Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 48759 

Dated: September 17, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23126 Filed 9–23–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Amended Notice 

of Meeting 

Notice is hereby given of a change in 

the meeting of the NIH Scientific 

Review Board, September 24, 2009, 

8 a.m. to 3 p.m., National Institutes of 

Health, Building 60, Chapel and Lecture 

Hall, 9000 Rockville Pike, Bethesda, MD 

20892 which was published in the 

Federal Register on September 14, 2009, 

74 FR 46998. 

The notice is being amended to cancel 

the September 24, 2009, Deliberating 

Organizational Changes and 

Effectiveness Working Group forum. 

Please see the Scientific Management 

Review Board Web site for the schedule 

of upcoming meetings at: http:// 

smrb.od.nih.qov. For further 

information contact Dr. Lyric Jorgenson, 

Office of Science Policy, Office of the 

Director, National Institutes of Health, 

Building 1, Room 218, MSC 0166, 9000 

Rockville Pike, Bethesda, MD 20892. 

Dated: September 16, 2009. 

Amy Patterson, 

Director, Office of Biotechnology Activities. 

[FR Doc. E9–23032 Filed 9–23–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Endocrinology, 

Metabolism, Nutrition and Reproductive 

Sciences Integrated Review Group; Cellular 

Aspects of Diabetes and Obesity Study 

Section. 

Date: October 5–6, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Ann A. Jerkins, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6154, 

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

4514, jerkinsa@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. 

(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: September 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23031 Filed 9–23–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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 

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: Interventions for Substance Abuse. 

Date: September 23, 2009. 

Time: 2 p.m. to 3:30 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: Michael Micklin, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3136, 

MSC 7759, Bethesda, MD 20892, (301) 435– 

1258, micklinm@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. 

(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: September 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23028 Filed 9–23–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Risk Communication Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Risk Communication 

Advisory Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on November 12, 2009, from 8 a.m. to 5 p.m. 

and November 13, 2009, from 8 a.m. to 2 p.m. 

Location: The Hilton Hotel, 8727 Colesville 

Rd., Silver Spring, MD 20910. 

Contact Person: Lee L. Zwanziger, Office of 

the Commissioner, Office of Policy, Planning 

and Preparedness, Office of Planning, Food 

and Drug Administration, 5600 Fishers Lane, 

rm. 14–90, Rockville, MD 20857, 301–827– 

2895, FAX: 301–827–4050, e-mail: 

RCAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington, DC 

area), code 8732112560. Please call the 

Information Line for up-to-date information 

on this meeting. A notice in the Federal 

Register about last minute modifications that 

impact a previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide timely 

notice. Therefore, you should always check 

the agency’s Web site and call the 


srobinson on DSKHWCL6B1PROD with NOTICES
48760 Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 

appropriate advisory committee hot line/ 

phone line to learn about possible 

modifications before coming to the meeting. 

Agenda: On November 12 and 13, 2009, 

the Committee will discuss strategies and 

programs designed to communicate with the 

public about the risks and benefits of FDAregulated products so as to facilitate optimal 

use of these products. For more specific 

agenda topics, please visit the following Web 

site and scroll down to the appropriate 

advisory committee link (http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm), or call the FDA Advisory 

Committee Information Line as detailed 

under ‘‘Contact Person’’. FDA intends to 

provide specific agenda topics at both these 

locations no later than 15 days before the 

meeting. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

November 4, 2009. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. on 

November 12, 2009, and between 

approximately 10:30 a.m. and 11:30 a.m. on 

November 13, 2009. Those desiring to make 

formal oral presentations should notify the 

contact person and submit a brief statement 

of the general nature of the evidence or 

arguments they wish to present, the names 

and addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on or 

before November 4, 2009. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to speak is 

greater than can be reasonably 

accommodated during the scheduled open 

public hearing session, FDA may conduct a 

lottery to determine the speakers for the 

scheduled open public hearing session. The 

contact person will notify interested persons 

regarding their request to speak by November 

5, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact Lee 

Zwanziger at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: September 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23001 Filed 9–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

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. ‘‘NIAID Science Education 

Awards.’’ 

Date: October 5, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

Bethesda, MD 20817 (Telephone Conference 

Call). 

Contact Person: Jay Bruce Sundstrom, PhD, 

Scientific Review Official, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, Room 

2217, 6700B Rockledge Drvie, MSC–7616, 

Bethesda, MD 20892–7616, (301) 496–2550, 

sundstromj@niaid.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. 

(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: September 18, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23121 Filed 9–23–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0444] 

Schmid Laboratories, Inc. et al.; 

Proposal To Withdraw Approval of Five 

New Drug Applications; Opportunity 

for a Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity to request a hearing on the 

agency’s proposal to withdraw approval 

of five new drug applications (NDAs) 

from multiple sponsors. The basis for 

the proposal is that the sponsors have 

repeatedly failed to file required annual 

reports for these applications. 

DATES: Submit written requests for a 

hearing by October 26, 2009; submit 

data and information in support of the 

hearing request by November 23, 2009. 

ADDRESSES: Requests for a hearing, 

supporting data, and other comments 

are to be identified with Docket No. 

FDA–2009–N–0444 and submitted to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of approved applications to 

market new drugs for human use are 

required to submit annual reports to 

FDA concerning each of their approved 

applications in accordance with 

§ 314.81 (21 CFR 314.81). The holders of 

the approved applications listed in table 

1 of this document have failed to submit 

the required annual reports and have 

not responded to the agency’s request by 

certified mail for submission of the 

reports. 


srobinson on DSKHWCL6B1PROD with NOTICES