Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices 45823

before the committee. Written

submissions may be made to the contact

person by September 5, 1997. Oral

presentations from the public will be

scheduled between approximately 12:30

p.m. and 1:30 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 5, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee deliberations: On

September 19, 1997, from 9:30 a.m. to

10 a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). FDA staff will

present to the committee confidential

information regarding pending or future

submissions.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: August 22, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–23020 Filed 8–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[OPL–016–N]

Medicare Program; September 22,

1997, Meeting of the Practicing

Physicians Advisory Council

AGENCY: Health Care Financing

Administration (HCFA), HHS.

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

September 22, 1997, from 9:00 a.m.

until 5:00 p.m. e.d.t.

ADDRESSES: The meeting will be held in

Room 800, 8th Floor, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT:

Jeffrey Kang, M.D., Executive Director,

Practicing Physicians Advisory Council,

Room 435–H, Hubert H. Humphrey

Building, 200 Independence Avenue,

S.W., Washington, DC 20201, (202) 690–

7874.

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

have been 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: Richard

Bronfman, D.P.M.; Wayne R. Carlsen,

D.O.; Gary C. Dennis, M.D.; Catalina E.

Garcia, M.D.; Mary T. Herald, M.D.;

Ardis Hoven, M.D.; Sandral Hullett,

M.D.; Jerilynn S. Kaibel, D.C.; Marie G.

Kuffner, M.D.; Marc Lowe, M.D.;

Katherine L. Markette, M.D.; Derrick L.

Latos, M.D.; Susan Schooley, M.D.;

Maisie Tam, M.D.; and Kenneth M.

Viste, Jr., M.D. The chairperson is

Kenneth M. Viste, Jr., M.D.

Council members will receive an

update on the Balanced Budget Act of

1997 as it relates to Medicare and

Medicaid. The agenda will provide for

discussion and comment on the

following topic: the Office of the

Inspector General’s Chief Financial

Officer’s Audit of the Health Care

Financing Administration for Fiscal

Year 1996.

Individuals or organizations who

wish to make 5-minute oral

presentations on the agenda issue

should contact the Executive Director by

12:00 noon, September 11, 1997, to be

scheduled. The number of oral

presentations may be limited by the

time available. A written copy of the

oral remarks should be submitted to the

Executive Director no later than 12:00

noon, September 15, 1997. Anyone who

is not scheduled to speak may submit

written comments to the Executive

Director by 12:00 noon, September 17,

1997. The meeting is open to the public,

but attendance is limited to the space

available.

(Section 1868 of the Social Security Act (42

U.S.C. 1395ee) and section 10(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: August 22, 1997.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 97–23090 Filed 8–28–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Notice Regarding Section 602 of the

Veterans Health Care Act of 1992

Rebate Option

AGENCY: Health Resources and Services

Administration.

ACTION: Notice.

SUMMARY: Section 602 of Pub. L. 102–

585, the ‘‘Veterans Health Care Act of

1992,’’ enacted section 340B of the

Public Health Service (PHS) Act,

‘‘Limitation on Prices of Drugs

Purchased by Covered Entities.’’ Section

340B provides that a manufacturer who

sells covered outpatient drugs to eligible

entities must sign a pharmaceutical

pricing agreement with the Secretary of

HHS in which the manufacturer agrees

to charge a price for covered outpatient

drugs that will not exceed that amount

determined under a statutory formula.

The purpose of this notice is to

request comments on the proposal of a

rebate option for State AIDS Drug

Assistance Programs (ADAPs) receiving

funds under Title XXVI of the PHS Act.

DATES: The public is invited to submit

comments on the proposed rebate
45824 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices

process by September 29, 1997. After

consideration of comments submitted,

the Secretary will issue the final

guideline.

ADDRESSES: Comments should be

submitted to: Annette Byrne, R. Ph.,

M.S., Director, Office of Drug Pricing,

Bureau of Primary Health Care, Health

Resources and Services Administration,

4350 East-West Highway, Bethesda, MD

20814, Phone (301) 594–4353; FAX

(301) 594–4982.

FOR FURTHER INFORMATION CONTACT:

Robert Staley, R. Ph., Senior Program

Manager, Office of Drug Pricing, Bureau

of Primary Health Care, Health

Resources and Services Administration,

4350 East-West Highway, Bethesda, MD

20814, Phone (301) 594–4353; Fax (301)

594–4982.

