24724 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 

February 1, 2011, letter, the Agency 

acknowledged AstraZeneca’s agreement 

to permit FDA to withdraw approval of 

IRESSA under § 314.150(d) and waive 

its opportunity for a hearing. 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(e)) and 

§ 314.150(d), and under authority 

delegated by the Commissioner to the 

Director, Center for Drug Evaluation and 

Research, approval of NDA 21–399, and 

all amendments and supplements 

thereto, is withdrawn (see DATES). 

Distribution of this product in interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the FD&C Act (21 U.S.C. 

355(a) and 331(d)). 

Dated: April 5, 2012. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2012–9944 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0376] 

Sanofi-aventis, U.S., LLC; Withdrawal 

of Approval of a New Drug Application 

for OFORTA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of a new drug application 

(NDA) for OFORTA (fludarabine 

phosphate) Tablets held by sanofiaventis, U.S., LLC (sanofi-aventis), 55 

Corporate Dr., Bridgewater, NJ 08807– 

0977. Sanofi-aventis has voluntarily 

requested that approval of this 

application be withdrawn, thereby 

waiving its opportunity for a hearing. 

DATES: Effective December 31, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6250, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: FDA 

approved OFORTA (fludarabine 

phosphate) Tablets on December 18, 

2008, under the Agency’s accelerated 

approval regulations, 21 CFR part 314, 

subpart H. OFORTA is approved for use 

as a single agent for the treatment of 

adult patients with B-cell chronic 

lymphocytic leukemia whose disease 

has not responded to or has progressed 

during or after treatment with at least 

one standard alkylating agentcontaining regimen. On February 10, 

2011, FDA requested that sanofi-aventis 

voluntarily withdraw OFORTA 

(fludarabine phosphate) Tablets from 

the market, because the postmarketing 

study required as a condition of 

approval under subpart H had not been 

completed and clinical benefit had not 

been verified. In a letter dated June 24, 

2011, sanofi-aventis requested that FDA 

withdraw approval of NDA 22–273 for 

OFORTA (fludarabine phosphate) 

Tablets under § 314.150(d), noting the 

lack of commercial demand for 

OFORTA and significant challenges to 

completing the postmarketing study. In 

that letter, sanofi-aventis also waived its 

opportunity for a hearing, otherwise 

provided under §§ 314.150 and 314.530. 

In a letter dated July 8, 2011, the Agency 

acknowledged sanofi-aventis’ agreement 

to permit FDA to withdraw approval of 

OFORTA under § 314.150(d) and waive 

its opportunity for a hearing. The 

Agency noted that the required 

postmarketing study had not been 

completed and clinical benefit had not 

been verified. 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(e)) and 

§ 314.150(d), and under authority 

delegated by the Commissioner to the 

Director, Center for Drug Evaluation and 

Research, approval of NDA 22–273, and 

all amendments and supplements 

thereto, is withdrawn (see DATES). 

Distribution of this product in interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the FD&C Act (21 U.S.C. 

355(a) and 331(d)). 

Dated: April 5, 2012. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2012–9943 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

National Advisory General Medical 

Sciences Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

General Medical Sciences Council. 

Date: May 24–25, 2012. 

Closed: May 24, 2012, 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1 & 

E2, 45 Center Drive, Bethesda, MD 20892. 

Open: May 25, 2012, 8:30 a.m. to 

Adjournment. 

Agenda: For the discussion of program 

policies and issues, opening remarks, report 

of the Director, NIGMS, and other business 

of the Council. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1 & 

E2, 45 Center Drive, Bethesda, MD 20892. 

Contact Person: Ann A. Hagan, Ph.D., 

Associate Director for Extramural Activities, 

NIGMS, NIH, DHHS, 45 Center Drive, Room 

2AN24H, MSC 6200, Bethesda, MD 20892, 

(301) 594–4499, hagana@nigms.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxis, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nigms.nih.gov/About/Council/ where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 24725 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: April 17, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–9880 Filed 4–24–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center; Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the Fogarty 

International Center Advisory Board. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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/or contract Proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable materials, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Fogarty International 

Center Advisory Board. 

Date: May 14–15, 2012. 

Closed: May 14, 2012, 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, Room 

B2C03, Bethesda, MD 20892. 

Open: May 15, 2012, 9 a.m. to 3 p.m. 

Agenda: Discussions will include the 

renewal of the five-year strategic plan and 

new priorities including emerging 

technologies such as distance learning and 

mHealth. 

Place: National Institutes of Health, 

Lawton L. Chiles International House, 

Bethesda, MD 20892. 

Contact Person: Robert Eiss, Public Health 

Advisor, Fogarty International Center, 

National Institutes of Health, 31 Center Drive, 

Room B2c02, Bethesda, MD 20892, (301) 

496–1415, EISSR@MAIL.NIH.GOV. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: www.nih.gov/ 

fic/about/advisory.html, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.106, Minority International 

Research Training Grant in the Biomedical 

and Behavioral Sciences; 93.154, Special 

International Postdoctoral Research Program 

in Acquired Immunodeficiency Syndrome; 

93.168, International Cooperative 

Biodiversity Groups Program; 93.934, Fogarty 

International Research Collaboration Award; 

93.989, Senior International Fellowship 

Awards Program, National Institutes of 

Health HHS) 

Dated: 

April 16, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–9882 Filed 4–24–12; 8:45 am] 

BILLING CODE 4140–01–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; Healthcare 

Delivery Methodologies Member 

Applications. 

Date: May 7, 2012. 

Time: 12 p.m. to 2 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: Jacinta Bronte-Tinkew, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3164, 

MSC 7770, Bethesda, MD 20892, (301) 806– 

0009, brontetinkewjm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Drugs, Alcohol and Learning. 

Date: May 16–17, 2012. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Michael Selmanoff, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3134, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1119, mselmanoff@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: April 16, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–9914 Filed 4–24–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of 

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 National Advisory 

Neurological Disorders and Stroke 

Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 


pmangrum on DSK3VPTVN1PROD with NOTICES