Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices 58007 

subcommittee was established by 

SACHRP in October 2006. SOH was 

established by SACHRP at its July 2009 

meeting, and is charged with identifying 

and prioritizing areas in which 

regulations and/or guidelines for human 

subjects research adopted by various 

agencies or offices within HHS would 

benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. 

Public Comment will be heard on 

both days. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend the meeting and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the designated contact persons. 

Members of the public will have the 

opportunity to provide comments on 

both days of the meeting. Public 

comment will be limited to five minutes 

per speaker. Any members of the public 

who wish to have printed materials 

distributed to SACHRP members for this 

scheduled meeting should submit 

materials to the Executive Director, 

SACHRP, prior to the close of business 

September 30, 2011. 

Dated: September 13, 2011. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections, Executive Secretary, Secretary’s 

Advisory Committee on Human Research 

Protections. 

[FR Doc. 2011–23863 Filed 9–16–11; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Group on 

Prevention, Health Promotion, and 

Integrative and Public Health 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health, Office of the Surgeon General of 

the United States Public Health Service. 

ACTION: Notice. 

SUMMARY: In accordance with Section 

10(a) of the Federal Advisory Committee 

Act, Public Law 92–463, as amended (5 

U.S.C. App.), notice is hereby given that 

a meeting is scheduled to be held for the 

Advisory Group on Prevention, Health 

Promotion, and Integrative and Public 

Health (the ‘‘Advisory Group’’). The 

meeting will be open to the public. 

Information about the Advisory Group 

can be obtained by accessing the 

following Web site: http:// 

www.healthcare.gov/center/councils/ 

nphpphc/index.html. 

DATES: The meeting will be held on 

October 3–4, 2011. 

ADDRESSES: Will be announced on the 

Web site: http://www.healthcare.gov/ 

center/councils/nphpphc/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Office of the Surgeon General, 200 

Independence Ave., SW.; Hubert H. 

Humphrey Building, Room 701H; 

Washington, DC 20001; 202–205–9517; 

prevention.council@hhs.gov. 

SUPPLEMENTARY INFORMATION: On June 

10, 2010, the President issued Executive 

Order 13544 to comply with the statutes 

under Section 4001 of the Patient 

Protection and Affordable Care Act, 

Public Law 111–148. This legislation 

mandated that the Advisory Group was 

to be established within the Department 

of Health and Human Services. The 

charter for the Advisory Group was 

established by the Secretary of Health 

and Human Services on June 23, 2010; 

the charter was filed with the 

appropriate Congressional committees 

and Library of Congress on June 24, 

2010. The Advisory Group has been 

established as a non-discretionary 

Federal advisory committee. 

The Advisory Group has been 

established to provide recommendations 

and advice to the National Prevention, 

Health Promotion and Public Health 

Council (the ‘‘Council’’). The Advisory 

Group shall provide assistance to the 

Council in carrying out its mission. 

The Advisory Group membership 

shall consist of not more than 25 nonFederal members to be appointed by the 

President. The membership shall 

include a diverse group of licensed 

health professionals, including 

integrative health practitioners who 

have expertise in (1) worksite health 

promotion; (2) community services, 

including community health centers; (3) 

preventive medicine; (4) health 

coaching; (5) public health education; 

(6) geriatrics; and (7) rehabilitation 

medicine. There are currently 16 

members of the Advisory Group 

appointed by the President. This will be 

the third meeting of the Advisory 

Group. 

Public attendance at the meeting is 

limited to the space available. Members 

of the public who wish to attend must 

register by 12 p.m. EST September 26, 

2011. Individuals should register for 

public attendance at 

prevention.council@hhs.gov by 

providing your full name and affiliation. 

Individuals who plan to attend the 

meeting and need special assistance 

and/or accommodations, i.e., sign 

language interpretation or other 

reasonable accommodations, should 

notify the designated point of contact 

for the Advisory Group. The public will 

have the opportunity to provide 

comments to the Advisory Group on 

October 3, 2011; public comment will 

be limited to 3 minutes per speaker. 

