[Federal Register Volume 62, Number 245 (Monday, December 22, 1997)]
[Notices]
[Pages 66871-66876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33297]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Number 816]


Individual Grants for Extramural Injury Research for Primary 
Prevention of Unintentional Injuries, Acute Care, Disability 
Prevention, and Biomechanics; Notice of Availability of Funds for 
Fiscal Year 1998

Introduction

    The Centers for Disease Control and Prevention (CDC) announces that 
applications are being accepted for Injury Prevention and Control 
Research Grants for fiscal year (FY) 1998.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a national activity to 
reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Unintentional Injuries. 
(To order a copy of Healthy People 2000, see the Section Where to 
Obtain Additional Information.)

Authority

    This program is authorized under Sections 301, 391-394 of the 
Public Health Service Act (42 USC 241, 280b-280b-3), as amended. 
Program regulations are set forth in Title 42 CFR Part 52.

Smoke-Free Workplace

    CDC strongly encourages all grant and cooperative agreement 
recipients to provide a smoke-free workplace and to promote the non-use 
of all tobacco products, and Public Law 103-227, the Pro-Children Act 
of 1994, prohibits smoking in certain facilities that receive Federal 
funds in which education, library, day care, health care, and early 
childhood development services are provided to children.

Eligible Applicants

    Eligible applicants include all nonprofit and for-profit 
organizations. Thus State and local health departments and State and 
local governmental agencies, universities, colleges, research 
institutions, and other public and private organizations, including 
small, minority and/or woman-owned businesses are eligible for these 
research grants. Current holders of CDC injury control research 
projects are eligible to apply.

    Note: An organization described in section 501(c)(4) of the 
Internal Revenue Code of 1986 which engages in lobbying activities 
shall not be eligible to receive Federal funds constituting an 
award, a grant, contract, loan, or any other form.

Availability of Funds

    Approximately $2.7 million is available for FY 1998 injury research 
grants that include funding for projects that address primary 
prevention of unintentional injuries (home and leisure, and motor 
vehicle related-injuries), acute care, the prevention of secondary 
conditions in persons with disabilities, and biomechanics.
    Approximately $1,800,000 is available to support 6-8 projects that 
address primary prevention of unintentional injuries (home and leisure, 
and motor vehicle related-injuries), acute care, and the prevention of 
secondary conditions in persons with disabilities. Awards will be made 
for a 12-month budget period within a project period not to exceed 
three years. The maximum funding level per year will not exceed 
$300,000 (including both direct and indirect costs). Applications that 
exceed the funding cap of $300,000 will be excluded from the 
competition and returned to the applicant.
    Approximately $900,000 is available to support 3-5 projects that 
address

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biomechanics. Awards will be made for a 12-month budget period within a 
project period not to exceed three years. The maximum funding level per 
year will not exceed $300,000 (including both direct and indirect 
costs). Applications that exceed the funding cap will be excluded from 
the competition and returned to the applicant.
    The specific program priorities for these funding opportunities are 
outlined with examples in this announcement under the subheading, 
``Programmatic Priorities.''
    Continuation awards within the project period will be made based on 
satisfactory progress demonstrated by investigators at work-in-progress 
monitoring workshops (travel expenses for this annual one day meeting 
should be included in the applicant's proposed budget), the achievement 
of workplan milestones reflected in the continuation application, and 
the availability of Federal funds. In addition, if funds are available, 
continuation awards may be eligible for increased funding to offset 
inflationary costs.

Use of Funds-Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. 1352 (which has been in effect since December 
23, 1989), recipients (and their subtier contractors) are prohibited 
from using appropriated Federal funds (other than profits from a 
Federal contract) for lobbying Congress or any Federal agency in 
connection with the award of a particular contract, grant, cooperative 
agreement, or loan. This includes grants/cooperative agreements that, 
in whole or in part, involve conferences for which Federal funds cannot 
be used directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.
    In addition, the current HHS Appropriations Act expressly prohibits 
the use of appropriated funds for indirect or ``grass roots'' lobbying 
efforts that are designed to support or defeat legislation pending 
before State legislatures. Section 503 of the law provides as follows:

    Section 503(a) No part of any appropriation contained in this 
Act shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for 
the preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress or any 
State legislature, except in presentation to the Congress or any 
State legislature itself .
    (b) No part of any appropriation contained in this Act shall be 
used to pay the salary or expenses of any grant or contract 
recipient, or agent acting for such recipient, related to any 
activity designed to influence legislation or appropriations pending 
before the Congress or any State legislature.

