Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB), 71005-71006 [E8-27668]
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Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
office in the Office of Public Health and
Science, Department of Health and
Human Services (HHS), is seeking
nominations of qualified candidates to
be considered for appointment as
members of the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP). SACHRP
provides advice and recommendations
to the Secretary, HHS, and the Assistant
Secretary for Health on matters
pertaining to the continuance and
improvement of functions within the
authority of HHS directed toward
protections for human subjects in
research. SACHRP was established by
the Secretary, HHS, on October 1, 2002.
OHRP is seeking nominations of
qualified candidates to fill two positions
on the Committee membership that will
be vacated in June of 2009.
DATES: Nominations for membership on
the Committee must be received no later
than January 23, 2009.
ADDRESSES: Nominations should be
mailed or delivered to Dr. Jerry
Menikoff, Director, Office for Human
Research Protections, Department of
Health and Human Services, 1101
Wootton Parkway, Suite 200; Rockville,
MD 20852. Nominations also may be
sent via e-mail to sachrp@hhs.gov or via
facsimile at 240–453–6909.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, Executive Director, SACHRP,
Office for Human Research Protections,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852, telephone: 240–
453–8141. A copy of the Committee
charter and list of the current members
can be obtained by contacting Ms.
Gorey, accessing the SACHRP Web site
at https://www.hhs.gov/ohrp/sachrp, or
requesting via e-mail at sachrp@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Committee provides advice on matters
pertaining to the continuance and
improvement of functions within the
authority of HHS directed toward
protections for human subjects in
research. Specifically, the Committee
provides advice relating to the
responsible conduct of research
involving human subjects with
particular emphasis on special
populations such as neonates and
children, prisoners, the decisionally
impaired, pregnant women, embryos
and fetuses, individuals and
populations in international studies,
investigator conflicts of interest and
populations in which there are
individually identifiable samples, data,
or information.
In addition, the Committee is
responsible for reviewing selected
ongoing work and planned activities of
the OHRP and other offices/agencies
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Jkt 217001
within HHS responsible for human
subjects protection. These evaluations
may include, but are not limited to, a
review of assurance systems, the
application of minimal research risk
standards, the granting of waivers,
education programs sponsored by
OHRP, and the ongoing monitoring and
oversight of institutional review boards
and the institutions that sponsor
research.
Nominations: The Office for Human
Research Protections is requesting
nominations to fill two positions for
voting members of SACHRP. The two
positions will become vacant in June of
2009. Nominations of potential
candidates for consideration are being
sought from a wide array of fields,
including, but not limited to: public
health and medicine, behavioral and
social sciences, health administration,
and biomedical ethics.
To qualify for consideration of
appointment to the Committee, an
individual must possess demonstrated
experience and expertise in any of the
several disciplines and fields pertinent
to human subjects protection and/or
clinical research.
The individuals selected for
appointment to the Committee can be
invited to serve a term of up to four
years. Committee members receive a
stipend and reimbursement for per diem
and any travel expenses incurred for
attending Committee meetings and/or
conducting other business in the
interest of the Committee.
Nominations should be typewritten.
The following information should be
included in the package of material
submitted for each individual being
nominated for consideration: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e. , specific
attributes which qualify the nominee for
service in this capacity), and a statement
that the nominee is willing to serve as
a member of the Committee; (2) the
nominator’s name, address and daytime
telephone number, and the home and/
or work address, telephone number, and
email address of the individual being
nominated; and (3) a current copy of the
nominee’s curriculum vitae. Federal
employees should not be nominated for
consideration of appointment to this
Committee.
The Department makes every effort to
ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
function. Every effort is made to ensure
that individuals from a broad
representation of geographic areas,
women and men, ethnic and minority
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71005
groups, and the disabled are given
consideration for membership on HHS
Federal advisory committees.
Appointment to this Committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status.
Documentation must be included in
the nomination to indicate that the
nominated individual is willing to serve
as a member of SACHRP. Individuals
who are selected to be considered for
appointment will be required to provide
detailed information regarding their
financial holdings, consultancies, and
research grants or contracts. Disclosure
of this information is necessary in order
to determine if the selected candidate is
involved in any activity that may pose
a potential conflict with the official
duties to be performed as a member of
SACHRP.
Dated: November 18, 2008.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. E8–27851 Filed 11–21–08; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Agency Recordkeeping/Reporting
Requirements Under Emergency
Review by the Office of Management
and Budget (OMB)
Title: Indian Tribes, Tribal
Organizations or Tribal Consortia Letter
of Intent to Operate a Title IV–E
Program.
OMB No.: New Collection.
Description: The Fostering
Connections to Success and Increasing
Adoptions Act of 2008 (Pub. L. 110–
351) added section 479B to the Social
Security Act (the Act), which allows
Indian Tribes the option to apply to the
Secretary to receive Federal funding to
support the administration of their own
foster care, adoption assistance and
relative guardianship programs under
title IV–E of the Act. The law also
amended the Act at section 476(c)(2)(ii)
to allow Indian Tribes to receive onetime development grants of up to
$300,000 to be used to offset the cost of
developing a title IV–E plan to carry out
the requirements of section 479B of the
Act, and required ACF to provide
technical assistance and
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71006
Federal Register / Vol. 73, No. 227 / Monday, November 24, 2008 / Notices
implementation services to Indian
Tribes regarding the title IV–E program.
