[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78419-78426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Youth Violence Prevention through Community-Level Change

    Announcement Type: New.
    Funding Opportunity Number: CE05-020.
    Catalog of Federal Domestic Assistance Number: 93.136.
    Key Dates:
    Letter of Intent Deadline: January 31, 2005.
    Application Deadline: March 30, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized under both section 391 (a) 
and 301 (a) of the Public Health Service Act, 42 U.S.C. section 280b 
(a).

    Background: Youth violence has been linked to a variety of factors, 
including individual, family, community, and societal characteristics. 
While much research has been conducted on

[[Page 78420]]

interventions with individuals and families, fewer interventions have 
focused on variables at the broader community level.
    Purpose: The purpose of the program is to announce the availability 
of fiscal year (FY) 2005 funds for a cooperative agreement to assess 
the efficacy or effectiveness of interventions designed to change 
community characteristics and social processes to reduce rates of youth 
violence perpetration and victimization. This program addresses the 
``Healthy People 2010'' focus area(s) of Injury and Violence 
Prevention.
    Measurable outcomes of the program will be in alignment with the 
following performance goal(s) for the National Center for Injury 
Prevention and Control (NCIPC): 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 on one 
conference call. The call for eligible applicants will be held on 
(January 20, 2005) from 2:30 p.m. to 4 p.m. (Eastern Time). The 
conference can be accessed by calling 888-528-9061 and entering access 
code 21415.
    The purpose of the conference call is to help potential applicants:
    1. Understand the Request for Application Process for the RFA 
 CE05-020 Youth Violence through Community-Level Change.
    2. Understand the scope and intent of the RFA  CE05-020 
Youth Violence Prevention through Community-Level Change.
    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.
    Research Objectives: There are a number of characteristics of 
communities that increase the probability of youth violence. Crime and 
violence tend to be high in areas in which at least 20 percent of the 
residents are poor (Lamison-White, 1996). These areas are often 
characterized by high concentrations of poverty and unemployment, high 
levels of residential instability, family disruption, crowded housing, 
drug-distribution networks, and low community participation (Sampson & 
Lauritsen, 1994). These areas also tend to have high rates of school 
dropouts, high rates of substance abuse and teenage pregnancy, and a 
disproportionate number of households headed by women (Eller, 1996; 
Proctor & Dalaker, 2002; Reiss & Roth, 1993).
    In addition to their demographic characteristics, economically poor 
neighborhoods differ from more affluent neighborhoods in a number of 
ways. Poor neighborhoods tend to be characterized by disorganization or 
a lack of neighborhood cohesion, and as a result, frequently lack 
effective social controls (Elliot et al., 1996; Sampson, Raudenbush & 
Earls, 1997). Factors such as high levels of transiency make it 
difficult for individuals to establish common values and norms, and to 
develop informal support networks. As a result, people living in such 
neighborhoods often experience a sense of social isolation and exhibit 
lower levels of attachment to the community. High levels of social 
disorganization also limit the ability of community residents to 
supervise and control adolescent peer groups, especially gangs (Sampson 
& Lauritsen, 1994).
    Research funded under this announcement is expected to further our 
understanding of how community-level interventions can reduce violence. 
A clear distinction is made here between community-based interventions, 
which are programs that are implemented in the community and/or by a 
community-based organization, from community-level interventions, which 
target community-level factors such as those described above (e.g., 
poverty, social cohesion, residential instability, neighborhood 
disorganization, etc.). Recipients are expected to implement and 
conduct an evaluation of an intervention that targets modifiable 
community-level variables that have been shown to increase the risk of 
youth violence and/or enhance the protective factors that decrease the 
risk of youth violence.
    Priority will be given to the evaluation of primary prevention 
interventions and programs that focus on the social and economic 
environment (relationships among people and settings) and/or the 
physical environment, over those that focus on criminal justice 
responses (e.g., community policing, arrest strategies). These include:
     Strategies to increase social integration and cohesion by 
increasing community participation as well as formal and informal 
social support.
     Strategies to improve the physical and social 
characteristics of neighborhoods (e.g., through environmental design 
changes).
     Strategies to improve financial, housing, and/or 
employment issues in impoverished areas.
     Efforts to deconcentrate areas with high rates of poverty 
and violence.
     Strategies to increase formal and/or informal supervision 
of youth (e.g., access to after school programs).
     Strategies to reduce community density and availability of 
alcohol and drugs.
     Strategies to improve family stability by changing 
community characteristics (e.g., increasing the presence of or access 
to family support services; increasing neighborhood or civic support to 
facilitate family cohesion).
     Strategies focusing on increasing communities' investment 
in schools and commitment to education (e.g., school-community 
partnerships; policies or incentives to increase school attendance and 
graduation rates).
    The proposed research is expected to detail one or more specific 
interventions for community-level variables, rather than propose a 
process for determining which interventions are appropriate for the 
chosen community. This program is intended to assess the effects of a 
community-level intervention alone, not as part of a larger multi-level 
intervention trial (a multi-level intervention trial is defined here as 
one that addresses the effects of community-level factors separately, 
and in combination with one or more components that address individual-
level or family-level factors).
    Research funded under this announcement is expected to adhere to 
high scientific standards, and to incorporate the following elements:
     Interventions and measures appropriate to the 
developmental level(s) and cultural/ethnic backgrounds of the 
population of interest.
     Interventions that are theoretically justified (i.e., 
include a conceptual model or theory of change, with proposed mediators 
and moderators, for how the intervention will produce the intended 
reductions in youth violence), and supported with epidemiologic, 
methodologic, and behavioral research.
     Stringent and rigorous evaluation designs, namely 
experimental and quasi-experimental designs with appropriate baseline/
pre-intervention data, post-intervention data, and at least one follow-
up data collection point; data from at least one comparison or control 
community; and data collected from multiple sources.
     Robust evaluation designs that collect and analyze process 
data (e.g., intervention fidelity and program exposure) and outcome 
data associated with the intervention using measures with documented 
validity and/or reliability. Outcomes and impacts

