18750 Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / Notices

investigational new drug (IND) process,

points-to-consider documents, resources

available from the National Institutes of

Health (NIH) to bring gene therapy from

the research laboratory to clinical trials,

and to conduct a series of workshops on

various issues concerning the

development, production, and use of

viral vectors for gene therapy. FDA

believes that the conference will benefit

interested parties, including industry,

NIH, and FDA, involved in this rapidly

advancing and changing field of gene

therapy.

DATES: The public conference will be

held on Thursday and Friday, July 11

and 12, 1996, 8 a.m. to 5 p.m.

Preregistration is requested by June 28,

1996. Registration will be held on both

days from 7:30 a.m. to 8 a.m.

ADDRESSES: The public conference will

be held at NIH, Bldg. 45, Natcher

Auditorium, 9000 Rockville Pike,

Bethesda, MD. There is no registration

fee. For a complete description of the

conference, agendas, speakers, and

session chairs check the FDA Biologics

Home Page at http://www.fda.gov/cber/

cberftp.html. The home page will be

updated as the conference gets closer.

FOR FURTHER INFORMATION CONTACT:

Regarding information on registration:

Margaret Fanning, NCI–FCRDC,

P.O. Box B, Frederick, MD 21702–

1201, 301–846–5865, or FAX 301–

846–5866.

Regarding information on the

conference agenda: Bette A.

Goldman, Center for Biologics

Evaluation and Research (HFM–

500), 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–

594–2860.

SUPPLEMENTARY INFORMATION: Gene

therapy is a dynamic and rapidly

advancing field of scientific study. The

purpose of this conference is twofold.

On July 11, 1996, FDA hopes to provide

the gene therapy community with an

education and understanding of the IND

review process. Many academic

investigators and researchers involved

in the research and development of gene

therapies are not familiar with the

regulatory process for the review of

IND’s. This lack of knowledge of the

IND process may decrease the efficiency

of pre-IND meetings and increase the

review burden on FDA staff. In order to

address this problem, the conference

will include a description of the IND

process, the use of ‘‘points-to-consider’’

and guideline documents, and resources

available from NIH to bring gene

therapy from the research laboratory to

clinical trials. On July 12, 1996, the

conference will serve as an opportunity

for FDA to hear concerns, issues, and

ideas from the gene therapy community.

There will be presentations of the

available scientific data from various

groups, followed by discussions, in

order to improve understanding of

scientific issues that are the foundation

of regulatory guidelines. Breakout

sessions will address the following:

Adenoviral vectors, ancillary products,

facilities and manufacturing,

information on getting started in gene

therapy development, retroviral vectors,

pharmacology, toxicology, and the

development of new vector systems.

The information obtained from this

conference may assist in the

development of future scientific and

regulatory policy or guidance.

Dated: April 19, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10484 Filed 4–26–96; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Program Announcement and Proposed

Project Requirements and Review

Criteria for Cooperative Agreements

for Partnerships for Health Professions

Education for Fiscal Year 1996

The Health Resources and Services

Administration (HRSA) announces that

applications will be accepted for fiscal

year (FY) 1996 Cooperative Agreements

for Partnerships for Health Professions

Education. This model/demonstration

program will be jointly funded under

sections 738(b) (Minority Faculty

Fellowship Program), 739 (Centers of

Excellence in Minority Health

Professions Education), and 740 (Health

Careers Opportunity Program) 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. The

goal of this program is to establish and

test a comprehensive model program in

a geographically defined area (e.g.,

region, state, metropolitan or rural area),

that incorporates a variety of

educational and community-based

entities in a formal continuum of

activities to increase the number and

quality of: (1) Minority and

disadvantaged health professionals to

provide health services to underserved

populations and (2) minority faculty

serving in health professions schools.

No comprehensive model currently

exists.

Rationale

The rationale for conducting this

model project is to:

1. Test the feasibility and

effectiveness of executing a

comprehensive program in a defined

geographic area, which encompasses a

dynamic coordinated educational

continuum designed to increase the

number and quality of minority/

disadvantaged health professionals and

minority faculty for health professions

schools. This program includes formal

linkages among several communitybased entities and educational

institutions.

