[Federal Register Volume 70, Number 9 (Thursday, January 13, 2005)]
[Notices]
[Pages 2457-2462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-654]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration


Responses to Questions Received in Response to Announcement of 
Availability of Discretionary Cooperative Agreements for Research Under 
the Crash Injury Research and Engineering Network (CIREN)

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

ACTION: Responses to questions received in response to the announcement 
of discretionary cooperative agreements to support the research 
conducted under the Crash Injury Research and Engineering Network 
(CIREN) and to increase its benefits to the public.

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SUMMARY: Federal Register, Volume 69, No. 235, Pages 71101-71118, 
announced the availability of discretionary Cooperative Agreement 
opportunities to provide funding to Level One Trauma Centers in support 
of the Crash Injury Research and Engineering Network (CIREN) from the 
National Highway Traffic Safety Administration (NHTSA). The NHTSA 
indicated that responses to all questions received by December 20, 
2004, would be published in the Federal Register and on the CIREN Web 
site: http://www-nrd.nhtsa.dot.gov/departments/nrd-50/ciren/CIREN.html. 
Those questions and answers are listed below:
    Question: Has the total funding amount of $3 million been confirmed 
for FY 2005?
    Answer: Yes.
    Question: The announcement does not mention cost-sharing or 
matching funds. Can it be assumed that neither will be required for 
this grant?
    Answer: This is a cooperative research agreement and it is assumed 
that there will be some ``in kind'' contributions by the Level One 
Trauma Center.
    Question: If cost sharing is not required, would it help an 
application, though, if matching funds were provided?
    Answer: Yes.
    Question: Do you advise applicants to contact you with project 
ideas before submitting applications? Or only if they have general 
questions?
    Answer: No. We are not looking for project ideas. The announcement 
for discretionary funding for the cooperative research agreements is 
very specific as to the work required. Applicants are not required to 
submit any project ideas.
    Question: The announcement does not mention this, but does this 
program have a CFDA number?
    Answer: Yes--it is 20-600.
    Question: How competitive is this program, i.e., for the last 
funding cycle, how many proposals were submitted and how many received 
funding?
    Answer: This is the first time that the CIREN program has issued a 
Request for Proposals (RFP). During the last funding cycle, awards were 
made via a letter of invitation to the existing centers to continue the 
work they were doing. At that time, the program and database were still 
in the developmental phase.
    Question: Is there anything else you would like applicants to know?
    Answer: No. Applicants should carefully read the Federal Register 
announcement to be certain of work requirements. As indicated in the 
Federal Register announcement, ``Interested applicants are advised that 
no separate application package exists beyond the contents of this 
announcement.''
    Question: For a proposed site that would like to do both pediatric 
and adult cases, does Level I funding require that the site track 50 
pediatric and 50 adult cases OR can the cases be mixed?
    Answer: The requirement is for a total of 50 cases.
    Question: Is the software from Volpe (a) provided free of charge, 
(b) included

[[Page 2458]]

