Agency Information Collection Request; 30-Day Public Comment Request, 57955-57956 [2010-23767]
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Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–5683. Send written comments and
recommendations for the proposed
information collections within 30 days
57955
State, Local, or Tribal Governments. The
clearance is also to make modifications
to the UDS tool, which includes the
exclusion of a large number of data
elements which significantly reduces
reporting burden for grantees, a change
in the name of the data collection tool
from the UDS to the Performance Data
System (PDS), and to increase the
frequency of reporting from semi-annual
to quarterly reporting. The
modifications are intended to evolve the
UDS into a system that improves OMH’s
ability to comply with Federal reporting
requirements and monitor and evaluate
performance by enabling the efficient
collection of more performance-oriented
data which are tied to OMH-wide
performance reporting needs.
of this notice directly to the OS OMB
Desk Officer; faxed to OMB at 202–395–
5806.
Proposed Project: Uniform Data Set
(UDS)—Reinstatement with Change—
OMB No. 0990–0275–Office of Public
Health Science (OPHS)—Office of
Minority Health.
Abstract: The Office of Minority
Health is requesting a three year OMB
approval on a revised collection,
Uniform Data Set (OMB No. 0990–
0275), the tool used by the Office
Minority Health (OMH) to collect
program management and performance
data for all OMH-funded projects.
Respondents for this data collection
include the project directors leading
OMH-funded projects. Affected public
includes not-for-profit institutions and
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
Type of
respondent
Number of
respondents
Number of
responses per
respondent
Average
buden hours
per response
Total burden
hours
PDS ...................................................
OMH Grantee ...................................
104
4
2.5
1,040
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–23756 Filed 9–22–10; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0275; 30day notice]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
srobinson on DSKHWCL6B1PROD with NOTICES
AGENCY:
approval on a revised collection,
Uniform Data Set (OMB No. 0990–
0275), the tool used by the Office
Minority Health (OMH) to collect
program management and performance
data for all OMH-funded projects.
Respondents for this data collection
include the project directors leading
OMH-funded projects. Affected public
includes not-for-profit institutions and
State, Local, or Tribal Governments. The
clearance is also to make modifications
to the UDS tool, which includes the
exclusion of a large number of data
elements which significantly reduces
reporting burden for grantees, a change
in the name of the data collection tool
from the UDS to the Performance Data
System (PDS), and to increase the
frequency of reporting from semi-annual
to quarterly reporting. The
modifications are intended to evolve the
UDS into a system that improves OMH’s
ability to comply with Federal reporting
requirements and monitor and evaluate
performance by enabling the efficient
collection of more performance-oriented
data which are tied to OMH-wide
performance reporting needs.
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–5683. Send written comments and
recommendations for the proposed
information collections within 30 days
of this notice directly to the OS OMB
Desk Officer; faxed to OMB at 202–395–
5806.
Proposed Project: Uniform Data Set
(UDS)—Reinstatement with Change—
OMB No. 0990–0275–Office of Public
Health Science (OPHS)—Office of
Minority Health.
Abstract: The Office of Minority
Health is requesting a three year OMB
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
PDS ..........................................
OMH Grantee ...........................
104
4
2.5
1,040
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57956
Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–23767 Filed 9–22–10; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Draft Revision of the Federalwide
Assurance
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office for Human Research
Protections.
ACTION: Notice.
AGENCY:
The Office for Human
Research Protections (OHRP), Office of
the Assistant Secretary for Health, is
announcing the availability of the draft
revised Federalwide Assurance (FWA)
form and Terms of Assurance, and is
seeking comment on these draft
documents. OHRP is proposing several
changes to simplify and shorten the
FWA form and Terms of Assurance.
Institutions engaged in non-exempt
human subjects research conducted or
supported by the Department of Health
and Human Services (HHS) must hold
an OHRP-approved FWA. The draft
revised FWA form and Terms of
Assurance, when finalized, will
supersede the current FWA documents
available on the OHRP Web site at
https://www.hhs.gov/ohrp/assurances/
assurances_index.html. OHRP will
consider comments received before
implementing any revisions to the FWA
documents.
DATES: Submit written comments by
October 25, 2010.
ADDRESSES: Submit written requests for
single copies of the draft revised FWA
form and Terms of Assurance to the
Division of Policy and Assurances,
Office for Human Research Protections,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–402–2071. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
draft revised FWA documents.
You may submit comments, identified
by docket ID number HHS–OPHS–
2010–0023, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Enter the above
docket ID number in the ‘‘Enter
Keyword or ID’’ field and click on
‘‘Search.’’ On the next web page, click on
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:52 Sep 22, 2010
Jkt 220001
the ‘‘Submit a Comment’’ action and
follow the instructions.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Irene Stith-Coleman, PhD, Office for
Human Research Protections, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852.
Comments received, including any
personal information, will be posted
without change to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Irene Stith-Coleman, PhD, Office for
Human Research Protections, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852, 240–453–6900; e-mail
Irene.StithColeman@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP is announcing the availability
of the draft revised FWA form and
Terms of Assurance, and is seeking
comment on these draft documents.
