28618 Federal Register / Vol. 60, No. 105 / Thursday, June 1, 1995 / Notices

participation in its review of the

application. To meet this requirement,

the agency is providing notice that The

Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, has filed an

application requesting approval for the

export of the human drug CAVERJECT

Sterile Powder (Alprostadil for

Injection) 20μg/mL vials to Sweden via

Belgium. The product is to be used for

the treatment of erectile dysfunction.

The application was received and filed

in the Center for Drug Evaluation and

Research on May 5, 1995, which shall

be considered the filing date for

purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by June 12,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: May 18, 1995.

Betty L. Jones,

Acting Deputy Director, Office of Compliance,

Center for Drug Evaluation and Research.

[FR Doc. 95–13352 Filed 5–31–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0124]

Medical Devices; Third Party Review of

Selected Premarket Notifications;

Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop to discuss a proposed

pilot program for third party review of

selected premarket notifications. The

purpose of the workshop is to provide

information on the pilot program and to

obtain public comments and suggestions

that may help FDA refine its plans for

third party review of selected premarket

notifications. This workshop is one

aspect of FDA’s efforts in pursuit of the

reinventing Government goals of the

National Performance Review as well as

the promotion and protection of the

public health.

DATES: The workshop will be held on

June 19, 1995, from 9 a.m. to 4:30 p.m.

Submit written notices of participation

by June 9, 1995. Participants and other

persons who want to be heard must be

present by 9 a.m. Submit written

comments by July 7, 1995. There is no

registration fee for this workshop.

Interested persons are encouraged to

register early because space is limited.

ADDRESSES: The workshop will be held

at the Doubletree Hotel Rockville

(formerly, the Holiday Inn Crowne

Plaza), 1750 Rockville Pike, Rockville,

MD. A limited number of overnight

accommodations have been reserved at

the Doubletree Hotel Rockville.

Attendees requiring overnight

accommodations may contact the hotel

at 301–468–1100 and reference FDA

meeting group GVL. Reservations will

be confirmed at the group rate based on

availability.

A registration form for the workshop

may be obtained by contacting

Sociometrics, Inc., 8300 Colesville Rd.,

Suite 550, Silver Spring, MD 20910,

301–608–2151 or 1–800–729–0890 (FAX

301–608–3542). Persons with

disabilities who require special

assistance to attend or participate in the

workshop can be accommodated if

advance notification is provided. If you

have a disability that affects your

attendance at, or participation in, this

meeting, please contact Ed Rugenstein,

Sociometrics, Inc., in writing and

identify your needs. The availability of

appropriate accommodations cannot be

assured unless prior written notification

is provided.

Written comments regarding the pilot

program may be submitted to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857. Those persons

who wish to make a presentation must

submit a written notice of participation

to the Dockets Management Branch

(address above), identified with the

docket number found in brackets in the

heading of this document, including

their name, address, telephone number,

business affiliation, a brief summary of

the presentation, and an estimate of the

amount of time required to make their

comments. FDA requests that

individuals or groups having similar

interests consolidate their comments

and present them through a single

representative. FDA may require joint

presentations by persons with common

interests.

Transcripts of the workshop will be

available from the Freedom of

Information Staff (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

6310 or FAX 301–443–1726.

FOR FURTHER INFORMATION CONTACT: Eric

J. Rechen, Center for Devices and

Radiological Health (HFZ–402), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2186, FAX 301–594–2977.

SUPPLEMENTARY INFORMATION:

I. Background

On April 6, 1995, FDA announced a

limited pilot program to test the

usefulness and practicality of third

party review of medical devices. Under

the proposed pilot, FDA will designate

private sector organizations to review

premarket notifications under section

510(k) of the Federal Food, Drug, and

Cosmetic Act (the act) (hereinafter

referred to as 510(k)’s). This initiative

will provide an alternative to FDA

review and is one aspect of FDA’s

efforts in pursuit of the reinventing

Government goals of the National

Performance Review. FDA expects the

pilot program will begin early in fiscal

year 1996.

FDA’s primary concern remains the

promotion and protection of the public

health. The proposed pilot will include

checks and balances to ensure a high

level of quality in the review of 510(k)’s.

II. Outline of the Proposed Third Party

Review Pilot

At this time, FDA has not determined

the final form of its pilot third party

review process. The initial pilot

program will be restricted to third party

review, but not clearance, of 510(k)’s.

During the pilot, the third party will

make a recommendation to FDA. FDA

will then make a decision based on the

third party’s documented review. The

purpose of the pilot is to test the

feasibility of third party review,

including the willingness of qualified

third parties to participate, and the

quality and timeliness of third party

reviews.

Industry participation in the pilot

program will be voluntary. An applicant

who does not wish to participate will be

able to continue to submit 510(k)’s to

FDA. The pilot will last 2 years, and

will be evaluated by FDA in the second

year.

FDA anticipates that the pilot

program will be limited to FDAdesignated class I and II devices that

involve low-to-moderate risk. The pilot
Federal Register / Vol. 60, No. 105 / Thursday, June 1, 1995 / Notices 28619

will exclude 510(k)’s that require

clinical data for a decision. Clear review

criteria must also be available, in the

form of FDA guidance documents,

consensus standards, or other

appropriate assessment tools. FDA has

prepared a preliminary list of devices

that may be included in the pilot (see

section IV. of this document for

information on obtaining a copy).

