67 FR 90 pgs. 31340-31344 - New Investigator Awards for Unintentional, Violence, and Acute Care, Disability, and Rehabilitation-Related Prevention Research; Notice of Availability of Funds

Type: NOTICEVolume: 67Number: 90Pages: 31340 - 31344
Docket number: [Program Announcement #02121]
FR document: [FR Doc. 02-11557 Filed 5-8-02; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version:  PDF Version

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement #02121]

New Investigator Awards for Unintentional, Violence, and Acute Care, Disability, and Rehabilitation-Related Prevention Research; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for an extramural grant program for new investigator awards in three research areas; unintentional injury prevention, violence-related injury prevention, and injury-related acute care and disability. This program addresses the "Healthy People 2010" focus areas of injury and violence prevention.

The purposes of this program are to:

1. Encourage researchers from a wide spectrum of disciplines such as public health, health care, medicine, criminal justice, and behavioral and social sciences to undertake research to prevent and control unintentional and violence-related injury and disability.

2. Support injury research by recent doctoral-level graduates or researchers who are redirecting their careers toward injury research.

3. Build the scientific base for the prevention and control of unintentional and violence-related injuries, disabilities, and deaths.

This program is designed to encourage qualified applicants who are beginning or redirecting their career 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 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. Applicants are encouraged to seek mentoring or collaboration with more senior level injury researchers in their proposed research.

Background and Significance

I. Unintentional Injury Prevention 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 1999, nearly 98,000 people died in the United States as a result of unintentional injury. Someone dies in this country every six minutes from causes such as motor vehicle crashes, falls, poisonings, drownings, fires and burns, pedestrians struck, bicycle crashes, or 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 visits to physicians' offices. Although the greatest cost of injury is human suffering, the financial costs also are staggering: over 200 billion dollars a year for medical care, wage and productivity losses and employer costs in 1998.

II. Violence Related Injury Prevention 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 1999, 46,000 people died from homicide and suicide in the United States. Among 15 to 24 year olds, homicide ranked 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 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.

III. Injury Related Acute Care, Disability, and Rehabilitation

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 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 non-existent. 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.

B. Eligible Applicants

Eligible institutions include any United States public or private universities or colleges, including, but not limited to schools or departments of public health, medicine, nursing, criminal justice, or the behavioral or social sciences. The performance site must be domestic.

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.

Applicants 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. Applicants must be within three years of receiving their doctoral or equivalent degree or redirecting their research to injury-related research.

Documentation of such redirection must be included in the application. Applicants who have been the principal investigator on a Public Health Service (PHS) injury-related research grant or who have had equivalent injury-related research support from an existing Injury Control Research Center (ICRC) are not eligible. Exceptions are researchers who have redirected their research areas from one area of injury research, e.g., acute care or biomechanics, to another area, e.g., violence prevention research. Recipients of dissertation research grants or NIH Small Grant Awards are eligible to apply.

C. Availability of Funds

Approximately $400,000 is expected to be available for up to four new investigator awards in FY 2002. It is expected that the awards will begin on or about September 30, 2002, and will be made for a 12-month budget period within a one-year project period. Grants will be awarded for twelve months, but may be extended without additional funds for up to a total of 24 months. Grant funds will not be made available to support the provision of direct patient care. The maximum funding level will not exceed $100,000 (direct and indirect costs). Applications that exceed the funding caps noted above will be excluded from the competition and returned to the applicant. The availability of Federal funding may vary and is subject to change.

Allowable Costs

Allowable costs include partial salary for the applicant; direct research project expenses, such as interviewer costs, data processing, payment to participants, statistical consultation services, and supplies; and travel to one scientific meeting, if adequately justified. No tuition support is allowed. Applicants should include travel costs for one, two-day trip to CDC in Atlanta to present research findings.

D. Program Requirements

Research Objectives

For the purpose of this program announcement, the highest priority will be given to research that addresses the following themes within each of the three broad research areas:

I. Unintentional Injury Prevention Research Priorities

1. Communications-based research that focuses on learning how to encourage practitioners and policy makers to adopt science-based programs, policies, laws, and regulations that reduce unintentional injuries.

2. Identifying modifiable human behaviors during a fire and evaluating interventions to prevent fire and burn injuries in fire emergencies.

3. Among children, determining the immediate causes of the most severe and disabling types of falls, and evaluating interventions that prevent serious falls in children.

4. Behavioral safety interventions that utilize applied behavioral analysis and other behavior modification strategies to change injury risk behaviors and risk taking of children and young adults.

5. Developing and evaluating methods to collect participation exposure and injury incidence data in sports, recreation (including playgrounds), and exercise.

6. Testing the effectiveness of implementing new innovative strategies to reduce alcohol impaired driving.

7. Evaluating the effectiveness of behavioral and environmental interventions to prevent pedestrian injury.

8. Measuring the efficacy and effectiveness of booster seats in reducing child injury or developing and testing interventions to increase the proper and consistent use of occupant protection devices among child occupants.

Research that focuses on interventions for unintentional injuries in high-risk groups or settings such as with the elderly, young children and members of minority groups, or in disadvantaged neighborhoods or communities, is especially encouraged.

