[Federal Register Volume 69, Number 223 (Friday, November 19, 2004)]
[Notices]
[Pages 67738-67744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25672]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Community-Based Interventions for Alcohol-Impaired Driving

    Announcement Type: New.
    Funding Opportunity Number: CE05-024.
    Catalog of Federal Domestic Assistance Number: 93.136.
    Dates:

    Letter of Intent deadline: December 20, 2004.
    Application deadline: February 7, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized under section 301(a) [42 
U.S.C. 2410(a)] of the Public Health Service Act, and section 391(a) 
[42 U.S.C. 280 b(a)] of the Public Service Health Act, as amended.
    Background: Prevention of alcohol-impaired driving is among the 
most important strategies to reduce motor vehicle-related injuries and 
deaths. ``Healthy People 2010: Health Objectives for the Nation'' has 
set objectives of reducing alcohol-related motor vehicle fatalities to 
no more than 4.0 per 100,000 persons and reducing alcohol-related motor 
vehicle injuries to no more than 65 per 100,000 persons, from 1998 
baselines of 5.9 and 113, respectively. To meet these objectives, the 
nation must reduce alcohol-impaired driving, community by community.
    According to health promotion theory, a multifaceted approach to 
the prevention of alcohol-impaired driving is desirable due to the 
potential for different interventions to work synergistically. The 
implementation and evaluation of multifaceted community-based 
interventions that target alcohol-impaired driving is necessary to 
measure the effectiveness of such efforts and provide data to inform 
future efforts.
    Purpose: This research study is a cooperative agreement that seeks 
to evaluate interventions to decrease alcohol-impaired driving in 
community settings and the resulting deaths and injuries. This 
announcement is appropriate for organizations that are currently 
conducting research of multifaceted, community-based intervention that 
targets alcohol- and/or motor vehicle-related injuries.
    Funds will be provided to: (1) Evaluate the supplementary benefits 
from adding one or more strategies to reduce alcohol-impaired driving 
to an existing multifaceted community-based program to prevent alcohol- 
and/or motor vehicle-related injuries; or (2) evaluate the results of 
an existing, effective multifaceted community-based intervention to 
reduce alcohol-impaired driving when applied to another community with 
different demographic characteristics.
    This project addresses the ``Healthy People 2010'' focus areas of 
Injury and Violence Prevention and Adverse Consequences of Substance 
Use and Abuse.
    Measurable outcomes of the project will be in alignment with the 
following performance goals for the National Center for Injury 
Prevention and Control (NCIPC):
     Conduct a targeted program of research to reduce injury-
related death and disability.
    Outcomes should also be in alignment with the following research 
priorities in transportation safety from the National Center for Injury 
Prevention and Control (NCIPC) Research Agenda:
     Evaluate strategies to implement and disseminate known, 
effective interventions to reduce alcohol-impaired driving and test the 
effectiveness of new, innovative strategies.
     Develop methodologies for and evaluate the effectiveness 
of various means to translate transportation safety research findings 
into public policy. The grantees are expected to widely disseminate the 
outcomes through traditional mechanisms, such as professional and peer-
reviewed journal publications.

Research Objectives

     Nature of the research problem--
    Research is needed to measure the effectiveness of multifaceted 
community-based interventions in reducing alcohol-impaired driving.
     Scientific knowledge to be achieved through research 
supported by this program--
    This research will help develop a better understanding of the 
extent to which: (1) Specific components of multifaceted interventions 
contribute to their effectiveness in reducing alcohol-impaired driving, 
and (2) outcomes generalize across communities with different 
demographic characteristics.

Objectives of This Research Program

     To assess the effectiveness of either: (1) Adding one or 
more strategies to reduce alcohol-impaired driving to an existing 
multifaceted community-based intervention to reduce alcohol- and/or 
motor vehicle-related injuries; or (2) implementing an existing 
community-based intervention targeting alcohol-impaired driving that 
has evidence of effectiveness in the current community to a separate 
community that has different demographic characteristics.
     To obtain process-related information regarding barriers 
to implementation of such interventions and the means to overcome them. 
This process and outcome information will be used to inform future 
community-based programs to reduce alcohol-impaired driving.
    The goals of the announcement can be accomplished in either of two 
ways. First, an existing community-based intervention can be 
supplemented by adding strategies targeting alcohol-impaired driving. 
For example, sobriety checkpoints could be integrated into a 
multifaceted intervention targeting high-risk alcohol consumption and 
related injuries. Alternatively, an existing community-based 
intervention targeting alcohol-impaired driving that has evidence of 
effectiveness in the current community could be implemented in a 
separate community that has different demographic characteristics. For 
example, an intervention that is underway in an urban community could 
be expanded to a rural community.

