Amendment_9_-_QA_and_Uniform_Cost_Assumption_Revision_-_Research_Area_003.pdf

Amendment #9

Solicitation HHS-NIH-NIAID-BAA2018

AMENDMENT NINE (9)

OFFICE OF ACQUISITONS

National Institute of Allergy and Infectious Diseases (NIAID)

5601 Fishers Lane, Room 3D32, MSC 9821 Rockville, MD 20852

Solicitation Number: HHS-NIH-NIAID-BAA2018

Date of Solicitation Issuance: 06/01/2018

Date of Amendment No.1 Issuance: 07/03/2018 Date of Amendment No.5 Issuance: 08/02/2018

Date of Amendment No.2 Issuance: 07/03/2018 Date of Amendment No.6 Issuance: 08/31/2018

Date of Amendment No.3 Issuance: 07/20/2018 Date of Amendment No.7 Issuance: 08/31/2018

Date of Amendment No.4 Issuance: 07/24/2018 Date of Amendment No.8 Issuance: 10/24/2018

Date of Amendment No.9 Issuance: 11/05/2018

Number of Pages: 4

Issued By:

George W. Kennedy, Contracting Officer

Email: kennedyg@mail.nih.gov

Phone: 240-669-5170

The hour and date specified for receipt of Offers remains unchanged.

Offerors must acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Include a statement of acknowledgement in your proposal submission. Failure of acknowledgement may result in rejection of your offer.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

PURPOSE OF SOLICITATION AMENDMENT

This amendment is applicable to RESEARCH AREA 003, “Collaborative Influenza Vaccine

Innovation Centers (CIVICs)”.

The purpose of this amendment is to revise Section 3.2.3.4. of solicitation HHS-NIH-NIAID-

BAA2018 as described below; and respond to questions received in response to Research Area

003: Collaborative Influenza Vaccine Innovation Centers (CIVICs).

mailto:kennedyg@mail.nih.gov

Section 3.2.3.4. – UNIFORM COST ASSUMPTIONS, paragraph c., is amended as follows:

c. Clinical Core: Assume establishment of clinical sample repository in the first year and maintenance of repository in subsequent years. Assume design and planning activities for future clinical trials and human challenge studies in the first year. Assume conduct of two (2) Phase I clinical trials in each of the second through sixth years. Assume conduct of one (1) Phase II clinical trial in the second, fourth and sixth year. Assume conduct of one (1) human challenge study in the second, fourth and sixth year. For the purposes of these cost assumptions, the Phase I clinical trials should include no more than 100 subjects, the Phase II clinical trials should include no more than 200 subjects and the human challenge studies should include no more than 200 subjects.

QUESTIONS AND RESPONSES:

The Government’s responses to questions received regarding RESEARCH AREA 003, “Collaborative Influenza Vaccine Innovation Centers (CIVICs)” are as follows:

1. Question: Will we have to recruit external experts for the CIVICs External Advisory

Group or will the composition of the group be determined by NIAID?

Answer: The CIVICs External Advisory Group (EAG) will be convened by

NIAID post-award. Offerors should not identify nor propose EAG members in the technical or business proposal and should not contact specific individuals regarding service on the EAG prior to contract award (see Section 3.2.3.4 –

UNIFORM COST ASSUMPTIONS, part g, bullet 3). Please note, that the EAG is different than the Senior Leadership Group (SLG) which is the management/leadership team for the Vaccine Center (Component A). The SLG should be included in proposal submissions for Component A (see Section

3.2.2.1.3.1 – Research Area 003 Component A: Vaccine Center, part 1).

2. Question: To provide an estimate on biorepository services, could the following details/assumptions be provided: What sample types, quantities, number of samples per patient, and storage temperatures should the Contractor assume will be stored annually. A schedule of assessments would be greatly helpful as well if possible.

Answer: For information on the clinical samples to be collected and analyzed, see section 3.2.2.1.3.1 – Research Area 003 Component A: Vaccine Center, section 3.

Immunologic Analyses.

3. Question: Is the base period restricted to 12 months for the Vaccine Center. (This was clarified for a different research area, but not for research area 003).

Answer: Yes, assume the base period is restricted to 12 months for the Vaccine

Center.

4. Question: If we are investigating multiple potential vaccines, but planning to carry forward only the successful candidates in the option years, given that we do not know currently which candidates are going to be successful, should we budget as if all of them are successful?

Answer: Candidate vaccines/platforms may be at varying stages of pre-clinical or early clinical (Phase I) development. The proposed studies and associated budgets should align with the stage of development. For budgeting purposes, it is acceptable to include studies to further develop all proposed vaccine candidates in option years. However, NIAID will work with the CIVICs Program Contractors post-award to down-select vaccine candidates and only the most promising candidates will advance into Phase I/II clinical trials.

5. Question: When providing the business proposal, specifically the budget template, the instructions ask for costs by year as well as task-based costs. We do not find a tab in the provided Excel workbook for a task-based budget. Should we create our own new tab in the provided template and add it into the Excel workbook? Or provide this information in a separate Excel workbook that we create?

Answer: Yes, create your own.

6. Question: Amendment 6 states: Assume conduct of two (2) Phase I clinical trials in the second year and each year after. To remain compliant and conduct two Phase I trials in the second year and each year thereafter (Y2, Y3, Y4, Y5, Y6, & Y7) requires us to start a new study in Y7, but study activities will not be complete at the end of the 12 month period. Because the total performance period (as stated in the BAA) should not exceed seven (7) years, what is recommended to remain compliant with the requirement to conduct two Phase I trials every year, but stay within the seven year total performance period?

Answer: Section 3.2.3.4 – UNIFORM COST ASSUMPTIONS, paragraph c.

Clinical Core will be amended as follows:

Clinical Core: Assume establishment of clinical sample repository in the first year and maintenance of repository in subsequent years. Assume design and planning activities for future clinical trials and human challenge studies in the first year.

Assume conduct of two (2) Phase I clinical trials in each of the second through sixth years. Assume conduct of one (1) Phase II clinical trial in the second, fourth and sixth year. Assume conduct of one (1) human challenge study in the second, fourth and sixth year. For the purposes of these cost assumptions, the Phase I clinical trials should include no more than 100 subjects, the Phase II clinical trials should include no more than 200 subjects and the human challenge studies should include no more than 200 subjects.

7. Question: Over the 7 year funding period, is it expected that our lead vaccines will be tested in clinical trials within that period of time? Or are we expected to have vaccines ready for clinical trials at the end of the 7 years?

Answer: Candidate vaccines/platforms may be at varying stages of pre-clinical or early clinical (Phase I) development and the studies proposed should align with the stage of development. It is anticipated that the most promising candidate vaccines will be tested in clinical trials within the 7 year performance period.

-- End of Amendment 9 --