[Federal Register Volume 64, Number 35 (Tuesday, February 23, 1999)]
[Notices]
[Pages 8820-8823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)
[Announcement 99036]


Extramural Grants for Trauma Care Systems Evaluation; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces that 
grant applications are being accepted for Injury Prevention and Control 
Research Grants (RO1s) for fiscal year (FY) 1999.
    This program addresses the priority areas of Violent and Abusive 
Behavior and Unintentional Injuries.
    The purpose of this program is to:
    1. Support injury prevention and control research on priority 
issues as delineated in: Healthy People 2000; Injury Control in the 
1990's: A National Plan for Action; Injury in America; Injury 
Prevention: Meeting the Challenge; and Cost of Injury: A Report to the 
Congress;
    2. Encourage professionals from a wide spectrum of disciplines such 
as engineering, medicine, health care, public health, health care 
research, behavioral and social sciences, and others, to undertake 
research to prevent and control injuries.
    3. Expand the development and evaluation of current or new 
intervention methods and strategies for preventing and controlling 
injuries.
    4. Build the scientific base for the prevention and control of 
injuries and deaths.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-profit organizations and by governments and their agencies; that 
is, universities, colleges, research institutions, hospitals, other 
public and private nonprofit and for-profit organizations, State and 
local governments or their bona fide agents, and federally recognized 
Indian tribal governments, Indian tribes, or Indian tribal 
organizations.
    Applicant requirements:
    1. A principal investigator who has conducted research, published 
the findings in peer-reviewed journals, and has specific authority and 
responsibility to carry out the proposed project.
    2. Demonstrated experience (on the applicant's project team) in 
conducting, evaluating, and publishing in peer-reviewed journals injury 
control research.
    3. Effective and well-defined working relationships within the 
performing organization and with outside entities that will ensure 
implementation of the proposed activities.
    4. The ability to carry out an injury control research project.
    5. The overall match between the applicant's proposed theme and 
research objectives and the program interests as described under the 
heading ``Programmatic Interests.''

    Note: Pub. L. 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.

C. Availability of Funds

    Approximately $1.5 million is available for one FY 1999 injury 
research grant that address the evaluation of trauma care systems. It 
is expected that the award will begin on or about September 1, 1999, 
and will be made for a 12-month budget period within a project period 
of up to three years. Funding estimates may vary and are subject to 
change.
    The maximum funding level for year one will not exceed $1,500,000 
(including both direct and indirect costs). Applications that exceed 
the funding cap of $1,500,000 will be excluded from the competition and 
returned to the applicant. Funding for years two and three may be 
increased to $2,000,000 per year (including both direct and indirect 
costs) bringing the maximum total for the three year project period to 
$5.5 million subject to the availability of Federal funds.

    Note: Grant funds will not be made available to support the 
provision of direct care. 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.

Programmatic Interests

    There is programmatic interest in comparing the costs and outcomes 
of trauma care between trauma center and non-trauma center hospitals. 
There is special interest in the central question of whether trauma 
centers provide more cost-effective care than non-trauma center 
hospitals. Priority is placed on collecting cost and outcome data in 
the same properly designed observational study, with special emphasis 
on collecting data on functional outcomes of trauma patients treated in 
trauma center and non-trauma center hospitals, including functional 
outcomes measured after hospital discharge. Functional outcome measures 
of interest include both generic and condition-

[[Page 8821]]

specific measures that are applicable to the health status and quality 
of life of trauma patients included in the study. The cost measure of 
interest is the monetary value of resources expended during acute 
hospitalization in a trauma center or non-trauma center hospital. A 
clearly defined traumatic injury condition or set of traumatic injury 
conditions is needed to facilitate data collection, follow up, and 
comparison between patients treated in different hospitals, 
appropriately adjusted for case-mix differences. A multi-hospital 
project, with diverse geographic representation, is most likely to 
yield generalizable findings and help establish a uniform approach to 
evaluating trauma costs and outcomes.

