[Federal Register Volume 69, Number 213 (Thursday, November 4, 2004)]
[Notices]
[Pages 64293-64300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Grants for New Investigator Training Awards for Unintentional 
Injury, Violence Related Injury, Injury Biomechanics, and Acute Injury 
Care Research

    Announcement Type: New.
    Funding Opportunity Number: CE05-021.
    Catalog of Federal Domestic Assistance Number: 93.136.
    Key Dates:
    Letter of Intent (LOI) Deadline: December 6, 2004.
    Application Deadline: February 2, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized under section 301 (a) [42 
U.S.C. 241(a)] of the Public Health Service Act, and section 
391(a)[42 U.S.C. 280b(a)] of the Public Service Health Act, as 
amended.

    Purpose: The Centers for Disease Control and Prevention (CDC) 
announces the availability of fiscal year (FY) 2005 funds for grants 
for new investigator training awards in four research areas: 
unintentional injury prevention, violence-related injury prevention, 
injury-related acute care/mass trauma research, and injury-related 
biomechanics research. This program addresses the ``Healthy People 
2010'' focus areas of Injury and Violence Prevention.
    The purposes of this program are to:
    <bullet> Solicit research applications that address the priorities 
reflected under the heading, ``Research Objectives''.
    <bullet> Encourage professionals from a wide spectrum of 
disciplines to conduct research aimed at preventing and controlling 
injuries more effectively.
    <bullet> Support injury research by new investigators who are 
doctoral-level graduates and who have not previously received injury-
related CDC R49 or their equivalent grants.
    <bullet> Build the scientific base for the prevention and control 
of unintentional- and violence-related injuries, disabilities, and 
deaths.

[[Page 64294]]

    <bullet> Encourage qualified applicants who are beginning to focus 
on injury-related research.
    The career development objectives of this program are to encourage 
scientists to develop independent research skills and to gain 
experience in advanced methods and experimental approaches in injury-
related research. This program is also intended to jump start the 
careers of researchers in injury prevention and control by providing 
support for pilot studies, enhancements to existing studies, or other 
studies that will serve as a foundation for a career in injury 
prevention and control. Applicants are required to have a mentor with 
extensive injury research experience who will assist the applicant with 
scientific and career-related issues during the period of the award.
    This program addresses the ``Healthy People 2010'' focus area of 
Injury and Violence Prevention.
    Measurable outcomes of the program will be in alignment with one 
(or more) of the following performance goal(s) for the National Center 
for Injury Prevention and Control (NCIPC):
    <bullet> Increase the capacity of injury prevention and control 
programs to address the prevention of injuries and violence.
    <bullet> Monitor and detect fatal and non-fatal injuries.
    <bullet> Conduct a targeted program of research to reduce injury-
related death and disability.

