Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67915

Dated: November 12, 2004. 

Alma L. Golden, 

Deputy Assistant Secretary for Population 

Affairs.

[FR Doc. 04–25758 Filed 11–19–04; 8:45 am] 

BILLING CODE 4150–34–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

2005 White House Conference on 

Aging Policy Committee

AGENCY: Administration on Aging, HHS.

ACTION: Notice of meeting.

SUMMARY: Pursuant to Section 10(a) of 

the Federal Advisory Committee Act as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the third Policy 

Committee meeting concerning 

planning for the 2005 White House 

Conference on Aging. The meeting will 

be open to the public, with attendance 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should inform the 

contact person listed below in advance 

of the meeting.

DATES: The meeting will be held 

Wednesday, December 1, 2004, from 9 

a.m. to 5 p.m.

ADDRESSES: The meeting will be held at 

the American Association of Homes and 

Services for the Aging, 2519 

Connecticut Avenue, NW., Conference 

Room, Washington, DC 20008–1520.

FOR FURTHER INFORMATION CONTACT:

Nora Andrews, (301) 443–2874, or email at Nora.Andrews@whcoa.gov.

SUPPLEMENTARY INFORMATION: Pursuant 

to the Older Americans Act 

Amendments of 2000 (Pub. L. 106–501, 

November 2000), the Policy Committee 

will meet to discuss delegate 

participation, the conference theme, and 

to review and discuss work of the 

subcommittees.

Josefina G. Carbonell, 

Assistant Secretary for Aging.

[FR Doc. 04–25747 Filed 11–19–04; 8:45 am] 

BILLING CODE 4154–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Cooperative Agreement Program for 

the National Academic Centers of 

Excellence on Youth Violence 

Prevention 

Announcement Type: New. 

Funding Opportunity Number: CE05–

018. 

Catalog of Federal Domestic 

Assistance Number: 93.136. 

Key Dates:

Letter of Intent Deadline: December 

22, 2004. 

Application Deadline: February 10, 

2005. 

I. Funding Opportunity Description

Authority: This program is authorized 

under sections 301(a) [42 U.S.C. 241(a)] and 

391(a) [42 U.S.C. 280b(a)] of the Public 

Service Health Act, as amended.

Purpose: The Centers for Disease 

Control and Prevention (CDC) 

announces the availability of fiscal year 

(FY) 2005 cooperative agreement funds 

to establish up to ten National 

Academic Centers of Excellence (ACE) 

on Youth Violence Prevention, serving 

as national models for the prevention of 

youth violence. The purpose of the 

Centers is to help communities prevent 

youth interpersonal violence. As of 

2005, Centers will be supported for up 

to ten years to promote a stable, long 

term focus on the complex problem of 

youth violence, fostering 

multidisciplinary and multi-sectoral 

interactions that can stimulate scientific 

creativity, speed new developments in 

youth interpersonal violence research 

and practice, and hasten translation of 

knowledge into health and community 

practice. Centers are expected to 

actively foster an environment 

conducive to reciprocally beneficial 

collaborations among health scientists, 

social scientists and the affected 

communities with the common goal of 

reducing youth interpersonal violence. 

Youth violence is defined as: The 

intentional use of physical force or 

power, threatened or actual, exerted by 

or against children, adolescents or 

young adults, ages 10–24, which results 

in or has a high likelihood of resulting 

in injury, death, psychological harm, 

maldevelopment, or deprivation. It 

includes violence between individuals 

or groups who may or may not know 

each other. It frequently takes place 

outside the home, in the streets, or in 

institutional settings, such as schools, 

workplaces, and prisons. Hereafter, 

youth violence and youth interpersonal 

violence will be used synonymously. 

This program addresses the ‘‘Healthy 

People 2010’’ focus area of Injury and 

Violence Prevention. For a copy of 

‘‘Healthy People 2010’’ visit the Internet 

site: http://www.health.gov/

healthypeople. 

Measurable outcomes of the program 

will be in alignment with one (or more) 

of the following performance goals for 

the National Center for Injury 

Prevention and Control (NCIPC): 

1. Increase the capacity of injury 

prevention and control programs to 

address the prevention of injuries and 

violence. 

2. Monitor and detect fatal and nonfatal injuries. 

3. Conduct a targeted program of 

research to reduce injury-related death 

and disability. 

Special Guidelines for Technical 

Assistance:

Conference Call: Technical assistance 

will be available for potential applicants 

during one conference call. 

The call for eligible applicants will be 

held on December 9, 2005 from 2:30 

p.m. to 4 p.m. (eastern time). The 

conference can be accessed by calling 1–

888–528–9061 and entering access code 

18046. 

The purpose of the conference call is 

to help potential applicants: 

1. Understand the Request for 

Application Process for the RFA (CE05–

018) for the National Academic Centers 

of Excellence on Youth Violence 

Prevention. 

2. Understand the scope and intent of 

the RFA (CE05–018) for the National 

Academic Centers of Excellence on 

Youth Violence Prevention. 

3. Become familiar with the Public 

Health Services funding policies and 

application and review procedures. 

Participation in this conference call is 

not mandatory. At the time of the call, 

if you have problems accessing the 

conference call, please call 404–639–

7550 for assistance. 

Program Objectives: The goal of this 

program is to reduce the incidence of 

youth violence in the defined 

community by achieving the following 

objectives: 

• Monitoring the magnitude and 

distribution of youth interpersonal 

violence. 

• Building the scientific 

infrastructure necessary to support the 

development and widespread 

application of effective youth violence 

prevention interventions. 

• Promoting interdisciplinary 

research strategies to address the 

problem of youth violence. 

• Fostering collaboration between 

academic researchers and communities. 

67916 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

• Mobilizing and empowering 

communities to address the problem of 

youth violence. 

Activities: Awardee activities during 

the course of the five-year award for this 

program are listed below. Additional 

information on the program activities is 

provided in the application content of 

this announcement. 

• Apply and refine a logic model for 

the academic center of excellence 

adapted from the national ACE Program 

conceptual framework or logic model 

(See Appendix 1 for a description) to fit 

the specific inputs, activities, outputs, 

and outcomes of the proposed center.

• Develop and implement a center 

evaluation plan and demonstrate how 

the center’s evaluation contributes to 

CDC’s national program evaluation, 

including the core performance 

indicators (see Appendix 2 for a list of 

the indicators.) 

• Develop, implement and evaluate 

center projects in conjunction with the 

center’s ‘‘defined community’’, (whether 

geographic or a non-geographic subgrouping) which the center’s activities 

will serve. Community is defined as a 

group of people who share some or all 

of the following: geographic boundaries; 

a sense of membership; culture and 

language; common norms, interests, or 

values; and common health risks or 

conditions (CDC/ATSDR Principles of 

Community Engagement, IOM 2002). 

Community refers to a population that 

has a distinct identity. It can mean 

residents of a geographic area, be that a 

catchment’s area, neighborhood, school 

district, city, county or region within a 

county. It can be used with a modifier 

or clause to describe a nongeographically based sub-grouping such 

as, but not exclusively: a community of 

youth violence prevention workers, a 

community of health professionals, or 

an ethnic or language community. 

• Establish or maintain a center 

community advisory committee to work 

with the defined community to achieve 

center goals. See Appendix 3, the 

glossary, for a definition and 

composition of the community 

committee. 

• Establish and maintain partnerships 

(e.g., state and local health departments, 

youth violence prevention and youth 

serving organizations, community 

groups and agencies, faith-based 

organizations and local businesses, and 

academic units), and include these 

partners, when applicable, in the center 

activities. See Appendix 3, the glossary, 

for a definition and composition of 

partnerships. 

• Establish and/or enhance 

surveillance systems to better measure 

the problem of youth violence and the 

impact of center activities and research 

in the defined community. 

• Identify youth violence prevention 

priorities within the defined 

community. 

• Carry out the center’s participatory, 

community-based core youth 

interpersonal violence research 

project(s) and the center’s five-year 

research agenda. Each center is required 

to conduct at least one core research 

project consistent with both the NCIPC 

Research Agenda and NCIPC’s mission. 

• Plan the core research project in 

collaboration with community partners. 

• Refine, carry out and evaluate the 

center’s community mobilization plan 

in partnership with a community’s 

individuals, groups, and organizations 

on a participatory and sustained basis. 

(See Appendix 3, the glossary, for a 

definition of community mobilization.) 

• When appropriate, collaborate with 

CDC, community partners, and other 

ACE centers to develop and finalize 

design for studies and activities, 

methodology, data collection measures, 

methods, and analyses and disseminate 

the results through presentations and 

publications to broad audiences, 

including public health. 

• Collect and report necessary data 

and information to CDC to assess 

progress toward centers’ goals and 

objectives and monitor overall 

performance. This should include, but 

will not be limited to, information 

related to the ACE Performance 

Indicators. (See Appendix 2 for list of 

indicators). 

• Develop an infrastructure of 

personnel and resources to support 

center functions and processes. This 

infrastructure should ensure that 

adequate personnel, facilities, 

technology, and university support 

exists to accomplish the goals and 

objectives of the center. 

• Provide training, technical 

assistance, and mentoring to health 

professionals, researchers, students, 

community members, and other 

partners, as appropriate, including other 

funded Academic Centers of Excellence 

on Youth Violence Prevention. 

• Obtain approval of the study 

protocol by the recipient’s local 

Institutional Review Board (IRB). 

Collaborate with CDC in the 

development of a research protocol for 

CDC Institutional Review Board (IRB) 

review, if appropriate. 

In a cooperative agreement, CDC staff 

is substantially involved in the program 

activities, above and beyond routine 

grant monitoring. CDC activities for this 

program are as follows: 

• Provide scientific input, serve as a 

scientific and professional resource, and 

collaborate with ACE staff on research, 

interpretation of findings, and the 

production of publications and 

presentations to disseminate study 

results. 

• Facilitate regular communication 

between CDC and the grantees to 

include, but not limited to conference 

calls and meetings, including the 

convening of annual ACE meetings to 

facilitate research collaboration and 

information sharing among centers. 

• Review, monitor, and evaluate 

scientific and operational 

accomplishments to assure progress 

toward program goals and objectives. 

The review will be based on the center’s 

logic model and the critical components 

of the model that are related to the 

achievement of core performance 

indicators. The review process will 

include but not be limited to conference 

calls, site visits, annual meetings, and 

required reports. 

• Collect, organize and disseminate 

information on ACE activities, including 

research. Inform recipients about any 

CDC policies, laws, and regulations 

pertaining to public health research and 

programmatic activities, conduct 

inquiries concerning allegations of 

scientific misconduct, and take 

necessary steps to bring program into 

compliance.

• When appropriate, assist in the 

development of a research protocol(s) 

for IRB review by all performance sites 

involved in the research project. If CDC 

researchers are significantly involved in 

the project, the CDC IRB will review and 

approve the protocol initially and on at 

least an annual basis until the research 

project is completed. 

II. Award Information 

Type of Award: Cooperative 

Agreement. CDC involvement in this 

program is listed in the Activities 

Section above. 

Mechanism of Support: U49. 

Fiscal Year Funds: 2005. 

Approximate Total Funding:

$6,800,000 (This amount is an estimate, 

and is subject to availability of funds). 

Approximate Number of Awards: 7–

10. 

