Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices 12219

good manufacturing practice regulations

and other regulatory requirements.

Materials providing guidance on ANDA

submissions and related topics will also

be discussed at the workshop.

Dated: March 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6410 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Notice Regarding Section 602 of the

Veterans Health Care Act of 1992

Rebate Mechanism

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: Section 602 of Public Law

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 process 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

process by April 14, 1997. After

consideration of comments submitted,

the Secretary will issue the final

guideline.

ADDRESS: Comments should be

submitted to: Annette Byrne, R. Ph.,

M.S., Director, Office of Drug Pricing

Program, 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

Program, 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 system) or received as a

required reduction in cost rebated after

purchase, dispensing, and payment are

completed (i.e., a rebate system).

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

mechanism (in addition to the discount

mechanism) should allow these groups

to access section 340B pricing.

The HRSA recognizes rebates

obtained by the State ADAPs as a

method of accessing the section 340B

discount price. The rebate for covered

outpatient drugs should be equal to or

greater than the section 340B discount

at the time of purchase price. 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.

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 procedure and

that instituting rebates will not increase

the potential for diversion.

Dated: March 10, 1997.

Ciro V. Sumaya,

Administrator.

[FR Doc. 97–6414 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4200–N–34]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due: May 13, 1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Oliver Walker, Housing, Department of

Housing & Urban Development, 451–7th

Street, SW, Room 9116, Washington, DC

20410.

FOR FURTHER INFORMATION CONTACT:

Daniel Kahn, telephone number (202)

708–2121 (this is not a toll-free number)

for copies of the proposed forms and

other available documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

The Notice is soliciting comments

from members of the public and

affecting agencies concerning the