Amendment_000001.pdf

(x)

DTNH2216R00024

x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

DOT/NHTSA

Washington DC 20590 1200 New Jersey Ave SE

DOT/NHTSA

NHTSA NPO-320

Washington DC 20590 1200 New Jersey Ave SE Office of Acquisition Management

08/02/2016000001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/06/2016

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not, is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Title: Crash Injury Research and Engineering Network (CIREN)

The purpose of Amendment 000001 is to provide responses to questions and to extended the

Request for Proposal (RFP) From August 12, 2016 To August 19, 2016, 12:00 p.m., EST.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

JANELLA DAVIS

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

NSN 7540-01-152-8070

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

RFP DTNH2216R00024

CIREN’s RFP Amendment 000001 Responses to Questions

1. PART III – SMALL BUSINESS SUBCONTRACTING PLAN

Question: Regarding the Small Business portion (SB), if a center already has the necessary expertise in house and does not anticipate subcontracts or consulting to small businesses can we state this for the “SB?”

NHTSA RESPONSE:

Federal Acquisition Regulation (FAR) 19.704, Subcontracting Plan Requirements, 52.219-8, Utilization of Small Business Concerns, and 52.219-9 Small Business Subcontracting Plan, applies to large businesses submitting proposals expected to exceed $700,000. “Failure to submit and negotiate an acceptable subcontracting plan or a statement supporting the absence of subcontracting opportunities shall render the Offeror ineligible for award of a contract”.

2. PART II: QUALIFICATIONS OF PROJECT PERSONNEL

Question: Can we use a Biosketch rather than Curricula Vitae for submission? The benefit of a biosketch is it is usually shorter and more concise.

NHTSA RESPONSE:

Yes, a Biosketch format will be acceptable as long as it adequately describes the individual’s qualifications and experience for their proposed role.

3. PART III – CORPORATE EXPERIENCE and PAST PERFORMANCE

Question: Are current CIREN sponsor POC (either CO or COTR) at NHTSA allowed to complete a past performance questionnaire for our proposal?

NHTSA RESPONSE:

Yes, current CIREN sponsor POC at NHTSA are allowed to complete a performance questionnaire for this solicitation requirement.

4. PART II: QUALIFICATIONS OF PROJECT PERSONNEL

Question: For joint proposals, can the Study Coordinator and the Data coordinator will be the same person in the combined MED/ENG joint proposal?

NHTSA RESPONSE:

Yes, the same individual may perform both roles in a combined center proposal. If additional support personnel are required for the combined proposal to accommodate one person acting as

Amendment 000001 Responses to Questions

Study Coordinator (SC) and Data Coordinator (DC), the combined proposal shall describe the proposed distribution/sharing of responsibilities.

5. PART II: QUALIFICATIONS OF PROJECT PERSONNEL

Question: Can there be Co-PIs on Medical Center only proposal? Can there be Co-PIs on the Engineering Center only proposal? Can there be Co-PIs on the integrated proposal?

NHTSA RESPONSE:

Yes, co-PIs are acceptable, though each PI or co-PI will be subject to the Key Personnel requirements stated in section G.11. Only one individual will be named on the contract as the Project Manager as described in section G.12.

6. G.12 PROJECT MANAGER

Question: How much time/effort is anticipated to be required of the Project Manager?

NHTSA RESPONSE:

There are no specific time requirements for the Project Manager – it is expected that the Principal Investigator or a Coordinator (Study or Data) could fill this requirement as described in section G.12 without requiring additional effort.

7. G.12 PROJECT MANAGER

Question: Does the project manager have to be an individual person, or can its duties be combined with those of the Study Coordinator (Med) or Data Coordinator (Eng) positions?

NHTSA RESPONSE:

The comment is the same as the response to number 6. There are no specific time requirements for the Project Manager – it is expected that the Principal Investigator or a Coordinator (Study or Data) could fill this requirement as described in section G.12 without requiring additional effort.

8. G.12 PROJECT MANAGER

Question: In addition to the Project Manager, will Institutional Officials be included on communications? Only Institutional Officials can bind the Institution and submit requests and formal documents on behalf of the Institution.

Amendment 000001 Responses to Questions

NHTSA RESPONSE:

It is possible to include Institutional Officials in a distribution list for contract-related communications. This would be arranged at the time of award.

9. SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO THE

OFFERORS OR RESPONDENTS

Question: Can you provide details on how to integrate the 1st and 2nd proposals into the 3rd proposal? For instance, do we refer to page numbers in the first two proposals in the integrated proposal, using references such as “in MED Volume 1.2” for example?

NHTSA Response:

The third proposal option described at the beginning of Section L, for providing services of both a Medical Center and an Engineering Center, requires the submission of individual proposals for each center type as well as an abbreviated proposal describing the proposed approach for integrating the two types of services in one CIREN center. This abbreviated proposal shall refer to the content in the Medical Center or Engineering Center proposals, and shall minimize repetition of material as much as possible. References may use a form such as “MC p. 14” or “EC III.B.2,” depending on the page/section identification method most appropriate for your documents, where MC and EC refer to the Medical Center and Engineering Center documents, respectively. The objective of the abbreviated proposal is to describe how the capabilities and qualifications from the Medical Center and Engineering Center proposals would be incorporated into a center performing both roles. It is understood that the personnel plan for a combined center may not simply be the summation of the personnel plans from the Medical Center and Engineering Center proposals – the abbreviated proposal for the combined center shall describe the levels of effort and distribution of responsibilities, but does not need to repeat personnel qualifications and experience already included in the MC and EC proposals. The combined proposal shall include a narrative that provides a justification for why a combined center award would be beneficial to NHTSA. The abbreviated proposal for a combined center approach shall be limited to 8 pages, with an emphasis on the justification, benefits to NHTSA, and the combined personnel plan.

Prior to being considered as a combined Medical and Engineering Center, an Offeror’s Medical Center and Engineering Center proposals must be each deemed technically acceptable by the evaluation committee.

Amendment 000001 Responses to Questions

10. G.5 TASK ORDER PROCEDURES and I.2.1 FAR 52.216-18 ORDERING (OCT 1995)

Question: The RFP states that the Government reserves the right to issue Task Orders orally. If awarded, will TO in fact be issued orally? Our institution requires modification of contracts and the award of funds be done so in writing.

NHTSA RESPONSE:

In accordance with the solicitation in sections G.5 Task Order Procedures, I.2.1 and the Federal Acquisition Regulations 52.216-18, Ordering, the Government has the right to issue oral Task Orders. However, it is NHTSA’s practice to supplement an oral Task Order with a written Task Order for formal documentation.

11. PART I-B.1. Labor Rates/Categories

Question: Our institution tracks effort in terms of Calendar Months and does not track effort in terms of hours. Please confirm that a submission reflecting Calendar Month effort is acceptable.

NHTSA RESPONSE:

Offerors may submit efforts reflecting calendar months along with an explanation/calculation explaining how the institution arrived to that effort.

12. On page 74 of RFP DTNH2216R00024 PART III – SMALL BUSINESS

SUBCONTRACTING PLAN

Failure to submit and negotiate an acceptable subcontracting plan or a statement supporting the absence of subcontracting opportunities shall render the Offeror ineligible for award of a contract.

Question: If we do not plan to utilize a subcontract and will be the primary contractor conducting all services does this form still need to be submitted, or is it possible to submit and state not applicable, then sign and submit. Can you please clarify what exactly need to be provide if we do not plan to have a subcontract.

NHTSA RESPONSE:

A statement for the Offeror supporting the absence of the plan shall be submitted if the Offer does not intend to submit a Subcontracting Plan. Also, see response to question 1.

13. Question: Are individuals who do expert witness work as a percentage of their effort outside of this contract allowed on the proposal? If so, are there any special requirements for their inclusion?

Amendment 000001 Responses to Questions

NHTSA RESPONSE:

In general, individuals who do expert witness work are NOT allowed to work under these contracts. Under the RFP, there is a limitation that prevents contractors from testifying on any matter related to work performed or information provided under a NHTSA contract. 48 CFR 1252.242-71, Contractor Testimony (See Section I. Transportation Acquisition Regulation clauses incorporated by reference). In addition, offerors are required to provide a conflict of interest statement that covers their own conflicts as well as any involving planned subcontractors and consultants. It is our view that continuing to engage in expert testimony work while working under this contract creates at least an appearance of a conflict of interest that would have to be mitigated before an offeror is allowed to perform.

As with prior CIREN efforts, the restriction on expert witnessing applies to any testimony related to motor vehicle crashes, accidents and incidents, including but not limited to passenger vehicles, motorcycles, trucks, and pedestrians among others. The only exception is for medical personnel testifying as to the care that they gave a specific patient. Under this limited circumstance, the medical personnel shall not mention their involvement in CIREN nor shall they "advertise" their involvement (past or present) in the CIREN Program as part of their testimony.

14. Section L, page 59, “Offerors may submit proposals for any of the following:”

Question: What are the expectations regarding the abbreviated technical and cost proposals for the combined application? I.e. what are the page limits and for the cost volume, is a full budget required?

NHTSA RESPONSE:

See response to question 9. A full combined cost proposal is required since it is not expected to be a simple summation of the stand-alone site types. There are no page limitations for cost proposals.

15. Question: Are there guidelines for line spacing (single, 1.5, or double spaced) of the volumes?

NHTSA RESPONSE:

Line spacing in the technical proposal shall be no less than 1.5. Font size shall be no less than 10 point. Margins shall be no less than one inch (1”). Page numbers shall be positioned at the bottom center of each page.

16. Question: Section L.11, page 74, “In accordance with FAR 52.219-9” We would like clarification on percentage breakdown listed in the instructions for the Small Business Subcontracting Plan. Are these percentages that need to be reflected on our budget?

Amendment 000001 Responses to Questions

NHTSA RESPONSE:

The percentages listed for the Small Business Subcontracting Plan are the goals for each category for which Offerors shall make an effort in meeting or the Offeror shall provide realistic goals for its organization.

17. Question: G.11 TAR 1252.237-73 KEY PERSONNEL lists the following as key personnel for an engineering center: Principal Investigator, Data Coordinator, Biomechanical Engineer. However, the biomechanical engineer is not listed in sections L or M. Please provide an outline of the qualifications for the biomechanical engineer as well as the evaluation criteria for the biomechanical engineer.

NHTSA RESPONSE:

The description of the Biomechanical Engineer for the Engineering Center was unintentionally left out of the RFP document and shall be included as a Key Personnel.

Section L.10, Part II Qualifications of Project Personnel for an Engineering Center shall include:

Biomechanical Engineer – The Biomechanical Engineer shall be an engineer with a demonstrated background in injury biomechanics and causation assessment. Responsibilities of the Biomechanical Engineer at a CIREN Engineering Center include, but are not limited to, leading the process of developing the injury causation scenarios, interpretation of relevant crash/biomechanical test data, understanding of crash dynamics and occupant kinematics, familiarity with vehicle safety restraint systems, assessment of factors influencing injury causation, and identification of engineering evidence relevant to the injury causation and mechanisms.

Section M.3 Evaluation Factors, 2. Qualifications of Project Personnel shall include:

Biomechanical Engineer [Engineering Center]

• Knowledge of injury biomechanics and anatomy

• Experience with field crash data

• Experience with analysis of medical records and radiology

• Experience with experimental and computational biomechanics studies

• Ability to apply biomechanical engineering principles to complex occupant response problems

18. Question: L. 10. Part III – Corporate experience and past performance: Are there a minimum or maximum number of completed past performance questionnaires that must/may be submitted to NHTSA?

Amendment 000001 Responses to Questions

NHTSA RESPONSE:

Offerors shall have 3 past performances questionnaires submitted on its behalf.

19. Question: L.11 Part I – Cost/Price information, Section B.4. Note: Is the subcontract checklist due to NHTSA with the proposal on 8/12/16 or can the checklist be submitted during negotiations or after an award is made to the offeror?

NHTSA Response:

The subcontract checklist is due to NHTSA with the proposal on 8/12/16.

NHTSA Response:

20. Question: Past CIREN awards have required the use of NIH salary maximums. Is it

NHTSA’s intent that such maximums be applied to this award?

NHTSA Response:

Salary caps do not apply to contracts.

21. Question: Section C.6: Base level requirements. Base level requirements are specified, including training and a kickoff teleconference. Should budgets for these activities be submitted separately from the budget for the sample task order requested in Part I-Cost/Price Information, Section A?

Yes, the Sample Task Order cost proposal is the primary basis for the cost evaluation, but Offerors shall also prepare a cost proposal for the base-level requirements that will become part of the base-level award.

22. Question: Does NHTSA intend for a biomechanical engineer to be key personnel for an

CIREN Engineering center? Section G11.b lists a biomechanical engineer as key personnel for a CIREN engineering center. However, PART II: QUALIFICATIONS OF PROJECT PERSONNEL does not provide a description of requirements for this position and this position is excluded from the list of key personnel on pgs 69 and 70 of the RFP.

