Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Notices 51867

• Documentation. Institutions should

clearly define documentation

requirements for securities transactions,

saving and safeguarding important

documents, as well as maintaining

possession and control of instruments

purchased.

An institution’s policies should also

provide guidelines for conflicts of

interest for employees who are directly

involved in purchasing and selling

securities for the institution from

securities dealers. These guidelines

should ensure that all directors, officers,

and employees act in the best interest of

the institution. The board may wish to

adopt policies prohibiting these

employees from engaging in personal

securities transactions with these same

securities firms without specific prior

board approval. The board may also

wish to adopt a policy applicable to

directors, officers, and employees

restricting or prohibiting the receipt of

gifts, gratuities, or travel expenses from

approved securities dealer firms and

their representatives.

Legal Risk

Legal risk is the risk that contracts are

not legally enforceable or documented

correctly. Institutions should adequately

evaluate the enforceability of its

agreements before individual

transactions are consummated.

Institutions should also ensure that the

counterparty has authority to enter into

the transaction and that the terms of the

agreement are legally enforceable.

Institutions should further ascertain that

netting agreements are adequately

documented, executed properly, and are

enforceable in all relevant jurisdictions.

Institutions should have knowledge of

relevant tax laws and interpretations

governing the use of these instruments.

Dated: September 29, 1997.

Joe M. Cleaver,

Executive Secretary, Federal Financial

Institutions Examination Council.

[FR Doc. 97–26207 Filed 10–2–97; 8:45 am]

BILLING CODE 6210–01–P, 6720–01–P, 6714–01–P,

4810–01–P, 7535–01–P

FEDERAL RESERVE SYSTEM

Formations of, Acquisitions by, and

Mergers of Bank Holding Companies

The companies listed in this notice

have applied to the Board for approval,

pursuant to the Bank Holding Company

Act of 1956 (12 U.S.C. 1841 et seq.)

(BHC Act), Regulation Y (12 CFR Part

225), and all other applicable statutes

and regulations to become a bank

holding company and/or to acquire the

assets or the ownership of, control of, or

the power to vote shares of a bank or

bank holding company and all of the

banks and nonbanking companies

owned by the bank holding company,

including the companies listed below.

The applications listed below, as well

as other related filings required by the

Board, are available for immediate

inspection at the Federal Reserve Bank

indicated. The application also will be

available for inspection at the offices of

the Board of Governors. Interested

persons may express their views in

writing on the standards enumerated in

the BHC Act (12 U.S.C. 1842(c)). If the

proposal also involves the acquisition of

a nonbanking company, the review also

includes whether the acquisition of the

nonbanking company complies with the

standards in section 4 of the BHC Act.

Unless otherwise noted, nonbanking

activities will be conducted throughout

the United States.

Unless otherwise noted, comments

regarding each of these applications

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than October 30,

1997.

A. Federal Reserve Bank of New

York (Betsy Buttrill White, Senior Vice

President) 33 Liberty Street, New York,

New York 10045-0001:

1. Canisteo Valley Corporation,

Canisteo, New York; to become a bank

holding company by acquiring 100

percent of the voting shares of First

State Bank, Canisteo, New York.

B. Federal Reserve Bank of Atlanta

(Lois Berthaume, Vice President) 104

Marietta Street, N.W., Atlanta, Georgia

30303-2713:

1. Great Southern Capital Corporation

Employee Stock Ownership Trust,

Meridian, Mississippi; to acquire at least

50 percent of the voting shares of Great

Southern Capital Corporation, Meridian,

Mississippi, and thereby indirectly

acquire Great Southern National Bank,

Meridian, Mississippi.

C. Federal Reserve Bank of St. Louis

(Randall C. Sumner, Vice President) 411

Locust Street, St. Louis, Missouri 63102-

2034:

1. First Citizens Bancshares, Inc.,

Dyersburg, Tennessee; to acquire 100

percent of the voting shares of Bank of

Troy, Troy, Tennessee.

Board of Governors of the Federal Reserve

System, September 30, 1997.

William W. Wiles,

Secretary of the Board.

[FR Doc. 97–26338 Filed 10–2–97; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 811]

National Institute for Occupational

Safety and Health; Research and

Demonstration Grants; Occupational

Safety and Health

Introduction

The National Institute for

Occupational Safety and Health

(NIOSH) of the Centers for Disease

Control and Prevention (CDC) is

soliciting grant applications for research

and demonstration projects related to

occupational safety and health (see the

section Availability of Funds).

