[Federal Register Volume 60, Number 219 (Tuesday, November 14, 1995)]
[Notices]
[Pages 57259-57262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28100]



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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration


Discretionary Cooperative Agreement Program to Support the 
Development of an Index to Quantify the Functional Outcome of Pediatric 
Motor Vehicle Injuries

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Announcement of Discretionary Cooperative Agreement Program to 
Support the Development of an Index to Quantify the Functional Outcome 
of Pediatric Motor Vehicle Injuries.

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SUMMARY: The National Highway Traffic Safety Administration (NHTSA) 
announces a discretionary cooperative agreement program to support 
research in the development of a derivative of the Functional Capacity 
Index that will be applicable to pediatric motor vehicle injuries, and 
solicits applications for projects under this program.

DATES: Applications must be received on or before January 17, 1996.

ADDRESSES: Applications must be submitted to the National Highway 
Traffic Safety Administration, Office of Contracts and Procurement 
(NAD-30), Attn: Amy Poling, 400 7th Street S.W., Room 5301, Washington 
DC 20590. All applications submitted must include a reference to NHTSA 
Cooperative Agreement Program No. DTNH22-94-H-06001.

FOR FURTHER INFORMATION CONTACT:
Questions relating to this cooperative agreement program should be 
directed to Stephen Luchter, Senior Policy Advisor, Office of Plans and 
Policy (NPP-32), National Highway Traffic Safety Administration, 400 
7th St. S.W., Room 5208, Washington, DC 20590; (202) 366-2576. General 
administrative questions may be directed to Amy Poling, Office of 
Contracts and Procurement, at (202) 366-9552.

SUPPLEMENTARY INFORMATION:

Background

    NHTSA's mission is to reduce injuries and fatalities on the 
nation's highways. In order to have an objective way to determine where 
to place its limited resources, the agency has developed an expertise 
in quantitative measures of the consequences of motor vehicle crashes. 
These efforts have been largely devoted 

[[Page 57260]]
to determining the economics costs resulting from the crash, including 
the costs of any resulting injuries or fatalities.
    Until recently the agency's focus has been on mitigating the 
effects of the most serious injuries, those that result in fatality. As 
fatality rates decreased, and knowledge of the magnitude of the long 
term consequences of non-fatal injuries increased, more attention began 
to be given to the non-fatal injury portion of the agency's mission. It 
soon became apparent that although a thorough understanding of the 
costs of injury was important, costs alone did not provide a complete 
picture of injury consequences. A decision was made to develop a 
measure of injury consequences in terms of time, and the product of 
that effort is the Functional Capacity Index.\1\
    The Functional Capacity Index consists of a set of alphabetical 
indicators representing the level of functioning for each of ten 
functional attributes, plus a numerical value that represents the 
relative value of the combination on a scale from 0.0 to 1.0. A value 
of 0.0 represents no loss of function, and a value of 1.0 represents a 
complete loss of function. The attributes are: eating, excreting, 
sexual function, arm/hand, bending/lifting, ambulation, sight, hearing, 
speech, and cognitive functions. Rigorous definitions were developed 
for each of these attributes at both full functioning and at 
appropriate levels of reduced functioning. Using the methods of Multi-
Attribute Utility Theory, the value judgments of a diverse population 
were determined for each level of functioning. Since these value 
judgment followed a normal distribution, the mean value was taken as 
representative. An algorithm was developed to combine the value 
judgments into a ``whole-body'' numerical value using a multiplicative 
model. An expert panel provided their judgment of the level of 
functioning one year post-injury for a previously healthy adult for 
each of the injuries listed in the AIS 90 dictionary.\2\
    These efforts have resulted in a useable index, which has been 
applied successfully to the agency's injury data base.\3\ When applied 
to a population, the parameter of interest becomes the Life-years Lost 
of Injury (LLI), which is the sum over the injured population of the 
product of the Functional Capacity Index (FCI) and the injured person's 
life expectancy. This parameter provides a measure of the effect on the 
entire society of a particular injury. The average Life-years Lost to 
Injury (LLI/incidence) is a measure of the relative severity of the 
injury to the average member of the population with that injury.
    At present, applications of the Index must be done with due care, 
taking into account the known limitations:
     Index values are based on the consensus judgment of an 
expert panel, not on clinical data. (A clinical validation project is 
currently underway to remove this limitation).
     The Index is not applicable to the pediatric or geriatric 
populations, due to the different effects of injury on these 
populations as compared to healthy adults.
     The Index is limited to single injuries. (The assumption 
is made in applications that the injury with the highest value of FCI 
can be used in a similar way as the highest AIS value injury is used as 
an indication of injury severity. The current effort at clinical 
validation is expected to yield data that will allow testing of 
hypotheses on how to use the Index for multiple injuries).
     The Index is applicable for a fixed time post injury. (A 
one year post-injury timeframe was chosen because it is known that the 
effects of many, though not all, injuries have stabilized at one year 
after the injury. Future efforts will consider this issue).
    This research effort focuses on removing the pediatric injury 
limitation in the application of the Functional Capacity Index. The 
possible use of the PEDI4 and WeeFim5 scales was considered 
for this project, but rejected as they have a number of limitations; 
these indices do not relate to specific injuries, but rather are 
applicable in a clinical setting for all injuries. Also, although these 
indices include the concept of age appropriate responses, these 
responses are not defined as an implicit part of the index.

