Amendment_1_10-12-18.pdf

Amendment 1

Questions and Responses to RFP NIHAO201800107

Operation of a Facility for the Study of Infectious Agents, Vaccines and Antimicrobials in Adult and Pediatric Human Subjects

1. Technical Proposal

Question:

a. P. 64: “The total page count of the Technical proposal shall not exceed 150 pages”.

Is this inclusive of all appendices, including biosketches, floor plans, organizational charts, laboratory SOPs, letters of collaboration, and specified Technical Proposal attachments 4,5,6,7?

Response: The Total Page Count is changed to 200 pages including all appendices.

b. Task Orders IB and IC specify that a “study physician” shall administer vaccine or challenge virus. May these tasks be performed by a qualified RN, NP, or PA, or must they be performed by a physician?

Response: Yes, these tasks may be performed by a qualified RN, NP, or PA.

c. Does the Government require the Offeror to provide clinical monitoring of data and clinical study assessment services by a Clinical Research Associate (CRA) under this contract or will the Government be providing these services?

Response: The Government will provide these services.

d: Can the Government confirm if the complete study report is required to be submitted in eCTD format?

Response: No

e. For Sample Task Order 1A (RSV study), Group 1 schedule of events included on page 6 of 9 of SOW, Attachment 3, Appendix A, Visits on Days 1, 2, 4, 6, 8 and 9 are listed as noncontact visits however, PE and nasal wash are listed as activities on days 4 and 6.

Can the Government confirm this table is accurate?

Response: Table 1 is not accurate. PE and nasal wash are not required on non-visit contact days 4 and 6.

2. Business Proposal

a. Please clarify whether the budget should include costs for:

i. Enrollment of up to 400 infants and children, 400 adults in an outpatient setting and

60 adults in an inpatient setting/year for 7 years OR

ii. Enrollment of 45 infants and children in Task Order 1A, 28 adults in Task Order 1B, and 42 adults in Task Order 1C.

Response: Yes

iii. If the budget should include up to 400, 400, and 60 as specified above, shall costs be integrated into a single budget or presented as separate budgets according to the type of research (core support, pediatric, adult outpatient, adult inpatient)

b. Cost assumptions: each sample task order lists personnel for project management, for example, Research Program Coordinator, Administrative and Budget Specialist, Data

Coordinator, Technical Writer, IT Specialist, Compliance Monitoring Specialist, Regulatory Specialist, but lists no clinical personnel and no laboratory personnel. Could you please clarify?

Response: Clinical Task Order should be with Clinical Task Order and Data Management with Data Management

c. P.4, Article B3: May we budget for costs that are unallowable without CO approval but have been essential to the conduct of our work and to data sharing, including:

i. Food for subjects in an isolation unit

ii. Patient care cost in the event of injury that is related to trial participation

iii. Leased satellite space for the conduct of pediatric trials

iv. Presentations at scientific meetings

d. Past performance: p.69 indicates “last 4 contracts completed during the past two years” and p. 105 indicates “each related contract completed within the last three years”. Please clarify which information is preferred.

Response: Page 69 should read “last 3 contracts completed within the past three years”

Delete [ALL CONTRACTS/THE LAST 5 CONTRACTS AWARDED]. Do not use the language on Page 105.

e. P. 54, Section K: (Reps and Certs): this is listed to be completed and included in the

Business Proposal (p.54) but is not included in the Business Proposal list of attachments.

Please confirm that it should be included.

Response: On Page 54 Delete No. 2. Only use SAM (1.).

3. General: Please confirm that submission should be via eCPS, and that hard copies of the proposal are not required. Are there file size limitations for eCPS?

Response: Hard Copies are not required. The maximum upload size for all proposal document(s) together is 387.19 MB

4. HHSAR Clause 352.231-70 is included in the RFP. It indicates that “an individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort

(costs) under the contract.” Consultants are not paid a “salary” and typically are just reimbursed by a company based on actual work performed. If a prime contractor uses a consultant with an hourly rate of $200 (which would appear to be in excess of the current

Executive Level II salary divided by 2,080 hours) and the consultant only works 100 hours on the contract during a given year, their compensation for the direct effort under the contract will equal only $20,000. If the only direct effort this consultant performs under the contract in an annual period results in annual compensation of only $20,000, please confirm that in this situation there would be no violation of 352.231-70, because the compensation paid for the direct effort under the contract is far below the Executive Level II threshold?