in the $10,000 Year 1 line item, or (c) should our agency include it as 
a budgeted expense?
    Answer: As indicated in Section XII, Application Contents, the 
$10,000 represents equipment (hardware) costs and should be added to 
your overall budget estimate for the base year. Software (required to 
run the CIREN applications only) and Volpe support is provided under a 
separate effort.
    Question: What impact does the loss of subjects to follow-up for 
the Quality of Life 6-month and 12-month questions have on the 
potential funding level adjustments (section V.2, paragraph 1)?
    Answer: NHTSA is aware that obtaining follow-up in a trauma study 
population is a difficult task. The production of follow-up data is a 
priority for the CIREN Program and for NHTSA. The collection of follow-
up data will be closely monitored and addressed on a case-by-case 
basis. If a site is unable to consistently collect follow-up data in 
sufficient production levels, then funding would be affected.
    Question: Does the $3,000,000 total amount available for funding 
include F&A or is F&A calculated above this funding level?
    Answer: $3,000,000 is the total amount of Federal funding currently 
available. All Fixed and Actual costs should be included in your 
overall budget estimates.
    Question: Are the resumes of staff included in the 50-page limit?
    Answer: No, you may include them as an appendix.
    Question: Is the SF 424 and detailed budget included in the 50-page 
limit?
    Answer: No, you may include them as an appendix.
    Question: Do you want a separate application for each performance 
level?
    Answer: No, unless you are going to approach the work in a 
different manner. However, We do need separate budget estimates (SF 424 
forms) for each level. The Federal Register Announcement states that 
``Separate budgets are requested for each Level of Effort for which the 
applicant wishes to apply.''
    Question: The Federal Register Announcement states that ``Separate 
budgets are requested for each Level of Effort for which the applicant 
wishes to apply.'' Are entire separate applications (e.g. entire 50 
pages with an original and 5 copies) required for each level? Or can we 
rather make one application, with some description of contingency plans 
that would be used if different Levels of Effort were awarded? This 
latter option would still include the separate budgets for each level, 
but would have only one 50-page application (with copies).
    Answer: Separate applications are not required unless your work 
plan is different for the different performance levels. One application 
is fine as long as you have separate budgets for each performance 
level.
    Question: If entire separate applications are required for each 
Level of Effort for which the applicant is applying, do separate sets 
of appendices need to be sent with each application or would one set 
suffice for all applications?
    Answer: Separate application packages are not required. Only one 
set of appendices are required EXCEPT for budget/financial forms.
    Question: If one application encompassing all three levels is 
permissible, is it mandatory? That is if we get into trouble with the 
page limits (especially as multiple 424 forms would need to be included 
within the 50 page limit), could we instead submit entirely separate 50 
page applications for each of the three funding levels?
    Answer: The 424 forms are not counted in the 50-page limit--put 
them in an appendix. A single application is not mandatory. You may 
submit separate 50 page applications for each of the three funding 
levels.
    Question: In Section XII. Application Contents, Section 1. 
Supplemental budget information is requested in addition to SF424 (A 
and B). Is there a particular form to use for supplemental budget 
information? Is a narrative budget justification sufficient to provide 
the supplemental information? Could PHS 398 form be used for this?
    Answer: The SF 424 forms are required. The PHS 398 form cannot be 
used. There are no particular additional forms. A narrative budget 
justification (along with the SF 424 forms) is sufficient as long as it 
contains the dollar value and what it relates to.
    Question: Is the budget information (either Form 424 (A and B) and/
or supplemental information or both the forms and supplemental 
information) included in the 50-page limit? Can supplemental 
information be placed in the appendix?
    Answer: Budget information and forms are not included in the 50-
page limit. They may be placed in the appendix along with any 
supplemental budget information.
    Question: I note that a separate Form 424 (one page) and Form 424A 
(two pages) are to be filled out for each level requested. However, 
Form 424B (two pages) would not seem to vary between the different 
levels. It is entitled ``Assurances--Non-Construction Programs'' and 
just requires a signature (no information to be provided). To save 
space (especially if only one 50 page application is to be submitted 
for all three levels combine), can one copy of this form suffice for 
all three levels?
    Answer: No. These forms are not included in the 50-page limit and 
can be put in the appendix. Please provide complete copies of each form 
for each level. This assures that each cost estimate for each level is 
a complete package. This also makes evaluation of the budget at the 
various levels easier.
    Question: Is there a specific amount that we should request for the 
first year for each level? Or should just put together a reasonable 
budget that we think will get the job done?
    Answer: Specific funding levels have not been established. Please 
put together a reasonable budget that you think will allow you to 
achieve the performance levels.
    Question: In submitting a proposed budget year by year for all 5 
years, are we allowed to vary the amount requested year by year? That 
is as salaries increase with inflation and raises, are we allowed to 
increase the amount we request each year.
    Answer: Yes.
    Question: Is more than one Co-Principal Investigator possible?
    Answer: No.
    Question: In Section XIII. CIREN System Requirements. 2. Staffing 
Requirements and Duties. It is stated that ``No staff member assigned 
to this work effort may be involved in any police, insurance or 
investigative activities.'' Does this apply to testifying as an expert 
witness for insurance companies or for any other party (e.g. as opposed 
to being employed by such insurance companies or other parties)?
    Answer: Yes.
    Question: If so, does this apply whether or not examination of 
vehicles is involved?
    Answer: Yes.
    Question: If so, does this apply whether or not severely damaged 
vehicles are involved? That is, does it make a difference if testifying 
for an insurance company (or other party) is restricted to examination 
of vehicles involved in crashes that would not qualify for CIREN 
inclusion criteria?
    Answer: Yes, it applies irrespective of the severity of damage.
    Question: In reference to Section X. Conflict of Interest--does 
testifying as an expert witness on automobile crashes constitute a 
potential conflict of interest that would need to be reported?
    Answer: Yes.
    Question: In reference to an Organizational Chart. Should this be 
included in the appendices (and thus outside of the 50 page limit) or 
as a part