Objective

    The Functional Capacity Index consists of objective definitions of 
functional attributes at full functioning and at various levels of 
reduced functioning for the injury descriptions in the 1990 Abbreviated 
Injury Scale. The Index consists of two parts. The first part is a set 
of ten alphabetical designations which indicate the anticipated 
functional level for each attribute one year post injury. The second 
part consists of a numerical ``whole body'' designation derived using 
the value judgments of a representative population. The current Index 
is applicable to previously healthy adults. The objective of this 
effort is to develop a derivative of the Functional Capacity Index that 
is applicable to previously health children, particularly those injured 
in motor vehicle crashes.
    The following issues have been identified and applicants should 
include a discussion of their approach to resolving them in their 
application.
    Developmental Level--The agency's hypothesis is that there are 
certain injuries where age is an important factor in estimating 
functional capacity one year post injury and others where it is 
not.6 Assuming this is correct, the work described here will 
identify the injuries that fit into these two categories. For example, 
healthy six-month-olds usually can't walk (but can crawl), can't speak 
intelligibly (but can usually communicate via sound), nor can they 
balance a checkbook. Thus injuries that affect mobility or vocal 
communication for six-month-olds are not likely to be properly scaled 
by the current Index. At age two most healthy children can perform the 
first two of these functions, but not the third. Thus, any Index must 
take into account these differences. Questions the applicant should 
address include the following:
     The current FCI levels were developed for ages 18 to 34, 
but they are believed to be applicable to a somewhat younger 
population. Is this limit 16, 12, 10? Are there different age limits 
for different injuries?
     How should the functional attributes be defined for the 
pediatric population for those injuries where the current Index is not 
applicable? Should they relate to what a child could do now (for 
example, crawling by a six-month-old), or to what the child could do 
when s/he becomes an adult (for example, being able to walk 150 feet 
and climb 12 steps)?
     In order to minimize complexity when applying the index 
there must be a simple, straightforward approach to accommodating the 
age variations. Is it necessary to have multiple indices, based on age 
categories, or can there be an adjustment factor to the current Index 
such as, if under 3, use the values in column B instead of the 
``standard'' values in column A?
     The relationships between chronological age and 
developmental age are not single valued functions for the entire 
population. How does one treat this issue in applying the Index?
    Physiological Factors--The consequences of a particular injury may 
be considerably different in young children than in adults. For 
example, bones that are still soft may heal with less residual loss of 
functional capacity than adult bones. On the other hand, injuries to 
central nervous system components that have not fully developed may 
arrest the development of the child and have a greater effect on long 
term functional capacity. How 

