7462 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices

Dated: February 10, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–4008 Filed 2–18–97; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 723]

Grants for Intimate Partner Violence

Prevention Research Notice of

Availability of Funds for Fiscal Year

1997

Introduction

The Centers for Disease Control and

Prevention (CDC) announces

applications are being accepted for

Intimate Partner Violence Prevention

Research Grants for fiscal year (FY)

1997. The 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 Violent and Abusive Behavior.

(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, as

amended (42 U.S.C. 241, 280b, 280b–1,

280b–1a, and 280b–3). Program

regulations are set forth in Title 42 CFR,

Part 52.

Eligible Applicants

Eligible applicants include all nonprofit and for-profit organizations. Thus

State and local health departments,

State and local governmental agencies,

universities, colleges, research

institutions, and other public and

private organizations, including small,

minority and/or woman-owned

businesses are eligible for these research

grants. Current holders of CDC injury

control research projects are eligible to

apply.

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 Public Law

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

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, child care, health

care, and early childhood development

services are provided to children.

Availability of Funds

Approximately $750,000 is expected

to be available to fund 3–4 injury

research grants in the area of intimate

partner violence. The specific program

priorities for these funding

opportunities are outlined with

examples in this announcement under

the section, ‘‘Programmatic Priorities.’’

It is expected that the awards will begin

on or about September 1, 1997, and will

be made for a 12-month budget period

within a project period of up to three

years. Funding may not exceed

$250,000 per year (including both direct

and indirect costs). Grant applications

that request more than the $250,000 per

year cap will be returned to the

investigator as non-responsive. Funding

availability may vary and is subject to

change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress demonstrated by

investigators at work-in-progress

monitoring workshops, the achievement

of workplan milestones reflected in the

continuation application, and the

availability of Federal funds. In

addition, continuation awards will be

eligible for increased funding to offset

inflationary costs depending upon 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

Intimate partner violence is a major

public health problem. Although men

are at much greater risk of fatal injury

due to interpersonal violence, women

are at much higher risk of nonfatal

injuries due to intimate partner

violence. National surveys estimate that

approximately 2 million women each

year are battered by an intimate partner,

and crime data from the Federal Bureau

of Investigation (FBI) record about 1,500

murders of women by husbands or

boyfriends each year. The Bureau of

Justice Statistics reports that women

sustained about 3.8 million assaults and

500,000 rapes a year in 1992 and 1993:

More than 75 percent of these violent

acts were committed by an intimate, a

husband, ex-husband, boyfriend, or exboyfriend. Studies estimate that

between 13 and 25 percent of all U.S.

women will experience rape in their

lifetimes.

These numbers are thought to be

underestimates of the actual number of

American women assaulted by intimate

male partners.

The total extent and severity of

violence-related nonfatal injuries is

unknown, but an increasing portion of

the nation’s health care and

rehabilitation systems’ resources are

devoted to attending to victims of

violence. Intimate partner violence

(including rape, physical battering, and

psychological abuse) are associated with

a host of both short-and long-term

problems, including physical injury and

illness, psychological symptoms, and

death. The consequences extend far

beyond the individual female victims,

affecting their children, families,

friends, and society as well.

Opportunities to understand and

prevent intimate partner violencerelated injuries and reduce their effects

are available. Maximizing these

opportunities for prevention requires a

broad approach, incorporating many

disciplines that heretofore have not

been an integral part of public health

efforts. Many of these opportunities and

research priorities are discussed in

Injury Control in the 1990s: A National

Plan for Action. Atlanta: Centers for

Disease Control and Prevention, 1993

and Healthy People 2000. Additional

background information can be found in

the following suggested readings:

Understanding Violence Against

Women, Violence and the Public’s

Health, Understanding and Preventing

Violence, and Violence in America: A

Public Health Approach. (To receive

information on these reports see the
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices 7463

section Where To Obtain Additional

Information);

B. Definitions

1. Injury: Injury is generally 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.

2. Intimate Partner Violence is

defined as threatened or actual use of

physical or sexual violence or

psychological/emotional abuse

perpetrated on a woman by a partner or

ex-partner that either results or has the

potential to result in injury or death.

