Grants and cooperative agreements; availability, etc.: Injury Control Research Centers Program,

[Federal Register: September 12, 2002 (Volume 67, Number 177)]

[Notices]

[Page 57817-57822]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr12se02-77]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03008]

Grants for Injury Control Research Centers; Notice of Availability of Funds

1. Purpose

   The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a grant for an Injury Control Research Center (ICRC). This program addresses the ``Healthy People 2010'' focus area of Injury and Violence Prevention. A copy of ``Healthy People 2010'' is available at the following Internet address: http://www.health.gov/healthypeople.

   The purposes of this program are:

   1. To support injury prevention and control research on priority issues as delineated in: Healthy People 2010; Injury Control in the 1990's: A National Plan for Action; Reducing the Burden of Injury: Advancing Prevention and Treatment; and the research priorities published in the National Center for

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      Injury Prevention and Control (NCIPC) Research Agenda. (For a copy of the NCIPC Research Agenda contact the Program Manager identified in the ``Where to Obtain Additional Information'' section of this announcement.)

   2. To integrate, in the context of a national program, the disciplines of engineering, epidemiology, medicine, biostatistics, public health, law and criminal justice, behavioral and social sciences in order to prevent and control injuries more effectively.

   3. To support the identification and description of injury problems, by identifying risk and protective factors that can be used to design and test injury prevention and control strategies. Evaluate current and new interventions for the prevention and control of injuries, and support the implementation of effective prevention and control strategies in the public and private sector.

   4. To provide technical assistance to injury prevention and control programs within a geographic region.

      Measurable outcomes of the program will be in alignment with the following performance goal for NCIPC: To increase external input on the research priorities, policies, and procedures related to the extramural research supported by CDC.

2. Authority And Catalog Of Federal Domestic Assistance Number

   This program is authorized under Sections 301, 391, 392, 393, and 394 of the Public Health Service Act, [42 U.S.C. 241, 280b, 280b-1, 280b-1a, and 280b-2] as amended. Catalog of Federal Domestic Assistance number is 93.136.

3. Eligible Applicants

   This announcement will provide funding for applicants in regions which do not have funded ICRCs and for applicants in regions which have funded centers who must re-compete for funding.

   Eligible applicants include all nonprofit and for-profit organizations in Region two, three, and six. Thus, universities, colleges, research institutions, hospitals, other public and private organizations, faith-based organizations, State and local health departments, and small, minority and/or women-owned businesses are eligible for these grants. Non-academic applicant institutions should provide evidence of a collaborative relationship with an academic institution.

   Eligible applicants are limited to organizations in Region two (New Jersey, New York, Puerto Rico, and Virgin Islands), Region three (Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia), and Region six (Arkansas, Louisiana, New Mexico, Oklahoma, and Texas).

   Note: ICRC grant awards are made to the applicant institution/ organization, not the Principal Investigator. An organization described in section 501(c)(4) of Title 26 which engages in lobbying activities shall not be eligible for the receipt of Federal funds constituting an award, grant, or loan.

4. Funds

   Availability of Funds:

   Approximately $905,500 is expected to be available in FY 2003 to fund one award. It is expected that the award will be $905,500 (total of direct and indirect costs). It is expected that the award will begin on or about September 1, 2003, and will be made for a 12-month budget period within a project period of up to five years. Applications that exceed the funding cap of $905,500 will be excluded from the competition and returned to the applicant. Funding estimates may change.

   Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

   Matching funds are not required for this program announcement, however other sources of funding must be documented.

   Use of Funds: Center funding is to be designated for two types of activities. One type of activity is considered ``Core'' and includes administration, management, general support services (e.g., statistical, library, media relations, and advocacy) as well as activities associated with research development, technical assistance, and education (e.g., seed projects, training activities, and collaborative and technical assistance activities with other groups). Funds may be allocated for trainee stipends, tuition remission, and trainee travel, in accordance with the current rates for the Public Health agencies. Indirect costs for these trainee-related activities are limited to eight percent.

