[Federal Register Volume 66, Number 177 (Wednesday, September 12, 2001)]
[Notices]
[Pages 47493-47497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22822]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2119-N]


Medicare, Medicaid, and CLIA Programs; Continuance of the 
Approval of the College of American Pathologists as a CLIA 
Accreditation Organization

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the continuance of the approval of the 
College of American Pathologists (CAP) as an accreditation organization 
for laboratories under the Clinical Laboratory Improvement Amendments 
of 1988 (CLIA). We found that the accreditation process of this 
organization provides reasonable assurance that the laboratories 
accredited by it meet the conditions required by CLIA statute and 
regulations. Consequently, laboratories that voluntarily become 
accredited by CAP in lieu of direct Federal oversight and continue to 
meet CAP requirements would 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 CLIA 
requirements. However, they are subject to Federal validation and 
complaint investigation surveys.

EFFECTIVE DATE: This notice is effective for the period September 12, 
2001 through September 30, 2007.

FOR FURTHER INFORMATION CONTACT: Val Coppola, (410) 786-3531.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    On July 31, 1992, we published a final rule in the Federal Register 
(57 FR 33992) that implemented section 353(e)(2) of the Public Health 
Service Act. Under this rule CMS may approve a private, nonprofit 
organization to accredit clinical laboratories (that is, an approved 
accreditation organization) under the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) 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). 
A laboratory accredited by an approved accreditation organization that 
meets and continues to meet all of the accreditation organization's 
requirements would be considered to meet CLIA condition level 
requirements as if it was inspected against CLIA regulations. The 
regulations in 42 CFR part 493, 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 in order to be approved. CMS approves an 
accreditation organization for a period not to exceed 6 years.

[[Page 47494]]

    In general, an approved accreditation organization must, among 
other conditions and requirements:
     Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by CMS.
     Apply standards and criteria that are equal to, or more 
stringent than, those condition level requirements established by CMS 
when taken as a whole.
     Provide reasonable assurance that these standards and 
criteria are continuously met by its accredited laboratories.
     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 in writing at least 30 days before the 
effective date of any proposed change in its standards.
     Notify the accredited laboratories of CMS's decision to 
withdraw its approval within 10 days of the withdrawal. A laboratory 
can be accredited if, among other things, it meets the standards of an 
approved accreditation organization and authorizes the accreditation 
body to submit records and other information to CMS as required.
    In addition to requiring the promulgation of criteria for approving 
and withdrawing the approval of an accreditation body, CLIA requires 
CMS to perform an annual evaluation by inspecting a sufficient number 
of laboratories accredited by an accreditation organization, as well 
as, by any other means that CMS determines appropriate.

I. Notice of Continued Approval of CAP as an Accreditation 
Organization

    In this notice, we approve CAP as an organization that may continue 
to accredit laboratories for purposes of establishing their compliance 
with CLIA. The Centers for Disease Control and Prevention and CMS 
(hereinafter referred to as ``we'') have examined the CAP application 
and all subsequent submissions to determine equivalency with the 
requirements under 42 CFR part 493, subpart E that an accreditation 
organization must meet to be granted approved status under CLIA. We 
have determined that CAP has complied with the applicable CLIA 
requirements and grant CAP approval as an accreditation organization 
under 42 CFR part 493, subpart E, September 12, 2001 through September 
30, 2007, for all specialty and subspecialty areas under CLIA.
    As a result of this determination, any laboratory that is 
accredited by CAP during this time period for an approved specialty or 
subspecialty is deemed to meet the applicable CLIA condition level 
requirements for laboratories found in 42 CFR part 493 and, therefore, 
is not subject to routine inspection by a State survey agency to 
determine compliance with CLIA requirements. However, the accredited 
laboratory is subject to validation and complaint investigation surveys 
performed by CMS, or any other Federal, State, local public agency, or 
nonprofit organization under an agreement with the Secretary.

III. Evaluation of CAP

    The following describes the process used to determine that CAP, as 
a private, nonprofit organization, provides reasonable assurance that 
the laboratories it accredits will meet the applicable requirements of 
CLIA.

