Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices 13443 

Internet (http://www.cms.hhs.gov/ 

FACA/04_APME.asp) for additional 

information and updates on committee 

activities. Press inquiries are handled 

through the CMS Press Office at (202) 

690–6145. 

SUPPLEMENTARY INFORMATION: 

Section 9(a)(2) of the Federal 

Advisory Committee Act authorizes the 

Secretary of Health and Human Services 

(the Secretary) to establish an advisory 

panel if the Secretary determines that 

the panel is ‘‘in the public interest in 

connection with the performance of 

duties imposed * * * by law.’’ Such 

duties are imposed by section 1804 of 

the Social Security Act (the Act), 

requiring the Secretary to provide 

informational materials to Medicare 

beneficiaries about the Medicare 

program, and section 1851(d) of the Act, 

requiring the Secretary to provide for 

‘‘activities * * * to broadly disseminate 

information to [M]edicare beneficiaries 

* * * on the coverage options provided 

under [Medicare Advantage] in order to 

promote an active, informed selection 

among such options.’’ 

The Panel is also authorized by 

section 1114(f) of the Act (42 U.S.C. 

1311(f)) and section 222 of the Public 

Health Service Act (42 U.S.C. 217a). The 

Secretary signed the charter establishing 

this Panel on January 21, 1999 (64 FR 

7899, February 17, 1999) and approved 

the renewal of the charter on January 21, 

2009. The Panel advises and makes 

recommendations to the Secretary and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS) on 

opportunities to enhance the 

effectiveness of consumer education 

strategies concerning the Medicare 

program. 

The goals of the Panel are as follows: 

• To provide recommendations on 

the development and implementation of 

a national Medicare education program 

that describes benefit options under 

Medicare. 

• To enhance the Federal 

government’s effectiveness in informing 

the Medicare consumer. 

• To make recommendations on how 

to expand outreach to vulnerable and 

underserved communities, including 

racial and ethnic minorities, in the 

context of a national Medicare 

education program. 

• To assemble an information base of 

best practices for helping consumers 

evaluate benefit options and build a 

community infrastructure for 

information, counseling, and assistance. 

The current members of the Panel are: 

Gwendolyn T. Bronson, SHINE/SHIP 

Counselor, Massachusetts SHINE 

Program; Dr. Yanira Cruz, President and 

Chief Executive Officer, National 

Hispanic Council on Aging; Stephen L. 

Fera, Vice President, Social Mission 

Programs, Independence Blue Cross; 

Clayton Fong, President and Chief 

Executive Officer, National Asian 

Pacific Center on Aging; Nan KirstenForte ́, Executive Vice President, 

Consumer Services, WebMD; Cathy 

Graeff, R.Ph., M.B.A., National, Senior 

Vice President, Communications and 

Industry Relations, National Council for 

Prescription Drug Programs; Dr. Carmen 

R. Green, Director, Pain Research 

Division, Associate Professor, 

Anesthesiology, University of Michigan 

Health System; Dr. Jessie C. Gruman, 

President and Chief Executive Officer, 

Center for the Advancement of Health; 

Cindy Hounsell, J.D., President, 

Women’s Institute for a Secure 

Retirement; Kathy Hughes, Vice 

Chairwoman, Oneida Nation; Gail Hunt, 

President and Chief Executive Officer, 

National Alliance for Caregiving; Dr. 

Andrew M. Kramer, Professor of 

Medicine, University of Colorado, 

Denver; Dr. Frank B. McArdle, Manager, 

Hewitt Research Office, Hewitt 

Associates; Sandy Markwood, Chief 

Executive Officer, National Area 

Agencies on Aging; Robert L. Mollica, 

Consumer; David Roberts, M.P.A., Vice 

President, Government Relations, 

Healthcare Information and 

Management Systems Society; Julie 

Bode ̈n Schmidt, Associate Vice 

President, Training and Technical 

Assistance Department, National 

Association of Community Health 

Centers; Rebecca Snead, Executive Vice 

President and Chief Executive Officer, 

National Alliance of State Pharmacy 

Associations. 

The agenda for the April 22, 2009 

meeting will include the following: 

• Recap of the previous (January 13, 

2009) meeting. 

• Subgroup Committee Work 

Summary. 

• Medicare Outreach and Education 

Strategies. 

• Public Comment. 

• Listening Session with CMS 

Leadership. 

• Next Steps. 

Individuals or organizations that wish 

to make a 5-minute oral presentation on 

an agenda topic should submit a written 

copy of the oral presentation to Lynne 

Johnson at the address listed in the 

ADDRESSES section of this notice by the 

date listed in the DATES section of this 

notice. The number of oral presentations 

may be limited by the time available. 

Individuals not wishing to make a 

presentation may submit written 

comments to Ms. Johnson at the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice. 

Individuals requiring sign language 

interpretation or other special 

accommodations should contact Ms. 

