62686 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 

It is important that HIPAA covered 

entities, vendors, and third party billers 

obtain the ASC X12 Version 5010 and 

the NCPDP Version D.0 error corrections 

and include them in their 

implementation of Version 5010 and 

Version D.0 standards. It should be 

noted that the HIPAA compliant 

versions include the error corrections. 

The Version 5010 and Version D.0 

HIPAA compliant standards should be 

incorporated into systems as soon as 

possible. There is urgency for entities to 

do so quickly in light of the HHSspecified Version 5010 and Version D.0 

January 1, 2011 testing date and the 

January 2012 implementation date. In 

addition, adhering to these time frames 

is critical for meeting the requirements 

to implement Version 5010 and Version 

D.0 prior to the October 2013 

implementation date for the ICD–10 

code set. 

The ASC X12 Standards for Electronic 

Data Interchange Technical Report Type 

3 and Errata may be obtained from the 

ASC X12, 7600 Leesburg Pike, Suite 

430, Falls Church, VA 22043; Telephone 

(703) 970–4480; Fax: (703) 970 4488. 

They also are available through the 

Internet at http://www.X12.org. 

The implementation specifications 

and the NCPDP D.0 Editorial Document 

may be obtained from the National 

Council for Prescription Drug programs, 

9240 East Raintree Drive, Scottsdale, AZ 

85260; Telephone (480) 477–1000; Fax: 

(480) 767–1042. They are also available 

through the Internet at http:// 

www.ncpdp.org. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Approved: October 6, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–25684 Filed 10–8–10; 11:15 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 170 

RIN 0991–AB76 

Health Information Technology: 

Revisions to Initial Set of Standards, 

Implementation Specifications, and 

Certification Criteria for Electronic 

Health Record Technology 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), Department of 

Health and Human Services. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: The Department of Health and 

Human Services (HHS) is issuing this 

interim final rule with a request for 

comment to remove the implementation 

specifications related to public health 

surveillance. 

DATES: Effective Date: This interim final 

rule is effective October 13, 2010. 

Comment Date: To be assured 

consideration, written or electronic 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 12, 2010. 

ADDRESSES: Because of staff and 

resource limitations, we cannot accept 

comments by facsimile (FAX) 

transmission. You may submit 

comments, identified by RIN 0991– 

AB76, by any of the following methods 

(please do not submit duplicate 

comments). 

• Federal eRulemaking Portal: Follow 

the instructions for submitting 

comments. Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word. 

http://www.regulations.gov. 

• Regular, Express, or Overnight Mail: 

Department of Health and Human 

Services, Office of the National 

Coordinator for Health Information 

Technology, Attention: Steven Posnack, 

Hubert H. Humphrey Building, Suite 

729D, 200 Independence Ave., SW., 

Washington, DC 20201. Please submit 

one original and two copies. 

• Hand Delivery or Courier: Office of 

the National Coordinator for Health 

Information Technology, Attention: 

Steven Posnack, Hubert H. Humphrey 

Building, Suite 729D, 200 Independence 

Ave., SW., Washington, DC 20201. 

Please submit one original and two 

copies. (Because access to the interior of 

the Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the mail drop slots 

located in the main lobby of the 

building.) 

Inspection of Public Comments: All 

comments received before the close of 

the comment period will be available for 

public inspection, including any 

personally identifiable or confidential 

business information that is included in 

a comment. Please do not include 

anything in your comment submission 

that you do not wish to share with the 

general public. Such information 

includes, but is not limited to: A 

person’s social security number; date of 

birth; driver’s license number; state 

identification number or foreign country 

equivalent; passport number; financial 

account number; credit or debit card 

number; any personal health 

information; or any business 

information that could be considered to 

be proprietary. We will post all 

comments received before the close of 

the comment period at http:// 

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or U.S. Department 

of Health and Human Services, Office of 

the National Coordinator for Health 

Information Technology, Hubert H. 

Humphrey Building, Suite 729D, 200 

Independence Ave., SW., Washington, 

DC 20201 (call ahead to the contact 

listed below to arrange for inspection). 

FOR FURTHER INFORMATION CONTACT: 

Steven Posnack, Director, Federal Policy 

Division, Office of Policy and Planning, 

Office of the National Coordinator for 

Health Information Technology, 202– 

690–7151. 

