Proposed Information Collection Activity; Comment Request, 58399-58400 [2010-23923]
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Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section/
FDAMA Section
No. of
Respondents
814.82(a)(9)
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
18
1
18
135
2,430
648
1
648
10
6,480
Section 201 (FDAMA) Agreement
Meeting
3
1
3
50
150
Section 202 (FDAMA) Expedited
Review Request
5
1
5
10
50
Section 205 (FDAMA) Effectiveness
Meeting
5
1
5
50
250
Section 208 (FDAMA) Classification
Panel Meetings
20
1
20
30
600
Section 209 (FDAMA) 100-day
meeting
28
1
28
10
280
2,050
13
2,050
1,214
89,004
814.84(b)
Totals
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
814.82(a)(5) and (a)(6)
1 There
Annual Frequency
per Recordkeeping
698
Total Annual
Records
1
Hours per
Recordkeeper
698
17
Total Hours
11,866
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[FR Doc. 2010–23912 Filed 9–23–10; 8:45 am]
BILLING CODE 4160–01–S
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: ANA Consultant and Evaluator
Qualifications Form.
OMB No.: 0970–0265.
Description: The ANA Consultant and
Evaluator Qualifications Form is used to
collect information from prospective
proposal reviewers in compliance with
42 U.S.C. 2991d–1. The form allows the
Commissioner of ANA to select
qualified people to review grant
applications for Social and Economic
Development Strategies (SEDS), Native
Language Preservation and
Maintenance, and Environmental
Regulatory Enhancement. The panel
review process is a legislative mandate
in the ANA grant funding process.
Respondents: Native Americans,
Native Alaskans, Native Hawaiians and
other Pacific Islanders.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of responses per
respondent
Average
burden hours
per response
Total burden
hours
ANA Consultant and Evaluator Qualifications Form .......................................
srobinson on DSKHWCL6B1PROD with NOTICES
Instrument
300
1
1
300
Estimated Total Annual Burden
Hours: 300.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
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16:12 Sep 23, 2010
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information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
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should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
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Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
proposed collection of information;
(c) the quality, utility, and clarity of the
information to be collected; and
(d) ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: September 21, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–23923 Filed 9–23–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Donor Management Research:
Improvements in Clinical Management
of Deceased Organ Donors
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Request for information.
AGENCY:
The Health Resources and
Services Administration (HRSA),
Division of Transplantation, is soliciting
input, feedback, and suggestions from
researchers and interested parties
within the organ donation and
transplant community regarding
guidance for a possible grant or contract
that focuses on improvements in
clinical management of deceased organ
donors.
Given the continued imbalance
between the demand for and supply of
deceased donor organs, it is essential
that deceased donors be managed
appropriately to optimize the number
and function of donor organs. It is
reasonable to expect that better clinical
donor management would improve
organ quality, organs transplanted per
donor (OTPD), and post-transplant
recipient outcomes.
DATES: Written or electronic comments
must be received by HRSA by October
15, 2010.
ADDRESSES: Please send all written
comments to James Bowman, MD
Medical Director, Division of
Transplantation, Healthcare Systems
Bureau, Health Resources and Services
Administration, 5600 Fishers Lane,
Suite 12C–06, Rockville, Maryland
20857; Telephone (301) 443–4861 Fax
(301) 594–6095; or e-mail:
jbowman@hrsa.gov.
Docket: For access to the docket to
view comments received, phone 301–
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
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16:12 Sep 23, 2010
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443–7577 to schedule an appointment
to view public comments.
FOR FURTHER INFORMATION CONTACT:
James Bowman, MD, Medical Director at
Division of Transplantation, Healthcare
Systems Bureau, Health Resources and
Services Administration, at the contact
information cited above.
