32654 Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate * 

Total cost 

burden 

Pediatrician and Family Physician Survey .............................. 1,200 600 $85.26 $51,156 

Total .................................................................................. 1,200 600 n/a 51,156 

* Based upon the higher of the two means of the hourly wages general pediatricians, National Compensation Survey: ‘‘May 2011 National Occupational Employment and Wage Estimates, United States.’’ U.S. Department of Labor, Bureau of Labor Statistics. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: May 21, 2013. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2013–12672 Filed 5–30–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Privacy Act of 1974; System of 

Records Notice 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), 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 

(5 USC 552a), the Agency for Healthcare 

Research and Quality (AHRQ) within 

the Department of Health and Human 

Services is establishing a new system of 

records, ‘‘Online Application Ordering 

for Products from the Healthcare Cost 

and Utilization Project (HCUP).’’ This 

online electronic ordering system will 

streamline and facilitate the 

dissemination of HCUP databases and 

software to qualified researchers and 

result in a more efficient process for 

both the public and the Agency. The 

HCUP program and the system of 

records for the online application 

ordering process are more thoroughly 

described in the SUPPLEMENTARY

INFORMATION section and System of 

Records Notice (SORN), below. 

DATES: Effective 30 days after 

publication. HHS/AHRQ may publish 

an amended System of Records Notice 

(SORN) in light of any comments 

received. 

ADDRESSES: Written comments should 

be sent to: HCUP Project Officer, Agency 

for Healthcare Research and Quality, 

540 Gaither Rd., Rockville, MD 20852 

OR to Email: HCUP@AHRQ.GOV. 

FOR FURTHER INFORMATION CONTACT: 

HCUP Project Officer, Agency for 

Healthcare Research and Quality, 540 

Gaither Rd., Rockville, MD 20852, 301– 

427–1410, or HCUP@AHRQ.GOV, 

SUPPLEMENTARY INFORMATION: 

I. Background on New System of 

Records, ‘‘Online Application Ordering 

for HCUP Products From the 

Healthcare Cost and Utilization Project 

(HCUP)’’ 

AHRQ is establishing this new system 

of records to cover personallyidentifiable information (PII) about 

individuals who purchase HCUP 

databases and software products for 

scientific research purposes through a 

new online ordering system. AHRQ’s 

research mission, the HCUP databases, 

and the online ordering process for 

HCUP databases and software products 

are explained in more detail below. 

A. AHRQ’s Research Mission 

The Healthcare Research and Quality 

Act of 1999 (‘‘the Act’’), Public Law 

106–129, amended Title IX of the Public 

Health Service act to establish AHRQ. 

The Act requires that AHRQ enhance 

the quality, appropriateness, and 

effectiveness of health services, and 

enhance access to such services, 

through the establishment of a broad 

base of scientific research and through 

the promotion of improvements in 

clinical and health systems practices, 

including the prevention of diseases and 

other health conditions. AHRQ 

promotes health care quality 

improvement by conducting and 

supporting: 

(1) Research that develops and 

presents scientific evidence regarding 

all aspects of health care; 

(2) Synthesis and dissemination of 

available scientific evidence for use by 

patients, consumers, practitioners, 

providers, purchasers, policy makers, 

and educato; and, 

(3) Initiatives to advance private and 

public efforts to improve health care 

quality. 

B. The HCUP Databases 

AHRQ created a family of health care 

databases and related software tools and 

products known as the Healthcare Cost 

and Utilization Project (HCUP, 

pronounced ‘‘H-Cup’’) to conduct and 

support its research activities. HCUP 

was developed through a Federal-State 

Industry partnership and sponsored by 

AHRQ; it includes the largest collection 

of longitudinal hospital care data in the 

United States, with all-payer, encounterlevel information beginning in 1988. 

The HCUP databases are annual files 

that contain anonymous information 

from hospital discharge records for 

inpatient care and certain components 

of outpatient care, such as emergency 

care and ambulatory surgeries. The 

project currently releases six types of 

databases created for research use on a 

broad range of health issues, including 

cost and quality of health services, 

medical practice patterns, access to 

health care programs, and outcomes of 

treatments at the national, state, and 

local market levels. HCUP also produces 

a large number of software tools to 

enhance the use of administrative health 

care data for research and public health 

use. The software tools use information 

available from a variety of sources to 

create new data elements, often through 

sophisticated algorithms, for use with 

the HCUP databases. 