Prohibition on Use of CDC Funds for Certain Gun Control Activities

    The Departments of Labor, Health and Human Services, and Education, 
and Related Agencies Appropriations Act, 1998, specifies that: ``none 
of the funds made available for injury prevention and control at the 
Centers for Disease Control and Prevention may be used to advocate or 
promote gun control.''
    Anti-Lobbying Act requirements prohibit lobbying Congress with 
appropriated Federal monies. Specifically, this Act prohibits the use 
of Federal funds for direct or indirect communications intended or 
designed to influence a Member of Congress with regard to specific 
Federal legislation. This prohibition includes the funding and 
assistance of public grassroots campaigns intended or designed to 
influence Members of Congress with regard to specific legislation or 
appropriation by Congress.
    In addition to the restrictions in the Anti-Lobbying Act, CDC 
interprets the language in the CDC's Appropriations Act to mean that 
CDC's funds may not be spent on political action or other activities 
designed to affect the passage of specific Federal, State, or local 
legislation intended to restrict or control the purchase or use of 
firearms.

Background and Definitions

A. Background

    By nearly every measure, injury ranks as one of the nation's most 
pressing health problems. More than 150,000 people die each year as a 
result of motor vehicle crashes, falls, fires, drownings, poisonings, 
suicides, homicides, and other types of injuries. Each year, 56 million 
people sustain injuries severe enough to require medical treatment, and 
for every 100 people injured, the effects are serious enough to require 
162 days of restricted activity. Thirty-four million injured persons 
visit emergency departments and another 2.7 million are hospitalized.
    Injury is the leading cause of death for Americans between the ages 
of one and 44 years, and the leading cause of potential years of life 
lost. Young children are at the greatest risk from car crashes (both as 
occupants and pedestrians), drownings, and fires. Adolescents and young 
adults, especially males, are at highest risk of death from motor-
vehicle crashes and gunshot wounds. For people older than 75, falls are 
the leading cause of death.
    Although the greatest cost of injury is in human suffering and 
loss, the financial cost of injury is estimated at more than $224 
billion, an increase of 42 percent in the last decade. These costs 
include direct medical care and rehabilitation costs as well as lost 
wages of the individual and productivity losses to the nation.
    Opportunities to understand and prevent unintentional injuries and 
reduce their effects are available. Maximizing these opportunities for 
prevention and control requires a broad approach which will incorporate 
many disciplines that previously have not been an integral part of 
public health efforts. Many of these opportunities and research 
priorities are identified in Healthy People 2000; Injury in America 
(National Academy Press, 2101 Constitution Avenue, NW, Washington, D.C. 
20418--ISBN0-309-03545-7); Injury Prevention: Meeting the Challenge 
(supplement to the American Journal of Preventive Medicine, (Vol. 5, 
no. 3, 1989); and Cost of Injury (Dorothy P. Rice, Ellen J. MacKenzie, 
and Associates, Cost of Injury: A Report to the Congress, San 
Francisco, California: Institute for Health and Aging, University of 
California and Injury Prevention Research Center, The Johns Hopkins 
University, 1989).