CDC is committed to achieving the

health promotion and disease

prevention objectives of Healthy People

2000, a national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Occupational Safety and Health. (For

ordering a copy of Healthy People 2000,

see the section Where to Obtain

Additional Information.)

Authority

This program is authorized under the

Public Health Service Act, as amended,

Section 301 (42 U.S.C. 241); the

Occupational Safety and Health Act of

1970, Sections 20(a) and 22 (29 U.S.C.

669(a) and 671); and the Federal Mine

Safety and Health Act of 1977, Section

501 (30 U.S.C. 951). The applicable

program regulations are in 42 CFR part

52.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Pub. L.

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds and in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants include domestic

and foreign non-profit and for-profit

organizations, universities, colleges,

research institutions, and other public

and private organizations, including

State and local governments and small,

minority and/or woman-owned

businesses. Exceptions: Foreign

organizations, as well as domestic

institutions with a foreign component,

are ineligible to apply for the Special
51868 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Notices

Emphasis Research Career Award

(SERCA) Grant and Small Grant

programs (additional guidance provided

under these mechanisms).

Note: An organization described in section

501(c)(4) of the Internal Revenue Code of

1986 which engages in lobbying activities

shall not be eligible to receive Federal funds

constituting an award, grant, contract, loan,

or any other form.

Availability of Funds

For fiscal year (FY) 1998, the budget

is projected to be $13,500,000. Of that

amount, $9,100,000 is committed to

support 47 non-competing continuing

awards. Therefore, $4,400,000 is

available for new and competing

renewal awards. The overall budget

includes funds for Small Business

Innovation Research (SBIR) grants and

for health and safety research related to

the construction industry. Target

amounts (continuing and new awards)

for certain grant mechanisms are as

follows: 10 R03 grants (about $375,000),

10 K01 grants (about $540,000), and 5

R29 grants (about $500,000).

Grant applications should be focused

on the research priorities described in

the section Funding Priorities that

include new research priorities

developed in a process which resulted

in defining a National Occupational

Research Agenda.

Background

In today’s society, Americans are

working more hours than ever before.

The workplace environment profoundly

affects health. Each of us, simply by

going to work each day, may face

hazards that threaten our health and

safety. Risking one’s life or health

should never be considered merely part

of the job.

In 1970, Congress passed the

Occupational Safety and Health Act to

ensure Americans the right to ‘‘safe and

healthful working conditions,’’ yet

workplace hazards continue to inflict a

tremendous toll in both human and

economic costs.

Employers reported 6.3 million work

injuries in 1994 and 515,000 cases of

occupational illness. An average of 16

American workers die each day from

injuries on the job. Moreover, even the

most conservative estimates find that

about 137 additional workers die each

day from workplace diseases.

Additionally, in 1994 occupational

injuries and deaths cost $120.7 billion

in wages and lost productivity,

administrative expenses, health care

and other costs. This does not include

the cost of occupational disease.

Occupational injury and disease

create needless human suffering, a

tremendous burden upon health care

resources, and an enormous drain on

U.S. productivity. Yet, to date, this

mainstream public health problem has

escaped mainstream public attention.

The philosophy of NIOSH is

articulated in the Institute’s vision

statement: Delivering on the Nation’s

Promise: Safety and Health at Work for

All People * * * Through Research and

Prevention. To identify and reduce

hazardous working conditions, the

Institute carries out disease, injury, and

hazard surveillance and conducts a

wide range of field and laboratory

research. Additionally, NIOSH sponsors

extramural research in priority areas to

complement and expand its efforts.

These are listed in the section Funding

Priorities.

Purpose

The purpose of this grant program is

to develop knowledge that can be used

in preventing occupational diseases and

injuries. Thus, NIOSH will support the

following types of applied research

projects: Causal research to identify and

investigate the relationships between

hazardous working conditions and

associated occupational diseases and

injuries; methods research to develop

more sensitive means of evaluating

hazards at work sites, as well as

methods for measuring early markers of

adverse health effects and injuries;

control research to develop new

protective equipment, engineering

control technology, and work practices

to reduce the risks of occupational

hazards; and demonstrations to evaluate

the technical feasibility or application of

a new or improved occupational safety

and health procedure, method,

technique, or system.

