Federal Register / Vol. 73, No. 15 / Wednesday, January 23, 2008 / Notices 3973 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health 

Final Effect of Designation of a Class 

of Employees for Addition to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), 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 Nuclear Materials and 

Equipment Corporation (NUMEC) in 

Apollo, Pennsylvania, as an addition to 

the Special Exposure Cohort (SEC) 

under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000. On November 29, 

2007, 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: 

Atomic Weapons Employer (AWE) 

employees who were monitored or should 

have been monitored for exposure to ionizing 

radiation while working at the Nuclear 

Materials and Equipment Corporation 

(NUMEC) in Apollo, Pennsylvania from 

January 1, 1957, through December 31, 1983, 

for a number of work days aggregating at least 

250 work days or in combination with work 

days within the parameters established for 

one or more other classes of employees in the 

Special Exposure Cohort. 

This designation became effective on 

December 29, 2007, as provided for 

under 42 U.S.C. 7384l(14)(C). Hence, 

beginning on December 29, 2007, 

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: January 15, 2008. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. E8–1018 Filed 1–22–08; 8:45 am] 

BILLING CODE 4160–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Scientific Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the Office of Research Integrity (ORI) 

and the Assistant Secretary for Health 

have taken final action in the following 

case: 

Scott E. Monte, Huntington Memorial 

Hospital: Based on the findings of an 

investigation conducted by Huntington 

Memorial Hospital (HMH) and 

information obtained by the Office of 

Research Integrity (ORI) during its 

oversight review, the U.S. Public Health 

Service (PHS) found that Scott E. Monte, 

L.V.N., former Clinical Research 

Associate, HMH, engaged in scientific 

misconduct by knowingly and 

intentionally falsifying and fabricating 

clinical research records in HMH cancer 

prevention and treatment protocols 

supported by National Cancer Institute 

(NCI), National Institutes of Health 

(NIH), awards U10 CA69651, U10 

CA12027, U10 CA32012, and U10 

CA86004. 

Specifically, Mr. Monte knowingly 

and intentionally: 

(1) Entered falsified and fabricated 

laboratory data or physical examination 

results on five (5) research protocol case 

report forms (CRFs); 

(2) Falsified a gynecological 

examination report in a physician’s 

progress note and entered the falsified 

document in the patient’s research 

chart; and 

(3) Fabricated progress notes for four 

patients and a case report form for one 

of these patients. 

ORI has implemented the following 

administrative actions for a period of 

three (3) years, beginning on January 7, 

2008: 

(1) Dr. Monte is debarred from any 

contracting or subcontracting with any 

agency of the United States Government 

and from eligibility or involvement in 

nonprocurement programs of the United 

States Government pursuant to HHS’

implementation of the OMB Guidelines 

to Agencies on Governmentwide 

Debarment and Suspension at 2 CFR 

Part 376; and 

(2) Dr. Monte is prohibited from 

serving in any advisory capacity to PHS, 

including but not limited to service on 

any PHS advisory committee, board, 

and/or peer review committee, or as a 

consultant. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852, (240) 453–8800. 

Chris B. Pascal, 

Director, Office of Research Integrity. 

[FR Doc. E8–1024 Filed 1–22–08; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology (ONC), 

DHHS 

Notice of Availability: Secretarial 

Recognition of Certain Healthcare 

Information Technology Standards 

Panel (HITSP) Interoperability 

Specifications as Interoperability 

Standards for Health Information 

Technology 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), DHHS. 

Authority: Executive Order 13335 

(‘‘Incentives for the Use of Health 

Information Technology and 

Establishing the Position of the National 

Health Information Technology 

Coordinator’’), Executive Order 13410 

(‘‘Promoting Quality and Efficient 

Health Care in Federal Government 

Administered or Sponsored Health Care 

Programs’’), Public Law 110–161, 

(‘‘Consolidated Appropriations Act, 

2008’’), 42 U.S.C.1395nn(b)(4), 42 U.S.C. 

1302(a), and 42 CFR 411.357(w). 