A. Requirements for Approving an Accreditation Organization Under CLIA

    To determine whether CMS should grant approval to CAP as a private, 
nonprofit organization for accrediting laboratories under CLIA for all 
requested specialty, and subspecialty areas of human specimen testing, 
we conducted a detailed and in-depth comparison of CAP's laboratory 
requirements to CLIA laboratory requirements. Our evaluation determined 
whether CAP meets the following requirements:
     Provides reasonable assurance to us that it requires the 
laboratories it accredits to meet requirements that are equal to, or 
more stringent than, the CLIA condition level requirements (for the 
requested specialties and subspecialties) and would therefore, meet the 
condition level requirements of CLIA if those laboratories had not been 
granted deemed status, and had been inspected against condition level 
requirements.
     Meets the applicable requirements of 42 CFR part 493, 
subpart E.
    As specified in the regulations of 42 CFR part 493, subpart E, our 
review of a private, nonprofit accreditation organization seeking 
approved status under CLIA, includes, but is not limited to, an 
evaluation of the following:
     Whether the organization's requirements for its accredited 
laboratories are equal to, or more stringent than, the condition level 
requirements of the CLIA regulations.
     The organization's inspection process to determine the:
    --Composition of the inspection teams, qualifications of the 
inspectors, and the ability of the organization to provide continuing 
education and training to all of its inspectors.
    --Comparability of the organization's full inspection and complaint 
inspection requirements to the Federal requirements including, but not 
limited to inspection frequency, and the ability to investigate and 
respond to complaints against its accredited laboratories.
    --Organization's procedures for monitoring laboratories that are 
out of compliance with its requirements.
    --Organization's ability to provide CMS with electronic data and 
reports that are necessary for effective validation and assessment of 
the organization's inspection process.
    --Organization's ability to provide CMS with electronic data 
related to the adverse actions resulting from unsuccessful proficiency 
testing (PT) participation in CMS-approved PT programs, as well as, 
data related to the PT failures, within 30 days of the initiation of 
the action.
    --Ability of the organization to provide CMS with electronic data 
for all its accredited laboratories, and the areas of specialty and 
subspecialty testing.
    --Adequate numbers of staff and other resources.
    --Organization's ability to provide adequate funding for performing 
the required inspections.
     The organization's agreement with CMS that requires it, 
among other things, to meet the following requirements:
    --Notify CMS of any laboratory that has had its accreditation 
denied, limited, suspended, withdrawn, or revoked by the accreditation 
organization, or any other adverse action taken against it by the 
accreditation organization within 30 days of such action.
    --Notify CMS within 10 days of a deficiency identified in an 
accredited laboratory if the deficiency poses an immediate jeopardy to 
the patients of the laboratory or a hazard to the general public.
    --Notify CMS of all newly accredited laboratories, or laboratories 
whose areas of specialty or subspecialty are revised, within 30 days.
    --Notify each laboratory accredited by the organization within 10 
days of CMS's withdrawal of approval of the organization as an 
accreditation organization.
    --Provide CMS with inspection schedules as requested, for the 
purpose of conducting onsite validation inspections.
    --Provide our agent, the State survey agency, or CMS with any 
facility-specific data that includes, but is not limited to, PT results 
that constitute unsuccessful participation in an approved PT program 
and notification

[[Page 47495]]

of the adverse actions or corrective actions imposed by the 
accreditation organization as a result of unsuccessful PT 
participation.
    --Provide CMS with written notification at least 30 days in advance 
of the effective date of any proposed changes in its requirements.
    --Provide upon the request by anyone, on a reasonable basis (and 
subject to applicable State law concerning disclosure of confidential 
information), any laboratory's PT results with the explanatory 
information needed to assist in the interpretation of the results.
    Laboratories that are accredited by an approved accreditation 
organization, among other things must comply with the following 
requirements:
     Authorize the organization to release to CMS all records 
and information required.
     Permit inspections as required by the CLIA regulations at 
42 CFR part 493, subpart Q (Inspection).
     Obtain a certificate of accreditation as required by 
Sec. 493.55 (Application for registration certificate and certificate 
of accreditation).