[[Page 2459]]

of the main text (and thus within the 50 page limit)?
    Answer: In the appendices.
    Question: Is there any particular format to follow for resumes.
    Answer: No.
    Question: Is there any page limit for the resumes?
    Answer: No.
    Question: Are resumes to be included as an appendix (and thus 
outside of the 50 page limit) or as a part of the main text (and thus 
within the 50 page limit)?
    Answer: As an appendix.
    Question: In reference to Section XII. Application Contents; 
Section H: Past Performance and Financial Responsibility. (1) 
References.--Three references are requested. Can this be multiple 
persons at the same agency and who handle the same grant/contract? For 
example, multiple people at the CDC or NIH handle grants run by our 
injury center. Can we list the various contacts at each institution as 
separate contacts or should it be one contact for each grant/contract?
    Answer: The three references should come from three different 
contracts/grants. Provided you satisfy that minimum requirement, you 
may, at your election, provide more than one contact for each contract/
grant.
    Question: We have been previously funded as a CIREN center. Can we 
list this cooperative agreement and the NHTSA staff who handle it as 
references?
    Answer: Yes--this may serve as one reference.
    Question: On the matter of three references--just to clarify: it 
seems that the questions on the references for the ``Applicant'' 
pertain to the institution that is applying for the award and not the 
individual Principal Investigator? (e.g., it is the institution that is 
the ``Applicant.'')
    Answer: It pertains to the Institution and not the individual. 
However, if there are no relevant institutional references, individual 
relevant references may be provided.
    Question: In Section XV. Terms and Conditions of Award. It is 
stated that ``Prior to award, each applicant shall comply with 
certification requirements. * * *'' Should these certifications be 
included with the application? Or are they to be submitted later, in 
the event an award is made? If included with the application, I imagine 
that they are external to the 50-page limit (e.g., included in the 
appendices)?
    Answer: Include the certifications with the application as part of 
an appendix.
    Question: Regarding the limit of 50 pages for the application--Are 
there any particular forms to use for this part? (other than the SF 424 
for the budget?)
    Answer: No--just the SF 424 forms--(SF 424, SF 424A, SF 424B).
    Question: Are there any particular requirements regarding font, 
font size, or margins?
    Answer: Yes--No font smaller than 10 point with one inch margins.
    Question: Regarding the SF424, Item 13: Proposed Project and Item 
15: Estimated Funding--Should these apply to the base year or to the 
entire 5 year project period?
    Answer : You should include separate budgets for the base year and 
for each option year.
    Question: CIREN System Requirements. 1. General Requirements. 
Paragraph 4 states: ``The Grantee CIREN center shall outline a plan to 
establish lines of communication among CIREN crash investigators and 
the quality control team to facilitate communication of medical 
technologies relating to crash research and the introduction of 
emerging technologies relating to occupant protection systems.'' Is 
this something that we are supposed to outline in the proposal itself 
or something that will come up afterwards?
    Answer: This is something that you can do after awards are made. 
However, you are free to submit your plans in the proposal.
