Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 42903 

than 18 years who are current 

participants in any pregnancy registry 

for a chronic condition; and 

(3) Health Care Providers: to include 

a mix of health care providers 

(including specialists, obstetriciangynecologists, and primary care 

providers) some who have participated 

in a pregnancy registry and some who 

have not participated in a pregnancy 

registry. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

60 1 1 1.0 60.0 

Total 60.0 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The study will involve about 60 

respondents and take approximately 1 

hour each to complete. These estimates 

are based on the Contractor’s extensive 

experience with mental models 

research. 

Dated: August 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20407 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

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 October 14, 2009, from 8 a.m. to 5 p.m. 

Location: The Inn and Conference Center, 

University of Maryland University College 

(UMUC), Marriott Conference Centers, 3501 

University Blvd. East, Adelphi, MD. The 

hotel telephone number is 301–985–7300. 

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 new 

drug application (NDA) 22–250, with the 

proposed trade name AMAYA (fampridine) 

10 milligram (mg) tablets, manufactured by 

Acorda Therapeutics, Inc. The proposed 

indication for this new drug product is to 

improve walking ability in individuals with 

multiple sclerosis (MS). MS is a neurological 

disease that may cause a wide variety of 

possible symptoms, including in some 

patients difficulty in walking. 

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 

September 29, 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 September 21, 

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 September 22, 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 a disability, please contact Diem-Kieu 

Ngo 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: August 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20380 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

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. 


pwalker on DSK8KYBLC1PROD with NOTICES
42904 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 

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 5, 2009, from 8 a.m. to 5 p.m. 

Location: Hilton Washington DC North/ 

Gaithersburg, The Ballrooms, 620 Perry 

Pkwy., Gaithersburg, MD. The hotel phone 

number is 301–977–8900. 

Contact Person: Nicole Vesely, 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– 

827–6793, FAX: 301–827–6776, 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 3014512542. 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 the 

following topics: 

(1) Supplemental biologics license 

application (sBLA) 103949/5153.0, 

PEGINTRON (peginterferon alfa-2b) 

injection, manufactured by Schering Corp. 

The proposed indication (use) for this 

product is as an adjuvant (additional) 

treatment for melanoma, a kind of skin 

cancer. The primary treatment for melanoma 

that is metastatic (has spread) to the lymph 

nodes is surgery to remove both the original 

cancer and lymph nodes surrounding the 

cancer. PEGINTRON’s proposed use is as a 

treatment in addition to, or as an ‘‘adjuvant,’’ 

to surgery. 

(2) New drug application (NDA) 022–465, 

proposed trade name VOTRIENT (pazopanib) 

tablets, manufactured by GlaxoSmithKline. 

The proposed indication (use) for this 

product is for the treatment of patients with 

advanced renal cell carcinoma, a form of 

kidney 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 

September 21, 2009. 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 

September 11, 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 September 14, 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 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: August 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20379 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, NIA. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

National Institute on Aging, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, NIA. 

Date: October 20–21, 2009. 

Closed: October 20, 2009, 8 a.m. to 8:30 

a.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Open: October 20, 2009, 8:30 a.m. to 11:55 

a.m. 

Agenda: Committee Discussion. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 20, 2009, 11:55 a.m. to 1 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Open: October 20, 2009, 1 p.m. to 2:30 p.m. 

Agenda: Committee Discussion. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 20, 2009, 2:30 p.m. to 2:45 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Open: October 20, 2009, 2:45 p.m. to 3:15 

p.m. 

Agenda: Committee Discussion. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 20, 2009, 3:15 p.m. to 4:15 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 21, 2009, 8 a.m. to 8:30 

a.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 


pwalker on DSK8KYBLC1PROD with NOTICES