B. Evaluation of the CAP Request for Continued Approval as an 
Accreditation Organization Under CLIA

    CMS has examined CAP's assurance that it requires the laboratories 
it accredits to be, and that the organization is in compliance with the 
following subparts of part 493:
1. Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program
    CAP has requested continued approval to accredit all specialties 
and subspecialties, and has submitted the following:
     Description of its inspection process, policies, PT 
monitoring process, and data management and analysis system.
     List of its inspection team size, composition, and 
education and experience.
     Investigative and complaint response procedures.
     CMS's notification agreements.
     Procedures for the removal or withdrawal of accreditation 
from a laboratory.
     Current list of accredited laboratories with announced or 
unannounced inspection process.
    We have determined that CAP has complied with the requirements 
under CLIA for approval as an accreditation organization under this 
subpart.
    Our evaluation identified areas of the CAP requirements that are 
more stringent than the CLIA requirements and apply to the laboratory 
as a whole. Rather than include them in the appropriate subparts 
multiple times, we list them here:
     CAP requires the directors of its accredited laboratories 
to sign an attestation that their laboratory(ies) are in compliance 
with all applicable Federal, State, and local laws.
     CAP lists extensive requirements for the Laboratory 
Information System (LIS) that include but, are not limited to the 
following areas:
    --Preservation, storage, and retrieval of laboratory and patient 
data.
    --Review of LIS programs for appropriate content and testing before 
use, when a new program is to be put in place, or when changes are made 
to existing programming.
    --Maintenance of the LIS facility (must be clean, well ventilated, 
and at proper temperature and humidity).
    --Protection of LIS against power interruptions and surges.
    --Readily available procedure manuals for LIS operators, adequately 
trained operators that know how to preserve data and equipment in 
emergency situations (for example, fire, software or hardware failure).
    --Protection of the LIS, its data, patient information, and 
programs from unauthorized use.
    --Entry of data and result reporting.
    --Verification and maintenance of LIS hardware and software.
    --Routine and emergency service and maintenance of the LIS.
    --Evaluation from the laboratory director of the LIS performance as 
it pertains to patient and clinician needs.
     CAP accredits laboratories that perform testing for any of 
the following areas and sets specific standards with which accredited 
laboratories must comply:
    --Athletic drug testing (for anabolic steroids, beta-blackers, 
cannabinoids, narcotics, and stimulants).
    --Forensic urine drug testing.
    --Parentage testing.
    --Reproductive laboratory testing (embryology).
2. Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Tests of Moderate Complexity (Including the Subcategory), 
High Complexity, or Any Combination of These Tests
    The CAP requirements for PT are in conformance with the CLIA 
statute that states the standards accreditation organizations must 
require all laboratories be tested by PT for each examination for which 
PT is available. The CAP PT requirements are more stringent than the 
CLIA regulations in Subpart I that lists specific tests in which the 
laboratory must enroll and participate in a CMS-approved PT program. 
CLIA exempts waived testing from PT, whereas CAP requires its 
accredited laboratories to participate in a CMS-approved PT program for 
all testing, including procedures waived under CLIA.
    We have determined that the actions taken by CAP to correct 
unsatisfactory (one failure) PT performance are equivalent to those of 
CLIA and that the actions taken to correct unsuccessful (2 in a row or 
2 out of 3 failures) PT performance of its laboratories are more 
stringent than those of CLIA. CAP utilizes an on-going electronic 
monitoring process that flags both unsatisfactory and unsuccessful 
results for all PT performance, both CLIA required analytes and all 
other testing for which PT is available and is required by CAP.
    CAP accredited laboratories are allowed 15 days to respond in 
writing to each unsatisfactory result. The response must indicate how 
the problem was investigated, the cause of the problem, the specific 
corrective action that was taken to prevent recurrence, and evidence 
that the problem was successfully corrected. CLIA regulations state 
that the laboratory must undertake appropriate training and employ the 
technical assistance that is necessary to correct problems associated 
with an unsatisfactory score, take remedial action, and document all 
steps taken.
    Unsuccessful PT performance, when identified by CAP, initiates 
immediate communication with the laboratory director. A written 
response must be submitted to CAP, explaining why the adverse results 
occurred, a description of the problem, and the actions taken to 
correct the problem. The laboratory must submit this information within 
10 working days. If, after review by CAP, it is determined that the 
laboratory's subsequent PT performance is within acceptable limits, no 
further action is taken. If the laboratory does not respond, fails to 
seriously address the problem, or cannot bring performance into 
acceptable limits, the CAP would evaluate the situation and either 
request that the laboratory cease testing for the analyte, specialty, 
or subspecialty in question, or, if warranted, revoke accreditation.
    CLIA regulations allow a laboratory to undertake training of its 
personnel or to obtain technical assistance or both, when the initial 
unsuccessful PT performance occurs instead of imposing alternative or 
principal sanctions.

