[Federal Register Volume 69, Number 235 (Wednesday, December 8, 2004)]
[Notices]
[Pages 71101-71118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26986]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration


Discretionary Cooperative Agreements for Research Under the Crash 
Injury Research and Engineering Network (CIREN)

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

ACTION: Announcement of discretionary cooperative agreements to support 
the research conducted under the Crash Injury Research and Engineering 
Network (CIREN) and to increase its benefits to the public.

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SUMMARY: The National Highway Traffic Safety Administration (NHTSA) 
announces discretionary Cooperative Agreement opportunities to provide 
funding to Level One Trauma Centers in support of the Crash Injury 
Research and Engineering Network (CIREN). NHTSA anticipates funding 
these Cooperative Agreements in annual installments for one base year 
plus 4 one-year option years at NHTSA's option and subject to available 
funding. Due to budgetary constraints and the levels of effort 
applicants may propose, NHTSA is uncertain as to the number of 
Cooperative Agreements that will be funded. However, multiple awards 
will be made under this announcement. These cooperative agreements will 
support projects to improve the prevention, treatment, and 
rehabilitation of motor vehicle crash injuries to reduce deaths, 
disabilities and human and economic costs. This Federal Register Notice 
solicits applications from Level One Trauma Centers. Interested 
applicants must follow the instructions in the application section of 
this Federal Register Notice. NHTSA will review the applications to 
determine which proposals will receive funding under this announcement.

DATES: Applications must be submitted to the National Highway Traffic 
Safety Administration, Office of Contracts and Procurement (NPO-220), 
Attention: Dianne Proctor, 400 Seventh Street, SW., Room 5301, 
Washington, DC 20590. All applications submitted must include a 
reference to NHTSA Cooperative Agreement Program Number DTNH22-05-H-
01001. Only complete packages received on or before 2 p.m. e.s.t. on 
February 8, 2005, will be considered for award.
    Applicants shall provide a complete mailing address where Federal 
Express mail can be delivered.

FOR FURTHER INFORMATION CONTACT: General administrative and 
programmatic questions may be directed to Dianne Proctor, Office of 
Contracts and Procurement, by e-mail at <a href="/cdn-cgi/l/email-protection#92d6fbf3fcf7bcc2e0fdf1e6fde0d2fcfae6e1f3bcf6fde6bcf5fde4"><span class="__cf_email__" data-cfemail="bbffd2dad5de95ebc9d4d8cfd4c9fbd5d3cfc8da95dfd4cf95dcd4cd">[email protected]</span></a> or 
by phone at (202) 366-9562 and Karin E. Eddy, Office of Contracts and 
Procurement, by e-mail at <a href="/cdn-cgi/l/email-protection#2c674d5e454202694848556c4244585f4d02484358024b435a"><span class="__cf_email__" data-cfemail="034862716a6d2d4667677a436d6b7770622d676c772d646c75">[email protected]</span></a> or by phone at (202) 
366-9568. To allow for sufficient time to address questions 
appropriately, all questions must be submitted in writing no later 2 
p.m. e.s.t., December 20, 2004, via e-mail to <a href="/cdn-cgi/l/email-protection#327953405b5c1c7756564b725c5a4641531c565d461c555d44"><span class="__cf_email__" data-cfemail="602b0112090e4e25040419200e081413014e040f144e070f16">[email protected]</span></a>. 
Response to the questions will be posted on http://www-nrd.nhtsa.dot.gov/departments/nrd-50/ciren/CIREN.html by January 10, 
2005 and in the Federal Register.
    Any changes to this date will be posted on the Web site. Interested 
applicants are advised that no separate application package exists 
beyond the contents of this announcement.

SUPPLEMENTARY INFORMATION:

I. Background

    Motor vehicles are the dominant means of travel in the United 
States for both personal and business trips and provide Americans with 
an extraordinary degree of mobility. Traffic fatalities account for 
more than 90% of all transportation-related fatalities. These injuries 
and fatalities are a major public health problem. More than 40,000 
people die each year as the result of injuries received in motor 
vehicle crashes and more than 3 million people are injured. Motor 
vehicle injuries comprise nearly half of all traumatic injury deaths.
    The large number of motor vehicle injuries places a considerable 
burden on the nation's health care system. It is estimated that about 
20 percent of all Emergency Medical Service (EMS) calls are motor 
vehicle related, and persons are treated in trauma centers largely as 
the result of motor vehicle crashes. This care results in a significant 
economic burden on society, estimated at more than $17 billion a year. 
Because motor vehicle injuries often have long-term effects, they are a 
leading cause of long-term disability.
    NHTSA is an agency of the U.S. Department of Transportation (DOT). 
NHTSA's mission is to save lives, prevent injuries and reduce traffic-

[[Page 71102]]

related health care and other economic costs. The agency develops, 
promotes and implements effective educational, engineering and 
enforcement programs with the goal of ending preventable tragedies and 
reducing economic costs associated with vehicle use and highway travel.
    As part of its mandate, NHTSA conducts research to improve motor 
vehicle and traffic safety, diagnose specific problems, implement 
standards and programs to address these problems and evaluate their 
impact.
    NHTSA has funded hospital-related studies since the 1980s. In 1991, 
NHTSA initiated the Highway Traffic Injuries Studies. Over the next 
several years, research projects were funded at four Level One Trauma 
Centers to collect detailed injury information on motor vehicle 
occupants involved in crashes. The four centers were: The National 
Study Center for Trauma and EMS/R Adams Cowley Shock Trauma Center in 
Baltimore, Maryland; the University of Medicine & Dentistry/New Jersey 
Medical School in Newark, New Jersey; the Children's National Medical 
Center in Washington, DC; and the William Lehman Injury Research 
Center/University of Miami School of Medicine/Ryder Trauma Center in 
Miami, Florida.
    In the summer of 1996, as part of a settlement agreement with the 
Department of Transportation, General Motors funded three additional 
Level One Trauma Centers. These centers are: The University of Michigan 
Medical Center in Ann Arbor, Michigan; Harborview Injury Prevention & 
Research Center in Seattle, Washington; and San Diego County Trauma 
System in San Diego, California. The addition of these three centers, 
along with the need for a uniform method to collect data, resulted in 
the formation of the Crash Injury Research and Engineering Network 
(CIREN).
    In April 1999, Mercedes-Benz announced the funding of an eighth 
trauma center-based research project at the University of Alabama at 
Birmingham. Funding for that Center ended in April 2004. In May 2000, 
Ford Motor Company announced the funding of a ninth trauma center-based 
research project at Inova Fairfax Hospital in Falls Church, Virginia. 
In September 2002, Honda assumed funding of the CIREN Center at Inova 
Fairfax Hospital. In November 2001, Froedtert Hospital and the Medical 
College of Wisconsin self-funded a tenth CIREN center at its facility.
    CIREN is a sponsor-led multi-center research program involving a 
collaboration of clinicians and engineers in academia, industry, and 
government pursuing in-depth studies of crashes, injuries, and 
treatments to improve processes and outcomes. Its mission is to improve 
the prevention, treatment, and rehabilitation of motor vehicle crash 
injuries to reduce deaths, disabilities, and human and economic costs.
    CIREN is also the name of a research tool developed, updated, 
enhanced and maintained by the Volpe National Transportation Systems 
Center (Volpe) in Cambridge, Massachusetts to help researchers collect 
and review injury data. Variables for CIREN crash reconstruction data 
are an extension of the National Automotive Sampling System (NASS) 
Oracle data model. Variables for the medical injury data are based on a 
variety of sources including the National Trauma Registry, the 
Orthopedic Trauma Association, and the Uniform Pre-Hospital EMS Data 
Elements. Support for the seven (7) currently federally-funded CIREN 
Centers ends on March 31, 2005.

II. Objective

    The objective of the Cooperative Agreements is to fund CIREN 
Centers to add to the scope of data and expertise available and to 
increase CIREN's benefits to the public. NHTSA intends to award up to 
ten (10) Cooperative Agreements (depending on available funding at the 
time of award and the levels of effort proposed by the applicants) to 
support the goals of this initiative. Each Cooperative Agreement 
recipient will be expected to identify and coordinate an effort that 
supports the goals outlined in CIREN System Requirements. (See Section 
XIII).

III. NHTSA Involvement

    NHTSA will be involved in all activities undertaken as part of the 
Cooperative Agreement program and will, for each Cooperative Agreement 
awarded:
    1. Provide a NHTSA Contracting Officer's Technical Representative 
(COTR) to participate in the planning and management of the Cooperative 
Agreement and to coordinate activities between the Grantee (i.e., award 
recipients of the resultant Cooperative Agreement) and NHTSA.
    2. Provide information and technical assistance from government 
sources within available resources as determined appropriate by the 
COTR and the NHTSA CIREN Program Manager.
    3. Review and provide comments on oral and written presentations, 
research notes, white papers and other material submitted for 
publication to medical, technical or scientific journals.
    4. Stimulate the exchange of information among Grantees and 
encourage research projects.

IV. Levels of Effort

    Applicants may be considered for any one (1) of three (3) possible 
levels of effort.
    Level 1--The Grantee CIREN Center shall prepare fifty (50) cases 
each year. In addition, the Grantee CIREN Center must prepare and 
submit to peer review publications three (3) papers related to NHTSA/
CIREN goals. One (1) paper must be submitted to a medically oriented 
automotive safety conference peer review publication and must use CIREN 
data. The second and third papers must be submitted to additional peer 
review publications. At least one (1) of these additional papers must 
use CIREN data. Papers should incorporate CIREN Center experience. The 
principal investigator or co-principal investigator is required to 
present research findings at all public meetings and grand rounds, with 
supporting staff in attendance as needed. CIREN project/data 
coordinator(s), crash investigator(s) and supporting staff, as 
appropriate, are required to attend all team meetings. The Grantee 
CIREN Center shall conduct outreach programs in its community. Target 
audiences shall include first responders (EMS, fire and law enforcement 
agencies), medical counterparts, and the general public.
    Level 2--The Grantee CIREN Center shall prepare forty (40) cases 
each year. In addition, the Grantee CIREN Center must prepare and 
submit to peer review publications two (2) papers related to NHTSA/
CIREN goals. One (1) paper must be submitted to a medically oriented 
automotive safety conference peer review publication and a second paper 
must be submitted to an additional peer review publication. Both papers 
must use CIREN data. Papers should incorporate CIREN Center experience. 
The principal investigator or co-principal investigator is required to 
present research findings at all public meetings and grand rounds, with 
supporting staff in attendance as needed. The Grantee CIREN Center may, 
with the prior written approval of the COTR or NHTSA CIREN Program 
Manager, elect not to attend one (1) of these meetings per year. CIREN 
project/data coordinator(s), crash investigator(s) and supporting 
staff, as appropriate, are required to attend all team meetings. The 
Grantee CIREN Center shall conduct outreach programs in its community. 
Target audiences shall include first responders (EMS, fire and

[[Page 71103]]

law enforcement agencies), medical counterparts, and the general 
public.
    Level 3--The Grantee CIREN Center shall prepare thirty (30) cases 
each year. In addition, the Grantee CIREN Center must prepare and 
submit to peer review publications one (1) paper related to NHTSA/CIREN 
goals. The Paper must use CIREN data, and should incorporate CIREN 
Center experience. The principal investigator or co-principal 
investigator is required to present research findings at all public 
meetings and grand rounds, with supporting staff in attendance as 
needed. The Grantee CIREN Center may, with the prior written approval 
of the COTR or NHTSA CIREN Program Manager, elect not to attend one (1) 
of these meetings per year. CIREN project/data coordinator(s), crash 
investigator(s) and supporting staff, as appropriate, are required to 
attend all team meetings. The Grantee CIREN Center shall conduct 
outreach programs in its community. Target audiences shall include 
first responders (EMS, fire and law enforcement agencies), medical 
counterparts, and the general public.

V. Funding

1. General

    Subject to the availability of funds, it is anticipated that NHTSA 
will award up to ten (10) Cooperative Agreements to support the goals 
of this initiative for a period of five (5) years (i.e., one base year 
and four one-year Option Years, if exercised). Each Grantee will be 
expected to coordinate an effort that supports the goals outlined in 
the CIREN System Requirements.
    NHTSA anticipates that approximately three million dollars 
($3,000,000.00) in total federal funding will be available for award of 
up to ten (10) Cooperative Agreements under this Federal Register 
Notice for the base year. Funding for each of the four (4) option years 
for each of the Grantees will be based on the availability of funds in 
future fiscal years.
    The total number of awards will depend on the number and quality of 
the proposals submitted and the funding available at the time of the 
award. Applicants are encouraged to submit applications for all levels 
of effort for which they wish to be considered. However, no applicant 
may receive an award for more than one level of effort. NHTSA will 
select from among the proposals received from the prospective CIREN 
Center(s) to obtain the best mix of price/performance for the program 
as a whole.