Third party review organizations will

be individually accepted by FDA. FDA

will establish and apply requirements

covering personnel qualifications as

well as controls over potential conflicts

of interest. FDA believes it is essential

that third party review organizations

maintain adequate independence from

the device industry. FDA is also

considering additional safeguards to

ensure the quality and impartiality of

third party reviews. Among the

safeguards being considered are: FDA

examination, acceptance, and oversight

of third party review organizations;

provision of training and standard

operation procedures for third parties;

audits of third party reviews; having

FDA personnel serve as on site advisors

to third party review bodies; and

database checks to track ongoing

reviews.

FDA expects that applicants who

submit a 510(k) to a third party during

the pilot will pay a fee directly to the

third party. FDA does not expect to take

part in setting fees, but rather intends to

leave this to be negotiated between the

third party review organization and the

applicant.

The full range of general controls

(current good manufacturing practices

(CGMP’s), medical device reporting,

prohibition against adulteration and

misbranding, etc.) and, where

appropriate, special controls (device

tracking, postmarket surveillance, etc.)

will be applicable to devices included

in the pilot program.

III. Purpose and Tentative Agenda of

the Workshop

The purpose of the workshop is to

obtain public comments and suggestions

that will help FDA refine its plans for

a pilot program for third party review of

selected 510(k)’s.

Joseph A. Levitt, Deputy Director for

Regulations and Policy, Center for

Devices and Radiological Health, FDA,

will preside. Mr. Levitt will be assisted

by other FDA officials.

FDA will open the workshop with a

summary of the framework for the

proposed pilot program. This

presentation will provide information

on the impetus, objectives, and scope of

the proposed pilot program. Following

FDA’s presentation, other participants

will make presentations. After

reviewing the notices of participation,

FDA will allocate the time available for

presentations among those persons who

properly file a written notice of

participation. FDA will schedule each

appearance and will notify each

participant by mail or telephone of the

time allotted to him or her and the

approximate time his or her

presentation is scheduled to begin. The

full schedule will be available at the

workshop and will subsequently be

placed on file in the Dockets

Management Branch under the docket

number found in brackets in the

heading of this document. Time

permitting, the workshop will also

include an opportunity for interested

persons who did not submit a notice of

participation to make brief statements or

comments. The workshop will then

proceed to a panel discussion of specific

issues that FDA must resolve before

third party reviews of 510(k)’s can

begin. Among the topics to be discussed

are the following: Which devices should

be eligible for third party review;

criteria for selection or acceptance of

private sector organizations to perform

reviews, including conflict of interest

protections; safeguards necessary to

ensure a fair and impartial review by a

third party; and funding of third party

reviews.

FDA is making available a list of

specific topics for written comment and

discussion at the workshop. (See section

IV. of this document for information on

how to obtain a copy.)

The workshop is informal, and the

rules of evidence will not apply. No

participant may interrupt the

presentation of another participant.

Only the presiding officer and panel

members may question participants at

the conclusion of their presentations.

IV. Obtaining Additional Information

on the Workshop

Information on the June 19, 1995,

workshop, including a more detailed

listing of the topics and issues on which

FDA is inviting comment and a list of

the devices proposed for inclusion in

the pilot, can be obtained from the

Dockets Management Branch (address

above) or by calling FDAs Facts-onDemand system. The Facts-on-Demand

system can be reached by calling 1–800–

899–0381 or 301–827–0111 on a touchtone phone. Follow the instructions

provided, and request DSMA shelf

number 150. The requested materials

will be sent by FAX.

Dated: May 25, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–13294 Filed 5–26–95; 10:22 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

RIN 0905–ZA89

Program Announcement and Proposed

Review Criteria for Grants for the

Minority Faculty Fellowship Program

for Fiscal Year 1995

The Health Resources and Services

Administration (HRSA) announces that

applications will be accepted for fiscal

year (FY) 1995 Grants for the Minority

Faculty Fellowship Program (MFFP)

under the authority of section 738(b),

title VII of the Public Health Service

Act, as amended by the Health

Professions Education Extension

Amendments of 1992, Pub. L. 102–408,

dated October 13, 1992. Comments are

invited on the proposed review criteria.

Approximately $210,000 will be

available in FY 1995 for this program.

It is anticipated that $210,000 will be

available to support about five

competing awards to schools and other

eligible entities averaging $42,000

which will cover the cost of the

following: stipend in an amount not

exceeding 50 percent of the regular

salary of a similar faculty member or

$30,000, which ever is less, and tuition,

fees and travel, where appropriate.

Purpose

The purpose of the MFFP is to

increase the number of

underrepresented minority faculty

members in health professions schools,

i.e., schools of medicine, osteopathic

medicine, dentistry, veterinary

medicine, optometry, podiatric

medicine, pharmacy, public health,

health administration, clinical

psychology, and other public or private

nonprofit health or educational entities.

Specifically, these grant awards are

intended to allow institutions an

opportunity to provide a fellowship to

individuals who have the potential for

teaching, administering programs, or

conducting research as faculty members.

Institutions must demonstrate a

commitment and ability to identify,

recruit, and select underrepresented

minorities in health professions. The

institutions’ training programs provide

the fellows with the techniques and

skills needed to secure an academic

career including competence in:

pedagogical skills, research

methodology, development of research