   Defined research projects constitute the second type of activity, and ICRCs are encouraged to work toward addressing the breadth of the field. Core activities and defined research projects may each constitute between 25 percent to 75 percent of the operating budget, and should be balanced in such a way that the ICRC demonstrates productivity in research as well as teaching and service. Applicants with less demonstrated expertise in research are encouraged to devote a larger percentage of funds to defined research projects in order to establish their capability as research centers of excellence.

   Grant funds will not be made available to support the provision of direct care. Studies may be supported which evaluate methods of care and rehabilitation for potential reductions in injury effects and costs. Studies can be supported which identify the effect on injury outcomes and cost of systems for pre-hospital, hospital, and rehabilitative care and independent living.

   Eligible applicants may enter into contracts, including consortia agreements (as set forth in the PHS Grants Policy Statement, dated April 1, 1994), as necessary to meet the requirements of the program and strengthen the overall application.

   Funding Preferences: Funding preference will be given to re- competing ICRCs. These centers represent a long-term investment for NCIPC and an established resource for Injury Control-related issues for their States and regions.

5. Program Requirements

   In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following activities:

   1. Applicants must demonstrate expertise and conduct research projects in at least one of the three phases of injury control (prevention, acute care, or rehabilitation) and are encouraged to be comprehensive.

   2. Applicants must document ongoing injury-related research projects or control activities currently supported by other sources of funding.

   3. Applicants must provide a director (Principal Investigator) who has specific authority and responsibility to carry out the project. The director must report to an appropriate institutional official, e.g., dean of a school, vice president of a university, or commissioner of health. The director must have no less than thirty percent effort devoted solely to this project with an anticipated range of thirty percent-fifty percent.

   4. Applicants must demonstrate experience in successfully conducting, evaluating, and publishing injury research and/or designing, implementing, and evaluating injury control programs.

   5. Applicants must provide evidence of working relationships with outside agencies and other entities which will allow for implementation of any proposed intervention activities.

   6. Applicants must provide evidence of involvement of specialists or experts in medicine, engineering, epidemiology, law and criminal justice, behavioral and social sciences, biostatistics, and/or

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      public health as needed to complete the plans of the center. These are considered the disciplines and fields for ICRCs. An ICRC is encouraged to involve biomechanicists in its research. This may be achieved through collaborative relationships as it is not a requirement that all ICRCs have biomechanical engineering expertise.

   7. Applicants must have established curricula and graduate training programs in disciplines relevant to injury control (e.g., epidemiology, biomechanics, safety engineering, traffic safety, behavioral sciences, or economics).

   8. Applicants must disseminate injury control research findings, translate them into interventions, and evaluate their effectiveness.

   9. Applicants must have an established relationship, demonstrated by letters of agreement, with injury prevention and control programs or injury surveillance programs being carried out in the region in which the ICRC is located. Cooperation with private-sector programs, e.g., ``Safe USA'' partnerships, is encouraged.

   10. Applicants should have an established or documented planned relationship with organizations or individual leaders in communities where injuries occur at high rates, e.g., minority communities.

6. Content

   The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Applications should include the following information:

   1. Face page

   2. Description (abstract) and personnel

   3. Table of contents

   4. Detailed budget for the initial budget period: The budget should reflect the composite figures for the grant. In addition, separate budgets (direct and indirect costs) and justifications should be provided for the following categories of activities:

      1. Core activities, including management and administrative functions, other non-research activities (e.g., education/training, consultation, technical assistance, translation/dissemination, program and policy development and evaluation, advocacy, and media activities, etc.), and small seed projects of less than $15,000 for one year or less.

      2. Research Studies:

      (1) Small studies of $15,000-75,000 for one to three years duration. These projects might be expansions of seed projects, either further developing methods or hypotheses in preparation for a larger investigation leading to the submission of an RO1 level proposal, or may be stand-alone investigations sufficient to yield results worthy of publication in a peer-reviewed journal and/or a technical report for a legislative body, governmental agency, or injury control program.