Approximate Average Award:

$830,000. 

Floor of Award Range: $680,000. 

Ceiling of Award Range: $980,000 

(Ceilings are for the first 12-month 

budget period and include both indirect 

and direct costs). 

Anticipated Award Date: September 

1, 2005. 

Budget Period Length: 12 months. 

Project Period Length: Five years. 

Throughout the project period, CDC’s 

commitment to continuation of awards 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67917

will be conditioned on the availability 

of funds, evidence of satisfactory 

progress by the recipient (as 

documented in required reports and site 

visits), and the determination that 

continued funding is in the best interest 

of the Federal Government. 

III. Eligibility Information 

III.1. Eligible Applicants 

Eligible applicants are academic 

institutions/centers with a focus on 

health, such as:

• Public and private nonprofit 

universities; 

• Colleges; 

• University-associated teaching 

hospitals. 

Eligible applicants may enter into 

contracts, including consortia 

agreements, as necessary to meet the 

requirements of the program and 

strengthen the overall application. A 

Bona Fide Agent is an agency/

organization identified by the academic 

institutions/centers as eligible to submit 

an application under the academic 

institutions/centers eligibility in lieu of 

an academic institutions/centers 

application. If you are applying as a 

bona fide agent of academic 

institutions/centers, you must provide a 

letter from the academic institutions/

centers as documentation of your status. 

Place this documentation behind the 

first page of your application form. 

III.2. Cost Sharing or Matching 

Matching funds are not required for 

this program announcement. 

III.3. Other 

CDC will not accept and review 

applications with budgets greater than 

the ceiling of the award range. 

Applications with budgets that exceed 

the ceiling of the award, which includes 

both direct and indirect costs, will be 

considered non-responsive, and will not 

be entered into the review process. You 

will be notified that your application 

did not meet the submission 

requirements. 

Special requirements: If your 

application is incomplete or nonresponsive to the requirements listed in 

this section, it will not be entered into 

the review process. You will be notified 

that your application did not meet 

submission requirements. 

• Late applications will be considered 

non-responsive. See section ‘‘IV.3 

Submission Dates and Times’’ for more 

information on deadlines. 

A National Academic Center of 

Excellence on Youth Violence 

Prevention is expected to have the 

following core components which 

together address the objectives of a 

center: (1) Administrative and 

Infrastructure Core, (2) Surveillance and 

Research Core and (3) Outreach and 

Education Core. The essential 

characteristics of a National Academic 

Center of Excellence on Youth Violence 

Prevention are as follows: 

• A core faculty in fields such as 

public health, epidemiology, 

biostatistics, social sciences, behavioral 

and environmental sciences, health and 

youth policy, economics, evaluation, 

and health administration. 

• Established working relationships 

with multidisciplinary faculty in the 

fields listed above and in other 

disciplines, such as, but not limited to, 

medicine, psychology, nursing, social 

work, education, urban planning, youth 

development and business.

• Graduate training programs relevant 

to youth violence prevention. 

• Demonstrated relationships with a 

broad range of community partners and 

expertise in developing, implementing 

and evaluating community-based youth 

participatory research and mobilization 

activities. 

• Demonstrated experience on the 

applicant’s project team in conducting, 

evaluating, and publishing communitybased participatory research (CPBR) in 

peer-reviewed journals. (See Appendix 

3, the glossary, for a definition of 

Community-based participatory 

research). 

• Effective and well-defined working 

relationships within the performing 

organization and with outside entities 

(as evidenced by letters of support and 

in memoranda of understanding). 

• An overall match between the 

applicant’s proposed research objectives 

and the program objectives as described 

under the heading, ‘‘Program 

Objectives’’. 

Only one application per institution 

will be accepted.

Note: Title 2 of the United States Code 

section 1611 states that an organization 

described in section 501(c)(4) of the Internal 

Revenue Code that engages in lobbying 

activities is not eligible to receive Federal 

funds constituting an award, grant, or loan.

Individuals Eligible To Become 

Principal Investigators 

Principal Investigator qualifications 

are as follows: 

• A principal investigator who has 

conducted community-based youth 

violence prevention research, published 

the findings in peer-reviewed journals, 

and has specific authority and 

responsibility to carry out the proposed 

project. 

Applications that do not meet the 

above requirements will be considered 

non-responsive. 

Individuals with the above-listed 

skills, knowledge, and resources 

necessary to carry out the proposed 

research are invited to work with their 

institution to develop an application for 

support. Individuals from 

underrepresented racial and ethnic 

groups as well as individuals with 

disabilities are always encouraged to 

apply for CDC programs. Each 

institution may submit only one 

application per round of competition. 

IV. Application and Submission 

Information 

IV. 1. Address To Request Application 

Package 

To apply for this funding opportunity, 

use application form PHS 398 (OMB 

number 0925–0001 rev. 5/2001). Forms, 

attachments and instructions are 

available in an interactive format on the 

CDC Web site, at the following Internet 

address: http://www.cdc.gov/od/pgo/

forminfo.htm. 

Forms and instructions are also 

available in an interactive format on the 

National Institutes of Health (NIH) Web 

site at the following Internet address: 

http://grants.nih.gov/grants/funding/

phs398/phs398.html. 

If you do not have access to the 

Internet, or if you have difficulty 

accessing the forms on-line, you may 

contact the CDC Procurement and 

Grants Office Technical Information 

Management Section (PGO–TIM) staff 

at: 770–488–2700. Application forms 

can be mailed to you. 

IV. 2. Content and Form of Application 

Submission 

Letter of Intent (LOI): Prospective 

applicants are asked to submit a Letter 

of Intent (LOI) that includes the 

following information and written in the 

following format:

• Maximum Number of Pages: Three. 

• Font Size: 12-point unreduced. 

• Paper Size: 8.5 by 11 inches. 

• Page Margin Size: One inch. 

• Printed only on one side of page. 

• Single spaced. 

• Written in plain language, avoid 

jargon.

Your LOI must contain the following 

information:

• Descriptive title of the proposed 

Center. 

• Name, address, e-mail address, 

telephone number, and facsimile 

number of the Principal Investigator. 

• Names of other key personnel. 

• Participating institutions. 

• Number and title of this RFA. 

67918 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

• Brief description of the proposed 

center’s research focus (a three to four 

line description). 

• Brief description of the scope and 

intent of the proposed center work 

(maximum one paragraph).

Note: Attachments, booklets, or other 

documents will not be accepted with the LOI.

Application: Follow the PHS 398 

application instructions for content and 

formatting of your application. If the 

instructions in this announcement differ 

in any way from the PHS 398 

instructions, follow the instructions in 

this announcement. For further 

assistance with the PHS 398 application 

form, contact PGO–TIM staff at 770–

488–2700, or contact GrantsInfo, 

Telephone (301) 435–0714, e-mail: 

GrantsInfo@nih.gov. 

Your application should address 

activities to be conducted over the 

entire five-year project period. 

For more information, see the CDC 

Web site at: http://www.cdc.gov/

funding.htm. 

This announcement uses just-in-time 

concepts. This announcement uses the 

non-modular budgeting format. The 

application narrative should consist of 

the following information: 

(1) Administrative and Infrastructure 

Core: To ensure that applicants have the 

administrative and infrastructure 

capacity to achieve the program 

objectives, applicants should describe 

the following:

(a) Defined Community: Applicants 

need to define and describe the center’s 

mission and the primary community 

(whether geographic or a nongeographic sub-grouping) that the 

center’s activities will serve. (See 

Appendix 3, Glossary of Terms, for a 

definition of community). Applicants 

should, at a minimum, address the 

following characteristics of the defined 

community, as they pertain to the type 

of community chosen: the size of the 

community; the demographic make up, 

socioeconomic and cultural 

characteristics; levels of youth violence 

and the prevalent risk and protective 

factors of, or encountered by, the 

defined community; the youth violence 

prevention infrastructure, levels of 

organization and support for 

interpersonal youth violence prevention 

interventions in the defined community; 

and the existence of health, education, 

justice, and other policies related to 

youth violence prevention in the 

defined community. Applicants should 

describe the linkages between the center 

and the defined community and 

document appropriate levels of 

engagement and collaboration that 

reflects the ability to carry out proposed 

center activities. 

(b) Evaluation: Applicants need to 

describe how they will develop a plan 

for evaluating the progress of the center 

in achieving its goals and the national 

performance indicators. Applicants 

should describe their capacity to: 

establish a five-year evaluation plan; 

conduct center-level evaluation; and 

collect data to determine the 

performance of the center using the 

national performance indicators. (See 

Appendix 2 for a description of 

Developing an Evaluation Framework: 

National Academic Centers of 

Excellence in Youth Violence 

Prevention.) To assure that applicants 

have this capacity, applicants should, at 

a minimum: 

(i) Describe their center-level logic 

model specifying the center’s youth 

violence prevention priorities and 

expected outcomes. Within the logic 

model, applicants should define the 

inputs, activities, outputs, outcomes, 

evaluation, and contextual conditions 

for the center. The logic model should 

be adapted from the national ACE 

Program conceptual framework (See 

Appendix 2.) In addition to the logic 

model, a narrative description of each 

component must be included. Please 

include the center’s mission within the 

narrative, limiting the mission statement 

to one to two sentences. Further, within 

this narrative briefly describe how the 

center’s model is related to the national 

ACE Program conceptual framework. 

(ii) Document experiences of center 

faculty in conducting process, 

outcomes, and impact evaluations in the 

past five years and address how the 

center will continue or enhance its 

evaluation expertise as it relates to the 

center-level evaluation. 

(iii) Describe how they will create a 

five-year plan for evaluating the critical 

components of the center’s logic model. 

The plan should be developed in 

collaboration with the center’s 

community committee and center 

partners and include: a description of 

how the plan will be developed; 

identification of resources and staff 

responsible for evaluation; specific 

evaluation questions, goals and 

objectives; quantitative and qualitative 

assessment of the centers activities to 

demonstrate program accomplishments 

and challenges; and a plan for 

identifying emerging challenges. 

(c) Infrastructure: Applicants should 

describe an infrastructure of personnel 

and resources required to develop 

center functions and processes. 

Applicants should have the capacity to 

recruit, hire, and retain faculty and staff 

with the expertise to implement center 

projects and activities; acquire, manage, 

and maintain the communications and 

information systems necessary to 

operate an ACE; and acquire and 

maintain university support for the 

center. To assure that applicants have 

this capacity, applicants should, at a 

minimum: 

(i) Provide an organizational chart for 

the center showing all organizational 

units and functions. The chart should 

also reflect the activities articulated in 

the center’s logic model. 

(ii) Describe the center’s staffing and 

management plan. Describe each 

proposed position and discuss how the 

position provides the scientific and 

technical expertise needed to carry out 

both research and non-research 

activities. Describe the minimum 

criteria and the required expertise for 

each position. Describe the 

qualifications of the proposed staff, how 

the proposed staff will interact with 

each other, with other faculty outside 

the center, and with the university’s 

leaders to accomplish the center’s goals 

and objectives. This discussion should 

highlight the following center staff: 

leadership; research; evaluation; 

communication and dissemination; 

training; information management; and 

fiscal and administration staff. 

(iii) Describe how your center will be 

integrated within the university 

structure. Describe the facilities in 

which staff will work and how these 

facilities enhance the center’s ability to 

complete the proposed activities. 