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Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices 32655 

C. The Ordering Process for HCUP 

Databases and Software 

To support AHRQ’s mission to 

improve health care through scientific 

research, HCUP databases and software 

tools are disseminated to users outside 

of HHS through a mechanism known as 

the HCUP Central Distributor, which is 

operated by a private contractor. 

Databases and software disseminated 

through the HCUP Central Distributor 

are referred to as ‘‘restricted access 

public release files;’’ they are publicly 

available, but only under restricted 

conditions. The HCUP Central 

Distributor enables qualified researchers 

to access uniform research data across 

multiple states with the use of one 

application process, consisting of the 

following: 

(1) HCUP Application. All persons 

wanting access to the HCUP databases 

must complete the application process. 

For state databases, a description of the 

individual’s planned use of the HCUP 

data will be reviewed to confirm that it 

is consistent with the data use 

restrictions that apply to the data. As an 

alternative to the online ordering form, 

paper versions of application packages 

will continue to be available for 

download at http://www.HCUPus.AHRQ.gov/tech_assist/centdist.JSP. 

(2) HCUP Data Use Agreement 

Training. All persons wanting access to 

the HCUP databases must complete this 

online training course. The purpose of 

the training is to emphasize the 

importance of data protection, reduce 

the risk of inadvertent violations, and 

describe the individual’s responsibility 

when using HCUP data. The training 

course can be accessed and completed 

online at http://www.HCUPus.AHRQ. 

gov/tech_assist/dua.JSP. 

(3) HCUP Data Use Agreement (DUA). 

All persons wanting access to the HCUP 

databases must sign a data use 

agreement. Each database has a unique 

DUA; an example DUA for the 

Nationwide Inpatient Sample database 

is available at http://www.HCUPus.AHRQ.gov/team/NISDUA.JSP. 

HCUP databases are released to 

researchers outside of AHRQ after the 

completion of required training and 

submission of an application that 

includes a signed HCUP Data Use 

Agreement (DUA). In addition, before 

restricted access public release statelevel databases are released, the user is 

asked for a brief description of their 

research to ensure that the planned use 

is consistent with HCUP policies and 

with the HCUP data use requirements. 

Fees are set for databases released 

through the HCUP Central Distributor 

depending on the type of database. The 

fees for sale of state-level data are 

determined by each participating 

Statewide Data Organization and 

reimbursed to those organizations. 

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 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 

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: 09–35–0003. 

SYSTEM NAME: 

‘‘Online Application Ordering for 

Products from the Healthcare Cost and 

Utilization Project (HCUP)’’. 

SECURITY CLASSIFICATION: 

Unclassified. 

SYSTEM LOCATION: 

Servers: The servers hosting the 

system will be housed at the Social & 

Scientific Systems data center located in 

Ashburn, VA. 

Portals: This system will be accessed 

via the Internet. 

System Software: System software 

will be maintained by Social & 

Scientific Systems, Silver Spring, MD. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

The system will contain personally 

identifiable information (PII) about 

individual researchers who purchase 

HCUP databases through use of an 

HCUP online application that includes 

payment of a fee and execution of a Data 

Use Agreement placing restrictions on 

use of the HCUP data. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The system will contain the following 

categories of records and PII data 

elements: 

(1) HCUP Application Form, 

containing the individual’s contact 

information (name, address, telephone 

number and email address), a coded 

number indicating that the individual 

completed the required HCUP Data Use 

Agreement Training, and a description 

of the individual’s planned use of the 

HCUP data. 

(2) Transaction Records, containing 

information on the database and/or 

software order and contact information 

for purchaser. Credit card numbers or 

bank account information from 

electronic orders will not be stored in 

the system after the transaction is 

complete. 

