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63. Deming, M., R. Tauxe, P. Blake et al.,

‘‘Campylobacter Enteritis at a University:

Transmission From Eating Chicken and From

Cats,’’ American Journal of Epidemiology,

vol. 126, no. 3, pp. 526–534, 1987.

64. Hopkins, R., R. Olmsted, and G. Istre,

‘‘Endemic Campylobacter jejuni Infection in

Colorado: Identified Risk Factors,’’ American

Journal of Public Health, 74(3), pp. 249–250,

1984.

65. Skirrow, M. B., M. J. Blaser, ‘‘Clinical

Aspects of Campylobacter Infection,’’ In:

Campylobacter, edited by I. Nachamkin and

M. Blaser, 2d ed., America Society

Microbiology, Washington, DC, pp. 69–88,

2000.

66. Altekruse, S., N. Stern, P. Fields, and

D. Swerdlow, ‘‘Campylobacter Jejuni—an

Emerging Foodborne Pathogen,’’ Emerging

Infectious Diseases, 5(1), pp. 28–35, 1999.

67. Saeed, A., N. Harris, and R. DiGiacomo,

‘‘The Role of Exposure to Animals in the

Etiology of Campylobacter Jejuni/coli

enteritis,’’ American Journal of

Epidemiology, 137(1), pp. 108–114, 1993.

68. Shane, S., ‘‘Campylobacteriosis,’’ In:

Diseases of Poultry, edited by B. Calnek, H.

Barnes, C. Beard, et al., 10th ed., Iowa State

University Press, Ames, pp. 235–245, 1997.

69. U.S. Department of Agriculture Food

Safety Inspection Service, Microbiology

Division, Nationwide Broiler Chicken

Microbiological Baseline Data Collection

Program, July 1994–June 1995 pp. 1–34,

April 1996.

70. U.S. Department of Agriculture Food

Safety Inspection Service, Microbiology

Division, Nationwide Raw Ground Chicken

Microbiological Survey pp 1–8, May 1996.

71. U.S. Department of Agriculture Food

Safety Inspection Service, Microbiology

Division, Nationwide Raw Ground Turkey

Microbiological Survey pp.1–8, May 1996.

72. Doyle, M. and J. Schoeni, ‘‘Isolation of

Campylobacter Jejuni From Retail

Mushrooms,’’ Applied and Environmental

Microbiology, 51(2), pp. 449–50, 1986.

73. Nachamkin, I., B. M. Allos, T. W. Ho,

‘‘Campylobacter Jejuni Infection and the

Association With Guillain-Barre Syndrome,’’

In: Campylobacter, edited by I. Nachamkin

and M. Blaser, 2d ed., American Society

Microbiology, Washington, DC, pp. 155–175,

2000.

74. Petruccelli, B. P., G. S. Murphy, J. L.

Sanchez, S. Walz, R. DeFraites, J. Gelnett, R.

L. Haberberger, P. Echeverria, and D. N.

Taylor, ‘‘Treatment of Traveler’s Diarrhea

With Ciprofloxacin and Loperamide,’’

Journal of Infectious Diseases, 165, pp. 557–

560, 1992.

75. FDA, CVM, Guideline: General

Principles for Evaluating the Safety of

Compounds Used in Food-Producing

Animals, July 1994.

Dated: October 24, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–27832 Filed 10–26–00; 10:43

am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Renewals

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

renewals of certain FDA advisory

committees by the Commissioner of

Food and Drugs (the Commissioner).

The Commissioner has determined that

it is in the public interest to renew the

charters of the committees listed below

for an additional 2 years beyond charter

expiration date. The new charters will

be in effect until the dates of expiration

listed below. This notice is issued under

the Federal Advisory Committee Act of

October 6, 1972 (Pubic Law 92–463 (5

U.S.C. app. 2)).

DATES: Authority for these committees

will expire on the dates indicated below

unless the Commissioner formally

determines that renewal is in the public

interest.

Name of committee Date of expiration

Gastrointestinal Drugs Advisory Committee March 3, 2002

Advisory Committee for Reproductive Health Drugs March 23, 2002

Arthritis Advisory Committee April 5, 2002

Veterinary Medicine Advisory Committee April 24, 2002

Anesthetic and Life Support Drugs Advisory Committee May 1, 2002

Blood Products Advisory Committee May 13, 2002

Pulmonary-Allergy Drugs Advisory Committee May 30, 2002

Drug Abuse Advisory Committee May 31, 2002

Science Advisory Board to the National Center for Toxicological ResearchJune 2, 2002

Peripheral and Central Nervous System Drugs Advisory Committee June 4, 2002

Psychopharmacologic Drugs Advisory Committee June 4, 2002

Transmissible Spongiform Encephalopathies Advisory Committee June 9, 2002

Science Board to the Food and Drug Administration June 26, 2002

Allergenic Products Advisory Committee July 9, 2002

Cardiovascular and Renal Drugs Advisory Committee August 27, 2002

Endocrinologic and Metabolic Drugs Advisory Committee August 27, 2002

Oncologic Drugs Advisory Committee September 1, 2002

64966 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee

Management Office (HFA–306), Food

and Drug Administration, 5600 Fishers

Lane, Rockville MD 20857, 301–827–

5496.

