TATRC-17-T-0093_AMENDMENT__2_Q&A.doc

SOLICITATION No: W81XWH-17-T-0093 AMENDMENT #2 – Government Response to Questions 1.Question: If a teaming partner will have a significant role and work share on this project, is it acceptable for this partner to hold the IRB and research agreements required for Phase One?

Answer: Yes

2. Question: Page 47, Section 5.0, Phase One, Part b ‐ indicates that the government seeks a vendor whose IRB meets various requirements. However, on page 25 Major Task 1 Subtask 6, it indicates the UTHSCSA IRB should be used. Can the government clarify UTHSCSA’s role in this project? Do vendors have to use the UTHSCSA IRB?

(Note: UTSCSA is also referenced in the following areas: on pg. 25 in Major Task 1, Subtask 8; pg. 26 Specific Aim 5, Task 5)

Answer: Vendors do NOT have to use the UTHSCSA IRB, but it MUST be an already recognized first level IRB for the Fort Hood area, as determined by BAMC Clinical Investigations, such as the UTHSCSA IRB.

3. Question: Phase One requires: A valid, approved, formal agreement in place with the government that allows the vendor to provide research support services at CDRAMC in accordance to the terms and conditions set forward to the Department of Clinical Investigations (DCI) at Brooke Army Medical Center (BAMC) at Fort Sam Houston; which has oversight authority over CDRAMC Behavioral Health Service research activities.

Is the government requiring this agreement to be specific just to CDRAMC only, or can an agreement that is a federal wide for research support services be accepted?

Answer: As stated, in the RFP, vendors need to have a formal agreement in place that allows them to conduct Behavioral Health research at the aforementioned site. Having a federal wide research support services agreement meets part of the requirement, but not the entire requirement.

4. Question: Phase One requires: A valid, approved, formal agreement that allows the Offeror to serve as the first level institutional review board (IRB) for CDRAMC in accordance with the terms and conditions set by the DCI, BAMC and DODI 3216.92, Subpart 3a(7).

Is the government requiring this agreement be with CDRAMC, or can an agreement that is federal wide for IRB services be accepted?

Answer: As stated, in the RFP, vendors need to have a formal agreement in place that allows them to conduct Behavioral Health research at the aforementioned site. Having a federal wide research support services agreement meets part of the requirement, but not the entire requirement.

5. Question: Within the statement of work, there is language regarding/modifying a CRADA between Army, UTSCSA and the Vendor. If this CRADA needs to be utilized for the purposes of this contract, does this need to be built into requirements for Phase One? And if so, is this already in place?

Answer: As stated, in the RFP, vendors need to have a formal agreement, such as a CRADA in place that allows them to conduct Behavioral Health research at the aforementioned site. If no such agreement exists at this time, vendors need to outline their approach and timeline to achieving this requirement.

6. Question: Specific Aim 4 Subtask 10 indicates the vendor should hire staff to support the study. Can the government clarify the roles of these staff? Are they different from those indicated as key personnel? This clarification will help in vendors prepare for the upcoming release of Phase 2 of this solicitation.

Answer: Vendors will need to hire staff, specifically those listed as key personnel. No other staff requirements are associated with this RFP.

7. Question: Is this RFP specific to the CRDAMC site or are other sites to be added/included?

Answer: The RFP is specific to CDRAMC, as stated in the RFP.

8. Question: If additional performance sites, would CRDAMC be the lead study site?

Answer: CDRAMC is the only performance site, not a lead for a multi-site study.

9. Question: Please confirm that the vendor is to complete all the tasks of the CRDAMC column and the Vendor column.

Answer: Vendor is to complete all of the vendor column tasks, the CRDAMC column represents government functions that will be completed by the government PI at CDRAMC.

10. Question: Can the government please elaborate on the role of UT Health San Antonio (UTHSCSA) as it relates to this effort?

Answer: Vendors do NOT have to use the UTHSCSA IRB, but it MUST be an already recognized first level IRB for the Fort Hood area, as determined by BAMC Clinical Investigations, such as the UTHSCSA IRB

11. Question: Would the government accept alternative staffing approaches and key personnel aligned with our approach to this effort?

Answer: Vendors are welcome to propose alternative staffing approaches, however, the key personnel identified in this RFP are approved for the research project by the government funding agency, and deviations from this approach may require significant delays to obtain approvals from the government to change course for this research project, which is not a preferred option.

12. Question: The Key Personnel requirements, in particular the Principal Investigator and Nurse Research Investigator, appear to have requirements that eliminate all competition except by companies/organizations such as UTHSCSA that are currently providing research support to CDRAMC. Can the key personnel requirements be revised to allow open competition?

Answer: The key personnel identified in this RFP are NOT specific to a vendor, but are specific to the requirements of this effort. Vendors are welcome to propose alternative key personnel requirements to meet the project goals.

13. Question: Is there a rough estimation when the Phase Two instructions of the solicitation would be released?

Answer: Phase Two instructions will only be provided to those offerors who successfully complete Phase One. Instructions for proposal submission for Phase Two will be provided at that time.