Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices 21403

ADDRESSES: You may mail or deliver

nominations for membership to the

following address: Health Care

Financing Administration, Attention:

Constance Conrad, 7500 Security Blvd.,

Mail Stop: South Building 3–02–01,

Baltimore, MD 21244.

A request for a copy of the Secretary’s

Charter for the Medicare Coverage

Advisory Committee (MCAC) should be

submitted to Maria Ellis, Office of

Clinical Standards and Quality, Health

Care Financing Administration, 7500

Security Blvd., Mail Stop: South

Building 3–02–01, Baltimore, MD

21244, or by e-mail to mellis@hcfa.gov.

The charter is also posted on the web at

www.hcfa.gov/coverage, and can be

readily printed from that site.

FOR FURTHER INFORMATION CONTACT:

Constance A. Conrad, Health Care

Financing Administration, 7500

Security Blvd., Baltimore, MD 21244,

410–786–4631.

SUPPLEMENTARY INFORMATION:

Background

The Medicare Coverage Advisory

Committee (MCAC) is governed by

provisions of the Federal Advisory

Committee Act, Public Law 92–463, as

amended (5 USC Appendix 2), which

sets forth standards for the formulation

and use of advisory committees, and

authorized by section 222 of the Public

Health Service Act as amended (42

U.S.C. 217A).

The MCAC consists of no more than

120 appointed members from among

authorities in clinical and

administrative medicine, biologic and

physical sciences, public health

administration, health care data and

information management and analysis,

the economics of health care, medical

ethics, and other related professions. A

maximum of 9 members are standard

voting members, and 24 are nonvoting

members, 12 of which are

representatives of consumer interests,

and 12 of which are representatives of

industry interests.

The MCAC functions on a panel basis.

The panels review and evaluate medical

literature, review technical assessments,

and examine data and information on

the effectiveness and appropriateness of

medical items and services that are

covered or eligible for coverage under

Medicare. Panel meetings generally

follow an agenda that we provide that

lists specific issues. The panels develop

technical advice to aid us in

determining reasonable and necessary

applications of medical services and

technology when we make national

coverage decisions for Medicare.

A few vacancies exist on the current

MCAC panel rosters, and terms for some

members currently serving will expire

before January 1, 2002. Accordingly, we

are requesting nominations for both

voting and nonvoting members to serve

on the MCAC. Nominees are selected

based upon their individual

qualifications and not as representatives

of professional associations or societies.

We have a special interest in ensuring

that women, minority groups, and

physically challenged individuals are

adequately represented on the MCAC.

Therefore, we encourage nominations of

qualified candidates from these groups.

All nominations and curricula vitae

for the MCAC should be sent to

Constance Conrad at the address above.

Criteria for Members

Nominees should have expertise in

one or more of the following fields:

clinical and administrative medicine,

biologic and physical sciences, public

health administration, health care data

and information management and

analysis, the economics of health care,

medical ethics, and other related

professions.

We are also seeking nominations for

nonvoting consumer and industry

representatives. Nominees for these

positions must possess appropriate

qualifications to understand and

contribute to the MCAC’s work.

Nominations must state that the

nominee is willing to serve as a member

of the MCAC and appears to have no

conflict of interest that would preclude

membership. Potential candidates will

be asked to provide detailed information

concerning such matters as financial

holdings, consultancies, and research

grants or contracts in order to permit

evaluation of possible sources of

conflict of interest.

Members are invited to serve for

overlapping 4-year terms; terms of more

than 2 years are contingent upon the

renewal of the MCAC by appropriate

action before its termination on

November 23, 2002. A member may

serve after the expiration of the

member’s term until a successor has

taken office.

Any interested person may nominate

one or more qualified persons. Selfnominations are also accepted.

Authority: 5 U.S.C. App. 2, section 10(a)(1)

and (a)(2).

(Catalog of Federal Domestic Assistance

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: April 6, 2001.

Jeffrey L. Kang,

Director, Office of Clinical Standards and

Quality, Health Care Financing

Administration.

[FR Doc. 01–10639 Filed 4–27–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3066–N]

Medicare Program; Meeting of the

Diagnostic Imaging Panel of the

Medicare Coverage Advisory

Committee—June 19, 2001

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting of the Diagnostic

Imaging Panel (the Panel) of the

Medicare Coverage Advisory

Committee. The Panel provides advice

and recommendations to the agency

about clinical issues. The Panel will

hear and discuss presentations from

interested persons regarding FDG

Positron Emission Tomography imaging

for breast cancer diagnosis and staging.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. App. 2, section 10(a)(1) and

(a)(2)).

DATES: The Meeting: The meeting will

be held on June 19, 2001 from 8 a.m.

until 4:30 p.m., E.D.T.

Deadline for Presentations and

Comments: June 5, 2001, 5 p.m., E.D.T.

Special Accommodations: Persons

attending the meeting who are hearing

or visually impaired, or have a

condition that requires special

assistance or accommodations, are

asked to notify the Executive Secretary

by May 26, 2001.

ADDRESSES: The Meeting: The meeting

will be held at the Baltimore

Convention Center, Room 321 and 322,

One West Pratt Street, Baltimore, MD

21201.

Presentations and Comments: Submit

formal presentations and written

comments to Janet A. Anderson,

Executive Secretary; Office of Clinical

Standards and Quality; Health Care

Financing Administration; 7500

Security Boulevard; Mail Stop S3–02–

01; Baltimore, MD 21244.

Website: You may access up-to-date

information on this meeting at

www.hcfa.gov/coverage.