2. Compare performance outputs of a

comprehensive approach versus the

output of several independent projects

operating in a defined geographic area

as is currently practiced.

3. Assess the cost effectiveness of a

comprehensive model versus a multiple

independent projects approach (testing

the hypothesis that approximately one

third of the costs for personnel and

overhead expenditures would be saved

through a comprehensive administrative

infrastructure).

4. Determine the potential for several

community and educational entities

forming a unified, effective, multidimensional, comprehensive

educational continuum under the

umbrella of a single lead institution.

5. Test the relative soundness of a

cooperative comprehensive approach

versus that of several projects acting

independently. This would facilitate

tracking, monitoring and retaining

targeted individuals through the

educational pathway to become health

professionals and/or faculty in health

professions schools.

This program announcement is

subject to reauthorization of the

legislative authorities and to the

appropriation of funds. Applicants are

advised that this program

announcement is a contingency action

being taken to assure that should

authority and funds become available

for this purpose, they can be awarded in

a timely fashion consistent with the

needs of the program as well as to

provide for even distribution of funds

throughout the fiscal year. At this time,

given a continuing resolution and the

absence of FY 1996 appropriations for

title VII programs, the amount of

available funding for this specific

cooperative agreement cannot be

estimated.

Purpose

The purposes of this program are to:

(1) Assist schools in supporting

programs of excellence in health
Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / Notices 18751

professions education for minority

students, (2) assist individuals from

disadvantaged backgrounds to

undertake education to enter and

graduate from a health professions

school and (3) to assist schools in

increasing the number of

underrepresented minority faculty

members at such schools. Applicants

are required to meet the statutory

requirements identified in sections

738(b), 739, and 740. Definitions

regarding each of these programs have

been published at 60 FR 62097, dated

December 4, 1995. In addition,

applicants must meet the requirements

of regulations as set forth in 42 CFR part

57, subparts S and V. Applicants may

request funding for up to three years. In

making awards, consideration will be

given to an equitable geographic

distribution of projects.

Eligibility

Applicants eligible to apply for this

model/demonstration program are

accredited schools of allopathic

medicine, osteopathic medicine,

dentistry, pharmacy, public health,

veterinary medicine, optometry, allied

health, chiropractic, podiatric medicine,

clinical psychology, health

administration and other public or

private nonprofit health or education

entities located in a State as defined in

section 799.

Proposed Project Requirements

The following project requirements

are proposed:

1. The Partnerships for Health

Professions Education cooperative

agreement is to include efforts to

increase the numbers and quality of:

(a) Minority and disadvantaged health

professionals who provide health

services to underserved populations and

(b) Minority faculty serving in health

professions schools.

This would be accomplished through

comprehensive geographically defined

cooperative initiatives involving several

educational and community-based

institutions and organizations.

Specifically, the project is to establish

and test a model comprehensive

program in a defined geographic area

(e.g. region, state, metropolitan or rural

area). The project would bring together

a variety of educational and community

entities into a formal educational

continuum that addresses:

(a) The needs of minority and

disadvantaged students through

graduation from a health professions

school, and

(b) Junior minority faculty aspiring to

senior faculty positions in health

professions schools.

2. The proposed model must

encompass formulation of academiccommunity educational partnerships

including:

(a) Formal linkages among health

profession and prehealth profession

schools, where both have strong

histories and established administrative

infrastructures for addressing the types

of purposes proposed in this model

program;

(b) Linkages among health professions

schools and community based health

care entities serving underserved

populations. This would allow targeted

health professions school students to be

offered experiences in the delivery of

health services in community-based

facilities located at sites remote from the

institution; and

c. Consortium arrangements (where

appropriate) among participating health

professions schools.

4. The Partnerships for Health

Professions Education Programs shall,

for a geographically prescribed area

establish:

(a) An educational and noneducational support system designed to

improve the quality of the minority

applicant pool involving preliminary

education, facilitating entry (including

post baccalaureate projects where

appropriate) and retention activities at

the health professions school level.

There should be an uninterrupted

continuum to assist students through

graduation from a health professions

school. This would be accomplished

through development and

implementation of activities related to

all the purposes identified in sections

738(b), 739, and 740 of the PHS Act.

