Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices 57475 

Location: The Marriott Inn and 

Conference Center, University of 

Maryland University College, 3501 

University Boulevard East, Adelphi, 

MD. The conference center telephone 

number is 301–985–7300. 

Contact Person: Elaine Ferguson, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO31–2417, Silver Spring, MD 

20993–0002, 301–796–9001, FAX: 301– 

847–8540, email: elaine.ferguson@fda.

hhs.gov, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512533. 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 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On October 18, 2010, the 

committee will consider the results and 

analyses of the TREAT (Trial to Reduce 

Cardiovascular Events with Aranesp 

Therapy) study of ARANESP 

(darbepoetin alfa), manufactured by 

Amgen, Inc. This meeting is a follow-up 

to the September 2007 advisory 

committee meeting at which the 

committee discussed updated 

information on the risks and benefits of 

erythropoeisis-stimulating agents (drugs 

that stimulate production of red blood 

cells), marketed under the brand names 

ARANESP, EPOGEN, and PROCRIT, 

manufactured by Amgen, Inc., when 

used in the treatment of anemia (low red 

blood cell counts) due to chronic kidney 

failure. 

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 October 11, 2010. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. 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 October 3, 2010. 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 October 4, 2010. 

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 Elaine 

Ferguson 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/Advisory

Committees/AboutAdvisoryCommittees/ 

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 15, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–23514 Filed 9–20–10; 8:45 am] 

BILLING CODE 4160–01–S 

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: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Cellular and Molecular 

Biology of Neurodegeneration Study Section. 

Date: October 14–15, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Donovan House, 1155 14th Street, 

NW., Washington, DC 20005. 

Contact Person: Laurent Taupenot, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4183, 

MSC 7850, Bethesda, MD 20892, 301–435– 

1203, taupenol@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Biobehavioral Regulation and 

Learning. 

Date: October 15, 2010. 

Time: 2:30 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: Biao Tian, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 3089B, MSC 7848, Bethesda, 

MD 20892, (301) 402–4411, tianbi@csr.nih.

gov. 

Name of Committee: Healthcare Delivery 

and Methodologies Integrated Review Group; 

Nursing and Related Clinical Sciences Study 

Section. 

Date: October 19–20, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: InterContinental Mark Hopkins 

Hotel, 999 California Street, San Francisco, 

CA 94108. 

Contact Person: Katherine Bent, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3160, 

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

0695, bentkn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Collaborative: Behavioral Genetics and 

Epidemiology Linked Applications. 

Date: October 20–21, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Avenue, NW., Washington, DC 20037. 

Contact Person: Suzanne Ryan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 


srobinson on DSKHWCL6B1PROD with NOTICES
57476 Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices 

Health, 6701 Rockledge Drive, Room 3139, 

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

1712, ryansj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Retinopathy 

Studies. 

Date: October 26, 2010. 

Time: 8 a.m. to 5:30 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: Raya Mandler, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217, 

MSC 7840, Bethesda, MD 20892, 301–402– 

8228, rayam@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Cell Biology. 

Date: October 26–27, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications, 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: Noni Byrnes, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5130, 

MSC 7840, Bethesda, MD 20892, (301) 435– 

1023, byrnesn@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflicts: Lung Injury and Fibrosis. 

Date: October 26–27, 2010. 

Time: 9 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: George M Barnas, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4220, 

MSC 7818, Bethesda, MD 20892, 301–435– 

0696, barnasg@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: BMIT/CMIP/MEDI Imaging 

Applications. 

Date: October 26, 2010. 

Time: 10 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn San Francisco 

Fisherman’s Wharf, 1300 Columbus Avenue, 

San Francisco, CA 94133. 

Contact Person: Weihua Luo, MD, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5114, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1170, luow@csr.nih.gov. 

Name of Committee: Genes, Genomes, and 

Genetics Integrated Review Group; Ethical, 

Legal, and Social Implications of Human 

Genetics Study Section. 

Date: October 26, 2010. 

Time: 2 p.m. to 5 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: Cheryl M. Corsaro, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2204, 

MSC 7890, Bethesda, MD 20892, (301) 435– 

1045, corsaroc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Population Sciences and 

Epidemiology. 

Date: October 27–28, 2010. 

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: Fungai Chanetsa, MPH, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3135, 

MSC 7770, Bethesda, MD 20892, 301–408– 

9436, fungai.chanetsa@nih.hhs.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Fellowship: 

Oncological Sciences. 

Date: October 27–28, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: DoubleTree Hotel Washington, 1515 

Rhode Island Avenue, NW., Washington, DC 

20005. 

Contact Person: Michael A. Marino, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6152, 

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

0601, marinomi@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: September 15, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–23541 Filed 9–20–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

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 

Mental Health Special Emphasis Panel, 

National Research Service Award 

Institutional Research Training Grants (NRSA 

T32). 

Date: October 20, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: St. Gregory Hotel, 2033 M Street, 

NW., Washington, DC 20036. 

Contact Person: Rebecca C Steiner, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd, Room 6149, MSC 9608, 

Bethesda, MD 20892–9608, 301–443–4525, 

steinerr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: September 14, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–23537 Filed 9–20–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

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 on 

Deafness and Other Communication 


srobinson on DSKHWCL6B1PROD with NOTICES