8538 Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Notices 

patient population is so small that 

individuals could, because of the small 

size, use this information to deduce the 

identity of a particular individual). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM— 

STORAGE: 

All records are stored on magnetic 

media. 

RETRIEVABILITY: 

Information may be retrieved by any 

of these personal identifiers: provider’s 

TIN (which could be a SSN); National 

Provider Identifier (NPI); Patient’s SSN 

or a Beneficiary’s HICN; a patient’s or 

beneficiary’s name in combination with 

the patient’s or beneficiary’s date of 

birth. 

SAFEGUARDS: 

Personnel having access to the system 

have been trained in the Privacy Act 

and information security requirements. 

Employees who maintain records in this 

system are instructed not to release data 

until the intended recipient agrees to 

implement appropriate management, 

operational and technical safeguards 

sufficient to protect the confidentiality, 

integrity and availability of the 

information and information systems 

and to prevent unauthorized access. 

Access to records in the LTCH database 

system will be limited to CMS 

personnel and contractors through 

password security, encryption, 

firewalls, and secured operating system. 

Any electronic or hard copies of 

financial-related records containing PII 

at CMS and contractor locations will be 

kept in secure electronic files or in file 

folders locked in secure file cabinets 

during non-duty hours. 

RETENTION AND DISPOSAL: 

Records containing PII will be 

maintained for a period of up to 10 

years after entry in the database. Any 

such records that are needed longer, 

such as to resolve claims and audit 

exceptions or to prosecute fraud, will be 

retained until such matters are resolved. 

Beneficiary claims records are currently 

subject to a document preservation 

order and will be preserved indefinitely 

pending further notice from the U.S. 

Department of Justice. 

SYSTEM MANAGER AND ADDRESS: 

Director, Division of Chronic & PostAcute Care, Quality Measurement & 

Health Assessment Group, Center for 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, 7500 

Security Boulevard, Mail Stop S3–02– 

01, Baltimore, MD 21244–1850. 

NOTIFICATION PROCEDURE: 

An individual record subject who 

wishes to know if this system contains 

records about him or her should write 

to the system manager who will require 

the system name, HICN, and for 

verification purposes, the subject 

individual’s name (woman’s maiden 

name, if applicable), and SSN 

(furnishing the SSN is voluntary, but it 

may make searching for a record easier 

and prevent delay). 

RECORD ACCESS PROCEDURE: 

An individual seeking access to 

records about him or her in this system 

should use the same procedures 

outlined in Notification Procedures 

above. The requestor should also 

reasonably specify the record contents 

being sought. (These procedures are in 

accordance with Department regulation 

45 CFR 5b.5(a)(2).) 

CONTESTING RECORD PROCEDURES: 

To contest a record, the subject 

individual should contact the system 

manager named above, and reasonably 

identify the record and specify the 

information to be contested. The 

individual should state the corrective 

action sought and the reasons for the 

correction with supporting justification. 

(These procedures are in accordance 

with Department regulation 45 CFR 

5b.7.) 

RECORD SOURCE CATEGORIES: 

Personally identifiable information in 

this database is collected by LTCH 

providers from and about LTCH patients 

and beneficiaries by means of the LTCH 

CARE Data Set. LTCH data is reported 

to CMS from LTCH providers through 

an on-line system known as LTCH 

Assessment Submission Entry and 

Reporting (LASER). 

EXEMPTIONS CLAIMED FOR THIS SYSTEM: 

None. 

Dated: January 10, 2013. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2013–02669 Filed 2–5–13; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974 

AGENCY: Department of Health and 

Human Services (HHS), Centers for 

Medicare & Medicaid Services (CMS). 

ACTION: Notice to establish a new system 

of records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

CMS is establishing a new system of 

records titled, ‘‘Health Insurance 

Exchanges (HIX) Program,’’ to support 

the CMS Health Insurance Exchanges 

Program established under provisions of 

the Affordable Care Act (PPACA) (Pub. 