SUPPLEMENTARY INFORMATION: 

Acronyms 

ARRA American Recovery and 

Reinvestment Act of 2009 

CDC Centers for Disease Control and 

Prevention 

CFR Code of Federal Regulations 

EHR Electronic Health Record 

HHS Department of Health and Human 

Services 

HIT Health Information Technology 

HITECH Health Information Technology for 

Economic and Clinical Health 

HL7 Health Level Seven 

NAICS North American Industry 

Classification System 

OMB Office of Management and Budget 

ONC Office of the National Coordinator for 

Health Information Technology 

ONC–ATCB ONC-Authorized Testing and 

Certification Body 

PHSA Public Health Service Act 

RFA Regulatory Flexibility Act 

RIA Regulatory Impact Analysis 

UMRA Unfunded Mandates Reform Act of 

1995 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 62687 

Table of Contents 

I. Background 

A. Legislative History 

B. Regulatory History 

1. Initial Set of Standards, Implementation 

Specifications, and Certification Criteria 

for EHR Technology; Interim Final Rule 

2. Initial Set of Standards, Implementation 

Specifications, and Certification Criteria 

for EHR Technology; Final Rule 

3. Proposed Establishment of Certification 

Programs for Health Information 

Technology; Proposed Rule 

4. Temporary Certification Program; Final 

Rule 

II. Discussion of the Interim Final Rule 

A. Public Health Surveillance 

Implementation Specifications 

B. Waiver of Proposed Rulemaking and 

Delay in Effective Date 

III. Response to Comments 

IV. Collection of Information Requirements 

V. Regulatory Impact Statement 

Regulation Text 

I. Background 

A. Legislative History 

The Health Information Technology 

for Economic and Clinical Health 

(HITECH) Act, Title XIII of Division A 

and Title IV of Division B of the 

American Recovery and Reinvestment 

Act of 2009 (ARRA) (Pub. L. 111–5), was 

enacted on February 17, 2009. The 

HITECH Act amended the Public Health 

Service Act (PHSA) and established 

‘‘Title XXX—Health Information 

Technology and Quality’’ to improve 

health care quality, safety, and 

efficiency through the promotion of 

health information technology (HIT) and 

the electronic exchange of health 

information. Section 3004 of the PHSA, 

as added by the HITECH Act, authorizes 

the Secretary of Health and Human 

Services (the Secretary) to adopt 

standards, implementation 

specifications, and certification criteria 

to enhance the interoperability, 

functionality, utility, and security of 

health information technology. Section 

3004(b)(1) of the PHSA more 

specifically directs the Secretary to 

adopt an initial set of standards, 

implementation specifications, and 

certification criteria, and permits their 

adoption through an interim final rule. 

B. Regulatory History 

1. Initial Set of Standards, 

Implementation Specifications, and 

Certification Criteria for EHR 

Technology; Interim Final Rule 

On January 13, 2010, HHS published 

in the Federal Register an interim final 

rule with a request for comment, which 

adopted an initial set of standards, 

implementation specifications, and 

certification criteria (75 FR 2014). The 

certification criteria adopted in that 

interim final rule established the 

required capabilities and specified the 

related standards and implementation 

specifications that certified electronic 

health record (EHR) technology would 

need to include to, at a minimum, 

support the achievement of meaningful 

use Stage 1 as proposed by CMS for 

eligible professionals and eligible 

hospitals under the Medicare and 

Medicaid EHR Incentive Programs. (For 

consistency with subsequent regulatory 

changes, hereafter, references to 

‘‘eligible hospitals’’ shall mean ‘‘eligible 

hospitals and/or critical access 

hospitals’’.) 

2. Initial Set of Standards, 

Implementation Specifications, and 

Certification Criteria for EHR 

Technology; Final Rule 

On July 28, 2010, HHS published in 

the Federal Register a final rule (75 FR 

44590) to complete the Secretary’s 

adoption of the initial set of standards, 

implementation specifications, and 

certification criteria, and to more closely 

align such standards, implementation 

specifications, and certification criteria 

with final meaningful use Stage 1 

objectives and measures (the ‘‘Standards 

and Certification Criteria Final Rule’’). 

