Renewal of Charter for the Secretary's Advisory Committee on Human Research Protections, 71443-71444 [2010-29517]
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Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices
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more of the acute inpatient psychiatric
beds in each of the affected markets.
The presumption of anticompetitive
harm created by the steep increases in
market concentration is further
supported by evidence of the intense
rivalry between UHS- and PSI-owned
facilities that would be eliminated by
the proposed acquisition. In each of the
local markets, consumers have
benefitted from the head-to-head
competition in the form of lower health
care costs, higher quality of care, and
improved service offerings. Left
unremedied, the proposed acquisition
likely would cause anticompetitive
harm by enabling UHS to profit by
unilaterally raising the reimbursement
rates negotiated with commercial health
plans. These costs are ultimately passed
on to consumers in the form of higher
premiums, co-pays, and other out-ofpocket costs. The loss of competition
also reduces UHS’s incentive to improve
quality and provide better service.
New entry is unlikely to deter or
counteract the anticompetitive effects of
the proposed acquisition. Among other
entry barriers, regulatory requirements
pose substantial barriers to entrants
attempting to establish new psychiatric
facilities or to expand their offerings in
the relevant markets. In particular,
Delaware and Puerto Rico require
Certificates of Need in order to enter or
significantly expand the number of beds
provided in the market. The availability
of suitable land, local zoning
regulations, and Medicare and Medicaid
certifications also impact significantly
the ability of firms to enter or expand.
As a result, new entry sufficient to
achieve a significant market impact is
unlikely to occur in a timely manner in
these markets.
The Proposed Consent Agreement
The proposed Consent Agreement
wholly remedies the anticompetitive
effects of the acquisition by requiring
the divestiture of all of the PSI or UHS
assets to a Commission-approved buyer
(or buyers) within six months of the
date the Consent Agreement becomes
final in Delaware and Las Vegas, and
within nine months in Puerto Rico.
Specifically, the proposed Consent
Agreement requires the divestiture of
four facilities that provide acute
inpatient psychiatric care, as well as
related outpatient clinics, contracts,
commercial trade names, and real
property, in the three geographic
markets. See Appendix A for a complete
list of the divestiture assets. Each
psychiatric facility and its associated
clinics to be divested in Delaware and
Puerto Rico is a stand-alone business,
and includes all of the assets necessary
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for a Commission-approved buyer to
independently and effectively operate
each facility. The two facilities in Las
Vegas are closely related and
complementary businesses and were
jointly managed within PSI; as such, the
two facilities together constitute a standalone business, and include all of the
assets necessary for a Commissionapproved buyer to independently and
effectively operate the business.
The proposed Consent Agreement
contains several provisions designed to
ensure that the divestitures are
successful. First, the Commission will
evaluate the suitability of possible
purchasers of the divested assets to
ensure that the competitive
environment that would have existed
but for the transaction is replicated by
the required divestitures. If UHS fails to
divest the assets within the required
time period to a Commission-approved
buyer, the Consent Agreement permits
the Commission to appoint a trustee to
divest the assets. Second, UHS is
required to provide transitional services
to the Commission-approved buyer.
These services will facilitate a smooth
transition of the assets to the acquirer,
and ensure continued and
uninterrupted operation of the assets
during the transition. Third, the Consent
Agreement requires UHS to remove any
contractual impediments that may deter
the current managers of the facilities to
be divested from accepting offers of
employment from any Commissionapproved acquirer and to obtain all
consents necessary to transfer the
required assets. Finally, to ensure that
the Commission will have an
opportunity to review any future
attempt by UHS to acquire any acute
inpatient psychiatric services provider
in any of the three geographic markets
at issue, the proposed Consent
Agreement contains a ten-year prior
notice provision.
The Hold Separate Order requires the
parties to maintain the viability of the
divestiture assets as competitive
operations until each facility is
transferred to a Commission-approved
buyer. Specifically, the parties must
maintain the confidentiality of sensitive
business information, and take all
actions necessary to prevent the
destruction or wasting of the divestiture
assets. After UHS acquires PSI, the Hold
Separate Order requires that UHS
separately hold and maintain the
divestiture assets and appoint a Hold
Separate Manager to operate these assets
pending their divestiture.
