44296 Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices 

treating physician, but inaccessible to a 

clerical employee who does not need 

such access to accomplish their job. 

Security also involves ensuring that data 

have not been altered or tampered with. 

b. Reliability goes to the accessibility 

and consistency with which data is 

retrieved and displayed. For example, 

the physician should be able to easily 

and consistently access laboratory test 

results through some consistent display 

mechanism that can be counted on to be 

available whenever it is needed. 

At HHS’ request, the CCHITrecommended ambulatory EHR 

certification criteria were presented to 

the American Health Information 

Community (AHIC) on May 16, 2006. 

After consideration, the AHIC 

recommended that the Secretary 

recognize CCHIT identified ambulatory 

EHR certification criteria that CCHIT 

recommended for use in 2006. This 

recommendation informed the 

Secretary’s decision to recognize these 

criteria. 

The Secretary also based his decision 

to recognize these criteria on the need 

for such criteria in the Departments 

recently published final rules for 

exceptions to the physician self-referral 

law and safe harbors to the Antikickback statute for electronic 

prescribing and EHR arrangements (RIN 

#0938–AN69 and 0991–AB36 

respectively). These rules are premised 

on: 

1. HHS having recognized one or 

more EHR certifying bodies, and 

2. HHS having recognized criteria for 

the certification of EHRs. 

A separate notice of availability has 

been published in the Federal Register 

to notify the public about the 

availability of a certification Guidance 

Document that provides interim 

guidance on the recognition of 

certification bodies. This document is 

also available at http://www.hhs.gov/ 

healthit. The CCHIT criteria that the 

Secretary has recognized serve to 

establish the initial EHR certification 

criteria that are referenced in the final 

physician self-referral law and Antikickback statute rules. 

The Secretary also based his decision 

to recognize the CCHIT criteria on a 

belief that providers will be more 

willing to invest in health IT if there is 

a way of ensuring that the products 

would perform as advertised. Stories 

abound about providers making large 

investments in EHRs only to discover 

that they do not meet their 

functionality, interoperability security 

and/or reliability needs. Certification 

could respond to investment fears 

generated by stories about failed 

investments. A reduction of such fears 

could further the Department’s goal of 

higher rates of sustained health IT 

adoption and interoperability. 

Finally, the Secretary’s decision to 

recognize these criteria was informed by 

the fact that the criteria have been 

validated through prototype testing. 

Any criteria not fully validated by the 

Pilot Test (fewer than 10% fell in this 

category) were not considered for 

recognition. 

In light of the consensus basis, HHS 

reliance, industry impact and 

demonstrated utility of the CCHIT 

criteria for functionality, 

interoperability, security and reliability, 

the Secretary has recognized these 

criteria. He has delegated authority to 

ONC to coordinate and oversee the 

incorporation of these criteria in 

relevant activities among Federal 

agencies and other partner 

organizations, as appropriate. 

FOR FURTHER INFORMATION CONTACT: John 

W. Loonsk, M.D. at (202) 205–0242. 

Dated: August 1, 2006. 

Karen Bell, 

Acting Deputy National Coordinator for 

Health IT. 

[FR Doc. 06–6690 Filed 8–1–06; 1:25 p.m.] 

BILLING CODE 4150–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Notice of Availability: Office of the 

National Coordinator for Health 

Information Technology (ONC) Interim 

Guidance Regarding the Recognition 

of Certification Bodies 

AGENCY: Office of the Secretary, HHS. 

Authority: EO 13335 (‘‘Incentives for the 

Use of Health Information Technology and 

Establishing the Position of the National 

Health Information Technology 

Coordinator’’) and Pub. L. 109–149 

(‘‘Departments of Labor, Health and Human 

Services, and Education, and Related 

Agencies Appropriations Act, 2006). 

SUMMARY: This notice provides the 

public with information about the 

availability of a Certification Guidance 

Document (CGD) at http://www.hhs.gov/ 

healthit. The CGD explains the factors 

that ONC will use to determine whether 

or not to recommend to the Secretary of 

the Department of Health and Human 

Services (the Secretary) that he 

recognize a body for certification. Once 

recognized, that body will have 

Recognized Certification Body (RCB) 

status. The CGD will serve as guide for 

ONC as it evaluates applications for 

RCB status and seeks to provide all of 

the information a body would need to 

apply for and obtain such status. By 

publishing the CGD, HHS will ensure a 

transparent and open process as a basis 

for these recommendations. 

To encourage a more widespread 

adoption of interoperable health 

information technology, the Department 

of Health and Human Services (HHS) 

published two final rules in August 

2006 regarding certain arrangements 

involving the donation of interoperable 

electronic health records (EHR) 

technology to physicians and other 

health care practitioners or entities. The 

first, published by the Centers for 

Medicare & Medicaid Services (CMS), 

promulgated an exception to the 

physician self-referral prohibition. The 

second, published by the Office of 

Inspector General (OIG), established a 

safe harbor under the anti-kickback 

statute. In order for the donation of EHR 

technology to be protected under the 

exception and safe harbor provisions of 

these rules, the technology must be 

interoperable. The exception and safe 

harbor provide that EHR software will 

be ‘‘deemed to be interoperable if a 

certifying body recognized by the 

Secretary has certified the software no 

more than 12 months prior to the date 

it is provided to the [physician/ 

recipient].’’ Both rules become effective 

60 days after publication. 