SUMMARY: By publication of this 

document, we are informing the public 

of the Secretary’s recognition of certain 

Healthcare Information Technology 

Standards Panel (HITSP) 

‘‘Interoperability Specifications’’ as 

interoperability standards for health 

information technology. The Secretary 

accepted these HITSP ‘‘Interoperability 

Specifications’’, Version 1.2, in 

December of 2006, and hereby 

recognizes them as interoperability 

standards in updated versions in 

January of 2008. The list of recognized 

interoperability standards is provided 

below and is available at http:// 

www.hitsp.org; click on ‘‘HITSP 

Interoperability Specifications HERE’’

box. 

SUPPLEMENTARY INFORMATION: The 

Healthcare Information Technology 

Standards Panel (HITSP) was created in 

2005 to serve as a cooperative 

partnership between the public and 

private sectors for the purpose of 

achieving a widely accepted and useful 

set of standards specifically to enable 

and support widespread interoperability 


ebenthall on PROD1PC69 with NOTICES
3974 Federal Register / Vol. 73, No. 15 / Wednesday, January 23, 2008 / Notices 

among healthcare software systems, as 

they will interact in a local, regional, 

and the Nationwide Health Information 

Network in the United States. 

Under a contract with the Department 

of Health and Human Services, the 

American National Standards Institute 

(ANSI) established HITSP, following a 

neutral and inclusive governance 

model. The process was built by 

vendors, standards development 

organizations (SDOs), consumers, 

payers, providers, etc. HITSP is a multistakeholder organization involving more 

than 600 different healthcare industry 

organizations and technical experts 

whose activities to date on these 

Interoperability Specifications represent 

more than 20,000 volunteer hours of 

effort. 

In March of 2006, HITSP was given 

three initial priority areas (use cases): 

Consumer Empowerment, 

Biosurveillance, and Laboratory 

Electronic Health Record 

Interoperability. HITSP converted those 

use cases into detailed requirements 

documents and examined more than 

700 standards that would meet those 

requirements and assessed their 

readiness and appropriateness. From 

those 700 standards, HITSP identified 

30 named standards, and produced 

detailed implementation guidance, 

‘‘constructs,’’ that describe the specific 

transactions and use of these named 

standards. The Secretary therefore is 

recognizing the ‘‘constructs’’ associated 

with the as interoperability standards to 

clarify the intended use and application 

of the ‘‘named standards’’. 

On October 31, 2006, HITSP 

presented to the American Health 

Information Community (AHIC) three 

sets of Interoperability Specifications. 

The AHIC is a Federal Advisory 

Committee Act (FACA) advisory body, 

chartered in 2005 to make 

recommendations to the Secretary on 

methods for accelerating the 

development and adoption of health 

information technology. At the October 

31, 2006, AHIC meeting, the members 

discussed the HITSP Interoperability 

Specifications and made the consensus 

recommendation that the 

Interoperability Specifications be 

recognized by the Secretary. Secretary 

Leavitt accepted these Interoperability 

Specifications in December 2006 with 

the intent to recognize them one year 

later, presuming that any changes would 

be minimal, reflecting public comment 

and/or of a minor and technical nature. 

On March 1, 2007, the Department 

published a Notice in the Federal 

Register (72 FR 9339) announcing the 

Secretary’s acceptance and planned 

recognition of certain interoperability 

specifications. 

The HITSP Panel approved the 

subsequent version of the 

interoperability specifications on May 

11, 2007. No additional constructs or 

standards were added as a result of 

implementation testing feedback. All 

changes were minor or of a technical 

nature to the implementation guidance. 

On June 12, 2007, HIC presented to 

Secretary Leavitt these completed 

Interoperability Specifications, 

including 28 of 30 completely balloted 

named standards and implementation 

guidance in the form of constructs. As 

detailed below, in December 2007, one 

of the two outstanding named standards 

passed ballot by its SDO; after the 

designated 6-month waiting period, this 

named standard and two associated 

constructs will achieve full recognition 

status by the Secretary in June 2008 by 

the Secretary. The final standard is still 

under ballot. 