Mechanisms of Support

Applications responding to this

announcement will be reviewed by staff

for their responsiveness to the following

program requirements. Grants are

funded for 12-month budget periods in

project periods up to five years for

research project grants and

demonstration project grants; three

years for SERCA grants; and two years

for small grants. Continuation awards

within the project period are made on

the basis of satisfactory progress and on

the availability of funds. The types of

grants NIOSH supports are as follow:

1. Research Project Grants (R01)

A research project grant application

should be designed to establish,

discover, develop, elucidate, or confirm

information relating to occupational

safety and health, including innovative

methods, techniques, and approaches

for dealing with problems. These

studies may generate information that is

readily available to solve problems or

contribute to a better understanding of

the causes of work-related diseases and

injuries.

2. Demonstration Project Grants (R18)

A demonstration project grant

application should address, either on a

pilot or full-scale basis, the technical or

economic feasibility of implementing a

new/improved innovative procedure,

method, technique, or system for

preventing occupational safety or health

problems. The project should be

conducted in an actual workplace where

a baseline measure of the problem will

be defined, the new/improved approach

will be implemented, a follow-up

measure of the problem will be

documented, and an evaluation of the

benefits will be conducted.

3. First Independent Research Support

and Transition (FIRST) Grants (R29)

The FIRST grant is to provide a

sufficient period of research support for

newly independent investigators to

initiate their own research and

demonstrate the merit of their own

research ideas. These grants are

intended to underwrite the first

independent investigative efforts of an

individual; to provide a reasonable

opportunity to demonstrate creativity,

productivity, and further promise; and

to help in the transition to traditional

types of research project grants. The

award is not intended for individuals in

mid-career who may be in transition to

another undertaking. It is for a distinct

research endeavor and may not be used

merely to supplement or broaden an

ongoing project.

Candidates must (1) be genuinely

independent of a mentor, yet at the

same time be at the beginning stages of

their research careers, (2) have no more

than 5 years of research experience

since completing post-doctoral research

training or its equivalent, (3) not be in

training status at the time of the award,

(4) have never been the principal

investigator (PI) on any Public Health

Service grant except a Small Grant (R03)

or a Special Emphasis Research Career

Award Grants (K01), and (5) the

applicant organizations must be

domestic. For non-U.S. citizens who

will be principal investigators, the

grantee institution must indicate in the

application that the individual’s visa

will allow the person to remain in the

country a sufficient length of time to

complete the project. Also, a U.S.

citizen must be identified who is a

permanent staff member of the grantee

institution and who, if the FIRST grant
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Notices 51869

recipient is unable to stay in the U.S.,

will be responsible for seeing the project

through to completion.

The PI must request 5 years of

support; otherwise, the application will

be reviewed as a traditional research

project (R01). There must be a

commitment of no less than 50 percent

effort to the proposed project. The total

direct cost for the 5-year period may not

exceed $350,000. The direct cost award

in any budget period may not exceed

$100,000. FIRST awards are not

renewable; however, a PI may submit an

R01 application to continue and extend

the research supported by a FIRST

award. Replacement of the PI on a

FIRST award will not be approved.

The application must include the

following documentation: (1) A letter or

memorandum is needed from a suitable

department head or dean which

addresses the eligibility of the proposed

PI to lead a research project

independently at the applicant

organization (i.e., Is the proposed PI

otherwise qualified to be the PI on a

traditional project grant?). When the

application is from the institution where

the proposed PI received post-doctoral

research training, it must be made

absolutely clear that the FIRST award

would be to support a research endeavor

independent of that conducted in the

former training environment. Details of

the intended commitment of the

institution to the project for the 5-year

period should be provided. (2) At least

three letters of reference must be

submitted. FIRST applicants are to

request the letters well in advance of the

application submission, advising the

referees to return the reference letters to

the applicant in sealed envelopes as

soon as possible. To protect the utility

and confidentiality of reference letters,

applicants are not to open the

envelopes. The sealed envelopes must

be attached to the front of the original

application. Reference letters should

reflect the investigator’s research

originality and potential for

independent investigation. A list of

individuals providing letters must be

included as Section 10 of the Research

Plan. Names, titles, and institutional

affiliation are needed for each person.

