[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17497]
[[Page Unknown]]
[Federal Register: July 19, 1994]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
Discretionary Cooperative Agreement To Support Research To
Evaluate the Validity of a Functional Capacity Index That Measures the
Consequences of Injuries Sustained in Motor Vehicle Crashes
agency: National Highway Traffic Safety Administration (NHTSA), DOT.
action: Announcement of Discretionary Cooperative Agreement Program.
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summary: The National Highway Traffic Safety Administration (NHTSA),
having developed an index for measuring the reduction of functional
capacity as a result of injuries sustained in motor vehicle crashes,
announces a discretionary cooperative agreement program to support
research in the validation of this index and solicits applications for
projects under this program.
dates: Applications must be received at the office designated below on
or before September 14, 1994.
addresses: Applications must be submitted to the National Highway
Traffic Safety Administration, Office of Contracts and Procurement
(NAD-30), Attn: Linda Boor, 400 7th Street SW., room 5301, Washington,
DC 20590. All applications submitted must include a reference to NHTSA
Cooperative Agreement Program No. DTNH22-94H-06014. Interested
applicants are advised that no separate application package exists
beyond the content of this announcement.
for further information contact: General administrative questions may
be directed to Linda Boor, Office of Contracts and Procurement, at
(202) 366-0607. Questions relating to this cooperative agreement should
be directed to Joan Harris, Planning and Policy Development Division,
(NPP-32), National Highway Traffic Safety Administration, 400 7th
Street SW., room 5208, Washington, DC 20590; (202) 366-2578. Copies of
documents referenced in this announcement will be provided upon request
to Joan Harris. Such documents include the final report results from
NHTSA Cooperative Agreement No. DTNH22-89-Z-06019 and the list of
approximately 300 injuries that most frequently occur in motor vehicle
crashes.
SUPPLEMENTARY INFORMATION:
Background
As a result of numerous improvements in highway and traffic safety,
the number of fatalities resulting from motor vehicle crashes has been
in a long term downtrend. The incidence of injured survivors, however,
has been increasing. As a result, although NHTSA's attention to
countermeasures to reduce fatalities continues undiminished, it is
being supplemented by attention to countermeasures that reduce the long
term consequences of serious injuries both to the injured individual
and society as a whole. In order to estimate these long term societal
and personal impacts, new analytical tools are being developed. One
such tool, called the Functional Capacity Index, measures the degree to
which an injured person will not be able to function as he/she did
before the injury. The Functional Capacity Index combines decrements in
each of ten dimensions of functioning into a whole body score. The
index was described in a request for comment on the proposed index (57
FR 13157; April 15, 1992). Basically, the index consists of qualitative
descriptions of level of functioning for ten attributes of total
functioning, (eating, excretory function, sexual function, ambulation,
hand and arm function, bending and lifting, visual function, auditory
function, speech, and cognitive function), and a numerical value for
each combination of levels of functioning derived from a sample of
value judgments of a diverse set of sub-populations.
General Description
The basic assumption of the Functional Capacity Index is that life
is its own best measure of value. This is in distinction to the human
capital economic approach to measuring consequences that assumes that
people are producers and consumers of goods and services. If there are
things a person cannot do as well following an injury as before, there
is a reduction in the person's overall functional capacity. With the
functional capacity approach, the consequences of an injury to
individuals of the same age and gender are the same, independent of
their economic contribution to society.
The Functional Capacity Index (FCI) assigns scores to the AIS
injury descriptions on a scale of 0 to 1.00, where 0 represents no
limitation of function and 1.00 represents maximum limitation of
function. The overall consequences of an injury are found by
multiplying the FCI by the injured person's remaining life expectancy.
This results in the Life-years Lost to Injury (LLI). The Functional
Capacity Index can vary with time as the injured person's condition
changes. Any effects of reduced life expectancy as a result of the
injury also can be accounted for. If the injury was fatal, all of the
remaining life expectancy is counted.
