Proposed Collection; Comment Request; Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance, 46945-46946 [2010-19164]
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46945
Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Notices
Number of
respondents
Instrument
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Report ..................................................................................
600
1
600
1
600
Total ..............................................................................
600
1
600
14
8,400
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: July 28, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–19121 Filed 8–3–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; the Drug Accountability
Record (Form NIH 2564) (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
SUMMARY:
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: The Drug Accountability Record
(Form NIH 2564) (OMB No. 0925–0240).
Type of Information Collection Request:
Extension with changes. Need and Use
of Information Collection: The Food and
Drug Administration (FDA) regulations
require investigators to establish a
record of receipt, use and disposition of
all investigational agents. The National
Cancer Institute (NCI), as a sponsor of
investigational agent trials, has the
responsibility to assure the FDA that
investigators in its clinical trials
program are maintaining systems for
agent accountability. In order to fulfill
these requirements, a standard
Investigational Drug Accountability
Report Form (DARF) NIH–2564, was
designed to account for agent
inventories and usage by protocols. The
data obtained from the agent
accountability record will be used to
keep track of the dispensing of
investigational agent anticancer agents
to patients. It is used by the NCI
management to ensure that
investigational agent supplies are not
diverted for inappropriate protocol or
patient use. The information is also
compared to patient flow sheets
(protocol reporting forms) during site
visits conducted for each investigator
every three years. All comparisons are
done with the intention of ensuring
protocol, patient and agent compliance
for patient safety and protection.
Frequency of Response: Approximately
16 times per year. Affected Public:
Private sector including businesses,
other for-profit organizations, and nonprofit institutions. Type of Respondents:
Investigators, pharmacists, nurses,
pharmacy technicians, and data
managers. The annualized respondents’
burden for record keeping is estimated
to require 6,714 hours (Table 1). There
are no capital costs, operating costs, or
maintenance costs to report.
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Type of respondents
Investigators, or Designees .............................................................................
mstockstill on DSKH9S0YB1PROD with NOTICES
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 enhance the quality, utility, and
clarity of the information collected; and
(4) 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
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collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Charles, Hall, RPh,
M.S., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, National Cancer
Institute, Executive Plaza North, Room
7149, 9000 Rockville Pike, Bethesda,
Maryland 20891. Or call non-toll-free
number 301–496–5725 or e-mail your
request, include your address to:
hallch@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.
FOR FURTHER INFORMATION CONTACT:
PO 00000
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Frequency of
response
16
Average time
per response
Annual burden
hours
6/60 (0.1)
6,714
Dated: July 28, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–19158 Filed 8–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Multi-Ethnic Study of
Atherosclerosis (MESA) Event
Surveillance
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
SUMMARY:
E:\FR\FM\04AUN1.SGM
04AUN1
46946
Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Notices
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: MultiEthnic Study of Atherosclerosis (MESA)
Event Surveillance. Type of Information
Request: Renewal (OMB No. 0925–
0493). Need and Use of Information
Collection: The study, MESA, is
identifying and quantifying factors
associated with the presence and
progression of subclinical
cardiovascular disease (CVD)—that is,
atherosclerosis and other forms of CVD
that have not produced signs and
symptoms. The findings provide
important information on subclinical
CVD in individuals of different ethnic
backgrounds and provide information
for studies on new interventions to
prevent CVD. The aspects of the study
that concern direct participant
evaluation received a clinical exemption
from OMB clearance (CE–99–11–08) in
April 2000. OMB clearance is being
sought for the contact of physicians and
participant proxies to obtain
information about clinical CVD events
Estimated
number of
respondents
Type of respondents
that participants experience during the
follow-up period. Frequency of
response: Once per CVD event. Affected
public: Individuals. Types of
Respondents: Physicians and selected
proxies of individuals recruited for
MESA. The annual reporting burden is
as follows: Estimated Number of
Respondents: 74; Estimated Number of
Responses per respondent: 1.0; Average
Burden Hours Per Response: 0.20; and
Estimated Total Annual Burden Hours
Requested: 14.7.
There are no capital, operating, or
maintenance costs to report.
Estimated
number of
responses per
respondent
Average
burden hours
per
response
Estimated
total annual
burden hours
requested
17
57
1.0
1.0
0.20
0.20
3.4
11.3
Total ..........................................................................................................
mstockstill on DSKH9S0YB1PROD with NOTICES
Physicians ........................................................................................................
Proxies .............................................................................................................