4. Special Emphasis Research Career

Award (SERCA) Grants (K01)

The SERCA grant is intended to

provide opportunities for individuals to

acquire experience and skills while

under the direction of at least one

mentor, and in so doing, create a pool

of highly qualified investigators who

can make future contributions to

research in the area of occupational

safety and health. SERCA grants are not

intended for individuals without

research experience, or for productive,

independent investigators with a

significant number of publications and

of senior academic rank. Moreover, the

award is not intended to substitute one

source of salary support for another for

an individual who is already conducting

full-time research; nor is it intended to

be a mechanism for providing

institutional support.

Candidates must: (1) Hold a doctoral

degree; (2) have research experience at

or above the doctoral level; (3) not be

above the rank of associate professor;

and (4) be employed at a domestic

institution. For non-U.S. citizens who

will be principal investigators, the

grantee institution must indicate in the

application that the individual’s visa

will allow the person to remain in the

country a sufficient length of time to

complete the project. Also, a U.S.

citizen must be identified who is a

permanent staff member of the grantee

institution and who, if the SERCA grant

recipient is unable to stay in the U.S.,

will be responsible for seeing the project

through to completion.

This non-renewable award provides

support for a three-year period for

individuals engaged in full-time

research and related activities. Awards

will not exceed $50,000 per year in

direct costs for salary support (plus

fringe benefits), technical assistance,

equipment, supplies, consultant costs,

domestic travel, publications, and other

costs. The indirect cost rate applied is

limited to 8 percent of the direct costs,

excluding tuition and related fees and

equipment expenses, or to the actual

indirect cost rate, whichever results in

the lesser amount.

A minimum of 60 percent time must

be committed to the proposed research

project, although full-time is desirable.

Other work in the area of occupational

safety and health will enhance the

candidate’s qualifications but is not a

substitute for this requirement. Related

activities may include research career

development activities as well as

involvement in patient care to the extent

that it will strengthen research skills.

Fundamental/basic research will not be

supported unless the project will make

an original contribution for applied

technical knowledge in the

identification, evaluation, or control of

occupational safety and health hazards

(e.g., development of a diagnostic

technique for early detection of an

occupational disease). Research project

proposals must be of the applicants’

own design and of such scope that

independent investigative capability

will be evident within three years. At

the completion of this three-year award,

it is intended that awardees should be

better able to compete for individual

research project grants awarded by

NIOSH.

SERCA grant applications should be

identified as such on the application

form. Section 2 of the application (the

Research Plan) should include a

statement regarding the applicant’s

career plans and how the proposed

research will contribute to a career in

occupational safety and health research.

This section should also include a letter

of recommendation from the proposed

advisor(s).

5. Small Grants (R03)

The small grant program is intended

to stimulate proposals from individuals

who are considering a research career in

occupational safety and health; as such,

the minimum time commitment is 10%.

It is expected that a recipient would

subsequently compete for other grant

mechanisms which are described above

in items 1 to 4. The award is not

intended to supplement ongoing or

other proposed research; nor is it

intended to be a mechanism for

providing institutional support. Please

note that fundamental/basic research is

generally not supported.

Small grant candidates are

predoctoral students, post-doctoral

researchers (within 3 years following

completion of doctoral degree or

completion of residency or public

health training), or junior faculty

members (no higher than assistant

professor). If university policy requires

that a more senior person be listed as

principal investigator, it should be clear

in the application which person is the

small grant investigator. For non-U.S.

citizens who will be principal

investigators, the grantee institution

must indicate in the application that the

individual’s visa will allow the person

to remain in the country a sufficient

length of time to complete the project.

Also, a U.S. citizen must be identified

who is a permanent staff member of the

grantee institution and who, if the small

grant recipient is unable to stay in the

U.S., will be responsible for seeing the

project through to completion. Except

for applicants who are assistant

professors, there must be one or more

named mentors to assist with the

project.

A biographical sketch is required for

the small grant investigator, as well as

for the supervisor and other key

consultants, as appropriate.