2. Potential Funding Level Adjustments

    As outlined below, initial funding levels set at the time of award 
shall be adjusted if production levels are not achieved during the 
period of performance. Each Grantee's performance will be evaluated 
formally at the end of the second, third and fourth quarters in each 
performance period (including base and option years) to verify that the 
Grantee has reached the production levels specified in Appendix 3, 
Annual CIREN Work Production Levels. (Note that these production levels 
apply to medical/crash cases and peer-reviewed papers.) The reviews are 
as follows:
a. Second Quarter Review
    A Grantee whose performance falls below any of the production 
levels outlined in Appendix 3 at the time of the second quarter review 
will be informed by the NHTSA Contracting Officer in writing that its 
performance is in jeopardy and that funding will be reduced to reflect 
the actual level of performance if production levels are not met by the 
end of the third quarter. The NHTSA Contracting Officer in consultation 
with the NHTSA COTR will make this determination.
b. Third Quarter Review
    A Grantee whose performance falls below any of the production 
levels outlined in Appendix 3 at the time of the third quarter review 
will be funded on a pro rata basis reflecting the actual level of 
performance. For example, Centers that do not meet their production 
levels as stated in Appendix 3 will have a pro rata amount deducted 
from their annual award. The pro rata amount will be based on the 
number of production units not achieved during that year. Production 
units are weighted as follows--one crash case equals one production 
unit and one peer reviewed research paper equals two production units 
(e.g., a Level 1 Grantee enrolling 50 medical/crash cases and 3 peer-
reviewed papers will have completed 56 production units).
c. Fourth Quarter Review (Final Performance Evaluation)
    A Grantee whose performance meets all production levels at the end 
of the performance period will receive all agreed upon funding.
    A Grantee whose performance falls below any of the production 
levels outlined in Appendix 3 at the end of the period of performance 
will be funded on a pro rata basis reflecting the actual level of 
performance.

3. Option Year Funding

a. Eligibility for Full Funding
    A Grantee whose performance meets all production levels by the end 
of the performance period will be eligible for funding at the same 
level of performance in the subsequent option year (if this option is 
exercised).
b. Eligibility for Reduced Funding
    Upon notification made by the NHTSA COTR, failure of a Grantee to 
meet any of the production levels outlined in Appendix 3, Annual CIREN 
Work Production Deliverables by the end of the then-current performance 
period will result in the following action taken by the NHTSA 
Contracting Officer:
    (1) The Grantee will be eligible for funding in the subsequent 
option year only at a lower level (e.g., a Level 1 Grantee who fails to 
meet the production levels will be considered only for Level 2 or Level 
3 in the subsequent option year; a Level 2 Grantee who fails to meet 
the production levels will be considered only for Level 3 in the 
subsequent option year);
    (2) During a year of reduced funding, the specified level of 
reduced funding will constitute the maximum available to the Grantee in 
that year, regardless of whether the Grantee's performance improves 
(e.g., a Level 1 Grantee who receives reduced funding as a Level 2 
Grantee in an option year cannot receive more than the Level 2 amount 
of funding in the year of reduced funding, despite exceeding the 
production levels for Level 2); and
    (3) If the Grantee's performance improves in a year of reduced 
funding, the Grantee's funding may be restored to a higher level of 
funding in a subsequent Option Year at NHTSA's discretion and subject 
to the availability of funds.
    A Grantee funded at Level 3 in any year that fails to meet any of 
the production levels specified in Appendix 3 at the end of the fourth 
quarter will be terminated from the CIREN program.
c. NHTSA's Option
    Notwithstanding paragraphs 3(a) and 3(b) above, the exercise of an 
option is in NHTSA's sole discretion. (See Section VII).

4. Miscellaneous Funding Conditions or Limitations

    Notwithstanding any other provision of this Federal Register 
Notice, to ensure that production levels are met, the Government will 
monitor performance at all times and reserves

[[Page 71104]]

the right to adjust levels of reimbursement at any time if performance 
or progress is deemed inadequate.
    To ensure that reimbursement is commensurate with performance 
during the performance period, a Grantee shall not be reimbursed for 
more than the greater of the pro rata funding amount for medical/crash 
cases and peer-reviewed papers completed or 25% of its total funding 
per quarter.
    Notwithstanding any other provision of this Federal Register 
Notice, the Government may elect to waive the requirement for 
submission of one or more peer-reviewed paper(s) in exchange for the 
Grantee's participation in special research programs, as outlined in 
Section 3(E) under Specific Work Requirements. The NHTSA Contracting 
Officer shall detail any such waiver in writing. Unless the Government 
elects to waive a requirement for submission of peer-reviewed papers, 
the production levels for submission of such papers are firm.

VI. Period of Performance

    The anticipated period of performance for any Cooperative Agreement 
awarded under this Federal Register Notice begins April 1, 2005 and 
ends March 31, 2006 for the base period. Each of the four (4) twelve 
(12) month option years will begin on April 1 and end on March 31 of 
the then exercised Option Year.

VII. Option Exercise

    The Government reserves the right to exercise up to (4) four-twelve 
(12) month Option Years. The total of the Base Year and Option Years 
(if exercised) shall not exceed five consecutive calendar years. The 
Government may extend the terms of this agreement by written notice to 
the Grantee approximately sixty (60) calendar days prior to expiration 
of the then-current option year. The exercise of an Option Period will 
be considered achieved upon the execution of a unilateral modification 
to the Cooperative Agreement.

VIII. Termination

    Notwithstanding any other provision of the agreement, upon ninety 
(90) days advance written notice by the NHTSA Contracting Officer, the 
performance under the Cooperative Agreement may be terminated in the 
event that the prescribed funds are not available or the performance of 
the effort does not produce the intended result.

IX. Eligibility Requirements

    The Applicant's principal or co-principal must be a clinically 
active emergency room trauma physician or a clinically active emergency 
medical physician or a clinically active specialist with experience 
relating to the diagnosis and treatment of motor vehicle injuries and 
must be closely affiliated with a Level One Trauma Center. The 
Applicant also must be affiliated with the engineering or biomechanics 
programs at a university to assist with the work that will be performed 
by the Center. The Applicant must receive a sufficient number of motor 
vehicle crash victims from which cases may be selected for the CIREN 
program.
    Interested applicants are advised that no fee or profit will be 
allowed under this Cooperative Agreement program.
    Applicants are encouraged to submit proposals that address all 
three (3) performance levels as outlined under Section IV Levels of 
Effort. However, applicants at their discretion may address less than 
three.
    Applicant shall not submit a proposal jointly with another trauma 
center.

X. Conflict of Interest

    It is the Department of Transportation's (DOT) policy to award 
cooperative agreements to only those applicants whose objectivity is 
not impaired because of any related past, present, or planned interest, 
financial or otherwise, in organizations regulated by DOT or in 
organizations whose interests may be affected substantially by 
Departmental activities. Based on this policy:
    (a) The applicant shall provide a statement in its proposal which 
describes in a concise manner all past, present or planned 
organizational, financial, contractual or other interest(s) with an 
organization regulated by DOT, or with an organization whose interests 
may be affected substantially by Departmental activities, and which is 
related to the work under this Federal Register Notice. The interest(s) 
described shall include those of the proposer, its affiliates, proposed 
consultants, proposed subcontractors and key personnel of any of the 
above. Past interest shall be limited to within one year of the date of 
the applicant's technical proposal. Key personnel shall include any 
person owning more than 20% interest in the applicant, and the 
applicant's corporate officers, its senior managers and any employee 
who is responsible for making a decision or taking an action under this 
Cooperative Agreement where the decision or action can have an economic 
or other impact on the interests of a regulated or affected 
organization.
    (b) The applicant shall describe in detail why it believes, in 
light of the interest(s) identified in (a) above, that performance of 
the proposed contract can be accomplished in an impartial and objective 
manner.
    (c) In the absence of any relevant interest identified in (a) 
above, the applicant shall submit in its proposal a statement 
certifying that to its best knowledge and belief no affiliation exists 
relevant to possible conflicts of interest. The applicant must obtain 
the same information from potential subcontractors prior to award of a 
subcontract under the resultant Cooperative Agreement.
    (d) The NHTSA Contracting Officer will review the statement 
submitted and may require additional relevant information from the 
applicant. All such information, and any other relevant information 
known to DOT, will be used to determine whether an award to the 
applicant may create a conflict of interest. If any such conflict of 
interest is found to exist, the NHTSA Contracting Officer may (1) 
disqualify the applicant, or (2) determine that it is otherwise in the 
best interest of the agency to contract with the applicant and include 
appropriate provisions to mitigate or avoid such conflict in the 
Cooperative Agreement awarded.
    (e) The refusal to provide the disclosure or representation, or any 
additional information required, may result in disqualification of the 
applicant for award. If nondisclosure or misrepresentation is 
discovered after award, the resulting Cooperative Agreement may be 
terminated. If after award, the Grantee discovers a conflict of 
interest with respect to the Cooperative Agreement awarded as a result 
of this Federal Register Notice, which could not reasonably have been 
known prior to award, an immediate and full disclosure shall be made in 
writing to the NHTSA Contracting Officer. The disclosure shall include 
a full description of the conflict, a description of the action the 
Grantee has taken, or proposes to take, to avoid or mitigate such 
conflict. The NHTSA Contracting Officer may, however, terminate the 
Cooperative Agreement for convenience if he or she deems that 
termination is in the best interest of the Government.

XI. Application Procedure

    Each Applicant shall submit one (1) original and five (5) copies of 
the application package via Federal Express to: DOT/NHTSA, Office of 
Contracts

[[Page 71105]]

and Procurement (NPO-220), 400 Seventh Street, SW., Room 5301, 
Washington, DC 20590, Attention: Dianne R. Proctor. Applications shall 
be single spaced, must be typed on one side of the page only, must not 
exceed 50 typed written single spaced pages and must include a 
reference to Cooperative Agreement Number DTNH22-05-H-01001. 
Appendices, which may be included, are not counted in the 50-page 
limit.
    Only complete packages received on or before 2 p.m. e.s.t. on 
February 8, 2005, will be considered. No facsimile transmissions will 
be accepted. Applications must contain a reference to NHTSA Cooperative 
Agreement Number DTNH22-05-H-01001. Unnecessarily elaborate 
applications beyond what is sufficient to present a complete and 
effective response to this Federal Register Notice must not be 
submitted.

XII. Application Contents

    1. The application package must be submitted with the Office of 
Management and Budget (OMB) Standard Form 424 (Rev 4-88, including 424A 
and 424B), Application for Federal Assistance, including 424A, Budget 
Information-Non-construction Program and 424B, Assurances-Non-
construction Programs, with the required information provided and the 
certified assurances included. A Standard Form 424A & 424B must be 
submitted and packaged separately for each level of effort for which 
the applicant wishes to be considered. (See Section IV.)
    Forms are electronically available for downloading at http://www.whitehouse.gov/omb/grants/index.html.
    While the Form 424A deals with budget information, and Section B 
identifies Budget Categories, the available space does not permit a 
level of detail that is sufficient to provide for a meaningful 
evaluation of proposed costs. Therefore, supplemental information must 
be provided which presents a detailed breakout of the proposed costs 
(detailed labor, including labor category, level of effort and rate; 
direct materials, including itemized equipment, travel and 
transportation, including projected trips and number of people 
traveling; subcontracts/subgrants with similar detail if known; and 
overhead) as well as any In-Kind contributions the Applicant proposes 
to contribute.
    The Applicant also shall provide documentation supporting all costs 
for which federal funding is being requested. The estimated costs must 
be separated and proposed by base year and by each of the four (4) one 
year option years, such that the applicants budget will reflect the 
total possible performance of five (5) years. For each performance 
level of effort, (i.e., 50 cases, 40 cases and 30 cases) for which the 
applicant wishes to be considered, applicants must provide separate 
budgets proposed by base year and by each of the four (4) one year 
option years, such that the applicants budget will reflect the total 
possible performance of five (5) years.
    For the Base Year only, the applicant's proposal must include 
$10,000.00 for Government Furnished Equipment, as described under 
Section XIII, Subsection 6. Specifically, the applicant's cost proposal 
must indicate, as a separate line item, for the Base Year only, 
$10,000.00 for Government Furnished Equipment under each performance 
level being proposed. For example,

Total Proposal Cost $10,000.00,
Equipment Cost $10,000.00,
Grand Total Proposed $20,000.00

    2. Program Narrative Statement: Applicants shall fully describe the 
work to be performed under the Cooperative Agreement. Applications must 
include the following information in the program narrative statement:
    (A) A table of contents including page number references.
    (B) Work Plan, Technical Approach, and Technical Capability and 
Understanding: A description of the goal(s) of the project/program and 
how the applicant plans to meet the goal(s), including specific 
methodologies for the completion of tasks associated with the 
initiating, tracking and submission of enrolled medical/crash cases. 
The Applicant shall include steps that will be used to enroll medical/
crash cases and perform in-house quality control of enrolled cases 
prior to submission to NHTSA's quality assurance contractor. The 
Applicant shall discuss technical problems, barriers and/or critical 
issues related to the successful completion of this Cooperative 
Agreement effort. This must be specific with respect to each level of 
effort for which the Applicant wishes to be considered. To facilitate 
evaluation of the Applicant's Technical Capability and Understanding, 
the proposal should include information explaining how the Applicant 
meets the following:
    (1) Understanding of the methodology used in an electronic data 
collection system for medical/crash case assignment, medical/crash case 
tracking, and consistency of data coding, quality control and 
timeliness of medical/crash case submissions;
    (2) Understanding of trauma system injury coding [Abbreviated 
Injury Scale (AIS), International Classification of Diseases 
Modifications (ICDM), Orthopaedic Trauma Assessment (OTA), Current 
Procedural Terminology (CPT)];
    (3) Ability to communicate effectively the results of research 
efforts in publications and to conduct effectively outreach activities 
to the community at large;
    (4) Understanding of all available clinical data systems on site.
    (C) Trauma Registry Data: The Applicant's affiliated Level One 
Trauma Center's trauma registry data for the last three (3) years and 
the number of motor vehicle crash occupants admitted to the trauma 
center. For each year, if available, the Applicant shall identify the 
maximum level of severity (AIS1-AIS6) for the injuries incurred by each 
admitted occupant.
    (D) Radiology Systems: A description of current radiology systems 
utilized and methods (digital or film) used to obtain radiological 
images for presentation and research. Describe technology available 
[Computed Tomography (CT), Magnetic Resonance Image (MRI), High Speed 
CT, etc.].
    (E) Patient Data Systems: A description of patient data systems 
utilized at Applicant's facility (100% electronic medical records 
versus hard copy paper medical records or a hybrid system) and what 
access Applicant has to these records (real time versus post discharge; 
central access versus network access).
    (F) Prior Work and Experience: A description of previous motor 
vehicle safety research work associated with medical cases and/or 
biomechanics. The Applicant shall not include prior work associated 
with pedestrians or motorcyclists. The Applicant shall demonstrate its 
experience with on-site, real-time capture of patients and data 
collection activities. The Applicant also shall describe its experience 
in research relating to the documentation of motor vehicle crash 
injuries and in relating these injuries with in-depth motor vehicle 
crash investigations. The Applicant shall demonstrate experience in 
managing a multi-disciplinary research project and in operating a 
business enterprise as evidenced by the organization of the entity, 
previous experience collecting medical data and in conducting in-depth 
crash reconstruction and investigations, and in understanding of 
related highway safety programs. The Applicant shall describe its 
experience in obtaining Institutional Research Board (IRB) approval for 
research objectives.