L. 111–148), as amended by the Health 

Care and Education Reconciliation Act 

of 2010 (Pub. L. 111–152). The Health 

Insurance Exchanges (HIX) Program 

includes Federally-facilitated Exchanges 

operated by CMS, CMS support and 

services provided to all Exchanges and 

state agencies administering Medicaid, 

CHIP and the BHP, and CMS 

administration of advance payment of 

premium tax credits and cost-sharing 

reductions. The system of records will 

contain personally identifiable 

information (PII) about certain 

individuals who apply or on whose 

behalf an application is filed for 

eligibility determinations for enrollment 

in a qualified health plan (QHP) through 

an Exchange, and for insurance 

affordability programs. Exchange 

functions that will utilize PII include 

eligibility, enrollment, appeals, payment 

processes and consumer assistance. The 

system will also contain information 

about qualified employers seeking to 

obtain health insurance coverage for its 

qualified employees through a Small 

Business Health Options Program 

(SHOP). In addition, the system will 

include PII of marketplace assisters, 

Navigators and Agents/Brokers, their 

officers, employers and contractors; 

contact information for QHP Issuers 

seeking certification that may contain 

personally identifiable information of 

their officers, and employees or 

contractors; employees and contractors 

of the Exchange and CMS. The program 

and the system of records are more 

thoroughly described in the 

Supplementary Information section and 

System of Records Notice (SORN), 

below. 

DATES: Effective Dates: Effective 30 days 

after publication. Written comments 

should be submitted on or before the 

effective date. HHS/CMS/CCIIO may 

publish an amended system of records 

notice (SORN) in light of any comments 

received. 

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, Office of 

Enterprise Management, CMS, Room 

S2–24–25, 7500 Security Boulevard, 

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Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Notices 8539 

1 42 CFR 435.948, 435.949. 

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 Information on Health Insurance 

Exchanges Contact: Karen Mandelbaum, 

JD, MHA, Office of Health Insurance 

Exchanges, Consumer Information and 

Insurance Systems Group, Center for 

Consumer Information and Insurance 

Oversight, 7210 Ambassador Road, 

Baltimore, MD 21244, Office Phone: 

(410) 786–1762, Facsimile: (301) 492– 

4353, E-Mail: 

karen.mandelbaum@cms.hhs.gov 

SUPPLEMENTARY INFORMATION: 

I. Health Insurance Exchanges Program 

The Affordable Care Act (ACA) 

requires Exchanges to use a single, 

streamlined application for consumers 

to use in applying for eligibility 

determinations for enrollment in a QHP 

through the Exchange, for insurance 

affordability programs, and for 

certifications of exemption from the 

individual responsibility mandate and 

penalty. The insurance affordability 

programs that the Exchanges will 

determine eligibility for include: (a) The 

advance payment of the premium tax 

credits (APTC); (b) cost-sharing 

reductions (CSR); (c) Medicaid, (d) 

Children’s Health Insurance Program 

(CHIP), and (e) Basic Health Plan (BHP), 

if a BHP is operating in the service area 

of the Exchange. The information 

requested on the application includes 

all of the information necessary for 

determining eligibility and enrolling 

individuals and qualified employees in 

a QHP through the Exchange or SHOP 

and for determining eligibility for 

insurance affordability programs. The 

applicant must be able to file this 

application online, by telephone, in 

person or by mail with the entity that is 

administering the eligibility and 

enrollment functions of the Exchange. 

This eligibility and enrollment process 

will be conducted in real-time through 

electronic data transfer. 

The applicant/enrollee, the 

application filer on behalf of other 

applicants, or the authorized 

representative of the applicant/enrollee 

will be asked to provide the minimum 

amount of information necessary to 

support the eligibility and enrollment 

processes of the above listed programs. 

The categories of information requested 

on the application include personal, 

employment, financial, demographic, 

and pregnancy status and tobacco use. 