Describe the center’s plan to enhance its 

core capacity over the five-year period, 

including the commitment and 

capability to obtain the communication, 

information systems, and other tools 

necessary to accomplish goals and 

objectives (i.e., computer equipment, 

telephones, facsimile machines, 

scanners, scientific software, etc.). 

(iv) Describe plans for crossdisciplinary training of new and 

established investigators, including: 

adequacy of facilities for workshops, 

seminars and other educational 

activities; capacity to train predoctoral 

and/or postdoctoral students in multidisciplinary interpersonal youth 

violence prevention research; and 

experience in effectively conducting 

mentoring and career development 

activities.

(d) Collaborations/Partnerships:

Applicants need to develop and 

describe the nature and range of 

partnerships needed to carry out center 

activities. An infrastructure of resources 

and personnel is required to support 

collaboration with partners and joint 

community mobilization efforts. (See 

Appendix 3, Glossary of Terms, for an 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67919

operational definition). Applicants 

should have the capacity to: Establish 

and maintain relationships with 

partners; facilitate the establishment 

and maintenance of the center’s 

community committee(s); and 

collaborate with partners on the 

planning and implementation of core 

research, dissemination, training, and 

mobilization efforts. To assure that 

applicants have this capacity, applicants 

should: 

(i) Describe the plan for establishing 

or maintaining the center’s community 

committee(s). (See Appendix 3, Glossary 

of Terms for additional information 

regarding the center community 

committee.) This plan should include, 

at a minimum, the following: The 

intended composition and membership 

of the committee and how the 

constituents reflect the defined 

community; the proposed mission and 

role for the committee in the center’s 

planning and activities, consistent with 

the logic model; a process for 

developing or refining guidelines for the 

community committee over the first 

year of the funding period; a plan for 

communication between the community 

committee and the center staff. 

Applicants must provide evidence of 

commitment and cooperation of current 

and potential members of the center’s 

community committee (e.g., letters of 

support, memorandums of 

understanding, or examples of prior 

collaboration.) 

(ii) Identify and describe other 

partners such as local and state health 

departments, youth violence prevention 

organizations, community groups and 

agencies, youth organizations, and 

academic units. At a minimum, 

applicants need to briefly describe: Past 

partners, new partners, and proposed 

partners; the proposed methods for 

establishing and maintaining these 

partnerships, including how the lessons 

learned from previous partnerships will 

be applied to the proposed methods; 

and the partners’ involvement in the 

center’s proposed activities. In this 

section, applicants should specifically 

address the partners’ role in developing 

this proposal and partners’ expectations 

about their roles in the planning and 

implementation of the center’s 

activities. 

(iii) Provide evidence of commitment 

and cooperation of current and potential 

partners (e.g., letters of support, 

memorandums of understanding, and 

examples of prior collaborations). 

2. Surveillance and Research Core:

Applicants need to describe and 

develop the infrastructure of resources 

and personnel required to support 

surveillance and research in the center. 

Applicants need to enhance 

surveillance efforts and conduct 

research, as described below: 

(a) Surveillance: Applicants should 

document experience in successfully 

developing, implementing and 

evaluating community level 

surveillance efforts in the last five years 

and describe plans to develop and/or 

enhance surveillance systems to be able 

to measure the problem of youth 

violence as well as determine impact of 

Center activities and research in the 

defined community. Applicants should 

address how your system will: Measure 

youth violence patterns in the defined 

community; be used to guide planning 

and evaluation of youth violence 

programs (e.g., determine in what 

components and areas where prevention 

efforts are making a difference); and 

advance the public health research 

related to youth violence. All proposed 

surveillance activities should include an 

appropriate translation and 

dissemination plan. To assure that 

applicants have this capacity, applicants 

should, at a minimum: Document 

experience in successfully developing, 

implementing and evaluating 

community level surveillance efforts in 

the last five years. 

(b) Research: Applicants should 

describe center capacity to: Establish a 

five-year research agenda; conduct core 

research and other prevention research 

as described in the research agenda; and 

effectively collaborate with partners in 

the identification, planning, 

implementation, and dissemination of 

core research. To assure that applicants 

have this capacity, applicants should, at 

a minimum: Document experience in 

successfully conducting, evaluating, and 

publishing youth interpersonal violence 

prevention research in the past five 

years; and describe community-based 

youth interpersonal violence prevention 

research activities and provide evidence 

of community involvement in those 

activities; and describe experience in 

conducting community-based 

participatory research in the past five 

years. 

Applicants should describe (the core 

elements of) a five year research agenda, 

including a description of the core 

youth interpersonal violence prevention 

research project(s), and smaller studies 

and seed projects, as described below. 

The research projects and the agenda 

should reflect the potential for a center 

with a clear mission that promotes 

multidisciplinary collaboration and 

career development. The research 

agenda must represent more than an 

interesting collection of projects. 

Research projects must be 

interdependent (materials, results, data, 

or methodologies are shared among the 

projects), interrelated (each project must 

have goals and objectives that focus on 

the common theme), and 

multidisciplinary (representing different 

scientific backgrounds, training and 

expertise). Centers must develop 

research projects on youth interpersonal 

violence prevention with a conceptual 

focus on the defined community and 

that provide evidence of the potential 

for meaningful inter-disciplinary 

collaboration, and that respond to the 

NCIPC Research Agenda. Clear 

definitions of procedures used to select 

proposed and future projects are 

required.

The core research project should 

address the following types of applied 

interpersonal youth violence prevention 

research articulated in the NCIPC 

Research Agenda and that furthers the 

center’s work in the defined 

community: intervention research, 

which examines the efficacy, 

effectiveness, economic efficiency of 

strategies, programs and policies in 

reducing or preventing youth 

interpersonal violence; and 

dissemination and dissemination 

implementation research (which 

includes research on the targeted 

distribution of information to a specific 

audience; and research on the use of 

strategies to introduce or change 

evidence-based youth interpersonal 

violence prevention interventions in 

specific settings). 

Applicants should also demonstrate 

the links to the community within 

which the research is framed, 

documenting appropriate levels of 

support and collaboration. If the 

research agenda is also supported by 

non-ACE Program funding sources, 

identify the other funders. 

The types of research projects centers 

are expected to carry out are listed 

below: 

(i) Core research projects are the larger 

scale projects with annual budgets 

exceeding 150,000 a year, including 

direct and indirect costs, and lasting up 

to five years. These projects typically 

will test hypotheses and employ more 

sophisticated methodologies and/or 

larger sample sizes than small studies. 

Core research projects require an RO1 

level summary as described in PHS 398 

(Revised 5/01 and updated 6/28/02) 

guidelines. 

(ii) Small studies of 25,000–150,000 a 

year, including direct and indirect costs, 

for one to three years duration, might be 

extensions of seed projects, either 

further developing methods or 

hypotheses in preparation for a larger 

investigation, or might be stand alone 

investigations sufficient to yield results 

67920 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

worthy of publication in a peerreviewed journal and/or a technical 

report for a legislative body, 

governmental agency or youth violence 

prevention organizations. 

(iii) Seed projects, under 25,000 

require a short write-up describing the 

youth interpersonal violence prevention 

context of the study, the objective, the 

design, the setting and participants, the 

intervention being addressed, main 

outcome measurements, expected 

results, timelines, costs. 

The applicant should use the 

following template to describe each 

proposed research project: 

• Title of the project. 

• Project Director/Lead Investigator 

for the project. 

• Institution(s)/partners involved in 

the project. 

• Categorization of the type of 

research (such as, but not exclusively, 

intervention, dissemination, and 

dissemination-implementation 

research). 

• Relationship of the project to the 

center’s mission and health priorities. 

• Relationship of the project to local 

youth interpersonal violence prevention 

priorities, HHS objectives (e.g., Healthy 

People 2010), and NCIPC Research 

Agenda.

• Indication of whether the project is 

new or ongoing. (If ongoing, describe 

the prior work on this project.) 

• Evidence of community 

participation in the planning, 

implementation, and evaluation of the 

project. Describe how the center will 

collaborate with partners on refining 

and developing the research 

methodology, recruiting of research 

participants, and reporting and 

disseminating research findings. 

• Summary of the research project:

(i) Background 

(ii) Importance 

(iii) Relevance to the defined 

community. 

(iv) Integration into 5 year research 

agenda 

(v) Goals and objectives 

(vi) Proposed timeframe for the project 

(vii) Setting and context 

(viii) Methods and measures 

(ix) Study participants and recruitment 

strategy. Provide evidence that the 

recipient (or a collaborating partner) 

has access to the study population 

and that the participation by the study 

population will be adequate to test 

hypotheses. 

(x) Expected outcomes 

(xi) Communication and dissemination 

Data Sharing and Release: Describe 

plans for the sharing and release of data, 

if applicable (See AR–25 for additional 

information). 

3. Outreach and Education Core: To 

ensure that applicants have the capacity 

to achieve the outreach and education 

program objectives, applicants should 

describe the following: 

(a) Community Mobilization:

Applicants need to describe a draft plan 

for community mobilization. Applicants 

should describe the infrastructure of 

resources and personnel to support 

community mobilization activities in 

the center and to develop and 

implement a community mobilization 

plan involving the primary community 

the center’s activities will serve. For a 

definition of Community Mobilization 

and Community Mobilization Plan 

(CMP), see Appendix 3, Glossary of 

Terms. The two overriding goals of a 

community mobilization plan should be 

to: enhance the community’s capacity to 

address the problem of youth violence 

and prevent or reduce youth violence. 

(For additional Guidance on how to 

develop a CMP, see: http://

www.phppo.cdc.gov/dphsdr/

documents/MAPPone_pager.doc and 

http://mapp.naccho.org/

mapp_introduction.asp). 

Applicants should have the capacity 

to: establish a five-year community 

mobilization plan (CMP); conduct 

community mobilization activities as 

required in the CMP; and effectively 

collaborate with partners in the 

identification, planning, 

implementation, and evaluation of the 

CMP. In addition, the CMP should 

provide evidence that applicant or their 

collaborating partners have access to the 

defined community population, and 

that the participation by the defined 

community population will be adequate 

to develop, implement and evaluate the 

plan. 

To assure that applicants have this 

capacity, applicants should at a 

minimum: 

(i) Provide evidence of having 

identified youth interpersonal violence 

prevention priorities, including 

disparities, within the defined 

community and of having identified 

them in collaboration with community 

partners.

(ii) Document experience in 

successfully developing, conducting, 

and evaluating community mobilization 

activities in the past five years. 

(iii) Describe how the CMP helps 

fulfill the center’s mission. If the 

community mobilization efforts are also 

supported by non-ACE Program 

collaborations, identify the other 

funders. 

(iv) Describe the center’s draft fiveyear CMP, including the goals and 

objectives. The applicant should use the 

following template and provide 

information to describe the community 

mobilization plan:

• Title of the plan; 

• Core staff and community partners; 

• Institution(s)/partners involved in 

the project; 

• Indication of whether the 

community mobilization plan is new or 

ongoing. (If ongoing, describe the prior 

work on this plan.) 

• Describe how the center will 

collaborate with partners: In the 

refinement of the CMP, in the 

development of the community 

mobilization methodology, for 

community recruitment, to report and 

disseminating information and 

activities, and to evaluate CMP 

outcomes. 