[[Page 78421]]

appropriate for this program include those that are measured at the 
neighborhood or community level and that focus on risk and protective 
factors specific to that level of intervention. Examples include: 
police records of neighborhood or community arrests for violent crimes, 
violent school incidents (aggregated to the school or system level), 
violent injury-related hospital or emergency department data aggregated 
by neighborhood or community, or intake rates for juvenile detention 
facilities.
     Evaluation designs that make use of multiple sources of 
data (where possible) to improve validity and reliability on each 
outcome selected.
     Evaluation designs that collect information on 
intervention processes, outcomes, mediators that lead to change in 
those outcomes and data that document the economic costs of the 
intervention from the societal and programmatic perspectives (e.g., 
cost to train implementers, implementation costs, and costs borne by 
participants). Measures are expected to have documented validity and 
reliability whenever possible. Outcomes are expected to be assessed at 
the appropriate level of intervention.
     Data analytic plans that are appropriate to the 
intervention, research design and hypotheses, data collection measures, 
and project period, and that anticipate and evaluate the effects of 
threats to the internal and external validity of the specified research 
design.
    Rigorous evaluations are needed to determine the effectiveness of 
interventions, programs, and policies addressing the prevention of 
violence. Experimental designs are strongly encouraged. However, NCIPC 
will consider other evaluation designs, if justified, as required by 
the needs and constraints in a particular setting.
    For effective interventions, it is possible to do cost-
effectiveness studies. To be comparable to other cost effectiveness 
studies, they should follow the guidelines in the following references:
    Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in 
Health and Medicine. New York: Oxford University Press, 1996.
    Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide 
to Decision Analysis and Economic Evaluation. Second Edition. New York: 
Oxford University Press, 2003.
    Activities: Awardee activities for this program are as follows:
     Establish goals and objectives that are realistic, 
measurable, and time-oriented for all phases of the project.
     Develop a research protocol for Institutional Review Board 
(IRB) for review and approval by all cooperating institutions 
participating in the research project.
     Design and develop intervention components, data 
collection instruments, implementation and evaluation protocols, and 
data management procedures.
     Pilot test research instruments for data collection.
     Collect and compile process and outcome data. Develop a 
protocol/manual documenting the intervention and the manner in which it 
was implemented, including any information on activities occurring 
prior to the start of the intervention, such as stakeholder meetings, 
collaborative building, or focus groups.
     Collect data on the economic costs of program 
implementation for use in economic evaluations.
     Prepare data for analysis and publication.
     Analyze data and disseminate findings through peer-
reviewed journals and presentations.
     Conduct one reverse site visit to meet with CDC staff in 
Atlanta on an annual basis.
     Complete all required reports as specified under Section 
VI.3 Reporting.
    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 and programmatic consultation. CDC will 
collaborate with project staff on decision-analyses, programmatic 
issues, and dissemination of the study results in publications and 
presentations.
     Assist in the development of a research protocol for IRB 
review by all cooperating institutions participating in the research 
project. The CDC IRB will review and approve the protocol initially and 
on at least an annual basis until the research project is finished.
     CDC staff will monitor and review scientific and 
operational accomplishments of the project through conference calls, 
site visits, and review of technical reports.

