HHS-NIH-NIAID-BAA2023-1 - Amendment Eight.pdf

HHS-NIH-NIAID-BAA2023-1

Page 1 of 4 Amendment Eight (8)

NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES (NIAID)

2023 DMID Omnibus Broad Agency Announcement (BAA):

No. HHS-NIH-NIAID-BAA2023-1

Solicitation Amendment Eight (8)

Issuing Office: OFFICE OF ACQUISITIONS

National Institute of Allergy and Infectious Diseases (NIAID)

5601 Fishers Lane, Room 3D38, MSC 9821

Bethesda, MD 20892-9821

Solicitation Number: HHS-NIH-NIAID-BAA2023-1

Date of Solicitation Issuance: January 11, 2023

Date of Amendment Eight Issuance: March 10, 2023

Number of Pages: Four (4)

Proposal Due Dates: The hour and date specified for receipt of offers for each

Research Area remains unchanged:

RESEARCH

AREA

TITLE PROPOSALS DUE*

Development of Vaccine Candidates for

Biodefense and Emerging Infectious

Diseases

April 11, 2023

Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant

(AMR) Infections and Emerging

Infectious Diseases

The Antiviral Program for Pandemics

(APP): Development of Antivirals for

Specific RNA Viral Families of

Pandemic Potential

March 13, 2023

Development of In Vitro Diagnostics for

Biodefense, Antimicrobial Resistant

Infections (AMR), and Emerging

Infectious Diseases

* Proposals must be received before 3:00 PM Eastern Time on the date specified herein.

Page 2 of 4 Amendment Eight (8)

Contracting Office Points of Contact:

Primary Contact:

Swee L. Teo, Contracting Officer

Email: teosl@niaid.nih.gov

Phone: 240-669-5173

Secondary Contact:

Ebony Taylor, Contract Specialist

Email: ebony.taylor@nih.gov

Phone: 240-292-0668

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment. Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

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

PURPOSE OF AMENDMENT EIGHT (8)

The purpose of Amendment Eight (8) is to:

I. Update the “Date Offers Due” in the SAM.Gov system for Research Areas 001, 002, and 004 to April

11, 2023, 3:00pm ET. Please note that the “Date Offers Due” for Research Area 003 remains unchanged at March 13, 2023, 3:00pm ET.

In eCPS, the 2023 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the four (4) Research Areas. Offerors shall ensure their proposal is submitted to the Research Area to which they are applying for in eCPS.

II. Provide the NIAID’s response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.

Please note, in the questions/responses below, specific organizational names have been removed or replaced where possible as well as other minor adjustments.

I. GOVERNMENT’S RESPONSES TO QUESTIONS RECEIVED REGARDING THIS

SOLICATION ARE AS FOLLOWS:

A. General Questions applicable to all Research Areas:

Question 1: Can you please confirm that the Human Subjects requirements, the

Vertebrate Animal Section, and References are included in the Technical Proposal page limits?

mailto:teosl@niaid.nih.gov mailto:ebony.taylor@nih.gov

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Response: If an offeror proposes animal study and/or clinical trials, the Vertebrate Animal

Section and/or Human Subjects requirements as well as references are included in the 75-page limitation for the Technical Proposal. Pages in excess of this 75-page limitation will be removed from the proposal. See section 4.3.2 of the BAA.

Question 2: We understand that the NIAID estimates up to $12.8 million for the award of 5-6 cost reimbursement type base contracts. Does NIAID cover 100% of the expenses related to the project or is there a % granted?

Response: In accordance with FAR 16.301-1, cost-reimbursement types of contracts provide for payment of allowable incurred costs, to the extent prescribed in the contract. These contracts establish an estimate of total cost for the purpose of obligating funds and establishing a ceiling that the contractor may not exceed (except at its own risk) without the approval of the contracting officer. At time of award, a contract will be fully funded for the Base period. At the discretion of the Government, an option(s) may be exercised and will be fully funded.

Cost sharing is permitted for proposals under this solicitation. See Section 4.3.3.1.22 of the BAA.

Question 3: The funding is announced for the year 2024, how will the funding for 2025 be managed? Is there an annual re-negotiation of the contract? Could the contract be interrupted?

