25550 Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices 

Operations, Office of the Chief Financial 

Officer, General Services 

Administration, 1800 F Street, NW., 

Washington DC, 20405. 

NOTIFICATION PROCEDURE: 

Employees may obtain information 

about whether they are a part of this 

system of records from the system 

manager at the above address. 

RECORD ACCESS PROCEDURES: 

Requests from individuals for access 

to their records should be addressed to 

the system manager. 

CONTESTING RECORD PROCEDURES: 

GSA rules for access to systems of 

records, contesting the contents of 

systems of records, and appealing initial 

determinations are published at 41 CFR 

Part 105—64. 

RECORD SOURCE CATEGORIES: 

The sources are individuals, other 

employees, supervisors, other agencies, 

management officials, and non-Federal 

sources such as private firms. 

[FR Doc. E9–12372 Filed 5–27–09; 8:45 am] 

BILLING CODE 6820–34–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; Health 

Information Technology Extension 

Program 

ACTION: Notice and request for 

comments. 

SUMMARY: This notice announces the 

draft description of the program for 

establishing regional centers to assist 

providers seeking to adopt and become 

meaningful users of health information 

technology, as required under Section 

3012(c) of the Public Health Service Act, 

as added by the American Recovery and 

Reinvestment Act of 2009 (Pub. L. 111– 

5) (ARRA). 

DATES: All comments on the draft Plan 

should be received no later than 5 p.m. 

on June 11, 2009. 

ADDRESSES: Electronic responses are 

preferred and should be addressed to 

HealthIT-comments@hhs.gov. Written 

comments may also be submitted and 

should be addressed to the Office of the 

National Coordinator for Health 

Information Technology, 200 

Independence Ave, SW., Suite 729D, 

Washington, DC 20201, Attention: 

Health IT Extension Program 

Comments. 

FOR FURTHER INFORMATION CONTACT: The 

Office of the National Coordinator for 

Health, Information Technology, 200 

Independence Ave, SW., Suite 729D, 

Washington, DC 20201, Phone 202–690– 

7151, E-mail: onc.request@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The American Recovery and 

Reinvestment Act of 2009 (Pub. L. 111– 

5) (ARRA) includes provisions to 

promote the adoption of interoperable 

health information technology to 

promote meaningful use of health 

information technology to improve the 

quality and value of American health 

care. These provisions are set forth in 

Title XIII of Division A and Title IV of 

Division B, which may together be cited 

as the ‘‘Health Information Technology 

for Economic and Clinical Health Act’’ 

or the ‘‘HITECH Act’’. 

The ARRA appropriates a total of $2 

billion in discretionary funding, in 

addition to incentive payments under 

the Medicare and Medicaid programs 

for providers’ adoption and meaningful 

use of certified electronic health record 

technology. 

Providers that seek to adopt and 

effectively use health information 

technology (health IT) face a complex 

variety of tasks. Those tasks include 

assessing needs, selecting and 

negotiating with a system vendor or 

reseller, and implementing workflow 

changes to improve clinical 

performance and, ultimately, outcomes. 

Past experiences have shown that 

without robust technical assistance, 

many EHRs that are purchased are never 

installed or are not used by some 

providers. 

Section 3012 of the Public Health 

Service Act (PHSA), as added by the 

HITECH Act, authorizes a Health 

Information Technology Extension 

Program to make assistance available to 

all providers, but with priority given to 

assisting specific types of providers. By 

statute, the health information 

technology extension program (or 

‘‘Extension Program’’) consists of a 

National Health Information Technology 

Research Center (HITRC) and Regional 

Extension Centers (or ‘‘regional 

centers’’). 

The major focus for the Centers’ work 

with most of the providers that they 

serve will be to help to select and 

successfully implement certified 

electronic health records (EHRs). While 

those providers that have already 

implemented a basic EHR may not 

require implementation assistance, they 

may require other technical assistance 

to achieve ‘‘meaningful user’’ status. All 

regional centers will assist adopters to 

effectively meet or exceed the 

requirements to be determined a 

‘‘meaningful user’’ for purposes of 

earning the incentives authorized under 

Title IV of Division B. Lessons learned 

in the support of providers, both before 

and after their initial implementation of 

the EHR, will be shared among the 

regional centers and made publicly 

available. 

