16342 Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices 

gladly accept written presentations from 

those who were unable to present due 

to time constraints. Presentations 

should be sent via email to Glenn 

McGuirk, at Glenn.McGuirk@

cms.hhs.gov. For new test codes, 

presenters should address all of the 

following items: 

• New test code(s) and descriptor. 

• Test purpose and method. 

• Costs. 

• Charges. 

• A recommendation, with rationale, 

for one of the two bases (crosswalking 

or gapfilling) for determining payment 

for new tests. 

Additionally, the presenters should 

provide the data which their 

recommendations are based. Written 

presentations from the public meeting 

will be available upon request, via 

email, to Glenn McGuirk at 

Glenn.McGuirk@cms.hhs.gov. 

Presentations regarding new test codes 

that do not address the above five items 

may be considered incomplete and may 

not be considered by CMS when making 

a determination. CMS may request 

missing information following the 

meeting to prevent a recommendation 

from being considered incomplete. 

Taking into account the comments 

and recommendations (and 

accompanying data) received at the 

public meeting, we intend to post our 

proposed determinations with respect to 

the appropriate basis for establishing a 

payment amount for each new test code 

and our preliminary determinations 

with respect to the reconsidered codes 

along with an explanation of the reasons 

for each determination, the data which 

the determinations are based, and a 

request for public written comments on 

these determinations on the CMS Web 

site by early September 2014. This Web 

site can be accessed at http://

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/

ClinicalLabFeeSched/

index.html?redirect=/

ClinicalLabFeeSched/. We also will 

include a summary of all comments 

received by August 4, 2014 (15 business 

days after the meeting). Interested 

parties may submit written comments 

on the proposed determinations for new 

test codes or the preliminary 

determinations for reconsidered codes 

by early October, 2014, to the address 

specified in the ADDRESSES section of 

this notice or electronically to Glenn 

McGuirk at Glenn.McGuirk@

cms.hhs.gov (the specific date for the 

publication of the determinations on the 

CMS Web site, as well as the deadline 

for submitting comments regarding the 

determinations will be published on the 

CMS Web site). Final determinations for 

new test codes to be included for 

payment on the CLFS for CY 2015 and 

reconsidered codes will be posted on 

our Web site in November 2014, along 

with the rationale for each 

determination, the data which the 

determinations are based, and responses 

to comments and suggestions received 

from the public. The final 

determinations with respect to 

reconsidered codes are not subject to 

further reconsideration. With respect to 

the final determinations for new test 

codes, the public may request 

reconsideration of the basis and amount 

of payment as set forth in § 414.509. 

III. Registration Instructions 

The Division of Ambulatory Services 

in the CMS Center for Medicare is 

coordinating the public meeting 

registration. Beginning June 9, 2014, 

registration may be completed on-line at 

the following web address: http://

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/

ClinicalLabFeeSched/

index.html?redirect=/

ClinicalLabFeeSched/. All the following 

information must be submitted when 

registering: 

• Name. 

• Company name. 

• Address. 

• Telephone numbers. 

• Email addresses. 

When registering, individuals who 

want to make a presentation must also 

specify which new test codes they will 

be presenting comments. A 

confirmation will be sent upon receipt 

of the registration. Individuals must 

register by the date specified in the 

DATES section of this notice. 

IV. Security, Building, and Parking 

Guidelines 

The meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. In 

planning your arrival time, we 

recommend allowing additional time to 

clear security. It is suggested that you 

arrive at the CMS facility between 8:15 

a.m. and 8:30 a.m., so that you will be 

able to arrive promptly at the meeting 

by 9:00 a.m. Individuals who are not 

registered in advance will not be 

permitted to enter the building and will 

be unable to attend the meeting. The 

public may not enter the building earlier 

than 8:15 a.m. (45 minutes before the 

convening of the meeting). 

Security measures include the 

following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. Persons without 

proper identification may be denied 

access to the building. 

• Interior and exterior inspection of 

vehicles (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Passing through a metal detector 

and inspection of items brought into the 

building. 

