Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Notices 50419 

will enhance competition between 

Lumie`re and River City—which 

Pinnacle tries to minimize today. The 

geographic positioning of the casinos 

(i.e., the fact that Lumie`re is closer to 

Ameristar St. Charles and River City 

than Ameristar St. Charles and River 

City are to each other) and the 

quantitative and qualitative evidence 

gathered during the investigation 

support the conclusion that competition 

will be enhanced by the divestiture of 

Lumie`re notwithstanding the 

competition of Ameristar and River 

City. 

If Pinnacle does not divest Lumie`re to 

a Commission-approved acquirer within 

six months, the Consent Order provides 

that a divestiture trustee may be 

appointed to sell Lumie`re, and includes 

a crown-jewel provision requiring the 

divestiture trustee to divest either 

Lumie`re or the Ameristar St. Charles 

casino. Until the completion of the 

divestiture, Pinnacle is required to abide 

by the Order to Hold Separate and 

Maintain Assets, which requires 

Pinnacle to hold Lumie`re separate and 

maintain its viability, marketability, and 

competitiveness until the Lumie`re 

divestiture is completed. The proposed 

Consent Order appoints a Hold Separate 

Monitor to manage Lumie`re’s operations 

pending the divestiture. 

Additionally, the proposed Consent 

Order requires Pinnacle, upon request 

by the acquirer and subject to prior 

approval of the Commission, to provide 

transitional services to the approved 

acquirer for one year, as needed, to 

assist the acquirer with the transfer of 

necessary administrative support 

services. Finally, the proposed Consent 

Order contains standard terms regarding 

the acquirer’s access to employees, 

protection of Material Confidential 

Information, and compliance-reporting 

requirements, among other things. 

B. Lake Charles 

In Lake Charles, the proposed Consent 

Order remedies the likely 

anticompetitive effects of the proposed 

acquisition by requiring Pinnacle to 

divest all of the assets associated with 

Ameristar’s development and 

construction of Mojito Pointe to a 

Commission-approved buyer within six 

months. The divestiture assets include 

the Mojito Pointe real property, licenses 

and permits, equipment, customer 

databases, intellectual property, 

contracts, books and records, including 

construction documents, and other 

assets necessary for a Commissionapproved acquirer to independently and 

effectively build, open, and operate 

Mojito Pointe. The proposed Consent 

Order would preserve five independent 

casino operators in Lake Charles and 

ensure that the owner of the Mojito 

Pointe assets has the incentive to 

expedite construction of Mojito Pointe 

and to compete vigorously with 

Pinnacle’s L’Auberge casino. 

Under the proposed Consent Order, 

the potential acquirer of Mojito Pointe is 

subject to prior approval by the 

Commission. If Pinnacle is unable to 

find a Commission-approved acquirer 

for Mojito Pointe within six months, the 

Consent Order provides for the 

appointment of a divestiture trustee and 

includes a crown-jewel provision that 

permits the divestiture trustee to divest 

either Mojito Pointe or Pinnacle’s 

L’Auberge casino. Additionally, the 

proposed Consent Order requires 

Pinnacle, upon request by the acquirer 

and subject to prior approval of the 

Commission, to provide transitional 

services to the approved acquirer for 

one year, as needed, to assist the 

acquirer with the transfer of necessary 

administrative support services. The 

proposed Consent Order also contains 

standard terms regarding the acquirer’s 

access to employees, protection of 

Material Confidential Information, and 

compliance-reporting requirements, 

among other things. 

The Hold Separate Order requires 

Pinnacle to hold Mojito Pointe separate 

until the Mojito Pointe divestiture is 

completed. Pinnacle is also required to 

maintain the economic viability, 

marketability, and competitiveness of 

Mojito Pointe and L’Auberge, the 

crown-jewel asset. The proposed 

Consent Order appoints a Hold Separate 

Monitor to oversee the development and 

construction of Mojito Pointe prior to 

divestiture. 

* * * * * 

The sole purpose of this analysis is to 

facilitate public comment on the 

proposed Consent Order. This analysis 

does not constitute an official 

interpretation of the proposed Consent 

Order or modify its terms in any way. 

By direction of the Commission. 

Richard C. Donohue, 

Acting Secretary. 

[FR Doc. 2013–20058 Filed 8–16–13; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; CMS Computer 

Match No. 2013–10; HHS Computer 

Match No. 1310 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice of Computer Matching 

Program (CMP). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, this notice announces the 

establishment of a CMP that CMS plans 

to conduct with the Department of 

Homeland Security (DHS), United States 

Citizenship and Immigration Services 

(USCIS). 

DATES: Effective Dates: Comments are 

invited on all portions of this notice. 

Public comments are due 30 days after 

publication. The matching program will 

become effective no sooner than 40 days 

after the report of the matching program 

is sent to the Office of Management and 

Budget (OMB) and Congress, or 30 days 

after publication in the Federal 

Register, whichever is later. 

ADDRESSES: The public should send 

comments to: CMS Privacy Officer, 

Division of Privacy Policy, Privacy 

Policy and Compliance Group, Office of 

E-Health Standards & Services, Offices 

of Enterprise Management, CMS, Room 

S2–24–25, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Comments received will be available for 

review at this location, by appointment, 

during regular business hours, Monday 

through Friday from 9:00 a.m.–3:00 

p.m., Eastern Time zone. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Wesolowski, Director, 

Verifications Policy & Operations 

Branch, Division of Eligibility and 

Enrollment Policy and Operations, 

Center for Consumer Information and 

Insurance Oversight, CMS, 7501 

Wisconsin Avenue, Bethesda, MD 

20814, Office Phone: (301) 492–4416, 

Facsimile: (443) 380–5531, E-Mail: 

Aaron.Wesolowski@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Computer Matching and Privacy 

Protection Act of 1988 (Pub. L.100–503), 

amended the Privacy Act (5 U.S.C. 552a) 

by describing the manner in which 

computer matching involving Federal 

agencies could be performed and adding 

certain protections for individuals 

applying for and receiving Federal 

benefits. Section 7201 of the Omnibus 


TKELLEY on DSK3SPTVN1PROD with NOTICES
50420 Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Notices 

Budget Reconciliation Act of 1990 (Pub. 