[[Page 71106]]

    (G) Qualifications of Project Personnel and Project Management 
Experience: A description of human resources to be used in this 
Cooperative Agreement effort. The Applicant shall identify the proposed 
project manager and other personnel considered critical to the 
successful accomplishment of the project, including a brief description 
of their respective organizational responsibilities and their 
qualifications to meet the staff requirements and duties herein 
described. The roles and responsibilities of the proposed team members 
and any others included in the application package shall be specified. 
The proposed level of effort in performing the various activities also 
shall be identified. The Applicant must furnish an organizational chart 
and resume for each proposed staff member.
    (H) Past Performance and Financial Responsibility: The Applicant 
shall provide the following information:
    (1) At least three (3) references who can attest to the past 
performance history and quality of work provided by the Applicant on 
previous assistance agreements and/or contracts.
    In doing so, the Applicant shall provide the following information 
for each reference:
    (a) Assistance Agreement/Contract Number;
    (b) Title and brief description of Assistance Agreement/Contract;
    (c) Name of organization, name of point of contact, telephone 
number, and e-mail address of point of contact at the organization with 
which the Applicant entered into an Assistance Agreement/Contract;
    (d) Dollar value of Assistance Agreement/Contract;
    (e) Any additional information to address the issue of past 
performance and financial responsibility.
    (2) The Applicant shall indicate if it has ever appeared on the 
General Service Administration's (GSA) List of Parties Excluded from 
Federal Procurement and Non-procurement Programs or on GSA's ``Excluded 
Parties List.'' If so, the Applicant shall discuss the circumstances 
leading up to its appearance on either of these lists and its current 
status to enter into Assistance Agreements (i.e., Cooperative 
Agreements and Grants) and/or Contracts.
    (3) The Applicant shall indicate if it has ever filed for 
bankruptcy or has had any financial problems that may affect its 
ability to perform under the Assistance Agreement.

XIII. CIREN System Requirements

1. General Requirements

    The Grantee CIREN Center regularly shall enroll, enter, and 
complete medical/crash case information as reflected in the CIREN 
computer applications provided by Volpe. The Grantee CIREN Center shall 
use its best, but at no time less than commercially reasonable, efforts 
to complete these cases as defined by the systems definitions. The 
Grantee CIREN Center shall provide adequate, secure storage for the 
CIREN server and the associated hardware provided as part of the cost 
of the Cooperative Agreement.
    The Grantee CIREN Center shall review case summaries and other 
narratives for information and remove any information that may suggest 
judgments of culpability. Culpability will be determined by law 
enforcement and judicial proceedings.
    The Grantee CIREN Center must, as part of its obligations, author 
papers for medical and/or engineering journals and periodicals; engage 
in collaborative research with the other CIREN centers and with NHTSA 
representatives; participate in telephone conference calls; participate 
in electronic or in-person ``grand rounds'' to review cases; 
participate in peer review of papers; and attend quarterly meetings in 
Washington, DC and other locations.
    The Grantee CIREN Center shall outline a plan to establish lines of 
communication among the CIREN crash investigators and the quality 
control team to facilitate the communication of medical technologies 
relating to crash research and the introduction of emerging 
technologies relating to occupant protection systems. This interaction 
will create a critical link between the NASS, Special Crash 
Investigations (SCI), and CIREN programs that will mutually benefit the 
field and medical personnel of each program.
    The Grantee CIREN Center shall review overall injury coding to 
ensure adherence to established procedures. All injuries shall be well 
documented through the use of radiological reports, including but not 
limited to CT-scans, X-rays, and Magnetic Resonance Images (MRIs). 
Injuries shall be sourced to occupant contact points identified in the 
crash reconstruction process.
    The Grantee CIREN Center shall hire and/or install qualified 
personnel in accordance with its personnel management plan and shall 
not accept as a staff member anyone who intends to start or continue 
police, insurance or investigative activities as a second profession 
during his or her involvement with the CIREN program.
    If evidence is detected that project personnel are participating in 
these activities after the award is made, NHTSA will require immediate 
removal of the responsible individual(s) from the project and written 
notification within one (1) business day to the NHTSA Contracting 
Officer that such removals have taken place. Grantee CIREN Centers that 
engage in police, insurance or investigative activities shall ensure 
that staff members assigned to CIREN do not engage in such activities. 
Organizations shall be required to provide assurances that staff 
members will not be assigned to the aforementioned duties.
    The Grantee CIREN Center's staff, contractors and subcontractors 
working on this project will be required to sign a confidentiality 
agreement for each Center, agreeing not to discuss or divulge the 
source of any data to third parties (i.e., anyone outside the CIREN 
Network). In addition, staff, contractors and subcontractors must sign 
security forms required by Volpe in order to be granted access to the 
CIREN database.
    The Grantee CIREN Center shall conduct outreach programs in its 
community. Target audiences shall include first responders (EMS, fire 
and law enforcement agencies), medical counterparts, and the general 
public.
    The Grantee CIREN Center shall participate in weekly telephone 
conferences with the NHTSA CIREN team and representatives of the other 
CIREN centers. The Grantee CIREN Center shall participate in Quarterly 
Team Meetings in Washington, DC and other locations. The Grantee CIREN 
Center shall participate in ``Grand Rounds'' at least yearly.
2. Staffing Requirements and Duties

    Note: No staff member assigned to this work effort may be 
involved in any police, insurance or investigative activities.

    Below are the descriptions of the general duties and the required 
and/or preferred experience levels for each of the professional labor 
categories NHTSA envisions as necessary to perform the work described 
in this Federal Register Notice. This list may not be exhaustive.
    For those labor category descriptions listed below that do not 
match those of the Applicant's organization, the Applicant shall 
specify in its proposal each such difference.
    Staff shall be comprised of full- and part-time individuals as 
specified and shall include a multi-disciplinary research team to 
support collaborative

[[Page 71107]]

research efforts, which includes the following individuals:
    (A) Principal Investigator. A full time Principal Investigator must 
be a clinically active emergency room trauma surgeon or a clinically 
active emergency medicine physician or a clinically active specialist 
with a minimum of five (5) years experience relating to diagnosis and 
treatment of motor vehicle injuries and must be a closely affiliated 
with a Level One Trauma Center.
    (B) Co-Principal Investigator. A Co-Principal Investigator (may be 
full time or part time) with biomechanical, engineering or 
epidemiological experience. This position requires that this person 
have an M.D. or a Ph.D. in one of the aforementioned areas. The Co-
Principal Investigator also may be a clinically-active trauma surgeon 
or a clinically active emergency medical physician or a clinically 
active specialist with experience relating to the diagnosis and 
treatment of motor vehicle injuries and must be closely affiliated with 
a Level One Trauma Center.
    (C) Crash Investigator. A full time Crash Investigator (may be 
contracted out) must be NASS-trained or willing to attend the crash 
investigator training in Oklahoma City. The Crash Investigator does not 
have to be NASS-certified at the time the proposal is submitted but 
must agree to take the next available class. A Crash Investigator 
handling crashes involving children ages 12 and under must be a 
certified Child Safety Seat Inspector and must maintain yearly 
certification.
    (D) Study Coordinator. A full-time Study Coordinator must oversee 
data collection coding efforts and outcome. The Study Coordinator shall 
be familiar with, and shall have a working knowledge of, the various 
injury coding criteria, including, but not limited to, International 
Classification of Diseases--9th Edition (ICD-9), Abbreviated Injury 
Scale (AIS), and Current Procedural Terminology (CPT) codes. The Study 
Coordinator shall possess basic computer skills and software packages 
for graphics, documents and presentations.
    (E) Other Staff. A statistician, trauma fellow, trauma technician, 
social worker, and graduate research assistant (Each of these positions 
may be part-time).
    Duties of the staff identified above and other suggested staff 
shall include:
    Principal Investigator: Maintains overall responsibility for the 
project.
    Co-Principal Investigator: Works closely with the Principal 
Investigator and provides additional biomechanical, engineering, 
clinical, or epidemiological experience in relation to crash injury 
mechanisms.
    Study Coordinator: Interacts with all project staff, is responsible 
for contacting the crash investigation team and for obtaining injury 
data, ambulance/helicopter run sheets, autopsy reports, photographs, 
and crash reconstruction reports.
    Trauma Fellow: Identifies eligible study patients and obtains the 
consent of the patients. Documents all injury data and follows the 
patients throughout their hospital stay. Provides valuable insight into 
the case history of each patient and presents clinical observations at 
case review meetings.
    Trauma Technician: Assists the Trauma Fellow in identifying 
eligible study patients and obtaining the consent of these patients. 
Takes photographs of patient injuries and collects x-rays, CT scans, 
etc. for presentation at case reviews.
    Social Worker: Interviews patients at the time of admission 
regarding circumstances of the crash, psycho social characteristics, 
risk-taking behaviors, etc. Obtains baseline and 6- and 12-month 
follow-up data on patient outcomes.
    Graduate Research Assistant: Examines epidemiological trends in 
motor vehicle injuries. Abstracts autopsy reports from the proper local 
or state authorities.
    Crash Investigator: Locates the vehicle(s) involved in the crash. 
Performs detailed, NASS quality crash reconstruction, documenting 
damage profiles, crush measurements, intrusions, occupant contact 
points, etc. Presents findings at case review meeting and participates 
in multi-disciplinary discussions concerning injury-producing 
mechanisms.

3. Specific Work Requirements

    Medical/Crash cases selected for inclusion shall follow the 
criteria outlined in Appendix 1, ``2005 CIREN Case Inclusion Criteria 
for Adults (13+)'' and ``2005 CIREN Inclusion Criteria for Infants and 
Children (12 and Under)'' of this Federal Register Notice. Utilizing 
the Automated Data Collection and Processing System provided by Volpe, 
the Grantee CIREN Center shall:
    (A) Collect Occupant and Injury Data. Collect occupant information 
and injury data, including a narrative description of all injuries, 
relevant test results (including x-rays, MRIs, CT-scans), pre-hospital 
and hospital medical data, rehabilitation and residual medical 
condition data, and available medical costs. Coding of enhanced injury 
information is derived from a variety of sources including the National 
Trauma Registry, the Orthopedic Trauma Association, CPT Codes, ICDM, 
and the EMS National Guidelines.
    The Grantee CIREN Center's medical team shall obtain patient 
consent prior to enrolling the patient in CIREN. Pertinent medical 
history and medical records detailing all care given the patient as a 
result of the motor vehicle crash shall be obtained and entered into 
the database. The SF 36 questionnaire shall be given to adult patients 
and the Pediatric Quality of Life questionnaire to all children (or 
their appropriate guardians) prior to discharge, and arrangements shall 
be made for completion of the 6-month and 12-month follow-up 
questionnaire to track outcome measurements. The team shall review 
injury information to ensure that all injuries have been identified, 
documented through photographs or radiological images, and coded per 
established NASS AIS-90 protocols (familiarity with the Association for 
the Advancement of Automotive Medicine's injury coding scheme will 
facilitate the fulfillment of this requirement).
    The number of medical/crash cases completed will depend on the 
level of effort the Grantee CIREN Center addresses in its work 
proposal. CIREN medical/crash cases are generally limited to people who 
are seriously injured in motor vehicle crashes and transported to the 
center participating in the study. Medical/crash cases will be selected 
based on CIREN criteria at the time of enrollment. Medical/crash cases 
are selected based on NHTSA priority issues. There are separate 
criteria for adults and children.
    The medical team also must obtain Institutional Review Board (IRB) 
approval for research objectives. The team should refer to the Federal 
Register Notice (Vol. 68, No. 59, page 15039) dated March 27, 2003, 
announcing NHTSA's status as a ``public health authority'' in gaining 
IRB approval to promote thorough and complete data access collection.
    At least one of the Principal Investigators must be a clinically 
active emergency room trauma surgeon or a clinically active emergency 
medicine physician or a clinically active specialist with experience 
relating to diagnosis and treatment of motor vehicle injuries and must 
be affiliated closely with a Level One Trauma Center.
    (B) Collect Crash Data. Collect crash reconstruction data, 
including detailed scene and vehicle inspections. Scene inspections 
shall include retrieval of physical evidence, determination of the 
location, direction and speed of