We note that all items brought to 

CMS, whether personal or for the 

purpose of demonstration or to support 

a demonstration, are subject to 

inspection. We cannot assume 

responsibility for coordinating the 

receipt, transfer, transport, storage, setup, safety, or timely arrival of any 

personal belongings or items used for 

demonstration or to support a 

demonstration. 

V. Special Accommodations 

Individuals attending the meeting 

who are hearing or visually impaired 

and have special requirements, or a 

condition that requires special 

assistance, should provide that 

information upon registering for the 

meeting. The deadline for registration is 

listed in the DATES section of this notice. 

Dated: March 14, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–06515 Filed 3–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3292–N] 

Medicare Program; Announcement of 

the Approval of the American 

Association for Laboratory 

Accreditation (A2LA) 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 the American Association 

for Laboratory Accreditation (A2LA) for 

approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program for all specialty and 

subspecialty areas under CLIA. We have 

determined that the A2LA meets or 


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Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices 16343 

exceeds the applicable CLIA 

requirements. We are announcing the 

approval and granting the A2LA 

deeming authority for a period of 4 

years. 

DATES: Effective Date: This notice is 

effective from March 25, 2014 to March 

26, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Flacks, (410) 786–6520. 

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 the A2LA as 

an Accreditation Organization 

In this notice, we approve the 

American Association for Laboratory 

Accreditation (A2LA) as an organization 

that may accredit laboratories for 

purposes of establishing their 

compliance with CLIA requirements for 

all specialty and subspecialty areas 

under CLIA. We have examined the 

initial A2LA 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 the A2LA meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that the A2LA 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 the A2LA approval as an 

accreditation organization under 

subpart E of part 493, for the period 

stated in the DATES 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 A2LA 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. The accredited 

laboratory, however, is subject to 

validation and complaint investigation 

surveys performed by CMS, or its 

agent(s). 

III. Evaluation of the A2LA Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that the A2LA 

accreditation program meets the 

necessary requirements to be approved 

by CMS and that, as such, CMS may 

approve the A2LA as an accreditation 

program with deeming authority under 

the CLIA program. The A2LA formally 

applied to CMS for approval as an 

accreditation organization under CLIA 

for all specialties and subspecialties 

under CLIA. 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 

The A2LA 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. The A2LA policies and 

procedures for oversight of laboratories 

performing laboratory testing for all 

CLIA specialties and subspecialties are 

equivalent to those of CLIA in the 

matters of inspection, monitoring 

proficiency testing (PT) performance, 

investigating complaints, and making 

PT information available. The A2LA 

submitted requirements for monitoring 

and inspecting laboratories in the areas 

of accreditation organization, data 

management, the inspection process, 

procedures for removal or withdrawal of 

accreditation, notification requirements, 

and accreditation organization 

resources. The requirements of the 

accreditation program submitted for 

approval are equal to or more stringent 

than the requirements of the CLIA 

regulations. 

Our evaluation identified the A2LA’s 

requirements pertaining to waived 

testing, provider performed microscopy 

procedures, and moderate complexity 

testing that are more stringent than the 

CLIA requirements. The A2LA’s 

requirements for high complexity 

testing are equivalent to the CLIA 

requirements. The A2LA will only 

accredit for waived tests or provider 

performed microscopy procedures if the 

laboratory is also applying for high or 

moderate complexity testing 

accreditation. Under the A2LA’s 

requirements, laboratories performing 

any of these levels of testing will be 

held to the high complexity personnel 

requirements for all testing that the 

A2LA will accredit (high, moderate, 

waived or provider performed 

microscopy), as well as the 

requirements for nonwaived testing 

located in Subparts H, J, K, M, Q, and 

applicable parts of R. 

In contrast, the CLIA requirements at 

§ 493.15 only require that a laboratory 

performing waived testing follow the 

manufacturer’s instructions and obtain a 

certificate of waiver. The CLIA 

requirements at § 493.19 require that a 

laboratory performing provider 

performed microscopy procedures meet 

personnel requirements located at 

§ 493.1355 through § 493.1365. The 

CLIA requirements at § 493.20 require 

that a laboratory performing moderate 

complexity testing meet the personnel 

requirements located at § 493.1403 

through § 493.1425. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

The A2LA’s requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.801 through 

§ 493.865. For instance, the A2LA 

requires that laboratories conduct 

proficiency testing activities for both 

primary and secondary test systems for 

waived and non-waived testing. The 

CLIA requirement at § 493.801(b)(6) 

requires proficiency testing activities for 

the primary test system and for nonwaived testing only. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

The A2LA requirements for the 

submitted subspecialties and specialties 

are equal to the CLIA requirements at 

§ 493.1100 through § 493.1105. 