    Question: Is the quality control team mentioned here the same one 
that currently exists in Indiana?
    Answer: Yes.
    Question: What are the approximate funding levels expected to be 
awarded for each center? Will these funding levels consider the 
expectation that the largest portion of budgets will be determined by 
fixed costs of staffing the necessary resources regardless of the 
volume of cases submitted?
    Answer: Specific funding levels have not been established. Please 
put together a reasonable budget that you think will allow you to 
achieve the performance levels.
    Question: Can occupants count toward center case volumes if they 
are treated at another level 1 trauma center, distinct from the CIREN 
site, assuming that similar quality medical data can be obtained? In 
particular, this might be important for cases where children and adults 
are treated at different hospitals.
    Answer: No.--Not unless the Center treating the occupants is part 
of the CIREN site medical network.
    Question: If a center out-performs the expected number of cases in 
a given year, can that center reapply in a subsequent year for a higher 
level of support?
    Answer: At NHTSA's discretion, a center exceeding the expected 
number of cases in a given year may be permitted to reapply for a 
higher level of support in an option year.
    Question: Regarding the requirement to demonstrate an understanding 
of the methodology used in electronic data collection systems, is this 
meant to be specific to the proprietary system used by CIREN or more 
generic expertise in data management systems?
    Answer: More generic expertise in data management systems related 
to scientific/engineering/medical research related to motor vehicle 
crashes.
    Question: Do the 3 letters of reference need to come from previous 
NHTSA-sponsored projects or any projects?
    Answer: Any relevant projects.
    Question: Clarify what is meant in Item XIII.1 by the requirement 
for a plan to establish lines of communication among the CIREN crash 
investigators and the quality control team? Is it expected that each 
CIREN site will develop this plan independent from other sites so that 
each site communicates separately from the others?
    Answer: This is a plan that can be detailed after awards are made. 
However, you are free to submit your plans in the proposal.
    Question: Provide further clarification on the potential scope of 
``special research programs'' which sites may be asked to contribute. 
(Item XIII.3.E) Will these programs be within the scope of work and 
budget of an individual CIREN center?
    Answer: Any such research projects will be within the scope of work 
and budget of an individual CIREN center.
    Question: Provide clarification on the age limits to be used to 
decide who gets the Pediatric Quality of Life and who gets an SF-36 
during the 6 and 12-month follow-up assessments.
    Answer: Age limits on the Pediatric Quality of Life are ages 2 to 
12. Thirteen years and older will get an SF 36.
    Question: Please confirm the following apparent assumptions 
regarding inclusion criteria for adult and pediatric CIREN cases, based 
on review of the tables in Appendix 1:
    a. Adult criteria
    i. Can rear-seated adults or those that are only belted (no airbag 
or airbag suppressed) in the front seat qualify if they otherwise meet 
the injury criteria in frontal impacts?
    Answer: Currently, rear-seated adult occupants in frontal 
collisions are not part of the CIREN inclusion criteria. However, the 
inclusion criteria can change with agency priorities. Adults in the 
front seat that are restrained with a

[[Page 2460]]