Types of behavior that fit within this

definition are commonly referred to as

domestic violence, sexual assault,

spouse abuse, date rape, partner abuse,

women battering, and acquaintance

rape. Public health approaches violence

as a health issue and consequently, uses

injuries, both fatal and nonfatal,

psychological and physical, to quantify

the impact of violence. Our primary

interest is in preventing violence against

adolescent and adult women that occurs

in the context of intimate relationships.

3. Intimate partner violence

prevention research projects are defined

as research designed to:

a. Elucidate the chain of causation—

the etiology and mechanisms—of

injuries related to intimate partner

violence; or

b. Yield results directly applicable to

identifying interventions to prevent

injuries and deaths due to intimate

partner violence; or

c. Evaluate the effect of policies,

programs, or interventions for intimate

partner violence on morbidity,

mortality, disability, and costs.

Purpose

The purposes of this program are to:

A. Build the scientific base for the

prevention of injuries and deaths due to

intimate partner violence as delineated

in Injury Control in the 1990s: A

National Plan for Action. Atlanta:

Centers for Disease Control and

Prevention, 1993 and Healthy People

2000.

B. Identify effective strategies to

prevent intimate partner violencerelated injuries.

C. Expand the development and

evaluation of current and new

intervention methods and strategies for

the primary prevention of intimate

partner violence-related injuries.

D. Encourage professionals from a

wide spectrum of disciplines such as

medicine, health care, public health,

criminology and criminal justice, and

behavioral and social sciences, to

undertake research to prevent and

control injuries from intimate partner

violence.

E. Encourage the training of predoctoral minority investigators to work

in the area of violence research.

Program Requirements

The following are applicant

requirements:

A. A principal investigator who has

conducted research, published the

findings, and has specific authority and

responsibility to carry out the proposed

project.

B. Demonstrated experience in

conducting, evaluating, and publishing

injury control research on the

applicant’s project team.

C. Effective and well-defined working

relationships within the performing

organization and with outside entities

which will ensure implementation of

the proposed activities.

D. Ability to carry out intimate

partner violence prevention research as

previously defined under Background

and Definitions, (B.3.a-c).

E. Overall match between the

applicant’s proposed theme and

research objectives, and the program

priorities as described under the

heading, ‘‘Programmatic Priorities.’’

Note: Grant funds will not be made

available to support the provision of direct

care services.

Eligible applicants may enter into

contracts, including consortia

agreements (as set forth in the PHS

Grants Policy Statement) as necessary to

meet the requirements of the program

and strengthen the overall application.

Programmatic Priorities

Applicants must propose research

that (1) enhances understanding of

social, economic, and environmental

factors that may be associated with

intimate partner violence, and (2)

determines the effectiveness of

prevention/intervention programs for

perpetrators of intimate partner

violence.

Enhance understanding of societal

level factors within a specific targeted

community that may be associated with

intimate partner violence and the costs

of such violence.

• Conduct research to determine

which societal level factors (e.g.,

crowding, socioeconomic status (SES),

norms about intimate partner violence,

levels of general violence, number of

liquor stores in the community, etc.)

contribute to perpetration of intimate

partner violence.

• Conduct studies to determine direct

and indirect costs of intimate partner

violence (such as days absent from work

or school, quality of life, numbers of

visits to mental health and medical care

providers, number of miscarriages,

mental and physical disabilities, impact

on child witnesses, etc.)

Determine the effectiveness of

prevention/intervention programs for

(potential or actual) perpetrators of

intimate partner violence.

• Develop and evaluate innovative or

alternative approaches or settings for

identifying and providing interventions

and/or deterrents for perpetrators of

intimate partner violence.

• Identify the components of effective

batterer interventions.

