Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 11735 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1, 

2008, THROUGH DECEMBER 31, 2008. 

PMA No./Docket No. Applicant TRADE NAME Approval Date 

P070015 

FDA–2008–M–0535 

Abbott Vascular Inc. XIENCE V EVEROLIMUS ELUTING CORONARY STENT 

SYSTEM & PROMUS ELUTING CORONARY STENT SYSTEM 

July 2, 2008 

P030025 (S28) 

FDA–2008–M–0547 

Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY 

STENT SYSTEM 

September 24, 2008 

P080004 

FDA–2008–M–0536 

Hoya Surgical Optics, Inc. HOYA ISPHERIC MODEL YA–60BB INTRAOCULAR LENS September 26, 2008 

H070004 

FDA–2008–M–0563 

Levitronix, LLC LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST 

SYSTEM (RVAS) 

October 7, 2008 

P060008 

FDA–2008–M–0593 

Boston Scientific Corp. TAXUS LIBERTE’ PACLITAXEL ELUTING CORONARY 

STENT SYSTEM 

October 10, 2008 

P050029 

FDA–2008–M–0601 

Stereotaxis, Inc. HELIOS II ABLATION CATHETER October 10, 2008 

H040004 

FDA–2008–M–0562 

Medtronic Sofamor Danek 

USA, Inc. 

INFUSE/MASTERGRAFT POSTEROLATERAL REVISION 

DEVICE 

October 10, 2008 

P050019 

FDA–2008–M–0596 

Boston Scientific Corp. CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS October 23, 2008 

H060002 

FDA–2008–M–0579 

Spiration, Inc. IBV VALVE SYSTEM October 24, 2008 

P060025 

FDA–2008–M–0594 

ATS Medical, Inc. ATS 3F AORTIC BIOPROSTHESIS October 30, 2008 

P080011 

FDA–2008–M–0608 

Coopervision Manufacturing, Ltd. BIOFINITY COMFILCON A (EXTENDED WEAR SOFT CONTACT LENSES) November 19, 2008 

P080007 

FDA–2008–M–0645 

Bard Peripheral Vascular 

Inc. 

BARD E-LUMINEXX VASCULAR STENT December 4, 2008 

P060006 

FDA–2008–M–0646 

Boston Scientific Corp. BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL 

PREMOUNTED STENT SYSTEM 

December 11, 2008 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: March 10, 2009. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E9–6026 Filed 3–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Simulations for Drug Related 

Science Education 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute on Drug Abuse (NIDA), the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. This proposed 

information collection was previously 

published in the Federal Register on 

June 26, 2008, (Vol. 73 No. 124, page 

36337) and allowed 60 days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after November 15, 

2008, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: 

Simulations for Drug Related Science 

Education. Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: This is a 

request for a one-time clearance to 

evaluate an interactive multimedia 

module developed by ArchieMD. This 

evaluation seeks to determine whether 

the multimedia module Archie MD: The 

Science of Drugs (1) Increases students’ 

knowledge in brain and heart biology 

and the effects drugs have on the body 

(2) Increases positive attitudes towards 

science education for high school 

students (3) Reinforce or instill negative 

attitudes towards substance abuse. In 

order to test the effectiveness of the 

interactive multimedia module, data 

will be collected in the form of pre and 

post test surveys from 10th and 11th 

grade high school students utilizing the 

developed module. The findings will 

provide valuable information regarding 

information pertaining to the use of 

interactive multimedia educational 

modules in high school science 

classrooms and their ability to increase 

knowledge and change attitudes and 

perceptions. 

Frequency of Response: 4. Affected 

Public: High school students engaged 

with the ArchieMD: The Science of 


sroberts on PROD1PC70 with NOTICES
11736 Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices 

Drugs program. Type of Respondent: 

Participants will include high school 

students enrolled in the tenth and 

eleventh grade. Estimated Total Annual 

Number of Respondents: 360. Estimated 

Number of Responses per Respondent: 

4. Average Burden Hours per Response: 

One high school period lasting 50 

minutes. Estimated Total Annual 

Burden Hours Requested: 1199.95. 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. The estimated 

annualized burden is summarized 

below. 

Type of respondents Number of 

respondents 

Frequency of 

response 

Average burden 

hours per 

response 

Estimated total 

burden hours 

requested 

Participants—High School Students ................................................ 360 4 .8333 1199.95 

Total .......................................................................................... 360 4 .8333 1199.95 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(2) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (3) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. 

Cathrine Sasek, Coordinator, Science 

Education Program, Office of Science 

Policy and Communications, National 

Institute on Drug Abuse, 6001 Executive 

Blvd, Room 5237, Bethesda, MD 20892, 

or call non-toll-free number (301) 443– 

6071; fax (301) 443–6277; or by e-mail 

to csasek@nida.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: March 12, 2009. 

Mary Affeldt, 

Associate Director for Management, National 

Institute on Drug Abuse. 

[FR Doc. E9–6037 Filed 3–18–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Survey of NHLBI 

Constituents’ Health Information 

Needs and Preferred Formats 

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: Survey of 

NHLBI Constituents’ Health Information 

Needs and Preferred Formats. Type of 

Information Collection Request: NEW. 

Need and Use of Information Collection: 

The purpose of this survey is to obtain 

information from NHLBI constituents 

(health professionals, patients and their 

families, and the general public) for the 

purpose of evaluating their health 

information and education needs and 

format preferences. The Consumer 

Services Team (CST) will use the data 

collected in this survey to create a 3- 

year Strategic Plan. The findings from 

the survey, described in the Strategic 

Plan, will be used to develop new 

health information materials for NHLBI 

constituents and to revise materials 

currently in the Institute’s portfolio. 

Frequency of Response: Once every 3 

years. Affected Public: Individuals. Type 

of Respondents: Individuals who have 

been consumers of NHLBI information 

within the past 3 years. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

2,450; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours Per Response: 0.2; and Estimated 

Total Annual Burden Hours Requested: 

162. The annualized cost to respondents 

is estimated at: $3,518.62. There are no 

Capital Costs, Operating Costs, and/or 

Maintenance Costs to report. 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours requested 

General Public ................................................................................. 1,075 0.33 0.2 71 

Private Companies .......................................................................... 332 0.33 0.2 22 

Public Sector Groups ....................................................................... 332 0.33 0.2 22 

Health Professionals ........................................................................ 711 0.33 0.2 47 

Totals ........................................................................................ 2,450 ............................ ............................ 162 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 


sroberts on PROD1PC70 with NOTICES