L. 101–508) further amended the 

Privacy Act regarding protections for 

such individuals. The Privacy Act, as 

amended, regulates the use of computer 

matching by Federal agencies when 

records in a system of records are 

matched with other Federal, state, or 

local government records. It requires 

Federal agencies involved in computer 

matching programs to: 

1. Negotiate written agreements with 

the other agencies participating in the 

matching programs; 

2. Obtain the Data Integrity Board 

approval of the match agreements; 

3. Furnish detailed reports about 

matching programs to Congress and 

OMB; 

4. Notify applicants and beneficiaries 

that the records are subject to matching; 

and, 

5. Verify match findings before 

reducing, suspending, terminating, or 

denying an individual’s benefits or 

payments. 

This matching program meets the 

requirements of the Privacy Act of 1974, 

as amended. 

Dated: August 14, 2013. 

Michelle Snyder, 

Chief Operating Officer, Centers for Medicare 

& Medicaid Services. 

CMS Computer Match No. 2013–10; 

HHS Computer Match No. 1310 

Name: ‘‘Computer Matching 

Agreement between the Centers for 

Medicare & Medicaid Services and the 

Department of Homeland Security, 

United States Citizenship and 

Immigration Services, for the 

Verification of United States Citizenship 

and Immigration Status Data for 

Eligibility Determinations’’. 

Security Classification: Unclassified. 

Participating Agencies: Department of 

Health and Human Services (HHS), 

Centers for Medicare & Medicaid 

Services (CMS), and Department of 

Homeland Security (DHS), United States 

Citizenship and Immigration Services 

(USCIS). 

Authority for Conducting Matching 

Program: Sections 1411 and 1413 of the 

Patient Protection and Affordable Care 

Act of 2010 (Pub. L. 111–148), as 

amended by the Health Care and 

Education Reconciliation Act of 2010 

(Pub. L. 111–152) (collectively, the 

ACA) require the Secretary of HHS to 

establish a program for determining 

eligibility for certain Insurance 

Affordability Programs and 

certifications of Exemption; in addition, 

these sections authorize use of secure, 

electronic interfaces and an on-line 

system for the verification of data and 

information related to Eligibility 

Determinations. 

Purpose(s) of the Matching Program: 

The purpose of the Computer Matching 

Agreement is to establish the terms, 

conditions, safeguards, and procedures 

under which USCIS will provide 

records, information, or data to CMS. 

CMS will access USCIS data needed to 

make Eligibility Determinations in its 

capacity as a Federally-facilitated 

Exchange, and Administering Entities 

(state agencies that administer Medicaid 

or the Children’s Health Insurance 

Program, and State-based Exchanges) 

will receive the results of verifications 

using USCIS data accessed through the 

CMS Data Services Hub to make 

Eligibility Determinations. Eligibility 

Determinations include initial 

determinations made upon application, 

renewals, annual or periodic 

redeterminations, and appeals. 

Data will be matched by CMS for the 

purpose of Eligibility Determinations 

enrollment in Insurance Affordability 

Programs and Eligibility Determinations 

for Exemptions. Specifically, USCIS will 

provide CMS with electronic access to 

immigrant, nonimmigrant, and 

naturalized or derived citizen status 

information contained within or 

accessed by the USCIS Verification 

Information System. Access to this 

information will assist with verification 

whether an applicant is lawfully 

present, a qualified non-citizen, a 

naturalized or derived citizen, and 

whether the 5 year bar applies and has 

been met in order to determine 

eligibility for the previously mentioned 

programs. 

Description of Records To Be Used In 

the Matching Program: The matching 

program will be conducted with data 

maintained by CMS in the Health 

Insurance Exchanges (HIX) Program, 

CMS System No. 09–70–0560, as 

amended. The system is described in 

System of Records Notices (SORNs) 

published at 78 FR 8538 (Feb. 6, 2013) 

and 78 FR 32256 (May 29, 2013). 

The matching program will also be 

conducted with data maintained by 

DHS in the Systematic Alien 

Verification for Entitlements (SAVE) 

System of Records Notice (SAVE 

SORN): DHS/USCIS–004 Systematic 

Alien Verification for Entitlements 

Program System of Records Notice, 77 

FR 47415 (August 8, 2012). 

Inclusive Dates of the Match: The 

CMP will become effective no sooner 

than 40 days after the report of the 

matching program is sent to OMB and 

Congress, or 30 days after publication in 

the Federal Register, whichever is later. 

The matching program will continue for 

18 months from the effective date and 

may be extended for an additional 12 

months thereafter, if certain conditions 

are met. 

[FR Doc. 2013–20173 Filed 8–16–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0924] 

Determination That LIDEX 

(fluocinonide) Cream and LIDEX–E 

(fluocinonide) Cream and Nine Other 

Drug Products Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Mark Geanacopoulos, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6206, 

Silver Spring, MD 20993–0002, 301– 

796–6925. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

sponsors must, with certain exceptions, 

show that the drug for which they are 

seeking approval contains the same 

active ingredient in the same strength 

and dosage form as the ‘‘listed drug,’’ 

which is a version of the drug that was 

previously approved. Sponsors of 

ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 


TKELLEY on DSK3SPTVN1PROD with NOTICES