Agency Information Collection Activities: Proposed Collection: Comment Request, 7481-7482 [2010-3167]
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Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Notices
seconded by Director John E. Bowman
(Acting Director, Office of Thrift
Supervision), concurred in by Director
Thomas J. Curry (Appointive), and
Chairman Sheila C. Bair, that
Corporation business required its
consideration of the matters which were
to be the subject of this meeting on less
than seven days’ notice to the public;
that no earlier notice of the meeting was
practicable; that the public interest did
not require consideration of the matters
in a meeting open to public observation;
and that the matters could be
considered in a closed meeting by
authority of subsections (c)(2), (c)(4),
(c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and
(c)(10) of the ‘‘Government in the
Sunshine Act’’ (5 U.S.C. 552b(c)(2),
(c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B),
and (c)(10)). The meeting was held in
the Board Room of the FDIC Building
located at 550 - 7th Street, NW.,
Washington, DC.
Dated: February 17, 2010.
Federal Deposit Insurance Corporation.
By:
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2010–3391 Filed 2–17–10; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
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AGENCY: Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice.
SUMMARY: Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold its
twenty-second meeting. The meeting
will be open to the public.
DATE: The meeting will be held on
Tuesday, March 9, 2010 from 8:30 a.m.
until 5 p.m. and Wednesday, March 10,
2010 from 8:30 a.m. until 5 p.m.
ADDRESSES: U.S. Department of Health &
Human Services, 200 Independence
Avenue, SW., Hubert H. Humphrey
Building, Room 800, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
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and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; e-mail address:
sachrp@osophs.dhhs.gov.
Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
On March 9, 2010, OHRP staff will
provide a summary of public comments
received on two recent draft guidance
documents: Institutional Review Board
(IRB) Continuing Review of Research
and IRB Approval of Research with
Conditions. Following this presentation,
there will be a panel that will examine
the context for resolution of regulatory
harmonization issues through the
Clinical Trials Transformation Initiative
and the International Council on
Harmonization and Good Clinical
Practice. After lunch, the day will
conclude with a report from the Subpart
A Subcommittee (SAS) focusing on
issues surrounding consent for future
use of specimens or data. SAS is
charged with developing
recommendations for consideration by
SACHRP about the application of
subpart A of 45 CFR part 46 in the
current research environment. This
subcommittee was established by
SACHRP at its October 2006 meeting.
On March 10, 2010, co-chairs of the
Subcommittee on Harmonization (SOH)
will discuss the charge, initial steps,
and membership of this new group. The
SOH was established by SACHRP at its
July 2009 meeting and is charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification, and/
or coordination. The remainder of
March 10 will be devoted to continuing
the previous day’s focus on the work of
the Subpart A Subcommittee. Public
comment will be heard on both days.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
SUPPLEMENTARY INFORMATION:
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7481
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
Thursday, March 4, 2010. Information
about SACHRP and the draft meeting
agenda will be posted on the SACHRP
Web site at: https://www.hhs.gov/ohrp/
sachrp/.
Dated: February 16, 2010.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. 2010–3271 Filed 2–18–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: The Health Education
Assistance Loan (HEAL) Program
Regulations (OMB No. 0915–0108)
Extension
The Health Education Assistance
Loan (HEAL) Program has regulations
that contain notification, reporting and
recordkeeping requirements to ensure
that the lenders, holders and schools
participating in the HEAL program
follow sound management procedures
in the administration of federallyinsured student loans. While the
regulatory requirements are approved
under the OMB number referenced
above, much of the burden associated
with the submission of required HEAL
forms and certain reporting
requirements is approved under
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Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Notices
separate OMB numbers. The table below
provides the estimate of burden for the
remaining regulations.
The estimates of burden are as
follows:
REPORTING REQUIREMENTS
Number of
transactions
Number of respondents
Total
transactions
Hours per
response
(min)
Total burden
hours
17 Holders .......................................................................................................
190 Schools .....................................................................................................
5
.4
78
78
12
10
16
13
Total Reporting .........................................................................................
........................
........................
........................
29
Total
transactions
Hours per
response
(min)
NOTIFICATION REQUIREMENTS
Number of
transactions
Number of respondents
Total burden
hours
7,930 Borrowers ..............................................................................................
17 Holders .......................................................................................................
190 Schools .....................................................................................................
1
7,910
.89
7,930
134,470
170
10
10
14
1,322
22,412
40
Total Notification .......................................................................................