Response:

There would be no violation of the threshold.

a. If the Government determines that this rule would apply in the situation above, please confirm whether the salary rate limitation rule does not apply to consultants or subcontractors that are paid on a fixed price basis (per project or per deliverable) rather than on an hourly basis?

Response:

Rule would apply to the hourly basis.

5. Section 4 on page 93, Certified Cost or Pricing Data, appears to require certified cost and pricing data. Per FAR 15.403-1(b), certified cost or pricing data should not be required when the prices are based on adequate price competition. Please confirm that the

Government expects it will receive independent bids from at least two or more responsible offerors, such that the requirement for certified cost or pricing data should not be required at the proposal stage?

Response: Doesn’t apply at this time.

6. The instructions related to the Small Business Subcontracting Plan regarding the goals set out in #11 on page 100. Please clarify whether the goal of “3% for Veteran-Owned Small

Businesses and Service Disabled Veteran Owned Small Business” means that the prime contractor can meet this goal through the use of either VOSBs and SDVOSBs (or both), or if each of these categories requires its own 3% target? The target is a combined 3%.

a. If the answer is that they are individual targets, our understanding is that an

SDVOSB is also a VOSB. Please confirm? Combined

b. Section J has a link to an HHS subcontracting plan template. Are offerors required to use this template or can we provide our own plan? Note the template has references to FY2017 goals. Use the template and update for 2018 goals.

7. The RFP includes the requirement for a Total Compensation Plan (TCP) on page 101. As this proposal will just result in a prime contract with no actual work, will the Government consider making the TCP an element of each Task Order rather than this RFP? The evaluation of the TCP is aimed at ensuring the proposed compensation structure is sufficient to retain qualified personnel and assuring program continuity. An analysis of compensation levels to assure they are appropriate to maintain professional employees makes more sense when applied against Task Order proposals where there is certainty over the professional employees that may be currently providing services or that may be needed to perform the specific work, and the specific labor categories and compensation rates can be provided.

Response: Must provide compensation plan with proposal.

8. In Section 12. Qualifications of the Offeror on page 105, the instructions for subpart d regarding Pertinent Contracts indicates the offerors should provide a listing of each related contract completed within the last 3 years or currently in process, but the instructions do not specify the number of contracts to be listed. Both of these sections are essentially past performance information. Please confirm that the Government does not want duplicative sections with identical or nearly identical write-ups and that offerors may combine the requested information into one section? Response: Do not use Page 105.

9. Section 14. Proposer's Annual Financial Report on page 106 of the RFP requires organizations to submit a copy of their most recent annual report. Our organization operates as a business unit of a publicly traded company. As such, we would submit an annual report for just our business unit operations, containing the items: balance sheet, income statement and aged receivables for the most recent year. Is this sufficient for the Government? If not, what additional items would you like to receive? Response: The balance sheet is sufficient.

10. Will the manufacturer of the study products maintain Products Liability Insurance with coverage for injuries to clinical study subjects for Sample Tasks 1A-1C? Response: We will post an amendment to respond to this question next week for 10. a, b, and c as well.

a. If yes, how much?

b. Confirm the manufacturer will issue letters of indemnification related to study subject injury to the prime contractor and clinical sites or other subcontractor requiring confirmation of liability coverage.

c. If not able to confirm, please confirm that the cost of products liability coverage is an allowable direct charge under this response?

11. Will the Sponsor provide access to its own database (CRIMSON) for the proposed SOWs or should the offeror propose and budget for a database?

Response: We will post an amendment to respond to this question next week.

12. May laboratory equipment other than freezers be proposed if necessary for completion of the work outlined in the sample task orders?

13. A clarification for the Qualifications of the Offeror section –

a. Item 12d – Pertinent Contracts – confirm 3 listings from federal and nonfederal sources.

b. Item 12 e – Pertinent Grants – confirm only from federal sources – also is this supposed to be part of the Performance History section rather than a listing of institution-wide grants?

Response: a: Just Federal Sources. b: Only Federal sources. This is just a performance history.