Registration through the designated 

contact for the public comment session 

is also required. Any member of the 

public who wishes to have printed 

materials distributed to the Advisory 

Group for this scheduled meeting 

should submit material to the designed 

point of contact no later than 12 p.m. 

EST September 26, 2011. 

Dated: September 8, 2011. 

Corinne M. Graffunder, 

Acting Designated Federal Officer, Advisory 

Group on Prevention, Health Promotion, and 

Integrative and Public Health Office of the 

Surgeon General. 

[FR Doc. 2011–23869 Filed 9–16–11; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; Report of a New 

System of Records 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

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 to support its shared savings 

programs, the first of which are the 

Medicare Shared Savings Program and 

Pioneer ACO Model (collectively 

referred to as the ACO program). The 

ACO program implements recent health 

care reform provisions of the Patient 

Protection and Affordable Care Act 

(PPACA), amending the Social Security 

Act (the Act). The system of records will 

contain personally identifiable 

information (PII) about certain 

individuals who participate in, or 

whose PII is used to determine 

eligibility of an Accountable Care 

Organization (ACO) to participate in, a 

shared savings program; i.e., Medicare 

fee-for-service (FFS) beneficiaries, sole 

proprietor health care ACO participants 

and ACO suppliers/providers, key 

leaders and managers of accountable 

care organizations (ACOs), and contact 

persons for ACOs. The program and the 

system of records are more thoroughly 

described in the Supplementary 

Information section and System of 

Records Notice (SORN), below. 

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58008 Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices 

DATES: CMS filed a new system report 

with the Chair of the House Committee 

on Government Reform and Oversight, 

the Chair of the Senate Committee on 

Homeland Security & Governmental 

Affairs, and the Administrator, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB) on September 14, 2011. To 

ensure that all parties have adequate 

time in which to comment, the new 

system, including routine uses, will 

become effective October 19, 2011. If 

CMS receives comments that require 

alterations to this notice, we will 

publish a revised notice in the Federal 

Register. 

ADDRESSES: The public should send 

comments to: CMS Privacy Officer, 

Division of Information Security & 

Privacy Management, Enterprise 

Architecture and Strategy Group, Office 

of Information Services, CMS, Room 

N1–24–08, 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 a.m.–3 p.m., 

Eastern Time zone. 

FOR FURTHER INFORMATION CONTACT: For 

Medicare Shared Savings Program: 

Rebecca Weiss, Program Analyst, 

Performance-Based Payment Policy 

Staff, Center for Medicare, Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Mail-stop: C5–15– 

12, Baltimore, MD 21244–1850. Office: 

410–786–8084, Facsimile: (410) 786– 

8005, E-mail address: aco@cms.hhs.gov. 

For Pioneer Aco Model: Alli Chandra, 

Health Insurance Specialist, Center for 

Medicare and Medicaid Innovation, 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Mailstop: S3–13–05, Baltimore, MD 

21244–1850. Office Ph: 410–786–1132, 

Facsimile: (410) 786–0487, E-mail 

address: alli.chandra@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: This 

System of Records Notice (SORN) 

addresses a new system which HHS is 

establishing to support CMS shared 

savings programs created as a result of 

the Patient Protection and Affordable 

Care Act (Pub. L. 111–148), the first of 

which are the Medicare Shared Savings 

Program and Pioneer ACO Model (ACO 

program) described in more detail 

below. 

I. Medicare Shared Savings Program 

The recently passed health care 

reform bill, the Affordable Care Act 

(PPACA) (Pub. L. 111–148), contains 

provisions that seek to reward quality 

care and takes steps toward paying for 

high quality and efficient care. One of 

these provisions, Section 3022, 

amended Title XVIII of the Social 

Security Act (the Act) (42 U.S.C. 1395 

et seq.) by adding new section 1899 to 

the Act to establish a shared savings 

program (SSP) that promotes 

accountability for a patient population, 

coordinates items and services under 

Parts A and B, and encourages 

investment in infrastructure and 

redesigned care processes for high 

quality and efficient service delivery. 