Yes, there was an omission. See description above for question 16.

Amendment 000001 Responses to Questions

23. Question: Section C.5: General Requirements Question: As it pertains to data entry, is the enrolling medical center responsible for entering all the case information – including the post-engineering review biotab – into the CIREN application database?

NHTSA Response:

The draft version of the CIREN manual indicates which entity is responsible for the different types of data entry (indicated in square brackets in section headings). The CIREN Medical Center will be responsible for developing the list of injuries and entering the injury codes into the data system (AIS, aspects, ICDM). The Medical Center shall also enter (link) the relevant invasive procedures, add injury-specific images (non-radiology), and enter any notes about the injury. The CIREN Engineering Center will enter the injury causation coding (BioTab) into the data system and select the radiology images to link to a given injury that best represent the nature of that injury and the causation coded (radiology images will be available from prior entry by the Medical Center). Of note is that the Engineering Center shall be responsible for writing the Injury Analysis narrative – this was not clearly indicated in the draft manual.

24. Section C.5.1.a: Screening, consent and enrollment of injured motor vehicle occupants

Question: Do the 50 CIREN cases enrolled per year by a medical center include the anticipated pedestrian, cyclist and motorcyclist cases presented in section C.2 (Background) and section L.10 (Technical proposal instructions), or are they strictly limited to motor vehicle occupants as suggested by section C.5.1.a of the Medical Center Sample Task Order statement.

NHTSA Response:

The Sample Task Order specifies 50 Standard CIREN occupant cases and there should be no consideration of pedestrian or other road user cases in the development of the Sample Task Order cost proposal. The Sample Task Order was included as a tool to evaluate cost proposals on a level playing field – all Offerors shall develop a cost proposal assuming an annual enrollment quota of 50 Standard motor vehicle occupant cases.

25. Question: Section C.5.3 All CIREN Centers, General Requirements Is it to be assumed that CIREN-related research projects will be funded through supplemental funding, as per previous contracts on an annual or as-needed basis?

NHTSA Response:

Yes, research projects will be funded if and when research-related Task Orders are issued by the government.

Amendment 000001 Responses to Questions

26. Section L.9: Proposal format Question: If a combined medical and engineering center is proposed, the RFP indicates 2 stand-alone proposals along with a third that describes how the engineering and medical centers will be integrated. The page count for the stand alone proposals is 50 (each). What is the limit for the third, combined approach, document?

NHTSA Response:

Prior to being considered as a combined Medical and Engineering Center, an Offeror’s Medical Center and Engineering Center proposals must be each deemed technically acceptable by the evaluation committee. Refer to response #9.

27. Section L.10, Part II: Qualifications of project personnel Question: If a combined medical and engineering center is proposed, does NHTSA have a preference or requirements (e.g., degree types) for who the principal investigator should be?

NHTSA RESPONSE:

Entities seeking a combined award must possess the personnel meeting requirements for both center types, so they may develop a proposal with co-PIs or they can choose one PI of record. PIs and co-PIs will be considered Key Personnel. There is no preference regarding who will serve as the Project Manager.

28. Section L.10, Part II: Qualifications of project personnel, Medical Center Question: Is a co-PI permitted at a Medical Center? Also, for secondary partner enrollment sites, what staff is required and do the same key personnel apply? Are Co-PIs permitted to be designated from these locations?

NHTSA RESPONSE:

Yes, a co-PI is permitted and a co-PI may be from a secondary enrollment site. There are no specific requirements for personnel at secondary enrollment sites, though the proposal must demonstrate a personnel plan and technical approach that balances increased enrollment potential with the added logistical complexity. Depending on the nature of the relationship between the primary and secondary sites, there may or may not be substantial personnel requirements to ensure success with such a setup.

29. Section L.10, Part II: Qualifications of project personnel, Engineering Center Question: Based on our experience, a full-time Data Coordinator is critical for an enrolling Medical Center but may not be for an Engineering Center. Is NHTSA open to considering alternative staffing and/or staffing levels, or are there additional roles and responsibilities anticipated for this person?

