Proposed Collection; Comment Request; Web-Based Assessment of the NHLBI Clinical Studies Support Center (CSSC), 14531-14533 [2012-5918]
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14531
Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices
are no Capital Costs to report. There are
no Operating or Maintenance Costs to
report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE
Estimated
number of
respondents
Data collection activity
Type of respondent
Home Air ...........................................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Home Water ......................................
Home Dust ........................................
School and Child Care Facility Air ....
School and Child Care Facility Water
School and Child Care Facility Dust
Small, focused survey and instrument design and administration.
Focus groups ....................................
Cognitive interviews ..........................
pmangrum on DSK3VPTVN1PROD with NOTICES
Total ...........................................
Estimated
total annual
burden hours
requested
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
2
1
8,000
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
4,000
2
1
8,000
2,000
2,000
2,000
2,000
1
1
1
1
1
1
1
1
2,000
2,000
2,000
2,000
2,000
2,000
500
500
1
1
1
1
1
1
2
2
2,000
2,000
1,000
1,000
...........................................................
69,000
........................
........................
78,000
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
FOR FURTHER INFORMATION CONTACT:
14:55 Mar 09, 2012
Average
burden hours
per response
4,000
4,000
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
validity of the methodology and
assumptions used; (3) Ways to minimize
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
VerDate Mar<15>2010
Estimated
number of
responses
per
respondent
Jkt 226001
instruments, contact Dr. Sarah L.
Glavin, Deputy Director, Office of
Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive Room 2A18, Bethesda,
Maryland 20892, or call non-toll free
number (301) 496–1877 or Email your
request, including your address to
glavins@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: March 6, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications National
Institute of Child Health and Human
Development.
[FR Doc. 2012–5946 Filed 3–9–12; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Web-Based Assessment of
the NHLBI Clinical Studies Support
Center (CSSC)
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 the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: Web-Based
Assessment of the Clinical Studies
Support Center (CSSC). Type of
Information Collection Request: New.
SUMMARY:
E:\FR\FM\12MRN1.SGM
12MRN1
14532
Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices
Need and Use of Information Collection:
Over the past decade Data Safety
Monitoring Boards (DSMBs),
Observational Safety Monitoring Boards
(OSMBs), and Protocol Review
Committees (PRCs) have become an
important quality standard in clinical
trials and research involving human
subjects. The National Heart, Lung, and
Blood Institute (NHLBI) alone currently
has approximately 60 active review
Committees. These include DSMBs,
OSMBs, and PRCs which are
independent groups convened to review
study protocols developed under NHLBI
funded Clinical Trial Networks. These
committees are composed of members
with expertise in biostatistics, clinical
trials, bioethics, and other specific
scientific and research areas. The
NHLBI is charged with ensuring the
highest quality of each Institute-funded
clinical research project and compliance
with Department of Health and Human
Services (DHHS)/National Institutes of
Health (NIH)/NHLBI regulations
regarding human subject protections
and safety monitoring. To carry out this
responsibility, the NHLBI program staff
instituted a new methodology for
supporting the administration of
NHLBI-appointed Committees in 2009.
The new methodology included the
establishment of the Clinical Studies
Support Center (CSSC) under the
direction of Westat, Inc. The CSSC is a
pilot program to support the operations
of NHLBI’s DSMBs, Observational
OSMBs, and PRCs for the Division of
Blood Diseases and Resources. Utilizing
Executive Secretaries to support each
NHLBI safety monitoring board, the
CSSC is responsible for documenting
standardized operating procedures
related to the administration of
monitoring committees and the support
center in a CSSC Manual of Operations
and Procedures (MOP); coordinating
meeting space and logistics for inperson meetings, Web conferences, and
teleconferences; managing distribution
of adverse event notifications to DSMB
chairs and members, new protocols, and
proposed amendments; and providing
Executive Secretaries who provide
scientific and administrative support to
document board recommendations
related to the safety and efficacy of trial
interventions and the quality and
completeness of clinical research study
data. To move forward with full
knowledge of current Committee
operations and to monitor the effect of
newly established procedures, Westat is
required, as part of this contract, to
conduct an assessment of the efficiency
and effectiveness of NHLBI CSSC
committee operations. As part of this
assessment, the NHLBI requires
feedback and advice regarding the
support provided by the CSSC for
monitoring board operations. To this
end, a Web-based questionnaire will be
administered to Chairs and members of
monitoring boards to learn about their
opinions about specific CSSC activities
and their satisfaction with the
performance of CSSC staff.