The three high level groupings of 

these interoperability standards are as 

follows. 

I. Electronic Health Record (EHR) 

Laboratory Results Reporting 

The purpose of the EHR 

interoperability specification is to allow 

ordering clinicians to electronically 

access laboratory results, and to allow 

non-ordering authorized clinicians to 

electronically access historical and 

other laboratory results for clinical care. 

The recognized version of the standard 

addresses the lack of harmonization 

among data interoperability standards 

including vocabulary and laboratory 

and other messaging standards; it also 

accommodates both laboratory message 

transaction and document-sharing 

paradigms. In addition, a laboratory 

message implementation guide has been 

completed to meet AHIC use case 

requirements. The EHR specification is 

complete and includes all of the 

implementation guidance necessary to 

implement and the final balloted work 

products of all the standards 

development organizations involved, 

with one caveat. The messaging 

standard for laboratories, HL–7 2.5.1, 

passed ballot in December 2007, with 

final implementation guidance to be 

incorporated into the HITSP 

specifications. This standard, along with 

an associated construct, the Lab Result 

Message Component (C36) will achieve 

full recognition status by the Secretary 

in June 2008. 

The interoperability standards—

Interoperability Specification including 

Constructs (Components, Transactions, 

and Transaction Packages) and Named 

Standards associated with EHR are 

listed below. 

Interoperability Specification 

Constructs (Components (C), 

Transactions (T), and Transaction 

Packages (TP)) for EHR 

• EHR Lab Reporting Interoperability 

Specification (HITSP V2.1 2007 IS01). 

• Lab Result Terminology Component 

(HITSP V2.0 2007 C35). 

• Lab Report Document Component 

(HITSP V2.0 2007 C37). 

• Secure Web Connection Component 

(HITSP V2.0 2007 C44). 

• View Lab Result From Web App 

Transaction (HITSP V2.0 2007 T18). 

• Patient Demographics Query 

Transaction (HITSP V2.0 2007 T23). 

• Notification of Document 

Availability Transaction (HITSP V2.0 

2007 T29). 

• Manage Sharing of Documents 

Transaction Package (HITSP V2.2 2007 

TP13). 

• Send Lab Result Message 

Transaction Package (HITSP V2.1 2007 

TP14). 

• Patient ID Cross-Referencing 

Transaction Package (HITSP V2.0 2007 

TP22). 

Named Standards for EHR 

• Portions of the Clinical Laboratory 

Improvement Amendments (CLIA) of 

1988 (42 CFR part 493). 

• Portions of the Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA)—Administrative 

Simplification. 

• Health Level Seven (HL7) Version 

2.5. 

• Health Level Seven (HL7) Version 

2.5/2.5.1. 

• Health Level Seven (HL7) Version 

3.0 Clinical Document Architecture 

(CDA/CDA R2). 

• Hypertext Transfer Protocol Secure 

(HTTPS) 443/tcp. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

3.0. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0—Registry Stored Query Transaction 

for XDS Profile Supplement. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0 XCA Supplement. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (TF) 


ebenthall on PROD1PC69 with NOTICES
Federal Register / Vol. 73, No. 15 / Wednesday, January 23, 2008 / Notices 3975 

Supplement—ITI–25 Notification of 

Document Availability (NAV) June 28, 

2005. 

• Integrating the Healthcare 

Enterprise (IHE) Laboratory Technical 

Framework Supplement 2006–2007 

Revision 1.0. 

• International Health Terminology 

Standards Development Organisation 

(IHTSDO) Systematized Nomenclature 

of Medicine Clinical Terms (SNOMED 

CT). 

• International Organization for 

Standardization (ISO) Electronic 

business eXtensible Markup Language 

(ebXML), Technical Specification # 

15000—Part 4: Registry services 

specification (ebRS), May, 2004. 

• Logical Observation Identifiers 

Names and Codes (LOINC). 

• Unified Code for Units of Measure 

(UCUM). 