The Department will utilize notice 

and comment rulemaking to formalize 

and finalize the policies and procedures 

that will govern whether ONC will 

recommend to the Secretary a body for 

RCB status. In the meantime, this 

guidance document identifies the 

factors to be considered by the Secretary 

in granting such recognition. In 

addition, the guidance sets forth an 

interim procedure that certifying bodies 

should follow in obtaining recognition 

by the Secretary. Until such time as the 

Department formalizes the procedure, a 

certifying body will be considered 

‘‘recognized by the Secretary’’ if it has 

become an RCB in accordance with the 

interim guidance. The guidance 

document seeks to reduce uncertainty 

about key aspects of the certification 

body recognition process. 

DATES: Public comment may be 

submitted on or before October 3, 2006. 

Comments may be submitted via e-mail 

to RCB-comments@hhs.gov or in written 

form to the address below. 

ADDRESSES: Steven Posnack, Program 

Analyst, Department of Health and 

Human Services, Office of the National 

Coordinator for Health Information 

Technology, 330 C Street, SW., Switzer 

Building, Room 4090, Washington, DC 

20201. 

Please refer to this guidance 

document when submitting comments. 


gechino on PROD1PC61 with NOTICES
Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices 44297 

FOR FURTHER INFORMATION CONTACT: 

Steven Posnack at 202–690–7151. 

Dated: July 31, 2006. 

Karen Bell, 

Acting Deputy National Coordinator for 

Health IT. 

[FR Doc. 06–6689 Filed 8–1–06; 1:25 pm] 

BILLING CODE 4150–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

Statement of Organization, Functions, 

and Delegations of Authority 

PART J (Agency for Toxic Substances 

and Disease Registry) of the Statement 

of Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (50 FR 25129–25130, dated 

June 17, 1985, as amended most 

recently at 70 FR 72839–72840, dated 

December 7, 2005) is amended to reflect 

the reorganization of the Agency for 

Toxic Substances and Disease Registry 

(ATSDR). 

Section T–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete item (11) of the functional 

statement for the Office of 

Communications (JAA4), Office of the 

Director (JAA), Office of the 

Administrator (JA), and insert the 

following: (11) provides publicationsrelated activities including preparing 

articles and drafting news releases, 

distributing publications, and 

bibliographic services, and. 

Delete item (8) of the functional 

statement for the Office of 

Communications (JAA4), and renumber 

the remaining items accordingly. 

Dated: July 21, 2006. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC). 

[FR Doc. 06–6676 Filed 8–3–06; 8:45 am] 

BILLING CODE 4160–70–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Final Effect of Designation of a Class 

of Employees for Addition to the 

Special Exposure Cohort 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) gives notice 

concerning the final effect of the HHS 

decision to designate a class of 

employees at the Pacific Proving 

Grounds, Enewetak Atoll, as an addition 

to the Special Exposure Cohort (SEC) 

under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000. On June 26, 2006, 

as provided for under 42 U.S.C. 

7384q(b), the Secretary of HHS 

designated the following class of 

employees as an addition to the SEC: 

Department of Energy (DOE) employees or 

DOE contractor or subcontractor employees 

who worked at the Pacific Proving Grounds 

(PPG) from 1946 through 1962 for a number 

of work days aggregating at least 250 work 

days, either solely under this employment or 

in combination with work days within the 

parameters (excluding aggregate work day 

requirements) established for other classes of 

employees included in the SEC, and who 

were monitored or should have been 

monitored. 

This designation became effective on 

July 26, 2006, as provided for under 42 

U.S.C. 7384l(14)(C). Hence, beginning 

on July 26, 2006, members of this class 

of employees, defined as reported in 

this notice, became members of the 

Special Exposure Cohort. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 513–533–6800 (this is 

not a toll-free number). Information 

requests can also be submitted by e-mail 

to OCAS@CDC.GOV. 

Dated: August 1, 2006. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 06–6681 Filed 8–3–06; 8:45 am] 

BILLING CODE 4163–19–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Decision To Evaluate a Petition To 

Designate a Class of Employees at 

General Atomics (Also Known as GA, 

and/or Division of General Dynamics, 

and/or John Jay Hopkins Laboratory 

for Pure and Applied Science), La 

Jolla, Laboratory for Pure and Applied 

Science), La Jolla, California, To Be 

Included in the Special Exposure 

Cohort 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees at 

General Atomics (also known as GA, 

and/or Division of General Dynamics, 

and/or John Jay Hopkins Laboratory for 

Pure and Applied Science), to be 

included in the Special Exposure Cohort 

under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000. The initial 

proposed definition for the class being 

evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: General Atomics. 

Location: La Jolla, California. 

Job Titles and/or Job Duties: 

Potentially worked in the locations: 

Æ Building 2 (Science laboratories A, 

B, and C). 

Æ Building 9 (Experimental Building). 

Æ Building 10 (Maintenance). 

Æ Building 11 (Service Building). 

Æ Building 21. 

Æ Building 22. 

Æ Building 23 (Hot Cell Facility). 

Æ Building 25. 

Æ Building 26. 

Æ Building 27 (Experimental Area 

Building #1). 

Æ Building 27–1 (Experimental Area 

Building #1). 

Æ Building 30 (LINAC Complex). 

Æ Building 31 (HTGR–TCF). 

Æ Building 33 (Fusion Building). 

Æ Building 34 (Fusion Doublet III). 

Æ Building 37 (SV–A). 

Æ Building 39 (SV–B). 

Æ SV–D. 

Period of Employment: January 1, 

1960 through December 31, 1969. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 


gechino on PROD1PC61 with NOTICES