Johnson at the address listed in the 

ADDRESSES section of this notice by the 

date listed in the DATES section of this 

notice. 

Authority: Sec. 222 of the Public Health 

Service Act (42 U.S.C. 217a) and sec. 10(a) 

of Public Law 92–463 (5 U.S.C. App. 2, sec. 

10(a) and 41 CFR 102–3). 

(Catalog of Federal Domestic Assistance 

Program No. 93.733, Medicare—Hospital 

Insurance Program; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 18, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–6773 Filed 3–26–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2282–N] 

Medicare, Medicaid, and CLIA 

Programs; Approval of the American 

Osteopathic Association as a CLIA 

Accreditation Organization 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces CMS’ 

grant of deeming authority to the 

American Osteopathic Association 

(AOA) under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program. We have determined 

that the requirements of the AOA 

accreditation process are equal to or 

more stringent than the CLIA condition 

level requirements, and that the AOA 

has met the requirements of CMS. 

Consequently, laboratories that are 

voluntarily accredited by the AOA and 

continue to meet the AOA requirements 

will be deemed to meet the CLIA 

condition level requirements for 

laboratories and therefore are not 

subject to routine inspection by State 

survey agencies to determine their 

compliance with Federal requirements. 

They are, however, subject to Federal 

validation and complaint investigation 

surveys conducted by CMS or its 

designee. 

DATES: Effective Date: This notice is 

effective from March 27, 2009 to March 

27, 2015. 

mstockstill on PROD1PC66 with NOTICES

13444 Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Todd, (410) 786–3385. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA), Public Law 100–578. CLIA 

replaced in its entirety section 353(e)(2) 

of the Public Health Service Act, as 

enacted by the Clinical Laboratory 

Improvement Act of 1967. We issued a 

final rule implementing the 

accreditation provisions of CLIA on July 

31, 1992 (57 FR 33992). Under the CLIA 

program, CMS may grant deeming 

authority to an accreditation 

organization that accredits clinical 

laboratories if the organization meets 

certain requirements. An organization’s 

requirements for accredited laboratories 

must be equal to, or more stringent than, 

the applicable CLIA program 

requirements in 42 CFR part 493 

(Laboratory Requirements). The 

regulations in subpart E (Accreditation 

by a Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program) 

specify the requirements an 

accreditation organization must meet to 

be an approved accreditation 

organization. We approve an 

accreditation organization for a period 

not to exceed 6 years. 

The approved accreditation 

organization must: 

• Use inspectors qualified to evaluate 

laboratory performance and agree to 

inspect laboratories at the frequency 

determined by CMS. 

• Apply standards and criteria that 

are equal to, or more stringent than, 

those condition level requirements 

established by CMS. 

• Assure that laboratories accredited 

by the accreditation organization 

continually meet these standards and 

criteria. 

• Provide CMS with the name of any 

laboratory that has had its accreditation 

denied, suspended, withdrawn, limited, 

or revoked within 30 days of the action 

taken. 

• Notify CMS at least 30 days before 

implementing any proposed changes in 

its standards. 

• If we withdraw our approval, notify 

the accredited laboratories of the 

withdrawal within 10 days of the 

withdrawal. 

CLIA requires that we perform an 

annual evaluation of approved 

accreditation organizations by 

inspecting a representative sample of 

laboratories accredited by the 

organization, as well as by any other 

means that we determine to be 

appropriate. 

The AOA was initially granted 

deeming authority under the CLIA 

program on July 21, 1995 (HSQ–229–N). 

II. Notice of Approval of the American 

Osteopathic Association as an 

Accreditation Organization 

In this notice, we approve AOA as an 

organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements. We have examined the 

AOA application and all subsequent 

submissions to determine equivalency 

with our requirements under subpart E 

of part 493 that an accreditation 

organization must meet to be approved 

under CLIA. We have determined that 

the AOA complies with the applicable 

CLIA requirements and grant the AOA 

deeming authority as an accreditation 

organization under subpart E, for the 

period stated in the ‘‘Effective Date’’ 

section of this notice for all specialty 

and subspecialty areas under CLIA. 

As a result of this determination, any 

laboratory that is accredited by the AOA 

during the effective time period for an 

approved specialty or subspecialty is 

deemed to meet the CLIA requirements 

for the laboratories found in part 493 of 

our regulations and, therefore, is not 

subject to routine inspection by a State 

survey agency to determine its 

compliance with CLIA requirements. 

The accredited laboratory, however, is 

subject to validation and complaint 

investigation surveys performed by 

CMS, or by any other validly authorized 

agent. 

III. Evaluation of the American 

Osteopathic Association Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that requirements of 

the AOA accreditation program are 

equal to or more stringent than the CLIA 

condition level requirements, and that 

the AOA has met requirements of 

subpart E of 42 CFR part 493. 

