Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices 25493

I. Background

Section 353 of the Public Health

Service Act (PHSA), as amended by the

Clinical Laboratory Improvement Act of

1988 (CLIA), requires laboratories that

perform tests on human specimens to

meet the requirements we establish.

Laboratories that also request to be paid

for services furnished to Medicare

beneficiaries must meet the

requirements of section 353 of the

PHSA, as stipulated in section 6141 of

the Omnibus Budget Reconciliation Act

of 1989, Public Law 101–239. Subject to

specific exceptions, laboratories must

have a current and valid CLIA certificate

to test human specimens to receive

payment from the Medicare or Medicaid

programs. Regulations implementing

section 353 of the PHSA are contained

in 42 CFR part 493 (Laboratory

Requirements).

Section 353(p) of the PHSA authorizes

us to exempt from the CLIA

requirements laboratories located in a

State that applies laboratory licensure

requirements equal to or more stringent

than those of CLIA. Part 493, subpart E

(Accreditation by a Private, Nonprofit

Accreditation Organization or

Exemption Under an Approved State

Laboratory Program) implements section

353(p) of the PHSA.

Section 493.553 sets forth the

information that must be submitted with

a State licensure program’s application

for CLIA approved status. Sections

493.551 and 493.553 provide that we

may exempt from CLIA requirements,

for a period not to exceed 6 years, State

licensed or approved laboratories in a

State if the State licensure program

meets specific conditions. After that

time, the State must re-apply to us for

continued exemption. Section

493.575(f) provides that we will publish

a notice in the Federal Register

containing justification for removing the

CLIA approved status of a State

licensure program.

II. CLIA Exemption of Licensed Oregon

State Laboratories

The State of Oregon’s period of

exemption began on June 13, 1996, with

the publication of our notice entitled,

‘‘Medicare, Medicaid, and CLIA

Programs; Clinical Laboratory

Improvement Amendments of 1988

Exemption of Laboratories in the State

of Oregon,’’ in the Federal Register (61

FR 30072). That exemption period

expired December 31, 1999. The State of

Oregon has formally notified us that it

will not be re-applying for exemption of

its licensed laboratories located within

the State. Without an application for

continued approval of Oregon’s

licensure program, we cannot continue

to exempt Oregon laboratories from the

CLIA requirement.

III. Removal of CLIA Approval of the

State of Oregon’s Laboratory Licensure

Program

The nearly 41⁄2-year exemption period

that we granted to laboratories in the

State of Oregon expired on December

31, 1999. Therefore, we are removing

the CLIA approved status of Oregon’s

licensure program effective May 2, 2000.

Authority: Section 353 of the Public Health

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

Dated: March 3, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–10882 Filed 5–1–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1134–N]

Medicare Program; Open Public

Meeting on May 18, 2000 to Discuss

the Coverage of Drugs and Biologicals

that Cannot be Self-Administered

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting to obtain input on the

Medicare program policy for drugs and

biologicals which cannot be selfadministered and are furnished as an

incident to a physician’s professional

service. The meeting will provide an

opportunity for providers, suppliers,

beneficiaries, beneficiary advocates, and

other interested parties to furnish

information and raise issues about the

program’s policy concerning the selfadministration of drugs and biologicals.

DATES: The meeting is scheduled for

May 18, 2000 from 9:30 a.m. until 3:30

p.m.

ADDRESSES: The meeting will be held at

the Health Care Financing

Administration headquarters, in the

auditorium, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

FOR FURTHER INFORMATION CONTACT:

Heidi Adams, (410) 786–1620.

SUPPLEMENTARY INFORMATION: 

Background

As suggested by the report language

accompanying section 219 of the

Department of Health and Human

Services Appropriations Act, 2000

(Public Law 106–113), we are

announcing the first of two ‘‘town hall’’

meetings to discuss our current policy

regarding Medicare coverage of drugs

and biologicals which cannot be selfadministered and are furnished as an

incident to a physician’s professional

service.

The purpose of the May 18th meeting

is to obtain focused input on how this

statutory provision should reasonably

be interpreted; how the evolution of

medical technology has affected

physician practice in selfadministration; how different

interpretations of the provision might

affect considerations of fairness and

equity among beneficiary populations;

and how physician practice may be

affected by different interpretations. Due

to time constraints and the need to focus

on the above topics, the agency is

unable to undertake a discussion of

options or ideas that require a statutory

change.

The format of the meeting will

include an introduction and opening

statements by the administration,

followed by 15-minute presentations by

panel members. These statements will

discuss the historical development of

the ‘‘self-administered’’ issue and will

examine the current policy and

information that has been gathered on

the issue. Following the short

presentations, the meeting will move to

an open dialogue.

Individuals interested in making a

presentation at the meeting or who need

special arrangements should contact

Heidi Adams at (410) 786–1620 or via

e-mail at HAdams@hcfa.gov no later

than May 7, 2000. Individuals should

identify the topics they wish to discuss

during their presentation. Because of

time constraints, only a limited number

of individuals will be able to make

presentations. In an effort to assure that

all viewpoints are represented, we will

notify participants who are selected to

make a presentation. We will not assign

presentation times until after May 7,

2000.

While the meeting is open to the

public, attendance is limited to space

available. Individuals must register in

advance as described below.

Registration

The Center for Health Plans and

Providers will handle registration for

the meeting. Individuals may register by

sending a fax to the attention of Heidi

Adams at (410) 786–0169. At the time

of registration, please provide your

name, address, telephone number,

company name and fax number.

Receipt of your fax will constitute

confirmation of your registration.