[[Page 71108]]

vehicle(s) and measurement of tire marks. Crush profile, deltaV, and 
Collision Deformation Classification (CDC) must be determined.
    Exterior vehicle inspections shall include detailed measurements of 
crash damage including amount of crush. Interior vehicle inspections 
shall include examination of glazing, restraint systems, steering 
column, seats and other interior components to document precisely the 
extent of damage (intrusion) and occupant contact points.
    Crash scene photographs should depict each involved vehicle's pre-
impact path of travel, point of impact and post-impact trajectory to 
final rest. Photographs of the vehicle shall include shots from all 
angles, with and without any gauges. Digital vehicle photographs shall 
be taken as specified in the ``National Automotive Sampling System CDS 
Digital Photography Guidelines'' (dated January 2002), provided to the 
Grantee CIREN Center.
    (C) Investigate and Reconstruct the Crash. Undertake to investigate 
and reconstruct the crash and document injuries sustained. The 
reconstructions will attempt to determine the location, crash direction 
and magnitude of the vehicle impact(s) and their relation to passenger 
compartment integrity.
    The crash investigator shall use the software package VISIO to draw 
and document the crash scene and shall be familiar with the functioning 
of various automotive components, including but not limited to air 
bags, safety belts, pretensioners, and event data recorders. The crash 
investigator shall be knowledgeable on basic inspection techniques for 
the exterior of the vehicle including crush measurement techniques. The 
crash investigator also shall be knowledgeable about basic inspection 
techniques for the interior of the vehicle including occupant seats, 
integrity, glazing, occupant area contact points, and intrusion.
    (D) Conduct Monthly Case Reviews. The Grantee CIREN Center shall 
conduct monthly medical/crash case review meetings to critique its own 
medical/crash cases including a quality control review of the data to 
help ensure more thorough acquisition, reporting, and coding of the 
crash and injury data. Crash dynamics shall be reviewed in order to 
enhance further the accuracy of injury source determination. The 
Grantee CIREN Center shall notify the NHTSA COTR and NHTSA CIREN 
Program Manager via email of the date, time, and place of the meeting 
at least two (2) weeks prior to the meeting date. The notification also 
shall include the year, make, model of the crash vehicles and 
information on the case occupant (age, sex, seating location and 
injuries sustained).
    Each medical/crash case must be reviewed within ninety (90) 
business days of the case discharge date. Discussion at the monthly 
medical/crash case review meetings shall review all aspects of each 
crash (i.e., scene diagram, vehicle movement, vehicle crush, vehicle 
intrusion, occupant location, occupant injuries and occupant 
kinematics). These reviews shall facilitate feedback to determine the 
completeness and accuracy of the data. These reviews shall include 
appropriate professional input from the multi-disciplinary team members 
based on their specific areas of expertise.
    (E) Participate in Special Research Programs. The Grantee CIREN 
Center may be asked to participate in special research programs when 
its area of expertise is needed to respond to NHTSA's priority research 
goals. The Grantee may be requested, secondary to area of expertise, to 
work directly with NHTSA on priority projects. This work effort may be 
substituted for one or more research paper requirements output for that 
particular Grantee subject to NHTSA's discretion.

4. Security Requirements

    CIREN deals with highly sensitive material that must not be exposed 
to improper access within the Grantee CIREN Center, across other CIREN 
centers, or across the wide area network. Personal and location data 
identifiers must not be accessible outside the Grantee CIREN Center 
originally acquiring the data.
    The Grantee CIREN Center shall follow established sanitization 
procedures for personally identifiable information as outlined in 
Appendix 2, ``Special Provisions'' of this Federal Register Notice. 
Information released to the general public shall not include any 
``personal and/or location identifiers'' or any ``sensitive medical 
information'' as defined in Appendix 2 of this Federal Register Notice 
and shall not be traceable back to the CIREN collection site or Center.

5. Processing Requirements

    Certain processing requirements must be in place in order to 
expedite crash investigation procedures and crash documentation, as 
well as documentation of initial treatment. These include the 
establishment and maintenance of a good working relationship with law 
enforcement agencies, tow yards, EMS staff, and rehabilitation clinics.
    Procedures shall be established for monthly in-house medical/crash 
case reviews. These reviews shall include detailed discussion of the 
CIREN cases, including all medical and crash-related data. These 
reviews shall take place before cases are submitted to NHTSA's quality 
assurance contractor for Quality Control.
    The project will involve participation in the systematic collection 
and evaluation of new data concerning motor vehicle crashes by a multi-
center network. The outcomes/products of this project may include 
publication in a professional journal and/or presentations at 
professional meetings. Participation at CIREN meetings (quarterly, 
team, grand rounds, etc.) is also required.

6. Computer Equipment

    Equipment required for work under an awarded Cooperative Agreement 
will be furnished by NHTSA as part of each Grantee CIREN Center's cost 
under the Agreement and will remain government-owned equipment. The 
cost of equipment will be charged against the Grantee's award amount. 
Grantees shall include a line item for $10,000 for each site in their 
budget for the base year to cover the cost of this equipment.
    During the period of performance of the Agreement, the Grantee 
CIREN Center will coordinate the planned purchase of all new or 
replacement computer systems (hardware and software) with computer 
personnel at the Volpe Center in defining the system specifications for 
the planned purchase. The Volpe Center is the centralized repository 
for the CIREN system and all CIREN data. System compatibility is a 
critical component of the CIREN network and this coordination is 
considered vital to maintaining system viability.
    The NHTSA COTR and Volpe must approve new equipment before 
purchasing if reimbursement is requested from CIREN funds. Equipment 
not approved will not be permitted to connect to the CIREN network.
    Grantees shall include a line item for $5,000 in their budget for 
option year three (3) to cover the cost of replacing any outdated 
equipment.
    The Grantee CIREN Center is responsible for keeping up to date on 
new versions of software as prescribed by Volpe. The Grantee CIREN 
Center shall have in-house Information Technology (IT) support and 
have, or arrange to have installed, a FTS 2000 T-1 line and be 
responsible for its monthly maintenance fees which will be deducted 
from the award total. This T1 line is dedicated to the CIREN through 
the FTS2000 provider and is connected

[[Page 71109]]

to the CIREN server. This server must be installed in a secure 
location. Past experience has shown that the minimal lead time for new 
installations is 60 days. If the Applicant will require this line to be 
installed, provide the physical location (room number, street address, 
including cross streets) where this server will be housed. Every effort 
will be made by the NHTSA COTR to expedite this installation. The T1 
line installation and configuration cost is $4,000 for each new site. 
This is a one-time charge and includes the installation fee and the 
labor required to coordinate and configure the T1 line into the CIREN 
system. Grantees shall include a line item in their budget for the base 
year for this expense. Maintenance of the T1 line is a continuing 
charge of $550.00 per month that will be paid by the Grantee. Grantees 
shall include a line item in their budget for the base year and all 
option years for this item.

XIV. Application Review Process and Evaluation Factors

    Each application package will be reviewed initially to confirm that 
the Applicant is an eligible candidate (as described under Eligibility 
Requirements) and has included all of the items specified in the 
Application Procedure section of this Federal Register Notice. The 
NHTSA Evaluation Committee will evaluate applications submitted by 
eligible candidates. Awards may be made to multiple offerors in any 
combination of the three (3) performance levels, as indicated in 
Section IV of the Federal Register Notice. It is anticipated that 
awards will be made in April 2005. The applications will be evaluated 
using the following criteria (listed in descending order of 
importance).

------------------------------------------------------------------------
                            Factor                               Weights
------------------------------------------------------------------------
Factor 1. Work Plan, Technical Approach and Technical                 40
 Capability and Understanding.................................
Factor 2. Personnel Qualifications, Management Capabilities...        30
Factor 3. Corporate Experience................................        15
Factor 4. Past Performance and Financial Responsibility.......        15
------------------------------------------------------------------------

    The proposed scoring system is based on a score of 1,000, which is 
the maximum score a proposal can accumulate by receiving an outstanding 
rating on each evaluation factor. The quality rating scheme and 
evaluation factor weights are:

------------------------------------------------------------------------
                 Factor                    Score      Weight    Maximum
------------------------------------------------------------------------
1......................................       0-10         40        400
2......................................       0-10         30        300
3......................................       0-10         15        150
4......................................       0-10         15        150
------------------------------------------------------------------------

    As shown below, each evaluation factor can receive a maximum score 
of ten points in accordance with the following quality-rating scheme 
and definitions:

0.0-3.9 Unsatisfactory.
4.0-6.9 Below Average.
7.0-7.9 Average.
8.0-8.9 Above Average.
9.0-10.0 Outstanding.

    0.0-3.9 Unsatisfactory--Grossly insufficient detail or inadequate 
approach, methods, organization, or capabilities. Serious deficiencies 
exist in significant areas; the proposal cannot be expected to meet the 
minimum Federal Register Notice requirements without major revisions. 
Or the proposal is so deficient that it is not capable of being 
evaluated.
    4.0-6.9 Below Average--Fails to meet the minimum Federal Register 
Notice requirements, but is of such a nature that it has correction 
potential without major revisions to the proposal.
    7.0-7.9 Average--Generally meets minimum Federal Register Notice 
requirements; responds to all major aspects of the Federal Register 
Notice; capable of achieving desired objectives of the procurement.
    8.0-8.9 Above Average--Extensive and detailed response to all 
Federal Register Notice requirements; potential for high quality 
performance results in one or more areas covered by the procurement.
    9.0-10.0 Outstanding--Comprehensive, in-depth response to all 
Federal Register Notice requirements; professionally superior approach. 
Consistently high quality performance results likely in all major areas 
covered by the procurement.
    1. Factor 1. Work Plan, Technical Approach, and Technical 
Capability and Understanding. Weight: 40. The evaluation of the 
Applicant's proposal shall include:
    (A) The adequacy of the Applicant's plan to enroll cases; complete 
tasks associated with the initiating, tracking, and submission of 
enrolled cases; and perform in-house quality control;
    (B) The adequacy of Applicant's staffing plan;
    (C) The Applicant's degree of understanding of trauma system injury 
coding and the methodologies used in an electronic data collection 
system;
    (D) The Applicant's ability to effectively communicate results of 
research efforts in publications.
    2. Factor 2. Personnel Qualifications, Management Capabilities. 
Weight: 30. This evaluation shall measure the qualifications of the 
Applicant's proposed Principal Investigator and other team members as 
demonstrated by their personnel's resumes and organizational chart with 
respect to the following:
    (A) The proposed Principal Investigator's experience in the 
management of, collection, coding, and validation of medical data;
    (B) The proposed team members' experience in verifying crash-
related physical evidence with the reported injury, injury mechanism, 
occupant kinematics, damage severity, and restraint usage;
    (C) The proposed team members' experience in applying scientific 
theories and in analyzing physical evidence, substantiating injury 
mechanisms, and reconstructing crash events and speeds;
    (D) The experience of the proposed Project Coordinator in managing 
the prospective research program.
    (E) Demonstrated proof (submission of 3 years of trauma registry 
data) that Applicant's medical institution receives a sufficient number 
of motor vehicle crash victims from which cases can be selected for the 
CIREN program.
    3. Factor 3. Corporate Experience Weight: 15. The Applicant's 
corporate experience on previous Assistance Agreements and/or Contracts 
shall be evaluated. This evaluation shall include:
    (A) The Applicant's demonstrated experience in managing a multi-
disciplinary research project and in operating a business enterprise as 
evidenced by the organization of the entity; previous experience 
collecting medical data and conducting in-depth crash reconstruction 
and investigations; experience in obtaining IRB approval for

[[Page 71110]]

research objectives; and understanding of related highway safety 
programs;
    (B) The Applicant's level of experience with on-site, real-time 
capture of patients; data collection activities; and delivery of 
products in the form of research papers, technical presentations, etc. 
to diverse audiences.
    4. Factor 4. Past Performance and Financial Responsibility. Weight: 
15. The Applicant's past performance and the extent to which the 
Applicant has fulfilled its performance and financial obligations on 
previous Assistance Agreements and/or Contracts shall be evaluated. 
This evaluation shall include:
    (A) The Applicant's record of complying with the terms and 
conditions applicable to previous Assistance Agreements and/or 
Contracts, including the quality of services or deliverables provided 
and the adherence to milestones and performance and delivery schedules;
    (B) The degree to which the Applicant efficiently achieved the 
purposes of previous Assistance Agreements and/or Contracts within the 
approved budget;
    (C) The degree to which the proposed Grantee complied with the 
terms and conditions of previous Assistance Agreements and/or 
Contracts;
    (D) The degree to which the proposed Grantee complied with 
applicable Office of Management and Budget (OMB) Circulars and/or the 
Federal Acquisition Regulation on previous Assistance Agreements and/or 
Contracts;
    (E) The level of financial stability possessed by the proposed 
Grantee.

XV. Terms and Conditions of Award

    Prior to award, each applicant shall 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 Requirement for Drug Free Work Place 
(Grants). Certification requirements are electronically available for 
download at http://www.whitehouse.gov/omb/grants/index.html.
    In addition, prior to award each applicant shall comply with the 
NHTSA General Provisions for Assistance Agreements. (Attached as 
Appendix 5.) The following exceptions to the NHTSA General Provisions 
for Assistance Agreements apply:
    Section 2 (Allowable Costs): Item (c) is not applicable to this 
requirement.
    Section 5 (Data Collection): This section is not applicable to this 
requirement.
    Section 7 (Rights in Data): This section is not applicable to this 
requirement. (See Appendix 2 Special Provisions for appropriate related 
material).