This non-renewable award provides

support for project periods of up to two

years to carry out exploratory or pilot

studies, to develop or test new

techniques or methods, or to analyze
51870 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Notices

data previously collected. Awards will

not exceed $25,000 per year in direct

costs for salary support (plus fringe

benefits), technical assistance,

equipment, supplies, consultant costs,

domestic travel, publications, and other

costs. The indirect costs will be based

upon the negotiated indirect cost rate of

the applicant organization. An

individual may not receive more than

two small grant awards, and then, only

if the awards are at different stages of

development (e.g., doctoral student,

post-doctoral researcher, or junior

faculty member).

Funding Priorities

The NIOSH program priorities, listed

below, are applicable to all of the above

types of grants listed under the section

Mechanisms of Support. These priority

areas were developed by NIOSH and its

partners in the public and private

sectors to provide a framework to guide

occupational safety and health research

in the next decade—not only for NIOSH

but also for the entire occupational

safety and health community.

Approximately 500 organizations and

individuals outside NIOSH provided

input into the development of the

National Occupational Research Agenda

(NORA). This attempt to guide and

coordinate research nationally is

responsive to a broadly perceived need

to address systematically those topics

that are most pressing and most likely

to yield gains to the worker and the

nation. Fiscal constraints on

occupational safety and health research

are increasing, making even more

compelling the need for a coordinated

and focused research agenda. NIOSH

intends to support projects that facilitate

progress in understanding and

preventing adverse effects among

workers. The conditions or examples

listed under each category are selected

examples, not comprehensive

definitions of the category. Investigators

may also apply in other areas related to

occupational safety and health, but the

rationale for the significance of the

research to the field of occupational

safety and health must be presented in

the grant application.

Potential applicants with questions

concerning the acceptability of their

proposed work are strongly encouraged

to seek programmatic technical

assistance from the contact listed in this

announcement under the section Where

to Obtain Additional Information.

The Agenda identifies 21 research

priorities. These priorities reflect a

remarkable degree of concurrence

among a large number of stakeholders.

The NORA priority research areas are

grouped into three categories: Disease

and Injury, Work Environment and

Workforce, and Research Tools and

Approaches. The NORA document is

available through the NIOSH Home

Page; http://www.cdc.gov/niosh/

nora.html.

NORA Priority Research Areas

Disease and Injury

Allergic and Irritant Dermatitis

Asthma and Chronic Obstructive

Pulmonary Disease

Fertility and Pregnancy Abnormalities

Hearing Loss

Infectious Diseases

Low Back Disorders

Musculoskeletal Disorders of the

Upper Extremities

Traumatic Injuries

Work Environment and Workforce

Emerging Technologies

Indoor Environment

Mixed Exposures

Organization of Work

Special Populations at Risk

Research Tools and Approaches

Cancer Research Methods

Control Technology and Personal

Protective Equipment

Exposure Assessment Methods

Health Services Research

Intervention Effectiveness Research

Risk Assessment Methods

Social and Economic Consequences of

Workplace Illness and Injury

Surveillance Research Methods

Applications Submission and Deadlines

and Review Dates

The research grant application Form

PHS–398 (OMB Number 0925–0001) is

to be used in applying for these grants.

These forms are available at most

institutional offices of sponsored

research; from the Extramural Outreach

and Information Resources Office,

Office of Extramural Research, 6701

Rockledge Drive, MS–C7910, Bethesda,

MD 20892–7910, telephone (301) 435–

0714; fax (301) 480–8443; Internet

girg@drgpo.drg.nih.gov; and from the

contacts listed under the section Where

to Obtain Additional Information.

The original and five copies of the

PHS–398 must be submitted to Division

of Research Grants, National Institutes

of Health, Suite 1040, 6701 Rockledge

Drive, MS–C7710, Bethesda, MD 20892–

7710, on or before the specified receipt

dates provided below. A mailing label is

provided in the Form PHS–398

application package.

The timetable for receiving

applications and awarding grants is

given below. This is a continuous

announcement, consequently, these

receipt dates will be on-going until

further notice.

Receipt date1 Initial review Secondary review Earliest possible

start date

Research and Demonstration Project Grants

February 1 ............................................... June/July ................................................ September .............................................. December 1.

June 1 ..................................................... Oct/Nov ................................................... January ................................................... April 1.

October 1 ................................................ Feb/Mar .................................................. May ......................................................... August 1.