• Summary of the Community 

Mobilization Plan. 

This should include: 

(i) Background; 

(ii) How the plan furthers the defined 

community youth violence prevention 

needs, and priorities; 

(iii) Describe how the CMP is 

integrated into the center’s five-year 

research agenda and the centers 

mission; 

(iv) Goals and objectives; 

(v) Proposed timeframe for the plan; 

(vi) Setting and context; 

(vii) Methods and measures; 

(viii) Community definition, 

participation and recruitment strategy; 

(ix) Expected outcomes; 

(x) Communication, dissemination, 

and evaluation. 

(b) Communication and 

Dissemination Activities: Applicants 

should outline how they will develop a 

communication plan and describe the 

communication and dissemination 

infrastructure and activities to be 

carried out to further the program goals. 

Applicants should have the capacity to: 

disseminate research by making its 

findings, methods, and tools available; 

keep stakeholders (i.e., researchers, 

practitioners, community members, and 

policymakers) abreast of the center’s 

accomplishments; produce products 

that reflect research progress and 

results, and participate in coordinated 

activities with other ACEs and their 

collaborating partners (e.g., state/local 

health departments, community groups, 

and youth violence prevention research 

and practice organizations) to facilitate 

linkages among ACEs and national/

state/local partners to ensure National 

Program objectives are being achieved. 

To assure that applicants have this 

capacity, applicants should, at a 

minimum: 

(i) Outline how a communication plan 

will be developed that defines and 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67921

describes how the center’s 

communication and dissemination 

activities will be integrated into the 

center’s activities, including the 

research agenda.

(ii) Address how the center will work 

with collaborators and other partners to 

extend the center’s reach; how the 

center’s activities and research will 

affect youth violence prevention 

policies impacting their community; 

and how other potential outcomes 

through communication and 

dissemination efforts will be identified. 

(iii) Describe the methods the center 

will use to translate, communicate, and 

disseminate its products and other 

information. Address how the center 

will produce, translate and distribute 

publications and materials such as 

scientific papers, conference reports, 

newsletters, and educational and 

training materials; plan proposed 

meetings, personal interactions, and 

sharing of information with 

collaborators for the development of 

long-term partnerships; provide 

electronic dissemination of products 

and other information through websites 

and any other means; and develop 

media releases and statements, or 

pursue opportunities for media 

coverage. 

(iv) Describe the center’s 

infrastructure of resources and 

personnel that will support the 

identified communication and 

dissemination activities. At a minimum, 

describe the center’s ability to: 

disseminate community-based youth 

violence prevention research in public 

health, allied disciplines and the 

constituent communities/stakeholders; 

translate the content of the center’s 

activities for different audiences; 

develop a plan that reflects the 

community’s youth demographic and 

cultural profile; and access personnel 

and resources, as applicable for layout 

and design, web site construction, 

photography, proofreading, and other 

development and production activities. 

(c) Training, Technical Assistance 

and Mentoring: Applicants should 

describe the center’s draft plan for 

providing training, technical assistance, 

and mentoring, and the infrastructure of 

resources and personnel required to 

support training, technical assistance, 

and mentoring of practitioners, 

researchers, students, community 

members, and other partners, as 

applicable. Applicants should have the 

capacity to assess, plan, implement, and 

evaluate training, technical assistance, 

or mentoring activities. Applicants, at a 

minimum, should address the 

following: 

(i) Describe the center’s assets or 

needs assessment (past, current, or 

proposed) for training, technical 

assistance, and mentoring. Explain 

collaboration with partners in the assets 

and needs assessment. 

(ii) Describe the center’s draft plan for 

providing training, technical assistance, 

and mentoring. This plan should 

include: goals and objectives; partner 

collaboration; and how the plan reflects 

the mission of the center and the assets 

and needs assessment described above. 

Describe how any lessons learned from 

prior training; technical assistance and 

mentoring activities during the past five 

years will be applied to the proposed 

plan. Additionally, describe training 

facilities and resources (e.g., ability to 

print materials, use video and computer 

equipment, and develop Web sites). 

(iii) Describe the opportunities and 

quality of the career development and 

mentoring plan for the junior 

investigators in the center. Applicants 

should describe the feasibility and 

potential for junior investigators to gain 

research experience in youth violence 

affecting at-risk populations. 

The narrative should be no more than 

100 pages (8.5′′ × 11′′), double-spaced, 

and printed on one side only, with oneinch margins on all sides and 

unreduced 12-point font. Appendices 

must be hard copy documents (i.e., no 

audiovisual materials or posters). 

In order to facilitate the preparation 

and review of the application, the 

application components should be 

organized according to the Table of 

Contents listed below. The table of 

contents below supersedes the 

instructions contained in the PHS 398. 

• Detailed Budget for the Initial 

Budget for the Entire Proposed Period 

for Each Project. 

• Budget for the Entire Proposed 

Period of Support for the Entire 

Proposed Center. 

• Detailed Budget Justification for 

Each Proposed Project/Activity for the 

Initial Budget Period. 

• Biographical Sketch-Principal 

Investigator/Program Director. 

• Other Biographical Sketches.

• Other Research Support. 

• Executive Summary with Overall 

Goals and Objectives of the Center. 

• Center Logic Model. 

• Application Narrative: 

Overall Description of the Proposed 

Center. 

Statement on the Institutional 

Commitment to the Proposed Center. 

Performance/Accomplishments in 

Last Project Period (Current Centers). 

Past Performance/Accomplishments 

Relevant to Proposed Center. 

Administrative and Infrastructure 

Core: Defined Community; Evaluation; 

Infrastructure; Collaborations/

Partnerships. 

Surveillance and Research Core: 

Surveillance Projects; Core Research 

Projects; Seed Projects. 

Outreach and Education Core: 

Community Mobilization; 

Communication and Dissemination 

Activities: Training, Technical 

Assistance, and Mentoring. 

The RFA label available in the PHS 

398 (rev. 5/2001) application form must 

be affixed to the bottom of the face page 

of the application. 

IV.3. Submission Dates and Times 

LOI Deadline Date: December 22, 

2004. 

CDC requests that you send a LOI if 

you intend to apply for this program. 

Although the LOI is not required, not 

binding, and does not enter into the 

review of your subsequent application, 

the LOI will be used to gauge the level 

of interest in this program, and to allow 

CDC to plan the application review. 

Application Deadline Date: February 

10, 2005. 

Explanation of Deadlines:

Applications must be received in the 

CDC Procurement and Grants Office by 

4 p.m. eastern time on the deadline 

date. If you send your application by the 

United States Postal Service or 

commercial delivery service, you must 

ensure that the carrier will be able to 

guarantee delivery of the application by 

the closing date and time. If CDC 

receives your application after closing 

due to: (1) carrier error, when the carrier 

accepted the package with a guarantee 

for delivery by the closing date and 

time, or (2) significant weather delays or 

natural disasters, you will be given the 

opportunity to submit documentation of 

the carriers guarantee. If the 

documentation verifies a carrier 

problem, CDC will consider the 

application as having been received by 

the deadline. 

This announcement is the definitive 

guide on application submission 

address and deadline. It supersedes 

information provided in the PHS 398 

application instructions. If your 

application is not received in the CDC 

Procurement and Grants office by the 

deadline above, it will not be eligible for 

review, and will be discarded. You will 

be notified that you did not meet the 

submission requirements. 

CDC will not notify you upon receipt 

of your application. If you have a 

question about the receipt of your 

application, first contact your courier. 

CDC will not notify you by mail upon 

receipt of your application, but if you 

still have any questions, contact the 

PGO–TIM staff at: 770–488–2700. Before 

67922 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

calling, please wait two to three days 

after the application deadline. This will 

allow time for applications to be 

processed and logged. 

IV.4. Intergovernmental Review of 

Applications 

Executive Order 12372 does not apply 

to this program. 

IV.5. Funding Restrictions 

Restrictions, which must be taken into 

account while writing your budget, are 

as follows: 

• Funds relating to the conduct of 

research will not be released until the 

appropriate assurances and Institutional 

Review Board approvals are in place. 

If you are requesting indirect costs in 

your budget, you must include a copy 

of your indirect cost rate agreement. If 

your indirect cost rate is a provisional 

rate, the agreement must be less than 12 

months of age. 

IV.6. Other Submission Requirements 

LOI Submission Address: Submit your 

LOI by express mail, delivery service, 

fax or e-mail to: 

Address for Express Mail or Delivery 

Service: NCIPC Extramural Resources 

Team, CDC, National Center for Injury 

Prevention and Control, 2945 Flowers 

Road, Yale Building, Room 2054, 

Atlanta, Georgia 30341. 

Address for U.S. Postal Service Mail:

NCIPC Extramural Resources Team, 

CDC, National Center for Injury 

Prevention and Control, 4770 Buford 

Hwy, NE., Mailstop K–62, Atlanta, GA 

30341, telephone: 770–488–4037, fax: 

770–488–1662, e-mail: cipert@cdc.gov.

Application Submission Address:

Submit the original and one copy of 

your application by mail or express 

delivery service to: Technical 

Information Management CE05–018, 

CDC Procurement and Grants Office, 

2920 Brandywine Road, Atlanta, GA 

30341.

At the time of submission, four 

additional copies of the application, and 

four copies of all appendices must be 

sent to: 

Address for Express Mail or Delivery 

Service: NCIPC Extramural Resources 

Team, CDC, National Center for Injury 

Prevention and Control, 2945 Flowers 

Road, Yale Building, Room 2054, 

Atlanta, Georgia 30341. 

Address for U.S. Postal Service Mail:

NCIPC Extramural Resources Team, 

CDC, National Center for Injury 

Prevention and Control, 4770 Buford 

Hwy, NE., Mailstop K–62, Atlanta, GA 

30341. 

Applications may not be submitted 

electronically at this time. 

V. Application Review Information 

V.1. Criteria 

Applicants are required to provide 

measures of effectiveness that will 

demonstrate the accomplishment of the 

objectives identified in the cooperative 

agreement. Measures of effectiveness 

must relate to the performance goals 

stated in the ‘‘Purpose’’ section of this 

announcement. Measures must be 

objective and quantitative, and must 

measure the intended outcome. These 

measures of effectiveness shall be 

submitted with the application and 

shall be an element of evaluation. 

The goals of CDC-supported research 

are to advance the understanding of 

biological systems, improve the control 

and prevention of disease and injury, 

and enhance health. In the written 

comments, reviewers will be asked to 

evaluate the application in order to 

judge the likelihood that the proposed 

research will have a substantial impact 

on the pursuit of these goals. 

The scientific review group will 

address and consider the following 

items in the determination of scientific 

merit. 

1. Administrative and Infrastructure 

Core (Total: 150 points) 

(a) Defined Community (25 points). 

To what extent does the applicant 

adequately define and describe the 

primary community that the center’s 

activities serve, such as: (i) The size of 

the defined geographic or nongeographic community, (ii) 

characteristics such as demographic 

make up, socioeconomic, and cultural 

characteristics, (iii) levels of youth 

violence and a description of the 

prevalent risk and protective factors, (iv) 

the youth violence prevention and 

public health infrastructure, including 

levels of organization and support for 

interpersonal youth violence prevention 

and community health interventions, (v) 

community assets and history of 

‘‘community participation, (vi) existing 

health, education, community, justice 

and other local policies related to youth 

violence prevention. How well does the 

applicant describe the center links to 

the defined community and document 

appropriate levels of engagement and 

collaboration? 