The certification criteria adopted in that 

final rule establish the required 

capabilities and specify the related 

standards and implementation 

specifications that certified EHR 

technology will need to include to, at a 

minimum, support the achievement of 

meaningful use Stage 1 by eligible 

professionals and eligible hospitals 

under the Medicare and Medicaid EHR 

Incentive Programs. Complete EHRs and 

EHR Modules will be tested and 

certified according to adopted 

certification criteria to ensure that they 

have properly implemented adopted 

standards and implementation 

specifications and otherwise comply 

with the adopted certification criteria. 

3. Proposed Establishment of 

Certification Programs for Health 

Information Technology; Proposed Rule 

On March 10, 2010, under the 

authority granted to the National 

Coordinator for Health Information 

Technology (the National Coordinator) 

by section 3001(c)(5) of the PHSA as 

added by the HITECH Act, HHS 

published in the Federal Register (75 

FR 11328) a rule proposing the 

establishment of two certification 

programs for purposes of testing and 

certifying health information 

technology. The first proposal would 

establish a temporary certification 

program whereby the National 

Coordinator would authorize 

organizations to test and certify 

Complete EHRs and/or EHR Modules. 

The second proposal would establish a 

permanent certification program to 

replace the temporary certification 

program. The permanent certification 

program included proposals that would 

separate the responsibilities for 

performing testing and certification, 

introduce accreditation requirements, 

establish requirements for certification 

bodies authorized by the National 

Coordinator related to the surveillance 

of Certified EHR Technology, and would 

include the potential for certification 

bodies authorized by the National 

Coordinator to certify other types of 

health information technology besides 

Complete EHRs and EHR Modules. 

4. Temporary Certification Program; 

Final Rule 

On June 24, 2010, HHS published in 

the Federal Register a final rule (75 FR 

36158) establishing the temporary 

certification program for HIT 

(Temporary Certification Program). The 

Temporary Certification Program, 

established under the authority granted 

to the National Coordinator by section 

3001(c)(5) of the PHSA, sets forth the 

process the National Coordinator will 

utilize to authorize organizations (ONCAuthorized Testing and Certification 

Bodies (ONC–ATCBs)) to test and certify 

Complete EHRs and/or EHR Modules to 

the certification criteria adopted by the 

Secretary in the Standards and 

Certification Criteria Final Rule. Once 

tested and certified, a Complete EHR or 

a combination of EHR Modules can be 

adopted by an eligible professional or 

eligible hospital to meet the definition 

of Certified EHR Technology as 

specified at 45 CFR 170.102 and used to 

help qualify for incentive payments 

under the Medicare and Medicaid EHR 

Incentive Programs. 

II. Discussion of the Interim Final Rule 

A. Public Health Surveillance 

Implementation Specifications 

In the Standards and Certification 

Criteria Final Rule, we adopted two 

content exchange standards for 

electronic submission to public health 

agencies for surveillance and reporting, 

Health Level Seven (HL7) versions 2.3.1 

and 2.5.1. (45 CFR 170.205(d)) 

Additionally, in response to public 

comment on the interim final rule 

published January, 2010, we adopted in 

the Standards and Certification Criteria 

Final Rule the following 

implementation specifications for HL7 

2.5.1: Public Health Information 

Network HL7 Version 2.5 Message 


jdjones on DSK8KYBLC1PROD with RULES
62688 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 

Structure Specification for National 

Condition Reporting Final Version 1.0 

and the Errata and Clarifications 

National Notification Message 

Structural Specification. (45 CFR 

170.205(d)(2)) We did not, however, 

adopt at that time implementation 

specifications for HL7 2.3.1. 

Since the publication of the Standards 

and Certification Criteria Final Rule, 

various stakeholders and state public 

health agencies have made numerous 

inquiries and expressed concerns about 

the appropriateness of these 

implementation specifications. Some 

stakeholder representatives indicated 

that they thought these implementation 

specifications may have been adopted in 

error. They noted that these 

implementation specifications do not 

appear to be appropriate for 

implementing the adopted standard, 

HL7 2.5.1 for public health surveillance 

(syndromic surveillance) purposes. 