SUPPLEMENTARY INFORMATION: Section

340B requires manufacturers, as a

condition for the receipt of Medicaid

matching funds with respect to their

covered outpatient drugs, to charge

participating entities no more than a

ceiling price for such drugs. This price

is determined by reducing the average

manufacturer price of the drug by a

rebate percentage. Entities eligible to

access section 340B pricing (covered

entities) include certain PHS grantees

(e.g., federally-qualified health centers,

certain family planning projects, AIDS

assistance programs, black lung clinics,

hemophilia treatment centers, Native

Hawaiian health centers, and centers

that treat sexually-transmitted disease

and/or tuberculosis) and certain

disproportionate share hospitals.

Section 340B has no explicit language

as to whether the required reduction in

price should be obtained by an initial

reduction in the purchase price (i.e., a

discount mechanism) or received as a

required reduction in cost rebated after

purchase, dispensing, and payment are

completed (i.e., a rebate option). Section

340B(a)(1) of the PHS Act provides that

the amount to be paid to the

manufacturers for covered drugs takes

‘‘into account any rebate or discount, as

provided by the Secretary. * * *’’

Further, section 340B does not specify

whether entities should receive the

section 340B pricing ‘‘through a point of

purchase discount, through a

manufacturer rebate, or through some

other mechanism. A mechanism that is

appropriate to one type of ‘‘covered

entity,’’ such as community health

centers, may not be appropriate to

another type, such as State AIDS drug

assistance programs * * * [T]he

Secretary of HHS * * * will use the

mechanism that is the most effective

and most efficient. * * *’’ H.R. Rep. No

102–384, 102d Cong., 2d Sess., pt. 2, at

16 (1992).

Initially, HRSA guidance for the

section 340B program described only a

discount process. Covered entities

generally preferred a discount system,

because they could negotiate lower

prices and needed less initial outlay of

drug purchasing money.

Although the discount system is

functioning successfully for most

covered entities, most ADAPs have drug

purchasing systems that have prevented

their participation in the section 340B

discount program. The use of a rebate

option (in addition to the discount

mechanism) should allow these groups

to access section 340B pricing.

The HRSA recognizes rebates

obtained by the State ADAPs that equal

or exceed the discount provided by the

statutory ceiling price as a method of

accessing the 340B program. State

ADAPs wishing technical assistance in

developing a rebate program should

contact HRSA’s Office of Drug Pricing at

(301) 594–4353 or (800) 628–6297.

Section 340B(a)(5)(A) of the PHS Act

reflects Congressional recognition that

there is a potential for drugs purchased

by a covered entity at the 340B discount

price to be subject to a Medicaid rebate,

if the drug is reimbursed by the

Medicaid program. State ADAPs need to

be aware that regardless of whether a

discount mechanism or a rebate option

is chosen to access 340B pricing, the

standards preventing duplicate

discounts on drugs still apply. Guidance

regarding billing State Medicaid

Agencies at actual acquisition cost plus

a dispensing fee established by the State

Medicaid agency, and the prevention of

duplicate discounts, was first published

in the Federal Register on May 7, 1993

(58 FR 27293) entitled ‘‘Duplicate

Discounts and Rebates on Drug

Purchases.’’ Further guidance was

published in the Federal Register on

December 29, 1993 (58 FR 68922). State

ADAPs may find it necessary to work

with State Medicaid Agencies to adapt

these guidelines to meet the unique

circumstances of each individual State,

such as provisions permitting

retroactive reimbursement of drug

purchases while Medicaid eligibility

was pending. This will assure that the

discount to the covered entity will be

passed on to the State Medicaid Agency.

The HRSA is sensitive to concerns

about diversion of covered drugs to

individuals who are not patients of the

covered entities. Guidelines have been

issued to minimize this potential, and

manufacturers have available to them

specified remedies if they believe

diversion has occurred. The HRSA

believes that these guidelines and

remedies will apply fully to drugs

purchased under a rebate option and

that instituting rebates will not increase

the potential for diversion.

Dated: August 22, 1997.

Claude Earl Fox,

Acting Administrator.

[FR Doc. 97–23019 Filed 8–28–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4235–N–18]

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:

Mark Johnston, room 7256, Department

of Housing and Urban Development,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1226; TDD

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 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with 24 CFR part 581 and

section 501 of the Stewart 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