B. Definitions

    1. Injury is defined as physical damage to an individual that 
occurs over a short period of time as a result of acute exposure to one 
of the forms of physical energy in the environment or to chemical 
agents or the acute lack of oxygen. The three phases of injury control 
are defined as prevention, acute care, and rehabilitation. Within these 
phases the major categories of injury are intentional, unintentional, 
and occupational. Intentional injuries result from interpersonal or 
self-inflicted violence, and include homicide, assaults, suicide and 
suicide attempts, elder and child abuse, violence against women, and 
sexual assault. Unintentional or unintended injuries include those that 
result from motor vehicle collisions, falls, fires, poisonings, and 
drownings. Occupational injuries occur at the worksite and include 
unintentional trauma such as work-related motor-vehicle injuries, 
drownings, electrocutions, and intentional injuries in the workplace 
such as homicide. Not included in this definition of occupational 
injuries are cumulative

[[Page 66873]]

trauma disorders, back injuries not caused by acute trauma, and effects 
of repeated exposures to chemical or physical agents.
    2. Individual injury control research projects (R01) are defined as 
research designed to:
    a. Elucidate the chain of causation--the etiology and mechanisms--
of injuries and subsequent disabilities; or
    b. Yield results directly applicable to identifying interventions 
to prevent injury occurrence or minimize disability; or
    c. Evaluate the effect of known interventions on injury morbidity, 
mortality, disability, and costs.

Purpose

    The purposes of this program are to:
    A. Support injury prevention and control research on priority 
issues as delineated in Healthy People 2000; Injury in America; Injury 
Prevention: Meeting the Challenge; and Cost of Injury.
    B. Encourage professionals from a wide spectrum of disciplines such 
as engineering, medicine, health care, public health, behavioral and 
social sciences, and others, to undertake research to prevent and 
control injuries.
    C. Expand the development and evaluation of current or new 
intervention methods and strategies for preventing unintentional 
injuries.
    D. Build the scientific base for the prevention of unintentional 
injuries and deaths.

Program Requirements

    The following are applicant requirements:
    A. 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.
    B. Demonstrated experience (on the applicant's project team) in 
conducting, evaluating, and publishing in peer-reviewed journals injury 
control research (as previously defined).
    C. Effective and well-defined working relationships within the 
performing organization and with outside entities that will ensure 
implementation of the proposed activities.
    D. The ability to carry out an injury control research project as 
previously defined under Background and Definitions, (B.2.a-c).
    E. The overall match between the applicant's proposed theme and 
research objectives and the program priorities as described under the 
heading ``Programmatic Priorities.''

    Note: Grant funds will not be made available to support the 
provision of direct care services. Eligible applicants may enter 
into contracts, including consortia agreements (as set forth in the 
PHS Grants Policy Statement) as necessary to meet the requirements 
of the program and strengthen the overall application.

