Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices 19097 

‘‘guideline.’’ In addition, guidance 

documents must not include mandatory 

language such as ‘‘shall,’’ ‘‘must,’’ 

‘‘require,’’ or ‘‘requirement,’’ unless 

FDA is using these words to describe a 

statutory or regulatory requirement. The 

guidance represents agency’s current 

thinking on the topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of applicable statutes and 

regulations. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

sections 1–5 of the guidance have been 

approved under OMB control no. 0910– 

0032 (expiration date April 30, 2010). 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VI. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/cvm or http:// 

www.regulations.gov. 

Dated: April 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9521 Filed 4–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Injury Prevention 

and Control, Initial Review Group, 

(NCIPC, IRG) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC announces the 

following meeting of the 

aforementioned review group: 

Times and Dates: 

8 a.m.–8:15 a.m., April 27, 2009 (Open). 

8:15 a.m.–4 p.m., April 27, 2009 (Closed). 

Place: Teleconference, Toll Free Number: 

(877) 468–4185, Participant Pass code: 447– 

5689. 

Status: Portions of the meetings will be 

closed to the public in accordance with 

provisions set forth in Section 552b(c)(4) and 

(6), Title 5, U.S.C., and the Determination of 

the Director, Management Analysis and 

Services Office, CDC, pursuant to Section 

10(d) of Public Law 92–463. 

Purpose: This group is charged with 

providing advice and guidance to the 

Secretary, Department of Health and Human 

Services, and the Director, CDC, concerning 

the scientific and technical merit of grant and 

cooperative agreement applications received 

from academic institutions and other public 

and private profit and nonprofit 

organizations, including State and local 

government agencies, to conduct specific 

injury research that focuses on prevention 

and control. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of applications submitted in 

response to Fiscal Year 2009 Requests for 

Applications related to the following 

individual research announcement: CE09– 

009, Youth Violence Prevention through 

Economic, Environmental, and Policy 

Change (U01). 

Agenda items are subject to change as 

priorities dictate. 

Due to programmatic issues that had to be 

resolved, the Federal Register notice is being 

published less than fifteen days before the 

date of the meeting. 

Contact Person for More Information: Lisa 

T. Garbarino, B.S., NCIPC, Extramural 

Research Program Office, CDC, 4770 Buford 

Highway, NE., M/S F62, Atlanta, Georgia 

30341–3724, Telephone: (404) 723–1527. 

The Director, Management Analysis and 

Services Office has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 21, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–9503 Filed 4–24–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Computational Modeling for 

Cardiovascular Devices; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Computational Modeling for 

Cardiovascular Devices.’’ FDA is cosponsoring the conference with the 

National Heart, Blood and Lung 

Institute of the National Institutes of 

Health and the National Science 

Foundation. The purpose of the public 

workshop is to facilitate discussion 

among FDA and other interested parties 

on the use of computational modeling in 

the design, development, and evaluation 

of cardiovascular medical devices. 

Date and Time: The public workshop 

will be held on June 1 and 2, 2009, from 

8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Hilton Washington DC/ 

Rockville Executive Meeting Center, 

1750 Rockville Pike, Rockville, MD 

20852. 

Contact Person: Donna R. Lochner, 

Center for Devices and Radiological 

Health (HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–4043, email: donna.lochner@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Holding This Public 

Workshop? 

The purpose of the public workshop 

is to facilitate discussion among FDA 

and other interested parties on the use 

of computational modeling in 

cardiovascular device design, 

development, and evaluation. 

II. What Are the Topics We Intend to 

Address at the Public Workshop? 

We hope to discuss a large number of 

issues at the public workshop, 

including, but not limited to: 

• Multi-scale modeling. 

• Imaging for cardiovascular device 

modeling. 

• Physiologic input data for 

cardiovascular device modeling. 

• Device-specific issues related to 

modeling, including a focus on heart 

valves, drug-eluting and bare metal 

stents, endovascular stents, cardiac 

rhythm management, and mechanical 

and circulatory support devices. 


pwalker on PROD1PC71 with NOTICES
19098 Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices 

• Regulatory issues with 

implementation of computer modeling. 

III. Is There a Fee and How Do I 

Register for the Public Workshop? 

There is a fee to attend the public 

workshop to defray the costs of meals 

provided and other expenses. The fee 

for the public workshop is $250. The 

registration process will be handled by 

BL Seamon. BL Seamon has extensive 

experience in planning, executing, and 

organizing educational meetings. 