II. Violence Related Injury Prevention Research

1. Evaluating strategies for disseminating and implementing evidence-based interventions or policies for the prevention of intimate partner violence, sexual violence, child maltreatment, youth violence, or suicidal behavior.

2. Evaluating the efficacy and effectiveness of interventions, programs, and policies to prevent intimate partner violence, sexual violence (includes both sexual violence against adults and child sexual abuse), child maltreatment, youth violence, or suicidal behavior.

3. Identifying common and unique risk and protective factors for the perpetration of intimate partner violence, sexual violence, child maltreatment, youth violence, or suicidal behaviors, and examining the relationships among these forms of violence.

III. Injury Related Acute Care, Disability, and Rehabilitation Priorities

1. Evaluating methods of using point-of-care clinical information systems to report injuries to public health agencies.

2. Measuring the benefits and costs of trauma care systems.

3. Identifying methods and strategies for ensuring that people with TBI or SCI receive needed services.

4. Determining the impact of TBI on special populations.

Other special conditions for new investigator research grants:

1. The applicant must be the designated principal investigator. The principal investigator must be responsible for planning, directing, and executing the proposed project.

2. The applicant must specify which of the three areas the proposal addresses: (1) Unintentional injury; (2) violence-related injury research; or (3) injury-related acute care, disability, and rehabilitation.

3. The 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).

4. Any publications directly resulting from the grant should be reported to the responsible CDC program official. The grantee also must cite receiving support from the National Center for Injury Prevention and Control, CDC in any publications directly resulting from the new investigator grant.

F. Content

Letter of Intent (LOI)

A LOI is optional for this program. The narrative should be no more than two double-spaced pages, printed on one side, with one inch margins, and unreduced font. The letter should identify the announcement number, the name of the principal investigator, and briefly describe the scope and intent of the proposed research work. The letter of intent does not influence review of funding decisions, but the number of letters received will enable CDC to plan the review more effectively and efficiently.

Application

Use the information in the Program Requirements and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative portion of the application must not exceed 25 pages.

Applications should follow the PHS-398 (Rev. 5/2001) application and Errata sheet and should include the following information:

1. The project's focus that justifies the research needs and describes the scientific basis for the research, the expected outcome, and the relevance of the findings to reduce injury morbidity, mortality, disability, and economic losses.

2. Specific, measurable, and time-framed objectives.

3. A detailed plan describing the methods that will achieve the objectives, including their sequence.

4. A description of the roles and responsibilities of the principal investigator and mentor, where appropriate.

5. A description of all project staff regardless of their funding sources. It should include their title, qualifications, experience, percentage of time each will devote to the project, as well as that portion of their salary to be paid by the grant.

6. A description of those activities related to, but not supported by the grant.

7. A description of the involvement of other entities that will relate to the proposed project, if applicable. It should include letters of organizational commitments of support and a clear statement of their roles.

8. A detailed budget for the grant.

9. An explanation of how the research findings will contribute to the national effort to reduce the morbidity, mortality and disability caused by injuries.

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:

1. An official transcript of the applicant's graduate school record, if within the last three years.

2. When relevant, documentation showing the researcher has redirected his or her career within the last three years.

3. An overview of the applicant's prior research training and experience, including a statement of the applicant's short-term and long-term research and career goals and intended career trajectory.

4. Where appropriate, a letter from the applicant's mentor or scientific collaborator that outlines the proposed plan for providing scientific advice and consultation to the applicant during the grant period and a biography of the mentor or senior-level collaborator, limited to two pages (use the Biographical Sketch page in application form PHS 398).

G. Submission and Deadline

Letter of Intent

On or before June 1, 2002, submit the LOI to the Grants Management Specialist identified in the Where to Obtain Additional Information section of this announcement.

Application

Submit the original and five copies of PHS 398 (OMB Number 0925-0001) (adhere to the instructions on the Errata Instruction sheet for PHS 398). Forms are in the application kit and at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm.

On or before 5 p.m. Eastern time on June 24, 2002, submit the application to: Technical Information Management-PA02121, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.

Deadlines

Applications shall be considered as meeting the deadline if they are received before 5 p.m. Eastern Time on the deadline date. Applicants sending applications by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with the guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Applications which do not meet the above-criteria, will not be eligible for competition and will be discarded.

Applicants will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Upon receipt, applications will be reviewed by CDC staff for completeness, responsiveness, and eligibility as outlined under the Eligible Applicants Section. Incomplete applications and applications that are not responsive will be returned to the applicant without further consideration. It is especially important that the applicant's abstract reflects the project's focus, because the abstract will be used to help determine the responsiveness of the application.

Applications which are complete and responsive may be subjected to a preliminary evaluation (triage) by a Special Emphasis Panel (SEP) to determine if the application is of sufficient technical and scientific merit to warrant further review by the panel; CDC will withdraw from further consideration applications judged to be non-competitive and promptly notify the principal investigator and the official signing for the applicant organization. Those applications judged to be competitive will be reviewed by the SEP and the secondary review group.

