Amendment_1_BAA-NIAID-NIHAI201700104.pdf

Amendment No. 1 to BAA-NIAID-NIHAI201700104 “Immune Mechanisms of Protection against Mycobacterium tuberculosis Center (IMPAc-TB)”

Amendment to Solicitation No.: BAA-NIAID-NIHAI2001700104

Amendment No.: 1

Issue Date: March 8, 2018

Effective Date:

Proposal Due Date:

March 8, 2018

August 15, 2018 at 3:00 p.m. (EST)

Issued By: Liem T. Nguyen Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane, MSC 9821 Rockville, MD 20892-9821

Point of Contact: Albert Nguyen, Contract Specialist 25T Unguyenal@niaid.nih.govU25T

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals remain unchanged. Offerors must acknowledge receipt of this amendment. Failure to provide your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to the solicitation and its amendments for additional Questions & Answers.

Question 1: May offerors include collaborations with NIH intramural researchers in proposals?

Response 1: Offerors may not propose the use of Government resources (including Government personnel) in response to this BAA. Exclusive access to Government resources may potentially constitute an unfair competitive advantage during the evaluation process. Due to procurement integrity regulations, offerors must be evaluated on their own capabilities independent of any access to Government resources not offered in the solicitation document to all potential offerors. However, as stated in the solicitation, the Government reserves the right to foster these collaborations after award.

Question 2: Are foreign institutions eligible to submit a proposal?

Response 2: Yes, foreign institutions are eligible to submit a proposal.

mailto:nguyenal@niaid.nih.gov

Question 3: Are guinea pigs a suitable small animal model for this program?

Response 3: Yes, please refer to the Research and Technical Objectives Section, Attachment 5, 3.c. of the BAA: Small animals (e.g., mice, guinea pig), such as: i. Extensive tissue immunologic analyses, coupled with analyses of systemic immune responses to Mtb infection or TB vaccines (as described above in bullet a.iii) ii. Comparative immunologic studies with human and NHP, with two major goals being to: 1) identify protective immune responses and determine mechanisms of these protective responses; and 2) improve the predictive value of the animal model(s) for evaluating Mtb vaccine efficacy (i.e., development of rigorous, portable immunologic endpoints that can be measured in and have biological relevance in humans and animals).

Question 4: Within a single proposal, can several sites collaborate on the conduct of immunologic studies associated with a particular model (i.e., small animal, NHP, human)?

Response 4: Yes, please refer to Attachment 4, Background and Introduction, paragraph 5: All qualified offerors are invited to apply to this solicitation. The IMPAc-TB program requires multidisciplinary expertise, including experts from outside the field of TB to bring fresh perspectives into this difficult area of science and immunologists with experience in immunologic analyses of different animal species (small animals, NHPs and humans). Therefore, the NIAID recognizes that a single organization or institution may not have the expertise and facilities required to perform all parts of the Technical Plan, and that it may be necessary for the Contractor to subcontract portions of the work.

Question 5: What are reasonable Costs for this Program?

Response 5: Please refer to the following:

• BAA Attachment 3, Broad Agency Announcement Description, paragraph 4: NIAID anticipates making one to three (1-3) awards for the entire IMPAc-TB program. NIAID estimates that the total cost (direct and indirect costs combined) of this program will be $19.5 million for the initial, non-severable base work, which is anticipated to last 12-18 months depending on an offeror’s technical approach and proposed milestones.

• While the inherent unknowns in a BAA (offeror developed SOW) make it difficult to determine the exact period and scope of performance, NIAID is limiting the maximum period of performance for this solicitation to seven (7) years and anticipates that total costs/year will be approximately $19.5M (depending upon availability of funds and contract performance).

• Part IV, Section L, 1.c (Estimate of Effort): Submissions in response to this BAA will represent each offeror's creative and innovative approach to the specific research. Therefore, the Government is unable to provide an estimate of effort but reminds all offerors that they shall propose effort that is consistent with the nature and complexity of their proposed research.

Question 6: Is a proposal with multiple PI leadership an option?