Specifically: 

• Section 1899(a)(1) of the Act 

requires the Secretary to establish the 

shared savings program no later than 

January 1, 2012. Section 1899(a)(1) (A) 

of the Act further provides that, ‘‘groups 

of providers of services and suppliers 

meeting criteria specified by the 

Secretary may work together to manage 

and coordinate care for Medicare feefor-service (FFS) beneficiaries through 

an accountable care organization 

(ACO).’’ 

• Section 1899(a)(1)(B) of the Act 

provides that ACOs that meet quality 

performance standards established by 

the Secretary are eligible to receive 

payments for ‘‘shared savings.’’ 

The Shared Savings Program is a 

voluntary program. The statute provides 

that, to participate in the program, an 

ACO must ‘‘provide the Secretary with 

such information regarding the ACO 

professionals participating in the ACO 

as the Secretary determines necessary to 

support the assignment of Medicare feefor-service beneficiaries to an ACO, the 

implementation of quality and other 

reporting requirements * * * and the 

determination of payments for shared 

savings.’’ The statute requires an ACO to 

meet certain eligibility criteria 

including, but not limited to, having ‘‘a 

formal legal structure that would allow 

the organization to receive and 

distribute payments for shared savings,’’ 

having ‘‘in place a leadership and 

management structure that includes 

clinical and administrative systems,’’ 

and demonstrating ‘‘to the Secretary that 

it meets patient-centeredness criteria 

specific by the Secretary.’’ In addition, 

the ACO must agree to participate for 

not less than 3 years, have a formal legal 

structure including primary care 

providers sufficient for the care of not 

less than 5000 beneficiaries, and meet 

others requirements. 

The statute defines an ACO as 

organization of health care providers 

that agrees to become accountable for 

the quality, cost, and overall care of 

Medicare beneficiaries who are enrolled 

in the traditional fee-for-service program 

who are assigned to it. The statute states 

that there are many types of 

organizational arrangements for 

eligibility to become an ACO, as 

determined appropriate by the 

Secretary. 

To qualify for shared savings 

payments, the ACO must meet specific 

cost and quality benchmarks. Quality 

performance standards will be 

determined by the Secretary and may 

include measures of clinical processes 

and outcomes, patient and/or caregiver 

experience, and utilization measures. 

An ACO will be eligible to receive a 

share (a percentage, and any limits, to 

be determined by the Secretary) of any 

savings if the actual per capita 

expenditures of its assigned Medicare 

beneficiaries are a sufficient percentage 

below its specified benchmark amount. 

The benchmark for each ACO will be 

based on the most recent available three 

years of per-beneficiary expenditures for 

Parts A and B services for Medicare FFS 

beneficiaries assigned to the ACO. The 

benchmark for each ACO will be 

adjusted for beneficiary characteristics 

and other factors as determined by the 

Secretary, and updated by the projected 

absolute amount of growth in national 

per capita expenditures for Parts A and 

B. 

II. Pioneer ACO Model 

Another provision of the Affordable 

Care Act (PPACA), Section 3021, 

amended Title XVIII of the Social 

Security Act (the Act) (42 U.S.C. 1395 

et seq.) by adding new section 1899 to 

the Act to establish the Center for 

Medicare and Medicaid Innovation 

(Innovation Center). The Innovation 

Center is tasked with development of 

the Pioneer ACO Model. Under the 

Pioneer ACO Model, the Innovation 

Center will engage up to 30 highly 

experienced provider organizations in 

testing alternative payment models that 

include escalating financial 

accountability and substantial quality/ 

patient experience standards 

(‘‘outcomes based arrangements’’). CMS 

intends to pursue payment models that 

(1) include escalating levels of financial 

accountability through successive 

performance periods during the 

Participation Agreement; (2) provide a 

transition to Population-Based Payment 

by the third performance period, and (3) 

are projected by CMS to generate 

Medicare savings by the end of the 

second performance period. 