II. Biosurveillance (BIO) 

The purpose of the BIO 

interoperability specification is to 

transmit essential ambulatory care and 

emergency department visit, utilization, 

and laboratory result data from 

electronically enabled healthcare 

delivery and public health systems in 

standardized and anonymized format to 

authorized Public Health Agencies with 

less than one day lag time. The BIO 

specification is complete and includes 

all of the implementation guidance 

necessary to implement and the final 

balloted work products of all the 

standards development organizations 

involved, with two exceptions. The 

messaging standard for laboratories, 

HL–7 2.5.1, passed ballot in December 

2007, with final implementation 

guidance to be incorporated into the 

HITSP specifications. This standard, 

along with two associated constructs, 

the Lab Result Message Component 

(C36) and the Resource Utilization 

Component (C47), will achieve full 

recognition status by the Secretary in 

June 2008. The Hospital Availability 

Exchange Standard (HAVE) is still 

under the SDO ballot process. 

The interoperability standards—

Interoperability Specification including 

Constructs (Components, Transactions, 

and Transaction Packages) and Named 

Standards associated with BIO are listed 

below. 

Interoperability Specification Constructs 

(Components (C), Transactions (T), and 

Transaction Packages (TP)) for BIO 

• Biosurveillance Interoperability 

Specification (HITSP V2.1 2007 IS02). 

• Anonymize Component (HITSP 

V2.1 2007 C25). 

• Lab Result Terminology Component 

(HITSP V2.0 2007 C35). 

• Lab Report Document Component 

(HITSP V2.0 2007 C37). 

• Encounter Message Component 

(HITSP V2.0 2007 C39). 

• Radiology Result Message 

Component (HITSP V2.0 2007 C41). 

• Encounter Document Component 

(HITSP V2.1 2007 C48). 

• Pseudonymize Transaction (HITSP 

V2.1 2007 T24). 

• Notification of Document 

Availability Transaction (HITSP V2.0 

2007 T29). 

• Manage Sharing of Documents 

Transaction Package (HITSP V2.2 2007 

TP13). 

• Patient ID Cross-Referencing 

Transaction Package (HITSP V2.0 2007 

TP22). 

• Sharing Radiology Results 

Transaction Package (HITSP V2.0 2007 

TP49). 

• Retrieve Form for Data Capture 

Transaction Package (HITSP V2.1 2007 

TP50). 

Named Standards for BIO: 

• American Medical Association 

(AMA) Current Procedural Terminology 

(CPT) Fourth Edition (CPT–4). 

• Clinical Care Classification (CCC) 

Version 2.0 [formerly known as the 

Home Healthcare Classification (HHCC) 

System]. 

• Portions of the Clinical Laboratory 

Improvement Amendments (CLIA) of 

1988 (42 CFR part 493). 

• Digital Imaging and 

Communications in Medicine (DICOM) 

Attribute Level Confidentiality 

Supplement: # 55. 

• Federal Information Processing 

Standards (FIPS) Codes for the 

Identification of the States, the District 

of Columbia and the Outlying Areas of 

the United States, and Associated Areas 

Publication # 5–2, May, 1987. 

• Portions of the Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA)—Administrative 

Simplification. 

• Health Level Seven (HL7) Version 

2.5. 

• Health Level Seven (HL7) Version 

2.5/2.5.1. 

• Health Level Seven (HL7) Version 

3.0. 

• Health Level Seven (HL7) Version 

3.0 Clinical Document Architecture 

(CDA/CDA R2). 

• Healthcare Common Procedure 

Coding System (HCPCS) Level II Code 

Set. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

3.0. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0—Registry Stored Query Transaction 

for XDS Profile Supplement. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0 XCA Supplement. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (TF) 

Supplement—ITI–25 Notification of 

Document Availability (NAV) June 28, 

2005. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (TF) 

Supplement—Retrieve Form for Data 

Capture (RFD) Sept 25, 2006. 

• Integrating the Healthcare 

Enterprise (IHE) Laboratory Technical 

Framework Supplement 2006–2007 

Revision 1.0. 