Background and Significance

Unintentional Injury Research
    For the purposes of this program announcement, unintentional 
injuries are defined as unintentional damage to the body resulting from 
acute exposure to thermal, mechanical, electrical, or chemical energy 
or from the absence of such essentials as heat or oxygen.
    Unintentional injuries continue to be a major public health 
problem. In 2000, 97,900 people died in the United States as a result 
of unintentional injuries. Someone dies every six minutes in the U.S. 
from causes such as motor vehicle crashes, falls, poisoning, drowning, 
fires and burns, pedestrians struck by vehicles, bicycle crashes, or 
choking and suffocation. In addition to deaths, injuries also 
constitute a significant cause of both permanent and temporary 
disability. In 2000, unintentional injuries resulted in an estimated 
29.1 million emergency department visits and millions more seek 
treatment for injuries from health care professionals. In addition to 
the emotional costs of injuries, the financial costs of unintentional 
injuries are staggering: well over $200 billion a year in medical care, 
wage and productivity losses and employer costs alone. Unintentional 
injuries are not accidents, they are predictable and they are 
preventable.
Violence Related Injury Research
    Deaths and injuries associated with interpersonal violence and 
suicidal behavior are also a major public health problem in the United 
States and around the world. In 2000, over 46,000 people died from 
homicide and suicide in the United States. Among 15 to 24 year olds, 
homicide and suicide ranked as the second and third leading causes of 
death. Violent deaths are the most visible consequence of violent 
behavior in our society. Morbidity associated with physical and 
emotional injuries and disabilities resulting from violence, however, 
also constitute an enormous public health problem. For every homicide 
that occurs each year there are over 100 nonfatal injuries resulting 
from interpersonal violence. For every completed suicide it is 
estimated that there are 20 to 25 suicide attempts. The mortality and 
morbidity resulting from violence are associated with a variety of 
types of violence including child maltreatment, youth violence, 
intimate partner violence, sexual violence, elder abuse, and self-
directed violence or suicidal behavior.
Biomechanics Research
    The field of biomechanics quantifies the response and tolerance of 
the human body to impact (e.g., motor vehicle collisions, playground 
falls, and child battering) and addresses the underlying mechanisms of 
injury, the forces deforming the body and the physiologic effects of 
injury to infants, children, adults and the aged population. Based on 
interdisciplinary research, the engineering factors are determined that 
deform the body and the medical consequences are quantified that affect 
vital functions. This knowledge is used to modify the design of 
protective systems to improve safety. Improved safety systems protect 
an individual from impact forces that can injure, and they can include 
protective equipment (cycling helmets) and environments (playground 
surfaces), occupant restraints (airbags and safety belts), and policies 
(rules to minimize spearing in football). Biomechanical knowledge can 
also be used to improve post-injury outcomes through physiologic models 
to address emergency medical treatments, pharmacologic interventions 
and rehabilitation to advance recovery.
    NCIPC's biomechanics program attempts to build on the basic 
knowledge of biomechanics and encourage interdisciplinary intervention-
oriented injury control research as supported in the CDC Injury 
Research Agenda.
Acute Injury Care Research
    Each year, Americans make between 30 and 40 million emergency 
department (ED) visits for injuries. While most injured patients are 
treated and released, many are admitted to inpatient trauma units and 
later receive rehabilitative services. The most favorable outcomes are 
achieved when acute care and subsequent rehabilitation are offered as 
early as possible and focus on returning patients to baseline or to an 
optimal level of functioning. Trauma systems are designed to match 
trauma patients with the acute care and rehabilitative facilities they 
need, but in many parts of the U.S. trauma systems are not fully 
operational or are nonexistent. Where these systems are lacking, as 
many as 30 percent to 40 percent of deaths among trauma patients are 
due to preventable problems in clinical care, including missed 
diagnoses and treatment delays.
    Injuries are a major cause of disabilities in the U.S. Central 
nervous system injuries (those to the brain and spinal cord) are most 
likely to result in serious long-term disability. Each year, an 
estimated 80,000 Americans sustain a traumatic brain injury (TBI) that 
results in disability; an estimated 5.3 million Americans live with 
TBI-related disability. Although physical impairments from the injury 
may contribute to TBI disability, cognitive deficits are the hallmark, 
frequently resulting in secondary conditions such as depression and 
other adverse outcomes such as the inability to work. An estimated 
177,000 to 200,000 people in the U.S. live with spinal cord injuries 
(SCI), and this number increases annually by as many as 20,000 
individuals.

Research Objectives

    Applicants are encouraged to propose studies that can feasibly be 
completed within the available funds and funding period. Proposed 
research for this program announcement must address one of the 
following research priorities. Applications that fail to address one of 
these topics will be deemed nonresponsive.
Unintentional Injury
    1. Develop a theory-based intervention for use of supervision of 
children to reduce unintentional injury outcomes.
    2. Evaluate existing and develop new methods to obtain exposure and 
injury

[[Page 64295]]

incidence data for sports, exercise and recreation-related injuries.
    3. Identify risk and protective factors related to injury from 
childhood falls, crashes involving young drivers or related to motor 
vehicle and pedestrian travel of older adults.
    4. Evaluate the effectiveness of environmental, behavioral, 
legislative or regulatory interventions to prevent pedestrian injuries 
or injuries related to sports, exercise, and recreation (including 
drowning).
    5. Assess how tailoring, training, packaging, feasibility (and 
other dimensions of an effective intervention or policy) would promote 
greater adoption, usability and uptake, especially for interventions 
that impact older adult falls injury, transportation safety, and sports 
& recreation injury prevention (including drowning).
    6. Evaluate theory-based strategies to increase dissemination of 
effective interventions that reduce injuries related to transportation, 
at home, or during recreation.
    For more information on the unintentional injury research 
objectives, see Attachment 2 of this announcement. The attachment is 
posted along with this announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm.
Violence Related Injury
    1. Conduct studies to build knowledge on methods, structures, and 
processes to implement evidence-based interventions, programs and 
policies to prevent intimate partner violence, child maltreatment and 
youth violence. This research is intended to bridge the gap between 
prevention research and everyday practice by building a knowledge base 
about how evidence-based violence prevention information and strategies 
are disseminated, translated and integrated for use by communities and 
policymakers.
    2. Evaluate the efficacy, effectiveness, and cost effectiveness of 
primary prevention interventions, programs, and policies to prevent 
perpetration of intimate partner violence, sexual violence, child 
maltreatment (includes physical, sexual, emotional abuse and neglect), 
youth violence or suicidal behavior. There is particular interest in 
assessing the impact of interventions, programs, or policies that may 
affect multiple forms of violence simultaneously.
    3. Identify protective factors across at least two levels of 
influence (e.g., individual, family, peers, school/workplace, 
neighborhood, community) that reduce risk for the perpetration of 
intimate partner violence, sexual violence, child maltreatment, youth 
violence or suicidal behavior among populations at elevated risk for 
engaging in such behaviors.
Injury Biomechanics
    1. Use biomechanics research and the knowledge of injury tolerance 
and injury mechanisms to develop and/or evaluate interventions that 
address the following specific injury prevention and control problems. 
An intervention can be broadly defined as a specific action, policy, 
device or strategy designed to address injury prevention and control:
    a. Falls that occur among older, community dwelling adults (e.g., 
hip pads).
    b. Injuries in mass trauma events.
    c. Severe and disabling falls among children.
    d. Sports, recreation, and exercise-related injuries (e.g., 
playground and other play environments, safety gear).
    e. Injuries associated with people initiating or increasing 
physical activity (e.g., training programs or protective devices).
    f. Injuries related to outdoor recreation (e.g., vehicle design).
    g. Motorcycling, bicycling and pedestrian injuries (e.g., improved 
helmets or environments).
    h. Injuries to child occupants of motor vehicles (e.g., universal 
fasteners and alternative restraint designs).
    i. Injuries to older drivers.
    j. Injuries associated with the effects of emerging vehicle 
technologies.
    2. Identify the biomechanics and specific injuries that would be 
highly predictive of diagnoses of intimate partner violence and child 
maltreatment, and improve case definitions.
    3. Advance the biomechanical understanding of traumatic injury 
(e.g., injuries to the brain, spinal cord, thorax/abdomen, extremities 
and joints) in children and older adults (greater than 65 years old) 
including: development of biofidelic models to elucidate injury 
physiology as well as pharmacologic, surgical, rehabilitation, and 
other interventions; improvement of injury assessment technology; 
impact injury mechanisms research; and quantification of injury-related 
biomechanical responses for critical areas of the human body (e.g., 
brain and vertebral injury with spinal cord involvement).
    4. Define the human tolerance limits for injury in children and 
older adults (greater than 65 years old), especially determining the 
differences in human tolerance by age, fitness level, and gender and 
the biomechanics and injury tolerances of tissue, bone, and other human 
structures as a prerequisite for developing interventions.
    5. Identify the modifiable risk factors for and mechanisms of 
nonfatal whiplash injuries of the neck and back.
Acute Injury Care
    1. Develop and evaluate protocols that provide onsite interventions 
in acute care settings or linkages to off-site services for patients at 
risk of injury or psychosocial problems following injury.
    2. Identify methods and strategies to ensure that people with 
traumatic brain injuries (TBI) and spinal cord injuries (SCI) receive 
needed services.
    3. Identify the effects on acute injury care of inter-
jurisdictional, legal, governmental, and interdisciplinary issues 
related to mass casualty events.
    4. Identify and evaluate the components of trauma systems which 
contribute to improvement in care of the injured.
    5. Develop and evaluate new methods for linking prehospital 
databases to trauma registries, and other hospital databases, including 
those related to subsequent levels of care (e.g., rehabilitation).
    Approximately $500,000 of the total award amount will be reserved 
to fund up to five proposals that address acute injury care research.
    Rigorous evaluations are needed to determine the effectiveness of 
interventions, programs, and policies addressing the prevention of 
injury. 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.