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: $1,200,000 (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: Two.
    Approximate Average Award: $600,000 (This amount is for the first 
twelve month budget period and includes both direct and indirect costs. 
Approximately $4,800,000 total is available over the entire four years 
of the project period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $600,000 (This ceiling is for the first 
twelve month budget period and includes both indirect and direct 
costs.)
    Anticipated Award Date: September 1, 2005.
    Budget Period Length: Twelve months.
    Project Period Length: Four years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for profit organizations and by governments and their agencies, such 
as:
     Public nonprofit organizations.
     Private nonprofit organizations.
     For profit organizations.
     Small, minority, women-owned businesses.
     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     Faith-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribes.
     Indian tribal organizations.
     State and local governments or their Bona Fide Agents 
(this includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna 
Islands, American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau).
     Political subdivisions of States (in consultation with 
States).
    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local

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government, you must provide a letter from the state or local 
government 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.

III.3. Other

    If you request a funding amount greater than the ceiling of the 
award range, which includes both direct and indirect costs, your 
application 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 non-
responsive 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.
     Demonstrated experience on the applicant's project team in 
conducting, evaluating, and publishing violence prevention research in 
peer-reviewed journals.
     Effective and well-defined working relationships within 
the performing organization and with outside entities expected to 
participate in the proposed research that will ensure implementation of 
the proposed activities, as evidenced by letters of support from the 
performing organization and outside entities.
     The overall match between the applicant's proposed 
research and the program priorities as described under the heading, 
``Research Objectives''.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     Principal Investigators (PIs) are encouraged to submit 
only one proposal in response to this program announcement. With few 
exceptions (e.g., research issues needing immediate public health 
attention) only one application per PI will be funded under this 
announcement.
     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 documented prior training 
and experience in conducting efficacy and effectiveness trials as 
evidenced by peer-reviewed publications of such studies, or current or 
previous research grants for efficacy or effectiveness trials.
     A principal investigator who has conducted violence 
prevention research, published the findings in peer-review journals, 
and has the specific authority and responsibility to carry out the 
proposed research.
    Any individual with the skills, knowledge, and resources necessary 
to carry out the proposed injury research is 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.

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 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): 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, your LOI will be used to gauge the level of interest in 
this program, and to allow CDC to plan the application review. Your LOI 
must be written in the following format:
     Maximum number of pages: Two.
     Font size: Twelve point unreduced.
     Paper size: Eight and a half by eleven inches.
     Page margin size: One inch.
     Single-spaced.
     Printed only on one side of page.
     Written in English, avoid jargon.
    Your LOI must contain the following information:
     Descriptive title of the proposed research.
     Name, address, E-mail address, and telephone number of the 
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement (PA).
     A brief description of the proposed intervention and 
evaluation plan.
    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: 
[email protected].
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal Government. Your DUNS number must be entered 
on line 11 of the facing page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely identifies 
business entities. Obtaining a DUNS number is easy and there is no 
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com 
or call 1-866-705-5711.
    For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    This announcement uses the non-modular budgeting format. Provide a 
detailed budget for each activity undertaken, with accompanying 
justification of all operating expenses that is consistent with the 
stated objectives and planned activities of the project.
    In addition to the instructions provided in the PHS 398 for writing 
the Description on page 2 of the PHS 398 form, structure the 
Description using the following components: (1) Statement of the 
problem, (2) purpose of the proposed research, (3) methods, including 
study population, data sources and any statistical analyses to be 
performed, and (4) implications for prevention.
    The Description (abstract) should answer the following questions:
     Does the Description state the hypothesis?
     Does the Description describe the objectives and specific 
aims?

[[Page 78423]]

     Does the Description state the importance of the research 
and how it is innovative?
     Does the Description outline the methods that will use to 
accomplish the goals?
    Is the language of the Description simple and easy to understand 
for a broad audience?
    You must include a research plan with your application. Your 
research plan should address activities to be conducted over the entire 
project period. Please follow the content requirements below in 
developing your research plan instead of those listed for the Research 
Plan in the PHS 398.
    The research plan should consist of the following information:
    1. Purpose of the Proposed Research: Describe the goals and 
objectives the proposal is designed to achieve in the short and long 
term. Specific research questions, hypotheses, and implications for 
prevention should also be included.
    2. Program Participants: Describe the demographic and geographic 
characteristics of the community and/or neighborhood targeted by the 
intervention. This section should include incidence, prevalence, 
morbidity, and/or mortality rates associated with youth violence within 
that community. In addition, the proposal should provide evidence that 
the recipient (or collaborating partner) has access to the target 
community, and that the participation by the target community in the 
intervention will be adequate to produce the intended outcomes.
    3. Intervention: Describe the proposed strategies or components of 
the intervention and the plan for implementing the intervention. 
Proposals should explicate the theoretical and empirical justification 
for the potential effectiveness of the intervention for reducing youth 
violence in the target community. This should include discussion of the 
modifiable risk and protective factors that will be influenced by the 
intervention of interest. The proposal should describe the location or 
setting in which the intervention component(s) will occur, and describe 
the relevance of this setting to the strategy and desired outcomes. The 
proposal should also describe how intervention fidelity will be 
monitored and measured.
    4. Methods: Describe the proposed evaluation design, data sources, 
methods and analysis plan for assessing the efficacy or effectiveness 
and/or for conducting an economic evaluation. The specific type of 
evaluation method chosen should reflect the nature of the intervention, 
feasibility, and ethical considerations. Potential threats to the 
validity of the study should be described along with how such threats 
will be recognized and addressed. The status of all necessary 
measurement instruments should be described. If any materials are not 
extant, the methods and time frame for measure development, pilot 
testing, and validation should be given. For data collected from 
archival records (e.g., hospital records, police records, etc.) the 
proposal should discuss issues of accessibility, reliability, and 
validity of those data.
    5. Project Management: Provide evidence of the expertise, capacity, 
and community support necessary to successfully implement and evaluate 
the intervention to reduce community indicators of youth violence. 
Existing and proposed positions for the project should be described by 
job title, function, general duties, level of effort and allocation of 
time. Management operation principles, structure, and organization 
should also be noted.
    6. Collaborative Efforts: List and describe any current or proposed 
collaboration with government, health, community-or faith-based 
organizations, minority organizations, and/or other researchers and 
academic institutions. Include letters of support and memoranda of 
understanding that specify the nature of past, present, and proposed 
collaborations, and the products/services/activities that will be 
provided by and to the applicant.
    The research plan should be no more than 25 pages (eight and a half 
by eleven inches in size), single-spaced, printed on one side only, 
with one-inch margins on all sides, and unreduced 12-point font.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.'' For additional help 
in preparing your application, please see the ``frequently asked 
questions'' section on the NCIPC Web page at: http://www.cdc.gov/ncipc/res-opps/2004pas.htm.

IV.3. Submission Dates and Times

    LOI Deadline Date: January 31, 2005. 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: March 30, 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 submit your application by the United States Postal 
Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery by the closing date and 
time. If CDC receives your submission 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 carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the submission as having 
been received by the deadline.
    This announcement is the definitive guide on LOI and application 
content, submission address, and deadline. It supersedes information 
provided in the 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 submission. If you have a 
question about the receipt of your LOI or application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: 770-488-2700. Before calling, please wait two to three days after 
the submission deadline. This will allow time for submissions 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 IRB 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 should 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:

[[Page 78424]]