(b) Program Evaluation (50 points). To 

what extent does the applicant: (i) 

Appropriately describe the center-level 

logic model and provide a narrative 

description of components of the logic 

model, (ii) sufficiently describe and 

justify how each component of the 

center’s logic model relates to or 

differentiates from the national ACE 

Program conceptual framework, (iii) 

describe relevant evaluation experiences 

and expertise as it relates to conducting 

an evaluation of the applicant’s center, 

(iv) articulate a five-year evaluation plan 

for evaluating the critical components of 

the center’s logic model, including the 

goals and objectives, and (v) illustrate 

how the center’s evaluation plan is 

related to the national ACE Program 

evaluation activities, which includes 

annual reporting on national 

performance indicators. 

(c) Infrastructure (25 points). To what 

extent does the applicant: (i) Provide a 

detailed organizational chart that 

represents the center’s activities, (ii) 

describe how the organizational 

structure facilitate the center’s activities, 

(iii) describe the positions needed to 

accomplish the center’s goals and 

objectives, (iv) propose a staffing plan 

with the required experience, expertise, 

and percentage of effort among the 

center’s leadership, research, 

evaluation, communications, training, 

information management, and fiscal 

administration staff to accomplish its 

proposed goals and objectives, (v) 

explain how it will increase its capacity 

over time, (vi) demonstrated the 

applicant’s commitment to the center 

(e.g., facilities, technological resources, 

etc.)and adequate university 

commitment to establish and maintain 

an identity for the proposed center. 

Is sufficient documentation of 

institutional endorsement of the 

proposed five-year research and 

community mobilization plans offered, 

including: (i) Letters of commitment 

from senior institutional officials from 

both collaborating institutions, (ii) 

letters of support that fully address and 

support the priorities and objectives of 

the center. 

(d) Collaborations/Partnerships (50 

points). To what extent does the 

applicant: (i) Describe the center’s 

community advisory committee, 

particularly its initial mission, roles, 

composition, and plans for developing 

or refining guidelines, (ii) provide 

letters of support or other evidence from 

these partners of active participation in 

this collaboration that fully address and 

support the priorities and objectives of 

the center, (iii) outline the past and 

newly established partnerships, the 

roles of these partners, and the methods 

for establishing and maintaining the 

partnerships, and (iv) articulate the 

proposed activities with the identified 

partners?

2. Surveillance and Research Core

(Total: 200 Points) 

(a) Surveillance (50 points). To what 

extent does the applicant: (i) Describe 

the establishment and/or enhancement 

of surveillance system(s) to be able to 

measure the problem of youth violence 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67923

in the chosen community, (ii) address 

how these efforts will lead to a better 

understanding of factors influencing 

youth violence prevention, and (iii) 

include an appropriate translation and 

dissemination plan for the proposed 

surveillance activities? 

(b) Research (150 points). To what 

extent does the applicant: 

(i) Describe the research project(s) 

linkage to the center’s mission and 

priorities identified in the logic model 

and the NCIPC Research Agenda? 

Outline a conceptual research 

framework, design, methods, and 

analyses that are well integrated, and 

appropriate to the aims of the center? 

Propose research project(s) that address 

an important research objective related 

to youth interpersonal violence 

prevention and disparities in the 

defined community? Explain how this 

research will lead to a better 

understanding of factors influencing 

youth violence prevention in the 

defined community? 

(ii) Articulate the significance of the 

proposed research, and describe the 

effect of these studies on the concepts 

or methods that drive the youth 

violence prevention field? Employ novel 

concepts, approaches or methods in 

youth violence prevention research? 

Explain how the research challenges 

existing paradigms or develops new 

methodologies or technologies? Propose 

research of sufficient originality, 

novelty, and innovation to make it 

highly relevant to the overall goals and 

objectives of the national ACE Program? 

Acknowledge potential problem areas 

and consider alternative 

interdisciplinary approaches? Offer 

clear evidence of significant 

interdisciplinary interactions in the 

conception, design, and proposed 

implementation of the research? 

(iii) Document collaboration with the 

community, providing clear evidence of 

community participation in developing 

and conducting the project? 

Demonstrate community support and 

liaison, and evidence of interaction 

with, and participation of community 

members and community leaders in the 

development and conduct of the 

research? Propose a design that 

demonstrates sensitivity to cultural and 

socioeconomic factors in the 

community? 

(iv) Demonstrate success in 

conducting, evaluating, and publishing 

previous community-based youth 

violence prevention research in the past 

five years? Demonstrate a reasonable 

degree of community-based 

participatory research, and being trained 

and well-suited to carry out this work? 

Propose work appropriate to the 

experience level of center researchers? 

(v) Describe a scientific environment 

conducive to the probability of success 

of the research to be conducted? 

Propose studies that take advantage of 

unique features of the scientific 

environment or employ useful 

collaborative arrangements? Provide 

evidence of adequate institutional and 

community support? 

(vi) Provide sufficient evidence 

regarding the development and 

implementation of effective 

communication channels between 

researchers and community members? 

Address plans for useful and successful 

practical dissemination of project 

activities and findings within the 

defined community? 

3. Outreach and Education Core

(Total: 150 Points) 

(a) Community Mobilization Plan (50 

points). To what extent does the 

applicant’s draft plan: 

(i) Enhance the community’s capacity 

to address the problem of youth 

violence and improve the health of the 

community, by preventing or reducing 

youth violence, particularly among 

those most affected? 

(ii) Present clear goals, objectives and 

activities that address the youth 

violence problem in the defined 

community? Address and take into 

account community contextual factors 

(i.e. socioeconomic and cultural context, 

level of youth violence, public health 

and youth violence prevention 

infrastructure, history of community 

participation and existing support for 

the issue)? 

(iii) Offer adequate evidence of center 

experience in successfully developing, 

conducting, evaluating, and publishing 

on community mobilization activities in 

the past five years? Delineate 

community involvement in the 

development of the CMP? 

(iv) Address the development and 

review of the plan (i.e. describe external 

review and critique mechanisms)? 

(b) Communications and 

Dissemination (50 points). To what 

extent does the applicant: (i) Address 

the diversity or special needs of the 

community or subgroups, (ii) describe 

communications and dissemination 

activities that are integrated into the 

center’s goals and objectives, (iii) 

anticipate how these activities will have 

an effect on local policies, and other 

potential outcomes, (iv) describe how 

the proposed methods for the center’s 

communication and dissemination 

activities to help accomplish the 

center’s goals and objectives, and (v) 

describe an adequate infrastructure of 

resources and personnel to support the 

center’s communication and 

dissemination activities?

(c) Training, Technical Assistance 

and Mentoring (50 points). To what 

extent does the applicant: (i) Describe 

and justify the center’s assets or needs 

assessments for training, technical 

assistance, or mentoring activities, (ii) 

outline a suitable training, technical 

assistance, and mentoring plan that 

reflects the mission of the center and the 

assets or needs assessment described 

above, (iii) describe the opportunities 

and quality of the career development 

and mentoring plan for the junior 

investigators in the center. 

Protection of Human Subjects from 

Research Risks: Does the applicant 

adequately address the requirements of 

Title 45 CFR part 46 for the protection 

of human subjects? This will not be 

scored; however, an application can be 

disapproved if the research risks are 

sufficiently serious and protection 

against risks is so inadequate as to make 

the entire application unacceptable. 

Inclusion of Women, Minorities in 

Research: Does the applicant adequately 

address the CDC Policy requirements 

regarding the inclusion of women, 

ethnic, and racial groups in the 

proposed research? (See Attachment 1, 

AR–2 for more information). This 

includes: (1) The proposed plan for the 

inclusion of both sexes and racial and 

ethnic minority populations for 

appropriate representation; (2) the 

proposed justification when 

representation is limited or absent; (3) a 

statement as to whether the design of 

the study is adequate to measure 

differences when warranted; and (4) a 

statement as to whether the plans for 

recruitment and outreach for study 

participants include the process of 

establishing partnerships with 

community(ies) and recognition of 

mutual benefits. 

Inclusion of Children as Participants 

in Research Involving Human Subjects.

The NIH maintains a policy that 

children (i.e., individuals under the age 

of 21) must be included in all human 

subjects research, conducted or 

supported by the NIH, unless there are 

scientific and ethical reasons not to 

include them. This policy applies to all 

initial (Type 1) applications submitted 

for receipt dates after October 1, 1998. 

NCIPC has adopted this policy for this 

announcement. 

All investigators proposing research 

involving human subjects should read 

the ‘‘NIH Policy and Guidelines’’ on the 

inclusion of children as participants in 

research involving human subjects that 

is available at: http://grants.nih.gov/

grants/funding/children/children.htm. 

67924 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

Budget: The reasonableness of the 

proposed budget and the requested 

period of support in relation to the 

proposed research. 

V.2. Review and Selection Process 

Applications will be reviewed by the 

Procurement and Grants Office (PGO) 

staff for completeness, and for 

responsiveness by the National Center 

for Injury Prevention and Control. 

Incomplete applications and 

applications that are non-responsive 

will not advance through the review 

process. Applicants will be notified that 

their application did not meet 

submission requirements. 

Applications that are complete and 

responsive to the announcement will be 

evaluated for scientific and technical 

merit by an appropriate peer review 

group or charter study section convened 

by the National Center for Injury 

Prevention and Control in accordance 

with the review criteria listed above. As 

part of the initial merit review, all 

applications may: 

• Undergo a process in which only 

those applications deemed to have the 

highest scientific merit by the review 

group, generally the top half of the 

applications under review, will be 

discussed and assigned a priority score. 

• Receive a written critique. 

• Receive, if deemed to have the 

highest scientific merit, a second 

programmatic level review by the 

Science and Program Review 

Subcommittee (SPRS) of the Advisory 

Committee for Injury Prevention and 

Control (ACIPC). 

Applications which are complete and 

responsive may be subjected to a 

preliminary evaluation (streamline 

review) by an external peer review 

committee, the National Center for 

Injury Prevention and Control Initial 

Review Group (IRG), to determine if the 

application is of sufficient technical and 

scientific merit to warrant further 

review by the IRG. 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 shall be further 

evaluated by a dual review process. 

All awards will be determined by the 

Director of the NCIPC based on priority 

scores assigned to applications by the 

primary review committee IRG, 

recommendations by the secondary 

review committee of the Science and 

Program Review Subcommittee of the 

Advisory Committee for Injury 

Prevention and Control (ACIPC), 

consultation with NCIPC senior staff, 

and the availability of funds. 

The primary review will be a peer 

review conducted by the IRG. All 

applications will be reviewed for 

scientific merit in accordance with the 

review criteria listed above. 

Applications will be assigned a score 

based on a scoring system of 100–500 

points, in which the strongest 

applications will receive a higher point 

score, and the weakest applications a 

lower point score.

