57276 Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; HIT 

Policy Committee Advisory Meeting; 

Notice of Meeting 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology, HHS. 

ACTION: Notice of meeting. 

This notice announces a forthcoming 

meeting of a workgroup of a public 

advisory committee of the Office of the 

National Coordinator for Health 

Information Technology (ONC). The 

meeting will be open to the public. 

Name of Committee: Health IT Policy 

Committee’s Governance Workgroup. 

General Function of the Health IT 

Policy Committee: To provide 

recommendations to the National 

Coordinator on a policy framework for 

the development and adoption of a 

nationwide health information 

technology infrastructure that permits 

the electronic exchange and use of 

health information as is consistent with 

the Federal Health IT Strategic Plan and 

that includes recommendations on the 

areas in which standards, 

implementation specifications, and 

certification criteria are needed. Purpose 

of the Governance Workgroup: To draft 

a set of recommendations on the scope 

and process of governance for the 

nationwide health information network, 

including measures to ensure 

accountability and oversight. The charge 

to the Governance Workgroup is to draft 

a set of recommendations on the scope 

and process of governance for the 

nationwide health information network, 

including measures to ensure 

accountability and oversight. 

DATE AND TIME: The meeting will be held 

on September 28, 2010, from 9 a.m. to 

5 p.m. Eastern Time. 

LOCATION: Washington Marriott 

Wardman Park Hotel, 2660 Woodley 

Road, NW., Washington, DC 20008. For 

up-to-date information, go to the ONC 

Web site, http://healthit.hhs.gov. 

CONTACT PERSON: Judy Sparrow, Office 

of the National Coordinator, HHS, 330 C 

Street, SW., Washington, DC 20201, 

202–205–4528, Fax: 202–690–6079, email: judy.sparrow@hhs.gov. Please call 

the contact person for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Agenda: The Workgroup will hear 

testimony from invited panelists on 

information on governance of the 

nationwide health information network. 

ONC intends to make background 

material available to the public no later 

than two (2) business days prior to the 

meeting. If ONC is unable to post the 

background material on its Web site 

prior to the meeting, it will be made 

publicly available at the location of the 

advisory committee meeting, and the 

background material will be posed on 

ONC’s Web site after the meeting, at 

http://healthit.hhs.gov. 

Procedure: Interested persons may 

present data, information, or views, in 

writing, on issues identified by the 

Workgroup. Written submissions may 

be made to the contact person on or 

before September 24, 2010. Written 

comments are limited to 10 pages, and 

should be either mailed to the address 

above or e-mailed to 

judy.sparrow@hhs.gov, with the Subject 

Line: Responses for Governance 

Workgroup. The questions the 

Workgroup is interested in are as 

follows: 

Panel 1: Governance Models in Other 

Domains 

1. Please share your experiences in 

establishing governance requirements to 

ensure trust in the privacy and security 

of the information exchange, e.g., to 

secure the data, to assure appropriate 

use of the data exchanged, to address 

responsibilities for obtaining consent, 

etcetera. Were governance requirements 

established to ensure a certain level of 

interoperability? What types of 

governance mechanisms and processes 

were established? What conditions, 

requirements, and processes facilitated 

the resolution of disputes between 

parties with differing interests? 

2. Please describe whether and how 

you have included multiple 

stakeholders in governance? To what 

extent have consumers been engaged? 

3. Please describe the relationship 

between the private sector parties and 

the government—was authority 

delegated from the government, did the 

government oversee either the 

governance process or the results of the 

process, was the government simply 

participating as a member of the group 

etc.? What changes, if any, would you 

recommend? Because the relationship 

between the government and the private 

sector may differ in governance 

mechanisms in technical and policy 

domains, please share your views as to 

how to determine and establish the most 

appropriate relationship. 

4. In considering the question as to 

how to determine the most appropriate 

governance mechanism, please address: 

the costs and benefits involved in 

delegation of authority from the 

government; the need for ensuring some 

degree of openness in the process of 

developing requirements when 

authority is delegated; and the most 

appropriate means available for 

determining compliance and enforcing 

any requirements that have been 

established through the governance 

mechanism. 

Panels 2 and 3: Governance Experience 

of Implementers of Health Information 

Exchange 

1. Please Provide an Introduction to 

Your Organization 

• Describe the stakeholders that are 

governed by the governance process. 

• Describe the group that executes the 

governance process. 

• How is the authority of the 

governing body established (contract, 

law, other)? 

2. Trust 

• Please share your experiences in 

governance mechanisms for trust—what 

types of governance mechanisms and 

processes do you have in place (or are 

needed) to promote trust in the 

exchange? 

