Submission for OMB Review; Comment Request; Web-Based Assessment of the Clinical Studies Support Center (CSSC), 31027-31028 [2012-12656]
Download as PDF
<![CDATA[
31027
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
simulation modeling of the U.S. blood
supply, including the possible
application of an FDA computer
simulation model of the U.S. blood
supply in support of emergency
preparedness and planning for potential
disruptions in blood donations; (2)
discuss with the blood community the
utility of simulation methods as a
complementary approach to support
planning for daily inventory needs and
forecasting for future blood donations
and demand; (3) discuss the capabilities
and limitations of the U.S. computer
simulation model, assumptions used in
the model and data gaps for model
validation; (4) describe and prioritize
future model enhancements to extend
the model predictions from red blood
cell units to other blood components,
such as plasma and platelets; and (5)
discuss the level of detail required for
a model to characterize the U.S. blood
supply and to develop possible
scenarios in which shortages may be
addressed through countermeasures
such as the use of local and
interregional transfers of blood and
blood components.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857, approximately 15 working days
after the public workshop at a cost of 10
cents per page. A transcript of the
public workshop will be available on
the Internet at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12593 Filed 5–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
srobinson on DSK4SPTVN1PROD with NOTICES
Submission for OMB Review;
Comment Request; Web-Based
Assessment of the Clinical Studies
Support Center (CSSC)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) 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
was previously published in the Federal
Register on March 12, 2011, Volume 77
No. 44, pages 14531–14533 and allowed
60-days for public comment. One
comment was 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
October 1, 1995, unless it displays a
current valid OMB control number.
Proposed Collection: Title: Web-Based
Assessment of the Clinical Studies
Support Center (CSSC). Type of
Information Collection Request: New.
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
Number of
respondents
Type of respondents
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 a 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.
Frequency of
responses
Average time
per response
Annual hour
burden
Table A.12.1. ESTIMATES OF HOUR BURDEN
D/OSMB Chairs ...........................................................................................
D/OSMB Members .......................................................................................
VerDate Mar<15>2010
16:31 May 23, 2012
Jkt 226001
PO 00000
Frm 00035
Fmt 4703
10
78
Sfmt 4703
E:\FR\FM\24MYN1.SGM
1
1
24MYN1
0.33
0.33
3.3
25.74
31028
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
Number of
respondents
Type of respondents
Frequency of
responses
Average time
per response
Annual hour
burden
Members in two D/OSMB ............................................................................
2
2
0.33
1.32
Total ......................................................................................................
90
........................
........................
30.36
TABLE 1–1 AND 1–2—ESTIMATE OF REQUESTED BURDEN HOURS AND DOLLAR VALUE OF BURDEN HOURS
Number of respondents
Type of respondents
Frequency of
response
Average time
per response
Hourly age
rate
Respondent
cost
Table A.12–2. ANNUALIZED COST TO RESPONDENTS
10
78
2
1
1
2
.33
.33
.33
100
100
100
330
2,574
132
Totals ............................................................................
srobinson on DSK4SPTVN1PROD 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
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.
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: Erin Smith,
Contracting Officer Technical
Representative, 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 30-days of the date of
this publication.
VerDate Mar<15>2010
16:31 May 23, 2012
Jkt 226001
Dated: May 1, 2012.
Keith Hoots,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, NIH.
Dated: May 14, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2012–12656 Filed 5–23–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Collection of Customer
Service, Demographic, and Smoking/
Tobacco Use Information From the
National Cancer Institute’s Cancer
Information Service (CIS) Clients (NCI)
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 Cancer Institute (NCI), 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: Collection
of Customer Service, Demographic, and
Smoking/Tobacco Use Information from
the National Cancer Institute’s Cancer
Information Service (CIS) Clients (NCI).
Type of Information Collection Request:
Revision of currently approved
collection 0925–0208 (expiration 08/30/
2012). Need and Use of Information
Collection: The National Cancer
Institute’s Cancer Information Service
(CIS) provides the latest information on
cancer, clinical trials, and tobacco
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
cessation in English and Spanish.
Clients are served by calling 1–800–4–
CANCER for cancer information; 1–877–
44U–QUIT for smoking cessations
services; using the NCI’s LiveHelp, a
web-based chat service; using NCI’s
Contact Us page on www.cancer.gov;
and using NCI’s Facebook page. CIS
currently conducts a brief survey of a
sample of telephone and LiveHelp
clients at the end of usual service—a
survey that includes three customer
service and twelve demographic
questions (age, sex, race, ethnicity,
education, household income, number
in household, and five questions about
health care/coverage). Characterizing
clients and how they found out about
the CIS is essential to customer service,
program planning, and promotion. The
NCI also conducts a survey of
individuals using the CIS’s smoking
cessation services—a survey that
includes 20 smoking/tobacco use
‘‘intake’’ questions that serve as a needs
assessment that addresses smoking
history, previous quit attempts, and
motivations to quit smoking. An
additional question is used with callers
who want to receive proactive call-back
services. Responses to these questions
enable Information Specialists to
provide effective individualized
counseling. The NCI’s CIS also responds
to cancer-related inquiries to its
Facebook page and its Contact Us form
on www.cancer.gov but does not collect
customer service or demographic
questions on these access channels.
Frequency of Response: Once. Affected
Public: Individuals or households. Type
of Respondents: People with cancer;
their relatives and friends; and general
public, including smokers/tobacco
users. Annualized estimates for
numbers of respondents and respondent
burden are presented in Table 1.
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31027-31028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Web-Based Assessment
of the Clinical Studies Support Center (CSSC)
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood
Institute (NHLBI), the National Institutes of Health (NIH) 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 was previously published in the Federal
Register on March 12, 2011, Volume 77 No. 44, pages 14531-14533 and
allowed 60-days for public comment. One comment was 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
October 1, 1995, unless it displays a current valid OMB control number.
Proposed Collection: Title: Web-Based Assessment of the Clinical
Studies Support Center (CSSC). Type of Information Collection Request:
New. 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 a
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.
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents respondents responses per response burden
----------------------------------------------------------------------------------------------------------------
Table A.12.1. ESTIMATES OF HOUR BURDEN
----------------------------------------------------------------------------------------------------------------
D/OSMB Chairs................................. 10 1 0.33 3.3
D/OSMB Members................................ 78 1 0.33 25.74
[[Page 31028]]
Members in two D/OSMB......................... 2 2 0.33 1.32
-----------------------------------------------------------------
Total..................................... 90 .............. .............. 30.36
----------------------------------------------------------------------------------------------------------------
Table 1-1 and 1-2--Estimate of Requested Burden Hours and Dollar Value of Burden Hours
Number of Frequency of Average time Hourly age Respondent
Type of respondents respondents response per response rate cost
----------------------------------------------------------------------------------------------------------------
Table A.12-2. ANNUALIZED COST TO RESPONDENTS
----------------------------------------------------------------------------------------------------------------
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.
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: Erin Smith, Contracting Officer Technical
Representative, 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 30-days
of the date of this publication.
Dated: May 1, 2012.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart,
Lung, and Blood Institute, NIH.
Dated: May 14, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-12656 Filed 5-23-12; 8:45 am]
BILLING CODE 4140-01-P
