[Federal Register Volume 69, Number 210 (Monday, November 1, 2004)]
[Notices]
[Pages 63392-63398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Grants for Dissertation Awards for Doctoral Candidates for 
Violence-Related and Unintentional Injury Prevention Research in 
Minority Communities

    Announcement Type: New.
    Funding Opportunity Number: CE05-025.
    Catalog of Federal Domestic Assistance Number: 93.136.
    Key Dates:
    Letter of Intent Deadline: December 1, 2004.
    Application Deadline: January 31, 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. 280 b (a)] of the Public Service Health Act, as 
amended.

    Purpose: The purposes of the program are to:
     Solicit research applications that address the priorities 
reflected under the heading, ``Research Objectives''.
     Build the scientific base for the prevention and control 
of injuries, disabilities, and deaths disproportionately experienced in 
minority communities.
     Encourage doctoral candidates from a wide spectrum of 
disciplines, including epidemiology, medicine, biostatistics, public 
health, law and criminal justice, behavioral, and social sciences to 
perform research in order to prevent and control injuries more 
effectively.
     Assist students in the completion of their dissertation 
research on a violence-related or unintentional injury topic.
     Encourage investigators to build research careers related 
to the prevention of violence-related or unintentional injuries, 
disabilities, and deaths in minority communities.
    This program addresses the ``Healthy People 2010'' focus area of 
Injury and Violence Prevention.
    A dissertation represents the most extensive research experience 
formulated and carried out by a doctoral candidate, with the advice and 
guidance of a mentor (the chair or another member of the dissertation 
committee). Dissertation research involves a major investment of the 
doctoral student's time, energy, and interest and its substance is 
often the basis for launching a research career. This research 
initiative is aimed at providing students with assistance to complete 
their dissertation research on a violence-related or unintentional 
injury topic and, thereby, increasing representation of junior 
investigators in violence-related or unintentional injury research.
    Injuries are the number-one killer of children and young adults in 
the United States. They are the leading cause of years of potential 
life lost before age 65. More than five million people in the U.S. 
report suffering from chronic, injury-related disabilities, and the 
lives of millions of others have been dramatically affected by injuries 
to themselves or someone they love. Funding for research to prevent 
these injuries falls into two categories: violence prevention, and the 
prevention of unintentional injury.

Violence

    Deaths and injuries associated with interpersonal violence and 
suicidal behavior are a major public health problem in the United 
States and around the world. In 1999, more than 46,000 people died from 
homicide and suicide in the United States. Among 15 to 24 year olds, 
homicide and suicide rank as the second and the 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 constitutes an enormous public health problem. For every homicide 
that occurs each year there are more than 100 non-fatal injuries 
resulting from interpersonal violence. For every completed suicide it 
is estimated that there are 20 to 25 suicide attempts. The mortality 
and morbidity associated with violence are associated with a variety of 
types of violence including child mistreatment, youth violence, 
intimate partner violence, sexual violence, elder abuse, and self-
directed violence or suicidal behavior.
    Violence has a disproportionate impact on racial and ethnic 
minorities. In 1999, homicide was the leading cause of death for 
African Americans and the second leading cause of death for Hispanics 
between the ages of 15 and 34. Suicide was the second leading cause of 
death for American Indians and Alaskan Natives and Asian and Pacific 
Islanders 15 to 34 years of age. It is important to note that existing 
research indicates that race or ethnicity, per se, is not a risk factor 
for violent victimization or a cause of violent behavior. Rather, 
racial or ethnic status is associated with many other factors that do 
influence the risk of becoming a victim or behaving violently. As a 
result, racial and ethnic minorities in the United States experience 
high rates of both violent victimization and perpetration. A better 
understanding of the factors that contribute to this vulnerability or 
protection from such risk is important to furthering effective violence 
prevention programs that address racial and ethnic minorities.

Unintentional Injury

    Unintentional injuries are a leading cause of death for Americans 
of all ages, regardless of gender, race, or economic status. 
Unintentional injuries are the leading cause of death for persons ages 
1-34 years, and the fifth leading cause of death overall. Nearly 
100,000 people