The sole purpose of this analysis is to
facilitate public comment on the
Consent Agreement. This analysis does
not constitute an official interpretation
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71443
of the Consent Agreement or modify its
terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2010–29511 Filed 11–22–10; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Renewal of Charter for the Secretary’s
Advisory Committee on Human
Research Protections
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, as amended (5
U.S.C. App), the U.S. Department of
Health and Human Services is hereby
announcing renewal of the charter for
the Secretary’s Advisory Committee on
Human Research Protections (SACHRP).
FOR FURTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections or Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville, MD
20852; Telephone: (240) 453–6900; Fax:
(240) 453–6909; e-mail address:
julia.gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: SACHRP
was established in October 2002. The
Committee was established to enhance
and expand the focus of the former
National Human Research Protections
Advisory Committee (NHRPAC), which
was terminated in August 2002.
SACHRP provides expert advice and
recommendations to the Secretary,
through the Assistant Secretary for
Health, on the conduct of research
involving human subjects with
particular emphasis on special
populations, such as neonates and
children, prisoners, and the decisionally
impaired; pregnant women, embryos,
and fetuses; individuals and
populations in international studies;
populations in which there are
individually identifiable samples, data,
or information; and investigator
conflicts of interest.
Since SACHRP was established,
renewal of the Committee charter has
been carried out at the appropriate
intervals as stipulated by FACA. The
previous Committee charter was
scheduled to expire on October 1, 2010.
On October 1, 2010, the Secretary of
SUMMARY:
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71444
Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices
Health and Human Services approved
for the Committee charter to be
renewed. The new charter was effected
and filed with the appropriate
Congressional offices and Library of
Congress on October 1, 2010. Renewal
of the SACHRP charter provides
authorization for the Committee to
operate until October 1, 2012.
A copy of the Committee charter is
available on the SACHRP Web site at
https://www.hhs.gov/ohrp/sachrp/
charter.htm. A copy of the Committee
charter also can be obtained by
accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
Web site address for the FACA database
is https://fido.gov/facadatabase.
Dated: November 16, 2010.
Jerry Menikoff,
Director, Office for Human Research
Protections, and Executive Secretary,
Secretary’s Advisory Committee on Human
Research Protections.
[FR Doc. 2010–29517 Filed 11–22–10; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Renewal of Charter for the Advisory
Committee on Blood Safety and
Availability
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, as amended (5
U.S.C. App), the U.S. Department of
Health and Human Services is hereby
announcing renewal of the charter for
the Advisory Committee on Blood
Safety and Availability (ACBSA).
FOR FURTHER INFORMATION CONTACT: Jerry
Holmberg, PhD; Senior Advisor for
Blood Policy and Executive Secretary,
Advisory Committee on Blood Safety
and Availability; Department of Health
and Human Services; 1101 Wootton
Parkway; Tower Building, Suite 250;
Rockville, MD 20852; Telephone: (240)
453–8803; Fax: (240) 453–8456; E-mail
address: acbsa@hhs.gov.
SUPPLEMENTARY INFORMATION: ACBSA
was established in 1996. The Committee
provides advice and guidance to the
Secretary, through the Assistant
Secretary for Health, on a range of blood
safety issues that encompass broad
public health and societal implications
that cannot be resolved through analysis
of scientific data alone. The range of
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SUMMARY:
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18:02 Nov 22, 2010
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issues on which the Committee is tasked
to provide advice and guidance
includes, but is not limited to: (1)
Definition of public health parameters
around safety and availability of the
blood and blood products; (2) broad
public health, ethical, and legal issues
related to transfusion and
transplantation safety; and (3)
implications for safety and availability
of various economic factors affecting
product cost and supply.
Since the ACBSA was established,
renewal of the Committee charter has
been carried out at the appropriate
intervals as stipulated by FACA. The
previous Committee charter was
scheduled to expire on October 9, 2010.