After further review of the 

implementation specifications and 

consultation with the Centers for 

Disease Control and Prevention (CDC), 

we have determined that these 

implementation specifications were 

adopted in error. The adopted 

implementation specifications provide 

direction to public health agencies on 

the structure and methodology for using 

HL7 2.5.1 to report ‘‘Nationally 

Notifiable Conditions’’ to CDC and do 

not provide additional clarity for how 

EHR technology would need to be 

designed to implement the adopted 

standard (HL7 2.5.1) or enable 

compliance with the capability 

identified in the certification criterion 

adopted at 45 CFR 170.302(l). Therefore, 

their adoption neither provides the 

appropriate or requisite implementation 

capability for the adopted standard, HL7 

2.5.1, nor, more importantly, would 

enable the user to ‘‘electronically record, 

modify, retrieve, and submit syndromebased public health surveillance 

information * * *,’’ as required by the 

adopted certification criterion, 45 CFR 

170.302(l). 

We have also heard from ONC–ATCBs 

as well as EHR technology developers 

that the erroneous adoption of these 

implementation specifications creates 

significant ambiguity and concern 

regarding whether these implementation 

specifications must be used for testing 

and certification. They correctly point 

out that because these implementation 

specifications are inappropriate for the 

adopted standard and would likely 

frustrate achieving the capability 

specified in the adopted certification 

criterion at 45 CFR 170.302(l), testing 

and certifying in accordance with them 

would be wasteful and unproductive. 

We understand further that while the 

erroneously adopted implementation 

specifications could be used to specify 

the structure and methodology for using 

HL7 2.5.1, their purpose is to facilitate 

the electronic exchange of de-identified 

Nationally Notifiable Conditions for 

notifiable disease reporting, which 

would not fulfill the fundamental 

requirements of syndromic surveillance. 

In contrast to notifiable disease 

reporting, where only data on patients 

with a notifiable disease diagnosis is 

sent to a public health agency, 

syndromic surveillance requires data 

from all patients that were seen in a 

health care setting. Moreover, 

syndromic surveillance requires data 

elements that the adopted 

implementation specifications do not 

address including: A patient’s chief 

complaint; date/time of visit; severity of 

illness (e.g., patient’s disposition status), 

specific indicators (e.g., pulse oximetry, 

measured temperature), and age. 

The adoption of these implementation 

specifications also presents an 

unnecessary obstacle for EHR 

technology developers, who are 

currently faced with the dilemma of 

implementing HL7 2.3.1 (even though 

their customers may need HL7 2.5.1 to 

report to their state public health 

agency), or alternatively, HL7 2.5.1 

according to the inappropriate 

implementation specifications, or 

unnecessarily to both standards, in 

order to seek certification. We believe 

that each of these alternatives places an 

unnecessary and unwarranted burden 

on EHR technology developers. 

For all of these reasons, we are 

revising 45 CFR 170.205(d)(2) to remove 

these particular adopted 

implementation specifications. We are 

also removing from 45 CFR 170.302(l) 

the text ‘‘(and applicable 

implementation specifications)’’ to 

provide additional clarity and to remove 

the unnecessary and unwarranted 

burden on ONC–ATCBs and perhaps 

ONC–ACBs. In addition, we are 

removing the reference to the 

implementation specifications in 45 

CFR 170.299(g) where it is incorporated 

by reference. 

B. Waiver of Proposed Rulemaking and 

Delay in Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register to provide a period for public 

comment before the provisions of the 

rule take effect in accordance with 

section 553(b) of the Administrative 

Procedure Act (APA) (5 U.S.C.553(b)). 

We also ordinarily provide a 30-day 

delay in the effective date of the 

provisions of a rule in accordance with 

section 553(d) of the APA (5 U.S.C. 

553(d)). However, we can waive both 

the notice and comment procedure and 

the 30-day delay in effective date if the 

Secretary finds for good cause that a 

notice and comment procedure and a 

30-day delay are impracticable, 

unnecessary, or contrary to the public 

interest, and incorporates a statement of 

the finding and the reasons in the final 

notice or rule that is issued. 