belt only (no airbag or airbag suppressed) may be included on a case-
by-case basis with prior approval by NHTSA.
    ii. Do the vehicle specifications for rollover crashes indicate 
that vehicles must be BOTH CY-8 AND 214 compliant or EITHER CY-8 OR 214 
compliant?
    Answer: Both.
    iii. Do fire-involved cases include non-crash events or only 
crashes?
    Answer: Only crashes. Non-crash fires may be included with NHTSA's 
permission on a case-by-case basis.
    b. Pediatric criteria
    i. Frontal crashes: Are booster seats included in the definition of 
a CRS?
    Answer: Yes.
    ii. Do children restrained with a seat belt or an airbag alone 
qualify for inclusion?
    Answer: Yes.
    iii. Is there interest in cases with airbag suppression?
    Answer: Yes--if the case occupant is under the age of 13.
    iv. Rear crashes: Are other forms of restraint including belts and 
forward-facing CRS (including boosters) allowable for inclusion?
    Answer: At this time, these forms of restraints may be included on 
a case-by-case basis with prior approval by NHTSA.
    v. Rollover crashes: Please clarify why qualifying vehicles must be 
214 compliant.
    Answer: CIREN concentrates on the evaluation of the newest, safest 
safety technologies.
    Question: Is the Principal Investigator or Co-Principal 
Investigator required to be 100% on the project?
    Answer: The Principal Investigator (or the Co-Principal 
Investigator) must be clinically active and full time at the Level One 
Trauma Center. NHTSA realizes that in order to be clinically active, 
one could not be dedicated 100% to the CIREN project. This also applies 
to your other staff. You should budget salaries based on the amount of 
time you feel should be allocated to each project the staff is working 
on.
    To further clarify the 100% participation, the main PI (and Co-PI 
if full-time) must be available for all key components of the CIREN 
process (case reviews, presentation of papers, relevant participant 
interaction with NHTSA, peers, first responders, EMS, etc.) The Co-PI, 
if part-time, must be available for a portion of these key components.
    Question: In terms of personnel, the RFP specifies that the 
Principal Investigator must be full-time. We are assuming since this 
person also must be a full-time trauma surgeon/ED MD that, by full-
time, you mean that this individual would be full-time at the 
institution and not full-time devoted to CIREN Center efforts. Is this 
a correct assumption?
    The RFP later goes on to say that the Crash Investigator and Study 
Coordinator must also be full-time. Would the same apply to these two 
personnel--that they are to be full-time at the institution but not 
necessarily full-time on their CIREN Center efforts? Or are they (and 
their salaries) expected to be 100% devoted to the CIREN program? We 
want to make sure we understand fully from a planning and budgeting 
standpoint.
    Answer: The Principal Investigator (or the Co-Principal 
Investigator) must be clinically active at the Level One Trauma Center. 
NHTSA realizes that in order to be clinically active, one could not be 
dedicated 100% to the CIREN project. This also applies to your other 
staff. You should budget salaries based on the amount of time you feel 
should be allocated to each project the staff is working on.
    To further clarify the 100% participation, the main PI must be 
available for all key components of the CIREN process (case reviews, 
presentation of papers, relevant participant interaction with NHTSA, 
peers, first responders, EMS, etc.) The Co-PI, if part-time, must be 
available for a portion of these key components.
    Question: What do you mean by a Principal Investigator or a Co-
Principal Investigator must be ``clinically active''?
    Answer: They must see patients on a regular basis in the acute care 
clinical setting and interact with the first responders when a crash 
victim is brought to the facility.
    Question: Why must the Principal Investigator or Co-Principal 
Investigator be ``clinically active''?
    Answer: It is important that there be dialog about the crash 
circumstances between the first responders and the principal 
investigator or the co-principal investigator. It is a goal of CIREN to 
achieve not only improved crash/injury education for EMS providers and 
physicians but also to facilitate the interaction and communication 
between these two professions to utilize this information to improve 
triage, transport and treatment of crash victims.
    Question: This is to clarify the requirements for Principal and Co-
Principal, as described in the announcement in the Federal Register. 
Section IX. Eligibility Requirements, First paragraph. This states 
that: ``The Applicant's principal or co-principal must be a clinically 
active emergency room trauma physician or a clinically active emergency 
medical physician or a clinically active specialist with experience 
relating to the diagnosis and treatment of motor vehicle injuries and 
must be closely affiliated with a Level One Trauma Center.''
    Later, the same topic is addressed: Section XIII. CIREN System 
Requirements. Sub-section 2. Staffing Requirements and Duties. (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 * * *'' Further information is then 
given on the requirements for a Co-Principal, including being a 
clinically active specialist or someone with biomechanical, engineering 
or epidemiological experience.
    It seems that the two definitions are slightly different, in that 
Section IX indicates that the principal OR co-principal must be one of 
the categories of clinically active specialist. On the other hand, 
Section XIII indicates that the principal MUST be a clinically active 
specialist, with some discretion as to what the co-principal may be. 
Thus, to clarify, please let us know whether someone such with 
biomechanical, engineering or epidemiological experience may be 
principal if the co-principal is a clinically active specialist.
    Answer: The principal investigator is full time at the facility and 
should be clinically active. The co-principal may be part-time and may 
be someone with biomechanical, engineering or epidemiological 
experience. The co-principal may also be clinically active. We have 
allowed some flexibility here--but either the principal or co-principal 
investigator MUST see patients on a regular basis in the acute care 
setting. Resumes are requested as attachments to the proposal, and it 
is recommended that appropriate qualifications be contained therein for 
staffing requirements.
    Question: For new centers, what dollar amounts should be budgeted 
for training by Volpe regarding the use of the CIREN database, by years 
1-5, all costs including travel, indirects, etc?
    Answer: Classroom training costs are handled independently from 
work under the CIREN cooperative agreements. However, each CIREN center 
is responsible for all related travel expenses (transportation, hotel, 
meals, etc.) for the training. Places for training can be Oklahoma 
City, Boston

