 4-18-07; 8:45 am]
BILLING CODE 4160-01-S

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