In this case, we find that notice and 

comment rulemaking is contrary to the 

public interest because it would 

unnecessarily delay the implementation 

of a complex statutory scheme and 

prevent the realization of certain 

legislative goals within the statutory 

timeframe. Under the HITECH Act, ONC 

and CMS promulgated several rules that 

establish a regulatory framework 

through which eligible professionals 

and eligible hospitals may seek to 

qualify for certain Medicare and 

Medicaid programs incentive payments. 

The Medicare and Medicaid EHR 

Incentive Programs final rule 

established the initial criteria eligible 

professionals and eligible hospitals 

must meet in order to qualify for an 

incentive payment, along with other 

program participation requirements. 

The HIT Standards and Certification 

Criteria interim final and final rules 

provided for the adoption of an initial 

set of standards, implementation, 

specifications, and certification criteria 

for electronic health record technology. 

In a separate final rule, ONC established 

a temporary certification program that 

allows Complete EHRs and EHR 

Modules to be tested and certified to the 

adopted certification criteria. 

In this regulatory framework, private 

organizations are provided the 

opportunity to apply to the National 

Coordinator for authorization as an 

ONC-Authorized Testing and 

Certification Body (ONC–ATCB). Once 

an organization is granted ONC–ATCB 

status and obtains authorization from 

the National Coordinator to test and 

certify Complete EHRs 

and/or EHR Modules, it will be subject, 

depending on the scope of its 

authorization, to the requirements 

specified at 45 CFR 170.445 (Complete 

EHR testing and certification) and/or 45 

CFR 170.450 (EHR Module testing and 

certification). These provisions require 

ONC–ATCBs to test and certify 

Complete EHRs and/or EHR Modules to 

all applicable certification criteria 

adopted by the Secretary at subpart C of 

part 170. Consequently, an ONC– 

ATCB’s failure to adhere to the testing 

and certification requirements of 

170.445 and/or 170.450 could subject 

that ONC–ATCB to adverse action by 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 62689 

the National Coordinator in accordance 

with 45 CFR 170.465 (Revocation of 

authorized testing and certification body 

status). Because ONC–ATCBs are 

required to test and certify Complete 

EHRs and/or EHR Modules in 

accordance with all applicable 

certification criteria, including 45 CFR 

170.302(l), and 45 CFR 170.302(l) 

requires that a Complete EHR or EHR 

Module would need to perform the 

specified capabilities in accordance 

with, in certain scenarios, the 

erroneously adopted implementation 

specification, the Complete EHR or EHR 

Module certified in accordance with 

those provisions would not be capable 

of fulfilling the fundamental 

requirements of syndromic surveillance, 

as explained above. Consequently, a 

Complete EHR or EHR Module that was 

developed in accordance with HL7 

Version 2.5.1 and would otherwise meet 

all other applicable certification criteria 

could not be successfully certified until 

the removal of the implementation 

specifications adopted in error. We 

therefore believe that if left unchanged 

the erroneous adoption of these 

implementation specifications would 

significantly and adversely impact the 

ability of ONC–ATCBs from issuing, and 

EHR technology developers from 

receiving, certifications in a timely 

manner. 

For all of the reasons stated, we 

believe that a notice and comment 

period would be contrary to the public 

interest. We therefore find good cause 

for waiving the notice and comment 

period for the removal of the 

erroneously adopted implementation 

specifications. 

We also believe that a 30-day delay in 

the effective date is contrary to the 

public interest for the reasons stated 

above and because this interim final 

rule with comment would alleviate an 

unnecessary burden on the health IT 

industry and impose no additional legal 

requirements upon the regulated 

community. We therefore find good 

cause for waiving the 30-day delay in 

the effective date for the removal of the 

relevant implementation specifications. 

We note, however, that we are providing 

the public with a 30-day period 

following publication of this interim 

final rule to submit comments. 

III. Response to Comments 

Because of the number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

V. Regulatory Impact Statement 

We have examined the impacts of this 

interim final rule with comment as 

required by Executive Order 12866 on 

Regulatory Planning and Review 

(September 30, 1993, as further 

amended), the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601 et seq.), section 

202 of the Unfunded Mandates Reform 

Act of 1995 (2 U.S.C. 1532) (UMRA), 

Executive Order 13132 on Federalism 

(August 4, 1999), and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Order 12866 (as amended 

by Executive Orders 13258 and 13422) 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). 