Research and Experimental Approaches To Achieve the Objectives

    The preferred approaches to assessing the effectiveness of the 
interventions include quasi-experimental research designs using time 
series data, comparison communities, or both (as appropriate given pre-
existing evaluation plans). Baseline measures of variables related to 
alcohol-impaired driving should be collected before implementation of 
the intervention or addition of the new intervention strategy(s). 
Direct assessment of driver blood alcohol content levels in roadside 
surveys is the preferred outcome variable. However, other acceptable 
outcome variables would be self-reported alcohol-impaired driving from 
appropriately designed telephone surveys or crashes likely to be 
alcohol-related, such as single-vehicle nighttime crashes.
    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

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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:
    1. This study will require the existence of a core coalition (or 
coalitions) that would ideally include representatives from the 
following groups:
     Community leaders, groups, and organizations (e.g., policy 
makers, safety advocates, schools, youth organizations, local media, 
health care providers, and social service agencies)
     Public health departments
     Transportation and traffic safety agencies
     Governors' highway safety representatives
     Law enforcement
     Academic evaluation experts
    2. Applicants will be expected to: (1) Incorporate one or more 
additional strategies related to alcohol-impaired driving into an 
existing community-based intervention; or (2) expand an existing, 
effective multifaceted community-based intervention to prevent alcohol-
impaired driving to a community with different demographic 
characteristics.
    Examples of effective or innovative strategies that the applicant 
is encouraged to consider include:
     Sobriety checkpoints to reduce alcohol-impaired driving. 
Key components of the intervention: Officer training in appropriate 
practices; implement or increase the frequency of sobriety checkpoints 
(or roving patrols if checkpoints are not feasible); develop a strategy 
for publicizing checkpoints through earned media (e.g., news stories) 
and/or paid media.
     Server intervention training. Key components of the 
intervention: Face-to-face training regarding legal obligations and 
methods of preventing patron intoxication for servers and other staff; 
training and/or on-site consultation with managers on responsible 
practices.
     Community-wide designated driver promotion. A key 
component of the intervention: A substantial majority of drinking 
establishments in the community offer and promote incentives for 
designated drivers.
    Applicants who choose to incorporate additional strategies into an 
existing community-based intervention may select other promising or 
innovative interventions to prevent alcohol-impaired driving. 
Justification for the selected interventions should be provided in the 
application. Applicants who choose to expand an existing community-
based intervention to an additional community must provide some 
evidence of the effectiveness of the existing intervention and issues 
related to generalizability in the new community.
    Applicants will also be expected to collect outcome data on the 
effectiveness of interventions in reducing alcohol-impaired driving, 
such as changes in alcohol-related crashes, injuries, or deaths, and 
perform process evaluations from community-based activities designed to 
reduce alcohol-impaired driving.
    CDC Activities for This Program Are as Follows:
    1. Assist to provide up-to-date scientific information, technical 
assistance, and guidance in project matters, where and when requested.
    2. Provide technical assistance and guidance in analysis and 
dissemination of results, including assistance in the preparation of 
manuscripts, where and when requested.
    3. Assist in ensuring human subjects assurances and protections are 
in place as necessary.
    4. Monitor and evaluate the scientific and operational 
accomplishments of the project, as needed. This may be accomplished 
through periodic site visits, telephone calls, electronic 
communication, and bi-annual reports.
    5. Convene meetings with recipient for the exchange of information.
    6. Review and approve, if needed, IRB protocols initially, and 
assist in filing IRB continuation applications, at CDC, on at least an 
annual basis until the research study, including analysis, 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: E11.
    FY Funds: 2005.
    Approximate Total Funding: $350,000 (This amount is an estimate and 
is subject to availability of funds.)
    Approximate Number of Awards: One.
    Approximate Average Award: $350,000 (This amount is for the first 
12-month budget period and includes both direct and indirect costs. 
Approximately $1,050,000 total is available over the entire three years 
of the project period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $350,000 (This ceiling is for the first 12-
month budget period and includes both indirect and direct costs.) If 
the budget proposed exceeds this amount, it will not be eligible for 
review, and will be discarded.
    Anticipated Award Date: September 1, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Three 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:
     Federally recognized Indian tribal organizations
     State, local, and tribal public health departments
     Transportation and traffic safety agencies
     Research Institutions
     Colleges and Universities
     Private non-profit organizations
     For-profit organizations
    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 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.
    Eligible applicants will be limited to those currently conducting a 
multifaceted community-based intervention trial targeting alcohol-
impaired driving, other high-risk alcohol use, or motor vehicle-related 
injuries. Due to the time and expense involved in building community 
coalitions, implementing interventions, and planning evaluations, the 
available funds are not sufficient to adequately support a trial for 
which these steps have not already taken place.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