[[Page 47496]]

    CAP also requires its accredited laboratories performing GYN 
cytology to participate in its external quality assurance program for 
PAP smear cytology. The Interlaboratory Comparison Program in 
Cervicovaginal Cytopathology currently enrolls all of CAP's 2,793 
accredited laboratories that perform GYN cytology. This program is a 
cervicovaginal cytopathology proficiency testing survey, in which all 
CAP accredited laboratories are required to participate. Currently 
there is no CMS-approved cytology PT program capable of enrolling all 
CLIA certified laboratories that perform GYN cytology testing.
3. Subpart J--Patient Test Management for Moderate Complexity 
(Including the Subcategory), High Complexity or Any Combination of 
These Tests
    The CAP requirements are equivalent to the CLIA requirements at 
Secs. 493.1101 through 493.1111. We have determined that CAP's 
requirements for an accredited laboratory include on report forms the 
dates and times of specimen collection (when appropriate), is more 
stringent than the requirements under CLIA.
4. Subpart K--Quality Control for Tests of Moderate Complexity 
(Including the Subcategory), High Complexity, or Any Combination of 
These Tests
    The quality control (QC) requirements of CAP have been evaluated 
against the phased-in, complexity based requirements of the CLIA 
regulations. We have determined that the QC requirements of CAP are 
more stringent than the CLIA requirements, when taken as a whole. Some 
specific areas of QC that are more stringent are as follows:
     The CAP laboratory safety requirements are specific and 
detailed.
    --Environmental safety requirements address electrical voltage, 
facility ventilation, lighting, temperature, humidity, emergency power 
source, and require remedial actions to be taken when necessary.
    --Requirements are in place for handling and disposal of 
biohazardous materials, fire safety and prevention of fire hazards, and 
OSHA regulations related to laboratories.
     The CAP requires procedure manuals to include the 
principal and clinical significance for each test, and their procedure 
manuals must include documentation of initial and annual reviews.
     CLIA regulations allow cytology slide preparations made 
using automated, semi-automated, or other liquid-based slide 
preparations that cover half or less of a slide to be counted as one 
half slide for cytology workload purposes. This allows a maximum of 200 
preparations to be examined by an individual in a 24-hour period. The 
CAP does not recognize these preparations as half slides, but rather as 
full slides to be included in an individual's 100 slide, 24-hour 
maximum allowable workload.
     CAP requires its accredited laboratories to use the 
appropriate reagent grade water for the testing performed, stating 
which type of water (from type I through type III) must be used in 
specific tests. Source water also must be evaluated for silicone 
levels.
     CAP accredited laboratories must verify all volumetric 
glassware and pipettes for accuracy and reproductability before use, 
and must recheck them periodically. These activities must be 
documented.
     CAP accredited laboratories that perform maternal serum 
alpha-fetoprotein, and amniotic fluid alpha-fetoprotein have specific 
requirements that must be met. These include a qualitative specimen 
evaluation, requesting and reporting information necessary for 
interpretation of results, for example, gestational age, maternal birth 
date, race, maternal weight, insulin-dependent diabetes mellitus, 
