50376 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices 

copy of the oral presentation to Lynne 

Johnson, Health Insurance Specialist, 

Division of Partnership Development, 

Center for Beneficiary Choices, Centers 

for Medicare & Medicaid Services, 7500 

Security Boulevard, Mail stop S2–23–

05, Baltimore, MD 21244–1850 or by 

email at Lynne.Johnson@cms.hhs.gov,

no later than 12 noon, e.d.t., September 

20, 2005. The number of oral 

presentations may be limited by the 

time available. Individuals not wishing 

to make a presentation may submit 

written comments to Ms. Johnson by 12 

noon, (e.d.t.), September 20, 2005. The 

meeting is open to the public, but 

attendance is limited to the space 

available. 

Special Accommodation: Individuals 

requiring sign language interpretation or 

other special accommodations should 

contact Ms. Johnson at least 15 days 

before the meeting.

Authority: Sec. 222 of the Public Health 

Service Act (42 U.S.C. 217a) and sec. 10(a) 

of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) 

and 41 CFR 102–3).

(Catalog of Federal Domestic Assistance 

Program No. 93.733, Medicare—Hospital 

Insurance Program; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: August 19, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 05–16800 Filed 8–25–05; 8:45 am] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Temporary Assistance for Needy 

Families (TANF) State Plan Guidance. 

OMB No.: 0970–0145. 

Description: The State plan is a 

mandatory statement submitted to the 

Secretary of the Department of Health 

and Human Services by the State. It 

consists of an outline of how the State’s 

TANF program will be administered 

and operated and certain required 

certifications by the State’s Chief 

Executive Officer. Its submittal triggers 

the State’s family assistance grant 

funding and it is used to provide the 

public with information about the 

program. If a State makes changes in its 

program, it must submit a State plan 

amendment. 

Respondents: The 50 States, the 

District of Columbia, Guam, Puerto Rico 

and the Virgin Islands.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents 

Number of responses per 

respondent 

Average

burden hours 

per response 

Total burden 

hours 

Temporary Assistance for Needy Families (TANF) State Plan Guidance ...... 54 0.5 33 891 

Estimated Total Annual Burden 

Hours: 891

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

grjohnson@acf.hhs.gov.

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov.

Dated: August 23, 2005. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 05–17008 Filed 8–25–05; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0149]

Animal Drugs, Feeds, and Related 

Products; Withdrawal of Approval of 

New Animal Drug Applications

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 16 new animal drug 

applications (NADAs) and 1 abbreviated 

NADA (ANADA) because the products 

are no longer manufactured or 

marketed. 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 the NADAs.

DATES: Withdrawal of approval is 

effective September 6, 2005.

FOR FURTHER INFORMATION CONTACT:

Pamela K. Esposito, Center for 

Veterinary Medicine (HFV–210), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 301–827–

7818, or e-mail: pesposit@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: The 

following sponsors have requested that 

FDA withdraw approval of the 16 

NADAs and 1 ANADA listed in table 1 

of this document because the products 

are no longer manufactured or 

marketed:

Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices 50377

TABLE 1.

Sponsor NADA Number, Product (Drug) 

21 CFR Section Affected, 

(Sponsor Drug Labeler 

Code) 

Abbott Laboratories, North Chicago, IL 

60064

NADA 99–568, FURANACE Caps (nifurpirinol) 529.1526 (000074) 

Biocraft Laboratories, Inc., 92 Route 46, 

Elmwood Park, NJ 07407

NADA 140–889, DERM–OTIC Ointment (neomycin sulfate, nystatin, thiostrepton, triamcinolone acetonide) 524.1600a (000332) 

First Priority, Inc., 1585 Todd Farm Dr., 

Elgin, IL 60123

NADA 48–646, THERAZONE Injection (phenylbutazone) 522.1720 (058829) 

Happy Jack, Inc., Snow Hill, NC 28580 NADA 121–556, Selenium Sulfide Suspension (selenium disulfide) 524.2101 (023851) 

NADA 121–723, Nitrofurazone Dressing 524.1580b (023851) 

NADA 125–137, FILARICIDE Capsules (diethylcarbamazine citrate) 520.622d (023851) 

IMPAX Laboratories, Inc., 30831 Huntwood 

Ave., Hayward, CA 94544

NADA 92–151, N-Butyl Chloride Canine Worming Caps 520.260 (000115) 

NADA 65–065, Tetracycline HCl Caps 520.2345a (000115) 

NADA 138–900, Dichlorophene/Toluene 520.580 (000115) 

Jorgensen Laboratories, Inc., 1450 North 

Van Buren Ave., Loveland, CO 80538

NADA 10–481, SUREJETS (salacylic acid) 529.2090 (048087) 

Pliva d.d., Ulica grada Vukovara 49, 10000 

Zagreb, Croatia 

ANADA, 200–232, GEOMYCIN 200 Injection (oxytetracycline) 522.1660a (011722) 

Purina Mills, Inc., P.O. Box 66812, St. Louis, 

MO 63166-6812

NADA 65–113 AUREO Sulfa Soluble Powder (chlortetracycline/

sulfamethazine) 

N/A (017800) 

Roche Vitamins, Inc., 45 Waterview Blvd., 

Parsippany, NJ 07054–1298

NADA 140–848, VETEEZE Injection (diazepam) 522.575 (063238) 

Teva Pharmaceuticals USA, 650 Cathill Rd., 

Sellersville, PA 18960

NADA 131–806, Furosemide Tablets 520.1010 (000093) 

Virbac AH, Inc., 3200 Meacham Blvd., Ft. 

Worth, TX 76137

NADA 10–886, Purina Liquid Wormer (piperazine citrate) N/A (051311) 

Wyeth Laboratories, Division of American 

Home Products Corp., P.O. Box 8299, 

Philadelphia, PA 19101

NADA 10–782, SPARINE Injection (promazine) 522.1962 (000008) 

NADA 55–008, BICILLIN Fortified (penicillin G benzathine and 

penicillin G procaine) 

522.1696a (000008) 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs 

(21 CFR 5.10), redelegated to the Center 

for Veterinary Medicine (21 CFR 5.84), 

and in accordance with § 514.115 

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that 

approval of NADAs 10–481, 10–782, 

10–886, 48–646, 55–008, 65–065, 65–

113, 99–568, 121–556, 121–723, 125–

137, 131–806, 138–900, 140–848, 140–

889, and ANADA 200–232, and all 

supplements and amendments thereto, 

is hereby withdrawn, effective 

September 6, 2005.

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: July 5, 2005.

Linda Tollefson,

Acting Director, Center for Veterinary 

Medicine.

[FR Doc. 05–16994 Filed 8–25–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Establishment 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2), the Director, National 

Institutes of Health (NIH), announces 

the establishment of the National 

Commission on Digestive Diseases 

(Commission). 

This Commission shall conduct an 

overview of the state-of-the-science in 

the field of digestive diseases research 

and develop a long-range plan for 

digestive diseases research consistent 

with the research mission of NIH. The 

overall plan will focus on the goal of 

improving the health of the nation 

through digestive diseases research and 

will include specific objectives and 

goals and a recommended time line for 

their implementation. 

Recommendations shall be made to the 

Director, NIH and to Congress. 

The Commission shall be composed 

of 16 members appointed by the 

Director, NIH and 18 nonvoting ex 

officio members. Of the appointed 

members, who shall have a broad 

diversity of scientific and professional 

experience, 12 shall be knowledgeable 

about digestive diseases as members of 

academic or medical research and 

practice communities involved in 

digestive diseases research, including