Response 6: Yes, a proposal with multiple Principal Investigators (PI) is an option. Please refer to section L.2.b. Technical Proposal Instructions, item 1.b.2. Other Investigators on page 53 of the solicitation.

Question 7: What is a non-severable completion option?

Response 7: Non-severable refers to work that is defined by a clear resulting end-product. The requirement is completed once the end-product (such as a study report) has been produced. The period of performance for non-severable work is based upon the amount of time anticipated to reach completion of the end-product (may be more or less than one year).

As stated in Attachment 3, BAA Description, page 95 of the solicitation, “Due to the inherent unknowns in a BAA (offeror developed SOW), it is difficult to determine the exact period of performance. NIAID anticipates an initial, non-severable, completion portion of work, which is anticipated to last 12-18 months depending on an offeror’s technical approach and proposed milestones. The government will fully fund the initial, non-severable, completion portion of work at the time of award.

Question 8: What is a severable completion option?

Response 8: By definition, severable work is not based upon the completion of an end-product. Severable work is based upon services that are continuing and recurring in nature and provide the government a benefit each time the individual service is performed. The period of performance is defined by a specific time period (not exceed 12 months) over which the contractor provides labor efforts to perform the ongoing services. If there are option(s) to extend the term of the contract, as set within the award, the government will exercise the option to extend the term of the contract (typically by 12-month segments) and provide annual funds.

Contracts resulting from this solicitation are anticipated to be based on upon non-severable completion segments of work (options) with defined end-products and not the performance of recurring severable services.

Question 9: 12-18 months seems very short for the expansive scope of work of the IMPAc-TB programs. Does the proposed SOW cover only 12-18 months?

Response 9: An initial, non-severable segment of base work is anticipated to last 12-18 months depending on an offeror’s technical approach and proposed milestones. NIAID is limiting the maximum period of performance for this solicitation to seven (7) years. Proposals should the include initial, non-severable base work plus all proposed non-severable segments of work (options) up to a maximum of seven (7) years combined.

Question 10: Does the $19.5 million for 2-3 IMPAc-TB Programs only cover the 12-18-month period?

Response 10: Yes. NIAID anticipates funding up to $19.5 million (total direct and indirect cost) for all awards combined for the initial, non-severable base work which is anticipated to last 12-18 months depending on the offerors technical approach and proposed milestones. Funding levels for additional non-severable work components beyond the initial non-severable base will be dependent upon the offeror’s proposed approach. The annual funding level for all awards combined is anticipated to be within the general funding level of the initial non-severable base. It is anticipated that negotiated additional non-severable work components will be included in the resultant contract award as options (up to a total period of performance of seven years) and will dependent upon factors such as availability of funds and contract performance.

Question 11: Does the listed funding amount extend beyond 12-18 months?

Response 11: Please refer to the responses to #1-5 above. NIAID estimates the total cost (direct and indirect costs combined) of this program will be $19.5M for the initial, non-severable base work, which is anticipated to last 12-18 months depending on an offeror’s technical approach and proposed milestones.

Question 12: Can an International Foundation be a coordinator to support a Leadership team?

Response 12: Yes, International participation is permitted.

Question 13: Are non-US partners eligible?

Response 13: Yes, Foreign entities are eligible to submit a proposal.

Question 14: Are there any quota for US/non-US partners?

Response 14: No, there is no quota for US/non-US partners.

Question 15: Is possible for a person to serve as Co-Investigator on more than one application?

Response 15: You may be proposed on more than one proposal as long as your total level of effort (inclusive of all activities) does not exceed 100%. In the event that both groups receive an award, you may not charge the government for the same services/work that you provide to each of the groups.

Question 16: Should the plan have yearly milestones or is the timing of milestones completely up to the offeror?

Response 16: Please refer to Technical Proposal Instructions section b.1.a.1 Objectives on Page 52.

“… Offerors shall also provide an Experimental Plan that provides detailed information on the specific product development activities that the Offeror is proposing to perform under contract funding. The Experimental Plan will include milestones and gates for Go/No Go decisions for advancing to the next stage of the Experimental Plan.”