    For randomized trials, applicants are encouraged to clearly state 
how study subjects, whether individuals or groups, were selected, 
randomized, and followed through the trial. One relevant useful 
guidance document is Moher D, Schulz KF, Altman D, The CONSORT 
Statement, JAMA 2001;285:1987-2001.

[[Page 64296]]

II. Award Information

    Type of Award: Grant.
    Mechanism of Support: R49.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $900,000. (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: Nine (Up to five of these awards will 
be made in the area of acute care research).
    Approximate Average Award: $100,000. (This amount includes both 
direct and indirect costs.)
    Floor of Award Range: None.
    Ceiling of Award Range: $100,000. (This amount includes both direct 
and indirect costs.)
    Anticipated Award Date: August 30, 2005.
    Budget Period Length: 12 months.
    Project Period Length: One year.
    Allowable costs include partial salary and tuition support for the 
applicant; direct research project expenses, such as trainee stipends, 
interviewer costs, data processing, participant incentives, statistical 
consultation services, and supplies; and travel to one scientific 
meeting, if adequately justified. Applicants should also include travel 
costs for one, two-day trip to CDC in Atlanta to present research 
findings.

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:
    <bullet> Public nonprofit organizations.
    <bullet> Private nonprofit organizations.
    <bullet> For profit organizations.
    <bullet> Small, minority, women-owned businesses.
    <bullet> Universities.
    <bullet> Colleges.
    <bullet> Research institutions.
    <bullet> Hospitals.
    <bullet> Community-based organizations.
    <bullet> Faith-based organizations.
    <bullet> Federally recognized Indian tribal governments.
    <bullet> Indian tribes.
    <bullet> Indian tribal organizations.
    <bullet> 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).
    <bullet> 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 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, 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.
    Eligible applicants may enter into contracts, including consortia 
agreements, as necessary to meet the requirements of the program and 
strengthen the overall application.
    It is especially important that the abstract of your grant 
application (Description, PHS 398 form page 2) reflects the project's 
focus, because the abstract will be used to help determine the 
responsiveness of the application.
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.
    <bullet> Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
    <bullet> Grant applications must demonstrate an overall match 
between the applicant's proposed theme and research objectives and the 
program priorities as described under the heading, ``Research 
Objectives.''
    <bullet> Applications must demonstrate effective and well-defined 
working relationships within the performing organization and with 
outside entities, which will ensure implementation of the proposed 
activities.
    <bullet> 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
    <bullet> The principal investigator must have a research or a 
health-professional doctorate-level degree from an accredited program 
and have demonstrated the capacity or potential for highly productive 
research in the period after the doctorate, commensurate with level of 
experience.
    <bullet> Applicants who have been the principal investigator on an 
RO1 or RO1-equivalent health-related research grant or who have had 
equivalent injury-related research support from an existing Injury 
Control Research Center (ICRC) are not eligible. Recipients of 
dissertation research grants or NIH Small Grant Awards are eligible to 
apply.
    <bullet> A principal investigator who has specific authority and 
responsibility to carry out the proposed project.
    <bullet> The ability of the principal investigator to carry out 
injury control research projects as defined under Attachment 1 of this 
program announcement. The attachment is posted along with this 
announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm.
    Applications, which do not meet the above requirements, will be 
considered non-responsive.
    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:

[[Page 64297]]

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:
    <bullet> Maximum Number of Pages: Two.
    <bullet> Font Size: 12-point unreduced.
    <bullet> Paper Size: 8.5 by 11 inches.
    <bullet> Page Margin Size: One inch.
    <bullet> Printed only on one side of page.
    <bullet> Single spaced.
    <bullet> Written in plain language, avoid jargon.
    Your LOI must contain the following information:
    <bullet> Descriptive title of the proposed research.
    <bullet> Name, address, e-mail address, and telephone number of the 
Principal Investigator.
    <bullet> Names of other key personnel.
    <bullet> Participating institutions.
    <bullet> Number and title of this Program Announcement.
    <bullet> Brief description of the scope and intent of the proposed 
research work.
    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: 
<a href="/cdn-cgi/l/email-protection#430431222d37300a2d252c032d2a2b6d242c35"><span class="__cf_email__" data-cfemail="226550434c56516b4c444d624c4b4a0c454d54">[email protected]</span></a>.
    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. Follow the 
PHS-398 instructions for non-modular budget research grant 
applications.
    An applicant organization has the option of having specific salary 
and fringe benefit amounts for individuals omitted from the copies of 
the application, which are made available to outside reviewing groups. 
To exercise this option: on the original and five copies of the 
application, the applicant must use asterisks to indicate those 
individuals for whom salaries and fringe benefits are not shown; 
however, the subtotals must still be shown. In addition, the applicant 
must submit an additional copy of page 4 of Form PHS-398, completed in 
full, with the asterisks replaced by the salaries and fringe benefits. 
This budget page will be reserved for internal staff use only.
    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:
    <bullet> Statement of the problem.
    <bullet> Purpose of the proposed research.
    <bullet> Methods, including study population, data sources and any 
statistical analyses to be performed.
    <bullet> Implications for prevention.
    The Description (abstract) should answer the following questions:
    <bullet> Does the Description state the hypothesis?
    <bullet> Does the Description describe the objectives and specific 
aims?
    <bullet> Does the Description state the importance of the research 
and how it is innovative?
    <bullet> Does the Description outline the methods that will be used 
to accomplish the goals?
    <bullet> Is the language of the Description simple and easy to 
understand for a broad audience?
    You must include a research plan in your application. The research 
plan should be no more than 25 pages, printed on one side, single 
spaced, with one half-inch margins, and unreduced 12-point font. The 
research plan should address activities to be conducted over the entire 
project period. Use the information in the Research Objectives, 
Administrative and National Policy Requirements, and Application Review 
Information sections to develop the application content. The research 
plan should include the following information:
    <bullet> The project's focus, a justification for the research 
proposed, and a description of the scientific basis for the research. 
The focus should be based on recommendations in ``Healthy People 2010'' 
(http://www.healthypeople.gov) and the ``CDC Injury Research Agenda,'' 
(http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and 
should seek creative approaches that will contribute to a national 
program for injury control.
    <bullet> Specific, measurable, and time-framed objectives.
    <bullet> A detailed plan describing the methods, which will achieve 
the objectives, including their sequence. A comprehensive evaluation 
plan is an essential component of the application.
    <bullet> A description of the roles and responsibilities of the 
principal investigator and the mentor.
    <bullet> A description of those activities related to, but not 
supported by, the grant.
    <bullet> A description of the involvement of other entities that 
will relate to the proposed project, if applicable. It should include 
commitments of support and a clear statement of their roles.
    <bullet> An explanation of how the research findings will 
contribute to the national effort to reduce the morbidity, mortality 
and disability caused by injuries within three to five years from 
project start-up.
    Additional materials required: In addition to the completed PHS 398 
application form, the applicant must also submit the following 
materials, attached to the application as appendices:
    <bullet> An official transcript of the applicant's graduate school 
record.
    <bullet> A statement describing the applicant's prior research 
training and experience and short and long term career goals in injury 
research, including a paragraph describing why he or she qualifies as a 
new investigator.
    <bullet> A letter from a senior injury researcher acknowledging 
that he or she has read the application and agrees to serve as a 
mentor. The letter should also include: (1) An outline of the mentor's 
specific roles and responsibilities and time commitment (percent time); 
(2) a proposed plan for providing scientific advice and consultation to 
the applicant; and (3) a two-page biography of the mentor. (Use the 
Biographical Sketch page in application form PHS 398.)
    <bullet> A justification for any proposed tuition support.
    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 grant 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: December 6, 2004.