[[Page 2461]]

or Washington, DC. Please provide your estimate for this. Reimbursement 
shall not exceed the maximum allowable per diem for any area.
    Travel costs for expenses incurred (based on maximum allowable 
government per diem) are reimbursed under this Cooperative Agreement 
(as part of the overall award amount). You will need to budget for 3 
one-week trips to Oklahoma City for the Crash Investigator for the 
first year only; travel to Boston for introductory training in the 
first year for all staff (one week); and travel to Washington, DC and 
other unspecified domestic locations for public meetings for staff as 
you designate. You should also budget for a one-week NASS update 
training held on a yearly alternating basis in either Las Vegas, Nevada 
or Orlando, Florida.
    In the first year, there will be three (3) one week trips to 
Oklahoma City for your crash investigator as well as (1) one 4-day trip 
to Las Vegas for NASS Update Training for the crash investigator. There 
will be a one-week introductory training class in Boston for all new 
staff involved in the CIREN project at your facility. We anticipate one 
other meeting in Washington, D.C. for staff of your choosing.
    In subsequent years, there will be 1 (one) 4-day trip for your 
crash investigator to either Orlando, Florida or Las Vegas, Nevada, on 
an alternating basis. We anticipate a total of three meetings--two 
public meetings--one in Washington, D.C. and one elsewhere and a Grand 
Rounds in Boston with staff of your choosing.
    Question: Are the travel costs predetermined by NHTSA? In either 
case what are those amounts for local and national travel?
    Answer: Travel costs are not predetermined by NHTSA. Travel costs 
for expenses incurred (based on maximum allowable government per diem) 
are reimbursed under this Cooperative Agreement (as part of the overall 
award amount). You will need to budget for 3 one-week trips to Oklahoma 
City for the Crash Investigator for the first year only; travel to 
Boston for introductory training in the first year for all staff (one 
week); and travel to Washington, D.C. and other unspecified domestic 
locations for public meetings for staff as you designate. You should 
also budget for a one-week NASS update training held on a yearly 
alternating basis in either Las Vegas, Nevada or Orlando, Florida.
    Question: What type of training is provided to new centers?
    Answer: Training on the CIREN Database is provided for all staff; 
training on crash reconstruction/documentation is provided for the 
Crash Investigator.
    Question: Who is anticipated to attend training? PI, Co-PI, Program 
Coordinator?
    Answer: The training in Oklahoma City (and the yearly NASS update 
training) is only for the Crash Investigator. The one-week training on 
the CIREN Database is for all staff identified as part of your 
facility's CIREN team. The PI and Co-PI are expected to be attend the 
one-week training for at least one day.
    Question: What costs should be budgeted for sending a team member 
to receive training to become a crash investigator?
    Answer: The training involves three (3) trips (for a period of one-
week each) to Oklahoma City (Air Fare, Hotel/Meals/Incidentals). Your 
budget estimates should reflect these trips.
    Question: Section XIII. CIREN System Requirements 1. General 
Requirements--Discusses Quarterly Meetings and one Grand Rounds. I 
would like to reflect appropriate travel in the budget. Should we 
budget for 4 or 5 meetings (in the past the Grand Rounds replaced a 
Public Meeting and was associated with one of the 4 Team Meetings)?
