55804 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Transmissible 

Spongiform Encephalopathies 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 October 28, 2010, from 8:30 

a.m. to approximately 5 p.m. and on 

October 29, 2010, from 8:30 a.m. to 

approximately 12:30 p.m. 

Location: Holiday Inn, Gaithersburg, 2 

Montgomery Village Ave., Gaithersburg, 

MD, 20879. 

Contact Person: Bryan Emery or 

Rosanna Harvey, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512392. 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 28, 2010, the 

Committee will discuss: (1) FDA’s risk 

assessment for potential exposure to the 

variant Creutzfeldt-Jakob disease (vCJD) 

agent in U.S.-licensed plasma-derived 

Factor VIII and (2) labeling of blood and 

blood components and plasma-derived 

products, including plasma-derived 

albumin and products containing 

plasma-derived albumin, to address the 

possible risk of transmission of vCJD. 

On October 29, 2010, the Committee 

will hear informational presentations 

related to FDA’s geographic donor 

deferral policy to reduce the possible 

risk of transmission of CJD and vCJD by 

blood and blood products and human 

cells, and tissue and cellular and tissue 

based products. The Committee will 

also hear updates on the following 

topics: The development of devices to 

remove transmissible spongiform 

encephalopathy agents from blood 

components and chronic wasting 

disease. 

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 21, 2010. 

Oral presentations from the public will 

be scheduled on October 28, 2010, 

between approximately 11 a.m. and 

11:45 a.m. and between approximately 

3:30 p.m. and 4 p.m. and on October 29, 

2010, between approximately 10:30 a.m. 

and 11 a.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 13, 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 14, 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 Bryan Emery 

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 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22805 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; 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 

General Medical Sciences Special Emphasis 

Panel, Phase II Clinical Trial in Septic Shock. 

Date: October 7, 2010. 

Time: 8:30 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of General 

Medical Sciences, National Institutes of 

Health, 45 Center Drive, Room 3AN18K, 

Bethesda, MD 20892. (Telephone Conference 

Call.) 

Contact Person: Brian R. Pike, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18B, Bethesda, MD 

20892. 301–594–3907. pikbr@mail.nih.gov. 

(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 

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: September 8, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22843 Filed 9–13–10; 8:45 am] 

BILLING CODE 4140–01–P 


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