Funding Preferences

    Preference will be given to applicants who include: 1. trauma 
center and non-trauma center hospitals (trauma center designation 
refers to designation by a recognized State or regional authority) from 
at least two of the four major geographic regions of the United States 
(Northeast, Midwest, South, and West); and 2. consultation with key 
stakeholder groups during the study design phase. These groups include 
trauma care professional and multi-disciplinary associations, State and 
regional emergency medical services (EMS) agencies responsible for 
trauma systems, managed care organizations and other health care 
policymakers and payers.
    In accordance with the US Bureau of the Census classification of 
the 50 States and the District of Columbia, the four major geographic 
regions of the United States are: Northeast--Maine, New Hampshire, 
Vermont, Massachusetts, Rhode Island, Connecticut, New York, New 
Jersey, Pennsylvania. Midwest--Ohio, Indiana, Illinois, Michigan, 
Wisconsin, Minnesota, Iowa, Missouri, North Dakota, South Dakota, 
Nebraska, Kansas. South--Delaware, Maryland, District of Columbia, 
Virginia, West Virginia, North Carolina, South Carolina, Georgia, 
Florida, Kentucky, Tennessee, Alabama, Mississippi, Arkansas, 
Louisiana, Oklahoma, Texas. West--Montana, Idaho, Wyoming, Colorado, 
New Mexico, Arizona, Utah, Nevada, Washington, Oregon, California, 
Alaska, Hawaii.

D. Application Content

    Applications should follow the PHS-398 (Rev. 5/95) 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. This focus should be based 
on recommendations in Healthy People 2000; Injury in America; Injury 
Prevention: Meeting the Challenge; and Cost of Injury and should seek 
creative approaches that will contribute to a national program for 
injury control.
    2. Specific, measurable, and time-framed objectives.
    3. A detailed plan describing the methods by which the objectives 
will be achieved and evaluated, including their sequence. A 
comprehensive evaluation plan is an essential component of the 
application.
    4. A description of the grant's principal investigator's role and 
responsibilities.
    5. A description of all the project staff regardless of their 
funding source. 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 
commitments of support and a clear statement of their roles.
    8. A detailed first year's budget for the grant with future annual 
projections, if relevant. Awards will be made for a project period of 
up to three years.
    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.

F. 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 April 15, 1999, submit to: Anne Fogelsong, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Announcement #99036, Centers for Disease Control and Prevention 
(CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146.
    Applications shall be considered as meeting the deadline if they 
are received at the above address on or before the deadline date; or 
sent on or before the deadline date, and received in time for the 
review process. Applicants should 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.

G. Evaluation Criteria

    (Please take special notice as elements of this section have 
changed since the last announcement. A more complete description of the 
grant award selection process policy can be obtained by calling the 
phone number found under Where to Obtain Additional Information in the 
application package).
    Upon receipt, applications will be reviewed by CDC staff for 
completeness and responsiveness as outlined under Eligible Applicants, 
subtitle, Applicant Requirements (Item 1-5). 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 
proposal.
    Applications which are complete and responsive will be subjected to 
a preliminary evaluation (triage) by a peer review committee, 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 determined by the Director of the National Center 
for Injury Prevention and Control (NCIPC) based on priority scores 
assigned to applications by the primary review committee, 
recommendations by the secondary review committee, consultation with 
NCIPC senior staff, and the availability of funds.
    1. The primary review will be a peer review conducted by the IRGRC. 
All proposals will be reviewed for scientific merit by a committee of 
no less than

[[Page 8822]]

