Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 71443 

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 

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 

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 

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 

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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 

http://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 http://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 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

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 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 

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 

http://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 http://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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES