45652 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

service, procedure, or product

represents the typical or ordinary

experience of members of the public

who use the service, procedure, or

product, unless the representation is

true, and competent and reliable

scientific evidence substantiates that

claim, or respondents clearly and

prominently disclose either: (1) What

the generally expected results would be

for program participants; or (2) the

limited applicability of the endorser’s

experience to what consumers may

generally expect to achieve, that is, that

consumers should not expect to achieve

similar results.

Paragraph VI of the proposed order

prohibits respondents from making any

representation about the relative or

absolute efficacy, performance, benefits,

safety, or success of any ophthalmic

service, procedure, or product

purporting to treat, mitigate, or cure any

refractive vision deficiency, unless the

representation is true and, at the time

the representation is made, proposed

respondents possess and rely upon

competent and reliable scientific

evidence that substantiates the

representation.

Paragraph VII of the proposed order

requires that proposed respondents: (1)

Not disseminate to any optometrist or

eye care provider any material

containing any representations

prohibited by the order; (2) send a

required notice to each optometrist or

eye care provider with whom proposed

respondents have done business since

January 1, 1994, requesting that the

optometrist cease using any materials

previously received from proposed

respondents that contain any claims

violative of the order, informing the

optometrist of this settlement, and

attaching a copy of this proposed

compliant and order; (3) in the event

that proposed respondents receive any

information that subsequent to receipt

of the required notice any optometrist or

eye care provider is using or

disseminating any advertisement or

promotional material that contains any

representation prohibited by the order,

immediately notify the optometrist or

eye care provider that proposed

respondents will terminate the

optometrist or eye care provider’s right

to market and/or perform PCM ortho-k

if he or she continues to use such

advertisements or promotional

materials; (4) terminate any optometrist

or eye care provider about whom

proposed respondents receive any

information that such person has

continued to use advertisements or

promotional materials that contain any

representation prohibited by the order

after receipt of the required notice; and

(5) for a period of three (3) years

following service of the order, send the

required notice to each optometrist or

eye care provider with whom proposed

respondents do business after the date

of service of the order who has not

previously received the notice; the

notices shall be sent no later than the

earliest of: (1) The execution of a sales

or training agreement or contract

between proposed respondents and the

prospective optometrist or eye care

provider; or (2) the receipt and deposit

of payment from a prospective

optometrist or eye care provider of any

consideration in connection with the

sale of any service or rights associated

with PCM ortho-k. The mailing shall not

include any other documents.

Paragraph VIII of the proposed order

contains record keeping requirements

for materials that substantiate, qualify,

or contradict covered claims and

requires the proposed respondents to

keep and maintain all advertisements

and promotional materials containing

any representation covered by the

proposed order. In addition, Paragraph

IX requires distribution of a copy of the

consent decree to current and future

officers and agents. Further, Paragraph

X provides for Commission notification

upon a change in the corporate

respondents. Paragraph XI requires

proposed respondent J. Mason Hurt,

O.D. to notify the Commission when he

discontinues his current business or

employment and of his affiliation with

any new business or employment. The

proposed order, in paragraph XII, also

requires the filing of a compliance

report.

Finally, Paragraph XIII of the

proposed order provides for the

termination of the order after twenty

years under certain circumstances.

The purpose of this analysis is to

facilitate public comment on the

proposed order, and it is not intended

to constitute an official interpretation of

the agreement and proposed order, or to

modify in any way their terms.

Donald S. Clark,

Secretary.

[FR Doc. 97–22902 Filed 8–27–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 809]

Grants for Injury Control Research

Centers; Notice of Availability of Funds

for Fiscal Year 1998

Introduction

The Centers for Disease Control and

Prevention (CDC) announces that grant

applications are being accepted for

Injury Control Research Centers (ICRCs)

for fiscal year (FY) 1998.

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 areas of Violent

and Abusive Behavior and

Unintentional Injuries. (To order a copy

of Healthy People 2000, see the Section

Where to Obtain Additional

Information.)

Authority

This program is authorized under

sections 301, 391, 392, 393, and 394 of

the Public Health Service Act (42 U.S.C.

241, 280b, 280b–1, 280b–1a, and 280b–

2). Program regulations are set forth 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 in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

This announcement will provide

funding for applicants in regions which

do not have funded ICRCs and for

applicants in regions which have

funded centers which must recompete

for funding.