Section 1411 of the Affordable Care Act 

requires verification of the information 

received from applicants/enrollees. The 

information provided by an applicant/ 

enrollee, or by an application filer on 

behalf of other applicants, on the 

application will be matched and 

verified against data provided by the 

Internal Revenue Service (IRS), Social 

Security Administration (SSA), 

Department of Homeland Security 

(DHS), Department of Veterans Affairs 

(VA),Department of Defense (DoD), 

Peace Corps, and Office of Personnel 

Management (OPM) that is maintained 

by the Federally-facilitated Exchange 

(FFE). State-based Exchanges (SBEs) 

will send requests for data matching 

through the Data Services Hub (Hub). 

Exchanges can also permit certain 

individuals and entities to assist 

applicants and enrollees. These include 

Navigators, Agents, Brokers and 

employees, agents and contractors of the 

Exchange (e.g. marketplace assisters). 

Section 1943(b) of the Social Security 

Act (as amended by Section 2201 of the 

Affordable Care Act), as implemented 

through regulations adopted by the 

Secretary of HHS,1 requires that 

Medicaid and CHIP agencies utilize the 

same streamlined enrollment system 

and secure electronic interface 

established in Section 1413 to verify 

information, including federal tax 

information, financial and quarters of 

coverage information held by the Social 

Security Administration, Social Security 

Number (SSN) and citizenship, needed 

to make an eligibility determination and 

facilitate a streamlined eligibility and 

enrollment system among all insurance 

affordability programs. This enrollment 

system and secure electronic interface is 

the same one developed by HHS to 

comply with sections 1411(c) and 

1411(d) of the Affordable Care Act for 

purposes of determining eligibility to 

enroll in a qualified health plan (QHP) 

through an Exchange State Medicaid, 

Chip and BHP agencies will send 

requests for data matching through the 

Data Services Hub (Hub). 

With respect to determinations of 

eligibility for Medicaid and CHIP, the 

FFE can make either an assessment of 

eligibility or a determination of 

eligibility. Unless the FFE assesses an 

applicant/enrollee as ineligible for a 

Medicaid, CHIP or BHP program and the 

applicant/enrollee requests to withdraw 

his/her application for Medicaid, CHIP 

or BHP, the FFE must notify the State 

Medicaid or CHIP agency and transmit 

all information obtained or verified by 

the CMS in operation of the FFE via 

secure electronic interface for that other 

agency to make a full determination of 

eligibility under those programs and 

provide the applicant with coverage. 

When applicants/enrollees receive a 

determination that they are qualified to 

enroll in a QHP and have chosen a QHP 

to enroll in, the Exchange will notify the 

QHP Issuers of individual enrollment 

selections and transmit the information 

necessary to implement, discontinue or 

modify enrollment and/or the level of 

payments processed and received 

through the APTC and CSR programs 

and information regarding the premium 

payments due from the enrollees. 

Enrollees are required to update 

information that would impact their 

eligibility status, and an Exchange will 

perform mid-year redeterminations 

using the same system used for initial 

determinations of eligibility when it 

receives updated information regarding 

an enrollee either directly from the 

enrollee or through a periodic 

examination of data sources. The 

Secretary along with the other 

appropriate agencies will establish an 

appeals process for individuals and 

employers when eligibility is denied as 

a result of inconsistencies between the 

information obtained from applicants/ 

enrollees and employers and 

information and data verified through 

the Exchange. CMS will also process 

enrollment and payment transactions to 

facilitate APTC payments for all 

Exchanges; SBEs will send this 

information to CMS through the Hub. 

The FFE will store eligibility and 

enrollment records, system user records, 

appeals records, consumer services 

records and SHOP employer records for 

all Exchanges. The Hub will be a passthrough for SBEs for providing 

information from applicants/enrollees to 

CMS and for the FFE to share data with 

SBEs, Medicaid, CHIP and BHP 

agencies. 

Each Exchange, including the FFE, 

will establish a SHOP to assist qualified 

employers and facilitate the enrollment 

of qualified employees into QHPs. 

Eligibility determinations are not made 

on the individual level in a SHOP; 

rather, the information that an employer 

is required to provide about employees 

includes, the name and address of the 

employer, number of employees, 

Employer Identification Number (EIN), 

and list of qualified employees and their 

tax ID numbers. 