[[Page 64298]]

    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
    Application Deadline Date: February 2, 2005.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office (PGO) (not NIH) 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 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 grant 
application content, submission address, and deadline. It supersedes 
information provided in the application instructions. If your 
application does not meet 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:
    <bullet> Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board (IRB) approvals are in place.
    <bullet> Grant funds will not be made available to support the 
provision of direct care.
    <bullet> Eligible applicants may enter into contracts, including 
consortia agreements, as necessary to meet the requirements of the 
program and strengthen the overall application.
    <bullet> Allowable costs include partial salary and tuition support 
for the applicant; direct research project expenses, such as trainee 
stipends, interviewer costs, data processing, participant incentives, 
statistical consultation services, and supplies; and travel to one 
scientific meeting, if adequately justified.
    <bullet> Applicants should also include travel costs for one, two-
day trip to CDC in Atlanta to present research findings.
    <bullet> Funds for tuition support are limited to no more than 20 
percent of the overall award and their use must be generally related to 
the content and methods of the proposed research.
    <bullet> Indirect costs for this trainee-related grant are limited 
to eight percent.
    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: NCIPC Extramural Resources Team, Centers 
for Disease Control and Prevention, 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: 
<a href="/cdn-cgi/l/email-protection#9ad9d3cadfc8cedad9ded9b4ddd5cc"><span class="__cf_email__" data-cfemail="f4b7bda4b1a6a0b4b7b0b7dab3bba2">[email protected]</span></a>.
    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management--CE05-021, 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: NCIPC 
Extramural Resources Team, CDC, National Center for Injury Prevention 
and Control.
    Address for Express Mail or Delivery Service: 2945 Flowers Road, 
Yale Building, Room 2054, Atlanta, Georgia 30341.
    Address for U.S. Postal Service Mail: 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 grant. 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 improve the control and 
prevention of disease and injury and to 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? Does the project include plans 
to measure progress toward achieving the stated objectives? Is there an 
appropriate work plan included?
    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)? Is there a

[[Page 64299]]