In order to plan for the review of
Tribal title IV–E plans and technical
assistance needs, the Administration for
Children and Families (ACF) is
requesting that all Federally recognized
Indian Tribes, Tribal organizations or
Tribal consortia (hereafter, ‘‘Tribes’’)
that plan to operate a title IV–E program
send a letter of intent to their ACF
Regional Program Manager by December
31, 2008.
ACF will ask Tribes to include in the
letter of intent the following
information:
1. The Federal fiscal year (FY) in
which the Tribe expects to begin
operation of a title IV–E program.
(According to the law, the earliest
possible implementation period is FY
2010.)
2. Information on the intended Tribal
service area for the Tribal title IV–E
program.
Respondents: Indian Tribes, Tribal
organizations and Tribal consortia.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Information collection
Letter of Intent .................................................................................................
Estimated Total Annual Burden
Hours: 562.
Additional Information: ACF is
requesting that OMB grant a 90-day
approval for this information collection
under procedures for emergency
processing by November 28, 2008. A
copy of this information collection, with
applicable supporting documentation,
may be obtained by calling the
Administration for Children and
Families, Reports Clearance Officer,
Robert Sargis at (202) 690–7275 or emailing to infocollection@acf.hhs.gov.
Comments and questions about the
information collection described above
should be directed to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for ACF, Office
of Management and Budget, Paperwork
Reduction Project, 725 17th Street, NW.,
Washington, DC 20503, (202) 395–7316.
Dated: November 13, 2008.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E8–27668 Filed 11–21–08; 8:45 am]
BILLING CODE 4184–01–M
Food and Drug Administration
[Docket No. FDA–2008–N–0589]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mental Models
Study of Health Care Providers’
Understanding of Prescription Drug
Effectiveness
AGENCY:
Food and Drug Administration,
sroberts on PROD1PC70 with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
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562
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the Mental Models Study of Health Care
Providers’ Understanding of
Prescription Drug Effectiveness.
Together with other information being
collected, the results from this study
will be used to help inform FDA about
how health care providers conceptualize
the drug effectiveness portion of the
risk/benefit tradeoff and how that
conceptualization differs from how
agency experts think about drug
effectiveness. The information gathered
in this study will be used to focus and
strengthen future planned quantitative
research. It will also contribute to FDA’s
ability to communicate drug
effectiveness information to health care
providers in labeling and other
communications.
Submit written or electronic
comments on the collection of
information by January 23, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Number of
responses per
respondent
1
Average
burden hours
per response
Total burden
hours
1
562
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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 to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Mental Models Study of Health Care
Providers’ Understanding of
Prescription Drug Effectiveness
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
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]]>Agencies
[Federal Register Volume 73, Number 227 (Monday, November 24, 2008)]
[Notices]
[Pages 71005-71006]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27668]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Agency Recordkeeping/Reporting Requirements Under Emergency
Review by the Office of Management and Budget (OMB)
Title: Indian Tribes, Tribal Organizations or Tribal Consortia
Letter of Intent to Operate a Title IV-E Program.
OMB No.: New Collection.
Description: The Fostering Connections to Success and Increasing
Adoptions Act of 2008 (Pub. L. 110-351) added section 479B to the
Social Security Act (the Act), which allows Indian Tribes the option to
apply to the Secretary to receive Federal funding to support the
administration of their own foster care, adoption assistance and
relative guardianship programs under title IV-E of the Act. The law
also amended the Act at section 476(c)(2)(ii) to allow Indian Tribes to
receive one-time development grants of up to $300,000 to be used to
offset the cost of developing a title IV-E plan to carry out the
requirements of section 479B of the Act, and required ACF to provide
technical assistance and
[[Page 71006]]
implementation services to Indian Tribes regarding the title IV-E
program.
In order to plan for the review of Tribal title IV-E plans and
technical assistance needs, the Administration for Children and
Families (ACF) is requesting that all Federally recognized Indian
Tribes, Tribal organizations or Tribal consortia (hereafter,
``Tribes'') that plan to operate a title IV-E program send a letter of
intent to their ACF Regional Program Manager by December 31, 2008.
ACF will ask Tribes to include in the letter of intent the
following information:
1. The Federal fiscal year (FY) in which the Tribe expects to begin
operation of a title IV-E program. (According to the law, the earliest
possible implementation period is FY 2010.)
2. Information on the intended Tribal service area for the Tribal
title IV-E program.
Respondents: Indian Tribes, Tribal organizations and Tribal
consortia.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Information collection Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Letter of Intent................................ 562 1 1 562
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 562.
Additional Information: ACF is requesting that OMB grant a 90-day
approval for this information collection under procedures for emergency
processing by November 28, 2008. A copy of this information collection,
with applicable supporting documentation, may be obtained by calling
the Administration for Children and Families, Reports Clearance
Officer, Robert Sargis at (202) 690-7275 or e-mailing to
infocollection@acf.hhs.gov.
Comments and questions about the information collection described
above should be directed to the Office of Information and Regulatory
Affairs, Attn: OMB Desk Officer for ACF, Office of Management and
Budget, Paperwork Reduction Project, 725 17th Street, NW., Washington,
DC 20503, (202) 395-7316.
Dated: November 13, 2008.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E8-27668 Filed 11-21-08; 8:45 am]
BILLING CODE 4184-01-M
