Proposed Collection; Comment Request; Simulations for Drug Related Science Education, 11735-11736 [E9-6037]
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11735
Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices
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 https://
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
sroberts on PROD1PC70 with NOTICES
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
VerDate Nov<24>2008
17:17 Mar 18, 2009
Jkt 217001
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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
E:\FR\FM\19MRN1.SGM
19MRN1
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.
Number of
respondents
Type of respondents
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report. The estimated
annualized burden is summarized
below.
Average burden
hours per
response
Frequency of
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
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondents
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 3year 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.
Average burden
hours per
response
Estimated total
annual burden
hours requested
1,075
332
332
711
0.33
0.33
0.33
0.33
0.2
0.2
0.2
0.2
71
22
22
47
Totals ........................................................................................
sroberts on PROD1PC70 with NOTICES
General Public .................................................................................
Private Companies ..........................................................................
Public Sector Groups .......................................................................
Health Professionals ........................................................................
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:
VerDate Nov<24>2008
18:55 Mar 18, 2009
Jkt 217001
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
E:\FR\FM\19MRN1.SGM
19MRN1
Agencies
[Federal Register Volume 74, Number 52 (Thursday, March 19, 2009)]
[Notices]
[Pages 11735-11736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6037]
-----------------------------------------------------------------------
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
[[Page 11736]]
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.
----------------------------------------------------------------------------------------------------------------
Average burden Estimated total
Type of respondents Number of Frequency of hours per burden hours
respondents response response 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