44294 Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices 

appropriate State Historic Preservation 

Officer (SHPO) on federal undertakings 

that have the potential to affect historic 

properties listed or eligible for listing in 

the National Register of Historic Places. 

EPA, Region 5 is currently in 

discussions with the Michigan SHPO 

regarding its determination that 

approval of the state biosolids 

management program would have no 

adverse effect on historic properties 

within the State of Michigan. 

B. Regulatory Flexibility Act 

Based on General Counsel Opinion 

78–7 (April 18, 1978), EPA has long 

considered a determination to approve 

or deny a State Clean Water Act (CWA) 

program submission to constitute an 

adjudication because an ‘‘approval,’’

within the meaning of the 

Administrative Procedure Act (APA), 

constitutes a ‘‘license,’’ which, in turn, 

is the product of an ‘‘adjudication.’’ For 

this reason, the statutes and Executive 

Orders that apply to rulemaking action 

are not applicable here. Among these 

are provisions of the Regulatory 

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

seq. Under the RFA, whenever a Federal 

agency proposes or promulgates a rule 

under section 553 of the APA, after 

being required by that section or any 

other law to publish a general notice of 

proposed rulemaking, the Agency must 

prepare a regulatory flexibility analysis 

for the rule, unless the Agency certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. If the Agency 

does not certify the rule, the regulatory 

flexibility analysis must describe and 

assess the impact of a rule on small 

entities affected by the rule. Even if the 

CWA program approval were a rule 

subject to the RFA, the Agency would 

certify that approval of the State 

proposed CWA program would not have 

a significant economic impact on a 

substantial number of small entities. 

EPA’s action to approve a CWA program 

merely recognizes that the necessary 

elements of the program have already 

been enacted as a matter of state law; it 

would, therefore, impose no additional 

obligation upon those subject to the 

state’s program. Accordingly, the 

Regional Administrator would certify 

that this Michigan biosolids 

management program, even if a rule, 

would not have significant economic 

impact on a substantial number of small 

entities. 

C. Unfunded Mandates Reform Act 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Public 

Law 104–4, establishes requirements for 

Federal agencies to assess the effects of 

their regulatory actions on state, local, 

and tribal governments and the private 

sector. Under section 202 of the UMRA, 

EPA generally must prepare a written 

statement, including a cost-benefit 

analysis, for proposed and final rules 

with ‘‘Federal mandates’’ that may 

result in expenditures to state, local, 

and tribal governments, in the aggregate, 

or to the private sector, of $100 million 

or more in any one year. Before 

promulgating an EPA rule for which a 

written statement is needed, section 205 

of the UMRA generally requires EPA to 

identify and consider a reasonable 

number of regulatory alternatives and 

adopt the least costly, most costeffective or least burdensome alternative 

that achieves the objectives of the rule. 

The provisions of section 205 do not 

apply when they are inconsistent with 

applicable law. Moreover, section 205 

allows EPA to adopt an alternative other 

than the least costly, most cost-effective 

or lease burdensome alternative if the 

Administrator publishes with the final 

rule an explanation why that alternative 

was not adopted. Before EPA establishes 

any regulatory requirements that may 

significantly or uniquely affect small 

governments, including tribal 

governments, it must have developed 

under section 203 of the UMRA a small 

government agency plan. The plan must 

provide for notifying potentially 

affected small governments, enabling 

officials of affected small governments 

to have meaningful and timely input in 

the development of EPA regulatory 

proposals with significant Federal 

intergovernmental mandates, and 

informing, educating, and advising 

small governments on compliance with 

the regulatory requirements. Today’s 

decision includes no Federal mandates 

for state, local or tribal governments or 

the private sector. The Act excludes 

from the definition of a ‘‘Federal 

mandate’’ duties that arise from 

participation in a voluntary Federal 

program, except in certain cases where 

a ‘‘Federal intergovernmental mandate’’

affects an annual Federal entitlement 

program of $500 million or more which 

are not applicable here. Michigan’s 

request for approval of its biosolids 

management program is voluntary and 

imposes no Federal mandate within the 

meaning of the Act. Rather, by having 

its biosolids management program 

approved, the state will gain the 

authority to implement the program 

within its jurisdiction, in lieu of EPA, 

thereby eliminating duplicative state 

and federal requirements. If a state 

chooses not to seek authorization for 

administration of a biosolids 

management program, regulation is left 

to EPA. EPA’s approval of state 

programs generally may reduce 

compliance costs for the private sector, 

since the state, by virtue of the approval, 

may now administer the program in lieu 

of EPA and exercise primary 

enforcement. Hence, owners and 

operators of biosolids management 

facilities or businesses generally no 

longer face dual federal and state 

compliance requirements, thereby 

reducing overall compliance costs. 

Thus, today’s decision is not subject to 

the requirements of sections 202 and 

205 of the UMRA. The Agency 

recognizes that small governments may 

own and/or operate biosolids 

management facilities that will become 

subject to the requirements of an 

approved state biosolids management 

program. However, small governments 

that own and/or operate biosolids 

management facilities are already 

subject to the requirements in 40 CFR 

parts 123 and 503 and are not subject to 

any additional significant or unique 

requirements by virtue of this program 

approval. Once EPA authorizes a state to 

administer its own biosolids 

management program and any revisions 

to that program, these same small 

governments will be able to own and 

operate their biosolids management 

facilities or businesses under the 

approved state program, in lieu of the 

federal program. Therefore, EPA has 

determined that this document contains 

no regulatory requirements that might 

significantly or uniquely affect small 

governments. 

List of Subjects 

Environmental protection, 

Administrative practice and procedures, 

Indian Country, Intergovernmental 

relations, Waste treatment and disposal, 

Water pollution control. 