      (2) Larger scale studies with annual budgets exceeding $75,000 and lasting up to five years. These projects typically will test hypotheses and employ more sophisticated methodologies and/or larger sample sizes than small studies.

      For seed projects, only modest descriptions are required within the application and/or clear definition of procedures used to select the projects. More detailed descriptions, commensurate with costs, are required for both small studies and larger scale projects.

      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 two copies of the application, the applicant must use asterisks to indicate those individuals for whom salaries and fringe benefits are not shown; the subtotals must still be shown. In addition, the applicant must submit an additional copy of page four 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.

   5. Budget for entire proposed project period including budgets pertaining to consortium/contractual arrangements.

   6. Biographical sketches of key personnel, consultants, and collaborators, beginning with the Principal Investigator and core faculty.

   7. Other support: This listing should include all other funds or resources pending or currently available. For each grant or contract include source of funds, amount of funding (indicate whether pending or current), date of funding (initiation and termination), and relationship to the proposed program.

   8. Resources and environment.

   9. Research plan:

      1. ICRCs are to develop a range of research and other non-research activities that are designed to advance the field of injury control through development of new scientific or surveillance methods, creation of new knowledge, and translation of knowledge into training, program and policy development and evaluation activities or other applications that will ultimately reduce injuries or their effects. ICRC applications should articulate how the activities of their program are integrated with each other, demonstrating ICRCs activities and their potential impact.

      2. A detailed research plan (design and methods) including hypothesis, expected outcome, value to field, measurable, and time- framed objectives consistent with the activities for each project within the proposed grant.

         (1) Seed projects require a short write-up describing the injury control context of the study, the objective, the design, the setting and participants, the intervention being addressed, main outcome measurements, expected results, time lines, cost (direct and indirect), and plans for translation/dissemination, and/or clear definition of procedures used to select the projects.

         (2) Small research projects require a ten to fifteen page summary describing the accomplishment of all the steps, including the development and testing of methods, instruments, and collection of preliminary data needed to take an innovative approach and develop it to the level of a larger investigation leading to the submission of an RO1 level proposal or a stand-alone investigation sufficient to yield results worthy of publication in a peer-reviewed journal and/or a technical report for a legislative body, governmental agency, or injury control program.

         (3) Large research projects require an RO1 level summary as described in the PHS 398 (Rev. 5/01) guidelines. The summary should be included as appendices of the application.

         (4) A detailed evaluation plan which should address outcome and cost-effectiveness evaluations as well as formative, efficacy, and process evaluation.

         In the research plan section of the application, include a description for each small and large research project:

         (1) Title of Project

         (2) Project Director/Lead Investigator

         (3) Institution(s)

         (4) Categorization as to ``Prevention, Acute Care, Rehabilitation, or Biomechanics''

         (5) Categorization as to which NCIPC research agenda priority area the project addresses. Also, a brief description on how it addresses that priority area. If a priority area is not addressed, provide an explanation

         (6) Categorization as to ``Seed Project, Small Project, or Large Project''

         (7) Categorization as to ``New or Ongoing Project''

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         (8) Cost/Year (Total of Direct and Indirect)

         (9) Research Training? Names, Degrees of Persons Trained or in Training

         (10) Key Words

         (11) Brief Summary of Project including Intended Application of Finding (Abstract)

      3. A description of the core faculty and their roles in implementing and evaluating the proposed programs. The applicant should clearly specify how disciplines will be integrated to achieve the ICRCs objectives.

      4. Charts showing the proposed organizational structure of the ICRC and its relationship to the broader institution of which it is a part and, where applicable, to affiliate institutions or collaborating organizations. These charts should clearly detail the lines of authority as they relate to the center or the project, both structurally and operationally. ICRC directors should report to an appropriate organizational level (e.g. dean of a school, vice president of a university, or commissioner of health), demonstrating strong institution-wide support of ICRC activities and ensuring oversight of the process of interdisciplinary activity.