Programmatic Priorities

    Grant applications for research projects that address primary 
prevention of unintentional injuries (home and leisure, and motor 
vehicle related-injuries ), acute care, the prevention of secondary 
conditions in persons with injury-related disabilities, and 
biomechanics are sought. The focus of grants should reflect the broad-
based need to control injury morbidity, mortality, disability, and 
costs.
    Applications must address a programmatic priority area as noted 
below. Examples of possible projects listed under the priority areas 
below are not exhaustive. Innovative alternative approaches are 
encouraged.
    For primary prevention of unintentional injuries, there is 
programmatic interest in the areas of home and leisure, and motor 
vehicle injuries:
    (1) Specifically, there is special programmatic interest in the 
development and evaluation of unintentional injury prevention 
strategies that can be applied in inpatient and outpatient clinical 
and/or managed care settings (e.g., HMOs, PPOs, clinics, clinicians' 
offices, academic health centers, etc.). For example, health care-based 
programs that reduce the injury risk to elderly drivers with medical 
conditions, fall prevention programs among the elderly, and other 
methods of delivering injury prevention through clinical practice or 
managed care settings, are acceptable.
    (2) There is interest in applying behavioral research to injury 
prevention science. That is, the application of behavior change 
strategies to injury problems. For example, applying ``stages-of-
change'' or the transtheoretical model to modify behaviors that will 
increase the protection of motor vehicle occupants, testing peer-to-
peer and cross-generational counseling approaches, applying elements of 
social learning theory or social cognitive theory to changing 
unintentional injury risk behaviors, or implementing interventions that 
take advantage of several theoretical approaches simultaneously are 
acceptable.
    (3) There is programmatic interest in research that evaluates the 
effects of making low-cost safety devices more available and or 
accessible to special and general populations. There is interest, as 
well, in the use of economic incentive systems, such as discounts and 
rebates, or through insurance programs (health, automobile or life). 
For example, these approaches could be studied as methods for 
increasing the use and maintenance of residential smoke detectors or 
sprinkler systems in high risk or rural neighborhoods, or to promote 
bicycle helmet ownership and use at the community level.
    Community based research is particularly relevant, and studies that 
replicate successful programs in new settings or with other populations 
are eligible.
    Unintentional injury prevention proposals primarily addressing the 
epidemiology of unintentional injuries will not be funded under this 
announcement.
    A more thorough discussion of methodologies for conducting 
prevention effectiveness research is presented in ``A Framework for 
Assessing the Effectiveness of Disease and Injury Prevention,'' (CDC 
Morbidity and Mortality Weekly Report, March 27, 1992, Volume 41, 
Number RR-3, pp. 5-11) and in ``Assessing the Effectiveness of Disease 
and Injury Prevention Programs: Costs and Consequences'\5\ (CDC 
Morbidity and Mortality Weekly Report, August 18, 1995, Vol. 44, No. 
RR10). To receive information on these reports see the section Where to 
Obtain Additional Information.
    In acute care there is programmatic interest in intensifying the 
role of the hospital emergency department and inpatient hospital trauma 
services in public health surveillance (e.g., emergency department 
surveillance systems, inpatient trauma registries), clinical prevention 
services (e.g., protocols, interventions, and referrals for patients 
injured in interpersonal violence or identified as alcohol drinkers who 
drink at a hazardous level), evaluation of acute care effectiveness and 
costs (e.g., studies of trauma care systems in terms of their impact on 
morbidity and disability, assessments of treatment modalities that are 
used conventionally or are emerging rapidly in mainstream clinical 
practice).
    (1) There is interest in establishing electronic linkages and 
common data elements across clinical information and public health 
surveillance systems (e.g., incorporating NCIPC's Data Elements for 
Emergency Department Systems, Release 1.0 in distributed record 
systems) to facilitate reporting of injury incidence and outcome data. 
There is interest in developing or further refining measures of injury 
severity (e.g., indices that stratify injuries by anatomic severity to 
facilitate evaluation of

