Questions_and_Answers_POC.docx

Questions and Answers RFP-17-100-SOL-00019

Question #1 – Can it be confirmed that the business volume is limited to 50 pages?

Answer: Yes that is correct, the business proposal shall not exceed 50 pages.

Question #2 – Can it be confirmed that BARDA does want respondents to price NHP studies.

Answer: Respondents need to price and be able to lead the NHP studies. This should include getting all the proper federal, state, and local licenses to be managing studies, obtaining, and shipping samples.

Question #3 – Is there a specific stockpile test quantity that BARDA is attempting to maintain?

Answer: BARDA would like to potentially put 100,000 point of care tests and a quantity of instruments to run those tests in the stockpile, if pre-EUA status is achieved with the FDA and funding permits during the Base Period. Once the full filing package has been reviewed and the FDA has approved the point of care test, BARDA would like to potentially add 900,000 additional tests to the stockpile, dependent on funding availability. The goal would be to potentially have 1,000,000 tests in the stockpile (100,000 from initial and 900,000 from post-approval stocking) and instruments to perform the testing.

Question #4 – We would appreciate more clarity on the CLIN tables on page 6 versus those on pages 13 and 14. CLINs 0002 through CLINs 0006 on page 6 pertain to the acquisition of specific numbers of tests. CLIN 0007 on page 6 pertains to the acquisition of additional tests at the discretion of the USG. However on page 13, CLIN0002 has both Objective 7 Establish Stockpile (the acquisition of the first 900,000 tests) and Objective 10 Additional Procurement. Based on the way CLIN0002 is written on page 13 more knowledge of the Additional Procurement would be appreciated. Moreover, the Additional Procurement seems to be linked to CLIN0007 on page 6.

Answer: First, there is a small supply of tests (about 100,000) to be potentially delivered to the United States Government, if the FDA is satisfied with the pre-EUA data for these tests. Second, once the full filing package is approved by the FDA, an option may be potentially exercised to purchase an additional 900,000 potential tests. This assumes the initial 100,000 tests have not expired. If they have, then the option would be potentially be exercised for the full 1,000,000. Third, as the tests expire, they will need to be replenished on a scheduled basis, potentially keeping the supply at 1,000,000, dependent on funding. Fourth, is a potential situational procurement which is unscheduled because either another agency potentially needs tests or if there is a nuclear incident, there may be a potential surge replenishment need because supply has been used up.

Question #5 – CLIN0003 on page 13 has both Objective 7-Maintain Stockpile and Objective 10-Additional Procurement. Is the acquisition of 1M tests (as discussed on page 6) under Maintain Stockpile or under Additional Procurement? Or does Maintain Stockpile refer to replenishment of the stockpile when tests are expired?

Answer: Maintaining the stockpile refers to potentially replenishing the tests as they expire and potentially performing the maintenance activities that are needed to keep the instruments fully functional.

Question #6 - While 500 stockpiled analyzers are adequate to test 1,000,000 patients in a week if sufficient operators are available and analyzers are allocated among test sites with no inefficiencies, perfect efficiency will not be achieved in a real incident. In particular, interviews with representative users of the analyzer suggest that fear of exposure to radiation may limit available operators. If limited operators are available, more analyzers would be needed to achieve the same throughput. If patients show up in larger numbers on certain days, more analyzers would be needed to deal with that surge. Finally, if patients distribute themselves among test sites differently than anticipated, more analyzers would be required to deal with higher patient throughputs at certain sites. Taking into account all these likelihoods, more analyzers may be needed. Would BARDA like Contractors to propose optional supplemental production at additional cost?

Answer: AMCG and BARDA would like respondents to propose the number of instruments likely to be needed to do 1 Million tests in 7 days.

Question #7 - Can BARDA provide a point of contact at the SNS so that we can plan logistics for shipping and instrument maintenance?

Answer: After any potential contract award, at the appropriate time, AMCG and BARDA will work with any potential awardee to plan logistics for potential shipping and instrument maintenance.

Question #8 - Validation studies will be developed and performed during the base period so the IRB-approved documents will be confirmed during that period. IRB approval for these specific studies will occur during (not before) the award. Please clarify the what is meant on page 51 by “Before the award… the Contractor must submit to the COR a copy of the current IRB-approved consent form, etc.”

Answer: If a potential contract is awarded, the required information can be provided after potential contract award but must be submitted before any applicable protocols can be potentially approved by the United States Government and before the applicable potential studies can begin under a potential contract.

Question #9 - For the mandatory criteria for eligibility, can BARDA confirm that “Immuno- compromised” patients (page 107) are defined as patients with CD4 counts < 200?

Answer: For the purposes of this RFP, data from immunocompromised patients can be those with a lymphocyte count below the normal range or patients with CD4 count < 200. The population needs to be clearly described in the mandatory criteria volume so the technical reviewers understand which of these patient types were test.

Question #10 - For some of the low frequency clinical study groups such as immune-compromised, or burn, or others, is it acceptable to use multiple samples from the same patient, understable conditions, taken 1 week apart?

Answer: Immunocompromised, burn, and other groups have sufficient frequency to obtain them. The problem with obtaining samples from the same people on different days is that the FDA wants to know that the special condition does not invalidate the test. If more than one sample from a patient is taken, they are not independently testing this hypothesis.

Question #11 - Some potential proposed partners may find the EVMS, IT Plan, and Security Plan requirements onerous. For example, some University medical centers may not have CCTV coverage. Small vendors may require modified IT or EVMS plans. Is this consistent with BARDA’s request?

Answer: It is the potential prime Offeror’s responsibility to ensure that all applicable EVMS, IT Plan and Security Plan requirements that are contained in the Solicitation are fully addressed in the proposal at both the proposed potential prime level and at all proposed potential subcontractor levels and that all applicable EVMS, IT Plan and Security Plan requirements that are contained in the Solicitation under any potential contract award are complied with at both the proposed potential prime level and at the proposed potential subcontractor levels.

Question #12 - Is the Validation and Manufacturing of the Biodosimeter considered an IT project per HHS OCIO Policy https://www.hhs.gov/ocio/policy/2008-0004.001.html?

Answer: No, the Validation and Manufacturing of the Biodosimeter is not considered an IT project per HHS OCIO Policy https://www.hhs.gov/ocio/policy/2008-0004.001.html.

Question #13 - Is the 3 page limit on for key personnel CVs called out in section L.4.2 meant to cover all CVs combined or per CV?

Answer: The 3 page limit is per individual CV.

Question #14 - May the hard copies of the proposal be printed double-sided, or must they be single-sided?

Answer: Hard copies of the proposal must be printed single-sided.

Question #15 - Can other information be included as appendices to the technical proposal in addition to the items described in L.4.2, assuming that all appendices fit within the 50 page length restriction?

Answer: The technical proposal may not exceed 50 pages. The appendix of the technical proposal may not exceed 50 pages. The offeror may include other information in addition to L.4.2 in the appendix of the technical proposal that is relevant to supporting the technical proposal and is within the 50 page limit for the appendix of the technical proposal.