Eligible applicants are limited to

organizations in Region 1 (Connecticut,

Massachusetts, Maine, New Hampshire,

Rhode Island, Vermont), Region 2 (New

Jersey, New York, Puerto Rico, Virgin

Islands), Region 3 (Delaware, District of

Columbia, Maryland, Pennsylvania,

Virginia, and West Virginia), Region 5

(Illinois, Indiana, Michigan, Minnesota,

Ohio, Wisconsin), Region 6 (Louisiana,

New Mexico, Oklahoma, Texas,

Arkansas), and Region 8 (Colorado,
Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45653

Montana, North Dakota, South Dakota,

Utah, and Wyoming).

Eligible applicants include all

nonprofit and for-profit organizations in

Regions 1, 2, 3, 5, 6, and 8. Thus,

universities, colleges, research

institutions, hospitals, other public and

private organizations, State and local

health departments, and small, minority

and/or women-owned businesses are

eligible for these grants. Applicants

from non-academic institutions should

provide evidence of a collaborative

relationship with an academic

institution.

The currently funded centers in

Regions 4, 7, 9, and 10 are eligible for

supplemental funding.

Note: ICRC grant awards are made to the

applicant institution/organization, not the

Principal Investigator.

Availability of Funds

Approximately $1,500,000 is expected

to be available FY 1998 to fund at least

two re-competing research centers or a

combination of recompeting and new

research center projects, depending on

the outcome of the review process.

It is expected that the awards will

begin on or around September 1, 1998,

and will be made for a 12 month budget

period within a project period of up to

three years for developing research

centers and five years for re-competing

research centers.

Funding estimates may vary and are

subject to change. Continuation awards

within the project period will be made

on the basis of satisfactory progress and

the availability of funds.

Developing research center awards

will not exceed $500,000 per year (total

of direct and indirect costs) with a

project period not to exceed three years.

Depending on availability of funds, recompeting research center awards may

range from $750,000 to $1,500,000 per

year (total of direct and indirect costs)

with a project period not to exceed five

years. The range of support provided is

dependent upon the degree of

comprehensiveness of the center in

addressing the phases of injury control

(i.e., Prevention, Acute Care, and

Rehabilitation) as determined by the

Injury Research Grants Review

Committee (IRGRC).

Incremental levels within this range

for successfully re-competing research

centers will be determined as follows:

Base funding (included in figures below) ............................................................................................................................. Up to $750,000.

One phase ICRC ...................................................................................................................................................................... Up to $1,000,000.

(addresses one of the three phases of injury control)

Two phase ICRC ..................................................................................................................................................................... Up to $1,250,000.

(addresses two of the three phases of injury control)

Comprehensive ICRC .............................................................................................................................................................. Up to $1,500,000.

(addresses all three phases of injury control)

The existing funded centers in

Regions 4, 7, 9, and 10 may submit

proposals for supplemental awards to

expand/enhance existing projects, to

add a new phase(s) to an existing ICRC

grant, or to add biomechanics project(s)

that support one or more phases. The

request should not exceed $250,000

(direct and indirect cost) per year.

Funding is subject to program need and

the availability of funds.

Use of Funds

Prohibition on use of CDC Funds for

Certain Gun Control Activities

The Departments of Labor, Health and

Human Services, and Education, and

Related Agencies Appropriations Act,

1997 specifies that: None of the funds

made available for injury prevention

and control at the Centers for Disease

Control and Prevention may be used to

advocate or promote gun control.

Anti-Lobbying Act requirements

prohibit lobbying Congress with

appropriated Federal monies.

Specifically, this Act prohibits the use

of Federal funds for direct or indirect

communications intended or designed

to influence a Member of Congress with

regard to specific Federal legislation.

This prohibition includes the funding

and assistance of public grassroots

campaigns intended or designed to

influence Members of Congress with

regard to specific legislation or

appropriation by Congress. In addition

to the restrictions in the Anti-Lobbying

Act, CDC interprets the new language in

the CDC’s 1997 Appropriations Act to

mean that CDC’s funds may not be spent

on political action or other activities

designed to affect the passage of specific

Federal, State, or local legislation

intended to restrict or control the

purchase or use of firearms.

Background and Definitions

A. Background

By nearly every measure, injury ranks

as one of the nation’s most pressing

health problems. Injuries result from

unintended events such as car crashes,

falls, drownings, fires, and from

intentional acts such as interpersonal

violence and suicide. The annual toll

includes the loss of more than 150,000

lives. Brain injury, spinal cord injury,

and burns requiring extensive

rehabilitative services number more

than 400,000 annually. Injuries are the

country’s leading cause of years of

potential life lost (YPLL) before age 65

(more than 3,600,000 YPLL annually in

1994). They are the leading cause of

death and disability in children and

young adults. Older Americans also

suffer unduly from the severe

consequences of injury. Many of the

resources of the nation’s health care

system are devoted to attending to

victims of injury, who occupy one of

every eight hospital beds. Injury is also

a primary cause of visits to physicians;

it accounted for 66 million such visits

in 1992. More than one-fourth of

persons who visit emergency

departments are seeking treatment for

injuries. For the United States the

aggregate lifetime cost of injuries

occurring in 1994 was estimated to be

$224 billion.

As telling as it is, the litany of injury

statistics ignores less quantifiable, but

equally important concerns—pain and

suffering, fear of injury among older

persons, grief over loss or disablement

of loved ones, and the inestimable

societal loss of unrealized future

contributions by children and young

adults who suffer fatal or incapacitating

injuries.

Fortunately, opportunities to

understand and prevent injuries and

reduce their effects are available. To

exploit these opportunities will require

a comprehensive approach to injury

control, utilizing many disciplines that

heretofore have not always been an

integral part of public health efforts.

However, it is not CDC’s intention that

all centers be individually

comprehensive, but that the

comprehensiveness of a priority-driven

injury control effort be achieved in the

national aggregate, building on the

individual strengths and geographic

balance of the various centers.

Many of these opportunities are

discussed in the National Research

Council and Institute of Medicine

report, Injury In America (National

Academy Press—ISBN 0–309–03545–7).

Research priorities are also discussed in

Injury Prevention: Meeting the
45654 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

Challenge (supplement to the American

Journal of Preventive Medicine, Vol. 5,

no. 3, 1989), Cost of Injury (Dorothy P.

Rice, Ellen J. Mackenzie, and

Associates, San Francisco, California:

Institute for Health and Aging,

University of California, and Injury

Prevention Research Center, The Johns

Hopkins University, 1989), Position

Papers from The Third National Injury

Control Conference (Centers for Disease

Control, Atlanta, Georgia, 1992), and

Injury Control in the 1990’s: A National

Plan for Action (Centers for Disease

Control and Prevention, Atlanta,

Georgia, 1993). Information on these

reports may be obtained from the

individuals listed in the section Where

to Obtain Additional Information.

B. Definitions

1. Injury is defined as physical

damage to an individual that occurs

over a short period of time as a result

of acute exposure to one of the forms of

physical energy in the environment, or

to chemical agents, or the acute lack of

oxygen. The three phases of injury

control are defined as prevention, acute

care, and rehabilitation. The major

categories of injury are intentional,

unintentional, and occupational.

Intentional injuries result from

interpersonal or self-inflicted violence,

and include homicide, assaults, suicide

and suicide attempts, child abuse,

spouse abuse, elder abuse, and rape.

Unintentional injuries include those

that result from motor vehicle

collisions, falls, fires, poisonings,

drownings, recreational, and sportsrelated activities. Occupational injuries

occur at the worksite and include

unintentional trauma (for example,

work-related motor-vehicle injuries,

drownings, and electrocutions), and

intentional injuries in the workplace.

Not included in this definition of

occupational injuries are cumulative

trauma disorders, back injuries caused

by acute trauma, and effects of repeated

exposure to chemical or physical agents.

2. An Injury Control Research Center

(ICRC) is defined as a scientificallybased organizational unit, generally, but

not exclusively, established within an

academic institution, which reports at

an organizational level high enough to

clearly demonstrate strong institutional

support for the development of an

interdisciplinary approach to the injury

problem (e.g., dean of a school,

university vice president, or

commissioner of health).

A comprehensive ICRC is designed to

allow the phases of injury control (i.e.,

research in prevention, acute care, and

rehabilitation) to be addressed by a

single organizational unit and managed

by an experienced research director

(dedicated investigator at no less than

30 percent effort with an anticipated

range of 30 percent-50 percent). The

design of the core should be the basis on

which both the research and practices of

the ICRC are built, further allowing for

in-depth application of key disciplines

(e.g., physicians, epidemiologists,

engineers, biomechanicists, social and

behavioral scientists, biostatisticians,

public health workers, and others) to the

phases of injury control. Expertise

(defined as: conducting ongoing high

quality injury research and publication

in peer reviewed scientific and

technical journal(s)) from appropriate

disciplinary groups must be included so

as to address the injury problem phases

chosen by the applicant.

A comprehensive ICRC can address

all three phases of injury control within

a single theme. For example, an ICRC

with a rehabilitation theme can address

prevention, acute care, and

rehabilitation within the overall theme

of rehabilitation.

A less comprehensive ICRC may be

designed to allow one or two of the

phases of the injury problem to be

addressed by a single organizational

unit; in such situations the remaining

phase(s) of the injury problem may be

addressed through collaborative

arrangements with other institutions or

organizations.

In keeping with CDC’s mission as the

nation’s prevention agency, ICRC

research is intended to progress from

basic research to applied research to the

development of interventions as

described in: Centers for Disease

Control, A Framework for Assessing the

Effectiveness of Disease and Injury

Prevention. MMWR 1992;41(RR–3).

While high quality research is to be

considered an essential ingredient of the

ICRC, equally important activities

include: information gathering and

dissemination; the ongoing provision of

training opportunities to students,

researchers, and voluntary, communitybased, and State and local health

department personnel; and

implementation of projects relating to

the development and evaluation of

injury surveillance or injury prevention

programs.

Purpose

The purposes of this program are:

A. To support injury prevention and

control research on priority issues as

delineated in: Healthy People 2000;

Injury Control in the 1990’s: A National

Plan for Action; Injury in America;

Injury Prevention: Meeting the

Challenge; and Cost of Injury: A Report

to the Congress;

B. To support ICRCs which represent

CDC’s largest national extramural

investment in injury control research

and training, intervention development,

and evaluation;

C. To integrate collectively, in the

context of a national program, the

disciplines of engineering,

epidemiology, medicine, biostatistics,

public health, law and criminal justice,

and behavioral and social sciences in

order to prevent and control injuries

more effectively;

D. To identify and evaluate current

and new interventions for the

prevention and control of injuries;

E. To bring the knowledge and

expertise of ICRCs to bear on the

development and improvement of

effective public and private sector

programs for injury prevention and

control; and

F. To facilitate injury control efforts

supported by various governmental

agencies within a geographic region.

Program Requirements

The following are applicant

requirements:

A. Applicants must demonstrate and

apply expertise in at least one of the

three phases of injury control

(prevention, acute care, or

rehabilitation) as a core component of

the center. The second and/or third

phases do not have to be supported by

core funding but may be achieved

through collaborative arrangements.

Comprehensive ICRCs must have all

three phases supported by core funding.

B. Applicants must document ongoing

injury-related research projects or

control activities currently supported by

other sources of funding.

C. Applicants must provide a director

(Principal Investigator) who has specific

authority and responsibility to carry out

the project. The director must report to

an appropriate institutional official, e.g.,

dean of a school, vice president of a

university, or commissioner of health.

The director must have no less than 30

percent effort devoted solely to this

project with an anticipated range of 30

to 50 percent.

D. Applicants must demonstrate

experience in successfully conducting,

evaluating, and publishing injury

research and/or designing,

implementing, and evaluating injury

control programs.

E. Applicants must provide evidence

of working relationships with outside

agencies and other entities which will

allow for implementation of any

proposed intervention activities.

F. Applicants must provide evidence

of involvement of specialists or experts

in medicine, engineering, epidemiology,
Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45655

law and criminal justice, behavioral and

social sciences, biostatistics, and/or

public health as needed to complete the

plans of the center. These are

considered the disciplines and fields for

ICRCs. An ICRC is encouraged to

involve biomechanicists in its research.

This, again, may be achieved through

collaborative relationships as it is no

longer a requirement that all ICRCs have

biomechanical engineering expertise.

G. Applicants must have an

established curricula and graduate

training programs in disciplines

relevant to injury control (e.g.,

epidemiology, biomechanics, safety

engineering, traffic safety, behavioral

sciences, or economics).

H. Applicants must demonstrate the

ability to disseminate injury control

research findings, translate them into

interventions, and evaluate their

effectiveness.

I. Applicants must have an

established relationship, demonstrated

by letters of agreement, with injury

prevention and control programs or

injury surveillance programs being

carried out in the State or region in

which the ICRC is located. Cooperation

with private-sector programs is

encouraged.