multiple gestations, median ranges calculated and recalculated yearly, 
results reported in multiples of the mean.
     The CAP lists specific requirements for newer 
methodologies. Molecular pathology and flow cytometry standards are 
presented in separate checklists and immunohistochemistry has specific 
requirements within histology.
     CAP retention requirements are the same or longer than 
those of CLIA.
5. Subpart M--Personnel for Moderate and High Complexity (Including the 
Subcategory) and High Complexity Testing
    The Standards for Laboratory Accreditation of the CAP states at 
Standard I, Director and Personnel Requirements (under item D, 
Personnel), that all laboratory personnel must be in compliance with 
applicable Federal, State, and local laws and regulations. This 
standard is implemented in the general laboratory requirement that 
there must be evidence in personnel records that all testing personnel 
have been evaluated against CLIA regulatory requirements for high 
complexity testing, and that all individuals qualify. CAP holds all 
technical personnel in its accredited laboratories to the CLIA high 
complexity personnel requirements. Therefore, we have determined that 
the personnel requirements of the CAP are more stringent than the 
personnel requirements of CLIA, when taken as a whole.
6. Subpart P--Quality Assurance for Moderate Complexity (Including the 
Subcategory) or High Complexity Testing, or Any Combination of These 
Tests
    We have determined that CAP's requirements are equal to, or more 
stringent than, the CLIA requirements of this subpart. CAP also offers 
an educational program (Q-Probes) to its accredited laboratories, that 
provides further information on quality assurance to the large, full 
service laboratories, that allows peer review and comparisons between 
facilities.
7. Subpart Q--Inspection
    We have determined that the CAP inspection requirements, taken as a 
whole, are equivalent to the CLIA inspection requirements. CAP has 
continued its Laboratory Accreditation Programs Inspection Training 
Seminars program. In the year 2000, there were 8 regional training 
programs held (hosting 747 participants) and 13 national training 
programs (hosting 433 participants) with 12 ad hoc training sessions 
presentations. In addition, 4 audio training conferences were held in 
which 6,351 inspection team leaders and team members participated.
    The CAP will continue its policy of biennial on-site announced 
inspections. An unannounced inspection would be performed when a 
complaint, lodged against a CAP accredited laboratory, indicates that 
problems exist within that laboratory that are likely to have serious 
and immediate effects on patient care.
    CAP requires a mid-cycle self-inspection of all accredited 
laboratories. All requirements for the mid-cycle self-inspection must 
be responded to in writing, and the responses must be submitted to CAP 
within a specified timeframe. CLIA regulations do not have this 
requirement.
8. Subpart R--Enforcement Procedures
    CAP meets the requirements of Subpart R to the extent that it 
applies to accreditation organizations. CAP policy stipulates the 
actions it takes when laboratories it accredits do not comply with its 
requirements and standards for accreditation. As demonstrated during 
its first period of approval, CAP denies accreditation to a laboratory 
when appropriate, and reports the denial to CMS within 30 days. CAP 
also provides an appeal process for laboratories that have had 
accreditation denied.

[[Page 47497]]