    Answer: For the first year, there will be a one-week training 
meeting in Boston for all staff, regardless of whether you are a new or 
existing center. The PI and Co-PI are expected to attend the one-week 
training for at least one day. All other key staff is expected to 
attend the entire week of training. We anticipate a ``volunteer'' 
meeting in May in Washington, DC and one ``mandatory attendance'' 
meeting also in Washington, DC. For all other years, we anticipate 
three meetings--two public meetings--one in DC and one elsewhere and a 
Grand Rounds in Boston.
    Question: Is OTA coded centrally?
    Answer: Yes, at this time with access to appropriate radiology 
images and reports.
    Question: For new centers, we don't have a list of Tier 1&2 
variables--will you provide this information? This has implications for 
data access and staffing.
    Answer: Tier 1 data is information that is collected on the crash 
including photos of the vehicle, scene diagrams, etc. (See page 71112 
of the Federal Register Notice). Tier 1 data includes the information 
that is available in the CIREN electronic cases that can be viewed on 
our Web site: http://www-nrd.nhtsa.dot.gov/departments/nrd-50/ciren/CIREN.html. Please refer to Appendix 2 for information on Tier 2 data.
    Question: What level of commitment is required of personnel at each 
of the three levels (30 cases v. 40 cases v. 50 cases/year)?
    Answer: This is the information we are asking you to supply us. See 
the section on Staffing in the Federal Register announcement.
    Question: What type of program evaluation is required?
    Answer: If, by program evaluation, you are referring to reporting 
requirements, quarterly progress and financial reports are required--as 
specified in the announcement. In addition, NHTSA evaluates each center 
on a quarterly basis to determine if production levels are being met, 
and funding will be adjusted if necessary, as specified in the 
announcement.
    Question: How are cases chosen? Does case selection have to be 
randomized or time frame dependent? Can we bias the 30-50 cases we 
select to reflect a priori concerns that coincide with existing 
research interests such as alcohol, underage drivers, etc?
    Answer: There are case selection criteria for all CIREN centers 
specified by NHTSA--see Appendix 1. All Centers must follow these 
criteria. As indicated in Appendix 1, there are a very small number of 
cases that can be pursued with NHTSA's approval, based on PI interest.
    Question: What was the amount of the previous awards and were the 
prior awards budgeted as cost per case?
    Answer: The amounts of previous awards were between $435,000 and 
$500,000. Awards were not budgeted as cost per case.
    Question: What is the time frame for concluding cases? All at once 
or rolling?
    Answer: See Appendix 3. You should complete your cases as soon as 
possible since payment depends on it. The SF 36 information will be on 
a rolling basis since follow-up information is collected at 6-month and 
12-month intervals.
    Question: If our budget projections are higher than the amount 
NHTSA is able to fund for any given Level, will we have the opportunity 
to make adjustments?
    Answer: Yes--as long as you have a good technical proposal.
    Question: A clerical position is not specifically identified in 
Staffing Requirements. If we can justify a part time position, can we 
include in the budget?
    Answer: Yes.
    Question: Section XII. Application Contents C. Trauma Registry 
Data, requests trauma registry data (for 3 years) and the number of 
motor vehicle crash occupants admitted to the Trauma Center, as well as 
the AIS for each