XVI. Reporting Requirements and Deliverables/Milestones of the 
Cooperative Agreement

    An awarded Cooperative Agreement will include the following 
requirements:

1. Progress Reports

    The Grantee CIREN Center shall provide quarterly progress reports 
to NHTSA. These reports shall describe work completed to date, any 
identified problem areas or concerns, and recommended solutions, 
including technical assistance from any of the parties in the 
Cooperative Agreement.

2. Financial Reports

    The Grantee CIREN Center shall provide quarterly financial reports 
to NHTSA. These reports shall include all costs for the current period, 
as well as cumulative costs. The Center is expected to stay within 
budget and provide a summary of expenditures using the following 
categories:
    (A) Personnel: Provide level of effort (percentage of time spent) 
and salary or estimated compensation. Include rate data for fringe 
benefits.
    (B) Travel and Accommodations: Travel and related costs are to be 
provided for all travel performed in support of the Cooperative 
Agreement. These costs include travel and other related expenses for 
essential staff to participate at CIREN conferences. Grantee and staff 
shall ensure that claims for hotel and meals are within maximum 
allowable per diem and will make every effort to obtain the lowest 
transportation fares available.
    (C) Supplies: Provide cost of office supplies, photographic slides, 
film and processing, postage/delivery, and copying charges.
    (D) Other Direct Costs: Include any other cost items deemed by the 
parties to be necessary and allowable as a direct expense to the 
effort, such as preparation of conference materials and publication 
costs resulting from publications directly relating to the Cooperative 
Agreement.
    (E) Indirect Costs: Include indirect costs allowable to the effort 
in accordance with the Grantee CIREN Center's negotiated indirect costs 
rate agreement established with the cognizant federal audit agency.

3. Property Inventory

    The Grantee CIREN Center shall maintain all Government-furnished 
equipment or Government acquired equipment in working order. The 
Grantee CIREN Center shall provide NHTSA with a yearly listing of all 
Government-furnished equipment or Government acquired equipment on the 
Contractor Inventory Schedule (NHTSA Form HS-324). The Grantee CIREN 
Center shall not dispose of any equipment without the prior written 
approval of the COTR.

4. Requirements for Printed Material

    The print materials must be provided to NHTSA in both laser format 
and appropriate media formats (disk, CD-ROM).

5. Program Materials

    Presentation materials for CIREN public meetings shall be submitted 
within two (2) weeks of the presentation and shall be submitted in the 
following formats for placement on CIREN's homepage of the World Wide 
Web:
    <bullet> Original application format, for example, *.doc *.ppt; 
etc.
    <bullet> Section 508 compliancy checklist.
    <bullet> A PDF file for viewing with Adobe acrobat.
    <bullet> An HTML file.
    Contractors preparing publications for NHTSA must submit them in a 
format ready for posting on the Web. All documents must be Section 508 
compliant and both Netscape (versions 4.0 or later) and Internet 
Explorer (versions 5.0 or later) compliant. All Web/HTML documents must 
comply with the accessibility standards of 36 CFR Sec.  1194.22 that 
implement Section 508 of the Rehabilitation Act of 1973. All 
submissions shall include a completed web-based Internet Information 
and Application Section 508 Checklist. These standards and guidelines 
are available for viewing in greater detail at the Access Board Web 
Site at: http://www.access-board.gov/sec508/guide/1194.22.htm.

    Issued on: December 3, 2004.
William T. Hollowell,
Acting Associate Administrator for Vehicle Safety Research.

[[Page 71111]]



                                            Appendix 1.--2005 CIREN Case Inclusion Criteria for Adults (13+)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Occupant           Injury        Case priorities/
           Crash type               Crash direction      Vehicle criteria    Restraint criteria      positions         thresholds           issues
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frontal.........................  10 to 2 o'clock....  CY-8 yrs...........  Airbag, Airbag and   Front row........  AIS>=3 or *.....  <bullet> Airbag or
                                  Full frontal.......                        Belt.                                                     airbag + belt/
                                  Offset frontal.....                                                                                  other safety
                                                                                                                                       tech.:
                                                                                                                                       --low delta V
                                                                                                                                       (below test std)
                                                                                                                                       with high AIS
                                                                                                                                       (ISS 13+)
                                                                                                                                       ---high delta V
                                                                                                                                       (above test std)
                                                                                                                                       with low AIS (ISS
                                                                                                                                       8-12).
                                                                                                                                      <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/
                                                                                                                                       capture))*non-
                                                                                                                                       catastrophic*.
---------------------------------
Side............................  8 to 10 o'clock....  CY-8 yrs...........  Any and all,         Any..............  AIS>=3 or *.....  <bullet> Occupant
                                  2 to 4 o'clock.....  FMVSS No 214          including                                                 on struck side,
                                                        Compliant.           unrestrained on                                           far side, and or
                                                                             struck side and                                           side impact where
                                                                             far side.                                                 airbag deploys at
                                                                                                                                       the case occupant
                                                                                                                                       position
                                                                                                                                       --low delta V
                                                                                                                                       (below test std)
                                                                                                                                       with high AIS
                                                                                                                                       (ISS 13+)
                                                                                                                                       --high delta V
                                                                                                                                       (above test std)
                                                                                                                                       with low AIS (ISS
                                                                                                                                       8-12).
                                                                                                                                      <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/capture))
                                                                                                                                       *non-
                                                                                                                                       catastrophic*.
---------------------------------
Rollover........................  All................  CY-8 yrs...........  Any and all,         Any..............  AIS>=3 or *.....  <bullet> Vehicles
                                                       FMVSS NO 214          including                                                 equipped with
                                                        Compliant.           unrestrained                                              rollover curtains/
                                                                             (EXCEPTION = 100%                                         other safety
                                                                             EJECTION).                                                tech. (pretension
                                                                                                                                       belts, Adv.
                                                                                                                                       Airbags).
                                                                                                                                      <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/capture))
                                                                                                                                       *non-
                                                                                                                                       catastrophic*.
---------------------------------
Fire............................  All................  Any................  Any and all,         Any..............  AIS>=2..........  <bullet> Burn
                                                                             including                                                 injury is AIS>=2
                                                                             unrestrained.                                            <bullet> Fuel
                                                                                                                                       system failure to
                                                                                                                                       cause fire.
---------------------------------
PI Special Interest**...........  Any................  Any................  Any................  Any..............  Any.............  <bullet> Maximum
                                                                                                                                       of 10% of sites
                                                                                                                                       total year case
                                                                                                                                       count +.
                                                                                                                                      <bullet> Must get
                                                                                                                                       NHTSA approval
                                                                                                                                       prior**.
Success Case***.................  Any................  CY-8 yrs...........  Appropriate          Any..............  Any.............  <bullet> High
                                                                             restraint usage                                           energy crashes
                                                                             (belt and/or                                              with little or no
                                                                             airbag).                                                  injury to the
                                                                                                                                       case occupant
                                                                                                                                       (ISS 0-7).
                                                                                                                                      <bullet>
                                                                                                                                       Fatalities or
                                                                                                                                       seriously injured
                                                                                                                                       occupant in the
                                                                                                                                       same vehicle w/
                                                                                                                                       comparable
                                                                                                                                       restraint/
                                                                                                                                       scenario.
                                                                                                                                      <bullet> Must get
                                                                                                                                       NHTSA approval
                                                                                                                                       prior***.
--------------------------------------------------------------------------------------------------------------------------------------------------------
*AIS of 2 in 2 or more body regions with medical significance.
*AIS of 2 in the lower extremity with articular injury, peri-prothestic fractures, or spine injuries requiring operative fixation or halo.
**Max. PI SI cases allowed per site per year would be 5 based on a 50 case enrollment. Site personnel must contact Mark Scarboro or Cathy McCullough
  from NHTSA to obtain approval prior to case occupant enrollment.
***Cases must be extraordinary for consideration--NHTSA approval required.


                                   Appendix 1.--2005 CIREN Inclusion Criteria for Infants and Children (12 and Under)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Occupant           Injury        Case priorities/
           Crash type               Crash direction      Vehicle criteria    Restraint criteria      positions         thresholds           issues
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frontal.........................  10 to 2 o'clock....  Any................  --CRS used by case   Front............  AIS>=1..........  <bullet> Airbag
                                  Full frontal.......                        occupant.           Any..............  AIS>=2..........   deployment at
                                  Offset frontal.....                                                                                  occupant
                                                                                                                                       position.
                                                                                                                                      <bullet> Advanced
                                                                                                                                       airbag systems.
                                                                                                                                      <bullet> Curtain
                                                                                                                                       type airbags.
                                                                                                                                      <bullet> Safety
                                                                                                                                       belt
                                                                                                                                       pretensioners.
                                                                                                                                      <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/capture)).
                                                                                                                                      <bullet> CRS
                                                                                                                                       misuse.
---------------------------------
Side............................  8 to 10 o'clock....  FVMSS NO 214         --CRS used by case   Any..............  AIS>=2..........  <bullet> Side
                                  2 to 4 o'clock.....   Compliant.           occupant.                                                 airbag systems.
                                                                            --2 or 3 point                                            <bullet> CRS
                                                                             manual belt.                                              misuse.
                                                                            --Side Airbag w/wo                                        <bullet>
                                                                             belt.                                                     Integrated 3 pt
                                                                            --Low priority =                                           belts in position
                                                                             unrestrained.                                             22,32...
                                                                                                                                      <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/capture)).
---------------------------------
Rear............................  4 to 8 o'clock.....  Any................  --Rear facing CRS    Any..............  AIS>=2..........  <bullet> CRS
                                                                             used by case                                              misuse.
                                                                             occupant.                                                <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/capture)).
---------------------------------

[[Page 71112]]

 
Rollover........................  N/A................  FVMSS NO 214         --CRS used by case   Any..............  AIS>=2..........  <bullet> Side
                                                        Compliant.           occupant.                                                 airbag systems
                                                                            --2 or 3 point                                             and roll
                                                                             manual belt.                                              curtains.
                                                                            --Airbag w/wo belt.                                       <bullet> Safety
                                                                            --Low priority =                                           belt
                                                                             unrestrained.                                             pretensioners
                                                                                                                                      <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/capture)).
---------------------------------
Fire............................  N/A................  Any................  Any................  Any..............  AIS>==2.........  <bullet> Fatality
                                                                                                                                       (worthy of
                                                                                                                                       review: useful
                                                                                                                                       crash scenario,
                                                                                                                                       complete autopsy
                                                                                                                                       (scan/capture)).
                                                                                                                                      <bullet> Fuel
                                                                                                                                       system failure to
                                                                                                                                       cause fire.
---------------------------------
PI Special Interest **..........  Any................  Any................  Any................  Any..............  Any.............  Maximum of 10% of
                                                                                                                                       sites total year
                                                                                                                                       case count. Must
                                                                                                                                       get NHTSA
                                                                                                                                       approval prior**.
---------------------------------
Success Case **.................  Any................  Any................  --Properly used and  Any..............  N/A.............  <bullet> High
                                                                             appropriate                                               energy crashes
                                                                             restraint type.                                           with little or no
                                                                                                                                       injury to the
                                                                                                                                       child/infant
                                                                                                                                       occupant.
                                                                                                                                      <bullet>
                                                                                                                                       Fatalities in the
                                                                                                                                       same vehicle
                                                                                                                                       (Must get NHTSA
                                                                                                                                       approval
                                                                                                                                       prior**).
--------------------------------------------------------------------------------------------------------------------------------------------------------
**Site personnel must contact Mark Scarboro or Cathy McCullough from NHTSA to obtain approval prior to case occupant enrollment on these cases.

Appendix 2--Special Provisions

    A. CIREN Data Collection Requirements. The CIREN database, as 
configured at this time, consists of approximately 900 discrete 
fields of data concerning motor vehicle crashes relating to crash 
reconstruction and medical injury profiles. Information collected 
for each case and about each case occupant must be sufficient to 
ensure data input for each of these fields of data, where applicable 
and available. The exact configuration of the CIREN database is 
subject to change as periodic upgrades are made to the system.
    B. Protection of Individual Privacy.
    1. Personal and/or Location Identifiers. Personal and/or 
Location Identifiers, which may be discrete (e.g., database 
elements) or visual (e.g., photographs that include the face, 
without masking), shall not be included in the CIREN database. The 
following information is deemed to be ``Personal and/or Location 
Identifiers'':
    Discrete Identifiers:
    Patient's name, address, telephone number
    Social Security Number, patient ID number
    Specific location identifiers (e.g., town, city, county, state, 
road name)
    Employment information
    Driver license number, license plate
    Vehicle Identification Number*
    Date of birth**
    Date of accident***
    Time of accident****
    * Last six digits (sequential production portion) of VIN will 
not appear in the CIREN database.
    ** Age only will appear in the CIREN database.
    *** Month and year only will appear in the CIREN database.
    **** ``Morning,'' ``Afternoon'' or ``Evening'' only will appear 
in the public CIREN database.
    Visual Identifiers: All photographs, drawings, etc., with 
recognizable identifiers to personal identity or to location of the 
crash. This includes unmasked photographs of faces, license plates, 
car vendor bumper plates, store signs, locality signs, and road 
signs.
    2. Sensitive Medical Information: Sensitive Medical Information 
shall be included in the database only in specially designated 
fields, as directed by Volpe or NHTSA. The following information is 
deemed to be Sensitive Medical Information:

    Patient photographs, X-rays, CT-Scans, MRIs, detailed medical 
information and/or history (e.g., surgical procedures and medical 
treatments, pre-existing medical conditions, laboratory results).
    3. Sanitization and Data Segregability. The Grantee CIREN 
Center, NHTSA, NHTSA's quality assurance contractor and Volpe shall 
work cooperatively to ensure that all data has been properly 
sanitized to remove all Personal and/or Location Identifiers, before 
the data are added to the CIREN database, and that all Sensitive 
Medical Information resides only in specially designated fields, so 
that such information is segregable from the remaining information 
in the database.
    4. Consent and Dissemination. The Grantee CIREN Center shall be 
responsible for obtaining informed consent for each case occupant, 
to the extent required by its Institutional Review Board. The 
Grantee CIREN Center shall ensure that such informed consent is 
sufficient under its established policies and procedures and 
consistent with applicable laws and regulations, to enable the 
information collected to be used and disseminated in full accord 
with the terms and restrictions of the Cooperative Agreement.
    C. Rights in Data and Use of Information.
    1. In General. For the purposes of this paragraph, CIREN Tier 1 
Data means all sanitized data resident in the CIREN database, 
excluding Sensitive Medical Information, as described above but 
including injury coding information based on the Abbreviated Injury 
Scale used by NHTSA; and CIREN Tier 2 Data means all sanitized data 
resident in the CIREN database, without exclusions.
    2. CIREN Tier 1 Data. CIREN Tier 1 Data shall be considered to 
be in the public domain and available for access or release by or to 
any person. The parties to the Cooperative Agreement shall have 
unlimited rights to use, disclose, or reproduce such data and to 
prepare derivative works, distribute copies to the public, and 
display such data publicly, in any manner or for any purpose 
permitted by law.
    3. CIREN Tier 2 Data.
    (a) Except as provided in Section C.3(b) of Appendix 2, access 
to CIREN Tier 2 Data shall be limited to trauma centers that are 
CIREN participants and the research sponsors (if any) that are 
parties to their agreements, NHTSA and its agents and contractors, 
and Volpe. Use of this data shall be strictly limited to the 
research purposes of the Cooperative Agreement in furtherance of 
traffic safety, medical research to reduce motor vehicle crash 
injuries, and improved vehicle design. Any other use is prohibited. 
Without limiting the generality of the foregoing, prohibited uses 
include but are not limited to any use in support of offensive or 
defensive litigation. NHTSA will protect all Sensitive Medical 
Information residing in the CIREN database from public dissemination 
to the full extent authorized by 5 U.S.C. 552.
    (b) The parties understand that, from time to time, access to 
CIREN Tier 2 Data by others may properly be authorized, by NHTSA 
only, for limited research purposes in furtherance of vehicle or 
traffic safety, injury reduction, and improved vehicle design, and 
subject to strict limitations against further disclosure. NHTSA 
agrees that any such authorization shall be subject to all 
applicable laws, regulations, policies, and procedures.
    D. Dissemination of Information By Educational Institutions.
    1. Publications. The Department of Transportation (``DOT'') 
desires widespread dissemination of the results of supported 
transportation research. Accordingly, the Grantee CIREN Center may 
publish documented research results in professional journals, books, 
trade publications, or other appropriate media. All costs of such 
academic publications shall be borne by the Grantee CIREN Center and 
shall not be

[[Page 71113]]

charged to NHTSA and/or Volpe under the Cooperative Agreement or any 
other Federal agreement.
    2. Disclaimer. Any copy of material published must contain an 
acknowledgment of NHTSA's support of the research effort with the 
cooperative agreement number and a disclaimer stating that the 
published material represents the position of the author(s) and not 
necessarily that of NHTSA. Articles for publication or papers to be 
presented to professional societies do not require authorization of 
NHTSA prior to release. However, two copies of each article shall be 
transmitted to the NHTSA COTR and the CIREN program manager for 
Agency review at least two weeks prior to the date of release or 
publication. A copy of the final paper once it is published or 
presented shall be submitted to the NHTSA COTR and the CIREN program 
manager.
    3. Press Releases. Press releases concerning the results or 
conclusions from any research conducted under the Cooperative 
Agreement shall not be made or otherwise distributed without the 
advance review and written consent of the other participating 
parties. Notwithstanding the foregoing, the parties may respond to 
media inquiries relating to articles or papers published or 
submitted for publication pursuant to Section D.2 of Appendix 2 of 
the Cooperative Agreement without first obtaining the consent of any 
other party.
    4. No Waiver. Notwithstanding the foregoing, publication or 
other presentation of data obtained through the Cooperative 
Agreement shall not release the Grantee CIREN Center or any of its 
employees from its obligation to prepare and submit other reports or 
case summaries containing the findings and results of research, as 
set forth in the Cooperative Agreement.

                                                 Appendix 3.--Annual CIREN Work Production Deliverables
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        2nd Qtr    2nd Qtr    2nd Qtr    3rd Qtr    3rd Qtr    3rd Qtr
                                                         review     review     review     review     review     review   Final Qtr  Final Qtr  Final Qtr
          Center level            Cases/yr  Papers/yr    cases     cases QC    paper      cases     cases QC    paper      cases     cases QC    paper
                                                        enrolled    ready      submit    enrolled    ready      submit    enrolled    ready*     submit
--------------------------------------------------------------------------------------------------------------------------------------------------------
Level 1
Year 1.........................         45          3         23          8          1         33         20          2         45         32          3
Year 2-5.......................         50          3         25          9          2         37         21          3         50         37          3
Level 2
Year 1.........................         36          2         18          6          1         27         15          1         36         24          2
Year 2-5.......................         40          2         20          7          1         30         16          2         40         30          2
Level 3
Year 1.........................         27          1         14          4          0         20         10          1         27         16          1
Year 2-5.......................         30          1         15          5          1         22         11          1         30         22         1
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Cases not completed for QC in the enrollment year must be completed in the first quarter of the subsequent year.
Standard timeline for ``QC Ready'' = Four months from enrollment.
QC Ready or ``In Review'' status indicates completion and site review of a crash case with the exception of the outcome data (SF-36/Peds QL).
Outcome data is required for CIREN cases within 14 months of the original crash date.
Paper submission may be waived if the CIREN site is participating in research on specific issues for NHTSA (See Section XIII(3)(E)).

Appendix 4--Definition of Acronyms

AIS Abbreviated Injury Scale
AIS-90 Abbreviated Injury Scale--1990 Version
CDC Collision Deformation Classification
CDS Crashworthiness Data System
CIREN Crash Injury Research and Engineering Network
CPT Current Procedural Terminology
CT Computed Tomography
DOT epartment of Transportation
EMS Emergency Medical Services
ICD-9 International Classification of Diseases--9th Edition
ICDM International Classification of Diseases Modifications
IT Information Technology
IRB Institutional Review Board
MRI Magnetic Resonance Image
NHTSA National Highway Traffic Safety Administration
NASS National Automotive Sampling System
OMB Office of Management and Budget
OTA Orthopaedic Trauma Assessment
SCI Special Crash Investigations
T1 Type of Communication Circuit
U.S. United States
VISIO A software package used to create scene diagrams

Appendix 5--General Provisions for Assistance Agreements National 
Highway Traffic Safety Administration

    This assistance agreement shall be subject, as applicable, to 
the administrative requirements contained in the following documents 
or regulations which are hereby incorporated by reference, with the 
same force and effect as if they were given in full text:
    49 CFR Part 18--Department of Transportation Uniform 
Administrative Requirements for Grants and Cooperative Agreements to 
State and Local Governments. http://www.dot.gov/ost/m60/grant/49cfr18.htm.
    49 CFR Part 19--Department of Transportation Uniform 
Administrative Requirements for Grants and Agreements with 
Institutions of Higher Education, Hospitals, and Other Nonprofit 
Organizations, and, for purposes of this agreement, with commercial 
organizations, except as otherwise provided elsewhere in these terms 
and conditions. http://www.dot.gov/ost/m60/grant/49cfr19.htm.
    49 CFR Part 20--Department of Transportation New Restrictions on 
Lobbying. http://www.dot.gov/ost/m60/grant/49cfr20.htm.
    49 CFR Part 29--Department of Transportation Government-wide 
Debarment and Suspension (Nonprocurement) and Government-wide 
Requirements for Drug-Free Workplace (Grants). http://www.dot.gov/ost/m60/grant/49cfr29.htm.
    In addition, the following provisions are applicable to this 
agreement that provides Federal financial assistance authorize by 
statute.

1. Definitions
2. Allowable Costs
3. Audit Requirements
4. Standard Patent Rights
5. Data Collection
6. Protection of Individual Privacy
7. Rights in Data
8. Restrictions on Printing
9. Other Administrative Provisions and Assurances
10. Order of Precedence

    1. Definitions. Throughout this assistance agreement, the 
following terms shall have the meanings set forth below:
    a. The term ``Secretary'' means the Secretary of the Department 
of Transportation or his duly authorized designee.
    b. The term ``Department'' means the Department of 
Transportation (DOT).
    c. The term ``Agency'' means the National Highway Traffic Safety 
Administration (NHTSA).
    d. The term ``Contracting Officer'' or ``CO'' means any person 
authorized to execute the agreement on behalf of the NHTSA.
    e. The term ``Contracting Officer's Technical Representative'' 
or ``COTR'' means the CO's authorized representative responsible for 
the programmatic/technical administration of the agreement, the 
evaluation of performance under the

[[Page 71114]]

agreement, the acceptance of technical reports, and for other 
specific responsibilities as may be stipulated in various provisions 
of the agreement.
    f. The term ``Grantee'' means the recipient of the award of the 
assistance agreement, whether a grant or cooperative agreement, and 
includes the following:
    (1) States, local governments or Federally recognized Indian 
tribal governments as defined in 49 CFR Part 18.
    (2) Nonprofit organizations including public and private 
institutions of higher education, public and private hospitals, and 
other quasi-public and private nonprofit organizations as further 
described in 49 CFR Part 19.
    (3) Commercial organizations including small and large 
businesses organized for profit; organizations which are not 
otherwise included among those specified in 49 CFR Part 18 or 49 CFR 
Part 19; or international organizations.
    g. The term ``Third-Party Contract'' means any legal instrument 
entered into between the grantee and a third party, or any lower 
tier, for the performance of a portion of the effort provided for 
under this assistance agreement and includes contracts, grants, and 
cooperative agreements.
    h. The term ``Third-Party Contractor'' means the recipient of a 
``Third-Party Contract.''
    i. The acronym ``OMB'' means the Office of Management and 
Budget.
    j. The acronym ``FAR'' means Federal Acquisition Regulation.

2. Allowable Costs.

    a. Payments up to the amount specified in the assistance 
agreement shall be made only for costs determined by the CO to be 
allowable, allocable and reasonable in performing the effort under 
the agreement in accordance with its terms and with the following 
cost principles:
    (1) OMB Circular A-21 (applicable to educational institutions).
    (2) OMB Circular A-87 (applicable to State and local governments 
and Federally-recognized Indian tribal governments).
    (3) OMB Circular A-122 (applicable to non-profit organizations).
    (4) FAR 31.2 (applicable to all other organizations).
    b. During performance of this assistance agreement, certain 
direct cost expenditures, not itemized in the approved budget, may 
become necessary. In order to avoid subsequent disallowances, or 
dispute based on unreasonableness or unallocability, written 
agreement in advance of the incurrence of such costs in appropriate. 
In addition, selected cost principles contain a number of items of 
cost for which prior approval is required. Direct cost expenditures 
requiring such written notification from the CO include, but are not 
limited to, the following.
    (1) Purchase or rental of any item of general purpose equipment 
having a useful life of more than two years and an acquisition cost 
of $500 or more; and all items of office and automatic data 
processing equipment, regardless of cost, if not itemized in the 
approved budget.
    (2) Purchase or rental of any item of special purpose equipment 
having a unit cost of $1,000 or more if not itemized in the approved 
budget.
    (3) Personnel movement of a special or mass nature not itemized 
in the approved budget.
    (4) Foreign travel (each separate trip) not itemized in the 
approved budget.
    (5) Domestic travel when not included in the approved budget or 
when the cumulative travel expenditures will exceed the approved 
travel budget by $500 or 25%, whichever is greater.
    (6) Consultant and professional services not itemized in the 
approved budget.
    (7) Subcontracts not identified in the approved budget, except 
those for incidental supplies, materials, and general support 
services.
    (8) Purchase or lease of any interest in real property, or 
improvements in real property not itemized in the approved budget.
    c. NHTSA may provide in advance for costs to be incurred or 
reimburse costs accrued by the grantee up to the maximum amount of 
the Federal assistance payable for the period of performance. 
However, payment of such costs, whether in advance or by 
reimbursement, shall not constitute a final determination by NHTSA 
of the allowability of such costs and shall not constitute a waiver 
of any violation of the terms of the assistance agreement committed 
by the grantee. NHTSA shall make a final determination as to the 
allowability only after the final audit is completed, if required, 
or at the time of final payment.
    d. NHTSA shall not be obligated to reimburse the grantee for 
outlays (costs) in excess of the Federally-funded amount of the 
assistance agreement unless and until the CO executes a modification 
which increases the Federally-funded amount. The Federally-funded 
amount is the amount actually obligated under the agreement which 
may be less than or equal to the budgeted Federal share of the 
agreement.
    3. Audit Requirements.
    a. If this assistance agreement is with an institution of higher 
education, hospital or other nonprofit organization, the grantee 
shall conduct audits in accordance with the provisions of OMB 
Circular A-133, ``Audits of Institutions of Higher Education and 
Other Nonprofit Organizations''.
    b. If this assistance agreement is with a State or local 
government of Federally-recognized Indian tribe government, the 
grantee shall obtain audits in accordance with the Single Audit Act 
of 1984 (31 U.S.C. 7501-7), as provided in 49 CFR Part 18.26.
    c. If this assistance agreement is with a commercial 
organization, the following conditions shall be applicable:
    (1) Examination of costs--The grantee shall maintain--and the CO 
or representatives of the CO shall have the right to examine and 
audit--books, records, documents, and other evidence and accounting 
procedures and practices, regardless of form (e.g., machine readable 
medial such as disk, tape, etc.) or type (e.g., data bases, 
applications software, data base management software, utilities, 
etc.), sufficient to reflect properly all costs claimed to have been 
incurred or anticipated to be incurred in performing this agreement. 
This right of examination shall include inspection at all reasonable 
times of the grantee's facilities, or parts of them, engaged in 
performing the agreement.
    (2) Reports--If the grantee is required to furnish cost, 
funding, or performance reports, the CO or representatives of the CO 
shall have the right to examine and audit books, records, or other 
documents, and supporting materials, for the purpose of evaluating 
(a) the effectiveness of the grantee's policies and procedures to 
produce data compatible with the objectives of these reports and (b) 
the data reported.
    (3) Availability--The grantee shall make available at its office 
at all reasonable times the materials described in paragraph (1) 
above, for examination, audit or reproduction, until the later of 3 
years after final payment or any resulting final settlement of a 
termination, appeal, litigation or claim, or for any shorter period 
specified in FAR Subpart 4.7, Records Retention, or for any longer 
period required by statute.
    (4) Except as otherwise provided in FAR Subpart 4.7, Records 
Retention, the grantee may transfer computer data in machine 
readable form from one reliable computer medium to another. The 
grantee's computer data retention and transfer procedures shall 
maintain the integrity, reliability, and security of the original 
data. The grantee's choice of form or type of materials described in 
paragraphs (1) and (2) of this clause affects neither the grantee's 
obligations nor the Government's rights under this clause.
    (5) The grantee shall insert a clause containing all the terms 
of this paragraph c in all third-party contracts over $10,000 with 
commercial organizations under this agreement, altering the clause 
only as necessary to identify properly the parties and the CO under 
the NHTSA prime agreement.
    4. Standard Patent Rights [The clause at 37 CFR Part 401.14(a), 
as modified below (or as further modified in accordance with the 
provisions of 37 CFR Part 401), shall be applicable to all 
assistance agreements involving the performance of research and 
development efforts by small business firms, non-profit 
organizations, State, local, and Federally-recognized Indian tribal 
governments, and unless otherwise provided, by other commercial 
organizations.]
    The following modifications to the clause at 37 CFR Part 
401.14(a) apply:
    a. The parenthetical information shall be removed from the title 
of the clause;
    b. The terms ``contract'' and ``contractor'' shall be replaced 
by the terms ``assistance agreement'' and ``grantee,'' respectively, 
as defined in these General Provisions (except that the grantee may 
modify these terms pursuant to paragraph (g)(1) of the clause for 
use in third-party contracts);
    c. The terms ``agency,'' ``Federal agency,'' and ``funding 
Federal agency'' shall be replaced by the term ``NHTSA'' (excepted 
that the grantee may modify these terms pursuant to paragraph (g)(1) 
of the clause for use in third-party contracts);
    d. The terms ``subcontract(s)'' and ``subcontractor'' shall be 
replaced by the terms ``third-party contract(s)'' and ``third-party 
contractor,'' respectively, as defined in these General Provisions;

