29774 Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices 

Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

Matters for Discussion: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘Nutrition and Obesity Policy Research 

and Evaluation Network (NOPREN) 

Coordinating Center, (SIP)14–026, and 

Nutrition and Obesity Policy Research 

and Evaluation Network (NOPREN) 

Collaborating Center, SIP14–027, Panel 

M, initial review.’’ 

Contact Person for More Information: 

M. Chris Langub, Ph.D., Scientific 

Review Officer, CDC, 4770 Buford 

Highway NE., Mailstop F–80, Atlanta, 

Georgia 30341, Telephone: (770) 488– 

3585, EEO6@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–11978 Filed 5–22–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Miner Safety and Health 

Training Program—Western United 

States (U60) RFA–OH–14–004, initial 

review. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 1:00 p.m.–4:00 p.m., June 

16, 2014 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters for Discussion: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Miner Safety and Health 

Training Program—Western United States 

(U60) RFA–OH–14–004,’’ initial review. 

Contact Person for More Information: 

George Bockosh, M.S., Scientific Review 

Officer, CDC/NIOSH, 1600 Clifton Road, 

Mailstop E–74, Atlanta, Georgia 30333, 

Telephone: (412) 386–6465. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–11969 Filed 5–22–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3291–N] 

Announcement of the Re-Approval of 

AABB (Foremerly Known as the 

American Association of Blood Banks) 

as an Accreditation Organization 

Under the Clinical Laboratory 

Improvement Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of AABB for approval as an 

accreditation organization for clinical 

laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program. We have 

determined that AABB meets or exceeds 

the applicable CLIA requirements. In 

this notice, we announce the approval 

and grant AABB deeming authority for 

a period of 6 years. This deeming 

authority is granted to AABB for the 

Blood Bank and Transfusion Service 

(BB/TS) program, the 

Immunohematology Reference 

Laboratory (IRL) program, the Molecular 

Testing (MT) program, and the Cellular 

Therapy (CT) program. 

DATES: Effective Date: This notice is 

effective from May 23, 2014 to May 25, 

2020. 

FOR FURTHER INFORMATION CONTACT: 

Daralyn Hassan, 410–786–9360. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, we 

may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of AABB as an 

Accreditation Organization 

In this notice, we approve AABB as 

an organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements for the following specialty 

and subspecialty areas under CLIA: 

• Microbiology, including 

Bacteriology, Mycology, and Virology. 

• Diagnostic Immunology, including 

Syphilis Serology, General Immunology. 

• Chemistry, including Routine 

Chemistry, Urinalysis, Toxicology. 

• Hematology. 

• Immunohematology, including 

ABO Group & Rh Group, Antibody 

Detection, Antibody Identification, 

Compatibility Testing. 

We have examined the initial AABB 

application and all subsequent 

submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that AABB meets or exceeds 

the applicable CLIA requirements. We 

have also determined that AABB will 

ensure that its accredited laboratories 

will meet or exceed the applicable 

requirements in subparts H, I, J, K, M, 

Q, and the applicable sections of R. 

Therefore, we grant AABB approval as 

an accreditation organization under 

subpart E of part 493, for the period 

stated in the DATES section of this notice 

for the submitted specialty and 

subspecialty areas under CLIA. As a 

result of this determination, any 

laboratory that is accredited by AABB 

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Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices 29775 

during the time period stated in the 

DATES section of this notice will be 

deemed to meet the CLIA requirements 

for the listed subspecialties and 

specialties, and therefore, will generally 

not be subject to routine inspections by 

a state survey agency to determine its 

compliance with CLIA requirements. 

However, the accredited laboratory is 

subject to validation and complaint 

investigation surveys performed by 

CMS, or its agent(s). 

III. Evaluation of the AABB Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that the AABB 

accreditation program meets the 

necessary requirements to be approved 

by CMS as an accreditation program 

with deeming authority under the CLIA 

program. AABB formally applied to 

CMS for approval as an accreditation 

organization under CLIA for the 

following specialties and subspecialties: 

• Microbiology, including 

Bacteriology, Mycology, Virology. 

• Diagnostic Immunology, including 

Syphilis Serology, General Immunology. 

• Chemistry, including Routine 

Chemistry, Urinalysis, Toxicology. 

• Hematology. 

• Immunohematology, including 

ABO Group & Rh Group, Antibody 

Detection, Antibody Identification, 

Compatibility Testing. 

