Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 71101

not be consistent with the goals and 

objectives of 49 U.S.C. 31315 and 

31136(e).

Basis for Renewing Exemptions 

Under 49 U.S.C. 31315(b)(1), an 

exemption may be granted for no longer 

than two years from its approval date 

and may be renewed upon application 

for additional two year periods. In 

accordance with 49 U.S.C. 31315 and 

31136(e), each of the 22 applicants has 

satisfied the entry conditions for 

obtaining an exemption from the vision 

requirements (67 FR 68719 and 68 FR 

2629). Each of these 22 applicants has 

requested timely renewal of the 

exemption and has submitted evidence 

showing that the vision in the better eye 

continues to meet the standard specified 

at 49 CFR 391.41(b)(10) and that the 

vision impairment is stable. In addition, 

a review of each record of safety while 

driving with the respective vision 

deficiencies over the past two years 

indicates each applicant continues to 

meet the vision exemption standards. 

These factors provide an adequate basis 

for predicting each driver’s ability to 

continue to drive safely in interstate 

commerce. Therefore, the FMCSA 

concludes that extending the exemption 

for each renewal applicant for a period 

of two years is likely to achieve a level 

of safety equal to that existing without 

the exemption. 

Comments 

The FMCSA will review comments 

received at any time concerning a 

particular driver’s safety record and 

determine if the continuation of the 

exemption is consistent with the 

requirements at 49 U.S.C. 31315 and 

31136(e). However, the FMCSA requests 

that interested parties with specific data 

concerning the safety records of these 

drivers submit comments by January 7, 

2005. 

In the past the FMCSA has received 

comments from Advocates for Highway 

and Auto Safety (Advocates) expressing 

continued opposition to the FMCSA’s 

procedures for renewing exemptions 

from the vision requirement in 49 CFR 

391.41(b)(10). Specifically, Advocates 

objects to the agency’s extension of the 

exemptions without any opportunity for 

public comment prior to the decision to 

renew, and reliance on a summary 

statement of evidence to make its 

decision to extend the exemption of 

each driver. 

The issues raised by Advocates were 

addressed at length in 69 FR 51346 

(August 18, 2004). The FMCSA 

continues to find its exemption process 

appropriate to the statutory and 

regulatory requirements.

Issued on: December 3, 2004. 

Rose A. McMurray, 

Associate Administrator, Policy and Program 

Development.

[FR Doc. 04–26983 Filed 12–7–04; 8:45 am] 

BILLING CODE 4910–EX–P

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. 

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 

Diane.Proctor@nhtsa.dot.gov or by 

phone at (202) 366–9562 and Karin E. 

Eddy, Office of Contracts and 

Procurement, by e-mail at 

Karin.Eddy@nhtsa.dot.gov 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 

Karin.Eddy@nhtsa.dot.gov. 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 longterm disability. 

NHTSA is an agency of the U.S. 

Department of Transportation (DOT). 

NHTSA’s mission is to save lives, 

prevent injuries and reduce trafficVerDate jul<14>2003 18:05 Dec 07, 2004 Jkt 205001 PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 E:\FR\FM\08DEN1.SGM 08DEN1
71102 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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 selffunded 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 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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 peerreviewed 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 

71104 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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 peerreviewed 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 peerreviewed 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 coprincipal 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 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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-Nonconstruction 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. 

71106 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

(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 inperson ‘‘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 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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 CoPrincipal 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 parttime). 

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 injuryproducing 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), prehospital 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 

71108 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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 preimpact 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 multidisciplinary 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 governmentowned 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 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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 onetime 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 Capability 

and Understanding ...................... 40 

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 multidisciplinary 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 

71110 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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: 

• Original application format, for 

example, *.doc *.ppt; etc. 

• Section 508 compliancy checklist. 

• A PDF file for viewing with Adobe 

acrobat. 

• 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 § 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.

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 71111

APPENDIX 1.—2005 CIREN CASE INCLUSION CRITERIA FOR ADULTS (13+) 

Crash type Crash direction Vehicle criteria Restraint criteria Occupant 

positions 

Injury 

thresholds Case priorities/issues 

Frontal ...................... 10 to 2 o’clock .........

Full frontal 

Offset frontal 

CY–8 yrs ................. Airbag, Airbag and 

Belt.

Front row .... AIS≥3 or * .. • Airbag or airbag + belt/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). 

• Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture))*non-catastrophic*. 

Side .......................... 8 to 10 o’clock .........

2 to 4 o’clock 

CY–8 yrs .................

FMVSS No 214 

Compliant 

Any and all, including unrestrained 

on struck side and 

far side.

Any ............. AIS≥3 or * .. • Occupant on struck side, far side, and 

or side impact where 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). 

• Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture)) *non- catastrophic*. 

Rollover .................... All ............................ CY–8 yrs .................

FMVSS NO 214 

Compliant 

Any and all, including unrestrained 

(EXCEPTION = 

100% EJECTION).

Any ............. AIS≥3 or * .. • Vehicles equipped with rollover curtains/other safety tech. (pretension 

belts, Adv. Airbags). 

• Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture)) *non-catastrophic*. 

Fire ........................... All ............................ Any .......................... Any and all, including unrestrained.Any ............. AIS≥2 ......... • Burn injury is AIS≥2 

• 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 .......................... CY–8 yrs ................. Appropriate restraint 

usage (belt and/or 

airbag).

Any ............. Any ............. • High energy crashes with little or no injury to the case occupant (ISS 0–7). 

• Fatalities or seriously injured occupant 

in the same vehicle w/comparable restraint/scenario. 

• 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) 

Crash type Crash direction Vehicle criteria Restraint criteria Occupant 

positions 

Injury 

thresholds Case priorities/issues 

Frontal ...................... 10 to 2 o’clock .........

Full frontal 

Offset frontal 

Any .......................... —CRS used by 

case occupant.

Front ...........

Any .............

AIS>=1 .......

AIS>=2 .......

• Airbag deployment at occupant position. 

• Advanced airbag systems. 

• Curtain type airbags. 

• Safety belt pretensioners. 

• Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture)). 

• CRS misuse. 

Side .......................... 8 to 10 o’clock .........

2 to 4 o’clock 

FVMSS NO 214 

Compliant.

—CRS used by 

case occupant.

—2 or 3 point manual belt 

—Side Airbag w/wo 

belt 

—Low priority = unrestrained 

Any ............. AIS>=2 ....... • Side airbag systems. 

• CRS misuse. 

• Integrated 3 pt belts in position 22,32... 

• Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture)). 

Rear ......................... 4 to 8 o’clock ........... Any .......................... —Rear facing CRS 

used by case occupant.

Any ............. AIS>=2 ....... • CRS misuse. 

• Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture)). 

71112 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

APPENDIX 1.—2005 CIREN INCLUSION CRITERIA FOR INFANTS AND CHILDREN (12 AND UNDER)—Continued

Crash type Crash direction Vehicle criteria Restraint criteria Occupant 

positions 

Injury 

thresholds Case priorities/issues 

Rollover .................... N/A .......................... FVMSS NO 214 

Compliant.

—CRS used by 

case occupant.

—2 or 3 point manual belt 

—Airbag w/wo belt 

—Low priority = unrestrained 

Any ............. AIS>=2 ....... • Side airbag systems and roll curtains. 

• Safety belt pretensioners 

• Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture)). 

Fire ........................... N/A .......................... Any .......................... Any .......................... Any ............. AIS≥=2 ....... • Fatality (worthy of review: useful crash 

scenario, complete autopsy (scan/capture)). 

• 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 

appropriate restraint type.

Any ............. N/A ............. • High energy crashes with little or no injury to the child/infant occupant. 

• 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 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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

Center 

level Cases/yr Papers/yr 

2nd Qtr 

review 

cases enrolled 

2nd Qtr 

review 

cases QC 

ready 

2nd Qtr 

review 

paper 

submit 

3rd Qtr 

review 

cases enrolled 

3rd Qtr 

review 

cases QC 

ready 

3rd Qtr 

review 

paper 

submit 

Final Qtr 

cases enrolled 

Final Qtr 

cases QC 

ready* 

Final Qtr 

paper 

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 DrugFree 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 

71114 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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 Federallyrecognized 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 Federallyfunded 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 Federallyrecognized 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 ‘‘thirdparty contractor,’’ respectively, as defined in 

these General Provisions; 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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 Federallyrecognized 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 

71116 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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. 

Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 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. 

llllllllllll. 

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. llllllllllll. 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. llllllllllll 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 thirdparty 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.

71118 Federal Register / Vol. 69, No. 235 / Wednesday, December 8, 2004 / Notices 

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety 

Administration 

[Docket No. NHTSA–2004–19738] 

Decision That Certain Nonconforming 

Motor Vehicles Are Eligible for 

Importation

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), DOT.

ACTION: Notice of decision by NHTSA 

that certain nonconforming motor 

vehicles are eligible for importation. 

SUMMARY: This document announces 

decisions by NHTSA that certain motor 

vehicles not originally manufactured to 

comply with all applicable Federal 

motor vehicle safety standards are 

eligible for importation into the United 

States because they are substantially 

similar to vehicles originally 

manufactured for importation into and/

or sale in the United States and certified 

by their manufacturers as complying 

with the safety standards, and they are 

capable of being readily altered to 

conform to the standards.