      5. Documentation of the involved public health agencies and other public and private sector entities to be involved in the proposed program, including letters that detail commitments of support and a clear statement of the role, activities, and participating personnel of each agency or entity.

7. Submission and Deadline

   Submit the original and two copies of PHS 398 (OMB Number 0925- 0001) and adhere to the instructions on the Errata Instruction sheet for PHS 398. Forms are available at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm. 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 at: 770-488-2700. Application forms can be mailed to you.

   The application must be received by 5 P.M. Eastern Time October 28, 2002. Submit the application to: Technical Information Management Section-PA03008, CDC Procurement and Grants Office, 2920 Brandywine Road, Suite 3000, Atlanta, Georgia 30341.

   Applications may not be submitted electronically.

   Deadline: The 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 a 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 returned to the applicant.

8. Evaluation Criteria

   Applications will be reviewed by CDC staff for completeness and responsiveness as outlined under the previous heading Program Requirements. Incomplete applications and applications that are not responsive will be returned to the applicant without further consideration.

   Applications which are complete and responsive may be subjected to a preliminary evaluation (triage) by the Injury Research Grant Review Committee (IRGRC) to determine if the application is of sufficient technical, and scientific merit to warrant further review by the IRGRC. Applications that are determined noncompetitive will not be considered, and IRGRC will promptly notify the investigator/program director and the official signing for the applicant organization. Applications determined to be competitive will be evaluated by a dual review process.

   Awards will be made based on priority scores assigned to applications by the IRGRC, programmatic priorities and needs determined by a secondary review committee (the Advisory Committee for Injury Prevention and Control), and the availability of funds. 1. Review by the Injury Research Grants Review Committee (IRGRC)

   Initial peer-review of ICRC grant applications will be conducted by the IRGRC. The IRGRC will recommend the application for further consideration. For those applications recommended for further consideration, a team of peer reviewers, including members of the IRGRC, will conduct on-site visits at each applicant institution, generate summary statements for the visits, and report the assessment to the IRGRC.

   Factors to be considered by the IRGRC include:

   1. The specific aims of the application, e.g., the long-term objectives and intended accomplishments. Approval of research projects (including new research projects proposed during the five-year funding cycle) is subject to peer-review.

      (1) Seed projects will be evaluated collectively on the mechanism for solicitation of projects, on the technical/scientific merit review, and on the selection and monitoring of projects.

      (2) Small projects will be evaluated individually on the innovative approach and proposed methods for achieving an investigation sufficient to support a submission of an RO1 level proposal and/or worthy of publication in a peer-reviewed journal and/or a technical report for a legislative body, governmental agency, or injury control program.

      (3) Large projects will be evaluated individually according to existing RO1 level project standards as described in the PHS 398 (Rev. 4/98) guidelines. The application must have a minimum of three large research projects approved in order to be recommended for further consideration.

   2. The scientific and technical merit of the overall application, including the significance and originality (e.g., new topic, new method, new approach in a new population, or advancing understanding of the problem) of the proposed research.

   3. The extent to which the evaluation plan will allow for the measurement of progress toward the achievement of stated objectives. Does your application specify how you will measure the effectiveness of your program?

   4. Qualifications, adequacy, and appropriateness of personnel to accomplish the proposed activities.

   5. The soundness of the proposed budget in terms of adequacy of resources and their allocation.

   6. In addition to conducting defined research projects, ICRCs are expected to devote substantial attention to activities directed at advancing the field through other activities that are designed to improve research capabilities and translate research into practice. Examples of activities include: Consultation and technical assistance that are responsive to regional and state priorities, professional training for researchers and practitioners, program development, and evaluation endeavors. The degree of effort devoted to these aspects of an ICRCs program should be clearly stated in the justification and the budget. The degree of effort may be varied and should reflect the specific focus and goals of the ICRC.