three reviewers with appropriate expertise using current National 
Institutes of Health (NIH) criteria to evaluate the methods and 
scientific quality of the proposal. Factors to be considered will 
include:
    a. The specific aims of the research project, i.e., the broad long-
term objectives, the intended accomplishment of the specific research 
proposal, and the hypothesis to be tested.
    b. The background of the proposal, i.e., the basis for the present 
proposal, the critical evaluation of existing knowledge, and specific 
identification of the injury control knowledge gaps which the proposal 
is intended to fill.
    c. The significance and originality from a scientific or technical 
standpoint of the specific aims of the proposed research, including the 
adequacy of the theoretical and conceptual framework for the research.
    d. The progress of preliminary studies (optional) pertinent to the 
application.
    e. The adequacy of the proposed research design, approaches, and 
methodology to carry out the research, including quality assurance 
procedures, plan for data management, and statistical analysis plan.
    f. The extent to which the research findings will lead to feasible, 
cost-effective injury interventions.
    g. The extent to which the evaluation plan will allow the 
measurement of progress toward the achievement of the stated 
objectives.
    h. Qualifications, adequacy, and appropriateness of personnel to 
accomplish the proposed activities.
    i. The degree of commitment and cooperation of other interested 
parties (as evidenced by letters detailing the nature and extent of the 
involvement).
    j. Gender and minority issues--Are plans to include both sexes and 
minoritities and their subgroups adequately developed (as appropriate 
for the scientific goals of the project)? Are strategies included for 
the recruitment and retention of human subjects?
    k. Human Subjects--Are the procedures proposed adequate for the 
protection of human subjects and are they fully documented? Are all 
procedures in compliance with applicable published regulations?
    l. The reasonableness of the proposed budget to the proposed 
research and demonstration program.
    m. Adequacy of existing and proposed facilities and resources.
    2. The secondary review will be conducted by the Science and 
Program Review Work Group (SPRWG) from the Advisory Committee for 
Injury Prevention and Control (ACIPC). At the SPRWG's request, Federal 
ex officio members may be invited to attend the secondary review. The 
Federal ex officio members will be responsible for identifying 
proposals in overlapping areas of research interest so that unwarranted 
duplication in federally-funded research can be avoided. At the SPRWG's 
request, NCIPC Division Associate Directors (ADS) for science may be 
invited to attend the secondary review to assure that research 
priorities of the announcement are understood and to provide background 
regarding current research activities. The SPRWG may 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 proposal's 
priority score as the primary factor in the selection process.
    b. The match between the proposal and the program announcement's 
programmatic interests and funding preferences.
    c. The relevance and balance of proposed research relative to the 
NCIPC programs and priorities.
    d. The significance of the proposed activities in relation to the 
priorities and objectives stated in Healthy People 2000, Injury in 
America, Injury Prevention, Meeting the Challenge, and Cost of Injury.
    e. Budgetary considerations.
    Only SPRWG members will vote on funding recommendations. These 
recommendations will be carried to the entire ACIPC in the form of a 
report. The ACIPC may vote to approve, disapprove, or modify the 
recommendations for funding. These recommendations will then be 
presented to the NCIPC Director for final decision.
    3. Continued Funding. Continuation awards made after FY 1999, but 
within the project period, will be made on the basis of the 
availability of funds and the following criteria:
    a. The accomplishments reflected in the progress report of the 
continuation application indicate that the applicant is meeting 
previously stated objectives or milestones contained in the project's 
annual workplan and satisfactory progress demonstrated through 
presentations at work-in-progress monitoring workshops.
    b. The objectives for the new budget period are realistic, 
specific, and measurable.
    c. The methods described will clearly lead to achievement of these 
objectives.
    d. The evaluation plan will allow management to monitor whether the 
methods are effective.
    e. The budget request is clearly explained, adequately justified, 
reasonable and consistent with the intended use of grant funds.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with an 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 report and performance report, no more than 90 
days after the end of the project period.
    Send all reports to: Anne Foglesong, Grants Management Specialist, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, 
Atlanta, Georgia 30341-4146.
    The following additional requirements are applicable to this 
program. For a complete description of each see Addendum 1 in the 
application package.

AR98-1--Human Subjects Certification
AR98-2--Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR98-9--Paperwork Reduction Act Requirements
AR98-10--Smoke-Free Workplace Requirement
AR98-11--Healthy People 2000
AR98-12--Lobbying Restrictions
AR98-13--Prohibition on Use of CDC funds for Certain Gun Control 
Activities

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 391(a) and 393(a) (42 
U.S.C. 280b(a) and 280b-1(a)) of the Public Health Service Act, as 
amended. The catalog of Federal Domestic Assistance number is 93.136.

J. Where To Obtain Additional Information

    Please refer to Program Announcement Number 99036 when requesting 
information. 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

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technical assistance may be obtained from: Anne Foglesong, Grants 
Management Specialist, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, 
Atlanta, Georgia 30341-4146, Telephone: (770) 488-2724, Email Address: 
[email protected].
    For program technical assistance, contact: Ted Jones, Program 
Manager, Office of Research Grants, National Center for Injury 
Prevention and Control, Centers for Disease Control and Prevention 
(CDC), 4770 Buford Highway, NE, Mailstop K-58, Atlanta, GA 30341-3724, 
Telephone (770) 488-4824, Internet address: [email protected].
    This and other CDC announcements are available through the CDC 
homepage on the Internet. The address for the CDC homepage is <http://
www.cdc.gov>.
    Interested applicants may receive a draft copy of the ``Policy for 
Solicitation and Selection of Injury Research Grant Proposals'' by 
calling 770/488-4265.

    Dated: February 17, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-4389 Filed 2-22-99; 8:45 am]
BILLING CODE 4163-18-P