    Some specific actions CAP takes in response to non-compliance or 
violation of its requirements or standards for accreditation include:
     When an accredited laboratory is identified as having 
intentionally referred a PT specimen to another laboratory for 
analysis, the CAP laboratory will be denied accreditation and be 
ineligible for CAP accreditation for 1 year. This action is similar to 
the CMS action of denial of certification for 1 year.
     When a CAP accredited laboratory participates 
unsuccessfully in PT for an analyte, subspecialty, or specialty, the 
laboratory must initiate corrective actions. The laboratory must submit 
to CAP documentation of a detailed investigation of the problem causing 
the unsuccessful performance with a corrective action plan within 10 
working days. Specific educational activity or the retention of the 
services of a consultant may be imposed. Failure to bring PT 
performance into acceptable limits or failure to seriously address the 
PT problem would cause CAP to request the laboratory to cease testing 
for the procedure(s) in question or, if warranted, revoke the 
laboratory's accreditation. This action is equivalent to the actions 
that CMS may take under this section.
     When CAP becomes aware of a problem in an accredited 
laboratory that is so severe and extensive that it could cause a 
serious risk of harm (immediate jeopardy) situation, an expedited 
evaluation is immediately undertaken by the Chair and Vice Chair of the 
Accreditation Committee, the Regional Commissioner and the Director of 
the Laboratory Accreditation Program. If it is determined that an 
immediate jeopardy situation exists, the laboratory is required to 
remove the jeopardy situation immediately or accreditation would be 
revoked. An on-site focused re-inspection may be performed to verify 
that the immediate jeopardy no longer exists. These actions are similar 
to CMS actions for immediate jeopardy.
     The CAP requires its accredited laboratories to correct 
all deficiencies within 30 days. CLIA deficiencies that are not 
condition level must be corrected in a timeframe that is acceptable to 
CMS, but no longer than 12 months. CLIA deficiencies that are condition 
level that are not considered immediate jeopardy must be corrected in 
an acceptable timeframe; however, CMS may impose one or more alternate 
sanctions or a principal sanction to motivate laboratories to correct 
these deficiencies. The CAP timeframe for correction of deficiencies, 
when taken as a whole, is more stringent than CLIA.
    We have determined that CAP's laboratory enforcement and policies 
are equivalent to the requirements of this subpart as they apply to 
accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

    The Federal validation inspections of CAP accredited laboratories 
may be conducted on a representative sample basis or in response to 
substantial allegations of noncompliance (complaint inspections). The 
outcome of those validation inspections, performed by our agent, the 
State survey agency, or us, will be CMS's principal means for verifying 
that the laboratories accredited by CAP 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 remove the approval of an 
accreditation organization (for example, CAP) for cause, before the end 
of the effective date of approval. If validation inspection outcomes, 
and the comparability, or validation review produce findings as 
described in Sec. 493.573 (Continuing Federal oversight of private 
nonprofit accreditation organizations and approved State licensure 
program), CMS will conduct a review of an approved accreditation 
organization's program. In addition, we will conduct a review, when the 
validation review findings, irrespective of the rate of disparity (as 
defined in Sec. 493.2), indicate systematic problems in the 
organization's processes that provide evidence that the organization's 
requirements, taken as a whole, are no longer equivalent to the CLIA 
requirements, taken as a whole.
    If CMS determines that CAP has failed to adopt or maintain 
requirements that are equal to, or more stringent than, the CLIA 
requirements, or systematic problems exist, CMS may give a probationary 
period, not to exceed 1 year, to CAP to adopt equal, or more stringent 
requirements. CMS will determine whether CAP retains its approved 
status as an accreditation organization under CLIA. If approved status 
is withdrawn, an accreditation organization such as CAP may resubmit 
its application to CMS if it revises its program to address the 
rationale for the denial, demonstrates that it can reasonably assure 
that its accredited laboratories meet CLIA condition level 
requirements, and resubmits its application for approval as an 
accreditation organization in its entirety. However, if an approved 
accreditation organization requests reconsideration of an adverse 
determination in accordance with subpart D (Reconsideration of Adverse 
Determinations--Deeming Authority for Accreditation Organizations and 
CLIA Exemption of Laboratories Under State Programs) of part 488 
(Survey, Certification, and Enforcement Procedures) of our regulations, 
it may not submit a new application until CMS issues a final 
reconsideration determination. If circumstances result in CAP having 
its approval withdrawn, we will publish a notice in the Federal 
Register explaining the basis for removing its approval.

Federalism

    We have reviewed this notice under the threshold criteria of 
Executive Order 13132, Federalism, and have determined that this notice 
will not have any negative impact on the rights, roles, and 
responsibilities of State, local, or tribal governments.

OMB Review

    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: July 18, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-22822 Filed 9-11-01; 8:45 am]
BILLING CODE 4120-01-P