25494 Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices

Meeting materials will be provided at

the time of the meeting.

If you have questions regarding

registration, please contact Heidi

Adams. We will accept written

comments, questions, or other materials

specifically dealing with the issue that

are received no later than 5 p.m. on May

7, 2000. Written submissions must be

sent to: Health Care Financing

Administration, ATTN: Heidi Adams,

C4–07–07, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

Authority: Section 1102 of the Social

Security Act (42 U.S.C. 1302).

(Catalog of Federal Domestic Assistance

Program No. 93.773 Medicare—Hospital

Insurance Program; and No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: April 26, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–10883 Filed 5–1–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Clarification—Fiscal Year (FY) 2000

Funding Opportunities Notice

AGENCY: Center for Substance Abuse

Treatment, Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Clarification of a Notice of

Funding Availability Regarding the

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Center for Substance Abuse Treatment

(CSAT) PRC Implementation Program

Funding Announcement.

SUMMARY: This notice is to inform the

public that a statement in the SAMHSA/

CSAT Guidance for Applicants No. TI

00–004 entitled, Cooperative Agreement

to Bridge the Gap: Phase II

Implementation of Community-Based

Practice/Research Collaboratives (Short

Title: PRC Implementation Program) has

been clarified. The Notice of Funding

Availability for the PRC Implementation

Program was published in the Federal

Register on March 28, 2000 (65 FR

16401–16403).

A sentence in the last paragraph of

Section II—Program Description,

subsection 3, Pilot and Knowledge

Application Evaluation Studies, has

been clarified by adding the words ‘‘per

year.’’ The revised sentence reads: ‘‘No

single Knowledge Application

Evaluation Study should exceed

$75,000 in direct costs per year.’’ The

full Guidance for Applicants is available

via the SAMHSA web site—

www.samhsa.gov, or from the National

Clearinghouse for Alcohol and Drug

Information (Telephone: 800–729–

6686).

Questions concerning the clarification

or other program issues may be directed

to: Frances Cotter, Project Director,

Office of Managed Care, Center for

Substance Abuse Treatment, SAMHSA,

Rockwall II, Suite 740, 5600 Fishers

Lane, Rockville, MD 20857, Telephone:

(301) 443–8796.

Dated: April 24, 2000.

Richard Kopanda,

Executive Office, Substance Abuse and

Mental Health Services Administration.

[FR Doc. 00–10838 Filed 5–1–00; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Office of the Secretary

Working Groups of the Invasive

Species Advisory Committee

AGENCY: Office of the Secretary, DOI.

ACTION: Establishment.

SUMMARY: This notice is published in

accordance with the provisions of the

Federal Advisory Committee Act (Pub.

L. 92–463). Pursuant to Executive Order

13112, the National Invasive Species

Council (Council) on behalf of the

Invasive Species Advisory Committee

(ISAC) is establishing working groups to

assist preparation of a National Invasive

Species Management Plan (Management

Plan) and ongoing stakeholder input to

assist ISAC and Council activities.

SUPPLEMENTARY INFORMATION:

Working Groups—Scope and Objectives

The purpose of the working groups is

to provide the ISAC and the Council

advice on a broad array of issues related

to preventing the introduction of

invasive species and providing for their

control and minimizing the economic,

ecological, and human health impacts

that invasive species cause. Six working

groups have been established as follows:

1. Communication, Outreach, and

Education

2. International Activities and

Cooperation

3. Policy and Regulation

4. Research, Information Sharing,

Documentation and Monitoring

5. Risk Analysis and Prevention

6. Management (Control and

Restoration)

The working groups will help

maintain a regular dialogue with

stakeholders to provide national

leadership regarding invasive species

issues. They will assist the ISAC and the

Council to (1) Prepare and issue a

Management Plan; (2) encourage

planning and action at local, tribal,

State, regional and ecosystem-based

levels to achieve the goals and

objectives of the management plan; (3)

develop recommendations for

international cooperation in addressing

invasive species; (4) develop, in

consultation with the Council on

Environmental Quality, guidance to

Federal agencies pursuant to the

National Environmental Policy Act on

invasive species matters; (5) facilitate

development of a coordinated network

to document, evaluate, and monitor

impacts from invasive species; (6)

facilitate establishment of an

information-sharing system on invasive

species that utilizes, to the greatest

extent practicable, the Internet; and (7)

support long-term continuance and

effective implementation of the

Management Plan.

Working groups have been organized

with federal and non-federal co-leaders.

The groups will utilize electronic

communications (email, listservers, and

web-based postings) to accelerate

development of Management Plan

input. The vision or scoping statements

developed by each working group will

reflect a more specific refinement of the

draft guiding principles now under

development by the ISAC. Priority

issues will be identified and the groups

will develop draft responses or actions

to be taken for consideration by the

ISAC. As part of the management

planning process, model projects will be

identified which improve coordination

and effectiveness and stimulate action.

The working groups will report to the

ISAC at least twice before the

Management Plan is due to be

completed in August, 2000. After

issuance of the plan, the working groups

will help implement the plan and begin

developing input for its biennial

revision.

Members of the working groups serve

without pay.

FOR FURTHER INFORMATION CONTACT:

Kelsey Passe ́, National Invasive Species

Council Program Analyst, Department of

the Interior; Email:

kelsey_passe@ios.doi.gov; Phone: (202)

208–6336; Fax: (202) 208–1526.

Dated: April 26, 2000.

William Y. Brown,

Science Advisor to the Secretary.

[FR Doc. 00–10868 Filed 5–1–00; 8:45 am]

BILLING CODE 4310–RK–P