This interim final rule with comment 

does not reach the economic threshold 

and, thus, is not considered a major 

rule. Therefore, an RIA has not been 

prepared. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Individuals 

and States are not included in the 

definition of a small entity. The entities 

impacted by this interim final rule most 

likely fall under the North American 

Industry Classification System (NAICS) 

code 541511 ‘‘Custom Computer 

Programming Services’’ specified at 13 

CFR 121.201 where the SBA publishes 

‘‘Small Business-Size Standards by 

NAICS Industry.’’ The size standard 

associated with this NAICS code is set 

at $25 million in annual receipts which 

‘‘indicates the maximum allowed for a 

concern and its affiliates to be 

considered small entities.’’ We are not 

preparing an analysis for the RFA 

because we have determined, and the 

Secretary certifies, that this interim final 

rule with comment imposes no new 

requirements on small entities and, as 

such, will not have a significant impact 

on a substantial number of small 

entities. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies assess anticipated costs 

and benefits before issuing any rule 

whose mandates require spending in 

any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2010, that threshold level is currently 

approximately $135 million. This 

interim final rule with comment will 

not impose an unfunded mandate on 

States, tribal government or the private 

sector of more than $135 million 

annually. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Since this interim final rule with 

comment does not impose any costs on 

State or local governments, the 

requirements of Executive Order 13132 

are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this interim 

final rule with comment was reviewed 

by the Office of Management and 

Budget. 

List of Subjects in 45 CFR Part 170 

Computer technology, Electronic 

health record, Electronic information 

system, Electronic transactions, Health, 

Health care, Health information 

technology, Health insurance, Health 

records, Hospitals, Incorporation by 

reference, Laboratories, Medicaid, 

Medicare, Privacy, Reporting and 

recordkeeping requirements, Public 

health, Security. 

■ For the reasons set forth in the 

preamble, 45 CFR subtitle A, subchapter 

D, part 170, is amended as follows: 

PART 170—HEALTH INFORMATION 

TECHNOLOGY STANDARDS 

IMPLEMENTATION SPECIFICATIONS, 

AND CERTIFICATION CRITERIA AND 

CERTIFICATION PROGRAMS FOR 

HEALTH INFORMATION 

TECHNOLOGY 

■ 1. The authority citation for part 170 

continues to read as follows: 

Authority: 42 U.S.C. 300jj–11; 42 U.S.C. 

300jj–14; 5 U.S.C. 552. 


jdjones on DSK8KYBLC1PROD with RULES
62690 Federal Register / Vol. 75, No. 197 / Wednesday, October 13, 2010 / Rules and Regulations 

■ 2. Section 170.205 is amended by 

revising paragraph (d)(2) to read as 

follows: 

§ 170.205 Content exchange standards 

and implementation specifications for 

exchanging electronic health information. 

* * * * * 

(d) * * * 

(2) Standard. HL7 2.5.1 (incorporated 

by reference in § 170.299). 

* * * * * 

■ 3. Section 170.299 is amended by 

revising paragraph (g) to read as follows: 

§ 170.299 Incorporation by reference. 

* * * * * 

(g) Centers for Disease Control and 

Prevention, National Centers for 

Immunization and Respiratory Diseases 

Immunization Information System 

Support Branch—Informatics 1600 

Clifton Road Mailstop: E–62 Atlanta, GA 

30333. 

(1) HL7 Standard Code Set CVX— 

Vaccines Administered, July 30, 2009, 

IBR approved for § 170.207. 

(2) Implementation Guide for 

Immunization Data Transactions using 

Version 2.3.1 of the Health Level Seven 

(HL7) Standard Protocol Implementation 

Guide Version 2.2, June 2006, IBR 

approved for § 170.205. 

(3) HL7 2.5.1 Implementation Guide 

for Immunization Messaging Release 

1.0, May 1, 2010, IBR approved for 

§ 170.205. 

(4) [Reserved] 

■ 4. Section 170.302 is amended by 

revising paragraph (l) to read as follows: 

§ 170.302 General certification criteria for 

Complete EHRs or EHR Modules. 

* * * * * 

(l) Public health surveillance. 