D. Subpart K—Quality System for 

Nonwaived Testing 

The A2LA requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.1200 through 

§ 493.1299. For instance, laboratories 


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16344 Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices 

that are performing waived testing in 

addition to moderate or high complexity 

testing will need to meet all 

requirements in subpart K, Quality 

System for Nonwaived Testing. The 

A2LA has more specific requirements 

for laboratory information systems than 

CLIA. In addition, prior to adding a new 

test to the laboratory’s accreditation, the 

A2LA requires the laboratory to submit 

performance specifications for review 

and approval. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the A2LA’s 

requirements are equal to or more 

stringent than the CLIA requirements at 

§ 493.1403 through § 493.1495 for 

laboratories that perform moderate and 

high complexity testing. Under the 

A2LA’s requirements, laboratories that 

perform moderate complexity testing 

must meet the personnel requirements 

for high complexity testing located at 

§ 493.1441 through § 493.1495. 

F. Subpart Q—Inspections 

We have determined that the A2LA 

requirements for the submitted 

subspecialties and specialties are equal 

to or more stringent than the CLIA 

requirements at § 493.1771 through 

§ 493.1780. The A2LA requires a two 

day onsite surveillance visit one year 

after the initial accreditation is granted. 

The A2LA requires annual review of all 

accredited laboratories. The laboratory 

is required to submit any updates on 

information about its organization, 

facilities, key personnel and results of 

any proficiency testing. Laboratories 

may be required to undergo an onsite 

surveillance visit if they do not submit 

their annual review documentation to 

the A2LA by the established 30 day 

deadline, if significant changes to the 

facility or organization have occurred, 

or if proficiency testing results have 

been consistently poor. The CLIA 

regulations do not have this 

requirement. 

G. Subpart R—Enforcement Procedures 

The A2LA meets the requirements of 

subpart R to the extent that it applies to 

accreditation organizations. The A2LA 

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 

A2LA will deny, suspend, or revoke 

accreditation in a laboratory accredited 

by the A2LA and report that action to 

us within 30 days. The A2LA also 

provides an appeals process for 

laboratories that have had accreditation 

denied, suspended, or revoked. 

We have determined that the A2LA’s 

laboratory enforcement and appeal 

policies are equal to 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 the A2LA 

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 the A2LA 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 A2LA, 

for cause, before the end of the effective 

date of approval. If we determine that 

the A2LA 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 the A2LA would be 

allowed to address any identified issues. 

Should the A2LA be unable to address 

the identified issues within that 

timeframe, we may, in accordance with 

the applicable regulations, revoke 

A2LA’s deeming authority under CLIA. 

Should circumstances result in our 

withdrawal of the A2LA’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 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. 

Authority: Section 353 of the Public Health 

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

Dated: March 14, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–06512 Filed 3–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0250] 

Draft Guidance for Industry on 

Labeling for Human Prescription Drug 

and Biological Products Approved 

Under the Accelerated Approval 

Regulatory Pathway; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Labeling for Human 

Prescription Drug and Biological 

Products Approved Under the 

Accelerated Approval Regulatory 

Pathway.’’ This draft guidance discusses 

FDA’s recommendations for developing 

the indication and usage statements in 

the prescribing information for drugs 

approved under the accelerated 

approval regulatory pathway (hereafter 

‘‘accelerated approval’’). The guidance 

also discusses labeling considerations 

for indications approved under 

accelerated approval when clinical 

benefit has been verified and FDA 

terminates the conditions of accelerated 

approval, or when FDA withdraws 

accelerated approval of an indication 

while other indications for the drug 

remain approved. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 27, 2014. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 


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