Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Notices 31917

primary endpoints for trials of drug

products.

This Level 1 draft guidance is being

issued consistent with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997). The draft guidance

represents the agency’s current thinking

on the development of drugs for the

treatment of FSD. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirement of the applicable statute,

regulations, or both.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: May 12, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–12594 Filed 5–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3034–N]

Medicare Program; Meeting of the

Executive Committee of the Medicare

Coverage Advisory Committee—June

6, 2000

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting of the Executive

Committee (the Committee) of the

Medicare Coverage Advisory Committee

(MCAC). The Committee will hear

reports from the Medical and Surgical

Procedures Panel meeting of April 12

and 13, 2000, during which biofeedback

and pelvic floor electrical stimulation in

the treatment of urinary incontinence

were deliberated. The Committee will

also discuss presentations from

interested persons regarding procedural

aspects of future public meetings of the

medical specialty panels of the MCAC.

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: June 6, 2000, from 8

a.m. until 3 p.m., E.D.T.

Deadline for Presentations and

Comments: May 17, 2000, 5 p.m., E.D.T.

Special Accommodations: Persons

attending the meeting who are hearing

impaired and require sign language

interpretation, or have a condition that

requires other special assistance or

accommodations, are asked to notify the

Executive Secretary by May 25, 2000.

ADDRESSES:

The Meeting: The meeting will be

held at the Baltimore Convention

Center, One West Pratt Street,

Baltimore, Maryland 21201.

Presentations and Comments: Submit

formal presentations and written

comments to Constance A. Conrad,

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/quality/8b.htm.

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:

Constance A. Conrad, Executive

Secretary, 410–786–4631.

SUPPLEMENTARY INFORMATION: On August

13, 1999, we published a notice (64 FR

44231) to describe the MCAC, which

provides advice and recommendations

to us about clinical issues.

Current Panel Members

Harold C. Sox, MD (Chairperson);

Thomas V. Holohan; Leslie P. Francis;

John H. Ferguson; Robert L. Murray;

Alan M. Garber; Michael D. Maves;

Frank J. Papatheofanis; Ronald M.

Davis; Daisy Alford-Smith; Joe W.

Johnson; Robert H. Brook; Linda A.

Bergthold; Randel E. Richner.

Meeting Topic

The Committee will hear reports from

the Medical and Surgical Procedures

Panel meeting of April 12 and 13, 2000,

during which biofeedback and pelvic

floor electrical stimulation in the

treatment of urinary incontinence. The

Committee will also hear and discuss

presentations from interested persons

regarding procedural aspects of future

public meetings of the medical specialty

panels of the MCAC.

Procedure and Agenda

This meeting is open to the public.

The Committee will hear oral

presentations from the public for

approximately 1 hour. The Committee

may limit the number and duration of

oral presentations to the time available.

If you wish to make formal

presentations you must notify the For

Further Information Contact, 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, the names and addresses of

proposed participants, and an estimate

of the time required to make the

presentation. We will request that you

declare at the meeting whether you have

any financial involvement with

manufacturers of any items or services

being discussed (or with their

competitors).

After the public presentation, we will

make a presentation to the Committee.

After our presentation, the Committee

will deliberate openly. Interested

persons may observe the deliberations,

but the Committee will not hear further

comments during this time except at the

request of the chairperson. Prior to the

review of the Medical Specialty Panel

recommendation, the Committee will

allow approximately a 30-minute open

public session for any attendee to

address issues specific to the topic.

After the open session, the members

will vote and the Committee 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: May 11, 2000.

Jeffrey L. Kang,

Director Office of Clinical Standards and

Quality, Health Care Financing

Administration.

[FR Doc. 00–12686 Filed 5–18–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1136–N]

Medicare Program; June 5, 2000,

Meeting of the Practicing Physicians

Advisory Council

AGENCY: Health Care Financing

Administration (HCFA), HHS.

31918 Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Notices

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Practicing Physicians Advisory

Council. This meeting is open to the

public.

DATES: The meeting is scheduled for

June 5, 2000, from 9 a.m. until 5 p.m.,

E.D.T.

ADDRESSES: The meeting will be held in

the Multipurpose Room/Auditorium,

first Floor, Health Care Financing

Administration Building, 7500 Security

Boulevard, Baltimore, Maryland 21244.

FOR FURTHER INFORMATION CONTACT: Paul

Rudolf, Executive Director, Practicing

Physicians Advisory Council, Room

435–H, Hubert H. Humphrey Building,

200 Independence Avenue, SW.,

Washington, D.C. 20201, (202) 690–

7874. News media representatives

should contact the HCFA Press Office,

(202) 690–6145. For additional

information and updates on committee

activities, please refer to the HCFA

Advisory Committees Information Line

1–(877)–449–5659 toll free or (410)–

786–9379 local or via the Internet at

http://www.hcfa.gov/fac.