The initial phase of the development of the Functional Capacity
Index has been completed. It consisted of developing definitions of the
functional attributes and their various capacity levels, choosing a
scaling approach, obtaining judgments of a cross section of the
population on the value of each attribute and capacity level,
developing an algorithm for combining values into a ``whole-body''
index based on multiattribute rating techniques, and applying the
attributes and capacity levels to the injuries described in the AIS 90
dictionary according to the composite opinion of a multi-disciplinary
panel of experts.
This request for applications is concerned with the next phase of
the development of the Functional Capacity Index, which is to perform
the necessary research to validate the conclusions reached through
initial development of the Index under Cooperative Agreement No.
DTNH22-89-Z-06019. It is assumed that the applicant is thoroughly
familiar with the Abbreviated Injury Scale 1990 revision.
The experimental design should consider a number of issues of
interest to the agency. In general, these relate to the need for
balance between a thorough and complete validation of the index, and
validation of injuries or categories of injuries of particular interest
to the agency.
1. The recipient will evaluate the functional capacity of people
injured in motor vehicle crashes, and the evaluation methods identified
may differ for injuries to the different body regions. In some cases
existing data may be available, and in others data may have to be
obtained by testing people for performance of the functional capacity
descriptors. It also is possible that disparate data sets will be used
for different body regions. The validation will be conducted for the
different body regions and different severity levels shown in the AIS
`90 dictionary with priority given to those injuries described in a
NHTSA listing of approximately 300 injuries that most frequently occur
in motor vehicle crashes. In addition, the validation process shall not
neglect minor and moderate injuries in any body region. The methodology
for each body region shall balance the cost and time required for
acquiring the data and the resulting statistical significance. In order
to apply the FCI, all injury data used in the evaluation shall be
converted, if necessary, to AIS-90.
2. The validation must include as a minimum a representative sample
of injuries to each body region and each severity level, as well as
injuries that affect each of the attributes of the index. This must be
balanced against the need to emphasize the less than 300 injuries that
most frequently occur in motor vehicle crashes out of the more than
1,300 injuries listed in the AIS `90 dictionary.
3. When weighted to the incidence of injury in motor vehicle
crashes, 88.5 percent of the most frequently occurring injuries had a
zero value for the FCI, as estimated by the expert panel. The research
effort must include validation of injuries with a zero value of FCI as
well as those with non-zero values.
4. The research design must include objective criteria for
determining agreement/disagreement with the results of the prior
effort.
Limitations
The concept of the Functional Capacity Index is broadly applicable
to all injuries, all ages, and changes in functional capacity as the
injured person experiences long term effects either to increase or
decrease capacity. At its present state of development, the index has
certain limitations which must be recognized in the validation
research:
1. The current index is directly applicable only to the conditions
one year post-injury for a previously healthy adult between the ages of
18 and 55. Changes in functional capacity from pre-existing conditions
are not included.
2. The index in its present form is not applicable to young
children, as the present functional capacity definitions do not take
into account the age dependent developmental levels of normal healthy
children.
3. The index in its present state of development is not applicable
to older persons, as it is well documented that similar trauma has a
greater effect on older persons.
4. The index in its present form is applicable to single injuries.
Methodologies to estimate the change in functional capacity resulting
from any synergistic effects of more than one injury, particularly
injuries to different body regions, remain to be developed.
5. The present Functional Capacity Index is limited to the injury
definitions in the 1990 version of the Abbreviated Injury Scale.
Although the International Classification of Disease (ICD) injury
descriptions are widely used, they generally do not contain sufficient
detail for the agency's countermeasure development purposes. Any
efforts to revise the current translation programs between ICD-9 and
AIS 85 to reflect the descriptions in AIS 90 would be applicable to the
Functional Capacity Index and minimize this limitation.
6. Although the psycho-behavioral consequences of injuries are
known to be significant, they are not included in the Functional
Capacity Index in its present state of development.
7. The Functional Capacity Index does not intend to include the
effect of ``fates worse than death''. These are states where people say
they would rather die than continue living with the particular
impairment. The agency position is that these are states of preference
rather than states of function.
