64314 Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact Paul Tran 

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/

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: October 14, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–26251 Filed 10–18–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Oncologic 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: Oncologic 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 December 2, 2010, from 8 a.m. to 5 p.m. 

Location: FDA White Oak Campus, 10903 

New Hampshire Ave., Building 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Information regarding special 

accommodations due to a disability, visitor 

parking, and transportation may be accessed 

at http://www.fda.gov/AdvisoryCommittees/

default.htm; under the heading ‘‘Resources 

for You’’, click on ‘‘White Oak Conference 

Center Parking and Transportation 

Information for FDA Advisory Committee 

Meetings’’. 

Contact Person: Nicole Vesely, Center for 

Drug Evaluation and Research, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, MD 

20993–0002, 301–796–9001, FAX: 301–847– 

8533, e-mail: Nicole.vesely@fda.hhs.gov, or 

FDA Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 301–451–2542. 

Please call the Information Line for up-todate 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 December 2, 2010, during the 

morning session, the committee will discuss 

biologics license application (BLA) 125377, 

with the proposed trade name Yervoy 

(ipilimumab), manufactured by Bristol-Myers 

Squibb Company. The proposed indication 

(use) for this product is for the treatment of 

advanced melanoma in patients who have 

received prior therapy. During the afternoon 

session, the committee will discuss new drug 

application (NDA) 022–405, with the 

proposed trade name Zictifa (vandetanib) 

Tablets, manufactured by iPR 

Pharmaceuticals, Inc., represented by 

AstraZeneca Pharmaceuticals LP (authorized 

U.S. agent). The proposed indication (use) for 

this product is for the treatment of patients 

with unresectable (non-operable) locally 

advanced or metastatic medullary thyroid 

cancer. 

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 16, 2010. Oral presentations from 

the public will be scheduled between 

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

between approximately 3:30 p.m. and 4 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 

November 8, 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 November 9, 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 Nicole 

Vesely 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: October 14, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–26247 Filed 10–18–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0487] 

Product Development Program for 

Interventions in Patients With Severe 

Bleeding Due to Trauma or Other 

Causes; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a 2-day public 

workshop entitled ‘‘Product 

Development Program for Interventions 

in Patients with Severe Bleeding Due to 

Trauma or Other Causes.’’ The purpose 

of this public workshop is to discuss 

possible paradigms for the evaluation of 

products indicated for use to stop severe 

bleeding. The workshop has been 

planned in partnership with the 

Department of Health and Human 

Services, Office of Public Health and 

Science; the National Heart, Lung and 

Blood Institute; and the Department of 

Defense. The public workshop will 

include presentations and panel 

discussions by experts from academic 

institutions, government agencies, and 

industry. 

Dates and Times: The public 

workshop will be held on December 9, 

2010, from 8 a.m. to 5:30 p.m. and 

December 10, 2010, from 8 a.m. to 

1 p.m. 

Location: The public workshop will 

be held at the Masur Auditorium, 10 

Center Dr., Bldg. 10, Clinical Center, 

National Institutes of Health, Bethesda, 

MD 20892. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

mstockstill on DSKH9S0YB1PROD with NOTICES

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. 

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