BAA 21R00019_ AMENDMENT 2.pdf

Amendment No. 2 to NIH-BAA-75N93021R00019

Amendment to Solicitation No.:

NIH-BAA-75N93021R00019

Amendment No. 2

Issue Date: March 04, 2022

Effective Date:

Proposal Due Date:

March 04, 2022

April 15, 2022 at 3:00 pm ET (UNCHANGED)

Issued By:

Liem T. Nguyen

Contracting Officer

NIH/NIAID

Office of Acquisitions

5601 Fishers Lane

Room 3C11 MSC 9821

Rockville, MD 20852

Point of Contact: Anuj Patel, Contract Specialist

Anuj.patel@nih.gov

Name and Address of Offeror: To All Potential Offerors

The cut-off date for questions for this solicitation is set at 3:00 pm ET 04/01/2022.

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

PURPOSE OF SOLICITATION AMENDMENT

The purpose of this amendment is to provide additional answers to questions received regarding the solicitation.

The answers 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 answers. All potential offerors are advised to refer to all previous amendments for additional questions and clarification.

The Government’s answers to questions received regarding this solicitation are as follows:

Question 1: Is there a page limit for the business proposal?

Answer 1: Please refer to Attachment 1, Section II- Formatting and Page Limitations, page 79/108, of the solicitation for details.

Question 2: Should the business proposal be organized using as shown in attachment 8? If so, for the elements of the business plan not described here, do these falls under Section V: Documentation required under section L?

Is there a desired order to these documents?

Answer 2: Please refer to the Attachment 8 and follow the Instructions provided within to prepare your proposal. As indicated in Section 5 of the Attachment, refer to Section L of the BAA for documentation requirements.

Question 3: Is there a limit on the number of subcontractors that can be included in the proposal?

Answer 3: There is no limit on the number of subcontractors that can be included in the proposal.

Question 4: Is there any distinction between consultants and subcontractors?

Answer 4: Service provided by an independent individual and charged by the hour performed is considered a consulting service. Service provided by a person or group of persons and conducted at another institution or business entity and has a budget for salary/fringes, materials & supplies, etc. is considered a subcontracting service.

Question 5: It appears that facilities and resources are included in both the technical (Section 7) and business proposals (Qualifications of the Offeror) – is this correct? Are the business and technical plans reviewed independently?

Answer 5: Yes, they are included in both technical and business. Technical proposal and Business proposal are reviewed independently.

Question 6: Is it true that there is no cap of direct cost for this funding opportunity?

Answer 6: Please refer to page 80 of the Solicitation, last paragraph of Attachment 3 – Broad Agency

Announcement, for funding information.

Question 7: Could it be maximum $4 million for 2 years ($2 million for each year) plus maximum 1 year no cost extension or $6 million for 3 years?

Answer 7: Please refer to page 80 of the Solicitation, last paragraph of Attachment 3 – Broad Agency

Announcement, for funding information.

Question 8: Please confirm if a public and state-controlled institution of higher education is eligible to submit a proposal under this RFA.

Answer 8: This solicitation is open to any type of organizations: commercial, non-profit, educational, or hospital.

Question 9: Should I prepare a Quad chart and abstract to facilitate our dialog?

Answer 9: Please refer to Attachment 5, pages 86-89 of the Solicitation for details regarding

Inclusion/Exclusion criterion, as well as instructions included in Attachment 7 for details regarding to the Technology Readiness Level (TRL) required for the subject solicitation.

Question 10: We selected to include in our study design: 1) sex (male/females) and 2) underlying diseases

(established interstitial lung disease model at the time of exposure). Are these 2 factors adequate to be considered responsive to the BAA?

Answer 10: Offerors need not include all confounding factors listed.

Question 11: On p. 85, the BAA states, “sample-to-answer time of 30 min or less,” while on p. 86, it states, “Assay time can range from 0.5 to several hours, depending on the intended use of the assay.” What is the detection time limit?

Answer 11: Offerors should describe the intended use of the biodosimetry signature/device. Based on that intended use, the sample to answer time frames are described on pages 85 and 86 respectively.

Question 12: We would like to propose GI-ARS primate studies on our radiation mitigator after our GLP tox studies. Is this allowable?

Answer 12: Offerors may propose any research activities that are aligned with advancing an MCM along the regulatory pathway; however, without completing proof of concept studies demonstrating radiation efficacy (survival benefit) of an MCM in the animal model of choice, it may be premature to propose GLP studies For more information, please read attachment 5- Research and Technical objectives (pg. 83 89).