(3) HCUP Data Use Agreement (DUA), 

containing the individual’s signature 

and contact information. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

42 U.S.C. 299–299a; 42 U.S.C. 

299c–2. 

PURPOSE(S) OF THE SYSTEM: 

HHS/AHRQ will use PII from this 

system for the following purposes: 

(1) Business Transaction: Contact 

information will be used to 

communicate with the individual and to 

ship the data to the individual (e.g., on 

a disk or other media). The description 

of the individual’s planned use of the 

HCUP data will be reviewed to confirm 

that it is consistent with the data use 

restrictions that apply to the data. 

(2) Payment Transaction: Credit card 

and bank account information will be 

used to complete orders for HCUP 

databases and software products. Credit 

card and e-check transactions collected 

by the HCUP information system will be 

transmitted securely to a PCI-compliant 

payment gateway for approval. The 

payment gateway will process the 

transaction and cause the funds to be 

transferred when the order is 

completed. 

(3) Enforcement of the HCUP Data Use 

Agreement (DUA): The individual’s 

signature and contact information on 

the HCUP DUA and the coded number 

on the application form indicating 

completion of HCUP Data Use 

Agreement Training will be used in the 

event that the individual violates the 

DUA, to enforce the data use 

restrictions. Most of these restrictions 

have been put in place to safeguard the 

privacy of individuals and 

establishments represented in the data. 

For example, data users can only use the 

data for research, analysis, and aggregate 

statistical reporting and are prohibited 

from attempting to identify any persons 

in the data. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES: 

The system may disclose records 

containing PII to parties outside HHS for 

the following routine uses: 


tkelley on DSK3SPTVN1PROD with NOTICES
32656 Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices 

(1) Records may be disclosed to 

agency contractors who have been 

engaged by the agency to assist in 

accomplishment of the HHS function 

relating to the purposes of this system 

of records and who need to have access 

to the records in order to assist HHS. 

(2) Records may be disclosed to the 

Department of Justice (DOA a court, or 

an adjudicatory body when: 

• The agency or any component 

thereof, or 

• Any employee of the agency in his 

or her official capacity, or 

• Any employee of the agency in his 

or her individual capacity where DOJ 

has agreed to represent the employee, or 

• The United States Government, is a 

party to litigation or has an interest in 

such litigation and, by careful review, 

HHS 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. 

(3) Records may be disclosed to 

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 federally funded programs, 

when disclosure is deemed reasonably 

necessary by HHS 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. 

(4) Records may be disclosed to 

appropriate federal agencies and 

Department contractors that have a need 

to know the information for the purpose 

of assisting the Department’s efforts to 

respond to a suspected or confirmed 

breach of the security or confidentiality 

of information maintained in this 

system of records, when the information 

disclosed is relevant and necessary for 

that assistance. 

The system may also disclose PII data 

for any of the uses authorized directly 

in the Privacy Act at 5 U.S.C. 552a(b)(2) 

and (b)(4)–(11). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM— 

STORAGE: 

Information will be collected via the 

online ordering application, fax, or 

email. Electronic records are stored in 

databases on magnetic tape, on magnetic 

disk and in secure electronic files at the 

contractor’s location (Social & Scientific 

Systems in Ashburn, VA) and at the 

tape storage facility: Storage Village 

White Flint, North Bethesda, MD. 

Credit card or e-check information 

will not be stored in the information 

system’s database after the transaction is 

completed. For those who cannot used 

the online application, the transaction 

can be completed with payments by 

check, purchase order, or wire transfer 

handled by fax or mail, and for these 

transactions, credit card or e-check 

information is destroyed when the order 

is completed. 

RETRIEVABILITY: 

The application and HCUP Data Use 

Agreement records will be retrieved by 

registrant/user name or User ID number. 

SAFEGUARDS: 

The identifiable information collected 

will be transmitted to the hosting server 

via an encrypted Secure Socket Layer 

(SSL) connection. Access to the 

database housing the identifiable 

information is accomplished through 

individual authorized administrative 

accounts. The server housing the 

identifiable information is located in a 

data center owned by Social & Scientific 

Systems and is located in Ashburn, VA. 