Awards will be determined by the Director of the NCIPC based on priority scores assigned to applications by the primary review committee (SEP), recommendations by the secondary review committee, the Advisory Committee for Injury Prevention and Control (ACIPC), consultation with NCIPC senior staff, and the availability of funds.

1. The primary review will be a peer review conducted by the SEP. All applications will be reviewed for scientific merit by a committee of no less than three reviewers with appropriate expertise using current National Institutes of Health (NIH) criteria to evaluate the methods and scientific quality of the application. Factors to be considered will include:

a. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced?

b. 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?

c. Innovation. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge or advance existing paradigms, or develop new methodologies or technologies?

d. Investigator. Is the principal investigator appropriately trained and well suited to carry out this work? Is the proposed work appropriate to the experience level of the principal investigator? Is the name and role of a scientific mentor or collaborator described?

e. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support?

f. Ethical Issues. What provisions have been made for the protection of human subjects and the safety of the research environments? Where relevant, how does the applicant plan to handle issues of confidentiality and compliance with mandated reporting requirements, e.g., suspected child abuse? Does the application adequately address the requirements of 45 CFR part 46 for the protection of human subjects? (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.) The degree to which the applicant has met 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.

(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.

g. Study Samples. Are the samples sufficiently rigorously defined to permit complete independent replication at another site? Have the referral sources been described, including the definitions and criteria? What plans have been made to include women and minorities, and their subgroups as appropriate for the scientific goals of the research? How will the applicant deal with recruitment and retention of subjects?

h. Dissemination. What plans have been articulated for disseminating findings?

The SEP will also examine the appropriateness of the proposed project budget and duration in relation to the proposed research and the availability of data required for the project.

2. 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 ex officio members will be invited to attend the secondary review, will receive modified briefing books, (i.e., abstracts, strengths and weaknesses from summary statements, and project officer's briefing materials). Federal ex officio members will be encouraged to participate in deliberations when proposals 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 Federal ex officio members. 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 the factors that the SPRS considered.

The committee's responsibility is to develop funding recommendations for the NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the NCIPC programs and priorities, and to assure that unwarranted duplication of federally funded research does not occur. The Secondary Review Committee has the latitude to recommend to the NCIPC Director, to reach over better-ranked proposals in order to assure maximal impact and balance of proposed research. The factors to be considered will include:

a. The results of the primary review including the application's priority score as the primary factor in the selection process.

b. The relevance and balance of proposed research relative to the NCIPC programs and priorities.

c. The significance of the proposed activities in relation to the priorities and objectives stated in "Healthy People 2010" and the Institute of Medicine report, "Reducing the Burden of Injury."

I. Other Requirements

Technical Reporting Requirements

Grantees must provide CDC with an original plus two copies of:

1. An annual progress report.

2. A financial status report, no more than 90 days after the end of the budget period.

3. A final financial report and performance report, no more than 90 days after the end of the project period.

4. At the completion of the project, the grant recipient will submit a brief (2,500 to 4,000 words written in non-scientific (laymen's) terms) summary highlighting 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.

Send all reports to the Grants Management Specialist identified in the Where to Obtain Additional Information section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment 1 in the application kit.

AR-1Human Subjects Certification

AR-2Requirements for inclusion of Women and Racial and Ethnic Minorities in Research

AR-3Animal Subjects Requirements

AR-9Paperwork Reduction Requirements

AR-10Smoke-Free Workplace Requirement

AR-11Healthy People 2010

AR-12Lobbying Restrictions

AR-13Prohibition on Use of CDC funds for Certain Gun Control Activities

AR-21Small, Minority, and Women-owned Business

AR-22Research Integrity

J. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301(a) (42 U.S.C. 2412(a)) of the Public Health Service Act and section 391(a)(42 U.S.C. 280(b)) of the Public Service Health Act, as amended. The catalog of Federal Domestic Assistance number is 93.136.

K. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC homepage on the Internet. The address for the CDC homepage is http://www.cdc.gov. Click on "Funding" then "Grants and Cooperative Agreements."

To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Nancy Pillar, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Program Announcement #02121, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341. Telephone: (770) 488-2721. Internet address: nfp6@cdc.gov.

For program technical assistance, contact:

I. For Unintentional Injury Prevention Research

David Sleet, PhD, Associate Director for Science, Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, NE, Mail Stop K-63, Atlanta, GA 30341-3724. Telephone: (770) 488-4699. Internet address: dsleet@cdc.gov.

II. For Violence Related Injury Prevention Research

Jim Mercy, PhD, Associate Director for Science, Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, NE, Mail Stop K-60, Atlanta, GA 30341-4723. Telephone: (770) 488-4699. Internet Address: jmercy@cdc.gov.

III. For Injury Related Acute Care, Disability, and Rehabilitation

Richard Sattin, MD, Associate Director for Science, Division of Injury Disability Outcomes and Programs, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, NE, Mail Stop K-58, Atlanta, GA 30341-4723. Telephone: (770) 488-4330. Internet address: rsattin@cdc.gov.

Dated: May 3, 2002.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

[FR Doc. 02-11557 Filed 5-8-02; 8:45 am]

BILLING CODE 4163-18-M