Institutions engaged in non-exempt
human subjects research conducted or
supported by HHS must hold an OHRPapproved FWA. The draft revised FWA
form and Terms of Assurance, when
finalized, will supersede the current
FWA documents available on the OHRP
Web site at https://www.hhs.gov/ohrp/
assurances/assurances_index.html. The
current FWA form has been approved
by the Office of Management and
Budget for use through May 31, 2011.
The draft revised FWA form and
Terms of Assurance have the following
key changes in comparison to the
current FWA documents:
(1) The current separate FWA forms
for U.S. and non-U.S. institutions have
been combined into a single form that
will still collect the same basic
information previously requested in the
current separate forms, except as noted
in items (3) and (4) below.
(2) The Terms of Assurance document
has been shortened and simplified. In
the current version, some portions of the
text appear twice; those duplications
have been eliminated by re-organizing
portions of the document. In addition,
there are several items covered in the
current version that are either not
required by the regulations to be part of
an assurance, or which are addressed in
the FWA form itself. These items have
been eliminated from the Terms of
Assurance document.
(3) The revised FWA form would
replace the current requirement that all
IRBs (both internal and external IRBs)
relied upon by the institution be
specifically designated with the
requirement that only internal IRBs be
specifically designated or that, if an
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institution does not have an internal
IRB, only one external IRB be
specifically designated. This change to
the FWA form is being proposed in
response to the recommendation from
the Secretary’s Advisory Committee on
Human Research Protections (SACHRP)
that the FWA be modified to remove the
current requirement to designate
specific IRBs within the assurance
document itself, replacing this with a
commitment by the institution to rely
only on registered IRBs (see SACHRP’s
July 15, 2009 letter to the Secretary on
the OHRP Web site at https://
www.hhs.gov/ohrp/sachrp/documents/
20090715LettertoHHSSecretary.pdf).
(4) The revised FWA form would no
longer request submission of the HHS
Institution Profile code or the Federal
Entity Identification number.
(5) The revised FWA form would
allow the FWA to be signed by the
institution’s signatory official
electronically and eliminate the need for
submission of a hard-copy signature
page by mail or facsimile. Upon
implementation of this change, OHRP
intends to require that institutions
submit all FWAs (including new
submissions, updates, and renewals)
using the electronic submission system
available through the OHRP Web site at
https://ohrp.cit.nih.gov/efile/, unless an
institution lacks the ability to do so
electronically. Such electronic
submission currently is required for IRB
registration. If an institution believed it
lacked the ability to submit its FWA
electronically, it would be required to
contact OHRP by telephone or email
and explain why it was unable to
submit its FWA electronically.
(6) The standard period of approval
for an FWA would be increased from
the current 3-year period to a 5-year
period.
II. Electronic Access
The draft revised FWA form and
Terms of Assurance are available on
OHRP’s Web site at https://www.hhs.gov/
ohrp/requests/.
III. Request for Comments
OHRP requests comments on the draft
revised FWA form and Terms of
Assurance. OHRP will consider all
comments before implementing any
revisions to the FWA documents.
Dated: September 16, 2010.
Jerry Menikoff,
Director, Office for Human Research
Protections.
[FR Doc. 2010–23759 Filed 9–22–10; 8:45 am]
BILLING CODE 4150–36–P
E:\FR\FM\23SEN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Pages 57955-57956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23767]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0275; 30-day notice]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed collection for public comment. Interested persons
are invited to send comments regarding this burden estimate or any
other aspect of this collection of information, including any of the
following subjects: (1) The necessity and utility of the proposed
information collection for the proper performance of the agency's
functions; (2) the accuracy of the estimated burden; (3) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (4) the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-5683. Send written comments and
recommendations for the proposed information collections within 30 days
of this notice directly to the OS OMB Desk Officer; faxed to OMB at
202-395-5806.
Proposed Project: Uniform Data Set (UDS)--Reinstatement with
Change--OMB No. 0990-0275-Office of Public Health Science (OPHS)--
Office of Minority Health.
Abstract: The Office of Minority Health is requesting a three year
OMB approval on a revised collection, Uniform Data Set (OMB No. 0990-
0275), the tool used by the Office Minority Health (OMH) to collect
program management and performance data for all OMH-funded projects.
Respondents for this data collection include the project directors
leading OMH-funded projects. Affected public includes not-for-profit
institutions and State, Local, or Tribal Governments. The clearance is
also to make modifications to the UDS tool, which includes the
exclusion of a large number of data elements which significantly
reduces reporting burden for grantees, a change in the name of the data
collection tool from the UDS to the Performance Data System (PDS), and
to increase the frequency of reporting from semi-annual to quarterly
reporting. The modifications are intended to evolve the UDS into a
system that improves OMH's ability to comply with Federal reporting
requirements and monitor and evaluate performance by enabling the
efficient collection of more performance-oriented data which are tied
to OMH-wide performance reporting needs.
Estimated Annualized Burden Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms Type of respondent Number of responses per hours per Total burden
respondents respondent response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
PDS......................................... OMH Grantee................... 104 4 2.5 1,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 57956]]
Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2010-23767 Filed 9-22-10; 8:45 am]
BILLING CODE 4150-05-P