The FFE will be responsible for 

performing oversight functions with 

respect to issuer compliance with 

market-wide and Exchange specific 

standards in connection with QHPs 

certified by the FFE. The FFE will 

require QHP Issuers to submit, as 

requested by the FFE, certified financial 

information including information 

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8540 Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Notices 

2The insurance affordability programs are: (a) 

The advance payment of the premium tax credits 

(APTC); (b) cost-sharing reductions (CSR); (c) 

Medicaid, (d) Children’s Health Insurance Program 

(CHIP), and (e) Basic Health Plan (BHP), if a BHP 

is operating in the service area of the Exchange. 

related to ownership and control and 

information demonstrating that the 

issuer is fiscally sound, information that 

is necessary to administer and evaluate 

the program, including but not limited 

to, enrollee complaints against the QHP 

issuer and their disposition, enrollee 

appeals and their disposition, formal 

actions, reviews, findings or other 

similar actions by States, other 

regulatory bodies or any other certifying 

or accrediting organization, and any 

other information deemed necessary by 

the FFE for the administration of the 

FFE or certification of QHPs. In 

addition, the FFE will require qualified 

health plans to periodically report the 

activities that the health plan has 

implemented in order to improve health 

outcomes. 

CMS will also administer the 

administration of advance payment of 

premium tax credits and cost-sharing 

reductions for all Exchanges. The PII 

that will be collected, disclosed and 

used as part of this administration 

includes QHP enrollment, premium 

payment information, and information 

about cost-sharing payments necessary 

to reconcile estimates of cost-sharing 

reductions with actual cost-sharing 

reductions. 

II. The Privacy Act 

The Privacy Act (5 U.S.C. 552a) 

governs the means by which the United 

States Government collects, maintains, 

and uses PII in a system of records. A 

‘‘system of records’’ is a group of any 

records under the control of a Federal 

agency from which information about 

individuals is retrieved by name or 

other personal identifier. The Privacy 

Act requires each agency to publish in 

the Federal Register a system of records 

notice (SORN) identifying and 

describing each system of records the 

agency maintains, including the 

purposes for which the agency uses PII 

in the system, the routine uses for 

which the agency discloses such 

information outside the agency, and 

how individual record subjects can 

exercise their rights under the Privacy 

Act (e.g., to determine if the system 

contains information about them). 

SYSTEM NUMBER: 

09–70–0560 

SYSTEM NAME: 

Health Insurance Exchanges (HIX) 

Program, HHS/CMS/CCIIO 

SECURITY CLASSIFICATION: 

Unclassified 

SYSTEM LOCATION: 

CMS Data Center, 7500 Security 

Boulevard, North Building, First Floor, 

Baltimore, Maryland 21244–1850, 

Health Insurance Exchanges Program 

(HIX) locations, and at various 

contractor sites. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

The system will contain personally 

identifiable information (PII) about the 

following categories of individuals who 

participate in or are involved with the 

CMS Health Insurance Exchanges 

Program: (1) Any applicant/enrollee 

who applies, or on whose behalf an 

application is filed, for an eligibility 

determination for a qualified health 

plan (QHP) through an Exchange, 

insurance affordability program, or for a 

certification of exemption; (2) 

Navigators, Agents, Brokers, individuals 

or entities that are required to register 

with an Exchange prior to assisting 

qualified individuals to enroll in QHPs 

through the Exchange; (3) officers, 

employees and contractors of the 

Exchange; (4) employees and 

contractors of CMS (e.g. marketplace 

assisters, appeals staff); (5) contact 

information and business identifying 

information of QHPs seeking 

certification; (6) persons employed by or 

contracted with an Exchange 

organization who provide home or 

personal contact information; and (7) 

any qualified employer and the 

qualified employees whose enrollment 

in a QHP is facilitated through a Small 

Business Health Options Program 

(SHOP). 