The HITECH Act prioritizes access to 

health information technology for 

uninsured, underinsured, historically 

underserved and other special-needs 

populations, and use of that technology 

to achieve reduction in health 

disparities. The Extension Program will 

include provisions in both the HITRC 

and regional centers awards to assure 

that the program addresses the unique 

needs of providers serving American 

Indian and Alaska Native, non-Englishspeaking and other historically 

underserved populations, as well as 

those that serve patients with maternal, 

child, long-term care, and behavioral 

health needs. 

II. Detailed Explanation and Goals of 

the Program 

The HITECH Act directs the Secretary 

of Health and Human Services, through 

the Office of the National Coordinator 

for Health Information Technology 

(ONC), to establish Health Information 

Technology Regional Extension Centers 

to provide technical assistance and 

disseminate best practices and other 

information learned from the Center to 

support and accelerate efforts to adopt, 

implement and effectively utilize health 

information technology. In developing 

and implementing this and other 

programs pursuant to the HITECH Act, 

ONC is consulting with other Federal 

agencies with demonstrated experience 

and expertise in information technology 

services, such as the National Institute 

of Standards and Technology. 

We propose that the goals of the 

regional center program should be to: 

—Encourage adoption of electronic 

health records by clinicians and 

hospitals; 

—Assist clinicians and hospitals to 

become meaningful users of electronic 

health records; and 

—Increase the probability that adopters 

of electronic health record systems 

will become meaningful users of the 

technology. 

The HITECH Act states that ‘‘the 

objective of the regional centers is to 

enhance and promote the adoption of 

health information technology 

through— 

(A) Assistance with the 

implementation, effective use, 

upgrading, and ongoing maintenance of 

health information technology, 

Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices 25551 

including electronic health records, to 

healthcare providers nationwide; 

(B) broad participation of individuals 

from industry, universities, and State 

governments; 

(C) active dissemination of best 

practices and research on the 

implementation, effective use, 

upgrading, and ongoing maintenance of 

health information technology, 

including electronic health records, to 

health care providers in order to 

improve the quality of healthcare and 

protect the privacy and security of 

health information; 

(D) participation, to the extent 

practicable, in health information 

exchanges; 

(E) utilization, when appropriate, of 

the expertise and capability that exists 

in Federal agencies other than the 

Department; and 

(F) integration of health information 

technology, including electronic health 

records, into the initial and ongoing 

training of health professionals and 

others in the healthcare industry that 

would be instrumental to improving the 

quality of healthcare through the 

smooth and accurate electronic use and 

exchange of health information.’’ 

To achieve the centers’ statutory 

objectives, we propose to establish 

regional centers to offer to all providers 

in a designated region access to 

information and to some level of 

assistance. The regional centers will 

become, upon award, members of a 

consortium that will be coordinated and 

facilitated by the Health Information 

Technology Research Center (HITRC) 

that the Secretary is directed to establish 

by Section 3012(b) of the PHSA as 

added by the HITECH Act. Whereas 

research and analysis of best practices 

regarding health IT utilization rests 

primarily with the HITRC, 

dissemination and implementation of 

those best practices learned from the 

HITRC will rest with the regional 

centers. 

Per Section 3012(c)(4) of the PHSA as 

added by the HITECH Act, each regional 

center shall ‘‘aim to provide assistance 

and education to all providers in a 

region but shall prioritize any direct 

assistance first to the following: 

• Public or not-for-profit hospitals or 

critical-access hospitals. 

• Federally qualified health centers 

(as defined in section 1861(aa)(4) of the 

Social Security Act). 

• Entities that are located in rural and 

other areas that serve uninsured, 

underinsured, and medically 

underserved individuals (regardless of 

whether such area is urban or rural). 

• Individual or small group practices 

(or a consortium thereof) that are 

primarily focused on primary care.’’ 

Regional centers will therefore, as a 

core purpose of their establishment, 

furnish direct, individualized, and (as 

needed) on-site assistance to individual 

providers. This intensive assistance is, 

per statute, to be prioritized to providers 

identified in the statute. We expect that 

on-site assistance will be a key service 

offered by the regional centers to 

providers prioritized by the statute for 

direct assistance, and will represent a 

significant portion of the regional 

centers’ activities. 