• Evaluate the effectiveness of

programs targeting children and young

adolescents that teach and foster healthy

interpersonal relationships as primary

prevention of future perpetration of

intimate partner violence.

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 brief (2–3 page) summary of

the study findings and a final financial

status report is due 90 days after the end

of the project period.

Application Content

Applications for injury control

research grants should include:

A. The project’s focus that justifies the

research need and describes the

scientific basis for the research, the

expected outcome, and the relevance of

the findings to reduce injury morbidity,

mortality, disability and economic

losses. This focus should be based on

recommendations in Injury Control in

the 1990s: A National Plan for Action.

Atlanta: Centers for Disease Control and

Prevention, 1993 and Healthy People

2000 and should seek creative

approaches that will contribute to a

national program for injury control.

B. Specific, measurable, and timeframed objectives.

C. A detailed plan describing the

methods, by which the objectives will

be achieved, including their sequence.

A comprehensive evaluation plan is an

essential component of the application.

D. A description of the role and

responsibilities of the project’s principal

investigator.

E. A description of all the project staff

regardless of their funding source. It

should include their title, qualifications,

experience, percentage of time each will

devote to the project, as well as that

portion of their salary to be paid by the

grant.

F. A description of the role, duties,

and responsibilities of the project’s pre-
7464 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices

doctoral minority investigator(s) (a

minimum of 15% of each pre-doctoral

minority investigator’s time should be

reflected in the project’s budget).

G. A description of those activities

related to, but not proposed to be

supported by the grant.

H. A description of the involvement

of other entities, (e.g., proposed study

sites), that will relate to the proposed

project, if applicable. It should include

commitments of support and a clear

statement of their roles.

I. A detailed first year budget for the

project with future annual projections, if

relevant.

J. Applicants must identify in a cover

letter one of the topics previously

outlined under the heading

Programmatic Priorities upon which

their project is focused.

K. An explanation of how the research

findings will lead to feasible, costeffective injury interventions.

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

screened by CDC staff for completeness

and responsiveness as outlined under

the previous heading, Program

Requirements (A-E). 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 a peer

review group to determine if the

application is of sufficient technical and

scientific merit to warrant a full review

by the Injury Research Grants Review

Committee (IRGRC); the 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. The first review following the

preliminary review (triage) will be a

peer review to be conducted on all

competitive applications. Factors to be

considered will include:

1. The specific aims of the research

project, i.e., the broad long-term

objectives, the intended

accomplishment of the specific research

proposal, and the hypothesis to be

tested.

2. The background of the proposal,

i.e., the basis for the present proposal,

the critical evaluation of existing

knowledge, and specific identification

of the injury control knowledge gaps

which the proposal is intended to fill.

3. The significance and originality

from a scientific or technical standpoint

of the specific aims of the proposed

research, including the adequacy of the

theoretical and conceptual framework

for the research.

4. For competitive renewal

applications, the progress made during

the prior project period. For new

applications, (optional) the progress of

preliminary studies pertinent to the

application.

5. The adequacy of the proposed

research design, approaches, and

methodology to carry out the research,

including quality assurance procedures,

plan for data management, and

statistical analysis plans, plans for

inclusion of minorities and both sexes.

6. The extent to which the evaluation

plan will allow for the measurement of

progress toward the achievement of the

stated objectives.

7. Qualifications, adequacy, and

appropriateness of personnel to

accomplish the proposed activities,

including pre-doctoral minority

investigator(s).

8. The degree of commitment and

cooperation of other interested parties

(as evidenced by letters detailing the

nature and extent of the involvement).

9. The reasonableness of the proposed

budget to the proposed research and

demonstration program.

10. Adequacy of existing and

proposed facilities and resources.

11. An explanation of how the

research findings will lead to feasible,

cost-effective injury interventions.