III. The Privacy Act 

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

governs the means by which the United 

States Government collects, maintains, 

and uses personally identifiable 

information (PII) in a system of records. 

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

records under the control of a Federal 

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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices 58009 

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). 

The Privacy Act permits an agency to 

disclose information about an 

individual (PII) without that 

individual’s consent if the information 

is to be used for a purpose that is 

compatible with the purpose(s) for 

which the information was collected. 

Any such disclosure of PII is known as 

a ‘‘routine use.’’ HHS/CMS will only 

release PII from this system as provided 

in the ‘‘Routine Uses’’ section below. 

Both identifiable and non-identifiable 

data may be disclosed under a routine 

use. HHS/CMS will only disclose the 

minimum PII necessary to achieve the 

purpose of the routine use, after 

determining that: 

• The use or disclosure is consistent 

with the reason that the PII was 

collected; 

• The purpose for which the 

disclosure is to be made can only be 

accomplished if the record is provided 

in individually identifiable form; 

• The purpose for which the 

disclosure is to be made is of sufficient 

importance to warrant the effect on and/ 

or risk to the privacy of the individual 

that additional exposure of the record 

might bring; 

• There is a strong probability that 

the proposed use of the data would in 

fact accomplish the stated purpose(s); 

and 

• The data are valid and reliable. 

Additionally, HHS/CMS will require 

the information recipient to: 

• Establish administrative, technical, 

and physical safeguards to prevent 

unauthorized use or disclosure of the 

record; 

• Remove or destroy at the earliest 

time all individually-identifiable 

information; and 

• Agree to not use or disclose the 

information for any purpose other than 

the stated purpose under which the 

information was disclosed. 

SYSTEM NUMBER: 

09–70–0598 

SYSTEM NAME: 

ACO Database System HHS/CMS/CM 

and HHS/CMS/CMMI. 

SECURITY CLASSIFICATION: 

Sensitive, unclassified. 

SYSTEM LOCATION: 

CMS Data Center, 7500 Security 

Boulevard, North Building, First Floor, 

Baltimore, Maryland 21244–1850 and at 

various accountable care organization 

(ACO) locations and 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 whose PII is used to 

determine eligibility of an ACO to 

participate in, a Health and Human 

Services (HHS) Centers for Medicare & 

Medicaid Services (CMS) Medicare 

shared savings program: 

• Medicare fee-for-service (FFS) 

beneficiaries who receive health care 

services coordinated and managed by a 

group of health care providers and 

suppliers organized to receive shared 

savings incentive payments, as an 

accountable care organization (ACO). 

• Any providers or suppliers 

participating in an ACO who are sole 

proprietorships, for whom certain 

business-identifying information may 

therefore constitute personally 

identifiable information. 

• Key leaders and managers of an 

ACO who provide certain personally 

identifiable information that is used to 

determine the ACO’s eligibility to 

participate in the program. 

• Any contact persons for an ACO 

who provide contact information for use 

in contacting them for information 

about the ACO. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

This system may include, but will not 

necessarily be limited to, the following 

categories of records, containing PII (or 

possible PII) data elements such as the 

following: 

• Medicare fee-for-service (FFS) 

beneficiary claims records, containing 

the beneficiary’s name, gender, Health 

Insurance Claim Number (HICN) (which 

could be the beneficiary’s Social 

Security Number), address, date of birth 

and description of provided services. 