CATEGORIES OF RECORDS IN THE SYSTEM: 

Information maintained in this system 

for individual applicant/enrollees 

includes, but may not be limited to, the 

applicant’s first name, last name, 

middle initial, mailing address or 

permanent residential address (if 

different from the mailing address), date 

of birth, Social Security Number (if the 

applicant has one), taxpayer status, 

gender, ethnicity, residency, email 

address, and telephone number. The 

system will also maintain information 

that will verify the information 

provided by the individual/enrollee or 

by the application filer on behalf of 

other applicants that will enable a 

decision about an applicant’s eligibility. 

The system will collect and maintain 

information that the applicant or the 

application filer on behalf of other 

applicants submits pertaining to (1) his 

or her citizenship or immigration status, 

because only individuals who are 

citizens or nationals of the U.S. or 

lawfully present are eligible to enroll; 

(2) enrollment in Federally funded 

minimum essential health coverage (e.g. 

Medicare, Medicaid, Federal Employees 

Health Benefit Program (FEHBP), 

Veterans Health Administration (Champ 

VA), Children’s Health Insurance 

Program (CHIP), Department of Defense 

(TRICARE), Peace Corps); (3) 

incarceration status; (4) Indian status; 

(5) enrollment in employer-sponsored 

coverage; (6) requests for and 

accompanying documentation to justify 

receipt of individual responsibility 

exemptions, including membership in a 

certain type of recognized religious sect 

or health care sharing ministry; (7) 

employer information; (8) status as a 

veteran; (9) limited health status 

information (pregnancy status, 

blindness, disability status); and (10) 

household income, including tax return 

information from the IRS, income 

information from the Social Security 

Administration, and financial 

information from other third party 

sources. Information will also be 

maintained with respect to the 

applicant’s enrollment in a QHP 

through the Exchange, the premium 

amounts and payment history. 

With respect to qualified employers 

and the qualified employees utilizing 

SHOP, the information maintained in 

the system includes but may not be 

limited to the name and address of the 

employer, number of employees, 

Employer Identification Number (EIN), 

and list of qualified employees and their 

tax ID numbers. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

The HIX program implements recent 

health care reform provisions of the 

Patient Protection and Affordable Care 

Act (PPACA) (Pub. L. 111–148) as 

amended by the Health Care and 

Education Reconciliation Act of 2010 

(Pub. L. 111–152) collectively the 

Affordable Care Act. Title 42 U.S.C. 

18031, 18041, 18081—18083 and 

section 1414 of the Affordable Care Act. 

PURPOSE(S) OF THE SYSTEM: 

The purpose of this system is to 

collect, create, use and disclose PII on 

individuals who apply for eligibility 

determinations for enrollment in a 

qualified health plan through the 

Exchange, for insurance affordability 

programs,2 and for certifications of 

exemption from the individual 

responsibility requirement and; and as 

needed to perform the Exchange 

minimum functions in 45 CFR 155.200; 

and to maintain records used to support 

all Health Insurance Exchanges under 

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Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Notices 8541 

the HIX Program established by CMS. 

The system will collect, create, use and 

disclose PII that will enable HHS to 

perform oversight and enforcement 

activities of QHP Issuers offering 

qualified health plans through the FFE. 

In addition, HHS, and any contractors 

assisting HHS, will use PII from the 

system to assist in accomplishing CMS 

functions relating to the purposes of this 

collection and who need to have access 

to the records in order to assist CMS. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM

A. ENTITIES WHO MAY RECEIVE DISCLOSURES

UNDER ROUTINE USE

These routine uses specify 

circumstances, in addition to those 

provided by statute in the Privacy Act 

of 1974, under which CMS may release 

information from the HIX without the 

consent of the individual to whom such 

information pertains. Each proposed 

disclosure of information under these 

routine uses will be evaluated to ensure 

that the disclosure is legally 

permissible, including but not limited to 

ensuring that the purpose of the 

disclosure is compatible with the 

purpose for which the information was 

collected. We are establishing the 

following routine use disclosures of 

information maintained in the system: 

1. To support Agency contractors, 

consultants, or CMS grantees who have 

been engaged by the Agency to assist in 

accomplishment of a CMS function 

relating to the purposes for this 

collection and who need to have access 

to the records in order to assist CMS. 