SUPPLEMENTARY INFORMATION:
Background
Since 2002, HRSA has funded the
Clinical Interventions to Increase Organ
Procurement (CIOP) Grant Program,
authorized by Public Health Service
Act, as amended, Section 377A(b), (42
U.S.C. 274f–1). The CIOP Grant Program
has provided support for the
implementation and evaluation of
highly promising strategies and
approaches serving as model
interventions for identifying appropriate
organ donor candidates, evaluating
donated organs, maintaining donor
clinical stability and optimizing
methods for organ procurement. Other
than the fiscal year 2007 CIOP grant
cycle, which focused on uncontrolled
donation after circulatory death donors,
the CIOP Program has not focused on
specific research issues. Since the
inception of the grant program, 19
grants have been awarded. While these
grants have furthered knowledge
regarding clinical management of
donors, the studies have generally
focused on specific organ systems and
not on donor management approaches
with the goal of optimizing all organ
systems.
The CIOP Grant Program was not
funded in Fiscal Year 2010 to allow
HRSA to consider how to best utilize
the limited Federal research funds
available in a more useful and beneficial
manner. There has been considerable
discussion among critical care and
transplant specialists regarding donor
management. A Donor Management
Task Force was convened in August
2010 to address relevant issues in donor
management practices. This task force
discussed: (1) Advancing the scientific
knowledge that influences organ donor
management practices; (2) promoting
the adoption of critical care and quality
improvement practices in each Donation
Service area (DSA) that optimize organ
viability and increase OTPD; (3)
ensuring that all patients meeting the
neurologic criteria for determination of
death are pronounced in a timely
manner so that organ donation
intentions may be fully honored; and (4)
ensuring that each donation case occurs
using the most appropriate donation
pathway: Either donation after
neurologic determination of death or
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donation after cardiac determination of
death. Although quality donor
management may be assumed to
improve transplantation outcomes, there
are limited scientifically rigorous
studies validating this assumption. The
studies that do exist involve a limited
number of DSAs. These studies do
suggest an improvement in OTPD based
on certain donor management practices,
but further investigation is needed.
Upon review of research possibilities
being discussed in meetings and in the
literature, HRSA believes that research
should be directed to help establish
evidence-based donor management
protocols.
Therefore HRSA is considering
funding through a grant or contract
mechanism to one or two parties, a total
of up to $1 million/year for three (3)
years to conduct a multicenter,
nationwide study focused on donor
management and improvement in
outcomes, particularly OTPD, organ
quality, and post-transplant recipient
outcomes.
Request for Comments
For this Request for Information,
respondents are asked to present their
experiences and opinions regarding the
importance of further study into donor
management and its outcomes.
Suggestions and comments concerning
specific areas of analysis are
encouraged. Such studies might
consider developing or refining a
validated tool useful for predicting
donor outcomes based upon appropriate
and readily available donor data (e.g.,
collected for purposes of OPTN data
submission, or routinely collected by
Organ Procurement Organizations).
Donor management study designs that
include OPTN data collected on most, if
not all, deceased donor organs will be
encouraged.
HRSA is seeking guidance from the
community to help structure either a
donor management study to be
accomplished by contract or targeted
research questions that will be
incorporated into the CIOP FY 2011
request for application.
Dated: September 16, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–23893 Filed 9–23–10; 8:45 am]
BILLING CODE 4165–15–P
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[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Pages 58399-58400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23923]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: ANA Consultant and Evaluator Qualifications Form.
OMB No.: 0970-0265.
Description: The ANA Consultant and Evaluator Qualifications Form
is used to collect information from prospective proposal reviewers in
compliance with 42 U.S.C. 2991d-1. The form allows the Commissioner of
ANA to select qualified people to review grant applications for Social
and Economic Development Strategies (SEDS), Native Language
Preservation and Maintenance, and Environmental Regulatory Enhancement.
The panel review process is a legislative mandate in the ANA grant
funding process.
Respondents: Native Americans, Native Alaskans, Native Hawaiians
and other Pacific Islanders.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ANA Consultant and Evaluator Qualifications 300 1 1 300
Form.......................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 300.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the
[[Page 58400]]
proposed collection of information; (c) the quality, utility, and
clarity of the information to be collected; and (d) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques or other forms of
information technology. Consideration will be given to comments and
suggestions submitted within 60 days of this publication.
Dated: September 21, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-23923 Filed 9-23-10; 8:45 am]
BILLING CODE 4184-01-P