SUPPLEMENTARY INFORMATION: The

Secretary of the Department of Health

and Human Services (the Secretary) is

mandated by section 1868 of the Social

Security Act to appoint a Practicing

Physicians Advisory Council (the

Council) based on nominations

submitted by medical organizations

representing physicians. The Council

meets quarterly to discuss certain

proposed changes in regulations and

carrier manual instructions related to

physicians’ services, as identified by the

Secretary. To the extent feasible and

consistent with statutory deadlines, the

consultation must occur before

publication of the proposed changes.

The Council submits an annual report

on its recommendations to the Secretary

and the Administrator of the Health

Care Financing Administration not later

than December 31 of each year.

The Council consists of 15 physicians,

each of whom has submitted at least 250

claims for physicians’ services under

Medicare or Medicaid in the previous

year. Members of the Council include

both participating and nonparticipating

physicians and physicians practicing in

rural and underserved urban areas. At

least 11 members must be doctors of

medicine or osteopathy authorized to

practice medicine and surgery by the

States in which they practice. Members

are invited to serve for overlapping 4-

year terms. In accordance with section

14 of the Federal Advisory Committee

Act, terms of more than 2 years are

contingent upon the renewal of the

Council by appropriate action before the

end of the 2-year term. The Council held

its first meeting on May 11, 1992.

The current members are: Jerold M.

Aronson; Richard Bronfman; Joseph

Heyman; Sandral Hullett; Stephen A.

Imbeau; Jerilynn S. Kaibel; Angelyn L.

Moultrie; Derrick K. Latos; Dale Lervick;

Sandra B. Reed; Amilu Rothhammer;

Maisie Tam; Victor Vela; Kenneth M.

Viste, Jr.; and Douglas L. Wood. The

Council Chairperson is Derrick L. Latos.

At this meeting, council members will

be updated on Physician Regulatory

Issues Team (PRIT); Physician Service

Plan (PSP); Advance Beneficiary Notices

(ABN); and the Chief Financial Officer

(CFO) audit and the error rate, including

analysis, claims review, and educational

effort. The agenda will provide for

discussion and comment on the updates

and following topics:

• Office of Financial Management

Program Integrity Customer Service Plan

(evaluation and improvement of

program integrity customer service to

providers).

• Private Fee for Service

Medicare+Choice and how to educate

physicians about this new option.

For additional information and

clarification on the topics listed, call the

contact person listed above.

Individual physicians or medical

organizations that represent physicians

that wish to make 5-minute oral

presentations on agenda issues should

contact the Executive Director by 12

noon, May 23, 2000, to be placed on the

schedule. Testimony is limited to listed

agenda issues, and the number of oral

presentations may be limited by the

time constraints. A written copy of the

presenter’s oral remarks should be

submitted to the Executive Director no

later than 12 noon, May 23, 2000, for

distribution to the Council members for

review before the meeting. Physicians

and organizations not scheduled to

speak may also submit written

comments to the Executive Director and

the Council members.

The meeting is open to the public, but

attendance is limited to the space

available. Individuals requiring sign

language interpretation for the hearing

impaired and/or other special

accommodation, should contact John

Lanigan at (202) 690–7418 at least 10

days before the meeting.

(Section 1868 of the Social Security Act (42

U.S.C. 1395ee) and sections 10(a) and

14(a)(1)(A) of Public Law 92–463 (5 U.S.C.

App. 2, section 10(a)); 45 CFR Part 11)

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: May 16, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–12660 Filed 5–18–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4557–N–20]

Federal Property Suitable as Facilities

To Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

FOR FURTHER INFORMATION CONTACT:

Clifford Taffet, room 7266, Department

of Housing and Urban Development,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1234; TTY

number for the hearing- and speechimpaired (202) 708–2565 (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–937–7588.

SUPPLEMENTARY INFORMATION: In

accordance with 24 CFR part 581 and

section 501 of the Steward B. McKinney

Homeless Assistance Act (42 U.S.C.

11411), as amended, HUD is publishing

this Notice to identify Federal buildings

and other real property that HUD has

reviewed for suitability for use to assist

the homeless. The properties were

reviewed using information provided to

HUD by Federal landholding agencies

regarding unutilized and underutilized

buildings and real property controlled

by such agencies or by GSA regarding

its inventory of excess or surplus

Federal property. This Notice is also

published in order to comply with the

December 12, 1988 Court Order in

National Coalition for the Homeless v.

Veterans Administration, No. 88–2503–

OG (D.D.C.).

Properties reviewed are listed in this

Notice according to the following

categories: Suitable/available, suitable/

unavailable, suitable/to be excess, and

unsuitable. The properties listed in the

three suitable categories have been

reviewed by the landholding agencies,

and each agency has transmitted to

HUD: (1) Its intention to make the

property available for use to assist the