The Science and Program Review 

Subcommittee (SPRS) of NCIPC’s 

Advisory Committee for Injury 

Prevention and Control (ACIPC) will 

conduct the secondary review. The 

ACIPC Federal agency experts will be 

invited to attend the secondary review, 

and will receive modified briefing books 

(i.e., abstracts, strengths and weaknesses 

from summary statements, and project 

officer’s briefing materials). ACIPC 

Federal agency experts will be 

encouraged to participate in 

deliberations when applications address 

overlapping areas of research interest, so 

that unwarranted duplication in 

federally funded research can be 

avoided and special subject area 

expertise can be shared. The NCIPC 

Division Associate Director for Science 

(ADS) or their designees will attend the 

secondary review in a similar capacity 

as the ACIPC Federal agency experts to 

assure that research priorities of the 

announcement are understood and to 

provide background regarding current 

research activities. Only SPRS members 

will vote on funding recommendations, 

and their recommendations will be 

carried to the entire ACIPC for voting by 

the ACIPC members in closed session. If 

any further review is needed by the 

ACIPC, regarding the recommendations 

of the SPRS, the factors considered 

would be the same as those considered 

by the SPRS. 

The secondary review committee’s 

responsibility is to develop funding 

recommendations for the NCIPC 

Director based on the results of the 

primary review, the relevance and 

balance of proposed research relative to 

the NCIPC programs and priorities, and 

to assure that unwarranted duplication 

of federally-funded research does not 

occur. The secondary review committee 

has the latitude to recommend to the 

NCIPC Director, to reach over betterranked proposals in order to assure 

maximal impact and balance of 

proposed research. The factors to be 

considered will include: 

a. The results of the primary review 

including the application’s priority 

score as the primary factor in the 

selection process. 

b. The relevance and balance of 

proposed research relative to the NCIPC 

programs and priorities. 

c. The significance of the proposed 

activities in relation to the priorities and 

objectives stated in ‘‘Healthy People 

2010,’’ the Institute of Medicine report, 

‘‘Reducing the Burden of Injury,’’ and 

the ‘‘CDC Injury Research Agenda.’’

d. Budgetary considerations.

Award Criteria: Criteria that will be 

used to make award decisions during 

the programmatic review include:

• Merit (as determined by peer review) 

• Availability of funds 

• Geographic diversity 

• Consistency with research priorities 

in CDC’s Injury Research Agenda 

V.3. Anticipated Announcement and 

Award Dates 

September 1, 2005. 

VI. Award Administration Information 

VI.1. Award Notices 

Successful applicants will receive a 

Notice of Grant Award (NGA) from the 

CDC Procurement and Grants Office. 

The NGA shall be the only binding, 

authorizing document between the 

recipient and CDC. The NGA will be 

signed by an authorized Grants 

Management Officer, and mailed to the 

recipient fiscal officer identified in the 

application. 

Unsuccessful applicants will receive 

notification of the results of the 

application review by mail. 

VI.2. Administrative and National 

Policy Requirements 45 CFR Part 74 and 

Part 92 

For more information on the Code of 

Federal Regulations, see the National 

Archives and Records Administration at 

the following Internet address: http://

www.access.gpo.gov/nara/cfr/cfr-tablesearch.html. 

The following additional 

requirements apply to this project:

• AR–1 Human Subjects 

Requirements. 

• AR–2 Requirements for Inclusion of 

Women and Racial and Ethnic 

Minorities in Research. 

• AR–9 Paperwork Reduction Act 

Requirements. Projects that involve 

the collection of information from ten 

or more persons and that are funded 

by cooperative agreements will be 

subject to review and approval by the 

Office of Management and Budget 

(OMB). 

• AR–10 Smoke-Free Workplace 

Requirements. 

• AR–11 Healthy People 2010. 

• AR–12 Lobbying Restrictions. 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67925

• AR–13 Prohibition on Use of CDC 

Funds for Certain Gun Control 

Activities. 

• AR–21 Small, Minority, WomenOwned Businesses. 

• AR–22 Research Integrity. 

• AR–23 States and Faith-Based 

Organizations. 

• AR–24 Health Insurance Portability 

and Accountability Act Requirements.

Additional information on AR–1 

through AR–24 can be found on the 

CDC Web site at the following Internet 

address: http://www.cdc.gov/od/pgo/

funding/ARs.htm.

• AR–25 Release and Sharing of Data.

Starting with the December 1, 2004 

receipt date, all ‘‘Requests for 

Applications (RFA)/Program 

Announcements (PA)’’ soliciting 

proposals for individual research 

projects of $500,000 or more in total 

(direct and indirect) costs per year 

require the applicant to include a plan 

describing how the final research data 

will be shared/released or explain why 

data sharing is not possible. Details on 

data sharing and release, including 

information on the timeliness of the 

data and the name of the project data 

steward, should be included in a brief 

paragraph immediately following the 

Research Plan Section of the PHS 398 

form. References to data sharing and 

release may also be appropriate in other 

sections of the application (e.g.

background and significance, or human 

subjects requirements). The content of 

the data sharing and release plan will 

vary, depending on the data being 

collected and how the investigator is 

planning to share the data. The data 

sharing and release plan will not count 

towards the application page limit and 

will not factor into the determining 

scientific merit or the priority scoring. 

Investigators should seek guidance from 

their institutions on issues related to 

institutional policies, and local IRB 

rules, as well as local, state and federal 

laws and regulations, including the 

Privacy Rule. 

Further detail on the requirements for 

addressing data sharing in applications 

for NCIPC funding may be obtained by 

contacting NCIPC program staff or by 

visiting the NCIPC Internet Web site at: 

http://www.cdc.gov/ncipc/osp/

sharing_policy.htm. 

VI.3. Reporting 

You must provide the CDC with 

original, plus two hard copies of the 

following reports: 

1. Interim progress report (PHS 2590, 

OMB Number 0925–0001, rev. 5/2001) 

no less than 90 days before the end of 

the budget period. The progress report 

will serve as your non-competing 

continuation application, and must 

contain the following elements: 

a. Current Budget Period Activities 

Objectives. 

b. Current Budget Period Financial 

Progress. 

c. New Budget Period Program 

Proposed Activity Objectives. 

d. Detailed Line-Item Budget and 

Justification. 

e. Measures of Effectiveness. 

f. Additional Requested Information. 

2. Financial status report, no more 

than 90 days after the end of the budget 

period. 

3. Final financial status and final 

performance reports, no more than 90 

days after the end of the project period. 

4. Additional requested information: 

The applicant will be responsible for 

submitting information on program 

performance. This will include, but is 

not limited to the following: providing 

information on all projects (i.e., core 

projects, special interest projects, and 

other funded projects) and products 

(i.e., publications, presentations, 

surveys, etc.); providing semi-annual 

updates on information requested by the 

program and provided in the 

application; and collaborating with the 

national ACE Program on the continued 

development and improvement of a 

reporting system.

These reports must be mailed to the 

Grants Management Specialist listed in 

the ‘‘Agency Contract’’ section of this 

announcement. 

VII. Agency Contacts 

We encourage inquiries concerning 

this announcement. For general 

questions about this announcement, 

contact: Technical Information 

Management Section, CDC Procurement 

and Grants Office, 2920 Brandywine 

Road, Atlanta, GA 30341–4146, 

telephone: (770) 488–2700. 

For questions about scientific/

research program technical issues 

contact: Thomas Vogelsonger, National 

Center for Injury Prevention and 

Control, Centers for Disease Control and 

Prevention, 4770 Buford Highway, NE. 

MS K–02, Atlanta, GA 30341, telephone: 

(770) 488–4823, FAX: (770) 488–1662, 

e-mail: TVoglesonger@cdc.gov.

For questions about peer review 

issues, contact: Gwen Cattledge, Ph.D., 

Centers for Disease Control and 

Prevention, National Center for Injury 

Prevention and Control, 4770 Buford 

Hwy, NE., Mailstop K–02, Atlanta, GA 

30341, telephone: 770–488–1430, email: GXC8@cdc.gov.

For financial, grants management, or 

budget assistance, contact: James 

Masone, Contracts Specialist, CDC 

Procurement and Grants Office, 2920 

Brandywine Road, Atlanta, GA 30341–

4146, telephone: 770–488–2736, FAX: 

770–488–2671, e-mail: ZFT2@cdc.gov.

VIII. Other Information 

This and other CDC funding 

opportunity announcements can be 

found on the CDC Web site, Internet 

address: http://www.cdc.gov. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’

To locate the following attachments/

appendices for this program 

announcement go to CDC Web site.

Dated: November 10, 2004. 

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

67926 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

Narrative Description of the Conceptual 

Framework for the National Academic 

Centers of Excellence for Youth 

Violence Prevention (ACE) Program 

The conceptual framework for the 

National Academic Centers of 

Excellence for Youth Violence 

Prevention (ACE) Program was 

developed to describe the future 

orientation of the program, its activities 

and the outcomes it expects to achieve. 

The national framework or logic model 

was created through a participatory 

process involving a diverse set of 

national, state, and local stakeholders 

and ACE grantees, and draws heavily 

from the Centers for Disease Control 

(CDC) Prevention Research Centers 

(PRC) model. The elements of the 

framework and its linkages are 

consistent with the Congressional 

language authorizing the establishment 

of the program, and CDC research 

policies. 

This model serves as a planning 

mechanism for center in guiding their 

activities during the 5-year grant period. 

The framework identifies the inputs, 

activities, outputs, and outcomes 

common to all ACE’s and shows the 

expected relationships among these 

components. The diagram of the 

framework summarizes how the 

program is presumed to work. Although 

the boxes of the framework are shown 

in a linear fashion, the relationships 

among them are expected to be 

complex, interactive, and recursive over 

time. 

The national framework does not 

imply that one size fits all. To reflect 

uniqueness, each ACE should create 

their own logic model by tailoring the 

national framework or logic model to 

the center’s specific activities and goals. 

The national framework cannot show 

the emphasis an individual ACE may 

place on one type of activity over 

another. The time required to achieve 

different outputs may vary among ACEs 

and depends on many factors, such as 

the type of research conducted and 

other activities undertaken, the amount 

of resources devoted to activities such 

as dissemination, and contextual 

factors. Thus, the framework does not 

specify the time it may take to achieve 

outputs or outcomes.

Diagram Note: The size of the boxes in the 

diagram depends on the amount of text in 

each box and does not denote the relative 

importance of a specific element.

Inputs. The first column of the 

conceptual framework, inputs, refers to 

the assumptions underlying a program 

and the infrastructure that must be in 

place before a program can be 

implemented. The four inputs the 

framework captures are described 

below. 

Youth Prevention Priorities. Each ACE 

is established to address youth 

interpersonal violence prevention 

priorities and enhance knowledge of 

effective youth violence prevention in a 

defined community. Community is 

defined as a group of people who share 

some or all of the following: geographic 

boundaries; a sense of membership; 

culture and language; common norms, 

interests, or values; and common health 

risks or conditions. [IOM 2002] [CDC/

ATSDR Principles of Community 

Engagement] It refers to a population 


EN22NO04.004</GPH>
Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67927

that has a distinct identity. It can mean 

residents of a geographic area, be that a 

catchement area, neighborhood, school 

district, city, county or region within a 

county. It can be used with a modifier 

or clause to describe a nongeographically based subgrouping such 

as, but not exclusively: a community of 

youth violence prevention workers, a 

community of health professionals, or 

an ethnic or language community. The 

ACE program focuses its research 

activities on the violence prevention 

issues of high priority to the defined 

community and that address state or 

national youth violence prevention 

priorities, and such gaps identified in 

the Research Agenda of CDC’s National 

Center for Injury Prevention and Control 

and those stated in Healthy People 2010.