    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: [email protected].
    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management--CE05-020, 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 various identified 
objectives of 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 must 
be submitted with the application and will 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 each of the 
following criteria equally in assigning the application's overall 
score, weighting them as appropriate for each application. The 
application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score. For example, an investigator may propose to carry out important 
work that by its nature is not innovative, but is essential to move a 
field forward.
    The review criteria are as follows:
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? Is the selection of a research 
design justified, and is the research design appropriate to answer the 
research question?
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Does the proposed 
research take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? If collaborations are being 
proposed, are the partners and their skills and expertise well 
described? Can proposed collaborations reasonably be expected to 
improve the quality of the implementation and evaluation of the 
intervention?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Intervention: Is the potential effectiveness of the proposed 
intervention within the target community theoretically justified and 
supported with epidemiologic, methodological, and behavioral research? 
How feasible is the implementation of the intervention as proposed? Can 
the intervention reasonably be predicted to produce the expected 
reductions in youth violence? Is the setting of implementation 
appropriate?
    Protection of Human Subjects From Research Risks: Does the 
application 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 and Minorities in Research: Does the application 
adequately address the CDC Policy requirements regarding the inclusion 
of women, ethnic, and racial groups in the proposed research? 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.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. The budget is 
not scored during the primary review.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO), and for responsiveness by the NCIPC. 
Incomplete applications and applications that are non-responsive to the 
eligibility criteria will not advance

[[Page 78425]]

through the review process. Applicants will be notified that their 
application did not meet submission requirements. Applicants will be 
notified 45 days prior to the award date regarding their application 
status.
    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 NCIPC 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.
     Applications deemed to have the highest scientific merit 
will receive a second programmatic level review by the Science and 
Program Review Subcommittee (SPRS) of the Advisory Committee for Injury 
Prevention and Control (ACIPC).
    Applications that are complete and responsive may be subjected to a 
preliminary evaluation (streamline review) by an external peer review 
committee, the NCIPC 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 
will 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 an external peer review conducted by the 
IRG. All applications will be reviewed for scientific merit using 
current NIH criteria (a scoring system of 100-500 points) to evaluate 
the methods and scientific quality of the application.
    The secondary review will be conducted by the Science and Program 
Review Subcommittee (SPRS) of the ACIPC. The external 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 Directors 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 will 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 better ranked 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:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.
     Geographic diversity.
     Racial/ethnic diversity.
     Balance of intervention approaches and strategies.
     Consistency with research priorities in CDC's Injury 
Research Agenda.
     Availability of funds within categories of violence and 
injury funding streams.

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 Award (NOA) from the 
CDC Procurement and Grants Office. The NOA shall be the only binding, 
authorizing document between the recipient and CDC. The NOA 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-table-search.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-8 Public Health System Reporting Requirements.
     AR-9 Paperwork Reduction Act Requirements.
     AR-10 Smoke-Free Workplace Requirements.
     AR-11 Healthy People 2010.
     AR-12 Lobbying Restrictions.
     AR-13 Prohibition on Use of CDC Funds for Certain Gun 
Control Activities.
     AR-14 Accounting System Requirements.
     AR-15 Proof of Non-Profit Status.
     AR-21 Small, Minority, and Women-Owned Business.
     AR-22 Research Integrity.
     AR-23 States and Faith-Based Organizations.
     AR-24 Health Insurance Portability and Accountability Act 
Requirements.
     AR-25 Release and Sharing of Data.
    Starting with the December 1, 2004 receipt date, all ``Requests for

[[Page 78426]]

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 CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC Web site) 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 and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement.
    For general questions, contact:
    Technical Information Management Section, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2700.
    For scientific/research issues, contact: Charlene Baker, PhD, 
Centers for Disease Control and Prevention, 4770 Buford Highway, NE, MS 
K-60, Atlanta, GA 30341, Telephone: 770-488-1737, E-mail: [email protected].
    For questions about peer review, contact: Gwendolyn Cattledge, PhD, 
Scientific Review Administrator, National Center for Injury Prevention 
and Control, Centers for Disease Control and Prevention (CDC), 4770 
Buford Highway, NE., Mailstop K-02, Telephone: 770-488-1430, E-mail: 
[email protected].
    For financial, grants management, or budget assistance, contact: 
James Masone, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, E-mail: 
[email protected].

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.''

    Dated: December 23, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-28619 Filed 12-29-04; 8:45 am]
BILLING CODE 4163-18-P