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

[Federal Register: June 13, 2000 (Volume 65, Number 114)]

[Notices]

[Page 37149-37153]

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

[DOCID:fr13jn00-81]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01007]

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) 2001 funds for Injury Control Research Center (ICRC) grants. This program addresses the ``Healthy People 2010'' priority areas of Injury Prevention, Unintentional Injury Prevention, and Violence and Abuse Prevention. For the conference copy of ``Healthy People 2010,'' visit the Internet site: 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; Injury in America; Injury Prevention: Meeting the Challenge; Cost of Injury: A Report to the Congress; and any list of research priorities published by the National Center for Injury Prevention and Control (NCIPC);

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

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

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

2. Eligible Applicants

   This announcement will provide funding for applicants in regions which do not have funded Injury Control Research Centers (ICRCs) and for applicants in regions which have funded centers which must re- compete for funding.

   Eligible applicants include all nonprofit and for-profit organizations in

   [[Page 37150]]

   Regions 1, 2, 5, 6, 7, 8, and 9. Thus, universities, colleges, research institutions, hospitals, other public and private 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 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont), Region 2 (New Jersey, New York, Puerto Rico, and Virgin Islands), Region 5 (Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin), Region 6 (Arkansas, Louisiana, New Mexico, Oklahoma, and Texas), Region 7 (Iowa, Kansas, Missouri, and Nebraska), Region 8 (Colorado, Montana, North Dakota, South Dakota, Utah, and Wyoming), and Region 9 (Arizona, California, Hawaii, Nevada, American Samoa, Guam, Mariana Islands, Marshall Islands, Micronesia, and Palau).

   Note:

   ICRC grant awards are made to the applicant institution/ organization, not the Principal Investigator.

   Note:

   Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

3. Availability of Funds

   Approximately $3,622,000 is expected to be available in FY 2001 to fund approximately four awards. It is expected that the average award will be $905,500 (total of direct and indirect costs). It is expected that the awards will begin on or around September 1, 2001, 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.

   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 8.0 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-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.

4. Program Requirements

   The following are applicant requirements:

   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 30 percent effort devoted solely to this project with an anticipated range of 30 percent--50 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 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, again, 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 demonstrate the ability to 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.

5. Application Content

   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

      [[Page 37151]]

   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 a one year period or less.

      2. Research Studies:

      (1) Small studies of $15,000-75,000 for each, of 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.

   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 so as to demonstrate the whole of the ICRCs activities and their potential impact.

      2. A detailed research plan (design and methods) including hypothesis and expected outcome, value to field, and specific, 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 10-15 page write up describing the accomplishment of all the steps, including the development and testing of methods, the instruments, and the 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 write up as described in the PHS 398 (Rev. 4/98) guidelines and 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.

         Include in the narrative for each small research project and large project in the research plan section of the application:

         (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 ``Seed Project, Small Project, or Large Project''

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

         (7) Cost/Year (Direct and Indirect)

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

         (9) Key Words

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

      3. A description of the core faculty and its role 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.

         An applicant organization has the option of having specific salary and fringe benefit amounts for individuals omitted from the copies of the application which are made available to outside reviewing groups. To exercise this option: on the original and five copies of the application, the applicant must use asterisks to indicate those individuals for whom salaries and fringe benefits are not shown; 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.

6. Submission and Deadline

   Submit the original and five copies of PHS 398 (OMB Number 0925- 0001)and adhere to the instructions on the Errata Instruction sheet for PHS 398). Forms are in the application kit.

   On or before November 1, 2000, submit the application to the Grants Management Specialist identified in the Where to Obtain Additional Information section of this announcement.

   [[Page 37152]]

   Applications shall be considered as meeting the deadline if they are either:

   1. Received on or before the deadline date; or

   2. Sent on or before the deadline date and received in time for submission to the independent review group. Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.

   Late Applications: Applications which do not meet the criteria in (1.) or (2.) above are considered late applications, will not be considered, and will be returned to the applicant.

7. Evaluation Criteria

   Upon receipt, 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. CDC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization. Those applications judged to be competitive will be further 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, which will recommend the application for further consideration or not 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 its 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. An 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 application objectives.

      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 such 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 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; 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?

      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 will be conducted by the Science and Program Review Work Group (SPRWG) of the ACIPC. The SPRWG 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 SPRWG 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 SPRWG. 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

         [[Page 37153]]

         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 under the heading, Availability of Funds.

   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; and

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

8. Other Requirements

   Technical Reporting Requirements

   Provide CDC with original plus two copies of

   1. progress report annually;

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

   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 Addendum 1 in the application kit.

   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

   1. 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.

10. Where To Obtain Additional Information

    For this announcement and other CDC announcements, see the CDC home page on the Internet: http://www.cdc.gov.

    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. A complete program description and information on application procedures are contained in the application package.

    If you have questions after reviewing the contents of all the documents, business management assistance may be obtained from: Joanne Wojcik, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), Colgate Building, Room 3000, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone 770-488-2717, Internet address: jcw6@cdc.gov

    Programmatic assistance may be obtained from: 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, Internet address: tdv1@cdc.gov.

    Please refer to Announcement 01007 when requesting information and submitting an application.

    Dated: June 7, 2000. Henry S. Cassell, III, Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

    [FR Doc. 00-14831Filed6-12-00; 8:45 am]

    BILLING CODE 4163-18-P