74
1.0
0.20
14.7
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 will have practical utility;
(2) The accuracy of the agency’s
estimate of burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of
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: To request
more information on the proposed
project or to obtain a copy of data
collection plans and instruments,
contact Dr. Diane Bild, Division of
Cardiovascular Sciences, NHLBI, NIH, II
Rockledge Centre, 6701 Rockledge
Drive, Suite 10122, MSC # 7936,
Bethesda, MD 20892–7936, or call nontoll-free number (301) 435–0457, or email your request, including your
address to: bildd@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.
VerDate Mar<15>2010
18:02 Aug 03, 2010
Jkt 220001
Dated: July 27, 2010.
Suzanne Freeman,
NHLBI Project Clearance Liaison, National
Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2010–19164 Filed 8–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Assessing the Long-Term
Impacts of the John E. Fogarty
International Center’s Research and
Training Programs
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
John E. Fogarty International Center, 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: Assessing the Long-Term
Impacts of the John E. Fogarty
International Center’s Research and
Training Programs.
Type of Information Collection
Request: New collection.
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Need and Use of Information
Collection: This study will inform
investment decisions and strategies
employed by the Fogarty International
Center for the purpose of strengthening
biomedical research capacity in low and
middle income countries. The primary
objective of the study is to develop
detailed case studies of the long-term
impacts of Fogarty’s research and
training programs on educational
institutions located in low and middle
income countries. The findings will
provide valuable information
concerning return on the Center’s
investments over the past twenty years
and effective strategies for promoting
research capacity development in the
future.
Frequency of Response: Once.
Affected Public: Individuals.
Type of Respondents: Current and
former NIH grantees; Current and former
NIH trainees in countries of interest;
Leaders and administrators at
institutions of interest; Policy-makers
and scientific leaders in countries of
interest.
Estimated Number of Respondents:
105 per institution; total of 10
institutions over five years.
Estimated Number of Responses per
Respondent: 1.
Average Burden Hours per Response:
1 hour for interview participants; 2
hours for focus group participants.
Estimated Total Annual Burden
Hours Requested: 290, and the
annualized cost to respondents is
estimated at $4,841.
E:\FR\FM\04AUN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 149 (Wednesday, August 4, 2010)]
[Notices]
[Pages 46945-46946]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19164]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Multi-Ethnic Study of
Atherosclerosis (MESA) Event Surveillance
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
[[Page 46946]]
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: Multi-Ethnic Study of Atherosclerosis
(MESA) Event Surveillance. Type of Information Request: Renewal (OMB
No. 0925-0493). Need and Use of Information Collection: The study,
MESA, is identifying and quantifying factors associated with the
presence and progression of subclinical cardiovascular disease (CVD)--
that is, atherosclerosis and other forms of CVD that have not produced
signs and symptoms. The findings provide important information on
subclinical CVD in individuals of different ethnic backgrounds and
provide information for studies on new interventions to prevent CVD.
The aspects of the study that concern direct participant evaluation
received a clinical exemption from OMB clearance (CE-99-11-08) in April
2000. OMB clearance is being sought for the contact of physicians and
participant proxies to obtain information about clinical CVD events
that participants experience during the follow-up period. Frequency of
response: Once per CVD event. Affected public: Individuals. Types of
Respondents: Physicians and selected proxies of individuals recruited
for MESA. The annual reporting burden is as follows: Estimated Number
of Respondents: 74; Estimated Number of Responses per respondent: 1.0;
Average Burden Hours Per Response: 0.20; and Estimated Total Annual
Burden Hours Requested: 14.7.
There are no capital, operating, or maintenance costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Physicians...................................... 17 1.0 0.20 3.4
Proxies......................................... 57 1.0 0.20 11.3
---------------------------------------------------------------
Total....................................... 74 1.0 0.20 14.7
----------------------------------------------------------------------------------------------------------------
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
will have practical utility; (2) The accuracy of the agency's estimate
of burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) Ways to minimize the burden of 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: To request more information on the
proposed project or to obtain a copy of data collection plans and
instruments, contact Dr. Diane Bild, Division of Cardiovascular
Sciences, NHLBI, NIH, II Rockledge Centre, 6701 Rockledge Drive, Suite
10122, MSC 7936, Bethesda, MD 20892-7936, or call non-toll-
free number (301) 435-0457, or e-mail your request, including your
address to: bildd@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.
Dated: July 27, 2010.
Suzanne Freeman,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2010-19164 Filed 8-3-10; 8:45 am]
BILLING CODE 4140-01-P