Authority: Clean Water Act, 33 U.S.C. 1251 

et seq. 

Dated: July 5, 2006. 

Norman Niedergang, 

Acting Regional Administrator, Region 5. 

[FR Doc. E6–12359 Filed 8–3–06; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL ACCOUNTING STANDARDS 

ADVISORY BOARD 

Notice of New Exposure Draft; 

Interpretation: Items Held for 

Remanufacture 

Board Action: Pursuant to 31 U.S.C. 

3511(d), the Federal Advisory 

Committee Act (Pub. L. 92–463), as 

amended, and the FASAB Rules of 

Procedure, as amended in April, 2004, 


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Federal Register / Vol. 71, No. 150 / Friday, August 4, 2006 / Notices 44295 

1HHS notes that the requirements of the HIPAA 

Security Rule continue to be applicable. 

notice is hereby given that the Federal 

Accounting Standards Advisory Board 

(FASAB) has issued an exposure draft, 

Interpretation: Items Held for 

Remanufacture. 

The proposed Interpretation would 

clarify the principles governing the 

classification, valuation and reporting of 

items that are in the process of major 

overhaul or remanufacture for sale or for 

internal use. The Exposure Draft is 

available on the FASAB home page 

http://www.fasab.gov/exposure.html. 

Copies can be obtained by contacting 

FASAB at (202) 512–7350. Respondents 

are encouraged to comment on any 

party of the exposure draft. 

Written comments are requested by 

October 16, 2006, and should be sent to: 

Wendy M. Comes, Executive Director, 

Federal Accounting Standards Advisory 

Board. 441 G Street, NW., Suite 6814, 

Mail Stop 6K17V, Washington, DC 

20548. 

FOR FURTHER INFORMATION CONTACT: 

Wendy Comes, Executive Director, 441 

G Street, NW., Washington, DC 20548, 

or call (202) 512–7350. 

Authority: Federal Advisory Committee 

Act, Pub. L. 92–463. 

Dated: August 1, 2006. 

Charles Jackson, 

Federal Register Liaison Officer. 

[FR Doc. 06–6677 Filed 8–3–06; 8:45 am] 

BILLING CODE 1610–01–M 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR Part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The application also will be 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Additional information on all bank 

holding companies may be obtained 

from the National Information Center 

website at www.ffiec.gov/nic/. 

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than August 31, 

2006. 

A. Federal Reserve Bank of Atlanta 

(Andre Anderson, Vice President) 1000 

Peachtree Street, N.E., Atlanta, Georgia 

30309: 

1. Piedmont Community Bank Group, 

Inc., Gray, Georgia; to become a bank 

holding company by acquiring 100 

percent of the voting shares of Piedmont 

Community Bank, Gray, Georgia. 

Board of Governors of the Federal Reserve 

System, August 1, 2006. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E6–12608 Filed 8–3–06; 8:45 am] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Notice of Availability: Secretarial 

Recognition of Certain Certification 

Commission for Healthcare 

Information Technology (CCHIT) 

Functionality, Interoperability, Security 

and Reliability Criteria for Ambulatory 

Electronic Health Records 

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: By this document we are 

informing the public of the Secretary’s 

recognition of certain Certification 

Commission for Healthcare Information 

Technology (CCHIT) criteria for 

ambulatory EHR functionality, 

interoperability, security and reliability 

standards. This list of recognized 

criteria is available by clicking the 

applicable link at http://www.hhs.gov/ 

healthit. 

The CCHIT was created in 2004 by an 

industry coalition of the American 

Health Information Management 

Association (AHIMA), the Health 

Information and Management Systems 

Society (HIMSS) and the National 

Alliance for Health Information 

Technology. CCHIT’s mission is to 

accelerate the adoption of HIT by 

creating an efficient, credible and 

sustainable product certification 

program. 

During the three comment cycles that 

generated the ambulatory EHR criteria 

that the Secretary has recognized, 

CCHIT received over 1500 comments 

from a wide range of stakeholders. 

Further outreach was achieved through 

the establishment of several large Town 

Hall presentations with attendances in 

the range of 500–1000 at Healthcare 

Information Management Systems 

Society (HIMSS) conferences as well as 

at more than thirty smaller 

presentations to a variety of 

associations, organizations and the press 

gatherings. 

CCHIT grouped its ambulatory EHR 

certification criteria recommendations 

into three groups, ‘‘functionality,’’

‘‘interoperability’’ and ‘‘security/ 

reliability.’’ For ease of understanding, 

the Secretary broke the security and 

reliability recommendations into 

separate categories. Definitions of these 

categories, and an example that 

illuminates the various functions of 

each category are as follows: 

1. Functionality criteria identify 

minimum required and provisional 

product features for documenting and 

managing a typical patient encounter. 

For example, a physician needs to be 

able to access his/her patient’s 

laboratory test results, so an example of 

a functional requirement is that an EHR 

would need to provide the capability of 

displaying laboratory test results. 

2. Interoperability criteria establish 

standards for how products interact 

with other products within and across 

care settings. For example, to ensure 

interoperability, the physician EHR 

noted above would need to be able to 

receive laboratory test results from 

another physician’s (within care 

settings) as well as from laboratory 

systems (across care settings). 

3. Security and reliability criteria are 

designed to help the security inspector 

assess a product’s ability to protect, 

manage and audit access to sensitive 

patient data. For clarity, we have broken 

these criteria into the two separate 

categories, security and reliability. 

a. Security 1 addresses the appropriate 

access to data by appropriate parties and 

the protection of data from improper 

manipulation. For example, laboratory 

test results should be accessible to a 


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