62658 Federal Register / Vol. 72, No. 214 / Tuesday, November 6, 2007 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Circulatory System Devices Panel of 

the Medical Devices 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: Circulatory 

System Devices Panel of the Medical 

Devices 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 November 29 and 30, 2007, 

from 8 a.m. to 6 p.m. 

Location: Gaithersburg Holiday Inn, 

Ballroom, 2 Montgomery Village Ave., 

Gaithersburg, MD. 

Contact Person: James Swink, Center 

for Devices and Radiological Health 

(HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–4179, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512625. 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: On November 29, 2007, the 

committee will discuss, make 

recommendations, and vote on a 

premarket approval application, 

sponsored by Abbott Vascular, for the 

XIENCE V Everolimus Eluting Coronary 

Stent System, which is indicated for 

improving coronary luminal diameter in 

patients with symptomatic heart disease 

due to de novo native coronary artery 

lesions (length = 28 millimeters (mm)) 

with reference vessel diameter of 2.5 

mm to 4 mm. 

On November 30, 2007, the committee 

will discuss, make recommendations, 

and vote on a premarket approval 

application, sponsored by Thoratec 

Corp., for the HeartMate II Left 

Ventricular Assist System (LVAS), 

which is intended for use as a bridge to 

transplantation in cardiac transplant 

candidates at risk of imminent death 

from non-reversible left ventricular 

failure. The HeartMate II LVAS is 

intended for use both inside and outside 

the hospital. 

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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2007 and 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 15, 2007. 

Oral presentations from the public will 

be scheduled for approximately 30 

minutes at the beginning of committee 

deliberations on each day and for 

approximately 30 minutes near the end 

of the deliberations on each day. 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 7, 2007. 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 8, 2007. 

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 AnnMarie 

Williams, Conference Management 

Staff, at 240–276–8932, 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/oc/advisory/ 

default.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 31, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E7–21779 Filed 11–5–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 30-Day 

Proposed Information Collection: 

Application for Participation in the IHS 

Scholarship Program 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

350(c)(2)(A) of the Paperwork Reduction 

Act of 1995 which requires 30 days for 

public comment on proposed 

information collection projects, the 

Indian Health Service (IHS) has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve the information collection 

listed below. This proposed information 

collection project was previously 

published in the Federal Register (72 

FR 45054) on August 10, 2007 and 

allowed 60 days for public comment. No 

public comment was received in 

response to the notice. The purpose of 

this notice is to allow 30 days for public 

comment to be submitted directly to 

OMB. 

Proposed Collection: Title: 0917–

0006, ‘‘Application for Participation in 

the IHS Scholarship Program.’’ Type of 

Information Collection Request: 

Previously Approved Collection. Form 

Number(s): IHS–856, 856–2 through 

856–8, IHS–815, IHS–816, IHS–817, 

IHS–818, D–02, F–02, F–04, G–02, G–

04, H–07, H–08, J–04, J–05, K–03, K–04, 

and L–03. Reporting formats are 

contained in an IHS Scholarship 

Program application booklet. Need and 

Use of Information Collection: This IHS 

Scholarship Branch needs this 

information for program administration 

and uses the information to solicit, 

process, and award IHS Pre-graduate, 

Preparatory, and/or Health Professions 

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Federal Register / Vol. 72, No. 214 / Tuesday, November 6, 2007 / Notices 62659 

Scholarship grants and monitor the 

academic performance of awardees, to 

place awardees at payback sites. The 

IHS Scholarship Program plans to 

streamline the application to reduce the 

time needed by applicants to complete 

and provide the information. The IHS 

Scholarship Program plans to use 

information technology to make the 

application electronically available on 

the internet have been delayed. Affected 

Public: Individuals, non-for-profit 

institutes and State, local or Tribal 

Government. Type of Respondents: 

Students pursuing health care 

professions. 

The table below provides: Types of 

data collection instruments, Estimated 

number of respondents, Number of 

responses per respondent, Annual 

number of responses, Average burden 

hour per response, and Total annual 

burden hour(s). 