(b) Minority faculty development

initiatives designed to recruit and

provide a formal structured program of

preparation in such areas as pedagogical

skills, program administration, grant

writing and publication skills, research

methodology, development of research

proposals and community service

abilities under a senior faculty mentor.

It should involve pre-faculty

appointment, faculty fellowship

opportunities and retention for junior

minority faculty in health professions

schools;

(c) Information resources and

curricula addressing minority health

issues and clinical education at

community based sites remote from the

health professions school that

predominantly serve underserved

populations; and

(d) Faculty and student research on

health issues particularly affecting

minority groups.

5. Measurable, outcome oriented and

time framed performance outcome

standards will be used to evaluate the

project.

6. All award recipients must agree to

maintain institutional expenditures of

non-Federal funds in an amount not less

than the previous fiscal year.

7. Program activities and experiences

related to the establishment of the

Partnerships for Health Professions

Education Program must be documented

in a format that would allow for future

duplication by other institutional

organizations.

Substantial Federal Programmatic

Involvement

It is anticipated that the Federal

government will have substantial

programmatic involvement with the

planning, development and

administration of the Partnerships for

Health Professions Education Program

and its outputs by:

1. Providing technical assistance,

guidance and reviewing changes needed

to conduct the project.

2. Reviewing and advising regarding

training content and methodologies and

formal faculty development regimens.

3. Providing advice regarding formal

linkage and consortium arrangements

which have been established for the

purpose of conducting the Partnerships

for Health Professions Education

Program.

4. Assisting in the modification of

student participant selection criteria

and processes.

5. Providing information relative to

proven evaluation methods, including

data collection methods, data analysis

techniques and participant tracking

systems.

6. Reviewing and advising on program

evaluation methods, including data

collection activities, data analysis

techniques and participant tracking

systems.

7. Reviewing and advising on the

documentation of the activities and

experiences related to establishment of

the Partnerships for Health Professions

Education Program.

8. Providing data and information

about Federal programs that may impact

the Partnerships for Health Professions

Education Program.

9. Participating in the review of

subcontracts awarded under the

Cooperative Agreement.

Proposed Review Criteria

The following criteria are proposed

for review of applications for this

program:

1. The relationship of the applicants

proposal to the purposes stated for the

Partnerships for Health Professions

Education Program, the
18752 Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / Notices

comprehensiveness and geographic base

of the proposed project, the extent to

which linkages with community entities

and institutions are documented, and

the degree to which the proposed

project plans are transferable to other

institutions.

2. The extent, institutional

commitment and outcomes of past

efforts and activities of the institution in

conducting minority/disadvantaged

programs, the extent to which applicant

data indicate trends, the numbers and

type (race/ethnicity, gender) of

individuals that can be expected to

benefit from the project, and suitability

of participant eligibility requirements,

selection criteria, and process.

3. The relevance of objective(s) to the

stated problem and need, and to model

purposes; their measurability and

attainability within a specific time

frame; and the extent to which they

represent outcome measures.

4. The scope of specific activities and

their relevance to the stated objectives

and projected outcomes; their

appropriateness for a Partnership for

Health Professions Education Program;

their soundness in terms of the extent

and nature of the academic content and

non-academic services; and their

validity as to the methodologies, logic

and sequencing proposed.

5. The administrative and managerial

capability of the applicant to conduct

the project, qualifications of the staff

and faculty, their academic and

experiential background and time

commitment, the nature and degree of

their involvement, and their experience

in working with the proposed target

group.

6. The appropriateness of the budget

for assuring effective utilization of

cooperative agreement funds and the

institutional or organizational plan for

phasing-in income from other sources

and developing self-sufficiency for

continuing the program after Federal

funding.

7. The degree to which the applicant

has made significant efforts to increase

the number of minority individuals

serving in faculty or administrative

positions at the health professions

school.

8. Techniques and methods to be

employed in evaluating the project.

National Health Objectives for the Year

2000

The Public Health Service urges

applicants to submit work plans that

address specific objectives of Healthy

People 2000. Potential applicants may

obtain a copy of Healthy People 2000

(Full Report; Stock No. 017–001–00474–

0) or Healthy People 2000 (Summary

Report; Stock No. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, D.C. 20402–9325

(Telephone 202–783–3238).