Dated: October 23, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27835 Filed 10–30–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2118–N]

Medicare, Medicaid, and CLIA

Programs; Continuance of the

Approval of COLA as a CLIA

Accreditation Organization

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

continued approval of COLA (formerly

the Commission on Office Laboratory

Accreditation) as an accreditation

organization for laboratories under the

Clinical Laboratory Improvement

Amendments of 1988 (CLIA) program.

We have found that the accreditation

process of this organization provides

reasonable assurance that the

laboratories accredited by it meet the

conditions required by CLIA law and

regulations. Consequently, laboratories

that voluntarily become accredited by

COLA in lieu of direct Federal oversight

and continue to meet COLA

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.

They are, however, subject to Federal

validation and complaint investigation

surveys.

EFFECTIVE DATE: This notice is effective

for the period October 31, 2000, through

December 31, 2002.

FOR FURTHER INFORMATION CONTACT: Val

Coppola, (410) 786–3531.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative

Authority

On July 31, 1992, HCFA issued a final

rule (57 FR 33992). Under section

353(e)(2) of the Public Health Service

Act (PHSA), HCFA may approve a

private, nonprofit organization to

accredit clinical laboratories (an

‘‘approved accreditation organization’’)

under the Clinical Laboratory

Improvement Amendments of 1988

(CLIA) program 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 Code

of Federal Regulations (CFR), part 493

(Laboratory Requirements). Therefore, 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

if it were inspected against CLIA

regulations. The regulations listed in

subpart E (Accreditation by a Private,

Nonprofit Accreditation Organization or

Exemption Under an Approved State

Laboratory Program) of part 493 specify

the requirements an accreditation

organization must meet to be an

approved accreditation organization.

HCFA approves an accreditation

organization for a period not to exceed

6 years.

In general, the 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 HCFA.

• Apply standards and criteria that

are equal to or more stringent than those

condition level requirements

established by HCFA when taken as a

whole.

• Provide reasonable assurance that

these standards and criteria are

continually met by its accredited

laboratories;

• Provide HCFA 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 HCFA in writing at least 30

days before the effective date of any

proposed changes in its standards.

• If HCFA withdraws its approval,

notify the accredited laboratories of the

withdrawal 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 to HCFA records and other

information HCFA may require.

Along with requiring the

promulgation of criteria for approving

the accreditation body and for

withdrawing this approval, CLIA

requires HCFA to perform an annual

evaluation by inspecting a sufficient

number of laboratories accredited by an

approved accreditation organization as

well as by any other means that HCFA

determines appropriate.

II. Notice of Continued Approval of

COLA as an Accreditation Organization

In this notice, we approve COLA as an

organization that may continue to

accredit laboratories for purposes of

establishing their compliance with CLIA

requirements. HCFA and Centers for

Disease Control and Prevention (CDC)

have examined the COLA application

and all subsequent submissions to

determine equivalency with HCFA

requirements under subpart E of part

493 that an accreditation organization

must meet to be granted approved status

under CLIA. We have determined that

COLA has complied with the applicable

CLIA requirements as of October 31,

2000, and grant COLA approval as an

accreditation organization under

subpart E, through August 31, 2002, for

the following specialty/subspecialty

areas:

• Bacteriology.

• Mycobacteriology.

• Mycology.

• Parasitology.

• Virology.

• Syphilis Serology.

• General Immunology.

• Routine Chemistry.

• Endocrinology.

• Toxicology.

• Urinalysis.

• Hematology.

• Immunohematology.

As a result of this determination, any

laboratory that is accredited by COLA

during this time period for an approved

specialty/subspecialty (listed above) is

deemed to meet the applicable CLIA

condition level requirements for the

laboratories found in part 493 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 HCFA, or by any other

Federal or State or local public agency

or nonprofit private organization under

an agreement with the Secretary.

III. Evaluation of COLA

The following describes the process

used to determine that COLA, as a

private, nonprofit organization, provides

reasonable assurance that laboratories it

accredits will meet the applicable

requirements of the CLIA and applicable

regulations.