SERCA and Small Grants

March 1 ................................................... June/July ................................................ August .................................................... November 1.

July 1 ....................................................... Oct/Nov ................................................... December ............................................... March 1.

November 1 ............................................ Feb/Mar .................................................. April ........................................................ July 1.

1 Deadlines for competing continuation applications or revised applications are 1 month later.

Applications must be received by the

above receipt dates. To prevent

problems caused by carrier delays,

retain a legible proof-of-mailing receipt

from the carrier, dated no later than one

week prior to the receipt date. If the

receipt date falls on a weekend, it will

be extended to Monday; if the date falls

on a holiday, it will be extended to the

following work day. The receipt date

will be waived only in extenuating

circumstances. To request such a

waiver, include an explanatory letter

with the signed, completed application.

No request for a waiver will be

considered prior to receipt of the

application.
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Notices 51871

Evaluation Criteria

Applications will be reviewed for

scientific merit by the chartered CDC/

NIOSH Occupational Safety and Health

Study Section (SOH), in accordance

with standard peer review procedures.

Following initial review for scientific

merit, the applications will receive a

secondary review for programmatic

importance. Notification of the scientific

review recommendations will be sent to

the applicants after the initial review.

Awards will be made based on results

of the initial and secondary reviews, as

well as availability of funds.

1. The initial (peer) review criteria

are:

• Scientific, technical, or medical

significance and originality of proposed

research.

• Availability, adequacy, and

competence of personnel, facilities, and

other resources needed to carry out the

project.

• Feasibility of the project and

likelihood of its producing meaningful

results.

• Appropriateness of the proposed

project period and budget request.

• Adequacy of the applicant’s

resources available for the project.

Demonstration grant applications will

be reviewed additionally on the basis of

the following criteria:

• Degree to which the project will

document baseline measures and

evaluate the benefits of an intervention

approach.

• Degree to which the project can be

expected to yield or demonstrate results

that will be useful and desirable on a

national or regional basis.

• Documentation of cooperation from

industry, unions, or other participants

in the project.

SERCA grant applications will be

reviewed additionally on the basis of

the following criteria:

• The review process will consider

the applicant’s scientific achievements,

the applicant’s research career plan in

occupational safety and health, and the

degree to which the applicant’s

institution offers a superior research

environment (supportive nature,

including letter(s) of reference from

advisor(s) which should accompany the

application).

Small grant applications will be

reviewed taking the following into

consideration:

• Applicants for small grants do not

have extensive experience with the

grants process, so there is leniency in

assigning priority scores.

2. The secondary (programmatic)

review criteria are:

• Relevance to occupational safety

and health by contributing to

achievement of research objectives

specified in Sections 20(a) and 22 of the

Occupational Safety and Health Act of

1970 and Section 501 of the Federal

Mine Safety and Health Act of 1977.

• Magnitude of the problem in terms

of numbers of workers affected.

• Severity of the disease or injury in

the worker population.

• Potential contribution to applied

technical knowledge in the

identification, evaluation, or control of

occupational safety and health hazards.

• Program balance.

• Policy and budgetary

considerations.

Questions regarding the above criteria

should be addressed to the

Programmatic Technical Information

Contact listed under Where to Obtain

Additional Information.

Technical Reporting Requirements

Progress reports are required annually

as part of the continuation application

(75 days prior to the start of the next

budget period). The annual progress

reports must contain information on

accomplishments during the previous

budget period and plans for each

remaining year of the project. Financial

status reports (FSR) are required no later

than 90 days after the end of the budget

period. The final performance and

financial status reports are required 90

days after the end of the project period.

The final performance report should

include, at a minimum, a statement of

original objectives, a summary of

research methodology, a summary of

positive and negative findings, and a list

of publications resulting from the

project.

Research papers, project reports, or

theses are acceptable items to include in

the final report. The final report should

stand alone rather than citing the

original application. Three copies of

reprints of publications prepared under

the grant should accompany the report.

Executive Order 12372 Review

Applications are not subject to review

as governed by Executive Order 12372.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.262.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Other Requirements

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations (45 CFR part 46)

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

Women and Racial and Ethnic

Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC) to

ensure that women and racial and

ethnic groups will be included in CDC/

ATSDR-supported research projects

involving human subjects, whenever

feasible and appropriate. Racial and

ethnic groups are those defined in OMB

Directive No. 15 and include American

Indian, Alaska Native, Asian, Pacific

Islander, Black and Hispanic.