........................
........................
........................
23,774
Total
transactions
Hours per
response
(min)
RECORDKEEPING REQUIREMENTS
Number of
transactions
Number of respondents
Total burden
hours
17 Holders .......................................................................................................
190 Schools .....................................................................................................
3,568
257
60,657
48,822
14
15
14,153
12,206
Total Recordkeeping ................................................................................
........................
........................
........................
26,359
Total ...................................................................................................
........................
........................
........................
50,162
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: February 5, 2010.
Sahira Rafiullah,
Director, Division of Policy Review and
Coordination.
[FR Doc. 2010–3167 Filed 2–18–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institutes of Health
Submission for OMB Review;
Comment Request; The
Atherosclerosis Risk in Communities
Study (ARIC)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
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Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 16, 2009, page
58962, and allowed 60 days for public
comment. Only 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 currently valid
OMB control number.
Proposed Collection
Title: The Atherosclerosis Risk in
Communities Study (ARIC). Type of
Information Collection Request:
Extension of a currently approved
collection (OMB No. 0925–0281). Need
and Use of Information Collection: This
project involves annual follow-up by
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telephone of participants in the ARIC
study, review of their medical records,
and interviews with doctors and family
to identify disease occurrence.
Interviewers will contact doctors and
hospitals to ascertain participants’
cardiovascular events. Information
gathered will be used to further describe
the risk factors, occurrence rates, and
consequences of cardiovascular disease
in middle aged and older men and
women. Frequency of Response: The
participants will be contacted annually.
Affected Public: Individuals or
households; Businesses or other for
profit; Small businesses or
organizations. Type of Respondents:
Individuals or households; doctors and
staff of hospitals and nursing homes.
The annual reporting burden is as
follows: Estimated Number of
Respondents: 11,992; Estimated Number
of Responses per Respondent: 1.0;
Average Burden Hours per Response:
0.2399; and Estimated Total Annual
Burden Hours Requested: 2,877.4. The
annualized cost to respondents is
estimated at $54,583, assuming
respondents’ time at the rate of $17.5
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[Federal Register Volume 75, Number 33 (Friday, February 19, 2010)]
[Notices]
[Pages 7481-7482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3167]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: The Health Education Assistance Loan (HEAL) Program
Regulations (OMB No. 0915-0108) Extension
The Health Education Assistance Loan (HEAL) Program has regulations
that contain notification, reporting and recordkeeping requirements to
ensure that the lenders, holders and schools participating in the HEAL
program follow sound management procedures in the administration of
federally-insured student loans. While the regulatory requirements are
approved under the OMB number referenced above, much of the burden
associated with the submission of required HEAL forms and certain
reporting requirements is approved under
[[Page 7482]]
separate OMB numbers. The table below provides the estimate of burden
for the remaining regulations.
The estimates of burden are as follows:
Reporting Requirements
----------------------------------------------------------------------------------------------------------------
Number of Total Hours per Total burden
Number of respondents transactions transactions response (min) hours
----------------------------------------------------------------------------------------------------------------
17 Holders....................................... 5 78 12 16
190 Schools...................................... .4 78 10 13
--------------------------------------------------------------
Total Reporting.............................. ............. .............. .............. 29
----------------------------------------------------------------------------------------------------------------
Notification Requirements
----------------------------------------------------------------------------------------------------------------
Number of Total Hours per Total burden
Number of respondents transactions transactions response (min) hours
----------------------------------------------------------------------------------------------------------------
7,930 Borrowers.................................. 1 7,930 10 1,322
17 Holders....................................... 7,910 134,470 10 22,412
190 Schools...................................... .89 170 14 40
--------------------------------------------------------------
Total Notification........................... ............. .............. .............. 23,774
----------------------------------------------------------------------------------------------------------------
Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
Number of Total Hours per Total burden
Number of respondents transactions transactions response (min) hours
----------------------------------------------------------------------------------------------------------------
17 Holders...................................... 3,568 60,657 14 14,153
190 Schools..................................... 257 48,822 15 12,206
---------------------------------------------------------------
Total Recordkeeping......................... .............. .............. .............. 26,359
===============================================================
Total................................... .............. .............. .............. 50,162
----------------------------------------------------------------------------------------------------------------
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 e-mail 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: February 5, 2010.
Sahira Rafiullah,
Director, Division of Policy Review and Coordination.
[FR Doc. 2010-3167 Filed 2-18-10; 8:45 am]
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