NHTSA Involvement
NHTSA, Planning and Policy Development Division, will be involved
in all activities undertaken as part of the performance of this
cooperative agreement 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 participate in the planning and management of
the cooperative agreement and to 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.
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 for up to 27
months. The total anticipated funding level is $250,000, with $125,000
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), 400 7th Street SW., Room 5301, Washington, DC 20590.
Applications must include a reference to NHTSA Cooperative Agreement
Program No. DTNH22-94H-06014. Only complete application packages
received on or before September 14, 1994 shall be considered.
Submission of three additional copies will expedite processing, but is
not required.
Application Content
1. The application package must be submitted with OMB 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. In preparing their cost proposals, applicants shall assume that
awards will be made by September 30, 1994, and should prepare their
applications accordingly.
2. A description of the objectives, goals, and anticipated outcomes
of the proposed research effort and the method or methods that will be
used must be included. This shall include an overall description of the
experimental design including a discussion of why this design is the
minimal cost program that can lead to a reliable validation of the
Functional Capacity Index. The validation effort should address
representative injuries for each body region and severity level, even
though those injuries may not be included on the priority listing. The
discussion will include at least the following:
(a) The approaches to be taken to compare the functional capacity
of persons who have received a variety of injuries to the estimated
level of functional capacity one year following injury for a previously
healthy adult. This discussion should cover the methods to be used for
each of the ten attributes as described in a request for comment on the
proposed index (57 F.R. 13157; April 15, 1992), and for each body
region described in the Abbreviated Injury Scale 1990 Revision as
published by the Association for the Advancement of Automotive
Medicine.
(b) The types and sources of data that will be used in the
validation process and how the actual comparison with the expert
judgement from the earlier work, as provided by NHTSA, will be
accomplished. It is recognized that a number of approaches may be taken
to validate the Functional Capacity Index pertaining to injuries to
different body regions or different severity levels. If the use of
disparate data sources are planned, the discussion shall indicate how
these data will be treated to insure that they are compatible.
(c) The arrangements made or agreements entered into to assure
access to data needed in the validation process. 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) The size of the population(s) used for the validation and the
statistical significance that can be expected from such a population.
(e) The criteria that will be used to accept or reject differences
between the final report from the earlier work to be provided by NHTSA
and the evaluation data.
(f) The approaches to insuring compatibility of data, particularly
if data from disparate data sets are used. In addition, applicant shall
address coordination of effort if multiple sites are included in the
proposal.
(g) An outline of the anticipated milestones and projected schedule
for completion of work.
3. In addition to the minimal cost program recommended that will
lead to a reliable validation of the Functional Capacity Index,
applicants may choose to describe alternate methodologies that may be
more costly than the basic approach but will result in greater
statistical validity or have other desirable features compared to the
basic approach.
4. 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.
5. A discussion of the management approach to be employed to ensure
that the research will be completed in a timely manner.
6. A description of the applicant's previous experience or on-going
research program that is related to this proposed research effort.
7. If data sources other than those owned by the applicant are to
be used in the proposed research, letters of intent to release the data
shall be included.
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 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, the relative
level of effort proposed for professional, technical and support staff.
3. The approaches to be employed to ensure timely completion of the
research.
Terms and Conditions of the Award
1. Prior to award, each 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 Learning, Hospitals and Other
Non-Profit Organizations; the cost principles of OMB Circulars A-21, or
A-122, or FAR 31.2, as applicable to the recipients, and the
requirements for a drug-free workplace set forth in 49 CFR Part 29.
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 Subtitle A 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 contract award, any data bases and computer
programs developed as part of this cooperative agreement on or before
the completion date of this award, and a camera ready reproducible
final report and technical summary within 27 months of contract award.
An original and two copies of each report shall be submitted to the
COTR.
Issued on: July 14, 1994.
Donald C. Bischoff,
Associate Administrator for Plans and Policy.
[FR Doc. 94-17497 Filed 7-18-94; 8:45 am]
BILLING CODE 4910-59-M