Electronically record, modify, retrieve, 

and submit syndrome-based public 

health surveillance information in 

accordance with the standard specified 

in § 170.205(d)(1) or § 170.205(d)(2). 

* * * * * 

Dated: October 6, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–25683 Filed 10–8–10; 11:15 am] 

BILLING CODE 4150–45–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 10–1805; MB Docket No. 10–117; RM– 

11601] 

Radio Broadcasting Services; Grants 

Pass, Oregon 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Audio Division, at the 

request of Three Rivers Broadcasting 

LLC, allots FM Channel 257A at Grants 

Pass, Oregon, as the community’s 

second commercial FM transmission 

service. Channel 257A can be allotted at 

Grants Pass, consistent with the 

minimum distance separation 

requirements of the Commission’s rules, 

at coordinates 42–25–25 NL and 123– 

26–25 WL, with a site restriction of 8.7 

km (5.4 miles) west of the community. 

See SUPPLEMENTARY INFORMATION infra. 

DATES: Effective November 12, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Dupont, Media Bureau, (202) 

418–2180. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 10–117, 

adopted September 24, 2010, and 

released September 27, 2010. The full 

text of this Commission decision is 

available for inspection and copying 

during normal business hours in the 

FCC Reference Information Center, 

Portals II, 445 12th Street, SW., Room 

CY–A257, Washington, DC 20554. The 

complete text of this decision also may 

be purchased from the Commission’s 

duplicating contractor, Best Copy and 

Printing, Inc., 445 12th Street, SW., 

Room CY–B402, Washington, DC 20554, 

(800) 378–3160, or via the company’s 

Web site, http://www.bcpiweb.com. This 

document does not contain proposed 

information collection requirements 

subject to the Paperwork Reduction Act 

of 1995, Public Law 104–13. In addition, 

therefore, it does not contain any 

proposed information collection burden 

‘‘for small business concerns with fewer 

than 25 employees,’’ pursuant to the 

Small Business Paperwork Relief Act of 

2002, Public Law 107–198, see 44 U.S.C. 

3506 (c)(4). The Commission will send 

a copy of this Report and Order in a 

report to be sent to Congress and the 

Government Accountability Office 

pursuant to the Congressional Review 

Act, see U.S.C. 801(a)(1)(A). 

List of Subjects in 47 CFR Part 73 

Radio, Radio broadcasting. 

■ For the reasons discussed in the 

preamble, the Federal Communications 

Commission amends 47 CFR Part 73 as 

follows: 

PART 73—RADIO BROADCAST 

SERVICES 

■ 1. The authority citation for Part 73 

continues to read as follows: 

Authority: 47 U.S.C. 154, 303, 334, 336. 

§ 73.202 [Amended] 

■ 2. Section 73.202(b), the Table of FM 

Allotments under Oregon, is amended 

by adding Grants Pass, Channel 257A. 

Federal Communications Commission. 

John A. Karousos, 

Assistant Chief, Audio Division, Media 

Bureau. 

[FR Doc. 2010–25751 Filed 10–12–10; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 635 

RIN 0648–XZ43 

Atlantic Highly Migratory Species; 

Inseason Action To Close the 

Commercial Non-sandbar Large 

Coastal Shark Research Fishery 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notification of fishery closure. 

SUMMARY: NMFS is closing the 

commercial shark research fishery for 

non-sandbar large coastal sharks (LCS). 

This action is necessary because 

landings for the 2010 fishing season 

have reached at least 80 percent of the 

available quota. 

DATES: The commercial shark research 

fishery for non-sandbar LCS is closed 

effective 11:30 p.m. local time October 

12, 2010 until, and if, NMFS announces, 

via a notice in the Federal Register that 

additional quota is available and the 

season is reopened. 

FOR FURTHER INFORMATION CONTACT: 

Karyl Brewster-Geisz or Peter Cooper, 

301–713–2347; fax 301–713–1917. 

SUPPLEMENTARY INFORMATION: The 

Atlantic shark fisheries are managed 

under the 2006 Consolidated Atlantic 

Highly Migratory Species (HMS) Fishery 

Management Plan (FMP), its 

amendments, and its implementing 

regulations found at 50 CFR part 635 


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