Because of the nationwide scope of 

the Medicare and Medicaid payment 

incentives for adoption and meaningful 

use of certified EHRs, the Extension 

Program should provide at least a 

minimal level of technical assistance 

across the nation. We propose that the 

minimal level of support must include 

the provision of unbiased information 

on mechanisms to exchange health 

information in compliance with 

applicable statutory and regulatory 

requirements, and information to 

support the effective integration of 

health information exchange activities 

into practice workflow. 

It is expected that each regional center 

will provide technical assistance within 

a defined geographic area, and that each 

defined geographic area will be served 

by only one center. At a minimum, the 

support should consist of materials 

designed to be widely and rapidly 

disseminated, both for provider selfstudy and for use by entities other than 

regional centers that have an interest 

and the ability to provide some 

assistance and information to providers 

adopting health IT. 

As required by Section 3012(c)(8) of 

the Public Health Service Act as added 

by the HITECH Act, all regional centers 

will be evaluated to ensure they are 

meeting the needs of the health 

providers in their geographic area in a 

manner consistent with specified 

statutory objectives. All lessons learned 

from these efforts will be exchanged 

across regional centers, and with other 

stakeholders, including but not limited 

to other federal programs, to promote 

the availability of highly effective 

support to providers across the nation. 

All regional centers will be expected to 

use the lessons learned as important, 

but not the only, information to guide 

their internal self-evaluation and 

ongoing improvement processes. 

A. Criteria for Determining Qualified 

Applicants 

Section 3012(c)(2) of the PHSA as 

added by the HITECH Act requires that: 

‘‘Regional centers shall be affiliated 

with any United States-based nonprofit 

organization, or group thereof, that 

applies and is awarded financial 

assistance under this section. Individual 

awards shall be decided on the basis of 

merit.’’ In addition, we propose the 

following requirements and preference 

criteria. 

Required Criteria may include: 

• Define the geographic region and 

the provider population within that 

region it proposes to serve. 

• Describe proposed levels and 

approaches of support for prioritized 

and other providers to be served. 

• Address how the applicant would 

structure its organization and staffing to 

enable providers served to have ready 

access to reasonably local health IT 

‘‘extension agents’’ and provide training 

and on-going support for these critical 

workers. 

• Demonstrate the capacity to 

facilitate and support cooperation 

among local providers, health systems, 

communities, and health information 

exchanges. 

• Demonstrate that the applicant is 

able to meet the needs of providers 

prioritized for direct assistance by 

Section 3012(c)(4) of the PHSA as added 

by the HITECH Act. 

• Propose an efficient and feasible 

strategy to furnish deep specialized 

expertise (in such areas as 

organizational development, legal 

issues, privacy and security, economic 

and financing issues, and evaluation) 

broadly to all providers served and 

intensive, individualized, ‘‘local’’ 

presence from an interdisciplinary 

extension agent to smaller groups of 

providers assigned to individual agents. 

Preference Criteria may include: 

• We propose to give preference to 

proposed regional center organizational 

plans and implementation strategies 

incorporating multi-stakeholder 

collaborations that leverage local 

resources. The local stakeholders and 

resources that applicants may wish to 

consider including in some 

combination, though not limited to, the 

following: Public and/or private 

universities with health professions, 

informatics, and allied health programs; 

state or regional medical/professional 

societies and other provider 

organizations; federally recognized state 

primary care associations; state or 

regional hospital organizations; large 

health centers and networks of rural 

and/or community health centers; other 

relevant health professional 

organizations; the regionally relevant 

state Area Health Education Center(s); 

health information exchange 

organizations serving providers in the 

25552 Federal Register / Vol. 74, No. 101 / Thursday, May 28, 2009 / Notices 

region; the Medicare Quality 

Improvement Organization(s)(QIO(s) 

serving providers that the proposed 

regional center aims to serve; state and 

tribal government entities in the center’s 

geographic service area including, but 

not limited to, public health agencies; 

libraries and information centers with 

health professional and community 

outreach programs; and consumer/ 

patient organizations. 