• How have you addressed privacy 

and security obligations (e.g., to 

safeguard information, to assure 

appropriate use of the data exchanged, 

to address responsibilities for obtaining 

consent, etc.) through governance? 

• Please describe how you have 

included multiple stakeholders in 

governance (e.g., how they were able to 

engage those stakeholders in effective 

participation? what challenges/enablers 

to engage in effective participation? To 

what extent have consumers been 

engaged?) 

• Please identify issues, if any, that 

still need to be addressed. What types 

of governance mechanisms are needed 

to promote trust to facilitate exchange? 

• What suggestions do you have for 

ONC for establishing governance in this 

area? 

2. Interoperability 

• Please share experiences in 

governance mechanisms for 

interoperability—what that types of 

governance mechanisms and processes 

do you have in place (or are needed) to 

promote interoperability in the 

exchange? 

• How are expectations for 

interoperability established and 

assured? 

• What suggestions do you have for 

ONC for establishing governance in this 

area? 


jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 181 / Monday, September 20, 2010 / Notices 57277 

3. Accountability, Enforcement and 

Oversight 

• Please share your experiences in 

establishing accountability, enforcement 

and oversight with regard to both trust 

and interoperability. 

• What suggestions do you have for 

ONC for establishing governance in this 

area? Examples of specific issues 

include: 

• How should organizations be vetted 

for participation? 

• How should the exchange of 

information be monitored for 

appropriateness in a large volume/ 

distributed environment? 

• How should information be 

provided to a consumer regarding who 

accessed his/her information? 

• How should consumer complaints 

be investigated? 

• How should ‘‘bad actors’’ be 

disciplined? 

Panel 4: Existing Governance 

Authorities 

1. Please describe the scope and 

jurisdiction of your authority/ 

authorities, with particular reference to 

areas that are/may be related to the 

exchange of health information over a 

network. 

2. Please describe how your 

authorities are implemented. 

3. Please offer suggestions to the 

Office of the National Coordinator for 

developing, implementing and 

coordinating governance. 

Persons attending ONC’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

ONC welcomes the attendance of the 

public at its advisory committee 

meetings. Seating is limited at the 

location, and ONC will make every 

effort to accommodate persons with 

physical disabilities or special needs. If 

you require special accommodations 

due to a disability, please contact Judy 

Sparrow at least seven (7) days in 

advance of the meeting. 

ONC is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://healthit.hhs.gov for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(Pub. L. 92–463, 5 U.S.C., App. 2). 

Dated: September 13, 2010. 

Judith Sparrow, 

Office of Programs and Coordination, Office 

of the National Coordinator for Health 

Information Technology. 

[FR Doc. 2010–23311 Filed 9–17–10; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the Agency; (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. 

Proposed Project: HRSA AIDS Drug 

Assistance Program Quarterly Report— 

(OMB No. 0915–0294)—Extension 

HRSA’s AIDS Drug Assistance 

Program (ADAP) is funded through Part 

B of Title XXVI of the Public Health 

Service Act, the Ryan White HIV/AIDS 

Program, which provides grants to 

States and Territories. The ADAP 

provides medications for the treatment 

of HIV disease. Program funds may also 

be used to purchase health insurance for 

eligible clients or for services that 

enhance access, adherence, and 

monitoring of drug treatments. 

Each of the 50 States, the District of 

Columbia, Puerto Rico, and several 

Territories receive ADAP grants. As part 

of the funding requirements, ADAP 

grantees submit quarterly reports that 

include information on patients served, 

pharmaceuticals prescribed, pricing, 

and other sources of support to provide 

AIDS medication treatment, eligibility 

requirements, cost data, and 

coordination with Medicaid. Each 

quarterly report requests updates from 

programs on number of patients served, 

type of pharmaceuticals prescribed, and 

prices paid to provide medication. The 

first quarterly report of each ADAP 

fiscal year (due in July of each year) also 

requests information that only changes 

annually (e.g., State funding, drug 

formulary, eligibility criteria for 

enrollment, and cost-saving strategies 

including coordinating with Medicaid). 

The quarterly report represents the 

best method for HRSA to determine how 

ADAP grants are being expended and to 

provide answers to requests from 

Congress and other organizations. 

The estimated annual burden is as 

follows: 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

1st Quarterly Report ........................................................ 57 1 57 3 171 

2nd, 3rd, & 4th Quarterly Reports ................................... 57 3 171 1 .5 256 .5 

Total .......................................................................... 57 ........................ 228 .......................... 427 .5 


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