DATES: These decisions became effective 

on the dates specified in Annex A.

FOR FURTHER INFORMATION CONTACT:

Coleman Sachs, Office of Vehicle Safety 

Compliance, NHTSA ((202) 366–3151).

SUPPLEMENTARY INFORMATION: 

Background 

Under 49 U.S.C. 30141(a)(1)(A), a 

motor vehicle that was not originally 

manufactured to conform to all 

applicable Federal motor vehicle safety 

standards shall be refused admission 

into the United States unless NHTSA 

has decided that the motor vehicle is 

substantially similar to a motor vehicle 

originally manufactured for importation 

into and sale in the United States, 

certified under 49 U.S.C. 30115, and of 

the same model year as the model of the 

motor vehicle to be compared, and is 

capable of being readily altered to 

conform to all applicable Federal motor 

vehicle safety standards. 

Petitions for eligibility decisions may 

be submitted by either manufacturers or 

importers who have registered with 

NHTSA pursuant to 49 CFR part 592. As 

specified in 49 CFR 593.7, NHTSA 

publishes notice in the Federal Register

of each petition that it receives, and 

affords interested persons an 

opportunity to comment on the petition. 

At the close of the comment period, 

NHTSA decides, on the basis of the 

petition and any comments that it has 

received, whether the vehicle is eligible 

for importation. The agency then 

publishes this decision in the Federal 

Register. 

NHTSA received petitions from 

registered importers to decide whether 

the vehicles listed in Annex A to this 

notice are eligible for importation into 

the United States. To afford an 

opportunity for public comment, 

NHTSA published notice of these 

petitions as specified in Annex A. The 

reader is referred to those notices for a 

thorough description of the petitions. 

No substantive comments were received 

in response to these notices. Based on 

its review of the information submitted 

by the petitioners, NHTSA has decided 

to grant the petitions. 

Vehicle Eligibility Number for Subject 

Vehicles 

The importer of a vehicle admissible 

under any final decision must indicate 

on the form HS–7 accompanying entry 

the appropriate vehicle eligibility 

number indicating that the vehicle is 

eligible for entry. Vehicle eligibility 

numbers assigned to vehicles admissible 

under this decision are specified in 

Annex A. 

Final Decision 

Accordingly, on the basis of the 

foregoing, NHTSA has decided that each 

motor vehicle listed in Annex A to this 

notice, which was not originally 

manufactured to comply with all 

applicable Federal motor vehicle safety 

standards, is substantially similar to a 

motor vehicle manufactured for 

importation into and/or sale in the 

United States, and certified under 49 

U.S.C. 30115, as specified in Annex A, 

and is capable of being readily altered 

to conform to all applicable Federal 

motor vehicle safety standards.

Authority: 49 U.S.C. 30141(a)(1)(A) and 

(b)(1); 49 CFR 593.8; delegations of authority 

at 49 CFR 1.50 and 501.8.

Claude H. Harris, 

Director, Office of Vehicle Safety Compliance.

Annex A—Nonconforming Motor Vehicles 

Decided To Be Eligible for Importation 

1. Docket No. NHTSA–2004–17647 

Nonconforming Vehicles: 2001–2002 

Mercedes Benz C–320 (203) Passenger 

Cars. 

Substantially Similar U.S.-Certified Vehicles:

2001–2002 Mercedes Benz C–320 (203) 

Passenger Cars. 

Notice of Petition Published at: 69 FR 24705 

(May 4, 2004). 

Vehicle Eligibility Number: VSP–441 

(effective date June 15, 2004). 

2. Docket No. NHTSA–2004–17766 

Nonconforming Vehicles: 2002–2004 

Mercedes Benz S–Class (220) Passenger 

Cars. 

Substantially Similar U.S.-Certified Vehicles:

2002–2004 Mercedes Benz S–Class (220) 

Passenger Cars. 

Notice of Petition Published at: 69 FR 29164 

(May 20, 2004). 

Vehicle Eligibility Number: VSP–442 

(effective date June 28, 2004). 

3. Docket No. NHTSA–2004–18610 

Nonconforming Vehicles: 1999 Cagiva Gran 

Canyon 900 Motorcycles. 

Substantially Similar U.S.-Certified Vehicles:

1999 Cagiva Gran Canyon 900 Motorcycles. 

Notice of Petition Published at: 69 FR 45110 

(July 28, 2004). 

Vehicle Eligibility Number: VSP–444 

(effective date September 2, 2004). 

4. Docket No. NHTSA–2004–18647 

Nonconforming Vehicles: 2004 Ferrari 360 

Series Passenger Cars.