Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Notices 17927 

[FR Doc. 2011–7373 Filed 3–30–11; 8:45 am] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0151] 

Withdrawal of Approval of New Animal 

Drug Applications; Chorionic 

Gonadotropin; Cuprimyxin; 

Diethylcarbamazine; Levamisole; 

Nitrofurazone; Phenylbutazone; 

Pyrantel; Tylosin; Tylosin and 

Sulfamethazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 13 new animal drug 

applications (NADAs). In a final rule 

published elsewhere in this issue of the 

Federal Register, FDA is amending the 

regulations to remove portions reflecting 

approval of these NADAs. 

DATES: Withdrawal of approval is 

effective April 11, 2011. 

FOR FURTHER INFORMATION CONTACT: John 

Bartkowiak, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9079, email: john.bartkowiak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

sponsors of the 13 approved NADAs 

listed in table 1 have requested that 

FDA withdraw approval because the 

products are no longer manufactured or 

marketed. 

TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF 13 NADAS

Sponsor NADA No. Product (Established Name of Drug) 

21 CFR Section Affected 

(Sponsor’s Drug Labeler 

Code) 

Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, 

NJ 07054–1298.

NADA 093–029 .................................................................

UNITOP Cream .................................................................

(cuprimyxin) .......................................................................

524.520 

(063238) 

Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., 

Chaska, MN 55318.

NADA 097–981 .................................................................

TYLAN 40 Sulfa-G Premix ................................................

(tylosin phosphate/sulfamethazine) ..................................

558.630 

(016968) 

Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 

60018.

NADA 100–840 .................................................................

Chorionic Gonadotropin for Injection ................................

(chorionic gonadotropin) ...................................................

522.1081 

(063323) 

Furst-McNess Co., Freeport, IL 61032 .............................. NADA 100–991 .................................................................

McNess Custom Premix L200 ..........................................

(tylosin phosphate) ............................................................

558.625 

(010439) 

Fort Dodge Animal Health, Division of Wyeth Holdings, a 

wholly owned subsidiary of Pfizer, Inc., 235 East 42d 

St., New York, NY 10017.

NADA 101–079 .................................................................

TRAMISOL–10% Pig Wormer ..........................................

(levamisole) .......................................................................

Not codified 

(000856) 

Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 

50704.

NADA 101–905 .................................................................

Mill Co-Medicator TY–10 ..................................................

(tylosin phosphate) ............................................................

558.625 

(017139) 

Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 

50704.

NADA 101–906 .................................................................

Mill Co-Medicator TS–40 Premix ......................................

(tylosin phosphate/sulfamethazine) ..................................

558.630 

(017139) 

Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 

32514.

NADA 102–824 .................................................................

Phenylbutazone Tablets ...................................................

(phenylbutazone) ..............................................................

520.1720a 

(055246) 

Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, 

MN 56011.

NADA 108–487 .................................................................

DEC Tabs .........................................................................

(diethylcarbamazine citrate) ..............................................

520.622a 

(015579) 

Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, 

MN 56011.

NADA 108–863 .................................................................

DEC Chewable Tabs ........................................................

(diethylcarbamazine citrate) ..............................................

520.622c 

(015579) 

Furst-McNess Co., Freeport, IL 61032 .............................. NADA 140–820 .................................................................

TYLAN 40 Sulfa-G Premix ................................................

(tylosin phosphate/sulfamethazine) ..................................

558.630 

(010439) 

Furst-McNess Co., Freeport, IL 61032 .............................. NADA 140–825 .................................................................

BANMINTH Intermediate Premix ......................................

(pyrantel tartrate) ..............................................................

558.485 

(010439) 

Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 

40511.

NADA 140–910 .................................................................

NFZ Wound Powder .........................................................

(nitrofurazone) ...................................................................

524.1580c 

(050749) 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs 

and redelegated to the Center for 

Veterinary Medicine, and in accordance 

with § 514.116 Notice of withdrawal of 

approval of application (21 CFR 

514.116), notice is given that approval 

of NADAs 93–029, 97–981, 100–840, 

100–991, 101–079, 101–905, 101–906, 

102–824, 108–487, 108–863, 140–820, 

140–825, and 140–910, and all 

supplements and amendments thereto, 

is hereby withdrawn, effective April 11, 

2011. 


wwoods2 on DSK1DXX6B1PROD with NOTICES
17928 Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Notices 

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: March 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7558 Filed 3–30–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Epidemiology. 

Date: April 18, 2011. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Denise Wiesch, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3150, 

MSC 7770, Bethesda, MD 20892, (301) 435– 

0684, wieschd@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Hematology and Endothelial 

Biology. 

Date: April 20–21, 2011. 

Time: 8 a.m. to 7 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Ai-Ping Zou, MD, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4118, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1777, zouai@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Endocrinology and Metabolism. 

Date: April 25, 2011. 

Time: 11 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Krish Krishnan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6164, 

MSC 7892, Bethesda, MD 20892, (301) 435– 

1041, krishnak@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group; Biomaterials and Biointerfaces Study 

Section. 

Date: April 27–28, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: InterContinental Chicago 

Magnificent Mile, 505 N. Michigan Avenue, 

Chicago, IL 60611. 

Contact Person: Steven J Zullo, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5146, 

MSC 7849, Bethesda, MD 20892, 301–435– 

2810, zullost@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 25, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–7617 Filed 3–30–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; DAIDS Clinical Trial 

Planning and Implementation Grants. 

Date: April 26, 2011. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Erica L. Brown, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–451–2639, 

ebrown@niaid.nih.gov 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Next Generation PrEP. 

Date: April 29, 2011. 

Time: 1:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Roberta Binder, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIAID/NIH/DHHS, 6700B Rockledge Drive, 

Room 3130, Bethesda, MD 20892–7616, 301– 

496–7966, rbinder@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 25, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–7644 Filed 3–30–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 


wwoods2 on DSK1DXX6B1PROD with NOTICES