Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 64315 

suite 200N, Rockville, MD 20852–1448, 

301–827–6129, FAX: 301–827–2843, 

e-mail: rhonda.dawson@fda.hhs.gov. 

Registration: Mail, fax, or e-mail your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

contact person (see Contact Person) by 

November 19, 2010. There is no 

registration fee for the public workshop. 

Early registration is recommended 

because seating is limited. Registration 

on the day of the public workshop will 

be provided on a space-available basis 

beginning at 7:30 a.m. 

If you need special accommodations 

due to a disability, please contact 

Rhonda Dawson (see CONTACT 

PERSON) at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: Severe 

bleeding may be encountered in both 

traumatic and non-traumatic clinical 

situations. New products for the 

treatment of severe bleeding are needed 

to reduce the need for blood 

transfusions, minimize complications 

resulting from blood loss, and improve 

patient outcomes. The development and 

approval of new products for use in 

treatment of severe bleeding, 

particularly severe bleeding resulting 

from trauma, has been complicated by 

the lack of a consensus definition of 

severe bleeding as well as the need to 

identify appropriate clinical endpoints 

for assessment of product safety and 

efficacy. Clinical endpoints may vary 

depending on the product indications, 

patient characteristics, nature of injury, 

whether the product acts locally or 

systemically, the nature of the product 

(e.g., device, drug, biologic, or 

combination), and conditions of use. 

Because it may not always be feasible 

to obtain standard informed consent, 

clinical trials of products used for the 

treatment of life-threatening severe 

bleeding resulting from trauma may 

raise significant ethical and legal 

considerations. Researchers studying 

products for use in such circumstances 

may need guidance to carry out 

appropriate consultation with 

representatives of the communities in 

which the clinical investigation will be 

conducted and from which the study 

participants will be selected. Clinical 

trials on products intended for use in 

trauma are also complicated by the 

difficulty of identifying patients who 

may meet study inclusion criteria. 

Given these challenges, further 

discussion is needed about how 

products approved for use for treatment 

of severe bleeding occurring during 

surgery or due to non-surgical 

conditions may best be evaluated for use 

in treatment of severe bleeding in 

trauma. 

The first day of the workshop will 

include presentations and panel 

discussions on the following topics: 

(1) Current clinical scientific knowledge 

concerning the pathophysiology of 

trauma and assessment of severe 

bleeding; (2) currently available locally 

acting and systemic products used to 

treat severe bleeding in trauma and nontrauma settings; (3) animal models for 

pre-clinical evaluation of products; (4) 

ethical considerations for clinical trials 

to evaluate products used in treatment 

of severe bleeding in trauma; and (5) 

clinical evaluation of products for 

bleeding interventions, including 

clinical trials and endpoints. The 

second day of the workshop will 

include a discussion of whether 

products with an indication for use in 

severe bleeding due to trauma can be 

evaluated in clinical settings other than 

a trauma clinical trial and a summary of 

the sessions presented at the workshop. 

Transcripts: Please be advised that as 

soon as a transcript is available, it can 

be obtained in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. A 

transcript of the public workshop will 

be available on the Internet at http://

www.fda.gov/BiologicsBloodVaccines/

NewsEvents/Workshops

MeetingsConferences/

TranscriptsMinutes/default.htm. 

Dated: October 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26212 Filed 10–18–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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 materials, 

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 

Neurological Disorders and Stroke Special 

Emphasis Panel, SPOTRIAS. 

Date: December 15, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. (Telephone 

Conference Call.) 

Contact Person: Richard D. Crosland, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Room 3208, 

MSC 9529, Bethesda, MD 20892–9529. 301– 

496–0635. Rc218u@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: October 13, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26321 Filed 10–18–10; 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 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 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 contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Medicinal Chemistry. 

Date: November 9–10, 2010. 

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

Agenda: To review and evaluate contract 

proposals. 

mstockstill on DSKH9S0YB1PROD with NOTICES

64316 Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 

Place: Hotel Palomar, 117 South 17th 

Street, Philadelphia, PA. 

Contact Person: Phillip F. Wiethorn, 

Scientific Review Administrator, DHHS/NIH/ 

NINDS/DER/SRB, 6001 Executive Boulevard, 

MSC 9529, Neuroscience Center, Room 3203, 

Bethesda, MD 20892–9529. 301–496–5388. 

wiethorp@ninds.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: October 13, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26320 Filed 10–18–10; 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 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 materials, 

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 

Neurological Disorders and Stroke Initial 

Review Group, Neurological Sciences and 

Disorders B. 

Date: October 28–29, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: One Washington Circle Hotel, 

Washington, DC. 

Contact Person: Ernest W. Lyons, PhD, 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, 301– 

496–4056. 

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. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group, NST–2 Subcommittee. 

Date: November 1–2, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Willard InterContinental 

Washington, 1401 Pennsylvania Avenue, 

NW., Washington, DC 20004. 

Contact Person: JoAnn McConnell, PhD, 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, 301– 

496–5324, Mcconnej@ninds.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. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: October 13, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26318 Filed 10–18–10; 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; Small 

Business: Radiation Therapy and Biology. 

Date: November 9–10, 2010. 

Time: 8 a.m. to 11 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Bo Hong, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 6194, MSC 7804, Bethesda, MD 

20892, 301–435–5879, hongb@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Cellular 

Neuroscience and Drug Discovery. 

Date: November 9–10, 2010. 

Time: 11 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Geoffrey G. Schofield, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040–A, 

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

1235, geoffreys@csr.nih.gov. 

Name of Committee: AIDS and Related 

Research Integrated Review Group;AIDS 

Clinical Studies and Epidemiology Study 

Section. 

Date: November 16, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Wardman Park Washington, 

DC Hotel, 2660 Woodley Road, NW., 

Washington, DC 20008. 

Contact Person: Hilary D Sigmon, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5222, 

MSC 7852, Bethesda, MD 20892, (301) 594– 

6377, sigmonh@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Program 

Project: Protein Folding, Dynamics and 

Thermodynamics in Regulation of 

Transcription. 

Date: November 17–19, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: James W. Mack, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4154, 

MSC 7806, Bethesda, MD 20892, (301) 435– 

2037, mackj2@csr.nih.gov. 

Name of Committee: AIDS and Related 

Research Integrated Review Group; AIDS 

Discovery and Development of Therapeutics 

Study Section. 

Date: November 19, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marina del Rey Marriott, 4100 

Admiralty Way, Marina del Rey, CA 90292. 

Contact Person: Eduardo A Montalvo, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5108, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1168, montalve@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–08– 

261: Emergency Medical Services for 

Children. 

Date: December 7, 2010. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

mstockstill on DSKH9S0YB1PROD with NOTICES