• As noted below, we propose to give 

preference to applicants identifying 

viable sources of matching funds. Viable 

sources could include grants from 

states, non-profit foundations, and 

payment for services from providers 

able to make such payment. For 

example, Medicaid providers could 

choose to contract with a regional center 

in lieu of a corporate vendor for 

implementation and meaningful use 

support services, for which costs are 

reimbursable under Section 1903 of the 

Social Security Act, as amended by the 

HITECH Act. A regional center could 

also, theoretically, seek to establish 

itself as a first-choice source of 

assistance that would realize net 

retained earnings on service to nonprioritized providers and use those 

retained earnings as a source of 

matching funds for its grant-funded 

activities. 

B. Maximum Support Levels Expected 

To Be Available to Centers Under the 

Program 

Given current national economic 

conditions, we propose to exercise the 

option in the HITECH Act to not require 

matching funds for awards made in FY 

2010. We will encourage use of 

matching funds and the coordination of 

existing resources to strengthen 

proposals for regional centers and 

potentially expand the number of 

providers that can be assisted. Review 

criteria may be established that give 

preference to proposals including 

matching funds but that do not 

automatically preclude otherwise 

technically meritorious proposals that 

do not include matching funds. 

We propose using ARRA funding for 

two-year awards made in FY2010 and 

furnishing providers in awardees’ areas 

with robust support. While we expect 

the actual ARRA funding awarded per 

center will vary based on the number 

and types of providers proposed to be 

served, and the amount of matching 

funds proposed by each regional center, 

we anticipate an average award value on 

the order of $1 million to $2 million per 

center. The maximum award value we 

anticipate making available to any one 

regional center is $10 million. Funding 

may also be approximately allocated to 

the regional centers in relative 

proportion to the numbers of prioritized 

direct assistance recipients identified in 

the HITECH Act. 

C. Procedures To Be Followed by the 

Applicants 

Timelines 

This notice makes public and invites 

comments on the draft description of 

the regional centers program and is not 

a solicitation of proposals to serve as 

extension centers under this program. 

The Federal Government will award 

funding for the regional centers through 

a solicitation of proposals, after 

considering the comments obtained 

through this notice. The availability of 

this solicitation will be broadly 

announced through appropriate and 

familiar means, including publication in 

the Federal Register of a Notice of the 

solicitation’s availability. This 

announcement of the solicitation will 

provide further details on the finalized 

requirements and application process 

for regional centers, pursuant to and in 

compliance with all applicable statutes 

and regulations, including but not 

limited to the Paperwork Reduction Act 

(44 U.S.C. 3501 et seq.). 

Applicants well prepared to provide 

robust extension services will likely 

need at least two months to provide 

high quality proposals. It is expected, 

however, that other potential applicants 

will need more time to prepare 

proposals. 

We propose to make initial awards for 

regional centers as early as the first 

quarter of FY2010 and continuing 

through the fourth quarter of FY2010. 

Multiple, closely spaced proposal 

submission dates will be established to 

allow each geographic area to begin 

receiving benefit of a regional center as 

soon as possible. We believe this 

approach is necessary to allow areas 

with well prepared applicants to begin 

work sooner, without excluding from 

consideration those areas where the best 

applicants require more time to convene 

a multi-stakeholder collaboration to 

develop a robust proposal that includes 

a viable organizational plan and 

implementation strategy. We solicit 

comment on our phased approach to 

proposal submission dates and issuance 

of awards. 

The target timeframe for awards is 

intended to enable regional centers to 

begin supporting provider adoption in 

time for providers to receive incentive 

payments with respect to Fiscal Year 

(hospitals) or Calendar Year 

(physicians) 2011 and 2012, when 

potential Medicare incentives are 

greatest. 

D. Comments on Draft Description 

ONC requests comments on this draft 

description of the regional centers 

within the Extension Program. Please 

send comments to the address, for 

receipt by the due date, specified at the 

beginning of this notice. 

Dated: May 22, 2009. 

Charles P. Friedman, 

Deputy National Coordinator for Health 

Information Technology. 

[FR Doc. E9–12419 Filed 5–27–09; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–0923–09BR] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection 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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Registration of individuals with 

Amyotrophic Lateral Sclerosis (ALS) in 

the National ALS Registry—New— 

Agency for Toxic Substances and 

Disease Registry (ATSDR), Coordinating