National Highway Traffic Safety Administration 2005 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. Federal Register Notice with a 60-day comment period was published on November 19, 2004 [69 FR 67774].

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice with a 60-day comment period was published on November 2, 2004 [69 FR 63568].

The purpose of this document is to announce the termination of a rulemaking in which the agency had considered adding additional conspicuity requirements applicable to low-speed vehicles (LSV), as well as a requirement that LSVs bear a label identifying the safety hazards associated with their operation in mixed traffic. Due to the absence of data showing a conspicuity-related safety problem with current LSV designs, the agency has decided to terminate the rulemaking.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice with a 60-day comment period was published on August 6, 2004 [FR Doc. 04-17991, Vol. 69, No. 151, Page 47980].

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register document with a 60-day comment period was published on September 29, 2004 [69 FR 58219].

This notice announces NHTSA's publication of three technical reports estimating how many lives have been saved by vehicle safety technologies meeting the Federal Motor Vehicle Safety Standards, and their costs. The reports' titles are: Lives Saved by the Federal Motor Vehicle Safety Standards and Other Vehicle Safety Technologies, 1960- 2002, Passenger Cars and Light Trucks; Cost and Weight Added by the Federal Motor Vehicle Safety Standards for Model Years 1968-2001 in Passenger Cars and Light Trucks; and Cost Per Life Saved by the Federal Motor Vehicle Safety Standards.

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: https://www-nrd.nhtsa.dot.gov/departments/nrd-50/ciren/CIREN.h tml. 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: Yesit 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 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 limitput 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 ``AssurancesNon-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 Interestdoes 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 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: Yesthis may serve as one reference. Question: On the matter of three referencesjust 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 applicationAre there any particular forms to use for this part? (other than the SF 424 for the budget?) Answer: Nojust the SF 424 forms(SF 424, SF 424A, SF 424B). Question: Are there any particular requirements regarding font, font size, or margins? Answer: YesNo font smaller than 10 point with one inch margins. Question: Regarding the SF424, Item 13: Proposed Project and Item 15: Estimated FundingShould 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 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: Yesif 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 personnelthat 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 herebut 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 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 meetingstwo public meetingsone 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 RequirementsDiscusses 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 meetingstwo public meetingsone 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 variableswill 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: https://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 requiredas 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 NHTSAsee 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: Yesas 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 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 registrythat 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 crashesno 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.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register document with a 60-day comment period was published on September 29, 2004 (69 FR 58219).

This document contains a correction to the due dates of reports under the early warning reporting rule.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register notice with a 60-day comment period was published on Monday, October 18, 2004, FR Doc. 04-23253.