Applicants should have an

established or documented planned

relationship with organizations or

individual leaders in communities

where injuries occur at high rates, e.g.,

minority health communities.

Grant funds will not be made

available to support the provision of

direct care. Studies may be supported

which evaluate methods of care and

rehabilitation for potential reductions in

injury effects and costs. Studies can be

supported which identify the effect on

injury outcomes and cost of systems for

pre-hospital, hospital, and rehabilitative

care and independent living.

Eligible applicants may enter into

contracts, including consortia

agreements (as set forth in the PHS

Grants Policy Statement, dated April 1,

1994), as necessary to meet the

requirements of the program and

strengthen the overall application.

Reporting Requirements

An original and two copies of the

financial status and progress reports are

due 90 days after the end of each budget

period. A final financial status and

progress reports are due 90 days after

the end of the project period.

Application Content

Applications for support of an ICRC

should follow the PHS–398 (Rev. 5/95)

application and Errata sheet, and should

include the following information:

1. Face page.

2. Description (abstract) and

personnel.

3. Table of contents.

4. Detailed budget for the initial

budget period: The budget should

reflect the composite figures for the

grant as well as breakdown budgets for

individual projects within the grant.

5. Budget for entire proposed project

period including budgets pertaining to

consortium/contractual arrangements.

6. Biographical sketches of key

personnel, consultants, and

collaborators, beginning with the

Principal Investigator and core faculty.

7. Other support: This listing should

include all other funds or resources

pending or currently available. For each

grant or contract include source of

funds, amount of funding (indicate

whether pending or current), date of

funding (initiation and termination),

and relationship to the proposed

program.

8. Resources and environment.

9. Research plan including:

a. A proposed theme for the ICRC’s

injury control activities. The proposed

activities should be clearly described in

terms of need, scientific basis, expected

interactions, and anticipated outcomes,

including the expected effect on injury

morbidity and mortality. In selecting the

theme, applicants should consider the

findings in Injury In America and the

Year 2000 Objectives for the Nation.

b. A detailed research plan (design

and methods) including hypothesis and

expected outcome, value to field, and

specific, measurable, and time-framed

objectives consistent with the proposed

theme and activities for each project

within the proposed grant.

c. A detailed evaluation plan which

should address outcome and costeffectiveness evaluation as well as

formative, efficacy, and process

evaluation.

d. A description of the core faculty

and its role in implementing and

evaluating the proposed programs. The

applicant should clearly specify how

disciplines will be integrated to achieve

the ICRC’s objectives.

e. Charts showing the proposed

organizational structure of the ICRC and

its relationship to the broader

institution of which it is a part, and,

where applicable, to affiliate institutions

or collaborating organizations. These

charts should clearly detail the lines of

authority as they relate to the center or

the project, both structurally and

operationally. ICRC’s should report to

an appropriate organizational level (e.g.

dean of a school, vice president of a

university, or commissioner of health),

demonstrating strong institution-wide

support of ICRC activity and ensuring

oversight of the process of

interdisciplinary activity.

f. Documentation of the involved

public health agencies and other public

and private sector entities to be

involved in the proposed program,

including letters that detail

commitments of support and a clear

statement of the role, activities, and

participating personnel of each agency

or entity.

An applicant organization has the

option of having specific salary and

fringe benefit amounts for individuals

omitted from the copies of the

application which are made available to

outside reviewing groups. To exercise

this option: on the original and five

copies of the application, the applicant

must use asterisks to indicate those

individuals for whom salaries and fringe

benefits are not shown; the subtotals

must still be shown. In addition, the

applicant must submit an additional

copy of page four of Form PHS–398,

completed in full, with the asterisks

replaced by the salaries and fringe

benefits. This budget page will be

reserved for internal staff use only.

Evaluation Criteria

Upon receipt, applications will be

reviewed by CDC staff for completeness

and responsiveness as outlined under

the previous heading Program

Requirements. Incomplete applications

and applications that are not responsive

will be returned to the applicant

without further consideration.

Applications which are complete and

responsive may be subjected to a

preliminary evaluation (triage) by the

Injury Research Grant Review

Committee (IRGRC) to determine if the

application is of sufficient technical and

scientific merit to warrant further

review by the IRGRC; CDC will

withdraw from further consideration

applications judged to be

noncompetitive and promptly notify the

principal investigator/program director

and the official signing for the applicant

organization. Those applications judged

to be competitive will be further

evaluated by a dual review process.