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trauma care processes and outcomes. Acute care-based, public health 
surveillance systems are most valuable where they provide comprehensive 
coverage of defined populations, are used to identify injury causes, 
risk factors, treatments and outcomes, and lend themselves to 
developing or refining clinical and epidemiologic measures of injuries 
including their severity and costs. Information on obtaining Data 
Elements for Emergency Department Systems, Release 1.0, can be found 
under the section Where to Obtain Additional Information.
    (2) There is interest in evaluating the effectiveness and costs of 
programs that identify patients at high risk for subsequent injury and 
provide on-site interventions or referrals to further define the role 
of clinical prevention services in acute care settings. There is 
interest in research that evaluates ways to overcome barriers to 
service provision in emergency departments and inpatient trauma 
services to encourage greater use of clinical prevention services shown 
to be effective and economical. Acute care practitioners are uniquely 
positioned to help reduce or eliminate injury risk factors in the 
patient populations they serve. In emergency departments and inpatient 
trauma services there are opportunities to introduce or extend clinical 
prevention services (e.g., screening and brief intervention for 
patients with mild to moderate alcohol problems and identification and 
referral of patients with severe alcohol problems to specialized 
alcohol treatment services).
    (3) There is interest in comprehensive evaluations of the 
effectiveness of trauma care systems (e.g., baseline and follow-up 
study of State or regional trauma care systems that identifies the 
system's impact on special populations such as children and the elderly 
as well as overall system effectiveness). There is interest in 
systematic studies in people of standard ways of delivering acute care 
as well as new interventions, particularly where key questions persist 
about benefits, risks, and costs (e.g., clinical trials of procedures, 
medications, or protocols used in trauma care). Systematic, 
empirically-based studies of effectiveness and costs are needed to 
evaluate poison control systems, trauma care systems, and specific 
diagnostic and therapeutic interventions currently used or rapidly 
emerging in acute care of injured persons.
    In disability prevention, there is programmatic interest in 
community-based research to prevent the occurrence and reduce the 
severity of disabilities or other adverse outcomes among persons with 
traumatic brain injury (TBI) and spinal cord injury (SCI). Adverse 
outcomes include secondary conditions such as pressure ulcers and 
contractures; cognitive, behavioral, or psychological disorders; and 
other definable conditions associated with TBI or SCI. Research topics 
relating to TBI or SCI must include any of the following:
    (1) Identifying risk factors associated with adverse outcomes 
following rehabilitation.
    (2) Developing or evaluating interventions that are delivered in 
the community setting or as part of outpatient rehabilitation care to 
prevent or minimize the impact of adverse outcomes or secondary 
conditions.
    (3) Defining the incidence of and adverse outcomes associated with 
mild TBI (i.e., nonfatal TBI not resulting in hospitalization) in a 
defined geopolitical population. Research proposals may address all age 
groups or may be limited to children and adolescents. Alcohol and drug 
use or dependence can be among a range of outcomes considered, but 
should not be the primary focus of the project.
    (4) Defining patterns of post acute care among persons with SCI or 
TBI resulting in hospitalization, using population-based data. The 
evolving nature of health care delivery may have changed the 
availability of rehabilitation, the location where rehabilitative 
services are delivered, the timing of services received, and the length 
of the rehabilitation period. Research in this area should define the 
type of facility where rehabilitation services are received, timing of 
rehabilitation service delivery, length of rehabilitation period, and 
payment source for services.
    Disability prevention proposals primarily addressing alcohol and 
other drug use or dependence will not be funded under this 
announcement.
    In biomechanics, there is programmatic interest in traumatic brain 
and spinal cord injury (TBI/SCI). This interest includes the 
biomechanical evaluation of intervention concepts and strategies (e.g., 
multi-use recreational helmets, mouth and face protection devices for 
athletes, energy-absorbing playground surfaces, hip pads, motor vehicle 
side impact and rollover countermeasures, etc.). There is special 
interest in defining human tolerance limits for injury among very young 
children, women, and older persons; the development of biofidelic 
models to elucidate injury physiology and pharmacologic, surgical, 
rehabilitation, and other interventions; improvements in injury 
assessment technology; understanding impact injury mechanisms; and 
quantifying injury-related biomechanical responses for critical areas 
of the human body (e.g., brain and vertebral injury with spinal cord 
involvement). Consideration will also be given to the biomechanics of 
thoracic and abdominal viscera, musculature and joints including the 
articular cartilage, tendons and ligaments.

Reporting Requirements

    An original and two copies of the financial status and progress 
reports are due 90 days after the end of each budget period. Final 
financial status and progress reports are due 90 days after the end of 
the project period.

Application Content

    Applications for injury control research grants should include:
    A. 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.
    B. Specific, measurable, and time-framed objectives.
    C. A detailed plan describing the methods by which the objectives 
will be achieved, including their sequence. A comprehensive evaluation 
plan is an essential component of the application.
    D. A description of the grant's principal investigator's role and 
responsibilities.
    E. 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.
    F. A description of those activities related to, but not supported 
by the grant.
    G. 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.
    H. A detailed first year's budget for the grant with future annual 
projections, if relevant. Awards will be made for project periods of up 
to three years.
    I. Applicants must identify the principal injury phase (prevention, 
acute care, rehabilitation) discipline

[[Page 66875]]

(biomechanics, epidemiology) or type of injury (intentional, 
unintentional) upon which their project focuses.
    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 salary and fringe amounts shown. This budget page will be 
reserved for internal staff use only.