Hotline: You may access up-to-date

information on this meeting on the

HCFA Advisory Committee Information

Hotline, 1–877–449–5659 (toll free) or

in the Baltimore area (410) 786–9379.

FOR FURTHER INFORMATION CONTACT:

Janet A. Anderson, Executive Secretary,

410–786–2700.

SUPPLEMENTARY INFORMATION: On August

13, 1999, we published a notice (64 FR

21404 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices

44231) to describe the Medicare

Coverage Advisory Committee (MCAC),

which provides advice and

recommendations to us about clinical

issues. This notice announces the

following public meeting of the

Diagnostic Imaging Panel (the Panel) of

MCAC.

Current Panel Members

Frank Papatheofanis, MD, PhD;

Barbara McNeil, MD, PhD; Carole

Flamm, MD, MPH; Jeffrey Lerner, PhD;

Michael Manyak, MD; Donna Novak,

BA; Manuel Cerqueira, MD; Kim

Burchiel, MD; Steven Guyton, MD; Sally

Hart, JD; Michael Klein, MBA

Meeting Topic

The Panel will hear and discuss

presentations from interested persons

regarding FDG Positron Emission

Tomography imaging for breast cancer

diagnosis and staging.

Procedure and Agenda

This meeting is open to the public.

The Panel will hear oral presentations

from the public for approximately 1.5

hours. The Panel may limit the number

and duration of oral presentations to the

time available. If you wish to make

formal presentations, you must notify

the respective Executive Secretary listed

in the FOR FURTHER INFORMATION

CONTACT section of this notice, and

submit the following by the Deadline for

Presentations and Comments date listed

in the DATES section of this notice: A

brief statement of the general nature of

the evidence or arguments you wish to

present, and the names and addresses of

proposed participants. A written copy of

your presentation must be provided to

each panel member prior to offering

your public comments. We will request

that you declare at the meeting whether

or not you have any financial

involvement with manufacturers of any

items or services being discussed (or

with their competitors).

After the public and HCFA

presentations, the Panel will deliberate

openly on the topic. Interested persons

may observe the deliberations, but the

Panel will not hear further comments

during this time except at the request of

the chairperson. The Panel will also

allow approximately a 30-minute open

public session for any attendee to

address issues specific to the topic. At

the conclusion of the day, the members

will vote and the Panel will make its

recommendation.

Authority: 5 U.S.C. App. 2, section 10(a)(1)

and (a)(2).

(Catalog of Federal Domestic Assistance

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: April 6, 2001.

Jeffrey L. Kang,

Director, Office of Clinical Standards and

Quality, Health Care Financing

Administration.

[FR Doc. 01–10638 Filed 4–27–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; Extended Lung Cancer

Incidence Follow-Up for the Mayo Lung

Project Participants

SUMMARY: In compliance with the

requirement of section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Center Institute (NCI), the

National Institutes of Health (NIH) will

publish periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection

Title: Extended Lung Cancer

Incidence Follow-Up for the Mayo Lung

Project Participants. Type of

Information Collection Request: NEW.

Need and Use of Information Collection:

The Mayo Lung Project (MLP) was an

NCI-funded randomized collection trial

(RCT) of lung cancer screening

conducted among 9,211 male smokers

from 1971 to 1983. No reduction in lung

cancer mortality was observed in the

MLP with an intense regimen of x-ray

and sputum cytology screening. Recent

analysis of updated mortality and case

survival data (through 1996) suggests

that lesions with little-to-no clinical

relevance (over-diagnosis) may have

been detected through screening in the

MLP intervention arm. Over-diagnosis

leads to unnecessary medical

interventions, including diagnostic and

treatment procedures that carry with

them varying degrees of risk.

Consequently, over-diagnosis can result

in considerable harm, including

premature death, which would not have

occurred in the absence of screening.

The persistence, after screening ends, of

an excess of lung cancer cases in the

intervention arm is the strongest

evidence in support of over-diagnosis,

but this information cannot be

adequately obtained with available MLP

data. Therefore, we propose to recontact the MLP participants and/or

their next-of-kin to determine the

participants who were diagnosed with

lung cancer after the formal end of the

Project. These data will allow the NCI

to either more-convincingly state or

perhaps refute the possibility of overdiagnosis in lung cancer screening, and

may be used to guide future research

agendas and lung cancer screening

policies. Frequency of response: Once.

Affected public: Individuals. Type of

respondents: MLP participants or their

next-of-kin. The annual reporting

burden is as follows: Maximum number

of respondents: 9200; Estimated number

of Responses per Respondent: 1.

Average Burden Hours Per Response:

0.25; Estimated Maximum Total Annual

Burden Hours Requested: 2300. The

annualized cost to respondents is

estimated at zero. There are no Capital

Costs to report. There are no Operating

or Maintenance Costs; to report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

should address one or more of the

following points: (1) Evaluate whether

the proposed collection of information

is necessary for the proper performance

of the function of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and (4) Minimize the burden

of the collection of information on those

who are to respond, including the use

of appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact: Dr. Pamela

Marcus, Epidemiologist, Biometry

Research Group, Division of Cancer

Prevention, National Cancer Institute,

Suite 344 EPN, 6130 Executive Blvd,

Bethesda, MD 20892–7354; or call nontool free 301–496–7468; or email

pm145q@nih.gov.

Comments due date: Comments

regarding this information collection are

best assured of having their full effect if

received on or before June 29, 2001.

Dated: April 20, 2001.

Reesa L. Nichols,

NCI Project Clearance Liaison.

[FR Doc. 01–10582 Filed 4–27–01; 8:45 am]

BILLING CODE 4140–01–M