Diagram Note: Two-way arrows connect 

the youth violence prevention priorities and 

box and the next three combined input 

boxes.

ACE Community Committee. CDC will 

require each ACE to form or work with 

an existing ACE Community Committee. 

This group comprises members of the 

ACE’s defined community and adult 

and youth representatives of agencies 

and organizations that serve the Center’s 

designated community. The Community 

Committee participates in the Center’s 

organization, research, or other 

activities. Committee members typically 

represent an identified group or 

population and participate in the 

committee in order to provide the 

perspective and knowledge of a 

designated population or group to the 

activities of the Center. 

The inputs provided by an ACE 

Community Committee to the ACE 

include guidance, advice on ACE 

agendas and plans, expertise, contacts, 

essential information about the 

designated community as well as 

intangible benefits. Some ACE’s may 

wish to form additional advisory 

groups, as needed, such as a policy 

board, a youth advisory board, or 

advisory committees for individual 

research projects. The decision to form 

these additional groups depends on the 

needs of the ACE and the community. 

ACE Infrastructure. Before conducting 

specific youth violence prevention 

research, projects, and health promotion 

activities, an ACE must have the 

necessary internal infrastructure. This 

infrastructure includes the necessary 

human resources capacity to recruit 

faculty with the necessary core 

expertise, diversity and sensitivity. It 

also includes the necessary evaluation 

expertise as well as faculty and staff 

who have the requisite 

multidisciplinary expertise to 

implement ACE projects and activities 

and experience working with the 

community, and expertise for evaluating 

the implementation of the ACE’s 

activities and to assess the ACE’s 

outcomes and accomplishments. The 

Centers are mandated to create an 

infrastructure that facilitates initiatives 

that involve researchers and 

practitioners from varied disciplines, 

and collaboration across university 

centers. Finally, ACE capacity requires 

communication and data systems that 

enable and facilitate work, and 

administrative capacity (e.g., financial 

resources). 

Relationships with Center Partners.

Each ACE is also expected to establish 

and maintain center partnerships with 

institutions such as state and local 

health, education, justice departments, 

other university partners, other ACEs, 

Injury Control Research Centers (ICRCs), 

Prevention Research Centers, national 

youth violence prevention 

organizations, and CDC. Partnerships 

are intended to strengthen the ACE’s 

surveillance, research, training, 

mentoring, community mobilizing and 

dissemination activities in its identified 

community. Partners can collaborate 

with the ACE in designing and 

conducting research and other ACE 

projects and in disseminating research 

findings, which are expected to help 

facilitate the translation of public health 

research and related activities to 

practice and policy.

Diagram Note: A dotted box around these 

three inputs indicates that the ACE, its 

community, and its external partners are the 

major stakeholders; they collaborate with 

each other to implement the ACE Program. 

The inputs for Community Committee, 

Infrastructure, and Relationships with 

Partners also have two-way arrows touching 

each other. A two-way arrow connects the 

combined boxes for these inputs with that for 

the next input. One-way arrows also connect 

the three boxes to the first two program 

activities.

Motivating Conditions for Developing 

and Maintaining Relationships. The 

conceptual framework also recognizes 

the conditions motivating the 

development and maintenance of 

relationships with community partners 

and others. These conditions may 

include trust and tangible or intangible 

benefits (such as access to expertise or 

acceptance by a community) and 

sharing of resources gained from the 

partnership. These conditions may 

influence a partner’s willingness to form 

a relationship with the ACE, the nature 

and strength of the relationship, and an 

ACE’s ability to sustain the relationship 

over time. 

Activities. The second and third 

columns of the conceptual framework 

capture the activities that include: 

developing a research agenda; 

developing a community mobilization 

plan; conducting surveillance, research, 

building capacity and implementing the 

community mobilization plan. (Multisectoral and multi-disciplinary 

collaboration and dissemination are 

inputs and outputs, respectively.) 

Research Agenda. An ACE is 

encouraged to engage stakeholders 

within its defined community in 

developing an overall research plan, 

identifying research priorities, selecting 

research projects, recruiting research 

participants, refining research methods, 

developing interventions, conducting 

research, and reporting and 

disseminating research findings. ACE 

Centers are charged with establishing a 

five-year research agenda with tied to 

one or more HHS objectives, Healthy 

People 2010, NCIPC Research Agenda, 

Guide to Community Prevention 

Services and local youth violence 

prevention research priorities. 

Community Mobilization Plan. ACEs 

are charged with the development and 

implementation of a five-year 

community mobilization or action plan 

(in collaboration with the Community 

Committee). Further, the development 

of a Community Mobilization Plan 

should be tied to the Research Agenda 

with an identified relationship to one or 

more youth violence prevention 

priorities.

Diagram Note: A two-way arrow connects 

the boxes for the development of the research 

agenda and the development of the 

community mobilization plan. One-way 

arrows connect the boxes for the mobilization 

plan and the research agenda to the next set 

of activities. A two-way arrow connects the 

research agenda and the mobilization plan as 

these processes should inform one another.

Conduct Core Activities:

• Surveillance. This core area 

includes the gathering, analysis and 

interpretation of surveillance data to 

enable the defined community with 

whom the ACE is working to better 

measure the problem of youth violence, 

and accurately reflect trends in the 

target community and the greater 

community. All Surveillance activities 

proposed should include an appropriate 

translation and dissemination plan. 

• Research. The research conducted 

should be informed by local priorities, 

the NCIPC Research Agenda, and 

contribute to new methods of study, 

understandings of, or ways to prevent 

youth interpersonal violence. In 

addition, ACEs may conduct research 

funded by other federal agencies and by 

state agencies, community-based 

67928 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

organizations, and foundations. All 

research is expected to be conducted 

using sound research methods that 

further the field of youth interpersonal 

prevention research. All research 

proposed under the ACE program 

should include an appropriate 

dissemination plan. 

• Build Capacity. ACEs are also 

charged with developing a five-year 

plan to train, provide technical 

assistance to, or mentor health 

professionals, researchers, practitioners, 

students, community members, and 

others. These activities, which are 

expected to be developed in 

collaboration with the recipients, may 

cover a range of topics, including youth 

violence prevention best practices, 

community building, research, and 

evaluation as well as other needs 

identified by ACE partners. ACEs may 

also train and provide technical 

assistance to community partners on 

implementing specific prevention and 

health promotion interventions, 

including effective practices. 

• Implement the Community 

Mobilization Plan. ACE’s are expected 

to form, nurture and advance 

partnerships with the community 

designed to implement evidence-based 

strategies or promising programs. 

Community implementation efforts can 

include convening stakeholders—

including the most affected—helping to 

organize across different sectors, 

fostering strategic alliances, and 

strengthening community bonds; 

assessing community resources; 

mapping community assets; and 

enabling a fuller understanding of and 

response to the nature and dynamics of 

local violence.

Diagram Note: Two-way arrows connect 

these four core activities to one another. Oneway arrows connect surveillance, research, 

capacity building, and community 

implementation to the three outputs 

(intervention implementation, 

communication and dissemination, and 

training and technical assistance).

Outputs. The fourth column captures 

outputs generated or produced as a 

result of program activities. Through the 

process of planning, carrying out public 

health-related youth violence 

prevention activities, and the promotion 

of collective action, it is expected that 

the professionals and community 

residents will gain increased skills and 

confidence (or a greater sense of 

‘‘efficacy’’) enhancing its capacity for 

prevention. Enhanced capacity includes 

an improved ability on the part of 

agencies and organizations to 

implement and make well-reasoned 

decisions about effective violence 

prevention programs and services. It 

also includes enhanced academic 

infrastructure in service-learning, 

student practicum opportunities. This 

capacity combines a community’s and a 

university’s commitment, resources, and 

skills to respond to public health needs 

and priorities. Another aspect of 

enhanced capacity is the development 

of skilled ‘‘violence preventers.’’ This 

term includes not only professionals—

both developing new skills for those 

entering the field as young researchers/

practitioners and improving existing 

skills of current violence prevention 

workers—but also providing skills to 

youth, parents, and volunteers. 

Community stakeholders who 

collaborate with the ACE’s in 

implementing research projects and 

who participate in ACE-sponsored 

training and technical assistance 

improve their skills as a result. The 

selected measurable products, or 

outputs, of these activities and 

processes are described below. 

Communication and Dissemination.

The communication and dissemination 

of research and evaluation findings are 

another type of output. These findings 

are typically published in peer-reviewed 

journals, books, and technical reports. 

They also may be presented to various 

audiences at professional conferences, 

community meetings, or other settings, 

and reported to the media. Findings 

from research conducted with a 

community should be shared with 

community partners and with other 

ACE’s. 

Intervention Implementation. Many 

ACEs develop, implement and test 

violence prevention strategies, programs 

and interventions in a community, 

encouraging the implementation of 

evidence-based strategies or promising 

programs. A program may rely on a 

curriculum, a manual, or a particular 

prevention strategy or health promotion 

tool, which is packaged and made 

available to interested organizations or 

individuals. 

Training, Technical Assistance. ACE’s 

training or technical assistance activities 

can include an assessment of the skills 

acquired, number of trainees and 

recipients of technical assistance, the 

number and duration of training or 

technical assistance events, and the 

satisfaction of participants with the 

training or technical assistance they 

received.

Diagram Note: Together, all the output 

boxes connect to a combined set of two 

outcome boxes through a one-way arrow. 

These two outcomes connect to each other by 

two-way arrows.

Outcomes. The last column of the 

conceptual framework shows the 

outcomes, or the intended effects of 

cumulative program activities over time. 

Improved Practice and Policy. One 

expected outcome of the ACE Centers’

activities is the uptake of interventions 

and improved youth interpersonal 

violence prevention practice and 

policies. Surveillance, research, 

capacity building, and community 

implementation activities conducted by 

the ACEs are expected to be translated 

into community practice or policies 

adopted by local and state health 

departments, schools, other public 

agencies (e.g., recreation departments, 

housing authorities), and communitybased organizations. Over time, these 

interventions and policies may be 

disseminated beyond an ACE’s defined 

community and receive widespread use. 

Reduction of Risk Factors/Increase in 

Protective Factors. Another expected 

outcome of the ACE Centers’ activities 

is the reduction of risk factors/increase 

of protective factors in the community, 

a result of the uptake of improved 

violence prevention practice and 

policies. 

Expanded Resources and Recognition.

An ACE may be able to expand its 

resources beyond the core funding, 

research faculty, and initial 

organizational and agency partnerships 

that were formed when it first received 

CDC funding. An ACE may also gain 

recognition within a community and the 

nation for expertise in a particular field 

or area of youth interpersonal violence 

prevention, and for its partnerships.

Diagram Note: One set of dotted lines 

surrounds the boxes for the two outcomes. A 

second set surrounds the two additional 

boxes below it (expanded resources and 

recognition). These groupings show the 

potential relationships with other 

components of the framework with which 

they are logically connected or which they 

are likely to influence or be influenced by. 

The outcomes flow back through motivating 

conditions and up the input column. They 

also connect to youth violence prevention 

agendas and down the input column. A oneway feedback arrow also extends from the 

outcomes back to the inputs of youth 

violence prevention priorities and motivating 

conditions for developing and maintaining 

relationships.