• Integrating the Healthcare 

Enterprise (IHE) Patient Care 

Coordination (PCC) Technical 

Framework Revision 3.0. 

• Integrating the Healthcare 

Enterprise (IHE) Radiology Technical 

Framework Revision 7.0. 

• International Classification of 

Diseases, 10th Revision, Procedure 

Coding System (ICD–10–CS). 

• International Classification of 

Diseases, 10th Revision, Related Health 

Problems (ICD–10–CM). 

• International Classification of 

Diseases, 9th Revision, Clinical 

Modifications (ICD–9–CM). 

• International Health Terminology 

Standards Development Organisation 

(IHTSDO) Systematized Nomenclature 

of Medicine Clinical Terms (SNOMED 

CT). 

• International Organization for 

Standardization (ISO) Health 

informatics—Pseudonymization, 

Unpublished Technical Specification 

# 25237. 

• International Organization for 

Standardization (ISO) Electronic 

business eXtensible Markup Language 

(ebXML), Technical Specification 

# 15000—Part 4: Registry services 

specification (ebRS), May, 2004. 

• Logical Observation Identifiers 

Names and Codes (LOINC ). 

• National Library of Medicine (NLM) 

Unified Medical Language System 

(UMLS) RxNorm. 

• National Uniform Billing 

Committee (NUBC) Uniform Bill 

Version 1992 (UB–92) Current UB Data 

Specification Manual Field 22, Patient 

Discharge Status, Codes. 

• Organization for the Advancement 

of Structured Information Standards 


ebenthall on PROD1PC69 with NOTICES
3976 Federal Register / Vol. 73, No. 15 / Wednesday, January 23, 2008 / Notices 

(OASIS) Emergency Data Exchange 

Language (EDXL) Distribution Element 

(DE). 

• Unified Code for Units of Measure 

(UCUM). 

III. Consumer Empowerment (CE) 

The purpose of the CE interoperability 

specification is to allow consumers to 

establish and manage permissions 

access, rights, and informed consent for 

authorized and secure exchange, 

viewing, and querying of their linked 

patient registration summaries and 

medication histories between 

designated caregivers and other health 

professionals. The CE specification is 

complete and includes all of the 

implementation guidance necessary to 

implement and the final balloted work 

products of all the standards 

development organizations involved. 

The interoperability standards—

Interoperability Specification including 

Constructs (Components, Transactions, 

and Transaction Packages) and Named 

Standards associated with CE are listed 

below. 

Interoperability Specification Constructs 

(Components (C), Transactions (T), and 

Transaction Packages (TP)) for CE 

• Consumer Empowerment 

Interoperability Specification (HITSP 

V2.1 2007 IS03). 

• Summary Documents Using CCD 

Component (HITSP V2.1 2007 C32). 

• Patient Demographics Query 

Transaction (HITSP V2.0 2007 T23). 

• Manage Sharing of Documents 

Transaction Package (HITSP V2.2 2007 

TP13). 

• Patient ID Cross-Referencing 

Transaction Package (HITSP V2.0 2007 

TP22). 

Named Standards for CE 

• Accredited Standards Committee 

(ASC) X12 Insurance Subcommittee 

(X12N) Implementation Guides Version 

004010 plus Addenda 004010A1. 

• Accredited Standards Committee 

(ASC) X12 Standards Release 004010. 

• American Society for Testing and 

Materials (ASTM) Standard 

Specification for Coded Values Used in 

the Electronic Health Record: # E1633–

02. 

• American Society for Testing and 

Materials (ASTM) Standard 

Specification for Continuity of Care 

Record (CCR): # E2369–05. 

• CDC Race and Ethnicity Code Sets. 

• Council for Affordable Quality 

Health Care (CAQH) Committee on 

Operating Rules for Information 

Exchange (CORE) Phase I Operating 

Rules. 

• Federal Medication Terminologies. 

• Health Care Provider Taxonomy. 

• Health Level Seven (HL7) EHR 

System Functional Model Draft 

Standard for Trial Use (DSTU). 