Frequency of Response: Once;
Affected Public: Individuals; Type of
Respondents: Monitoring board
members. The annual reporting burden
is as follows: Estimated Number of
Respondents: 90; Estimated Number of
Responses per Respondent: 1; Average
Burden of Hours per Response: 0.33 and
Estimated Total Annual Burden Hours
Requested: 30.36. The annualized cost
to respondents is estimated at: $3.036
(based on $100 per hour). There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Table 1–1 and 1–2: Estimate of
Requested Burden Hours and Dollar
Value of Burden Hours
TABLE A.12–1—ESTIMATES OF HOUR BURDEN
Number of
respondents
Type of respondents
Frequency of
responses
Average time
per response
Annual hour
burden
D/OSMB Chairs .............................................................................................
D/OSMB Members .........................................................................................
Members in two D/OSMB ..............................................................................
10
78
2
1
1
2
0.33
0.33
0.33
3.3
25.74
1.32
Total ........................................................................................................
90
........................
........................
30.36
TABLE A.12–2—ANNUALIZED COST TO RESPONDENTS
Number of
respondents
Type of respondents
Frequency of
response
Average time
per response
Hourly wage
rate
Respondent
cost
10
78
2
1
1
2
.33
.33
.33
100
100
100
330
2,574
132
Totals ............................................................................
pmangrum on DSK3VPTVN1PROD with NOTICES
DSMB Chairs .......................................................................
DSMB Members ...................................................................
Members in two D/OSMB ....................................................
90
........................
........................
........................
3,036
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
VerDate Mar<15>2010
14:55 Mar 09, 2012
Jkt 226001
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 collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
the data collection plans and
instruments, contact Erin Smith,
Contracting Officer’s Technical
Representative, NHLBI, Room 9149,
6701 Rockledge Drive, Bethesda, MD
20892–7950, or call 301–435–0050, or
Email your request to
smithee@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
E:\FR\FM\12MRN1.SGM
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Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices
Dated: February 16, 2012.
Keith Hoots,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, NIH.
Dated: February 29, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2012–5918 Filed 3–9–12; 8:45 am]
BILLING CODE 4140–01–P
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: March 6, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–5928 Filed 3–9–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
pmangrum on DSK3VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel
Basic Research in Calcific Aortic Valve
Disease.
Date: April 4, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crystal Gateway Marriott 1700
Jefferson Davis Highway Arlington, VA
22202.
Contact Person: David A Wilson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7204, Bethesda, MD 20892–7924, 301–435–
0299, wilsonda2@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel
COPD Genetic Epidemiology.
Date: April 4, 2012.
Time: 10 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health One
Democracy Plaza 6701 Democracy Boulevard
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Stephanie J Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
VerDate Mar<15>2010
14:55 Mar 09, 2012
Jkt 226001
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; ‘‘BRAD’’.
Date: March 30, 2012.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852.
Contact Person: Sherry L. Dupere, Ph.D.,
Director, Division of Scientific Review,
Division of Scientific Review, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, NIH, 6100
Executive Blvd., Room 5B01, Bethesda, MD
20892, 301–451–3415, duperes@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: March 2, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–5932 Filed 3–9–12; 8:45 am]
BILLING CODE 4140–01–P
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14533
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review: Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Bioengineering Sciences and Technologies:
Shared Instrument Review.
Date: March 21–22, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Ping Fan, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5154,
MSC 7840, Bethesda, MD 20892, 301–408–
9971, fanp@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
Biophysical and Biomechanical Aspects of
Embryonic Development.
Date: March 26–27, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Elena Smirnova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5187,
MSC 7840, Bethesda, MD 20892, 301–435–
1236, smirnove@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Research in Biomedicine and Agriculture
Using Agriculturally Important Domestic
Species.
Date: March 27, 2012.
Time: 9 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\12MRN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 48 (Monday, March 12, 2012)]
[Notices]
[Pages 14531-14533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5918]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Web-Based Assessment of the
NHLBI Clinical Studies Support Center (CSSC)
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 the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: Web-Based Assessment of the Clinical
Studies Support Center (CSSC). Type of Information Collection Request:
New.