• ACO eligibility and contact records, 

containing the ACO name and address 

(which could be the home address of a 

key leader or manager of the ACO); ACO 

participant or ACO provider/supplier 

names and addresses (which could 

include home addresses for any sole 

proprietor providers/suppliers in the 

ACO); ACO participant Tax 

Identification Number (TIN) (which 

could be a Social Security Number for 

a sole proprietor ACO participant or 

ACO provider/supplier in the ACO); 

National Provider Identifier (NPI) 

(which is considered PII for an 

individual provider/supplier); and (for 

individuals serving as key leaders or 

managers of an ACO) the individual’s 

name and address (which could be a 

home address). 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

The Patient Protection and Affordable 

Care Act (Pub. L. 111–148), which 

amended Title XVIII of the Social 

Security Act (the Act) (42 U.S.C. 1395 

et seq.) to add new section 1899 to the 

Act to establish a Medicare Shared 

Savings Program (MSSP); and Section 

3021 of the Patient Protection and 

Affordable Care Act, which amended 

Title XI of the Social Security Act (the 

Act) (42 U.S.C. 1301 et seq.) to add new 

section 1115A to the Act to establish the 

Center for Medicare and Medicaid 

Innovation. 

PURPOSE(S) OF THE SYSTEM: 

The system will enable the HHS 

Centers for Medicare & Medicaid 

Services (CMS) to administer the ACO 

program. Relevant HHS personnel, and 

any CMS contractors, grantees and 

consultants assisting them, will use 

personally identifiable information (PII) 

from this system on a ‘‘need to know’’ 

basis for these purposes: 

• Beneficiary claims information and 

ACO eligibility and contact information 

will be used to support the regulatory, 

reimbursement and policy functions of 

shared savings programs and to combat 

fraud, waste and abuse in certain health 

benefits programs. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OR USERS AND

THE PURPOSES OF SUCH USES: 

Any of the PII from this system may 

be disclosed outside HHS for these 

routine uses: 

1. To obtain assistance from other 

Federal agencies that help HHS, 

pursuant to agreements with CMS, to 

determine the eligibility of ACO 

applicants to participate in the program. 

For example, a TIN (which may be a 

Social Security Number) may be shared 

with the U.S. Federal Trade 

Commission (FTC) and the U.S. 

Department of Justice (DOJ) for purposes 

of obtaining their assessment of the 

ACO applicant’s market share status. 

2. To provide ACOs with information 

they need to meet requirements and 

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58010 Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices 

implement quality and other reporting 

requirements of the program. 

3. To provide information to the U.S. 

Department of Justice (DOJ), a court, or 

an adjudicatory body when (a) the 

Agency or any component thereof, or (b) 

any employee of the Agency in his or 

her official capacity, or (c) any 

employee of the Agency in his or her 

individual capacity where the DOJ has 

agreed to represent the employee, or (d) 

the United State Government, is a party 

to litigation or has an interest in such 

litigation, and by careful review, CMS 

determines that the records are both 

relevant and necessary to the litigation 

and that the use of such records by the 

DOJ, court, or adjudicatory body is 

compatible with the purpose for which 

the agency collected the records. 

4. 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. 

5. To assist appropriate Federal 

agencies and HHS contractors that have 

a need to know the information for the 

purpose of assisting HHS’s 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. 

ADDITIONAL CIRCUMSTANCES AFFECTING

DISCLOSURE OF PII ABOUT BENEFICIARIES: 

To the extent that the beneficiary 

claims records in this system contain 

Protected Health Information (PHI) as 

defined by HHS regulation ‘‘Standards 

for Privacy of Individually Identifiable 

Health Information’’ (45 CFR parts 160 

and 164, subparts A and E), disclosures 

of such PHI that are otherwise 

authorized by these routine uses may 

only be made if, and as, permitted or 

required by the ‘‘Standards for Privacy 

of Individually Identifiable Health 

Information’’ (see 45 CFR 164–512 (a) 

(1)). In addition, HHS policy will be to 

prohibit release even of data not directly 

identifiable with a particular 

beneficiary, except pursuant to one of 

the routine uses or if required by law, 

if HHS determines there is a possibility 

that a particular beneficiary can be 

identified through implicit deduction 

based on small cell sizes (instances 

where the patient population is so small 

that individuals could, because of the 

small size, use this information to 

deduce the identity of a particular 

beneficiary). 