The data center is protected via 24/7 

guards at all entrances, video 

monitoring systems, biometric hand 

readers, cage locks, and system 

firewalls. 

• The information stored is captured 

and transmitted over an SSL connection 

for secure encrypted transmission. 

• Access to the database is only 

permissible at the administrator level 

and is done so either (a) in order to 

fulfill the applicants request, (b) for 

system maintenance, or (c) in the event 

of a DUA violation. 

• The server housing the system is 

located in a secure facility with 24/7 

guards at the entrance points, camera 

monitoring systems, biometric hand 

readers, and cage locks. 

The information collected by the 

electronic form will be stored in a SQL 

Server 2008 database. Data stored in the 

database will remain there indefinitely 

until requested by AHRQ. SSS performs 

nightly backups of the database. The 

backups are encrypted and stored 

offsite. At the conclusion of the 

contract, the information system as well 

as a current copy of the database can be 

provided to AHRQ by request. 

The information system uses a 

defense-in-depth strategy when it comes 

to user access. Users are assigned 

individual credentials along with role 

based least-privileged user account 

(LUA). The LUA approach ensures that 

users follow the principle of least 

privilege and always log on with limited 

user accounts. This strategy also aims to 

limit the use of administrative 

credentials to administrators, and then 

only for administrative tasks. 

RETENTION AND DISPOSAL: 

Information in the application and 

Data Use Agreement will be retained for 

approximately twenty years, and may be 

kept longer if needed for enforcement, 

audit, legal, or other agency purposes. 

Retention is necessary for enforcement 

of data restrictions in the event of a Data 

Use Agreement violation. Storage will 

be in an electronic format that is 

encrypted, backed up, and stored in two 

secure locations. 

PII related to the business transaction 

will be retained for up to 90 days so that 

a public user can return to their 

password protected account and 

complete their order. If a user forgets 

his/her password, the system will reset 

it and convey that information via 

email. 

Information related to the payment 

process will not be retained after the 

transaction has been completed. 

Payment options will include credit 

card, e-check, check, purchase order or 

wire transfer. Information to complete 

credit card and e-check transactions will 

be collected by the information system 

and transmitted securely to a PCIcompliant payment gateway for 

approval. The payment gateway product 

will process the transaction and cause 

the funds to be transferred when the 

transaction is captured at the time of 

shipment. Credit card or e-check 

information will not be stored in the 

information system’s database. 

Payments by check, purchase order, or 

wire transfer will be handled by fax or 

mail. 

SYSTEM MANAGER AND ADDRESS: 

HCUP Project Officer, Center for 

Delivery, Organization, and Markets, 

540 Gaither Road, Rockville, MD 20850, 

Telephone: 301–427–1410, 

HCUP@AHRQ.GOV. 

Individuals wishing to know if this 

system contains records about them 

should write to the System Manager. 

RECORD ACCESS PROCEDURE: 

Individuals seeking access to records 

about them in this system should follow 

the same instructions indicated under 

‘‘Notification Procedure’’ and indicate 

the record(s) to which access is sought 

(i.e., application form or HCUP Data Use 

Agreement). 

CONTESTING RECORD PROCEDURES: 

Individuals seeking to contest the 

content of information about them in 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices 32657 

this system should follow the same 

instructions indicated under 

‘‘Notification Procedure.’’ The request 

should reasonably identify the record, 

specify the information contested, state 

the corrective action sought, and 

provide the reasons for the correction, 

with supporting justification. 

RECORD SOURCE CATEGORIES: 

All information will be collected 

directly from the individual applicants/ 

users of the Web site, when they 

complete the online application forms. 

EXEMPTIONS CLAIMED FOR THIS SYSTEM: 

None. 

Dated: May 21, 2013. 

Carolyn M. Clancy, 

AHRQ Director. 

[FR Doc. 2013–12671 Filed 5–30–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (BSC, NCEH/ 

ATSDR) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting of the 

aforementioned committee: 

Times and Dates: 8:30 a.m.–3:00 p.m., 

June 27, 2013; 8:30 a.m.–12:00 p.m., 

June 28, 2013. 