   7. Details of progress in the most recent funding period should be provided in the application if the applicant is submitting a re- competing

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      application. Documented examples of success include: Development of pilot projects; completion of high quality research projects; publication of findings in peer reviewed scientific and technical journals; number of professionals trained; ongoing provision of consultation and technical assistance; integration of disciplines; translation of research into implementation; and impact on injury control outcomes including legislation, regulation, treatment, and behavior modification interventions.

   8. Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects?

   9. Does the applicant meet 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, 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 or communities and recognition of mutual benefits.

   10. Does the application adequately address the requirements of the ``PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions?' 2. Review by the CDC Advisory Committee for Injury Prevention and Control (ACIPC)

       Secondary review of ICRC grant applications with a priority score of 350 or better from the initial peer-review by the IRGRC will be conducted by the Science and Program Review Section (SPRS) of the ACIPC. The SPRS consists of ACIPC members, Federal Ex Officio participants, and organizational liaisons. The Federal Ex Officio participants will be responsible for identifying proposals in overlapping areas of research interest so that unwarranted duplication in federally funded research can be avoided. The NCIPC Division Associate Directors for Science (ADS) or their designees will address the SPRS to assure that research priorities of the announcement are understood and to provide background regarding current research activities. These recommendations will be presented to the entire ACIPC in the form of a report by the Chairman of the SPRS. The ACIPC will vote to approve, disapprove, or modify these recommendations for funding consideration.

       These recommendations, based on the results of the review by the IRGRC, the relevance and balance of the proposed research relative to the NCIPC programs and priorities, and the assurance of no duplication of federally-funded research, are presented to the Director, NCIPC, for funding decisions.

       Factors to be considered by the ACIPC include:

   1. The results of the peer-review.

   2. The significance of the proposed activities as they relate to national program priorities, geographic balance, and the achievement of national objectives.

   3. The overall balance of the ICRC program in addressing the three phases of injury control (prevention, acute care, and rehabilitation); the control of injury among populations who are at increased risk, including racial/ethnic minority groups, the elderly and children; the major causes of intentional and unintentional injury; and the major disciplines of injury control (such as biomechanics, epidemiology, and behavioral science).

   4. Budgetary considerations. The ACIPC will recommend annual funding levels as detailed is section ``D. Funds'' of this announcement. 3. Continued Funding

      Continuation awards within the project period will be made on the basis of the availability of funds and the following criteria:

   1. The accomplishments of the current budget period show that the applicant's objectives as prescribed in the yearly work plans are being met.

   2. The objectives for the new budget period are realistic, specific, and measurable.

   3. The methods described will clearly lead to achievement of these objectives.

   4. The evaluation plan allows management to monitor whether the methods are effective by having clearly defined process, impact, and outcome objectives, and the applicant demonstrates progress in implementing the evaluation plan.

   5. The budget request is clearly explained, adequately justified, reasonable, and consistent with the intended use of grant funds.

      1. Other Requirements

      Technical Reporting Requirements

      Provide CDC with the original plus two copies of:

      1. Annual progress report. The progress report will include a data requirement that demonstrates measures of effectiveness.

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

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

      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 I of this announcement as posted on the CDC home web page.

      AR-1 Human Subjects Certification 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 Requirement AR-11 Healthy People 2010 AR-12 Lobbying Restrictions AR-13 Prohibition on Use of CDC funds for Certain Gun Control Activities AR-20 Conference Activities within Grants/Cooperative Agreements

10. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page Internet address--http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative Agreements''. For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

    For business management and budget assistance, contact: Nancy Pillar, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-2751, E-mail: nfp6@cdc.gov.

    For program technical assistance, contact: Tom Voglesonger, Program Manager, Office of Research Grants, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, NE., (K58), Atlanta, GA 30341-3724, Telephone: 770-488-4265, E-mail: tdv1@cdc.gov.

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    Dated: September 5, 2002. Sandra R. Manning, Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

    [FR Doc. 02-23151Filed9-11-02; 8:45 am]

    BILLING CODE 4163-18-P