In reviewing these materials, we 

reached the following determinations 

for each applicable part of the CLIA 

regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

AABB submitted its mechanism for 

monitoring compliance with all 

requirements equivalent to conditionlevel requirements, a list of all its 

current laboratories and the expiration 

date of their accreditation, and a 

detailed comparison of the individual 

accreditation requirements with the 

comparable condition-level 

requirements. We have determined that 

AABB policies and procedures for 

oversight of laboratories performing 

laboratory testing for the submitted 

CLIA specialties and subspecialties are 

equivalent to those required by our 

CLIA regulations in the matters of 

inspection, monitoring proficiency 

testing (PT) performance, investigating 

complaints, and making PT information 

available. AABB submitted 

documentation regarding its 

requirements for monitoring and 

inspecting laboratories, and describing 

its own standards regarding 

accreditation organization data 

management, inspection processes, 

procedures for removal or withdrawal of 

accreditation, notification requirements, 

and accreditation organization 

resources. We have determined that the 

requirements of the accreditation 

programs submitted for approval are 

equal to or more stringent than the 

requirements of the CLIA regulations. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

We have determined that the AABB’s 

requirements are equal to the CLIA 

requirements at § 493.801 through 

§ 493.865. Like CLIA, all of AABB’s 

accredited laboratories are required to 

participate in an HHS-approved PT 

program for tests listed in subpart I. 

Additionally, AABB administers a nonregulated PT program to challenge the 

ability of the laboratories in the IRL 

program to resolve complex serological 

problems. Laboratories in the MT 

program are required to participate in a 

graded PT program or a sample 

exchange program. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

We have determined that the AABB’s 

requirements are equal to the CLIA 

requirements at § 493.1100 through 

§ 493.1105. 

D. Subpart K—Quality System for 

Nonwaived Testing 

We have determined that the AABB 

requirements are equal to or more 

stringent than the CLIA requirements at 

§ 493.1200 through § 493.1299. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the AABB 

requirements are equal to the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

F. Subpart Q—Inspections 

We have determined that the AABB 

requirements are equal to the CLIA 

requirements at § 493.1771 through 

§ 493.1780. AABB will continue to 

conduct biennial onsite inspections. 

G. Subpart R—Enforcement Procedures 

We have determined that the AABB 

meets the requirements of subpart R to 

the extent that such requirements are 

utilized by accreditation organizations. 

AABB policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, AABB 

will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by AABB and report that action to us 

within 30 days. AABB also provides an 

appeals process for laboratories that 

have had accreditation denied, 

suspended, or revoked. 

We have determined that AABB’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 

laboratories accredited by AABB 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 our agents, or the state 

survey agencies, will be our principal 

means for verifying that the laboratories 

accredited by AABB 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 AABB, for 

cause, before the end of the effective 

date of approval. If we determine that 

AABB has failed to adopt, maintain and 

enforce requirements that are equal to, 

or more stringent than, the CLIA 

requirements, or that systemic problems 

exist in its monitoring, inspection or 

enforcement processes, we may impose 

a probationary period, not to exceed 1 

year, in which AABB would be allowed 

to address any identified issues. Should 

AABB be unable to address the 

identified issues within that timeframe, 

CMS may, in accordance with the 

applicable regulations, revoke AABB’s 

deeming authority under CLIA. 

Should circumstances result in our 

withdrawal of AABB’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 

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29776 Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices 

with the accreditation process for 

clinical laboratories under the CLIA 

program, codified in 42 CFR part 493 

subpart E, are currently approved by 

OMB under OMB approval number 

0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

Dated: May 12, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–11918 Filed 5–22–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10525] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

any of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments must be received by 

July 22, 2014: 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

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

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10525 Health Plan Monitoring 

System Level I and Level II Data Entry 

for the Program of All-Inclusive Care 

for the Elderly 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Existing collection in use 

without an OMB control number); Title 

of Information Collection: Health Plan 

Monitoring System Level I and Level II 

Data Entry for the Program of AllInclusive Care for the Elderly; Use: This 

information collection would require 

Program of All-Inclusive Care for the 

Elderly (PACE) organizations to enter 

Level I and Level II data into the CMS’s 

Health Plan Monitoring System. The 

collected information will be used to 

develop a quality improvement strategy 

for PACE. Form Number: CMS–10525 

(OMB control number: 0938-New); 

Frequency: Quarterly and occasionally; 

Affected Public: Private sector— 

Business or other for-profits and Notfor-profit institutions); Number of 

Respondents: 100; Total Annual 

Responses: 7,000; Total Annual Hours: 

1,575. (For policy questions regarding 

this collection contact Tamika Gladney 

at 410–786–0648). 

Dated: May 20, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–11947 Filed 5–22–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10520] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

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