Data collection instrument(s) Number of 

respondents 

Responses per 

respondent 

Total annual 

response 

Burden hour per 

response *

Annual burden 

hours 

Scholarship Application (IHS–856) ........... 1500 1 1500 1.00 (60 min) .... 1500 

Checklist (856–2) ...................................... 1500 1 1500 0.13 (8 min) ...... 195 

Course Verification (856–3) ...................... 1500 1 1500 0.70 (42 min) .... 1050 

Faculty/Employer Application (856–4) ...... 1500 2 3000 0.83 (50 min) .... 2490 

Justification (856–5) .................................. 1500 1 1500 0.75 (45 min) .... 1125 

Federal Debt (856–6) ................................ 1500 1 1500 0.13 (8 min) ...... 195 

Job Experience only (856–7) .................... 25 1 25 0.83 (50 min) .... 21 

Accept/Decline (856–8) ............................. 650 1 650 0.13 (8 min) ...... 84 

Receipt of Application (815) ..................... 1500 1 1500 0.03 (2 min) ...... 45 

Address Change Notice (816) .................. 25 1 25 0.02 (1 min) ...... 25 

Scholarship Program Agreement (817) .... 850 1 850 0.05 (3 min) ...... 43 

Stipend Checks (D–02) ............................. 100 1 100 0.13 (8 min) ...... 13 

Enrollment (F–02) ..................................... 1300 1 1300 0.13 (8 min) ...... 169 

Academic Problem/Change (F–04) .......... 50 1 50 0.13 (8 min) ...... 6 

Request Assistance (G–02) ...................... 217 1 217 0.13 (8 min) ...... 28 

Summer School (G–04) ............................ 193 1 193 0.10 (6 min) ...... 19 

Health Professions Contract (818) ........... 850 1 850 0.05 (3 min) ...... 33 

Placement (H–07) ..................................... 250 1 250 0.18 (11 min) .... 45 

Graduation (H–08) .................................... 250 1 250 0.17 (10 min) .... 43 

Site Preference (J–04) .............................. 150 1 150 0.13 (8 min) ...... 20 

Travel Reimb (J–05) ................................. 150 1 150 0.10 (6 min) ...... 15 

Status Report (K–03) ................................ 250 1 250 0.25 (15 min) .... 63 

Preferred Assignment (K–04) ................... 200 1 200 0.75 (45 min) .... 150 

Request of Deferment (L–03) ................... 20 1 20 0.13 (8 min) ...... 3 

Total ................................................... 15,830 .............................. .............................. ........................... 7,380 

*For ease of understanding, burden hours are also provided in actual minutes. 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely fashion; 

(c) the accuracy of public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); (d) 

whether the methodology and 

assumptions used to determine the 

estimates are logical; (e) ways to 

enhance the quality, utility, and clarity 

of the information being collected; and 

(f) ways to minimize the public burden 

through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Send your 

written comments and suggestions 

regarding the proposed information 

collection contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time to: Office of Management and 

Budget, Office of Regulatory Affairs, 

New Executive Office Building, Room 

10235, Washington, DC 20503, 

Attention: Desk Officer for IHS. 

To request more information on the 

proposed collection or to obtain a copy 

of the data collection instrument(s) and/ 

or instruction(s) contact: Mrs. Chris 

Rouleau, IHS Reports Clearance Officer, 

12300 Twinbrook Parkway, Suite 450, 

Rockville, MD 20852–1601; call non-toll 

free (301) 443–5938; send via facsimile 

to (301) 443–2316; or send your e-mail 

requests, comments, and return address 

to: Christina.Rouleau@ihs.gov. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having full effect if 

received within 30 day of the date of 

this publication. 

Dated: October 29, 2007. 

Robert G. McSwain, 

Acting Director, Indian Health Service. 

[FR Doc. 07–5520 Filed 11–5–07; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; The Framingham Study 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH) will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: The 

Framingham Study. Type of Information 

Request: Revision (OMB No. 0925–

0216). Need and Use of Information 

Collection: The Framingham Study will 

conduct examinations and morbidity 

and mortality follow-up in original, 

offspring, and third generation 

participants for the purpose of studying 

the determinants of cardiovascular 

disease. Frequency of response: The 

mstockstill on PROD1PC66 with NOTICES