B. The second review will be

conducted by the Advisory Committee

for Injury Prevention and Control. The

factors to be considered will include:

1. The results of the peer review.

2. The significance of the proposed

activities in relation to the objectives

outlined under the section,

‘‘Programmatic Priorities.’

3. National needs.

4. Overall distribution among:

• the major disciplines of violencerelated injury prevention: social and

behavioral science, biomechanics, and

epidemiology;

• populations addressed (e.g.,

batterers, adolescents, racial and ethnic

minorities, the elderly, children, urban,

rural).

5. Budgetary considerations (e.g.,

preference may be given to applicants

who submit proposals requesting

funding for research projects of one to

two years duration).

6. Additional consideration will be

given to those applicants who provide

evidence of an injury research training

program for pre-doctoral minority

investigators.

C. 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 reflected in

the progress report of the continuation

application indicate that the applicant is

meeting previously stated objectives or

milestones contained in the project’s

annual workplan and satisfactory

progress has been demonstrated through

monitoring presentations or work-inprogress workshops;

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 will allow

management to monitor whether the

methods are effective; and

5. The budget request is clearly

explained, adequately justified,

reasonable and consistent with the

intended use of grant funds.

Executive Order 12372 Review

Applications are not subject to the

review requirements of Executive Order

12372.

Public Health System Reporting

Requirement

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.136.
Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices 7465

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.

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.

Women and Minority Inclusion Policy

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 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.

Application Submission and Deadlines

A. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Specialist (whose address is reflected in

section B, ‘‘Applications’’). It should be

postmarked no later than March 20,

1997. The letter should identify the

announcement number, name the

principal investigator, and specify the

priority area of study the proposal

addresses as outlined under the section

Programmatic Priorities. The letter of

intent does not influence review or

funding decisions, but it will enable

CDC to plan the review more efficiently,

and will ensure that each applicant

receives timely and relevant information

prior to application submission.

B. Applications

Applicants should use Form PHS–398

(OMB No. 0925–0001 Revised 5/95) and

adhere to the ERRATA Instruction Sheet

for Form PHS–398 contained in the

Grant Application Kit. Please submit an

original and five copies, on or before

April 22, 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 321,

Atlanta, Georgia 30305, telephone (404)

842–6796.

C. Deadlines

1. Applications shall be considered as

meeting a deadline if they are either:

A. Received at the above address on

or before the deadline date, or

B. Sent on or before the deadline date

to the above address, and received in

time for the review process. 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 mailings.

2. Applications which do not meet the

criteria 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 723.

You will receive a complete program

description, information on application

procedures, and application forms.

Business management technical

information may be obtained from Lisa

Tamaroff, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

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

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6796 or internet:

<lgt1.cdc.gov≤.

Programmatic technical assistance

may be obtained from Ted Jones, Project

Officer, Extramural Research Grants

Branch, National Center for Injury

Prevention and Control, Centers for

Disease Control and Prevention (CDC),

Mailstop K–58, 4770 Buford Highway,

NE., Atlanta, Georgia 30341–3724,

telephone (770) 488–4824, internet:

<tmj1.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.

Please refer to Announcement

Number 723 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) through

the Superintendent of Documents,

Government Printing Office,

Washington, D.C. 20402–9325,

telephone (202) 512–1800.

Copies of Injury Control in the 1990s:

A National Plan for Action. Atlanta:

Centers for Disease Control and

Prevention, 1993 and A Framework for

Assessing the Effectiveness of Disease

and Injury Prevention, (CDC, Morbidity

and Mortality Weekly Report, March 27,

1992, Volume 41, Number RR–3, pages

5–11) may be obtained by calling (770)

488–4265.

Information for obtaining the

suggested readings, Understanding

Violence Against Women, Violence and

the Public’s Health, Understanding and

Preventing Violence, and Violence in

America: A Public Health Approach, is

included on a separate sheet with the

application kit.

Dated: February 11, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–4010 Filed 2–18–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 93F–0195]

Fish and Fishery Products Hazards

and Controls Guide; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the