Place: CDC, 4770 Buford Highway, 

Atlanta, Georgia 30341. 

Status: Open to the public, limited 

only by the space available. The meeting 

room accommodates approximately 60 

people. 

Purpose: The Secretary, Department 

of Health and Human Services (HHS) 

and by delegation, the Director, CDC 

and Administrator, NCEH/ATSDR, are 

authorized under Section 301(42 U.S.C. 

241) and Section 311(42 U.S.C. 243) of 

the Public Health Service Act, as 

amended, to: (1) Conduct, encourage, 

cooperate with, and assist other 

appropriate public authorities, scientific 

institutions, and scientists in the 

conduct of research, investigations, 

experiments, demonstrations, and 

studies relating to the causes, diagnosis, 

treatment, control, and prevention of 

physical and mental diseases and other 

impairments; (2) assist states and their 

political subdivisions in the prevention 

of infectious diseases and other 

preventable conditions and in the 

promotion of health and well being; and 

(3) train state and local personnel in 

health work. The BSC, NCEH/ATSDR 

provides advice and guidance to the 

Secretary, HHS; the Director, CDC and 

Administrator, ATSDR; and the 

Director, NCEH/ATSDR, regarding 

program goals, objectives, strategies, and 

priorities in fulfillment of the agency’s 

mission to protect and promote people’s 

health. The board provides advice and 

guidance that will assist NCEH/ATSDR 

in ensuring scientific quality, 

timeliness, utility, and dissemination of 

results. The board also provides 

guidance to help NCEH/ATSDR work 

more efficiently and effectively with its 

various constituents and to fulfill its 

mission in protecting America’s health. 

Matters To Be Discussed: The agenda 

items for the BSC Meeting on June 27– 

28, 2013 will include NCEH/ATSDR 

Office of the Director updates: 

Environmental Health Emergencies 

updates, Lead Poisoning Prevention 

Activities updates, Epi Aids at NCEH/ 

ATSDR update, Strategic Planning 

updates; and updates by BSC Federal 

Expert members on current activities at 

the National Institute for Occupational 

Safety and Health, U.S. Department of 

Energy, National Institute for 

Environmental Health Services and the 

U.S. Environmental Protection Agency. 

Agenda items are subject to change as 

priorities dictate. 

SUPPLEMENTARY INFORMATION: The 

public comment period is scheduled on 

Thursday, June 27, 2013 from 2:30 p.m. 

until 2:45 p.m., and on Friday, June 28, 

2013 from 10:00 a.m. until 10:15 a.m. 

Contact Person for More Information: 

Sandra Malcom, Committee 

Management Specialist, NCEH/ATSDR, 

CDC, 4770 Buford Highway, Mail Stop 

F–61, Chamblee, Georgia 30345; 

telephone 770/488–0575 or 770/488– 

0755, Fax: 770/488–3377; Email: 

smalcom@cdc.gov. The deadline for 

notification of attendance is June 21, 

2013. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention (CDC). 

[FR Doc. 2013–12912 Filed 5–30–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10302, CMS– 

R–290 and CMS–10437] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Collection 

Requirements for Compendia for 

Determination of Medically-accepted 

Indications for Off-label Uses of Drugs 

and Biologicals in an Anti-cancer 

Chemotherapeutic Regimen Use: 

Section 182(b) of the Medicare 

Improvement of Patients and Providers 

Act (MIPPA) amended section 

1861(t)(2)(B) of the Social Security Act 

(42 U.S.C. 1395x(t)(2)(B)) by adding at 

the end the following new sentence: ‘On 

and after January 1, 2010, no compendia 

may be included on the list of 

compendia under this subparagraph 

unless the compendia has a publicly 

transparent process for evaluating 

therapies and for identifying potential 

conflicts of interest.’ We believe that the 

implementation of this statutory 

provision that compendia have a 

‘‘publicly transparent process for 

evaluating therapies and for identifying 

potential conflicts of interests’’ is best 

accomplished by amending 42 CFR 

414.930 to include the MIPPA 

requirements and by defining the key 

components of publicly transparent 


tkelley on DSK3SPTVN1PROD with NOTICES