Awards will be made based on

priority scores assigned to applications

by the IRGRC, programmatic priorities

and needs determined by a secondary

review committee (the Advisory

Committee for Injury Prevention and

Control), and the availability of funds.

A. Review by the Injury Research Grants

Review Committee

Peer review of ICRC grant

applications will be conducted by the

IRGRC, which may recommend the
45656 Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices

application for further consideration or

not for further consideration. As a part

of the review process the committee

may conduct a site visit to the applicant

organization for re-competing ICRCs.

New applicants may be asked to travel

to CDC for a meeting with the

committee.

Factors to be considered by IRGRC

include:

1. The specific aims of the

application, e.g., the long-term

objectives and intended

accomplishments.

2. The scientific and technical merit

of the overall application, including the

significance and originality (e.g., new

topic, new method, new approach in a

new population, or advancing

understanding of the problem) of the

proposed research.

3. The extent to which the evaluation

plan will allow for the measurement of

progress toward the achievement of

stated objectives.

4. Qualifications, adequacy, and

appropriateness of personnel to

accomplish the proposed activities.

5. The soundness of the proposed

budget in terms of adequacy of

resources and their allocation.

6. The appropriateness (e.g.,

responsiveness, quality, and quantity) of

consultation, technical assistance, and

training in identifying, implementing,

and/or evaluating intervention/control

measures that will be provided to public

and private agencies and institutions,

with emphasis on State and local health

departments, as evidenced by letters

detailing the nature and extent of this

commitment and collaboration. Specific

letters of support or understanding from

appropriate governmental bodies must

be provided.

7. Evidence of other public and

private financial support.

8. Details of progress made in the

application if the applicant is

submitting a re-competing application.

Documented examples of success

include: development of pilot projects;

completion of high quality research

projects; publication of findings in peer

reviewed scientific and technical

journals; number of professionals

trained; provision of consultation and

technical assistance; integration of

disciplines; translation of research into

implementation; impact on injury

control outcomes including legislation,

regulation, treatment, and behavior

modification interventions.

B. Review by CDC Advisory Committee

for Injury Prevention and Control

(ACIPC)

Factors to be considered by ACIPC

include:

1. The results of the peer review.

2. The significance of the proposed

activities as they relate to national

program priorities and the achievement

of national objectives.

3. National and programmatic needs

and geographic balance.

4. Overall distribution of the thematic

focus of competing applications; the

nationally comprehensive balance of the

program in addressing the three phases

of injury control (prevention, acute care,

and rehabilitation); the control of injury

among populations who are at increased

risk, including racial/ethnic minority

groups, the elderly and children; the

major causes of intentional and

unintentional injury; and the major

disciplines of injury control (such as

biomechanics and epidemiology).

5. Budgetary considerations, the

ACIPC will establish annual funding

levels as detailed under the heading,

Availability of Funds.

C. Applications for Supplemental

Funding

Existing CDC Injury Centers may

submit an application for supplemental

grant awards to support research work

or activities. Applications should be

clearly labeled to denote their status as

requesting supplemental funding

support. These applications will be

reviewed by the IRGRC and the ACIPC.

D. Continued Funding

Continuation awards within the

project period will be made on the basis

of the availability of funds and the

following criteria:

1. The accomplishments of the

current budget period show that the

applicant’s objectives as prescribed in

the yearly workplans are being met;

2. The objectives for the new budget

period are realistic, specific, and

measurable;

3. The methods described will clearly

lead to achievement of these objectives;

4. The evaluation plan allows

management to monitor whether the

methods are effective by having clearly

defined process, impact, and outcome

objectives, and the applicant

demonstrates progress in implementing

the evaluation plan;

5. The budget request is clearly

explained, adequately justified,

reasonable, and consistent with the

intended use of grant funds; and

6. Progress has been made in

developing cooperative and

collaborative relationships with injury

surveillance and control programs

implemented by State and local

governments and private sector

organizations.

Funding Preference

Special consideration will be given to

re-competing Injury Control Research

Centers. These centers as established

and on-going and serve as a resource for

Injury Control related issues for their

States and regions.

Executive Order 12372 Review

Applications are not subject to the

review requirements of Executive Order

12372.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirement.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.136.