[[Page 57261]]
should these concerns be incorporated into the Index?
    Value Judgment--The theoretical basis for the Index numerical 
values is that they reflect the value judgments of the exposed 
population. Not only does one not expect pre-schoolers to understand 
the issues, it is unlikely that they would be able to communicate their 
thoughts using the approach taken in the initial development of the 
Index. However, it is conceivable that 8 or 10 year olds would be able 
to comprehend these effects and be able to communicate them adequately. 
The question then is whose judgments are applicable--parents, 
pediatricians, educators, etc., and when should one consider the 
child's judgment? If this method is not applicable at all, what other 
approaches are appropriate to arrive at a quantitative whole body 
value?
    Compatibility with the Existing Functional Capacity Index--The 
product of this research must be compatible with the Functional 
Capacity Index. Although there are a number of ways to approach the 
pediatric injury problem, there must be a seamless relationship between 
the results of this research and the Index applicable to the adult 
population.
    Index Validation--The product of this research effort will be 
clinically validated estimates of functional capacity one year post 
injury for a representative set of pediatric injuries experienced in 
motor vehicle crashes. What validation methods does the applicant 
propose so that the results will be broadly representative of the 
national experience?

NHTSA Involvement

    NHTSA, Office of Plans and Policy, will be involved in all 
activities undertaken as part oft he cooperative agreement program and 
will:
    1. Provide, on an as-available basis, one professional staff 
person, to be designated as the Contracting Officer's Technical 
Representative (COTR), to serve as a co-investigator participating in 
the technical planning and management of the cooperative agreement 
project and coordinate activities between the organization and NHTSA.
    2. Make available information and technical assistance from 
government sources, within available resources and as determined 
appropriate by the COTR.
    3. Provide liaison with other government agencies and 
organizations, as appropriate.
    4. Stimulate the exchange of ideas.
    5. Due to the complex nature of this research, a multidisciplinary 
intergovernmental group of representatives interested in pediatric 
injuries will guide the substantive work under this agreement.
    The NHTSA Contracting Officer's Technical representative will chair 
this group. It is anticipated that this group will include 
representatives from the National Institute of Child Health and Human 
Development, the National Center for Rehabilitation Medicine and the 
Bureau of Maternal and Child Health.

Period of Support

    The research effort described in this announcement will be 
supported through the award of a single cooperative agreement. It is 
anticipated that the project performance period will be up to 27 
months, including submission of the final report. The total anticipated 
funding level is $200,000.00, with $100,000.00 to be provided in the 
first incremental period. The application for Federal Assistance should 
address what is proposed and can be accomplished within the time and 
funding constraints.

Eligibility Requirements

    In order to be eligible to participate in this cooperative 
agreement program, an applicant must be an educational institution or 
research organization. For-profit research organizations may apply; 
however, no fee or profit will be allowed.

Application Procedure

    Applicants must submit one original and two copies of their 
application package to: NHTSA, Office of Contracts and Procurement 
(NAD-30), Attn: Amy Poling, 400 7th Street SW., Room 5301, Washington, 
DC 20590. Applications must include a reference to NHTSA Cooperative 
Agreement Program No. DTNH22-96-H-06001. Only complete application 
packages received on or before January 17, 1996 shall be considered. 
Submission of three additional copies will expedite processing, but is 
not required.
    1. The application package must be submitted with a Standard Form 
424 (rev. 4-88, including 424A and 424B), Application for Federal 
Assistance, with the required information filled in and certified 
assurances signed. While the Form 424A deals with budget information 
and Section B identifies budget categories, the available space does 
not permit a level of detail which is sufficient to provide for a 
meaningful evaluation of the proposed total costs. A supplemental sheet 
shall be provided which presents a detailed breakdown of the proposed 
costs. The budget shall identify any cost-sharing contribution proposed 
by the applicant, as well as any additional financial commitments made 
by other sources. In preparing their cost proposals, applicants shall 
assume that the award will be made by February 21, 1996, and should 
prepare their applications accordingly.
    2. Applications shall include a project narrative statement which 
addresses the following:
    (a) Identifies the objectives, goals, and anticipated outcomes of 
the proposed research effort and the approach or methods that will be 
used to achieve these ends, and discusses the specific issues 
previously mentioned in this Notice, i.e., developmental level, 
physiological factors, value judgment, compatibility with the existing 
Functional Capability Index, and index validation;
    (b) Identifies the proposed plan for conducting the activities of 
the research effort, including a schedule of milestones and their 
target dates, and for assessing the project accomplishments. It shall 
also include a plan for the effective dissemination of the research 
results;
    (c) Identifies the types and sources of data that will be used in 
this research effort, including approaches to insure compatibility of 
data and the arrangements made or agreements entered into to insure 
access to needed data. Prior to submitting any such data to NHTSA, the 
recipient will be required to purge any information from which the 
personal identity of individuals may be determined;
    (d) Identifies the proposed program director and other key 
personnel identified for participation in the proposed research effort, 
including description of their qualifications and their respective 
organizational responsibilities; and
    (e) Describes the applicant's previous experience or on-going 
research program that is related to this proposed research effort.

