Advisory Committee on Organ Transplantation Request for Nominations for Voting Members, 5855-5856 [E8-1730]
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Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Notices
or practice would appear to encompass
all behavior that could be called a UMC
or a violation of the Sherman or Clayton
Acts. The Commission’s discussion of
the UAP liability standard accepts the
view that all business enterprises—
including large companies—fall within
the class of consumers whose injury is
a worthy subject of unfairness scrutiny.
If UAP coverage extends to the full
range of business-to-business
transactions, it would seem that the
three-factor test prescribed for UAP
analysis would capture all actionable
conduct within the UMC prohibition
and the proscriptions of the Sherman
and Clayton Acts. Well-conceived
antitrust cases (or UMC cases) typically
address instances of substantial actual
or likely harm to consumers. The FTC
ordinarily would not prosecute behavior
whose adverse effects could readily be
avoided by the potential victims—either
business entities or natural persons.
And the balancing of harm against
legitimate business justifications would
encompass the assessment of
procompetitive rationales that is a core
element of a rule of reason analysis in
cases arising under competition law.
The prospect of a settlement can lead
one to relax the analytical standards that
ordinarily would discipline the decision
to prosecute if the litigation of asserted
claims was certain or likely. This is
particularly the case when, as in this
matter, the respondent has indicated
during negotiations that, for various
reasons, it will not litigate and will
accept a settlement. If the Commission
had in mind specific analytical grounds
for including both theories of liability
(for example, because each theory
standing alone contained weaknesses as
foundations for the settlement), the
Analysis omits them. In the logic of the
Analysis, the UAP theory subsumes the
UMC standard and makes the UMC
provision superfluous. If the UAP
concept is so broad, it is not evident
what reasoning in this case supports the
parallel inclusion of the UMC claim.
More generally, it seems that the
Commission’s view of unfairness would
permit the FTC in the future to plead all
of what would have been seen as
competition-related infringements as
constituting unfair acts or practices.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Organ
Transplantation Request for
Nominations for Voting Members
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill vacancies
on the Advisory Committee on Organ
Transplantation (ACOT). The ACOT
was established by the Amended Final
Rule of the Organ Procurement and
Transplantation Network (OPTN) (42
CFR part 121) and, in accordance with
Public Law 92–463, was chartered on
September 1, 2000.
DATES: The agency must receive
nominations on or before March 3, 2008.
All nominations should be
submitted to the Executive Secretary,
Advisory Committee on Organ
Transplantation, Healthcare Systems
Bureau, HRSA, Parklawn Building,
Room 12C–06, 5600 Fishers Lane,
Rockville, Maryland 20857. Federal
Express, Airborne, UPS, etc., mail
delivery should be addressed to
Executive Secretary, Advisory
Committee on Organ Transplantation,
Healthcare Systems Bureau, HRSA, at
the above address.
FOR FURTHER INFORMATION CONTACT:
Gregory Fant, Ph.D., Executive
Secretary, Advisory Committee on
Organ Transplantation, at (301) 443–
8728 or e-mail
Gregory.Fant@hrsa.hhs.gov.
ADDRESSES:
As
provided by 42 CFR 121.12 (64 FR
56661), the Secretary established the
Advisory Committee on Organ
Transplantation. The Committee is
governed by the Federal Advisory
Committee Act (5 U.S.C. Appendix 2),
which sets forth standards for the
formation and use of advisory
committees.
The ACOT advises the Secretary,
acting through the Administrator,
HRSA, on all aspects of organ
procurement, allocation, and
transplantation, and on other such
matters that the Secretary determines.
One of its principal functions is to
advise the Secretary on ways to
maximize Federal efforts to increase
living and deceased organ donation
nationally. Other matters that have been
reviewed by the ACOT include:
SUPPLEMENTARY INFORMATION:
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5855
• Concerns about U.S. citizens
traveling abroad in order to receive
organ transplants (also known as
transplant tourism);
• Collection of data on the long-term
health status of living donors;
• Organ Procurement and
Transplantation Network development
and distribution within the transplant
community a set of practice guidelines
to be followed with respect to public
solicitation of organ donors, both living
and deceased;
• Standards of coverage for living
donors relating to future adverse events;
and
• CMS reimbursement of organ
procurement organizations for donation
after cardiac death.
The ACOT consists of up to 25
members, including the Chair. Members
and Chair shall be selected by the
Secretary from individuals
knowledgeable in such fields as organ
donation, health care public policy,
transplantation medicine and surgery,
critical care medicine and other medical
specialties involved in the identification
and referral of donors, non-physician
transplant professions, nursing,
epidemiology, immunology, law and
bioethics, behavioral sciences,
economics and statistics, as well as
representatives of transplant candidates,
transplant recipients, organ donors, and
family members. To the extent
practicable, Committee members should
represent the minority, gender and
geographic diversity of transplant
candidates, transplant recipients, organ
donors and family members served by
the OPTN. In addition, the Director,
Centers for Disease Control and
Prevention; the Administrator, Centers
for Medicare and Medicaid Services; the
Commissioner, Food and Drug
Administration; the Director, National
Institutes of Health; and the Director,
Agency for Healthcare Research and
Quality (or the designees of such
officials) serve as non-voting ex officio
members.