[[Page 14532]]
Need and Use of Information Collection: Over the past decade Data
Safety Monitoring Boards (DSMBs), Observational Safety Monitoring
Boards (OSMBs), and Protocol Review Committees (PRCs) have become an
important quality standard in clinical trials and research involving
human subjects. The National Heart, Lung, and Blood Institute (NHLBI)
alone currently has approximately 60 active review Committees. These
include DSMBs, OSMBs, and PRCs which are independent groups convened to
review study protocols developed under NHLBI funded Clinical Trial
Networks. These committees are composed of members with expertise in
biostatistics, clinical trials, bioethics, and other specific
scientific and research areas. The NHLBI is charged with ensuring the
highest quality of each Institute-funded clinical research project and
compliance with Department of Health and Human Services (DHHS)/National
Institutes of Health (NIH)/NHLBI regulations regarding human subject
protections and safety monitoring. To carry out this responsibility,
the NHLBI program staff instituted a new methodology for supporting the
administration of NHLBI-appointed Committees in 2009. The new
methodology included the establishment of the Clinical Studies Support
Center (CSSC) under the direction of Westat, Inc. The CSSC is a pilot
program to support the operations of NHLBI's DSMBs, Observational
OSMBs, and PRCs for the Division of Blood Diseases and Resources.
Utilizing Executive Secretaries to support each NHLBI safety monitoring
board, the CSSC is responsible for documenting standardized operating
procedures related to the administration of monitoring committees and
the support center in a CSSC Manual of Operations and Procedures (MOP);
coordinating meeting space and logistics for in-person meetings, Web
conferences, and teleconferences; managing distribution of adverse
event notifications to DSMB chairs and members, new protocols, and
proposed amendments; and providing Executive Secretaries who provide
scientific and administrative support to document board recommendations
related to the safety and efficacy of trial interventions and the
quality and completeness of clinical research study data. To move
forward with full knowledge of current Committee operations and to
monitor the effect of newly established procedures, Westat is required,
as part of this contract, to conduct an assessment of the efficiency
and effectiveness of NHLBI CSSC committee operations. As part of this
assessment, the NHLBI requires feedback and advice regarding the
support provided by the CSSC for monitoring board operations. To this
end, a Web-based questionnaire will be administered to Chairs and
members of monitoring boards to learn about their opinions about
specific CSSC activities and their satisfaction with the performance of
CSSC staff.
Frequency of Response: Once; Affected Public: Individuals; Type of
Respondents: Monitoring board members. The annual reporting burden is
as follows: Estimated Number of Respondents: 90; Estimated Number of
Responses per Respondent: 1; Average Burden of Hours per Response: 0.33
and Estimated Total Annual Burden Hours Requested: 30.36. The
annualized cost to respondents is estimated at: $3.036 (based on $100
per hour). There are no Capital Costs to report. There are no Operating
or Maintenance Costs to report.
Table 1-1 and 1-2: Estimate of Requested Burden Hours and Dollar Value
of Burden Hours
Table A.12-1--Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents respondents responses per response burden
----------------------------------------------------------------------------------------------------------------
D/OSMB Chairs................................... 10 1 0.33 3.3
D/OSMB Members.................................. 78 1 0.33 25.74
Members in two D/OSMB........................... 2 2 0.33 1.32
---------------------------------------------------------------
Total....................................... 90 .............. .............. 30.36
----------------------------------------------------------------------------------------------------------------
Table A.12-2--Annualized Cost to Respondents
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Hourly wage Respondent
Type of respondents respondents response per response rate cost
----------------------------------------------------------------------------------------------------------------
DSMB Chairs..................... 10 1 .33 100 330
DSMB Members.................... 78 1 .33 100 2,574
Members in two D/OSMB........... 2 2 .33 100 132
-------------------------------------------------------------------------------
Totals...................... 90 .............. .............. .............. 3,036
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate the accuracy of the agency's 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 collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Erin Smith, Contracting Officer's Technical
Representative, NHLBI, Room 9149, 6701 Rockledge Drive, Bethesda, MD
20892-7950, or call 301-435-0050, or Email your request to
smithee@nhlbi.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
[[Page 14533]]
Dated: February 16, 2012.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart,
Lung, and Blood Institute, NIH.
Dated: February 29, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-5918 Filed 3-9-12; 8:45 am]
BILLING CODE 4140-01-P