prior history of conducting injury-related research?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? Is there an appropriate degree of 
commitment and cooperation of other interested parties as evidenced by 
letters detailing the nature and extent of the involvement?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Dissemination: What plans have been articulated for disseminating 
findings?
    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.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the PGO and for 
responsiveness by NCIPC. 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 panel convened by the NCIPC in accordance with the review 
criteria listed above. As part of the initial merit review, all 
applications will:
    <bullet> 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.
    <bullet> Receive a written critique.
    The primary review will be a peer review conducted by NCIPC Initial 
Review Group (IRG). Applications may be subjected to a preliminary 
evaluation (streamline review) by the IRG to determine if the 
application is of sufficient technical and scientific merit to warrant 
further review. NCIPC 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 the IRG. These 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 Advisory Committee for Injury 
Prevention and Control (ACIPC). The ACIPC Federal agency experts will 
be invited to attend the secondary review and will receive modified 
briefing books (i.e., abstracts, strengths and weaknesses from summary 
statements, and project officer's briefing materials).
    ACIPC Federal agency experts will be encouraged to participate in 
deliberations when applications address overlapping areas of research 
interest, so that unwarranted duplication in federally funded research 
can be avoided and special subject area expertise can be shared. The 
NCIPC Division Associate 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 ACIPC 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:
    <bullet> The results of the primary review including the 
application's priority score as the primary factor in the selection 
process.
    <bullet> The relevance and balance of proposed research relative to 
the NCIPC programs and priorities.
    <bullet> 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.'' (See Attachment 1, Resource 
Materials.) The attachment is posted along with this announcement on 
the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm).
    <bullet> Budgetary considerations.
    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 ACIPC, consultation with 
NCIPC senior staff, and the availability of funds.
    Award Criteria: Criteria that will be used to make award decisions 
during the programmatic review include:

[[Page 64300]]

    <bullet> Scientific merit (as determined by peer review).
    <bullet> Availability of funds.
    <bullet> Programmatic priorities.

V.3. Anticipated Announcement and Award Dates

    August 30, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
    <bullet> AR-1 Human Subjects Requirements.
    <bullet> AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research.
    <bullet> AR-3 Animal Subjects Requirements.
    <bullet> AR-9 Paperwork Reduction Act Requirements.
    <bullet> AR-10 Smoke-Free Workplace Requirements.
    <bullet> AR-11 Healthy People 2010.
    <bullet> AR-12 Lobbying Restrictions.
    <bullet> AR-13 Prohibition on Use of CDC Funds for Certain Gun 
Control Activities.
    <bullet> AR-21 Small, Minority, and Women-Owned Business.
    <bullet> AR-22 Research Integrity.
    Additional information on AR-1 through AR-22 can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
    <bullet> AR-25 Release and Sharing of Data.
    Starting with the December 1, 2003 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 toward 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: 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. Financial status report, no more than 90 days after the end of 
the budget period.
    2. The final performance report, no more than 90 days after the end 
of the project period. The final performance report will be a brief 
summary (2,500 to 4,000 words in length) written in non-scientific 
[laymen's] terms. The report should highlight the findings and their 
implications for injury prevention programs, policies, environmental 
changes, etc. The grant recipient will also include a description of 
the dissemination plan for research findings. This plan will include 
publications in peer-reviewed journals and ways in which research 
findings will be made available to stakeholders outside of academia 
(e.g., State injury prevention program staff, community groups, public 
health injury prevention practitioners, and others). CDC will place the 
summary report and each grant recipient's final report with the 
National Technical Information Service (NTIS) to further the agency's 
efforts to make the information more available and accessible to the 
public.
    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: Paul Smutz, Ph.D, Project 
Officer, 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) 488-1508, E-mail: 
<a href="/cdn-cgi/l/email-protection#1b6c68766e6f612a5b787f78357c746d"><span class="__cf_email__" data-cfemail="f087839d85848ac1b0939493de979f86">[email protected]</span></a>.
    For questions about peer review, contact: Gwendolyn Cattledge, 
Ph.D, Scientific Review Administrator, 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: <a href="/cdn-cgi/l/email-protection#690e110a51290a0d0a470e061f"><span class="__cf_email__" data-cfemail="37504f540f7754535419505841">[email protected]</span></a>.
    For financial, grants management, or budget assistance, contact: 
Pamela Render, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-
2712, E-mail: <a href="/cdn-cgi/l/email-protection#40100c1273002324236e272f36"><span class="__cf_email__" data-cfemail="d989958bea99babdbaf7beb6af">[email protected]</span></a>.

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.''

William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-24616 Filed 11-3-04; 8:45 am]
BILLING CODE 4163-18-P


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