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III.3. Other

    If you request a funding amount greater than the ceiling of the 
award range, 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.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     In order to plan the application review more effectively 
and efficiently, CDC requires that you submit a Letter of Intent (LOI) 
to apply for this program. See ``IV.3. Submission Dates and Times'' for 
more information on deadlines.
     The applicant should provide evidence that the performing 
organization is conducting a multifaceted community-based intervention 
to prevent alcohol-and/or motor vehicle-related injuries that could 
feasibly be expanded according to the terms of this RFA. This expansion 
could be accomplished either by adding a new alcohol-impaired driving 
strategy to the intervention, or by implementing the intervention in an 
additional community.
     The applicant should provide evidence of effective and 
well-defined collaborative relationships within the performing 
organization and among the coalition members that will ensure 
implementation of the proposed activities. Documentation, such as 
letters of collaboration, describing the specific commitments and 
responsibilities that will be undertaken by the coalition members and 
community organizations must be included in an appendix.
     The applicant and its collaborative team should provide 
evidence of prior experience in implementing and evaluating community-
based interventions. This experience must be documented by including 
publications such as those from peer-reviewed journal articles or 
technical reports in the appendix of the application.
     The recipient should provide evidence of access to target 
populations and experience with accessing community leaders and 
community-level groups.
     The applicant must provide a written evaluation plan for 
the existing community-based intervention that details how the added 
intervention strategies or site will be incorporated. This plan should 
include: (1) A list of outcome measures and the data source for each 
measure, and (2) baseline measurement results for each outcome 
variable.
     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.
    Applications that do not meet the above requirements will be 
considered non-responsive.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed injury research as outlined above 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.
    Principal investigators 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 principal investigator will be funded under this 
announcement.

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)

    Your LOI must be written in the following format:
     Maximum number of pages: 2 pages
     Font size: 12-point unreduced
     Single-spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in plain language, avoid jargon
    Your LOI must contain the following information:
    [cir] Descriptive title of the proposed research
    [cir] Name, address, E-mail address, telephone number, and FAX 
number of the Principal Investigator
    [cir] Names of other key personnel
    [cir] Participating institutions
    [cir] Number and title of this Announcement
    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].
    Your research plan should address activities to be conducted over 
the entire project period.
    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 face 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.
    In addition to the instructions provided in the PHS 398 for writing 
the research plan on page 2 of the PHS 398 form, structure the research 
plan 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

[[Page 67741]]

prevention. The narrative portion of the application must not exceed 25 
double-spaced pages with unreduced 12-point font.
    The research plan (abstract) should answer the following questions:
     Does the research plan state the hypothesis?
     Does the research plan describe the objectives?
     Does the research plan state the importance of the 
research and how it is innovative?
     Does the research plan outline the methods that will use 
to accomplish the goals?
     Is the language of the research plan simple and easy to 
understand for a broad audience?
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    Letter of Intent (LOI): December 20, 2004.
    CDC requires that you submit a LOI if you intend to apply for this 
program. Although the LOI will not be evaluated, and does not enter 
into review of your subsequent application, failure to submit a timely 
LOI will preclude you from submitting an application.
    Application Deadline Date: February 7, 2005.
    Explanation of Deadlines: LOIs and applications must be received in 
the CDC procurement by 4 p.m. Eastern time on the deadline date. If you 
submit your LOI and 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 carriers 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 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

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for State and local governmental review of proposed Federal 
assistance applications. You should contact your State single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. 
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

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.
    Sufficient time and resources should be devoted to preparing an 
acceptable IRB package. Funds for human subjects recruitment and human 
subjects research will be withheld until appropriate IRB approval has 
been obtained.
     Reimbursement of pre-award costs is not allowed.
    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:

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--[CE05-024], 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

[[Page 67742]]