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 in a DB2 and/or Oracle 

relational database management 

environment (DASD data storage 

media). Any hard copies of ACO 

program-related records containing PII 

at HHS/CMS, ACO and contractor 

locations will be kept in hard-copy file 

folders locked in secure file cabinets 

during non-duty hours. 

RETRIEVABILITY: 

Information may be retrieved by any 

of these personal identifiers: ACO 

participant TIN (which could be a sole 

proprietor provider/supplier’s Social 

Security Number), National Provider 

Identifier (NPI), or beneficiary Health 

Insurance Claim Number (HICN)) 

(which may be the beneficiary’s Social 

Security Number). 

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 ACO 

Database System will be limited to CMS 

personnel, and any contractors, grantees 

and consultants assisting them, through 

password security, encryption, 

firewalls, and secured operating system. 

Future system enhancements may 

allow for ACOs, ACO participants or 

ACO provider/suppliers, and 

beneficiaries to be external users of the 

system, for purposes of viewing and 

inputting their records in this system. 

Access controls will ensure that each 

external user is restricted to viewing 

only the user’s own records, not records 

pertaining to other users. 

Any electronic or hard copies of ACO 

program-related records containing PII 

at HHS/CMS, an ACO, and any 

contractor, grantee or consultant 

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 containing PII will be 

maintained for a period of up to 10 

years after entry in the database. Any 

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, Performance-Based Payment 

Policy Staff, Center for Medicare, 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Mailstop: C5–15–12, Baltimore, MD 

21244–1850; and 

Director, Pioneer ACO Model, Center 

for Medicare and Medicaid Innovation, 

Centers for Medicare and Medicaid 

Services, Mailstop: S3–13–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

NOTIFICATION PROCEDURE: 

Individuals wishing to know if this 

system contains records about them 

should write to one of the system 

managers and include the pertinent 

personal identifier used for retrieval of 

their records (i.e., TIN, NPI or 

beneficiary Health Insurance Claim 

Number). 

RECORD ACCESS PROCEDURE: 

Individuals seeking access to records 

about them in this system should follow 

the same instructions indicated under 

‘‘Notification Procedure’’ and 

reasonably specify the record contents 

being sought. (These procedures are in 

accordance with Department regulation 

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

CONTESTING RECORD PROCEDURES: 

Individuals seeking to contest the 

content of information about them in 

this system should follow the same 

instructions indicated under 

‘‘Notification Procedure.’’ The request 

should reasonably identify the record 

and specify the information being 

contested, state the corrective action 

sought, and provide 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 

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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices 58011 

1 In this document, we use the terms ‘‘price 

incentive’’ and ‘‘coupon’’ interchangeably to refer to 

the types of promotional offers to be addressed in 

our study. 

Medicare Beneficiary Database (MBD) 

(09–70–0536), from the National Claims 

History File (NCH) (09–70–0558), and 

from ACOs that provide the information 

as required to perform the statutory 

functions of beneficiary assignment, 

implementation of quality and other 

reporting requirements, and 

determination of shared savings. 

EXEMPTIONS CLAIMED FOR THIS SYSTEM: 

None. 

Dated: September 14, 2011. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2011–23959 Filed 9–15–11; 11:15 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0465] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study: Effect of Promotional Offers in 

Direct-to-Consumer Prescription Drug 

Print Advertisements on Consumer 

Product Perceptions 

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 October 19, 

2011. 

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–New and 

title ‘‘Experimental Study: Effect of 

Promotional Offers in Direct-toConsumer Prescription Drug Print 

Advertisements on Consumer Product 

Perceptions.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.Vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In compliance with 44 U.S.C. 3507, 

FDA has submitted the following 

proposed collection of information to 

OMB for review and clearance. 