Register online at http:// 

www.blseamon.com. Although the 

facility is spacious, registration will be 

on a first-come, first-served basis. 

If you need special accommodations 

due to a disability, please contact Donna 

R. Lochner at least 7 days before the 

public workshop. 

IV. Where Can I Find Out More About 

This Public Workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, and 

other relevant information will be 

posted, as it becomes available, on the 

Internet at http://www.fda.gov/cdrh/ 

dsma/workshop.html. 

Dated: April 16, 2009. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E9–9474 Filed 4–27–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Part C Early Intervention Services 

Grant 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of Noncompetitive 

Replacement Award to Joseph P. 

Addabbo Family Health Center. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) will be 

transferring Ryan White HIV/AIDS Part 

C Early Intervention Services Grant 

funds (authorized by Title XXVI of the 

Public Health Service Act) originally 

awarded to Caritas Health Care, Inc., to 

the Joseph P. Addabbo Family Health 

Center in order to ensure continuity of 

critical HIV medical care and treatment 

services to clients in Jamaica/Southeast 

Queens, Borough of Queens, New York 

City, New York. 

SUPPLEMENTARY INFORMATION: 

Former Grantee of Record: Caritas 

Health Care, Inc. 

Original Period of Grant Support: July 

1, 2006, to June 30, 2011. 

Replacement Awardee: Joseph P. 

Addabbo Family Health Center. 

Amount of Replacement Award: 

$388,253. 

Period of Replacement Award: The 

period of support for the replacement 

award is March 1, 2009, to March 31, 

2010. 

Authority: Section 2651 of the Public 

Health Service Act, 42 U.S.C. 300ff–51. 

CFDA Number: 93.918. 

Justification for the Exception to 

Competition: The former grantee, Caritas 

Health Care, Inc., notified HRSA that it 

would not continue providing services 

after February 28, 2009, as it is ceasing 

operations. It is critical that there be 

continuity in the medical care and 

treatment of approximately 430 lowincome patients with HIV/AIDS in the 

original service area, Jamaica/Southeast 

Queens, Borough of Queens, New York 

City, in New York. The Joseph P. 

Addabbo Family Health Center is 

located in the same geographical area 

previously served by Caritas Health 

Care, Inc., is a current Part C grantee 

with an established record of providing 

critical HIV/AIDS care and treatment, 

and has purchased the St. Dominic’s 

Family Health Center facility, one of the 

sites where the Ryan White services for 

Caritas Health Care, Inc., were provided. 

This temporary replacement award will 

ensure that there is no disruption of 

critical care and services to the service 

population while the service area is recompeted. 

This service area will be included in 

the upcoming competition for the Part C 

HIV Early Intervention Services 

competing application process for 

project periods starting April 1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Maria C. Rios, via e-mail 

mrios@hrsa.gov, or via telephone, 301– 

443–0493. 

Dated: April 17, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–9516 Filed 4–24–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Application for Overflight 

Program/Advance Notice for Aircraft 

Landings 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security. 

ACTION: 60-day notice and request for 

comments; extension of an existing 

collection of information: 1651–0087. 

SUMMARY: As part of its continuing effort 

to reduce paperwork and respondent 

burden, CBP invites the general public 

and other Federal agencies to comment 

on an information collection 

requirement concerning the Application 

for Overflight Program/Advance Notice 

for Aircraft Landings. This request for 

comment is being made pursuant to the 

Paperwork Reduction Act of 1995 (Pub. 

L. 104–13; 44 U.S.C. 3505(c)(2)). 

DATES: Written comments should be 

received on or before June 26, 2009, to 

be assured of consideration. 

ADDRESSES: Direct all written comments 

to the U.S. Customs and Border 

Protection, Attn.: Tracey Denning, 

Office of Regulations and Rulings, 799 

9th Street, NW., 7th Floor, Washington, 

DC 20229–1177 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to U.S. Customs and 

Border Protection, Attn.: Tracey 

Denning, Office of Regulations and 

Rulings, 799 9th Street, NW., 7th Floor, 

Washington, DC 20229–1177, Tel. (202) 

325–0265. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). The comments 

should address: (a) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimates of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden including 

the use of automated collection 

techniques or the use of other forms of 

information technology; and (e) the 

annual costs burden to respondents or 

record keepers from the collection of 

information (a total capital/startup costs 


pwalker on PROD1PC71 with NOTICES