On October 8, 2010, the Secretary of
Health and Human Services approved
for the Committee charter to be
renewed. The new charter was effected
and filed with the appropriate
Congressional offices and Library of
Congress on October 9, 2010. Renewal
of the ACBSA charter provides
authorization for the Committee to
operate until October 9, 2012.
A copy of the Committee charter is
available on the ACBSA Web site at
https://www.hhs.gov/ash/bloodsafety/. A
copy of the Committee charter also can
be obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The Web site address
for the FACA database is https://fido.gov/
facadatabase.
Dated: November 17, 2010.
Jerry A. Holmberg,
Senior Advisor for Blood Policy, Executive
Secretary, Advisory Committee on Blood
Safety and Availability.
[FR Doc. 2010–29518 Filed 11–22–10; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0422]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information From
United States Firms and Processors
That Export to the European
Community
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
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information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
23, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0320. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Information From United States Firms
and Processors That Export to the
European Community (OMB Control
Number 0910–0320)—Revision
The European Community (EC) is a
group of 27 European countries that
have agreed to harmonize their
commodity requirements to facilitate
commerce among member States. EC
legislation for intra-EC trade has been
extended to trade with non-EC
countries, including the United States.
For certain food products, including
those listed in this document, EC
legislation requires assurances from the
responsible authority of the country of
origin that the processor of the food is
in compliance with applicable
regulatory requirements. The European
Commission, the executive branch of
the EC, requires countries trading with
any of the EC member countries to
provide lists of firms and processors
approved to export certain animalderived commodities to the EC. As
stated in the notice published in the
Federal Register of April 4, 1996 (61 FR
15077), FDA established a list of U.S.
firms and processors that intended to
export shell eggs, dairy products, and
game meat and game meat products to
the EC.
Although the 1996 Federal Register
notice did not include on the list firms
and processors exporting raw, bulk
collagen, and gelatin intended for
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]]>Agencies
[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Pages 71443-71444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29517]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Renewal of Charter for the Secretary's Advisory Committee on
Human Research Protections
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, as
amended (5 U.S.C. App), the U.S. Department of Health and Human
Services is hereby announcing renewal of the charter for the
Secretary's Advisory Committee on Human Research Protections (SACHRP).
FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director,
Office for Human Research Protections or Julia Gorey, J.D., Executive
Director, SACHRP; U.S. Department of Health and Human Services, 1101
Wootton Parkway, Suite 200, Rockville, MD 20852; Telephone: (240) 453-
6900; Fax: (240) 453-6909; e-mail address: julia.gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: SACHRP was established in October 2002. The
Committee was established to enhance and expand the focus of the former
National Human Research Protections Advisory Committee (NHRPAC), which
was terminated in August 2002. SACHRP provides expert advice and
recommendations to the Secretary, through the Assistant Secretary for
Health, on the conduct of research involving human subjects with
particular emphasis on special populations, such as neonates and
children, prisoners, and the decisionally impaired; pregnant women,
embryos, and fetuses; individuals and populations in international
studies; populations in which there are individually identifiable
samples, data, or information; and investigator conflicts of interest.
Since SACHRP was established, renewal of the Committee charter has
been carried out at the appropriate intervals as stipulated by FACA.
The previous Committee charter was scheduled to expire on October 1,
2010. On October 1, 2010, the Secretary of
[[Page 71444]]
Health and Human Services approved for the Committee charter to be
renewed. The new charter was effected and filed with the appropriate
Congressional offices and Library of Congress on October 1, 2010.
Renewal of the SACHRP charter provides authorization for the Committee
to operate until October 1, 2012.
A copy of the Committee charter is available on the SACHRP Web site
at https://www.hhs.gov/ohrp/sachrp/charter.htm. A copy of the Committee
charter also can be obtained by accessing the FACA database that is
maintained by the Committee Management Secretariat under the General
Services Administration. The Web site address for the FACA database is
https://fido.gov/facadatabase.
Dated: November 16, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections, and Executive
Secretary, Secretary's Advisory Committee on Human Research
Protections.
[FR Doc. 2010-29517 Filed 11-22-10; 8:45 am]
BILLING CODE 4150-36-P