Response: Funding for the Base period is not yearly. The total duration of the Base period should be consistent with the nature and complexity of the offeror’s proposed research and may vary depending on the scope of the project and technical objectives. An offeror’s initial proposal should contain the offeror’s best terms from a price and technical standpoint. See Section 4.1.3.4.

In your Business Proposal, you must provide a summary budget reflecting the total costs for the

Base period and each option over the period of performance using the “Breakdown of Proposed

Estimated Costs (plus fee) and Labor Hours” format. See Section 4.3.3 of the BAA.

Post-award, there is no annual re-negotiation of the contract. In proposing performance periods for the Base and each Option, an offeror should make a reasonable estimate of the time in months and resources that would be needed to complete the activities under the Base and each Option.

The total performance period comprised of the combined Base and all options proposed by an offeror should not exceed five (5) years. See Section 3.2 of the BAA. For additional clarification, please see response to Question 1.a under Research Area 002 of Amendment Three.

A contract may be terminated by the Government for convenience. See item 9, Section 3.4.4.1 of the BAA.

Question 4: Do you have an idea of the success rate for the research area 002?

Response: The Government cannot comment on the success rate for each Research Area. The merit of each Technical Proposal will be evaluated by a peer review group. Offerors must demonstrate in their proposal that they have the necessary expertise and capabilities for conducting the proposed research. The evaluation will be based on the demonstrated capabilities of the offerors in relation to the needs of the project as set forth in the BAA. Each proposal must demonstrate the feasibility of its approach and its relevance to the Research and Technical

Objectives of the BAA. The selection of proposals for award is based upon the evaluation factors, importance to agency programs, and funding availability. See Section 6 of the BAA.

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Question 5: Are there specific intellectual properties conditions?

Response: The awardee is solely responsible for the timely acquisition of all appropriate property rights, including intellectual property rights, and all materials needed for the awardee to perform the project. See Section 4.3.3.1.21 of the BAA.

A contract resulting from this BAA will incorporate general data rights and/or additional data rights for any data, including new discovery, developed under the contract. See Section 5.49

Contract Clauses for a Cost Reimbursement Research and Development Contract. Included in the list of clauses is FAR 52.227-14 Rights in Data – General (May 2014).

Question 6: The links to attachments 13, 14, and 15 in the Omnibus BAA appear to be broken. We have searched for them online with no success. Are you able to provide updated links?

Response: Here are the updated links for:

• Attachment 13 – HHS Section 508 Product Assessment Template:

https://www.section508.gov/sell/vpat/.

• Attachment 14 – PHS Human Subjects and Clinical Trials Information Form:

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/PHSHumanSubjectsAndClinicalTrialsInfo_3_0-V3.0.pdf

• Attachment 15 – Cumulative Inclusion Enrollment Report:

https://grants.nih.gov/grants/funding/phs398/CumulativeInclusionEnrollmentReport.pdf.

A word/pdf copy of each Attachment above is provided herewith.

B. RESEARCH AREA 002

Question 1: Would Research Area 002 of this Notice would be an appropriate option for development of therapeutic mAbs for COVID-19?

Response: Human Coronaviruses are listed in the NIAID Emerging Infectious Diseases list and monoclonal antibodies (mAB) are not excluded from Research Area 002; therefore, a mAB therapeutic approach to COVID-19 would be allowed, provided the proposal complies with all

Research Area 002 requirements.

C. RESEARCH AREA 004

Question 1: Regarding Research Area 0004, Protein Detection objective, can the proposed solution focus only on protein targets necessary for high confidence detection or does the proposed solution also need to focus on protein targets produced from antibiotic resistance genes for the same organism that is targeted for high confidence detection?

Response: The proposed development program for protein detection may focus solely on protein targets for high-confidence pathogen ID. Proposed program need not additionally focus on detection of resistance-gene products.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.section508.gov%2Fsell%2Fvpat%2F&data=05%7C01%7Cannie.gersch%40nih.gov%7C613a6996781441cc031708db20e1023c%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638139922998852116%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Zp8z5O2U6kc1QodEkrnkGdedD1o70%2BW9yZvZFxoRQJ8%3D&reserved=0 https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/PHSHumanSubjectsAndClinicalTrialsInfo_3_0-V3.0.pdf https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/PHSHumanSubjectsAndClinicalTrialsInfo_3_0-V3.0.pdf https://grants.nih.gov/grants/funding/phs398/CumulativeInclusionEnrollmentReport.pdf