Education and Service Linkage

As part of its long-range planning,

HRSA will be targeting its efforts to

strengthening linkages between U.S.

Public Health Service education

programs and programs which provide

comprehensive primary care services to

the underserved.

Smoke-Free Workplace

The Public Health Service strongly

encourages all grant recipients to

provide a smoke-free workplace and to

promote the non-use of all tobacco

products and Public Law 103–227, the

Pro-Children Act of 1994, prohibits

smoking in certain facilities that receive

Federal funds in which education,

library, day care, health care, and early

childhood development services are

provided to children.

Additional Information

Interested persons are invited to

comment on the proposed project

requirements and review criteria. The

comment period is 30 days. All

comments received on or before May 29,

1996 will be considered before the final

project requirements and review criteria

are established. Written comments

should be addressed to Dr. Ciriaco Q.

Gonzales, Director, Division of

Disadvantaged Assistance, Bureau of

Health Professions, Health Resources

and Services Administration, Parklawn

Building, Room 8A–09, 5600 Fishers

Lane, Rockville, Maryland 20857. All

comments received will be available for

public inspection and copying at the

Division of Disadvantaged Assistance,

Bureau of Health Professions, at the

above address, weekdays (Federal

holiday excepted) between the hours of

8:30 a.m. and 5:00 p.m.

Application Availability

Application materials are available on

the World Wide Web at address: http:/

/www.os.dhhs.gov/hrsa/bhpr. Click on

the file name you want to download to

your computer. It will be saved as a selfextracting WordPerfect 5.1 file. Once the

file is downloaded to the applicant’s PC,

it will still be in a compressed state. To

decompress the file, go to the directory

where the file has been downloaded and

type in the file name followed by a

<return>. The file will expand into a

WordPerfect 5.1 file. Applicants are

strongly encouraged to obtain

application materials from the World

Wide Web via the Internet.

However, for applicants who do not

have Internet capability, application

materials are also available on the

Bureau of Health Professions (BHPr)

Bulletin Board. Use your computer and

modem to call (301) 443–5913. Set your

modem parameters to 2400 baud, parity

to none, data bits to 8, and stop bits to

1. Set your terminal emulation to ANSI

or VT–100.

Once you have accessed the BHPr

Bulletin Board, you will be asked for

your first and last name. It will also ask

you to choose a password. Remember

Your Password! The first time you logon

you ‘‘register’’ by answering a number of

other questions. The next time you

logon, BHPr’s Bulletin Board will know

you.

Press (F) for the (F)iles Menu and (L)

to (L)ist Files. Press (L) again to see a list

of numbered file areas. To see a list of

files in any area, type the number

corresponding to that area. Competitive

application materials for grant programs

administered by the Bureau of Health

Professions are located in the File Area

item ‘‘B’’ titled Grants Announcements.

To (R)ead a file or (D)ownload a file,

you need to know its exact name as

listed on BHPr’s Bulletin Board. Press

(R) to (R)ead a file and type the name

of the file. Press (D) to (D)ownload a file

to your computer. You need to know

how your communications software

accomplishes downloading.

When you have completed your tour

of BHPr’s Bulletin Board for this

session, press (G) for (G)oodbye and

press <enter>.

If you have difficulty accessing the

BHPr Bulletin Board, please try the

Internet address listed above. If you do

not have Internet capability and need

assistance in accessing the BHPr

Bulletin Board or technical assistance

with any aspect of the BHPr Bulletin

Board, please call Mr. Larry DiGiulio,

Systems Operator for the BHPr Bulletin

Board at (301) 443–2850 or

‘‘ldigiuli@hrsa.ssw.dhhs.gov’’.