Amendment 000001 Responses to Questions

NHTSA RESPONSE:

Yes, NHTSA is open to considering alternative staffing and/or staffing levels. The Data Coordinator at an Engineering Center does not need to be fully devoted to the CIREN project – this was an oversight in the description provided in Section L.10 for the Engineering Center staff. The Data Coordinator is still considered key personnel, but this individual is not expected to be full-time on CIREN.

30. Section L.11, Part I.C: Other Direct Costs Question: Will NHTSA provide the CIREN center computers to access the CIREN database and program applications?

NHTSA RESPONSE:

Yes, NHTSA will provide the necessary information technology hardware as Government Furnished Equipment, though information technology hardware requirements will be more clearly described in the Task Order(s).

31. Section Attachment J6. Inclusion Criteria v4 Question: Can NHTSA provide additional clarification for what constitutes a brain injury? Specifically, is brain injury alone, without other body injuries, sufficient to qualify? What severity of brain injury, alone or in combination with other qualifying injuries, would meet eligibility for enrollment?

NHTSA RESPONSE:

An isolated AIS 2+ anatomical brain injury, with or without any other injuries to the patient, meets the Brain inclusion criterion for motor vehicle occupants. Based on the AIS 2005/08 classification, qualifying anatomical brain injuries fall within the range of codes between

140202.5 and 140698.3 (excluding NFS codes). Concussive injuries with AIS severity 2 or higher, combined with an MAIS 1 for all other injuries, are also eligible for the Brain inclusion criterion for motor vehicle occupants. Based on the AIS 2005/08 classification, qualifying concussive injuries fall within the range of codes between 161004.2 and 161013.5. Note that inclusion eligibility is based also on vehicle, restraint, and occupant position criteria.

32. Question: Please provide a list of research questions that were addressed in the currently ongoing set of CIREN projects funded by NHTSA.

Research topics funded in the past include trauma triage and Advanced Automatic Collision Notification (AACN), lumbar spine response in frontal crashes, using digital radiology to estimate bone mineral density, in-depth analyses of brain and thoracic trauma, and investigations

Amendment 000001 Responses to Questions into lower extremity injury causation. A more complete list of prior CIREN research topics can be found at http://www.nhtsa.gov/Research/Crash+Injury+Research+(CIREN)/Research

33. Question: Is the estimated value of $10-20 million over the course of the 5 years of the project for all centers or for one year for all centers, or something else?

NHTSA RESPONSE:

Yes, the estimated value is over the course of the 5-year requirement (inclusive of any issued Task Orders) for all centers combined.

34. Question: Does an engineering center need to be associated with a proposed trauma center in order to be considered?

No. The requirements for an Engineering Center do not include access to traffic crash victims admitted to a trauma center.

35. Question: Are the engineering centers and trauma centers evaluated separately or together?

The proposals for Engineering Centers will be evaluated separately from those for Medical Centers, as each center type has unique evaluation factors.

36. Question: What software tools and models will NHTSA make available for use under the project?

NHTSA will provide the necessary software to meet CIREN center requirements. The required software consists of custom data entry applications and commercial scene and vehicle analysis packages.

37. Question: Is the 10-20 million estimated value for the basic operation of the CIREN centers, or does that also include amounts for additional research that NHTSA may fund based on specific suggestions?

The estimated total included some funding for additional research. See response to question 33.

38. Question: With respect to page 8 of the RFP 1(e) re: funding of suggested research project, what type of research projects are going to be of interest to NHTSA? Please give http://www.nhtsa.gov/Research/Crash+Injury+Research+(CIREN)/Research

Amendment 000001 Responses to Questions more insight with projects related to safety. (For example, project related to the occurrence of bilateral carotid artery shearing in pedestrian impacts.)

The purpose of funding additional research projects through the CIREN program is to encourage more in-depth research on observations seen in the crashes CIREN investigates and to examine methods to improve trauma care and analysis. Since CIREN focuses on injury causation in occupants of newer vehicles, CIREN participants have the opportunity to observe new trends in how humans interact with the latest occupant safety technologies. CIREN researchers are then encouraged to translate these observations into small research projects to determine how advancements in vehicle technology and enhancements in crashworthiness goals translate to real-world performance. Furthermore, the interaction between the engineering and medical communities in the CIREN program has the potential to spawn research ideas in areas that could improve assessment and treatment of injuries. These studies may or may not lead to greater NHTSA research efforts, but research funding through the CIREN program provides NHTSA with a mechanism to conduct initial studies to determine relevance and potential.