2. To disclose information to another 

Federal agency, agency of a State 

government, a non-profit entity 

operating an Exchange for a State, an 

agency established by State law, or its 

fiscal agent to (A) make eligibility 

determinations for enrollment in a QHP 

through an Exchange, insurance 

affordability programs, and 

certifications of exemption from the 

individual responsibility requirement, 

(B) to carry out the HIX Program, and 

(C) to perform functions of an Exchange 

described in 45 CFR 155.200, including 

notices to employers under section 

1411(f) of the Affordable Care Act. 

3. To disclose information about 

applicants in order to obtain 

information from other Federal agencies 

that help CMS, pursuant to agreements 

with CMS, to determine the eligibility of 

applicants to enroll in QHPs through an 

Exchange, in insurance affordability 

programs, or for a certification of 

exemption from the individual 

responsibility requirement. 

4. To assist a CMS contractor 

(including, but not limited to Medicare 

Administrative Contractors, fiscal 

intermediaries, and carriers) that assists 

in the administration of a CMSadministered health benefits program, 

or to a grantee of a CMS-administered 

grant program, when disclosure is 

deemed reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste or abuse in such program. 

5. To assist another Federal agency or 

an instrumentality of any governmental 

jurisdiction within or under the control 

of the United States (including any state 

or local governmental agency), that 

administers, or that has the authority to 

investigate potential fraud, waste or 

abuse in a health benefits program 

funded in whole or in part by Federal 

funds, when disclosure is deemed 

reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste or abuse in such programs. 

6. To assist appropriate Federal 

agencies and CMS contractors and 

consultants that have a need to know 

the information for the purpose of 

assisting CMS’ efforts to respond to a 

suspected or confirmed breach of the 

security or confidentiality of 

information maintained in this system 

of records, provided that the 

information disclosed is relevant and 

necessary for that assistance. 

7. To assist the U.S. Department of 

Homeland Security (DHS) cyber security 

personnel, if captured in an intrusion 

detection system used by HHS and DHS 

pursuant to the Einstein 2 program. 

8. To provide information about 

applicants to application filers, who are 

filing on behalf of those applicants, 

when relevant and necessary to 

determine eligibility to enroll in QHPs 

or in insurance affordability programs. 

9. To QHP issuers for purposes of 

administering advance payment of 

premium tax credits and cost-sharing 

reductions. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM— 

STORAGE: 

Electronic records will be stored on 

both tape cartridges (magnetic storage 

media) and in a relational database 

management environment (DASD data 

storage media). Any hard copies of 

program related records containing PII 

at CMS and contractor locations will be 

kept in secure hard-copy file folders 

locked in secure file cabinets during 

non-duty hours. 

RETRIEVABILITY: 

The records will be retrieved 

electronically by a variety of fields, 

including but not limited to first name, 

last name, middle initial, date of birth, 

or Social Security Number (SSN). 

SAFEGUARDS: 

Personnel having access to the system 

have been trained in the Privacy Act 

and information security requirements. 

Employees who maintain records in this 

system are instructed not to release data 

until the intended recipient agrees to 

implement appropriate management, 

operational and technical safeguards 

sufficient to protect the confidentiality, 

integrity and availability of the 

information and information systems 

and to prevent unauthorized access. 

Access to records in the HIX Database 

system will be limited to authorized 

CMS personnel and contractors through 

password security, encryption, 

firewalls, and secured operating system. 

Any electronic or hard copies of records 

containing PII at CMS, exchanges and 

contractor locations will be kept in 

secure electronic files or in hard-copy 

file folders locked in secure file cabinets 

during non-duty hours. 

RETENTION AND DISPOSAL: 

Records are maintained with 

identifiers for all transactions for a 

period of 10 years after they are entered 

into the system. Records are housed in 

both active and archival files in 

accordance with CMS data and 

document management policies and 

standards. 

SYSTEM MANAGER AND ADDRESS: 

Director, Consumer Information and 

Insurance Systems Group, Center for 

Consumer Information and Insurance 

Oversight, Centers for Medicare & 

Medicaid Services, 7501 Wisconsin 

Ave, 9th Floor, Bethesda, MD 20814. 