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? Will study advance scientific knowledge 
of how to implement and evaluate community-based interventions for 
preventing alcohol-impaired driving.
    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? To what extent do the 
applicant's work plan and timetable include:
     The identification of representatives to be named as 
members of the coalition, including a description of the areas of 
expertise covered by each; the specific roles and responsibilities of 
each in implementing this project; methods for making decisions; etc.
     Memorandum of agreement and understanding or letters of 
support from these collaborating organizations as an appendix, and the 
extent to which these letters indicate that the applicant and the other 
collaborating organizations have established a ``working partnership'' 
which specifies the active roles each will have in the study.
     Plans for collecting or obtaining and analyzing baseline 
(pre-intervention) and follow-up data for the measures of 
effectiveness.
     A description of the process used in selecting the 
intervention strategies to be implemented or sites to be added.
     A description of proposed methods for implementing and 
evaluating the additional intervention strategies or sites.
     Initial plans to rigorously evaluate the interventions, 
including appropriate measures of effectiveness. Measures should be 
objective and quantifiable and include measures of alcohol-impaired 
driving and/or alcohol-related crashes.
     Availability of adequate facilities and appropriately 
trained staff to carry out this activity.
     Acknowledgement of potential problem areas and plans to 
consider alternative tactics.
    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? If new, innovative strategies to reduce alcohol-impaired 
driving are tried, what is the rationale for selecting them and the 
likelihood they will succeed?
    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)? Does the principal investigator, co-investigator, or 
subcontractor have extensive experience in implementing community-based 
research and programs? Does the Principal Investigator have the 
authority to manage the project?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Does the proposed 
study take advantage of unique features of the scientific environment 
or employ useful collaborative arrangements? Is there evidence of 
institutional support? To what extent have the applicant and proposed 
collaborators documented:
     Their history and current capacity to provide a leadership 
function in convening and facilitating the work of the coalition.
     Their history and current capacity to provide a leadership 
function in the implementation and evaluation of the selected alcohol-
impaired driving prevention activity.
     Their history and current capacity to present findings at 
national conferences and prepare peer-reviewed manuscripts.
     Their organizational capacity to realize the objectives of 
the cooperative agreement.
     Their management operation, structure and/or organization. 
An organizational chart of the applicant's organization should be 
included as an appendix. Additionally, the applicant should include 
within their management plan the specific role and mechanisms to be 
established to ensure effective coordination, communication and shared 
decision making among the involved agencies/organizations.
     A staffing plan for the project, noting existing staff as 
well as additional staffing needs. The responsibilities of individual 
staff members including the level of effort and allocation of time for 
each project activity by staff position should be included.
     Resumes, biosketches, and/or position descriptions (i.e. 
for current staff, in-kind, and proposed positions to be funded under 
this cooperative agreement) should be included as an appendix. This 
should include the use of consultants, as appropriate.
     A continuation plan in the event that key staff leave the 
project, how new staff will be smoothly integrated into the project, 
and assurances that resources will be available when needed for this 
project.
     Previous experience of project staff to submit required 
reports on time.
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
     Has the investigator developed an adequate plan for 
disseminating the study results?
    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.
    Applicants should consider the need for IRB submissions early in 
the grant cycle to avoid delays and restrictions on funds.
    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

[[Page 67743]]

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.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) and for responsiveness by the National Center 
for Injury Prevention and Control. Incomplete applications and 
applications that are non-responsive to the eligibility criteria 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 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.
     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 which are complete and responsive may be subjected to 
a preliminary evaluation (streamline review) by an external peer review 
committee, the Special Emphasis Panel (SEP), to determine if the 
application is of sufficient and scientific merit to warrant further 
review by the SEP. 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. A dual review process will evaluate 
applications that are complete and responsive.
    All awards will be determined by the Director of the NCIPC based on 
priority scores assigned to applications by the primary review 
committee SEP, recommendations by the external 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 SEP. A 
committee of reviewers with appropriate expertise will review all 
applications for scientific merit using current National Institutes of 
Health (NIH) criteria (a scoring system of 100--500 points) to evaluate 
the methods and scientific quality of the application. All categories 
are of equal importance, however, the application does not need to be 
strong in all categories to be judged likely to have a major scientific 
impact.
    The secondary review will be conducted by the Science and Program 
Review Subcommittee (SPRS) of the Advisory Committee for Injury 
Prevention and Control (ACIPC). 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 would be the same as those considered by the SPRS.
    The Subcommittee'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 Subcommittee 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:
     The results of the primary review including the 
application's priority score as the primary factor in the selection 
process.
     The relevance and balance of proposed research relative to 
the NCIPC programs and priorities.
     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 NCIPC Injury ``Research Agenda.''
     Budgetary considerations including the extent to which the 
budget is reasonable, clearly justified, and consistent with the 
intended use of funds.
    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 of 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.

[[Page 67744]]

 AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research.
 AR-7 Executive Order 12372.
 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-22 Research Integrity.
 AR-23 States and Faith-Based Organizations.
 AR-24 Health Insurance Portability and Accountability Act 
Requirements (HIPAA).

    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 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. Budget.
    e. Measures of Effectiveness.
    f. Dissemination activities.
    g. 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: L.J. David Wallace, MS, 
Injury Prevention Specialist, National Center for Injury Prevention and 
Control, Centers for Disease Control and Prevention (CDC), 4770 Buford 
Highway, NE., Mailstop K-02, Atlanta, GA 30341; Telephone: 770/488-
4712, E-mail: [email protected].
    For questions about peer review, contact: Gwendolyn Cattledge, 
PhD., Scientific Review Administrator, Associate Director for 
Extramural Research, National Center for Injury Prevention and Control, 
Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, 
NE., Mailstop K-02; Atlanta, GA 30341; 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; Telephone: 770/488-
2736, 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: November 10, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-25672 Filed 11-18-04; 8:45 am]
BILLING CODE 4163-18-P