Other Requirements

A. 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.

B. 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

PHS-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.

C. Women, Racial and Ethnic Minorities

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDC

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,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic.

Applicants shall ensure that women,

racial and ethnic minority populations
Federal Register / Vol. 62, No. 167 / Thursday, August 28, 1997 / Notices 45657

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 the review of

applications for scientific merit, review

groups will evaluate proposed plans for

inclusion of minorities and both sexes

as part of the scientific assessment and

assigned score. 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,

Friday, September 15, 1995, pages

47947–47951.

D. Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by this grant program will

be subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act.

Application Submission and Deadlines

A. Preapplication Letter of Intent

In order to schedule and conduct site

visits as part of the formal review

process, potential applicants are

encouraged to submit a nonbinding

letter of intent to apply. It should be

postmarked no later than one month

prior to the submission deadline of

October 5, 1997, for the application. The

letter should be submitted to the Grants

Management Specialist whose address

is given in Part B of this Section. The

letter should identify the relevant

announcement number for the response,

name the principal investigator, and

specify the injury control theme or

emphasis of the proposed center (e.g.,

acute care, biomechanics, epidemiology,

prevention, intentional injury, or

rehabilitation). The letter of intent does

not influence review or funding

decisions, but it will enable CDC to plan

the review more efficiently.

B. Applications

Applicants should use application

Form PHS–398 (OMB No. 0925–0001

Revised 5/95) and adhere to the

ERRATA Instruction Sheet contained in

the Grant Application Kit. The narrative

section for each project within an ICRC

should not exceed 25 typewritten pages.

Refer to the instruction in section 1,

page 6, of PHS–398 for font type and

size. Applications not adhering to these

specifications may be returned to

applicant.

Applicants must submit an original

and five copies on or before November

5, 1997, to Lisa G. Tamaroff, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Atlanta, GA 30305.

C. Deadlines

Applications shall be considered as

meeting the deadline above if they are

either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to

the peer review committee. Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailing.

Applications which do not meet the

criteria in C.1. or C.2. above are

considered late applications and will be

returned to the applicant.

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 809.

You will receive a complete program

description, information on application

procedures and application forms.

Business management technical

assistance may be obtained from Lisa G.

Tamaroff, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 321, Atlanta, GA 30305,

telephone (404) 842–6796 or internet:

lgt1.cdc.gov.

Programmatic technical assistance

may be obtained from Tom Voglesonger,

Program Manager, Injury Control

Research Centers, National Center for

Injury Prevention and Control, Centers

for Disease Control and Prevention

(CDC), 4770 Buford Highway, MS–K58,

Atlanta, GA 30341–3724, telephone

(770) 488–4265 or internet address:

tdv1.cdc.gov.

This and other CDC announcements

are also available through the CDC

homepage on the Internet. The address

for the CDC homepage is http://

www.cdc.gov.

CDC will not send application kits by

facsimile or express mail (even at the

request of the applicant).

Please refer to Announcement 809

when requesting information and

submitting an application.

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),

referenced in the Introduction, through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: August 22, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–22900 Filed 8–27–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Intent To Reallot Part C—Protection

and Advocacy Funds to States for

Developmental Disabilities

Expenditures

AGENCY: Administration on

Developmental Disabilities,

Administration for Children and

Families, Department of Health and

Human Services.

ACTION: Notice of intent to reallot Fiscal

Year 1997 Funds, pursuant to Section

125 and Section 142 of the

Developmental Disabilities Assistance

and Bill of Rights Act, as amended

(Act).

SUMMARY: The Administration on

Developmental Disabilities herein gives

notice of intent to reallot funds which

were set aside in accordance with

Section 142(c)(5) of the Act. Of the

$806,682 which was set aside for

technical assistance and Indian

Consortiums, $534,360 was utilized for

technical assistance and $136,161 was

awarded to an Indian Consortium.

Therefore, the balance of $136,161 has

been released for reallotment.

Any State or Territory which wishes

to release funds or cannot use the

additional funds under Part C—

Protection and Advocacy program for

Fiscal Year 1997 should notify Joseph

Lonergan, Director, Division of Formula,

Entitlement and Block Grants, Office of

Management Services, Office of Program

Support, Administration for Children

and Families, Department of Health and

Human Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, in writing within thirty (30) days

of the date of this promulgation.

Reallotment awards are anticipated to