Questions regarding grants policy and

business management issues should be

directed to Ms. Wilma Johnson, Acting

Chief, Centers and Formula Grants

Section (wjohnson@hrsa.ssw.dhhs.gov),

Grants Management Branch, Bureau of

Health Professions, Health Resources

and Services Administration, Parklawn

Building, Room 8C–26, 5600 Fishers

Lane, Rockville, Maryland 20857. If you

are unable to obtain the application

materials electronically, you may obtain

application materials in the mail by

sending a written request to the Grants

Management Branch at the address

above. Written requests may also be sent

via FAX (301) 443–6343 or via the

Internet listed above. Completed
Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / Notices 18753

applications should be returned to the

Grants Management Branch at the above

address.

If additional programmatic

information is needed, please contact

Dr. Ciriaco Q. Gonzales, Director,

Division of Disadvantaged Assistance,

Bureau of Health Professions, Health

Resources and Services Administration,

Parklawn Building, Room 8A–17, 5600

Fishers Lane, Rockville, Maryland

20857.

Paperwork Reduction Act

The standard application form PHS

6025–1, HRSA Competing Training

Grant Application, and General

Instructions have been approved by the

Office of Management and Budget under

the Paperwork Reduction Act. The OMB

Clearance Number is 0915–0060.

The deadline date for receipt of

applications is July 12, 1996.

Applications will be considered to be

‘‘on time’’ if they are either:

(1) Received on or before the

established deadline date, or

(2) Sent on or before the established

deadline date and received in time for

orderly processing. (Applicants should

request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

Late applications not accepted for

processing will be returned to the

applicant. In addition, applications

which exceed the page limitation and/

or do not follow format instructions will

not be accepted for processing and will

be returned to the applicant.

This program is not subject to the

provisions of Executive Order 12372,

Intergovernmental Review of Federal

Programs (as implemented through 45

CFR part 100). This program is also not

subject to the Public Health System

Reporting Requirements.

Dated: April 17, 1996.

Ciro V. Sumaya,

Administrator.

[FR Doc. 96–10483 Filed 4–26–96; 8:45 am]

BILLING CODE 4160–15–P

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 for opportunity

for public comment on proposed data

collection projects, the Substance Abuse

and Mental Health Services

Administration will publish periodic

summaries of proposed projects. To

request more information on the

proposed projects or to obtain a copy of

the data collection plans and

instruments, contact the SAMHSA

Reports Clearance Officer on (301) 443–

0525.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project

National Household Survey on Drug

Abuse—Revision—The National

Household Survey on Drug Abuse

(NHSDA) is a survey of the civilian,

noninstitutionalized population of the

Unitied States, age 12 and over. The

data are used to determine the

prevalence of use of cigarettes, alcohol,

and illicit substances, and illicit use of

prescription drugs. The results are used

by SAMHSA, ONDCP, Federal

government agencies, and other

organizations and researchers to

establish policy, direct program

activities, and better allocate resources.

For 1997, the core NHSDA

questionnaire will remain unchanged;

however, several special topic modules

are expected to change. The total annual

burden estimate is 30,220 hours as

shown below:

Number of

respondents

Number of

responses

per respondent

Average

burden per

response

(hrs.)

Total burden

(hrs.)

Household screener ......................................................................................................... 53,082 1 0.05 2,654

NHSDA questionnaire ...................................................................................................... 23,320 1 1.18 27,566

Send comments to Deborah Trunzo,

SAMHSA Reports Clearance Officer,

Room 16–105, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: April 23, 1996.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 96–10501 Filed 4–26–96; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Endangered and Threatened Species

Permit Application

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of receipt of application.

The following applicant has applied

for a permit to conduct certain activities

with endangered species. This notice is

provided pursuant to section 10(c) of

the Endangered Species Act of 1973, as

amended (16 U.S.C. 1531 et seq.).

PRT–813910

Applicant: Dr. Michael I. Kelrick,

Northeast Missouri State University,

Kirksville, Missouri.

The applicant requests a permit to

take (collection of seed, stems, leaves)

Missouri bladderpod (Lesquerella

filiformis) at the Wilson’s Creek

National Battlefield, Republic, Missouri,

for the purpose of enhancement of

species through propagation and

scientific research.

Written data or comments should be

submitted to the Regional Director, U.S.

Fish and Wildlife Service, Division of

Endangered Species, 1 Federal Drive,

Fort Snelling, Minnesota 55111–4056,

and must be received within 30 days of

the date of this publication.