• Health Level Seven (HL7) Version 

2.5. 

• Health Level Seven (HL7) Version 

2.5/2.5.1. 

• Health Level Seven (HL7) Version 

3.0. 

• Health Level Seven (HL7) Version 

3.0 Clinical Document Architecture 

(CDA/CDA R2). 

• HL7 Implementation Guide: CDA 

Release 2—Continuity of Care 

Document (CCD), Release 1.0, April 1, 

2007. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

3.0. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0—Registry Stored Query Transaction 

for XDS Profile Supplement. 

• Integrating the Healthcare 

Enterprise (IHE) IT Infrastructure 

Technical Framework (ITI–TF) Revision 

4.0 XCA Supplement. 

• Integrating the Healthcare 

Enterprise (IHE) Patient Care 

Coordination (PCC) Technical 

Framework Revision 3.0. 

• International Organization for 

Standardization (ISO) Electronic 

business eXtensible Markup Language 

(ebXML), Technical Specification 

# 15000—Part 4: Registry services 

specification (ebRS), May, 2004. 

• Logical Observation Identifiers 

Names and Codes (LOINC ). 

• National Council for Prescription 

Drug Programs (NCPDP) SCRIPT 

Standard Version 8.1. 

• Revisions to the Standards for the 

Classification of Federal Data on Race 

and Ethnicity. 

We recognize that certain legal 

obligations may flow from the 

recognition of these interoperability 

standards. First, pursuant to Executive 

Order 13410 (EO 13410) dated August 

22, 2006, recognition of interoperability 

standards would require each Federal 

health agency, as it implements, 

acquires, or upgrades health information 

technology systems used for the direct 

exchange of health information between 

agencies and with non-Federal entities, 

to ‘‘utilize, where available, health 

information technology systems and 

products that meet interoperability 

standards recognized by the Secretary.’’

Therefore, Federal agencies would be 

required to appropriately consider 

health information technology systems 

and products that comply with these 

Interoperability Specifications when 

purchasing, implementing, or upgrading 

such items. 

Similarly, the EO 13410 directs 

Federal agencies to contractually 

require, to the extent permitted by law, 

certain entities with whom they do 

business, to use, where available, health 

information technology systems and 

products that meet recognized 

interoperability standards. 

In addition, the regulations 

promulgated on August 8, 2006 (see 71 

FR 45140 and 71 FR 45110) established 

exceptions and safe harbors to the 

physician self-referral law and the antikickback statute, respectively, for 

certain arrangements involving the 

donation of electronic prescribing and 

electronic health records (EHR) 

technology and services. The EHR 

exception and safe harbor require that 

the software be ‘‘interoperable’’ as 

defined in the regulations. The rules 

also provide that certain software will 

be deemed to be ‘‘interoperable’’ if that 

software has been certified by a 

certifying body recognized by the 

Secretary within 12 months prior to the 

donation. Under the interim guidance 

for the recognition of certifying bodies 

published by the ONC (‘‘Office of the 

National Coordinator for Health 

Information Technology (ONC) Interim 

Guidance Regarding the Recognition of 

Certification Bodies’’), for an 

organization to be recognized as a 

recognized certifying body (RCB), the 

organization must: 

Have in place a demonstrated process 

for and experience in certifying 

products to be in compliance with 

criteria recognized by the Secretary; 

Have a method by which they can 

incorporate all applicable standards 

and certification criteria recognized 

by the Secretary into their 

certification processes; and 

Have the ability to adapt their processes 

to emerging certification criteria 

recognized by the Secretary. 

The RCBs would therefore have to 

certify such products in conformity 

with, among other provisions, these 

interoperability specifications for the 

certified products to meet the 

interoperability deeming provisions of 

the physician self-referral exception and 

anti-kickback safe harbor, respectively. 

The Secretary is mindful that the 

ability of software to be interoperable 

evolves as technology develops. 