Evaluation Criteria

    Upon receipt, applications will be reviewed by CDC staff for 
completeness and responsiveness as outlined under the previous heading, 
Program Requirements (A-E). Incomplete applications and applications 
that are not responsive will be returned to the applicant without 
further consideration. Applications that are complete and responsive 
may be subjected to a preliminary evaluation by a peer review group to 
determine if the application is of sufficient technical and scientific 
merit to warrant further review (triage); the 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 score ranking by the 
Injury Research Grants Review Committee (IRGRC), programmatic 
priorities and needs as determined by the Advisory Committee for Injury 
Prevention and Control, and the availability of funds.
    A. The first review will be a peer review conducted by the IRGRC on 
all applications. Factors to be considered will include:
    1. 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.
    2. 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.
    3. 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.
    4. For competitive renewal applications, the progress made during 
the prior project period. For new applications, (optional) the progress 
of preliminary studies pertinent to the application.
    5. 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.
    6. The extent to which the research findings will lead to feasible, 
cost-effective injury interventions.
    7. The extent to which the evaluation plan will allow the 
measurement of progress toward the achievement of the stated 
objectives.
    8. Qualifications, adequacy, and appropriateness of personnel to 
accomplish the proposed activities.
    9. The degree of commitment and cooperation of other interested 
parties (as evidenced by letters detailing the nature and extent of the 
involvement).
    10. The reasonableness of the proposed budget to the proposed 
research and demonstration program.
    11. Adequacy of existing and proposed facilities and resources.
    B. The second review will be conducted by the Advisory Committee 
for Injury Prevention and Control. The factors to be considered will 
include:
    1. The results of the peer review.
    2. 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.
    3. National needs.
    4. Program balance among the three phases of injury control: 
prevention, acute care, and rehabilitation; the major disciplines of 
injury control: biomechanics and epidemiology; target populations 
(e.g., adolescents, children, racial and ethnic minorities, rural 
residents, farm families, and people with low incomes); and
    5. Budgetary considerations.
    C. Continued Funding:
    Continuation awards made after FY 1998, but within the project 
period, will be made on the basis of the availability of funds and the 
following criteria:
    1. 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.
    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 will allow management to monitor whether the 
methods are effective.
    5. The budget request is clearly explained, adequately justified, 
reasonable and consistent with the intended use of grant funds.

Executive Order 12372 Review

    Applications are not subject to the review requirements of 
Executive Order 12372.

Public Health System Reporting Requirement

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.136.

Other Requirements

A. Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations, 45 CFR Part 46, regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
forms provided in the application kit.

B. Animal Subjects

    If the proposed project involves research on animal subjects, the 
applicant must comply with the ``PHS Policy on Humane Care and Use of 
Laboratory Animals by Awardee Institutions.'' An applicant organization 
proposing to use vertebrate animals in PHS-supported activities must 
file an Animal Welfare Assurance with the Office for Protection from 
Research Risks at the National Institutes of Health.

C. Women, Racial and Ethnic Minorities

    It is the policy of the CDC to ensure that women and racial and 
ethnic groups will be included in CDC

[[Page 66876]]

supported research projects involving human subjects, whenever feasible 
and appropriate. Racial and ethnic groups are those defined in OMB 
Directive No. 15 and include American Indian or Alaska Native, Asian, 
Black or African American, Hispanic or Latino, Native Hawaiian or other 
Pacific Islander. Applicants shall ensure that women, racial and ethnic 
minority populations are appropriately represented in applications for 
research involving human subjects. Where clear and compelling rationale 
exist that inclusion is inappropriate or not feasible, this situation 
must be explained as part of the application.
    In conducting the review of applications for scientific merit, 
review groups will evaluate proposed plans for inclusion of minorities 
and both sexes as part of the scientific assessment and assigned score. 
This policy does not apply to research studies when the investigator 
cannot control the race, ethnicity and/or sex of subjects. Further 
guidance to this policy is contained in the Federal Register, Vol. 60, 
No. 179, Friday, September 15, 1995, pages 47947-47951.

D. Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by this grant program will be subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Application Submission and Deadlines

A. Preapplication Letter of Intent

    Although not a prerequisite of application, a non-binding letter of 
intent-to-apply is requested from potential applicants. The letter 
should be submitted to the Grants Management Specialist (whose address 
is reflected in section B, ``Applications''). It should be postmarked 
no later than two months prior to the planned submission deadline, 
(e.g., January 26 for February 25 submission). The letter should 
identify the announcement number, name the principal investigator, and 
specify the injury phase or discipline addressed by the proposed 
project. The letter of intent does not influence review or funding 
decisions, but it will enable CDC to plan the review more efficiently, 
and will ensure that each applicant receives timely and relevant 
information prior to application submission.

B. Applications

    Applicants should use Form PHS-398 and adhere to the ERRATA 
Instruction Sheet for Form PHS-398 contained in the Grant Application 
Kit. Please submit an original and five copies on or before February 
25, 1998 to: Lisa G. Tamaroff, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, 
Atlanta, GA 30305.

C. Deadlines

    1. Applications shall be considered as meeting the deadline if they 
are either:
    A. Received at the above address on or before the deadline date, or
    B. Sent on or before the deadline date to the above address, and 
are 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 mailings.
    2. Applications that do not meet the criteria above are considered 
late applications and will be returned to the applicant.

Where To Obtain Additional Information

Application Packet

    To receive additional written information call 1-888-GRANTS4. You 
will be asked to leave your name, address, and phone number and will 
need to refer to Announcement #816. CDC will not send application kits 
by facsimile or express mail. Please refer to Announcement #816 when 
requesting information and submitting an application.

Internet

    This and other CDC announcements are also available through the CDC 
homepage on the Internet. The address for the CDC homepage is [http://
www.cdc.gov]. For your convenience, you may be able to retrieve a copy 
of the PHS Form 398 from [http://www.nih.gov80/grants/funding].

Business Management Technical Information

    If you need further assistance after reviewing the contents of the 
documents business management information may be obtained from Lisa 
Tamaroff, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Mailstop E-13, Atlanta, GA 30305, telephone (404) 842-6796 
or Internet:[email protected].

Programmatic Technical Assistance

    If you have programmatic question you may obtain information from 
Ted Jones, Program Manager, Extramural Research Grants Branch, National 
Center for Injury Prevention and Control, Centers for Disease Control 
and Prevention (CDC), Mailstop K-58, 4770 Buford Highway, NE., Atlanta, 
GA 30341-3724, telephone (770) 488-4824, Internet: [email protected].
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) through the Superintendent of 
Documents, Government Printing Office, Washington, DC 20402-9325, 
telephone (202) 512-1800.
    The document, ``Data Elements for Emergency Department System, 
Release 1.0'', and subsequent revisions can be found at the National 
Center for Injury Prevention and Control Web site: http://www.cdc.gov/
ncipc/pub-res/deedspage.htm.
    Information for obtaining copies of Injury in America (National 
Academy Press, 2101 Constitution Avenue, NW, Washington, DC 20418--
ISBN0-309-03545-7); Injury Prevention: Meeting the Challenge 
(supplement to the American Journal of Preventive Medicine, (Vol. 5, 
no. 3, 1989); Cost of Injury (Dorothy P. Rice, Ellen J. MacKenzie, and 
Associates, Cost of Injury: A Report to the Congress, San Francisco, 
California: Institute for Health and Aging, University of California 
and Injury Prevention Research Center, The Johns Hopkins University, 
1989); A Framework for Assessing the Effectiveness of Disease and 
Injury Prevention,'' (CDC Morbidity and Mortality Weekly Report, March 
27, 1992, Volume 41, Number RR-3, pp. 5-11); and in ``Assessing the 
Effectiveness of Disease and Injury Prevention Programs: Costs and 
Consequences'' (CDC Morbidity and Mortality Weekly Report, August 18, 
1995, Vol. 44, No. RR10) is included on a separate sheet with the 
application kit.

    Dated: December 16, 1997.
Joseph R. Carter,
Acting Associate Director, Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-33297 Filed 12-19-97; 8:45 am]
BILLING CODE 4160-18-U