[[Page 2462]]

admitted occupant. I would like to clarify the definition for each 
request. My interpretation is: (1) Number of MVCs admitted to Trauma 
Center (not all MVCs are injured severely enough to meet Registry 
criteria).
    Answer: NHTSA realizes that not all motor vehicle crash (MVC) 
victims meet the criteria for the trauma registry--that is why we want 
the actual number of MVCs on the trauma registry. The cases selected 
for inclusion in CIREN are the more severe ones.
    Question: Do you want the Number of MVCs meeting Trauma Registry 
criteria (or do you want everyone that meets Registry criteria-gunshots 
etc)?
    Answer: No, the Federal Register announcement indicates that we 
only want motor vehicle crashes--no motorcycles or pedestrians (since 
CIREN does not currently collect data on these crashes).
    Question: Section XII. Application Contents C. Trauma Registry 
Data, requests trauma registry data (for 3 years) and the number of 
motor vehicle crash occupants admitted to the Trauma Center, as well as 
the AIS for each admitted occupant Do you want the AIS for all MVCs or 
just those meeting Trauma Registry criteria (AIS is not assigned for 
non-registry patients)?
    Answer: The Federal Register Announcement indicates that the AIS 
should be provided for all cases where it is available. The request is 
for the maximum AIS per case. For example if your group admits 1000 MVC 
(car/truck) occupants in a given time frame (3 years) and the AIS 
scores are recorded. The following is an example of what is being 
requested.

Max AIS1 = 300 occupants,
Max AIS2 = 250 occupants,
Max AIS3 = 200 occupants,
Max AIS4 = 100 occupants,
Max AIS5 = 100 occupants,
Max AIS6 = 50 occupants.

    If only severely injured patients are assigned to the Registry, 
provide those AIS scores. If you have any way of determining the AIS 
for patients not assigned to the registry, please provide that 
information also.
    Question: In Section XII. Application Contents--F. Prior Work 
Experience, can we include our prior experience as a CIREN Center.
    Answer: Yes.
    Question: In Section XII. Application Contents H. Past Performance 
and Financial Responsibility--Can we use our past CIREN contract as a 
reference?
    Answer: Yes. You may include the CIREN contract as one reference.
    Question: The RFP states in Supplementary Information, Section V. 
Funding, Section XII Application Contents, Letter H. Past Performance 
and Financial Responsibility, 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.'' Does this mean we provide 3 contacts that someone 
from NHTSA will phone and discuss our performance or 3 letters written 
by people who can attest to our performance?
    Answer: You should provide three persons or entities that we 
(NHTSA) can contact about your performance. Please provide contract/
grant number, period of performance and contact information.
    Question: On page 1 of the SF 424A Form, the first column--asks for 
Grant Program Function or Activities--is there an explanation as to 
what functions/activities should be placed here?
    Answer: Complete instructions for filling out this form can be 
found on the following Web site: http://www.whitehouse.gov/omb/grants/sf424a.pdf.
    Question: On Page 1 of the SF 424A Form, the second column asks for 
the CFD Assistance numbers--I retrieved the catalogue on line but have 
no clue what numbers to place in here.
    Answer: It is 20-600.
    Question: On Page 1 of the SF 424A Form, Section B--Budget 
Categories--I am assuming that the column numbering (1-4) are to 
coincide with the Grant Program Function/Activities noted in Section 
A--Is this assumption correct?
    Answer: No. You need to put your actual budget amount for each of 
these categories in this section on the form. You may also provide your 
detailed budgets for each year on regular paper for further 
clarification.
    Question: Is there a definition of Federal and Non-Federal funds?
    Answer: Federal funds are those you would receive from the Federal 
Government. Non-Federal Funds are those you would get from other 
sources--including your ``in kind'' contributions.
    Question: Can you explain the difference in Sections D and E, which 
are forecasting future budget years?
    Answer: Section D is your budget for the first year. Section E is 
your budget for each option year. Remember--you must submit budgets for 
EACH performance level.

    Issued on: January 7, 2005.
Michael Perel,
Acting Associate Administrator for Vehicle Safety Research.
[FR Doc. 05-654 Filed 1-12-05; 8:45 am]
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