Consequently, if an enforcement action 

is initiated for an allegedly improper 

donation of EHR non-certified software, 


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Federal Register / Vol. 73, No. 15 / Wednesday, January 23, 2008 / Notices 3977 

the Secretary would review whether the 

software was interoperable, as defined 

in the regulations. The Secretary would 

consider the prevailing state of 

technology at the time the items or 

services were provided to the recipient. 

As explained in the regulations, the 

Secretary understands that parties 

should have a reasonable basis for 

determining whether the EHR software 

is interoperable. We therefore indicated 

that ‘‘it would be appropriate—and, 

indeed, advisable—for parties to consult 

any standards and criteria related to 

interoperability recognized by the 

Department.’’

Compliance with these standards and 

criteria, as we explained in the 

regulations, ‘‘will provide greater 

certainty to donors and recipients that 

products meet the interoperability 

requirement, and may be relevant in an 

enforcement action.’’

Based on the changing nature of 

technological development noted above, 

the Secretary has accepted and 

recognized these Interoperability 

Specifications. He has also delegated 

authority to ONC to coordinate and 

oversee the incorporation of these 

Interoperability Specifications in 

relevant activities among Federal 

agencies and other partner 

organizations, as appropriate. 

FOR FURTHER INFORMATION CONTACT: 

Judith Sparrow at (202) 690–7151. 

Dated: January 17, 2008. 

Robert M. Kolodner, 

National Coordinator for Health Information 

Technology, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. 08–234 Filed 1–17–08; 1:18pm] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–08–05CZ] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Assessing the Diabetes Detection 

Initiative for Policy Decisions—New—

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Type II diabetes is a chronic disease 

that affects more than 18 million 

Americans, approximately 5 million of 

whom do not know that they have the 

disease. As the disease progresses, it 

often causes severe complications, 

including heart disease, blindness, 

lower extremity arterial disease, and 

kidney failure. American Indians, 

African Americans, Latino Americans, 

and some Asian Americans and Pacific 

Islanders are disproportionately affected 

by diabetes. Identifying persons who 

have undiagnosed diabetes and treating 

them could prevent or delay diabetes 

complications. 

In November 2003 the Diabetes 

Detection Initiative (DDI) was launched 

in 10 regional locations around the U.S. 

to identify a portion of the estimated 5 

million people with undiagnosed Type 

II diabetes. The DDI was designed to 

refer persons at increased risk of Type 

II diabetes to diagnostic testing, and if 

appropriate, to follow-up treatment. 

Whether or not the DDI should be 

expanded to other communities 

depends on the health benefit and costs 

of the program. The CDC plans to 

conduct a one-year study to provide this 

critical information. 

The planned information collection 

will assess the resources used, the cost 

per case detected, and the perceived 

benefit of the DDI to patients. 

Information for the assessment will be 

obtained by conducting the following 

surveys: (1) A health clinic leadership 

survey will be completed by the clinic 

director or representative of each of the 

43 clinics that participated in the DDI. 

The survey will obtain information on 

all activities and resources used at the 

clinic level related to diabetes 

screening, detection, and outreach 

services. Approximately 30 of the 43 

eligible clinics are expected to 

participate in the survey. (2) A patient 

survey will be administered to a sample 

of 600 patients from the participating 

clinics. The survey will collect 

information about each patient’s 

background and out-of-pocket medical 

and non-medical direct health care costs 

(e.g., co-payments, transportation costs, 

and the value of the patient’s time 

associated with clinic visits). The DDI 

Patient Survey will include a computerassisted personal interview (CAPI) 

module to collect information about 

each patient’s stated preferences with 

respect to diabetes screening options. 

The results of the study will also 

provide information needed for 

evaluating the long-term costeffectiveness of screening for 

undiagnosed diabetes in the United 

States. 

There are no costs to the respondents 

other than their time. The total 

estimated annualized burden hours are 

263. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

(in hours) 

DDI Clinic Representatives ................. DDI Health Clinic Leadership Survey .............................. 30 1 1 

Patients at DDI Clinics ........................ Screening Questions for the DDI Patient Survey ............ 1,000 1 2/60 

DDI Patient Survey ........................................................... 600 1 20/60 


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