Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 38211 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6200, 

MSC 7804, (For courier delivery, use MD 

20817), Bethesda, MD 20892. 301–435–1715. 

nga@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: July 27, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–18360 Filed 7–30–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Arthritis 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: Arthritis 

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 September 16, 2009, from 8:30 a.m. 

to 3:15 p.m. 

Location: Holiday Inn, The Ballrooms, 

Two Montgomery Village Ave., 

Gaithersburg, MD. The hotel telephone 

number is 301–948–8900. 

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 

3014512532. 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 

biologics license application (BLA) 12– 

5338, clostridial collagenase, Auxilium 

Pharmaceuticals, Inc., for the proposed 

treatment of advanced Dupuytren’s 

disease. Dupuytren’s disease is a 

condition in which the tendons of the 

hand that help move the fingers of the 

hand become thickened and scarred. 

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 1, 2009. 

Oral presentations from the public will 

be scheduled between approximately 

12:45 p.m. to 1:45 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 August 24, 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 August 25, 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/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: July 23, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–18356 Filed 7–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Antiviral 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: Antiviral 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 8, 2009, from 8 a.m. to 

5 p.m. 

Location: The Inn and Conference 

Center, University of Maryland 

University College (UMUC), 3501 

University Blvd. East, Adelphi, Md. The 

hotel telephone number is 301–985– 

7300. 

Contact Person: Paul Tran, 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: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572) in the 

Washington, DC area, code 3014512531. 

Please call the Information Line for upto-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 


PWALKER on DSK8KYBLC1PROD with NOTICES
38212 Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 

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 

an efficacy supplement for new drug 

application (NDA) 022–128, maraviroc 

300 milligram tablets, Pfizer, Inc., 

proposing a new indication for the 

treatment of antiretroviral-naive patients 

with chemokine (c-c motif) receptor 5 

(CCR5—tropic human 

immunodeficiency virus (HIV). 

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 24, 2009. 

Oral presentations from the public will 

be scheduled between approximately 11 

a.m. and 12 noon. 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 16, 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 17, 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 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/ 

AdvisoryCommitttees/

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: July 21, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–18355 Filed 7–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Foreign Assembler’s 

Declaration (With Endorsement by 

Importer) 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 30–Day notice and request for 

comments; Extension of an existing 

information collection: 1651–0031. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) of the Department of 

Homeland Security has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act: Foreign Assembler’s 

Declaration (with Endorsement by 

Importer). This is a proposed extension 

of an information collection that was 

previously approved. CBP is proposing 

that this information collection be 

extended with no change to the burden 

hours. This document is published to 

obtain comments from the public and 

affected agencies. This proposed 

information collection was previously 

published in the Federal Register (74 

FR 28712) on June 17, 2009, allowing 

for a 60-day comment period. This 

notice allows for an additional 30 days 

for public comments. This process is 

conducted in accordance with 5 CFR 

1320.10. 

DATES: Written comments should be 

received on or before August 31, 2009. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

the proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to the OMB Desk Officer for Customs 

and Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–5806. 

SUPPLEMENTARY INFORMATION: U.S. 

Customs and Border Protection (CBP) 

encourages the general public and 

affected Federal agencies to submit 

written comments and suggestions on 

proposed and/or continuing information 

collection requests pursuant to the 

Paperwork Reduction Act (Pub. L. 104– 

13). Your comments should address one 

of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency/component, 

including whether the information will 

have practical utility; 

(2) Evaluate the accuracy of the 

agencies/components estimate of the 

burden of The proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collections of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

techniques or other forms of 

information. 

Title: Foreign Assembler’s Declaration 

(with Endorsement by Importer). 

OMB Number: 1651–0031. 

Form Number: None. 

Abstract: The Foreign Assembler’s 

Declaration with Importer’s 

Endorsement is used by CBP to 

substantiate a claim for duty free 

treatment of U.S. fabricated components 

sent abroad for assembly and 

subsequently returned to the United 

States. 

Current Actions: There are no changes 

to the information collection. This 

submission is being made to extend the 

expiration date. 

Type of Review: Extension (without 

change). 

Affected Public: Businesses. 

Estimated Number of Respondents: 

2,730. 

Estimated Annual Burden per 

Respondent: 110.77 hours. 

Estimated Total Annual Burden 

Hours: 302,402. 


PWALKER on DSK8KYBLC1PROD with NOTICES