[[Page 71115]]

    e. The terms ``to be performed by a small business firm or 
domestic non-profit organization'' shall be deleted from paragraph 
(g)(1) of the clause;
    f. The following subparagraph shall be added at the end of 
paragraph (f) of the clause;
    (5) The grantee agrees to provide, upon request by the CO, 
periodic (but no more frequently than annual) listing of all subject 
inventions which were disclosed to NHTSA pursuant to paragraph 
(c)(1) and/or a report (DD Form 882) prior to the close-out of the 
assistance agreement listing all subject inventions or stating that 
there were none.
    g. Paragraphs (g)(2) and (g)(3) of the clause shall be deleted; 
and
    h. Paragraph (I) of the clause, entitled ``Communications,'' 
shall read as follows:
    (I) Communications All notifications required by this clause 
shall be submitted to the NHTSA CO.
    5. Data Collection. (Paperwork Reduction Act of 1980) [This 
clause shall be applicable to all assistance agreements involving 
the collection of information as defined in 5 CFR 1320.7]
    a. OMB requires review and approval of plans and reports used to 
collect identical information from 10 or more persons (other than 
Federal employees) under assistance agreements sponsored by NHTSA. A 
collection of information undertaken by a grantee is considered to 
be ``sponsored'' by NHTSA only if:
    (1) The grantee is collecting information at the specific 
request of NHTSA; or
    (2) The terms and conditions of the agreement require specific 
approval by NHTSA of the collection of information or the collection 
procedures.
    b. Unless otherwise specified, data collection conducted under 
the assistance agreement is the responsibility of the grantee, and 
NHTSA support of the effort does not constitute NHTSA approval of 
the survey design, questionnaire content, or data collection 
procedures. The grantee shall not represent to respondents that such 
data is being collected for, or in association with, NHTSA or any 
Federal agency without the specific written approval of such data 
collection plan or device by NHTSA. However, this requirement is not 
intended to preclude mention of NHTSA support of the effort in 
response to any inquiry or acknowledgement of such support in any 
publication of data.
    6. Protection of Individual Privacy. [This clause shall be 
applicable to all assistance agreements under which the grantee, or 
its employees, or its third-party contractors, administrator any 
system of records on individuals on behalf of the Federal 
Government.]
    a. Privacy Act Notification. The design, development, or 
operation of any system of records on individuals to accomplish a 
Government function is subject to the Privacy Act 1974, Public Law 
93-579, December 31, 1974 (5 U.S.C. 552a) and applicable 
regulations. Violations. Violation of the Act may involve the 
imposition of criminal penalties.
    b. The grantee agrees to:
    (1) Comply with the Privacy Act of 1974 (the Act), and rules and 
regulations issued pursuant to the Act when performance under this 
agreement involves the design, development, or operation of any 
system of records on individuals to be operated by the grantee, its 
employees, or its third party contractors to accomplish a Government 
function.
    (2) Notify the NHTSA CO when the grantee anticipates operating a 
system of records on individuals on behalf of the Government in 
order to accomplish the requirements of this agreement, if such 
system contains information about individuals which will be 
retrieved by the individuals name or other particular identifier 
assigned to the individual. A system on individuals subject to the 
Act may not employed in the performance of this agreement until the 
necessary approval and publication requirements applicable to the 
system have been carried out. The grantee agrees to collect, 
maintain, disseminate, and use such records in accordance with the 
requirements of the Act, and comply with all applicable requirements 
of the Act.
    (3) Include the Privacy Act Notification contained in this 
agreement in every solicitation and in every resulting third-party 
contract and in every third-party contract awarded without a 
solicitation, when the performance of work under the third-party 
contract requires the design, development operation of a system of 
records on individuals that is subject to the Act.
    (4) Include this clause b. including this paragraph, in all 
third-party contracts under this agreement that requires the design, 
development, or operation of a system of records on individuals that 
is subject to the Act.
    c. For the purposes of the Privacy Act, when the agreement 
involves the design, development, or operation of a system of 
records on individuals to accomplish a Government function, the 
grantee, its employees, and its third party contractors are 
considered to be employees of the government respect to the 
Government function, and the requirements of the Act, including 
civil and criminal penalties for violation of the Act, are 
applicable. In addition, failure to comply with the provisions of 
the Act or of this clause will make this agreement subject to 
termination.
    d. The terms used in this clause have the following meanings:
    (1) ``Operation of a system of records'' means performance of 
any of the activities associated with maintaining the system of 
records on behalf of the Government, including the collection, use, 
and dissemination of records.
    (2) ``Record'' means any item, collection or grouping of 
information about an individual that is maintained by the grantee on 
behalf of the Government including, but not limited to, education, 
financial transactions, medical history, and criminal or employment 
history and that contains the person's name, or the identifying 
number, symbol, or other identifying particular assigned to the 
individual, such as a fingerprint or voiceprint or photograph.
    (3) ``System of records on individuals'' means a group of any 
records under the control of the grantee on behalf of the Government 
from which information is retrieved by the name of the individual or 
by some indemnifying number, symbol, or other particular assigned to 
that individual.
    7. Rights in Data. [This clause is applicable in its entirety to 
all assistance agreements and third-party contracts, except those 
involving State local, and Federally-recognized Indian tribal 
governments, tribal governments, for which this clause applies only 
where not inconsistent with 49 CFR 18.34, and Nonprofit 
Organizations, for which this clause applies only where not 
inconsistent with 49 CFR 19.36.]
    a. Definitions.
    (1) ``Computer software,'' as used in this clause, means 
computer programs, computer, computer databases, and documentation 
thereof.
    (2) ``Data'' as used in this clause, means recorded information, 
regardless of form or the media on which it may be recorded. The 
term includes technical and computer software. The term does not 
include information incidentenal to agreement administration, such 
as financial, administrative, cost or pricing, or management 
information.
    (3) ``Form, fit, and function data,'' as used in this data 
relating to items, components, or processes that are sufficient to 
enable physical and functional interchangeably, as well as data 
identifying source, size, configuration, mating, and attachment 
characteristics, functional characteristics, and performance 
requirements; except that for computer software it means data 
identifying source, functional characteristics, and performance 
specifications, but specifically excludes the source code, 
algorithm, process, formulae, and flowcharts of the software.
    (4) ``Limited Rights,'' as used in this clause, means the rights 
of the Government limited rights data as set forth in the Limited 
Rights Notice of subparagraph g(2).
    (5) ``Limited rights data,'' as used in this clause, means data 
(other than computer software) that embody trade secrets or are 
commercial or financial and confidential or privileged, but only to 
the extent that the data pertains to items, components, or processes 
developed at private expense, including minor modifications thereof.
    (6) ``Restricted computer software,'' as used in this clause, 
means computer software developed at private expense and that is a 
trade secret; is commercial or financial and is confidential or 
privileged; or is published copyrighted computer software; including 
minor modifications of such computer software.
    (7) ``Restricted rights,'' as used in this clause, means the 
rights of the Government in restricted computer software, as set 
forth in a Restricted Rights Notice of subparagraph g(3), or as 
otherwise may be provided in a collateral agreement incorporated in 
and made part of this agreement, including minor modifications of 
such computer software.
    (8) ``Technical data,'' as used in this clause, means data 
(other than computer software), which are of scientific or technical 
nature.
    (9) ``Unlimited rights,'' as used in this clause, means the 
right of the Government to use, disclose, reproduce, prepare 
derivative

[[Page 71116]]