[[Page 63393]]

die each year as a result of unintentional injury. In fact, on average, 
every six minutes someone in the U.S. dies from causes such as motor 
vehicle crashes, falls, poisonings, drownings, fires, bicycle crashes, 
suffocation, or pedestrians being struck by motor vehicles. Millions of 
Americans also experience nonfatal unintentional injuries each year. 
Approximately one in ten people a year experience a nonfatal injury 
serious enough to require a visit to an emergency department.
    Although everyone is vulnerable to injury, some groups are at 
higher risk for unintentional injuries than others. For example, among 
all ethnic groups in the U.S., American Indians/Alaska Natives have the 
highest unintentional injury death rate (i.e., 61 per 100,000 
population compared with 41 per 100,000 for African Americans and 36 
per 100,000 for Whites). African American children from birth through 
nine years have unintentional injury death rates almost twice as high 
as those of White children. Hispanic teenagers have higher motor 
vehicle occupant death rates than African American or White teenagers 
after adjusting for amount of travel.
    There is a critical need for highly qualified scientists to carry 
out research on violence and unintentional injury that can help in the 
development, implementation, and evaluation of effective injury 
prevention programs. In particular, scientists are needed who bring an 
understanding and sensitivity to the problems of violence and 
unintentional injury as they affect minority communities. The purpose 
of this extramural research training grant program is to attract young 
scientists to the field of injury prevention by encouraging doctoral 
candidates from a variety of disciplines to conduct violence and 
unintentional injury prevention research and hopefully carry this focus 
on throughout their careers. The number of individuals, who are members 
of minority groups, and who are engaged in injury-related prevention 
research, is currently small. This research program should also attract 
young minority scientists to the field of violence and unintentional 
injury prevention research.
    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):
     Increase the capacity of injury prevention and control 
programs to address the prevention of injuries and violence.
     Monitor and detect fatal and non-fatal injuries.
     Conduct a targeted program of research to reduce injury-
related death and disability.

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 in a minority community. Applications 
that fail to address these topics will be deemed nonresponsive.

Violence Related Injury

    Any research priority listed in following chapters from NCIPC's 
research agenda: Preventing Intimate Partner Violence, Sexual Violence, 
and Child Maltreatment, Preventing Suicidal Behavior, or Preventing 
Youth Violence. NCIPC's research agenda can be accessed online at the 
following address: http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm.

Unintentional Injury

    Any research priority listed in following chapters from NCIPC's 
research agenda; Preventing Injuries at Home and in the Community, 
Preventing Injuries in Sports, Recreation, and Exercise, or Preventing 
Transportation Injuries. NCIPC's research agenda can be accessed online 
at the following address: http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm.
    Rigorous evaluations are needed to determine the effectiveness of 
interventions, programs, and policies addressing the prevention of 
violence. Experimental designs are strongly encouraged. However, NCIPC 
will consider other evaluation designs, if justified, as required by 
the needs and constraints in a particular setting.
    For effective interventions, it is possible to do cost-
effectiveness studies. To be comparable to other cost effectiveness 
studies, they should follow the guidelines in the following references: 
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in 
Health and Medicine. New York: Oxford University Press, 1996. Haddix 
AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide to 
Decision Analysis and Economic Evaluation. Second Edition. New York: 
Oxford University Press, 2003.
    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.

II. Award Information

    Type of Award: Grant.
    Mechanism of Support: R49.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $125,000. (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: Five (four awards will be made in the 
area of violence prevention research and 1 award will be made in the 
area of unintentional injury prevention research).
    Approximate Average Award: $ 25,000. (This amount includes both 
direct and indirect costs.)
    Floor of Award Range: None.
    Ceiling of Award Range: $ 25,000. (This amount includes both direct 
and indirect costs.)
    Anticipated Award Date: August 30, 2005.
    Budget Period Length: 12 months.
    Project Period Length: One year.

III. Eligibility Information

III.1. Eligible applicants

    Assistance will be provided to any United States public or private 
institution. The institution must support an accredited doctoral level 
training program. The performance site must be domestic.

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.
    A dissertation research training grant may not be transferred to 
another institution, except under unusual and compelling circumstances 
(such as if the mentor moves to a new institution and both the mentor 
and the applicant wish to move together).
    The responsible program official for CDC must be informed if there 
is a change of a mentor. A biographical sketch of the new mentor must 
be provided for approval by the CDC program official.

[[Page 63394]]

    Two copies of the completed dissertation, including abstract, must 
be submitted to the CDC program official and will constitute the final 
report of the grant. The dissertation must be officially accepted by 
the dissertation committee or university official responsible for the 
candidate's dissertation and must be signed by the responsible 
university official.
    Any publications directly resulting from the grant should be 
reported to the CDC program official. The grantee also should cite 
receiving support from the NCIPC and CDC, both in the dissertation and 
any publications directly resulting from the dissertation-training 
grant.
    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.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     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.''
     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.

