Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices 27809 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Grant Opportunities (RC2) ARRA. 

Date: July 15–16, 2009. 

Time: 7 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Hyatt Regency Hotel, 

Bethesda, MD. 

Contact Person: Ruth Grossman, DDS, 

Scientific Review Officer, National Institute 

of Biomedical Imaging and Bioengineering, 

6707 Democracy Boulevard, Room 960, 

Bethesda, MD 20892. 301–496–8775. 

grossmanrs@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.701, ARRA Related 

Biomedical Research and Research Support 

Awards., National Institutes of Health, HHS) 

Dated: June 4, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13677 Filed 6–10–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; 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 

Biomedical Imaging and Bioengineering 

Special ARRA Revisions Competing 

Supplements. 

Date: July 16, 2009. 

Time: 12:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Biomedical 

Imaging and Bioengineering, 6707 

Democracy Boulevard, Suite 920, Bethesda, 

MD 20892 (Telephone Conference Call). 

Contact Person: John K. Hayes, PhD, 

Scientific Review Officer, 6707 Democracy 

Boulevard, Suite 959, Bethesda, MD 20892, 

301–451–3398, hayesj@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.701, ARRA Related 

Biomedical Research and Research Support 

Awards, National Institutes of Health, HHS) 

Dated: June 4, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–13668 Filed 6–10–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Peripheral and Central Nervous 

System Drugs 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: Peripheral and 

Central Nervous System Drugs 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 August 11, 2009, from 8 a.m. to 

5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd, Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Diem-Kieu Ngo, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827– 

7001, FAX: 301–827–6776, e-mail: 

diem.ngo@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512543. 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: The committee will discuss a 

new drug application (NDA) for a 

radiopharmaceutical proposed for a 

special type of brain imaging in patients 

with movement disorders. NDA 22–454, 

Ioflupane I 123 Injection (proposed 

trade name DaTSCAN), GE HealthCare, 

is proposed for detecting loss of 

functional nigrostriatal dopaminergic 

neurons by single photon emission 

computed tomography (SPECT) imaging 

in patients presenting with symptoms or 

signs of dopaminergic 

neurodegeneration. 

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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2009 and 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 July 28, 2009. 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 July 20, 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 July 21, 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 


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