Applicants shall ensure that women and

racial and ethnic minority populations

are appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is inappropriate or not feasible, this

situation must be explained as part of

the application. In conducting review

for scientific merit, review groups will

evaluate proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and scoring. This

policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, pages 47947–47951,

and dated Friday, September 15, 1995.

Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions. An applicant organization

proposing to use vertebrate animals in

CDC-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.
51872 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Notices

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to refer to announcement #811.

You will receive a complete program

description, information on application

procedures, and application. Business

management information may be

obtained from Joanne Wojcik, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., MS–E13,

Atlanta, GA 30305, telephone (404)

842–6535; fax: (404) 842–6513; Internet:

jcw6@cdc.gov.

Programmatic technical assistance

may be obtained from Roy M. Fleming,

Sc.D., Associate Director for Grants,

National Institute for Occupational

Safety and Health, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Building 1, Room

3053, MS–D30, Atlanta, GA 30333,

telephone: (404) 639–3343; fax: (404)

639–4616; Internet: rmf2@cdc.gov.

Please refer to announcement number

811 when requesting information and

submitting an application.

This and other CDC Announcements

can be found on the CDC home page

(http://www.cdc.gov) under the

Funding section.

CDC will not send application kits by

facsimile or express mail (even at the

request of the applicant).

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, DC 20402–9325, telephone

(202) 512–1800.

Dated: September 29, 1997.

Linda Rosenstock,

Director, National Institute for Occupational

Safety and Health, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–26275 Filed 10–2–97; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

The Centers for Disease Control and

Prevention (CDC) Announces the

Following Workshop

Name: Workshop on Enhancing

Community Participation to Restore

Public Trust and Improve Science in

Health Research.

Times and Dates: 8:30 a.m.–5:30 p.m.,

October 16, 1997. 8 a.m.–4:45 p.m.,

October 17, 1997.

Place: CDC, Auditorium A, 1600

Clifton Road, NE, Atlanta, Georgia

30333.

Status: Open to the public, limited

only by the space available. The meeting

room accommodates approximately 100

people.

Purpose: The primary purpose of this

workshop is to provide guidance to

public health researchers on the

inclusion of communities in the

planning, conduct, and application of

research.

History has demonstrated, when

medical and public health science is

planned and conducted in the absence

of considering the social context of its

work, people have been harmed. As a

result, society has responded with laws

and regulations to protect human

subjects who participate in research.

Lacking in this discussion has been the

issue of planning and conducting

research that involves and impacts

communities. This workshop will

provide a unique opportunity to open

dialogue between government,

communities, and researchers. This

dialogue should result in a proposed

framework through which CDC

promotes public health, advances

democratic principles, establishes an

ethical basis for community-based

research, enhances scientific credibility,

and provides mechanisms for building

public trust while advancing the science

of public health.

Matters To Be Discussed: Agenda

items include: identifying strategies for

partnering with communities in

research and overcoming distrust;

legacy from the Tuskegee Study of

Untreated Syphilis; review of human

subjects protection; role of the

community in protecting human

subjects; assets that communities bring

to research; and assets that researchers

bring to communities.

After the above comments and

discussions, the workshop will be

divided into five breakout sessions

which will include: (I) Strategies, Issues,

and Barriers; (II) Research Design

Scenarios; (III) Critique of Strategies

Elicited in Breakout Session II; (IV)

Community Concerns and Issues; and

(V) Final Recommendations.

Contact Persons for More Information:

Michael J. Sage, Deputy Chief, Radiation

Studies Branch, Division of

Environmental Hazards and Health

Effects, National Center for

Environmental Health, CDC, 4770

Buford Highway, NE (F–35), Atlanta,

Georgia 30341–3724, telephone 770/

488–7040, FAX 770/488–7044; or Kate

M. MacQueen, Ph.D., Division of HIV/

AIDS Prevention, National Center for

HIV, STD and TB Prevention, CDC, 1600

Clifton Road, NE (E–45), Atlanta,

Georgia 30333, telephone 404/639–

6146, FAX 404/639–6129.

Dated: September 29, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–26243 Filed 10–2–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0401]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by November

3, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.