works, distribute copies to the public, and perform publicity and 
display publicity, in any manner and for any purpose, and to have or 
permit others to do so.
    b. Allocation of rights.
    (1) Except as provided in paragraph c of this clause regarding 
copyright, the Government shall have unlimited rights in--
    (i) Data first produced in the performance of this agreement;
    (ii) Form, fit, and function data delivered under this 
agreement;
    (iii) Data delivered under this agreement (except for restricted 
computer software) that constitutes manuals or instructional and 
training material for installation, operation, or routine 
maintenance and repair of items, components, or processes delivered 
or otherwise furnished for use under this agreement, and
    (iv) All other data delivered under this agreement unless 
provided otherwise for limited rights data or restricted computer 
software in accordance with paragraph of this clause.
    (2) The grantee shall have the right to--
    (i) Use, release to others, reproduce, distribute, or publish 
any data first produced or specifically used by the grantee in the 
performance agreement unless provided otherwise in paragraph (d) of 
this clause;
    (ii) Protect from unauthorized disclosure and use those data 
which are limited rights data or restricted computer software to the 
extent provided in paragraph g of this clause;
    (iii) Substantiate use of, add or correct limited rights, 
restricted rights or copyright notices and to take other appropriate 
action, in accordance with paragraph e and f of this clause; and
    (iv) Establish claim to copyright sustaining and first produced 
in the performance of this contract to the extent provided in 
subparagraph c(1) of this clause.
    c. Copyright.
    (1) Data first produced in the performance of this agreement. 
Unless provided otherwise in paragraph d of this clause, the grantee 
may establish, without prior approval of the CO, claim to copyright 
subsisting in scientific and technical articles based upon or 
containing any data first produced in the performance of this 
agreement and published in academic, technical or professional 
journals, symposia proceedings or similar works. The prior, express 
written permission of the agreement of the CO is required to 
establish claim to copyright subsisting in all other data first 
produced in the performance of this agreement. When claim to 
copyright subsisting in all other data first produced in the 
performance of this agreement. When claim to copyright is made, the 
grantee shall affix the applicable copyrights notices of 17 U.S.C 
401 or 402 and acknowledgment of Government sponsorship (including 
agreement number) to the data when such data are delivered to the 
Government, as well as when the data are published or deposited for 
registration as a published work in the U.S. Copyright Office.
    For data other than computer software the grantee grants to the 
Government, and others acting on its behalf, a paid-up, 
nonexclusive, irrevocable worldwide license in such copyrighted data 
to reproduce, prepare derivative works, distribute copies to the 
public, and perform publicity and display publicity, by or on behalf 
of the Government. For computer software, the grantee grants to the 
Government and others acting in its behalf, a paid-up, nonexclusive, 
irrevocable worldwide license in such copyrighted computer software 
to reproduce, prepare derivative works, and perform publicity and 
display publicity, by or on its behalf of the Government.
    (2) Data not first produced in the performance of this 
agreement. The grantee shall not, without prior written permission 
of the CO, incorporate in data delivered under this agreement any 
data not in first produced in the performance of this agreement and 
which contains the copyright notice of 17 U.S.C. 401 or 402 unless 
the grantee identifies such data and grants to the Government, or 
acquires on its behalf, a license of the same scope as set forth in 
subparagraph c(1) of this clause, provided, however, that if such 
data are computer software Government shall acquire a copyright 
license as set forth in subparagraph g(3) of this clause or as 
otherwise may be provided in a collateral agreement incorporated in 
or made part of this agreement.
    (3) Removal of copyright notices. The Government agrees not to 
remove any copyright notices placed on data pursuant to this 
paragraph c, and to include such notices on all reproduction of the 
data.
    d. Release, Publication and use of data.
    (1) The grantee shall have the right to use, release to others, 
reproduce, distribute, or publish any data first produced or 
specifically used by the grantee in the performance of this 
agreement, except to the extent that such data may be subject to the 
Federal export control or national security laws or regulations, or 
unless otherwise provided in this paragraph of this clause or 
expressly set forth in this agreement.
    (2) The grantee agrees that to the extent it receives or is 
given access to data necessary for the performance of this agreement 
which contains restrictive markings, the grantee shall treat the 
data in accordance with such markings unless otherwise specifically 
authorized in writing by the CO.
    e. Unauthorized markings of data.
    (1) Notwithstanding any other provisions of this agreement 
concerning inspection or acceptance, if any data delivered under 
this agreement are marked with the notices specified in subparagraph 
g(2) or g(3) of this clause and use of such is not authorized by 
this clause, or if such data bears any other restrictive or limiting 
markings not authorized by this agreement, the CO may at anytime 
either return the data to the grantee, or cancel or ignore the 
markings. However, the following procedures shall apply prior to 
canceling or ignoring the markings:
    (i) The CO shall make written inquiry to the grantee affording 
the grantee 30 days from receipt of the inquiry to provide written 
justification to substantiate the propriety of the markings;
    (ii) The grantee fails to respond or fails to provide written 
justification to substantiate the property markings within the 30-
day period (or a longer time not exceeding 90 days approved in 
writing by the CO for good cause shown), the Government shall have 
the right to cancel or ignore the markings at any time after the 
said period and the data will no longer be made subject to any 
disclosure prohibitions.
    (iii) If the grantee provides written justification to 
substantiate the propriety of the markings within the period set in 
subdivision e(1)(i) of this clause, the CO shall consider such 
written justification and determine whether or not the markings are 
to be canceled or ignored. If the CO determines that the markings 
are authorized, the grantee shall be so notified in writing. If the 
CO determines, with concurrence of the head of the contracting 
activity, that the markings are not authorized, the CO shall furnish 
the grantee a written determination, which determination shall 
become the final agency decision regarding the appropriateness of 
the markings unless the grantee files suit in a court of contempt 
jurisdiction within 90 days of receipt of the CO's decision. The 
Government shall continue to abide by the markings under this 
subdivision e(1)(iii) until final resolution of the matter either by 
the CO's determination becoming final (in which instance the 
Government shall thereafter have the right to cancel or ignore the 
marking at any time and the data will no longer be made subject to 
any disclosure prohibitions) or by final disposition of the matter 
by court decision if suit is filed.
    (2) The time limits in the procedures set forth in subparagraph 
e(1) of this clause may be modified in accordance with regulations 
implementing the Freedom of Information Act (5 U.S.C. 552) if 
necessary to respond to a request hereunder.
    f. Omitted or incorrect markings.
    (1) Data delivered to the Government without either the limited 
rights or restricted rights notice as authorized by paragraph g of 
this clause, or the copyright notice required by paragraph c of this 
clause, shall be deemed to have been furnished with unlimited 
rights, and the Government assumes no liability for the disclosure, 
use, or reproduction of such data. However, to the extent the data 
has not been disclosed without restriction outside the Government, 
the grantee may request, within 6 months (or longer time approved by 
the CO for good cause shown) after delivery of such data; permission 
to have notices placed on qualifying data, at the greater grantee's 
expense, and the CO may agree to do so if the grantee--
    (i) Identifies the data to which the omitted notice is to be 
applied;
    (ii) Demonstrates that the omission of the notice was 
inadvertent;
    (iii) Establishes that the use of the proposed notice is 
authorized; and
    (iv) Acknowledges that the Government has no liability respect 
to the disclosure or use of any such data made prior to the addition 
of the notice or resulting from the omission of the notice.
    (2) The CO may also (i) permit correction at the grantee's 
expense, of incorrect notices if the grantee identifies the data on 
which correction of the notice is to be made, and demonstrates that 
the correct notice is authorized, or (ii) correct any incorrect 
notices.

[[Page 71117]]

    g. Protection of limited rights data and restricted computer 
software.
    (1) When data other than that listed in subdivision b(1)(i), 
(ii) and (iii) of this clause are specified to be delivered under 
this agreement and qualify as either limited rights data or 
restricted computer software, if the grantee desires to continue 
protection of such data, the grantee shall withhold such data and 
not furnish them to the Government under this agreement. As a 
condition to this withholding the grantee shall identify the data 
being withheld and furnish form, fit, and function data in lieu 
thereof. Limited rights data that is formatted as a computer 
database for delivery to the Government are to be treated as limited 
rights data and not restricted computer software.
    (2) Notwithstanding subparagraph g(1) of this clause, the 
agreement may identify and specify the delivery of limited rights 
data, or the CO may require by written request the delivery of 
limited rights data that has been withheld or would otherwise be 
withholdable. If delivery of such data is so required, the grantee 
may affix the following ``Limited Rights Notice'' to the data and 
the Government will thereafter treat the data, subject to the 
provisions of paragraph e and f of this clause, in accordance with 
such Notice:

Limited Rights Notice

    (a) These data are submitted with limited rights under NHTSA 
Agreement No. ------------------------ .
    These data may be reproduced and used by the Government with the 
express limitation that they will not, without written permission of 
the grantee, be used for purpose of manufacture or disclosed outside 
the Government; except that the Government may disclose these data 
outside the Government for the following purposes, if any, provided 
that the Government makes such disclosure subject to prohibition 
against further use and disclosure:
    (i) Use (except for manufacture) by support service contractors.
    (ii) Evaluation by nongovernmental evaluators.
    (iii) Use (except for manufactures) by other grantees or 
contractors participating in the Government's program of which the 
agreement is a part, for information and use in connection with the 
effort of work performed under each agreement or contract.
    (iv) Release to a foreign government, or instrumentality 
thereof, as the interests of the United States may require, for 
information or evaluation by such government.
    b. This Notice shall be marked on any reproduction of these data 
in whole or in part.

(End of notice)

    (3)(i) Notwithstanding subparagraph g(1) of this clause, the 
agreement may identify and specify the delivery of restricted 
computer software, or the CO may require by written request the 
delivery of restricted computer software that has been withheld or 
would otherwise be withheld. If delivery of such computer software 
is so required, the grantee may affix the following ``Restricted 
Rights Notice'' to the computer software and the Government will 
thereafter treat the computer software, subject to paragraphs e and 
f of this clause, in accordance with the Notice:

Restricted Rights Notice

    (a) This computer software is submitted with restricted rights 
under NHTSA Agreement No. ------------------------ . It may not be 
used, reproduced, or disclosed by the Government except as provided 
in a paragraph (b) of this Notice or as otherwise expressly stated 
in the agreement.
    (b) This computer software may be--
    (1) Used or copied for use in or with the computer for which it 
was acquired, including use at any Government installation to which 
such computer or computers may be transferred;
    (2) Use or copied for use in a backup computer if any computer 
for which it was acquired is non-operative;
    (3) Reproduced for safekeeping (archives) or backup purposes;
    (4) Modified, adapted, or combined with other computer software, 
provided that the modified, combined, or adapted portions of the 
derivative software incorporating restricted computer software are 
made subject to the same restricted rights; and
    (5) Disclosed to and reproduced for use by support service 
contractors in accordance with subparagraphs (b)(1) through (4) of 
this clause, provided the Government makes such disclosure or 
reproduction subject to these restricted rights; and
    (6) Used or copied for use in or transferred to a replacement 
computer.
    (c) Notwithstanding the foregoing, if this computer software is 
published copyrighted computer software, it is licensed to the 
Government, without disclosure prohibitions, with the minimum rights 
set forth in paragraph (b) of this clause.
    (d) Any other rights or limitations regarding the use, 
duplication, or disclosure of this computer software are to be 
expressly stated in, or incorporated in the agreement.
    e. This Notice shall be marked on any reproduction software, in 
whole or in part.

(End of notice)

    (3)(ii) Where it is impractical to include the Restricted Rights 
Notice on restricted computer software, the following short-form 
Notice may be used in lieu thereof:

Restricted Rights Notice--Short Form

    Use, reproduction, or disclosure is subject to restrictions set 
forth in NHTSA Agreement No. ------------------------ with (name of 
Grantee).

(End of notice)

    (3)(iii) If restricted computer software is delivered with the 
copyright notice of 17 U.S.C. 401, it will be presumed to be 
published copyrighted computer software licensed to the Government 
without disclosure prohibitions, with the minimum rights set forth 
in paragraph b of this clause, unless the grantee includes the 
following statement with such copyright notice: ``Unpublished--
rights reserved under the Copyright Laws of the United States.''
    h. Third Party Contracts. The grantee has the responsibility to 
obtain from its third-party contractors all data and rights therein 
necessary to fulfill the grantee's obligations to the Government 
under this agreement. If a third-party contractor refuses to accept 
terms affording the Government such rights, the grantee shall 
promptly bring such refusal to the attention of the CO and not 
proceed with the third-party contract award without further 
authorization.
    i. Relationship to patents. Nothing contained in this clause 
shall imply a license to the Government under any patent or be 
construed as affecting the scope of any license or other right 
otherwise granted to the Government.
    8. Restrictions on Printing.
     a. Governments Printing and Binding Regulations are published 
by the Joint Committee on Printing, Congress of the United States. 
These regulations are applicable to NHTSA when NHTSA bears the 
entire cost of printing of materials exclusively for its own use.
    b. This assistance agreement is not made primarily or 
substantially for the purpose of typesetting or having material 
printed for NHTSA use.
    c. The grantee may reproduce reports, data, or otherwise written 
material requires under the terms of the agreement for the use of 
NHTSA, provided that the material duplicated does not exceed 5,000 
units of only one page, or that the items consisting of multiple 
pages do not exceed 25,000 units in the aggregate. Grantees must 
advise the CO if the estimated quantities will exceed these ceilings 
so that Department/Committee approval can be obtained.
    d. These restrictions do not preclude the writing, editing, 
preparation of manuscript copy and related illustrations material, 
or the publication of findings by grantees; or the administrative 
printing requirements of the grantee required for its own use to 
respond to the terms of the agreement.
    9. Other Administrative Provisions and Assurances.
    a. No Government Obligations to Third Parties. Absent its 
specific consent, the NHTSA shall not be subject to any obligations 
or liabilities with respect to any person or entity not a party to 
this agreement in connection with performance under the agreement, 
notwithstanding its occurrence in or approval of the solicitation or 
award of any third-party contract.
    b. Severability. If any provisions of this agreement are held 
invalid, the remainder of this agreement shall not be affected 
thereby if such remainder would then continue to conform to the 
terms and requirements of applicable law.
    c. The grantee assures and certifies that no member of or 
delegate to Congress, or resident Commissioner, will be admitted to 
any share or part of this assistance agreement, or to any benefit 
arising from it. And further, it shall comply with the provisions of 
18 U.S.C. 1913 which prohibits the direct or indirect use of any 
funds appropriated by Congress to pay for any personal service, 
advertisement, telegram, telephone, letter, printed or written 
matter, or any other device intended or designed to influence a 
member of Congress, to favor or oppose, any legislation or 
appropriation, whether before or after the introduction of any bill 
or resolution proposing such legislation or appropriation.

[[Page 71118]]

    d. The grantee warrants that it has not paid and agrees not to 
pay any bonus, commission or fee for the purpose of obtaining 
approval of its application for the financial assistance agreement.
    e. The grantee assures that it shall comply with all applicable 
provisions of Federal, State and local law. Nothing in this 
agreement shall require the grantee to observe or enforce compliance 
with any provision hereof, perform any other act or do any other 
thing in contravention of applicable State or territorial law; 
provided that if any of provisions of the agreement would require 
the grantee to violate any applicable State or territorial law, the 
grantee will at once notify the CO in writing in order that 
appropriate modifications may be made to the agreement to remedy the 
violation.
    All limits and standards set forth in this agreement are minimum 
requirements, and shall not affect the application of more stringent 
State or local standards, provided however, that in its procurement 
actions under this agreement, the grantee shall not give any 
preference to or discriminate against goods and services produced or 
manufactured in any country, State or other geographical area, 
except as provided in paragraph f below.
    f. The grantee assures and certifies that all manufactured 
products, steel, and cement used in carrying out this agreement are 
produced in the United States, in accordance with Section 165 of the 
Surface Transportation Assistance Act of 1982 (Pub. L. 97-424; 96 
Stat. 2097) unless the Secretary of DOT has determined under Section 
165 that it is appropriate to waive this requirement.
    10. Order of Precedence.
    In the event of any inconsistency between any provisions of this 
agreement, the following order of precedence shall apply:
    a. Statement of Purpose (excluding the grantee's proposal, if 
incorporated).
    b. Special provisions contained in the assistance agreement.
    c. General Provisions, whether referenced or stated in full 
text, contained herein.
    d. The grantee's proposal (if incorporated).

[FR Doc. 04-26986 Filed 12-7-04; 8:45 am]
BILLING CODE 4910-59-P


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