Specifically, HRSA is requesting
nominations for voting members of the
ACOT representing: Health care public
policy; transplantation medicine and
surgery, including pediatrics; critical
care medicine; nursing; epidemiology
and applied statistics; immunology; law
and bioethics; behavioral sciences;
economics and econometrics; organ
procurement organizations; transplant
candidates/recipients; transplant/donor
family members; and living donors.
Nominees will be invited to serve a 4year term beginning between January
and July 2009.
HHS will consider nominations of all
qualified individuals with a view to
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5856
Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Notices
ensuring that the Advisory Committee
includes the areas of subject matter
expertise noted above. Individuals may
nominate themselves or other
individuals, and professional
associations and organizations may
nominate one or more qualified persons
for membership on the ACOT.
Nominations shall state that the
nominee is willing to serve as a member
of the ACOT and appears to have no
conflict of interest that would preclude
the ACOT membership. Potential
candidates will be asked to provide
detailed information concerning
financial interests, consultancies,
research grants, and/or contracts that
might be affected by recommendations
of the Committee to permit evaluation of
possible sources of conflicts of interest.
A nomination package should include
the following information for each
nominee: (1) A letter of nomination
stating the name, affiliation, and contact
information for the nominee, the basis
for the nomination (i.e., what specific
attributes, perspectives, and/or skills
does the individual possess that would
benefit the workings of ACOT), and the
nominee’s field(s) of expertise; (2) a
biographical sketch of the nominee and
a copy of his/her curriculum vitae; and
(3) the name, return address, and
daytime telephone number at which the
nominator can be contacted.
The Department of Health and Human
Services has special interest in assuring
that women, minority groups, and the
physically disabled are adequately
represented on advisory committees;
and therefore, extends particular
encouragement to nominations for
appropriately qualified female,
minority, or disabled candidates.
Dated: January 22, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–1730 Filed 1–30–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Proposed
Collection; Comment Request;
Formative Research and Pilot Studies
for the National Children’s Study
SUMMARY: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Child Health and Human
Development (NICHD), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on November 19,
2007, pages 65047–8, and allowed 60
days for public comment. One comment
was received questioning the utility of
the proposed data collection. 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: Formative
Research and Pilot Studies for the
National Children’s Study. Type of
Information Collection Request: New.
Need and use of information collection:
The NICHD seeks to obtain OMB’s
generic approval to conduct formative
research and pilot studies to be used in
the development of instruments,
materials, and procedures for the
National Children’s Study (NCS). The
NCS is a long-term cohort study of
environmental influences on child
health and development authorized
under the Children’s Health Act of 2000.
Further details pertaining to the NCS
background and planning, including the
NCS Research Plan, can be found at:
https://nationalchildrensstudy.gov. The
proposed data collection program will
include community outreach materials,
Estimated
number of
respondents
rwilkins on PROD1PC63 with NOTICES
Type of respondents (estimated hourly rate)
Small focused studies ($10) ............................................................................
Focus groups with potential participants ($10) ................................................
Focus groups with health care professionals ($50) ........................................
Focus groups with community leaders ($10) ..................................................
Medical provider feedback on materials through informal in-person contacts
($50) .............................................................................................................
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medical provider and participant
materials, questionnaires and measures,
use of technology such as Interactive
Voice Recognition (IVR), and other
aspects related to data collection.
Activities will include small focused
studies to test data collection items and
methods on a specific or targeted
population, validation of questionnaires
for targeted populations, focus groups
within the NCS communities to test
forms and procedures, cognitive
interviews to test data items, and the
use of materials on targeted populations
such as medical providers and
hospitals, and materials translated into
other languages. These activities will be
conducted over the life of the study to
develop procedures and materials for
each stage of data collection. The results
of these pilot tests will be used to
maximize the efficiency of study
procedures, materials, and methods for
community outreach, engagement of the
medical community, for recruiting and
retaining study subjects prospectively
across study visits and to ensure that
data collection methodologies are
efficient and valid for all potential
participants. Without this information,
NCS will be hampered in its efforts to
effectively publicize the NCS, gain
public and professional support, and
effectively recruit and retain
respondents and collect data over the
life of the Study. Affected entities:
Individuals. Types of respondents:
People potentially affected by this
action are pregnant women or women of
childbearing age, their husbands or
partners, health care professionals, and
community leaders. The annual
reporting burden is as follows:
Estimated Number of Respondents:
3,150. Frequency of Response: On
occasion (see Burden table). The
Estimated Number of Responses per
Respondent: 1. Average Burden Hours
Per Response: Varies with study type.
Estimated Total Annual Burden Hours
Requested: 5,825. The estimated
annualized cost to respondents is
$114,250 (based on rates listed in the
burden table). There are no Capital
Costs to report. There are no Operating
or Maintenance Costs to report.
