12218 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On June 20, 1996, CDRH approved the

application by a letter to the applicant

from the Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under 21 CFR part 12 of FDA’s

administrative practices and procedures

regulations or a review of the

application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

21 CFR 10.33(b). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of the review

to be used, the persons who may

participate in the review, the time and

place where the review will occur, and

other details.

Petitioners may, at any time on or

before April 14, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: January 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–6409 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97N–0083]

Abbreviated New Drug Applications;

Positron Emission Tomography

Radiopharmaceuticals; Notice of a

Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop to provide information

to the positron emission tomography

(PET) radiopharmaceutical industry on

submitting abbreviated new drug

applications (ANDA’s) and other

regulatory issues affecting PET

radiopharmaceutical drug products. The

workshop will provide guidance on

topics such as ANDA regulatory

requirements, registration and listing

requirements, chemistry and

manufacturing controls, sterility

assurance, bioequivalence requirements,

and labeling. An agenda and materials

to be discussed at the workshop will be

available before the workshop.

DATES: The workshop will be held on

Monday, April 28, 1997, from 8 a.m. to

5 p.m. Because space is limited,

interested persons are encouraged to

register as soon as possible.

Preregistration will be accepted through

April 18, 1997. There is no registration

fee for the workshop. The

administrative docket will remain open

until June 27, 1997, to receive written

comments, data, information, or views

on the workshop and materials

distributed at the workshop.

ADDRESSES: The workshop will be held

at the Parklawn Bldg., 5600 Fishers

Lane, conference rm. D, Rockville, MD

20857. Persons interested in attending

should pre-register by faxing their name,

title, organization name if any, address,

telephone and fax numbers to the

contact person. Registrants’ fax numbers

should be provided, so that registration

can be confirmed by return fax.

Before the workshop, the agenda and

materials to be discussed at the

workshop will be available via the

Internet using the World Wide Web

(WWW). To connect to the Center for

Drug Evaluation and Research (CDER)

Home Page, type http://www.fda.gov/

cder and go to the ‘‘What’s Happening’’

section. A transcript of the workshop

will be available from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857,

approximately 15 business days after

the workshop at a cost of 10 cents per

page.

Written comments on the workshop

or materials discussed at the workshop

can be submitted until June 27, 1997, to

the Dockets Management Branch (HFA–

305), 12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of

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 notice. Received

comments may be viewed at the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Susan C. Lange, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–160),

5600 Fishers Lane, Rockville, MD

20857, 301–443–0260, FAX 301–594–

0746.

SUPPLEMENTARY INFORMATION:

I. Background

PET is a diagnostic imaging modality

consisting of onsite production of

radionuclides that are usually

intravenously injected into patients for

diagnostic purposes. The potential

usefulness of a PET

radiopharmaceutical is based upon the

product’s interaction with a biochemical

process in the body.

Over the last 20 years, there has been

increasingly widespread commercial

use of a growing number of PET

radiopharmaceuticals. Having

considered the available information,

including that presented to the agency

at a March 1993 hearing and in written

materials, in the Federal Register of

February 27, 1995 (60 FR 10593), FDA

provided additional notice and

guidance to the industry stating how the

agency would apply its regulatory

authority to PET drug products.

Since the approval of one new drug

application for F–18 FDG, PET drug

product manufacturers have sought

information on the submission of

ANDA’s. Details of the ANDA

submission process will be discussed at

the workshop. Other topics to be

addressed include registration and

listing requirements, chemistry and

manufacturing controls, sterility

assurance, bioequivalence requirements,

labeling, and compliance with current
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