     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

     The doctoral candidate must be the designated principal 
investigator. The principal investigator will be responsible for 
planning, directing, and executing the proposed project with the advice 
and consultation of the mentor and dissertation committee.
     Applicants must be students in good standing enrolled in 
an accredited doctoral degree program.
     The applicant must have the skill and academic training to 
conduct the proposed research and have the authority and responsibility 
to carry out the proposed project.
     To receive this funding, applicants must have successfully 
defended their dissertation proposal. This must be verified in a letter 
of certification from the mentor (the chair or another member of the 
dissertation committee). CDC requests that if available, the letter of 
certification be submitted with the grant application, or before the 
negotiation and award.
     Applicants must be conducting or intending to conduct 
research in one of the areas described under the ``Research 
Objectives'' in the Program Requirement's section of this announcement.
     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) website 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: Two
 Font size: 12-point unreduced
 Paper size: 8.5 by 11 inches
 Page margin size: One inch
 Printed only on one side of page
 Single spaced
 Written in plain language, avoid jargon
    Your LOI must contain the following information:
 Descriptive title of the proposed research
 Name, address, email address, and telephone number of the 
Principal Investigator
 Names of other key personnel
 Participating institutions
 Number and title of this Program Announcement
 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: 
[email protected].
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
on line 11 of the 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.
    In addition to the instructions provided in the PHS 398 for writing 
the Description on page 2 of the PHS 398

[[Page 63395]]

form, structure the Description using the following components:
     Statement of the problem;
     Purpose of the proposed research;
     Methods, including study population, data sources and any 
statistical analyses to be performed;
     Implications for prevention.
    The Description (abstract) should answer the following questions:
     Does the Description state the hypothesis?
     Does the Description describe the objectives and specific 
aims?
     Does the Description state the importance of the research 
and how it is innovative?
     Does the Description outline the methods that will be used 
to accomplish the goals?
     Is the language of the Description simple and easy to 
understand for a broad audience?
    You must include a research plan in your application. The research 
plan should be no more than 15 pages, printed on one side, single 
spaced, with one half-inch margin, 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:
     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.
     Specific, measurable, and time-framed objectives.
     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.
     A description of the roles and responsibilities principal 
investigator.
     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.
     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:
     A letter from the applicant's mentor which:
    a. Fully identifies the members of the dissertation committee.
    b. Certifies that the mentor has read the application and believes 
that it reflects the work to be completed in the dissertation. (Letters 
certifying approval of the dissertation proposal must be received 
before negotiation and award of the grant.)
    c. Certification that the institution's facilities and general 
environment are adequate to conduct the proposed research.
     A tentative time line for completion of the research, the 
dissertation, and the dissertation defense.
     An official transcript of the applicant's graduate school 
record showing that the applicant has completed all required course 
work for the degree with the exception of the dissertation.
     A statement of the applicant's career goals and intended 
career trajectory.
     A biography of the mentor, limited to two pages (use the 
Biographical Sketch page in application form PHS 398).
    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 1, 2004.
    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
    Application Deadline Date: January 31, 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:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board (IRB) approvals are in place.
     Grant funds will not be made available to support the 
provision of direct care including medical and/or psychiatric care.
     Eligible applicants may enter into contracts, including 
consortia agreements, as necessary to meet the requirements of the 
program and strengthen the overall application.
     Allowable costs include partial salary support for the 
applicant; such as interviewer expenses, data processing, participant 
incentives, statistical consultant services, supplies, dissertation 
printing costs, and travel to one scientific meeting, if adequately 
justified.

[[Page 63396]]

     Applicants should also include travel costs for one, two-
day trip to CDC in Atlanta to present research findings.
     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: 
[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--CE05-025, 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 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

[[Page 63397]]

panel convened by the NCIPC in accordance with the review criteria 
listed above. As part of the initial merit review, all applications 
will:
     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.
    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 would 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:
     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 ``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.)
     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:
     Scientific merit (as determined by peer review);
     Availability of funds;
     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:
     AR-1 Human Subjects Requirements
     AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research
     AR-3 Animal Subjects Requirements
     AR-9 Paperwork Reduction Act Requirements
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-13 Prohibition on Use of CDC Funds for Certain Gun 
Control Activities
     AR-21 Small, Minority, and Women-Owned Business
     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.
     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

[[Page 63398]]

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, Project 
Officer, Office of the Director, 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: [email protected].
    For questions about peer review, contact: Gwendolyn Cattledge, 
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: 
Pamela Render, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770/488-
2712, E-mail: [email protected].

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.''

    Dated: October 21, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-24027 Filed 10-29-04; 8:45 am]
BILLING CODE 4163-18-P