NOTIFICATION PROCEDURE: 

An individual record subject who 

wishes to know if this system contains 

records about him or her should write 

to the system manager who will require 

the system name, and for verification 

purposes, the subject individual’s name 

(woman’s maiden name, if applicable), 

and SSN (furnishing the SSN is 

voluntary, but it may make searching for 

a record easier and prevent delay). 

RECORD ACCESS PROCEDURE: 

An individual seeking access to 

records about him or her in this system 

should use the same procedures 

outlined in Notification Procedures 

above. The requestor should also 

reasonably specify the record contents 

being sought. (These procedures are in 

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8542 Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Notices 

accordance with Department regulation 

45 CFR 5b.5 (a) (2).) 

CONTESTING RECORD PROCEDURES: 

To contest a record, the subject 

individual should contact the system 

manager named above, and reasonably 

identify the record and specify the 

information being contested. The 

individual should state the corrective 

action sought and the reasons for the 

correction with supporting justification. 

(These procedures are in accordance 

with Department regulation 45 CFR 

5b.7.) 

RECORD SOURCE CATEGORIES: 

Personally identifiable information in 

this database is obtained from the 

application submitted by or on behalf of 

individuals/applicants seeking 

eligibility determinations, from 

qualified employers and other 

employers who provide employersponsored coverage, from other Federal 

and state agencies needed to make 

eligibility determinations, from 

marketplace assisters facilitating the 

eligibility and enrollment processes, 

from QHPs, from State-based Exchanges 

that provide information to perform the 

statutory functions, from states 

participating in State Partnership 

Exchanges pursuant to the State 

Partnership Memorandum of 

Understanding, and from third party 

data sources to determine eligibility as 

described in this notice. 

EXEMPTIONS CLAIMED FOR THIS SYSTEM: 

None 

Dated: January 31, 2013. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2013–02666 Filed 2–5–13; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0306] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Administrative 

Detention and Banned Medical Devices 

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 March 8, 

2013. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0114. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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. 

Administrative Detention and Banned 

Medical Devices—(OMB Control 

Number 0910–0114)—Extension 

FDA has the statutory authority under 

section 304(g) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 334(g)) to detain during 

established inspections devices that are 

believed to be adulterated or 

misbranded. Section 800.55 (21 CFR 

800.55), on administrative detention, 

includes among other things, certain 

reporting requirements and 

recordkeeping requirements. Under 

§ 800.55(g), an applicant of a detention 

order must show documentation of 

ownership if devices are detained at a 

place other than that of the appellant. 

Under § 800.55(k), the owner or other 

responsible person must supply records 

about how the devices may have 

become adulterated or misbranded, in 

addition to records of distribution of the 

detained devices. These recordkeeping 

requirements for administrative 

detentions permit FDA to trace devices 

for which the detention period expired 

before a seizure is accomplished or 

injunctive relief is obtained. 

FDA also has the statutory authority 

under section 516 of the FD&C Act (21 

U.S.C. 360f) to ban devices that present 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury. Section 895.21 (21 CFR 

895.21), on banned devices, contains 

certain reporting requirements. Section 

895.21(d) describes the procedures for 

banning a device when the 

Commissioner of Food and Drugs (the 

Commissioner) decides to initiate such 

a proceeding. Under 21 CFR 895.22, a 

manufacturer, distributor, or importer of 

a device may be required to submit to 

FDA all relevant and available data and 

information to enable the Commissioner 

to determine whether the device 

presents substantial deception, 

unreasonable and substantial risk of 

illness or injury, or unreasonable, direct, 

and substantial danger to the health of 

individuals. 

During the past several years, there 

has been an average of less than one 

new administrative detention action per 

year. Each administrative detention will 

have varying amounts of data and 

information that must be maintained. 

FDA’s estimate of the burden under the 

administrative detention provision is 

based on FDA’s discussion with one of 

three firms whose devices had been 

detained. 

In the Federal Register of April 10, 

2012 (77 FR 21564), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

800.55(g) .............................................................................. 1 1 1 25 25 

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