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
1,250
350
350
350
1
1
1
1
1.5
3.0
3.0
3.0
1,875
1,050
1,050
1,050
700
1
0.5
350
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]]>Agencies
[Federal Register Volume 73, Number 21 (Thursday, January 31, 2008)]
[Notices]
[Pages 5855-5856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1730]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Organ Transplantation Request for
Nominations for Voting Members
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) is
requesting nominations to fill vacancies on the Advisory Committee on
Organ Transplantation (ACOT). The ACOT was established by the Amended
Final Rule of the Organ Procurement and Transplantation Network (OPTN)
(42 CFR part 121) and, in accordance with Public Law 92-463, was
chartered on September 1, 2000.
DATES: The agency must receive nominations on or before March 3, 2008.
ADDRESSES: All nominations should be submitted to the Executive
Secretary, Advisory Committee on Organ Transplantation, Healthcare
Systems Bureau, HRSA, Parklawn Building, Room 12C-06, 5600 Fishers
Lane, Rockville, Maryland 20857. Federal Express, Airborne, UPS, etc.,
mail delivery should be addressed to Executive Secretary, Advisory
Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, at
the above address.
FOR FURTHER INFORMATION CONTACT: Gregory Fant, Ph.D., Executive
Secretary, Advisory Committee on Organ Transplantation, at (301) 443-
8728 or e-mail Gregory.Fant@hrsa.hhs.gov.
SUPPLEMENTARY INFORMATION: As provided by 42 CFR 121.12 (64 FR 56661),
the Secretary established the Advisory Committee on Organ
Transplantation. The Committee is governed by the Federal Advisory
Committee Act (5 U.S.C. Appendix 2), which sets forth standards for the
formation and use of advisory committees.
The ACOT advises the Secretary, acting through the Administrator,
HRSA, on all aspects of organ procurement, allocation, and
transplantation, and on other such matters that the Secretary
determines. One of its principal functions is to advise the Secretary
on ways to maximize Federal efforts to increase living and deceased
organ donation nationally. Other matters that have been reviewed by the
ACOT include:
Concerns about U.S. citizens traveling abroad in order to
receive organ transplants (also known as transplant tourism);
Collection of data on the long-term health status of
living donors;
Organ Procurement and Transplantation Network development
and distribution within the transplant community a set of practice
guidelines to be followed with respect to public solicitation of organ
donors, both living and deceased;
Standards of coverage for living donors relating to future
adverse events; and
CMS reimbursement of organ procurement organizations for
donation after cardiac death.
The ACOT consists of up to 25 members, including the Chair. Members
and Chair shall be selected by the Secretary from individuals
knowledgeable in such fields as organ donation, health care public
policy, transplantation medicine and surgery, critical care medicine
and other medical specialties involved in the identification and
referral of donors, non-physician transplant professions, nursing,
epidemiology, immunology, law and bioethics, behavioral sciences,
economics and statistics, as well as representatives of transplant
candidates, transplant recipients, organ donors, and family members. To
the extent practicable, Committee members should represent the
minority, gender and geographic diversity of transplant candidates,
transplant recipients, organ donors and family members served by the
OPTN. In addition, the Director, Centers for Disease Control and
Prevention; the Administrator, Centers for Medicare and Medicaid
Services; the Commissioner, Food and Drug Administration; the Director,
National Institutes of Health; and the Director, Agency for Healthcare
Research and Quality (or the designees of such officials) serve as non-
voting ex officio members.
Specifically, HRSA is requesting nominations for voting members of
the ACOT representing: Health care public policy; transplantation
medicine and surgery, including pediatrics; critical care medicine;
nursing; epidemiology and applied statistics; immunology; law and
bioethics; behavioral sciences; economics and econometrics; organ
procurement organizations; transplant candidates/recipients;
transplant/donor family members; and living donors. Nominees will be
invited to serve a 4-year term beginning between January and July 2009.
HHS will consider nominations of all qualified individuals with a
view to
[[Page 5856]]
ensuring that the Advisory Committee includes the areas of subject
matter expertise noted above. Individuals may nominate themselves or
other individuals, and professional associations and organizations may
nominate one or more qualified persons for membership on the ACOT.
Nominations shall state that the nominee is willing to serve as a
member of the ACOT and appears to have no conflict of interest that
would preclude the ACOT membership. Potential candidates will be asked
to provide detailed information concerning financial interests,
consultancies, research grants, and/or contracts that might be affected
by recommendations of the Committee to permit evaluation of possible
sources of conflicts of interest.
A nomination package should include the following information for
each nominee: (1) A letter of nomination stating the name, affiliation,
and contact information for the nominee, the basis for the nomination
(i.e., what specific attributes, perspectives, and/or skills does the
individual possess that would benefit the workings of ACOT), and the
nominee's field(s) of expertise; (2) a biographical sketch of the
nominee and a copy of his/her curriculum vitae; and (3) the name,
return address, and daytime telephone number at which the nominator can
be contacted.
The Department of Health and Human Services has special interest in
assuring that women, minority groups, and the physically disabled are
adequately represented on advisory committees; and therefore, extends
particular encouragement to nominations for appropriately qualified
female, minority, or disabled candidates.
Dated: January 22, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-1730 Filed 1-30-08; 8:45 am]
BILLING CODE 4165-15-P
