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. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0077] 

Withdrawal of Approval of New Animal 

Drug Applications; Pyrantel; Tylosin; 

Tylosin and Sulfamethazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 

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. 

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 


cprice-sewell on PROD1PC66 with NOTICES