Contextual Conditions. The box 

across the bottom of the conceptual 

framework is for contextual conditions, 

which are socioeconomic, political, and 

cultural factors external to the ACE 

Program that may not be within its 

control but which may influence the 

implementation of activities and 

achievement of outcomes. Note that 

these conditions may relate to all 

components of the framework. 

Evaluation. Evaluation is a part of the 

ACE Program (noted at the top of the 

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 67929

framework) that extends across all the 

inputs, activities, outputs, and 

outcomes, except for the ultimate 

outcome. The arrow to each column 

signifies that the ACE Program will 

evaluate aspects of each component, 

guided by performance monitoring and 

evaluation questions. Many factors can 

contribute to the final outcome, and 

empirical data demonstrating a causal 

link between proposed program 

activities and improvements in 

community health are lacking. 

Therefore, the ACE Program will not 

evaluate the ACEs’ effect on violenceinduced death, disability and injury 

among adolescents, but will evaluate 

program effect on improved practice 

and policy, and reduction of risk 

factors/increase in protective factors. 

The ACE Program evaluation will 

collect data that may include 

information about how inputs are being 

used to shape the ACE Program, which 

activities are undertaken by the 

collective program, the quality of the 

activities, and the specific outcomes the 

program is accomplishing. CDC, ACEs, 

and other stakeholders can use 

evaluation findings for many purposes, 

including modifying program activities 

or enhancing and strengthening 

relationships with community partners. 

Evaluation findings also provide 

information that can be shared with 

external stakeholders, can help 

document the program’s value, and may 

provide justification for continuing or 

increasing program funding.

Appendix 2.—List of Indicators for the 

National Academic Center of 

Excellence on Youth Violence 

Prevention Program 

1. Evidence of ACE Community 

Committee participation in the 

determination of ACE violence 

prevention priorities. 

2. Level of ACE Community 

Committee members satisfaction with 

participation. 

3. Evidence of establishment of 

partnerships and maintenance of 

partnerships. 

4. Establishment of a Community 

Mobilization Plan. 

5. Establishment of a Research 

Agenda. 

6. Evidence of community 

improvements in the ability to monitor 

and describe youth violence. 

7. Extent to which the research 

portfolio is contributing to new methods 

of study, understandings of, or ways to 

prevent youth violence. 

8. Evidence that the ACE Center is 

mobilizing the community to implement 

evidence-based strategies or promising 

programs. 

9. Evidence of a communication and 

dissemination plan, developed with 

input from key partners. 

10. Evidence of producing and 

disseminating research findings through 

peer-reviewed publications, and 

educational or technical materials. 

11. Evidence of a plan for training 

researchers, practitioners and 

community members. 

12. Extent to which center activities 

and evidence-based strategies have been 

translated into the outcomes listed. 

13. Extent to which researchers, 

practitioners, and community members 

have been trained, mentored, or 

provided technical assistance in youth 

violence prevention. 

14. Evidence of new grants, contracts 

or other resources awarded to the ACE 

Center or its partners. 

Appendix 3.—Glossary of Terms 

Youth Interpersonal Violence 

Youth interpersonal violence is 

defined as: The intentional use of 

physical force or power, threatened or 

actual, exerted by or against children, 

adolescents or young adults, ages 10–24, 

which results in or has a high likelihood 

of resulting in injury, death, 

psychological harm, maldevelopment or 

deprivation. Youth interpersonal 

violence encompasses peer and 

community violence between 

individuals or groups who may or may 

not know each other. This form of 

violence frequently takes place outside 

the home, in the streets, or in 

institutional settings, such as schools, 

workplaces, and prisons. Youth 

violence also encompasses violence that 

occurs between youth and family 

members and other intimate relations. 

The nature of violence can be physical, 

sexual, and psychological. (Adapted 

from WHO Report on Violence and 

Health, 2002). [Adapted from WHO 

Report on Violence and Health. To 

access the Report go to: http://

www.who.int/

violence_injury_prevention/violence/

world_report/en/ ]. 

Community 

Community is defined as a group of 

people who share some or all of the 

following: geographic boundaries; a 

sense of membership; culture and 

language; common norms, interests, or 

values; and common health risks or 

conditions. [IOM 2002] [CDC/ATSDR 

Principles of Community 

Engagement].—It refers to a population 

that has a distinct identity. It can mean 

residents of a geographic area, such as 

a catchment area, neighborhood, school 

district, city, county or region within a 

county. It can be used with a modifier 

or clause to describe a nongeographically based sub-grouping such 

as, but not exclusively: A community of 

youth violence prevention workers, a 

community of health professionals, or 

an ethnic or language community. 

Community Mobilization 

Community mobilization is a process 

through which action is stimulated by a 

community itself or by others, that is 

planned, carried out, and evaluated by 

a community’s individuals, groups, and 

organizations on a participatory and 

sustained basis to reduce or prevent 

youth violence, and improves health. 

[Save the Children/Health 

Communication Partnership] 

Community Mobilization Plan (CMP) 

The plan is a general description of 

how you and your partners intend work 

with a particular community to mobilize 

around youth violence prevention. A 

mobilization plan defines the overall 

goals and objectives and identifies a 

process that will help interested 

communities achieve them, not to 

determine specific community actions 

or activities. The two overriding goals of 

community mobilization are to: 1. 

Enhance the community’s capacity to 

address the problem of youth violence; 

2. Prevent or reduce youth violence, 

thereby improving the health of the 

community. 

The goal of a community mobilization 

plan must be related to local youth 

violence prevention priorities. Where 

communities perceive a pressing youth 

violence prevention need, communities 

themselves may define the goal. 

Alternatively, ACEs and their 

stakeholders may identify a goal based 

on an analysis of community health 

indicators (e.g., frequency and severity 

of specific health problems and 

feasibility to address them). [Health 

Communication Partnership] 

Community Participation 

The active involvement of the 

members of a community in the 

planning, creation, operation, 

evaluation, dissemination and oversight 

of an initiative or project. 

Community Committee 

A group of individuals that represent 

groups and organizations within the 

Center’s designated community. The 

Community Committee participates in 

the Center’s organization, research, or 

other activities. Committee members 

typically represent an identified group 

or population and participate in the 

committee in order to provide the 

perspective and knowledge of a 

67930 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Notices 

designated population or group to the 

activities of the Center. 

CDC will require each ACE to form an 

ACE Community Committee. This group 

should comprise members of the ACE’s 

defined community and adult and youth 

representatives of agencies and 

organizations serving that community. 

The inputs provided by an ACE 

Community Committee to the ACE 

include guidance, advice on ACE 

agendas and plans, expertise, contacts, 

essential information about the 

designated community as well as 

intangible benefits. Some ACE’s may 

wish to form additional advisory 

groups, as needed, such as a policy 

board, a youth advisory board, or 

advisory committees for individual 

research projects. The decision to form 

these additional groups depends on the 

needs of the ACE and the community. 

Center Partnerships 

Each ACE is also expected to establish 

and maintain center partnerships with 

institutions such as state and local 

health, education justice departments, 

other university partners, other ACEs, 

Injury Control Research Centers (ICRCs), 

Prevention Research Centers, national 

youth violence prevention 

organizations, and CDC. Partnerships 

are intended to make the ACE’s 

surveillance, research, training and 

mentoring, community mobilizing and 

dissemination activities relevant to its 

identified community. Partners can 

collaborate with the ACE in designing 

and conducting research and other ACE 

projects and in disseminating research 

findings, which are expected to help 

facilitate the translation of public health 

research and related activities to 

practice and policy. 

Community-Based Participatory 

Research (CBPR) 

Scientific inquiry conducted in 

communities in which community 

members, persons affected by condition 

or issue under study and other key 

stakeholders in the community’s health 

have the opportunity to be full 

participants in each phase of the work 

(from conception—design—conduct—

analysis—interpretation—conclusions—

communication of results). 

Definition Developed by Inter Agency 

Working Group for CBPR, Convened by 

NIEHS, NIH, August 2, 2002 

According to the CARE–CDC Health 

Initiative, A Model for Global 

Participatory Research, in communitybased participatory research, the 

definition of scientific rigor is 

broadened to encompass community 

participation in decisionmaking at every 

phase of the research process: defining 

the problem, setting goals, selecting 

methods, interpreting data, and 

recommending policy. Essential to this 

philosophical construct is the assurance 

of quality decision making throughout 

the research process. In the document 

Building Community Partnerships in 

Research, participatory research is 

described as the gold standard toward 

which all federally funded research 

should aspire. (5)(p7). [Building 

Community Partnerships in Research: 

Recommendations and Strategies. 

Executive Summary. Washington, DC: 

U.S. Dept of Health and Human 

Services; April 7, 1998.]

[FR Doc. 04–25667 Filed 11–19–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0494]

Guidance for Industry on Changes to 

an Approved New Drug Application or 

Abbreviated New Drug Application; 

Specifications—Use of Enforcement 

Discretion for Compendial Changes

AGENCY: Food and Drug Administration.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Changes to an Approved NDA 

or ANDA; Specifications—Use of 

Enforcement Discretion for Compendial 

Changes.’’ This guidance informs new 

drug application (NDA) and abbreviated 

new drug application (ANDA) holders 

of FDA’s plan to use enforcement 

discretion with regard to the regulation 

on changes to an approved application. 

This regulation describes the filing 

requirement that a relaxation of 

acceptance criteria or deletion of a test 

to comply with an official compendium 

must be reported in a changes-beingeffected-in-30-days supplement (CBE–

30). FDA does not intend to take 

enforcement action if manufacturers 

continue to submit such changes in 

their annual reports. The use of 

enforcement discretion will give the 

agency time to clarify that some of these 

types of postapproval changes can be 

submitted in an annual report, rather 

than in a CBE–30. The agency intends 

to clarify this issue in an upcoming 

revision to a guidance for industry.

DATES: Submit written or electronic 

comments on agency guidances at any 

time.

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. 

Requests and comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

David J. Cummings, Center for Drug 

Evaluation and Research (HFD–357), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–443–5187.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of April 8, 

2004 (69 FR 18728), FDA published a 

final rule entitled ‘‘Supplements and 

Other Changes to an Approved 

Application.’’ In the same issue of the 

Federal Register (69 FR 18768), FDA 

announced the availability of the 

guidance for industry entitled ‘‘Changes 

to an Approved NDA or ANDA’’ (the 

changes guidance). Under 

§ 314.70(c)(2)(iii) (21 CFR 

314.70(c)(2)(iii)) of the final rule, the 

relaxation of an acceptance criterion or 

deletion of a test to comply with an 

official compendium that is consistent 

with FDA statutory and regulatory 

requirements must be submitted as a 

CBE–30 (see section VIII.C.1.e of the 

changes guidance).

FDA is issuing this guidance to 

explain that it is using enforcement 

discretion with regard to 

§ 314.70(c)(2)(iii) to address concerns 

raised by stakeholders. FDA plans to 

clarify that some of these types of 

changes can be submitted in an annual 

report, instead of a CBE–30 supplement, 

in a revision of the guidance for 

industry entitled ‘‘Changes to an 

Approved NDA or ANDA; Questions 

and Answers.’’

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collection of information in