Review Process and Criteria

    Initially, all applications will be reviewed to confirm that the 
applicant is an eligible recipient and to assure that the application 
contains all of the information required by the Application Contents 
section of this notice.
    Each complete application from an eligible recipient will then be 
evaluated by a Technical Evaluation Committee. The Technical Evaluation 
Committee will be augmented by non-voting specialty experts from the 
National Institute of Child Health and Human Development, the National 
Center for Rehabilitation Medicine and the Bureau 

[[Page 57262]]
of Maternal and Child Health. The applications will be evaluated using 
the following criteria:
    1. The technical merit of the proposed research effort, including 
the feasibility of the approach, planned methodology and anticipated 
results.
    2. The adequacy of the organizational plan for accomplishing the 
proposed research effort, including the qualifications and experience 
of the research team, the various disciplines represented, and the 
relative level of effort proposed for professional, technical and 
support staff.
    3. The adequacy of the plans for disseminating the research results 
to effectively contribute to the base of knowledge through the 
scientific literature, popular press, etc.

Terms and Conditions of the Award

    1. Prior to award, the recipient must comply with the certification 
requirements of 49 CFR Part 20, Department of Transportation New 
Restrictions on Lobbying, and 49 CFR Part 29, Department of 
Transportation Government-wide Debarment and Suspension (Non-
procurement) and Government-wide Requirements for Drug-Free Workplace 
(Grants).
    2. During the effective period of the cooperative agreement awarded 
as a result of this notice, the agreement shall be subject to the 
general administrative requirements of 49 CFR Part 19, Department of 
Transportation Uniform Administrative Requirements for Grants and 
Agreements with Institutions of Higher Education, Hospitals and Other 
Non-Profit Organizations; the cost principles of OMB Circular A-21, or 
A-122, or FAR 31.2, as applicable to the recipient, and the NHTSA 
General Provisions for Assistance Agreements.
    3. If human subjects are to be used in any portions of this 
research, applications must include certification that the applicable 
provisions of 49 CFR Part 11 and NHTSA Order 700-1 will be followed.
    4. Reporting Requirements and Deliverables: The recipient shall 
submit a quarterly performance report in letter format within 15 days 
after each quarter; a draft final report and draft technical summary 
within 24 months after award; a camera ready reproducible final report 
and technical summary, and any data bases and computer programs 
developed as part of this cooperative agreement, within 27 months of 
award. An original and two copies of each report shall be submitted to 
the COTR.

    Issued on: November 7, 1995.
Donald C. Bischoff,
Associate Administrator for Plans and Policy.

References

    1. MacKenzie E J et al., Development of the Functional Capacity 
Index (FCI), DOT HS 808 160 July 1994
    2. Association for the Advancement of Automotive Medicine, The 
Abbreviated Injury Scale, 1990 Revision, Des Plaines IL
    3. Luchter S. An Estimate of the Long Term Consequences of Motor 
Vehicle Injuries, Proceedings of the Enhanced Safety Vehicle 
Conference, May 1994
    4. Haley S M et al., Pediatric Evaluation of Disability 
Inventory, New England Medical Center, 1989
    5. Granger C V, Hamilton B B, Kayton R. Functional Independence 
Measure for Children (WeeFIM), Research Foundation, State University 
of New York, 1987
    6. This hypothesis is an extension of the approach to pediatric 
injury severity in the Abbreviated Injury Scale. Except for brain 
hematomas, blood loss in severe lacerations, or internal bleeding 
due to abdominal or thoracic injuries, the AIS '90 scale does not 
differentiate between pediatric and other populations. See The 
Abbreviated Injury Scale 1990 Revision p4 for a discussion of 
pediatric injury severity.

[FR Doc. 95-28100 Filed 11-13-95; 8:45 am]
BILLING CODE 4910-59-M