The AOA formally reapplied to CMS 

for approval as an accreditation 

organization under CLIA for all 

specialties and subspecialties. We 

evaluated the AOA application to 

determine compliance with our 

implementing and enforcement 

regulations, and the deeming/exemption 

requirements of the CLIA rules. 

We verified that the AOA 

accreditation program requirements and 

methods require the laboratories it 

accredits to be in compliance with the 

following subparts of part 493 as 

explained below, and that the 

organization meets or exceeds the 

following subparts of part 493 as 

explained below: 

Subpart E—Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program 

The AOA submitted the specialties 

and subspecialties that it would 

accredit; a comparison of its 

accreditation requirements to CLIA 

condition level requirements; a 

description of its inspection process and 

its proficiency testing (PT) monitoring 

process; its data management and 

analysis system; a listing of the size, 

composition, education and experience 

of its inspection teams; its investigative 

and complaint response procedures; its 

notification agreements with CMS; its 

procedures for removing or withdrawing 

laboratory accreditation; its current list 

of accredited laboratories; and its 

announced or unannounced inspection 

process. 

The AOA met the requirements of 

part 493 subpart E as they apply to 

accreditation organizations. 

Subpart H—Participation in Proficiency 

Testing for Laboratories Performing 

Nonwaived Testing 

The AOA requirements are equal to 

the CLIA requirements at § 493.801 

through § 493.865. 

Subpart J—Facility Administration for 

Nonwaived Testing 

The AOA requirements are equal to 

the CLIA requirements at § 493.1100 

through § 493.1105. 

Subpart K—Quality System for 

Nonwaived Testing 

The AOA requirements are equal to or 

more stringent than the CLIA 

requirements at § 493.1200 through 

§ 493.1299. 

Subpart M—Personnel for Nonwaived 

Testing 

The AOA requirements are equal to or 

more stringent than the CLIA 

requirements at § 493.1351 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

Subpart Q—Inspections 

The AOA requirements are equal to or 

more stringent than the CLIA 

requirements at § 493.1771 through 

§ 493.1780. The AOA will continue to 

perform onsite inspections every 2 

years. 

Subpart R—Enforcement Procedures 

The AOA meets the requirements of 

subpart R to the extent that they apply 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 58 / Friday, March 27, 2009 / Notices 13445 

to accreditation organizations. The AOA 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

AOA will deny, suspend, or, revoke 

accreditation in a laboratory accredited 

by the AOA and report that action to 

CMS within 30 days. The AOA also 

provides an appeal process for 

laboratories that have had accreditation 

denied, suspended, or revoked. 

We have determined that the AOA’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of part 493 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

AOA accredited laboratories may be 

conducted on a representative sample 

basis or in response to substantial 

allegations of noncompliance (that is, 

complaint inspections). The outcome of 

those validation inspections, performed 

by CMS or its agents, or the State survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by the AOA remain in 

compliance with CLIA requirements. 

This Federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of the AOA, 

for cause, before the end of the effective 

date of approval. If we determine that 

the AOA failed to adopt requirements 

that are equal to, or more stringent than, 

the CLIA requirements, or that systemic 

problems exist in its inspection process, 

we may give it a probationary period, 

not to exceed 1 year, to allow the AOA 

to adopt comparable requirements. 

Should circumstances result in our 

withdrawal of the AOA’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program, codified in 42 

CFR part 493 subpart E, are currently 

approved by OMB under OMB approval 

number 0938–0686. 

Authority: Section 353 of the Public Health 

Service Act (42 U.S.C. 263a). 

Dated: February 13, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–5473 Filed 3–26–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: Temporary Assistance for Needy 

Families/National Directory of New 

Hires Match Results Report. 

OMB No.: 0970–0311. 

Description: Section 453(j)(3) of the 

Social Security Act (the Act) allows for 

matching between the National 

Directory of New Hires (maintained by 

the Federal Office of Child Support 

Enforcement (OCSE)) and State TANF 

Agencies for purposes of carrying out 

responsibilities under programs funded 

under part A of Title IV of the Act. To 

assist OCSE and the Office of Family 

Assistance (OFA) in measuring savings 

to the TANF program attributable to the 

use of NDNH data matches, the State 

TANF Agencies have agreed to provide 

OCSE with a written description of the 

performance outputs and outcomes 

attributable to the State TANF Agency’s 

use of NDNH match results. This 

information will help OCSE 

demonstrate how the NDNH supports 

the OCSE’s mission and strategic goals. 

Respondents: State TANF Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

TANF/NDNH Match Results Report ................................................................ 40 4 0.17 27.20 

Estimated Total Annual Burden 

Hours: 27.20. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: March 23, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–6804 Filed 3–26–09; 8:45 am] 

BILLING CODE 4184–01–P 

mstockstill on PROD1PC66 with NOTICES