Experimental Study: Effect of 

Promotional Offers in Direct-toConsumer Prescription Drug Print 

Advertisements on Consumer Product 

Perceptions—(OMB Control Number 

0910–New) 

Section 502(n) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 352(n)) requires 

advertisements for prescription drugs to 

include, among other things, ‘‘such 

information in brief summary relating to 

side effects, contraindications, and 

effectiveness as shall be required in 

regulations.’’ Under this authority, FDA 

has issued regulations to require most 

prescription drug advertisements to 

provide a ‘‘true statement of information 

in brief summary relating to side effects, 

contraindications, and effectiveness.’’ 

(§ 202.1(e) (1) (21 CFR 202.1(e)(1)). To 

satisfy this requirement, an 

advertisement that makes claims about 

a prescription drug must also include a 

‘‘fair balance’’ of information about the 

benefits and risks of the advertised 

product, in terms of both content and 

presentation (§ 202.1(e)(5)(ii)). In part, 

§ 202.1(e)(6)(i) states that [a]n 

advertisement for a prescription drug is 

false, lacking in fair balance, or 

otherwise misleading, or otherwise 

violative of section 502(n) of the act, 

among other reasons, if it [c]ontains a 

representation or suggestion, not 

approved or permitted for use in the 

labeling, that a drug is better, more 

effective, useful in a broader range of 

conditions or patients (as used in 

§ 202.1 ’’patients’’ means humans and 

in the case of veterinary drugs, other 

animals) safer, has fewer, or less 

incidence of, or less serious side effects 

or contraindications than has been 

demonstrated by substantial evidence or 

substantial clinical experience (as 

described in paragraphs (e)(4)(ii)(b) and 

(e)(4)(ii)(c) of § 202.1) whether or not 

such representations are made by 

comparison with other drugs or 

treatments, and whether or not such a 

representation or suggestion is made 

directly or through use of published or 

unpublished literature, quotations, or 

other references. 

FDA’s current regulations provide a 

limited exception to the requirement in 

§ 202.1(e)(1), of presenting a true 

statement of information in brief 

summary, for ‘‘reminder 

advertisements’’ (‘‘reminder ads’’)— 

advertisements that draw attention to 

the name of the product but do not 

make representations about the 

product’s indication(s) or dosage 

recommendations (§ 202.1(e)(2)(i)). 

(Certain drugs are not permitted to 

qualify for the reminder advertisement 

exemption.) To meet the terms of this 

exemption, reminders ads must in 

general be limited to the proprietary and 

established name of the product and the 

established name of each active 

ingredient in the drug product. 

Reminder ads may also (optionally) 

contain information about the product’s 

quantitative ingredients, dosage form, 

quantity, price, and manufacturer, as 

well as other written, printed, or graphic 

matter containing no representation or 

suggestion relating to the product. 

Further, reminder ads that are intended 

to provide consumers with information 

concerning the price charged for a 

prescription drug product need not meet 

the terms of § 202.1(e)(2)(i) in order to 

be exempt from § 202.1(e)(1) if they 

meet all of the conditions in § 200.200 

(21 CFR 200.200). That regulation, in 

turn, applies to prescription drug 

reminders ads that are intended solely 

to provide consumers with information 

concerning the price charged for a 

prescription for a particular drug 

product, and the reminder ad contains 

no representation or suggestion 

concerning the drug product’s safety, 

effectiveness, or indications for use 

(§ 200.200(a)(1) and (b)). 

A topic of ongoing interest for 

consumer product manufacturers and 

retailers is the use of consumer-oriented 

sales promotions such as free trial 

offers, discounts, money-back 

guarantees, and rebates. Such 

promotions are widely used in many 

product categories, including 

prescription drugs. 

Prior research has demonstrated that 

the type of promotion offered can affect 

how consumers respond to the 

promotion (Refs. 1, 2, and 3). Price 

incentives 1 may act as cues about 

product quality. For example, a price 

incentive may not only act as an 

economic incentive to buy the product, 

it may also artificially enhance 

consumers’ perceptions of the product’s 

quality (Ref. 4). In the case that 

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