Q_and_A_-_Research_Area_004_-_IMM-HIS.pdf

Amendment of Solicitation HHS-NIH-NIAID-BAA2019-1

Research Area 004: Characterizing and Improving Humanized Immune System Mouse Models

(IMM-HIS)

AMENDMENT FOUR (4)

OFFICE OF ACQUISITONS: National Institute of Allergy and Infectious Diseases (NIAID) 5601 Fishers Lane, Suite 300, Rockville, MD 20852

Date of Solicitation Issuance: 02/22/2019 Date of Amendment No.1 Issuance: 05/01/2019 Date of Amendment No.2 Issuance: 05/09/2019 Date of Amendment No.3 Issuance: 05/23/2019

Date of Amendment No.4 Issuance: 08/02/2019 Number of Pages: 3

Point of Contact: Division of Allergy, Immunology, and Transplantation (DAIT)

Research Area 004: Characterizing and Improving Humanized Immune System Mouse Models

(IMM-HIS)

Liem Nguyen, Contracting Officer Phone: (240) 669-5144; E-mail: liem.nguyen@nih.gov

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 AMENDMENT 4:

The purpose of this amendment is to provide responses to questions received regarding Research Area 004: Characterizing and Improving Humanized Immune System Mouse Models (IMM-HIS).

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

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

Division of Allergy, Immunology, and Transplantation (DAIT) Research Area 004:

Characterizing and Improving Humanized Immune System Mouse Models (IMM-HIS)

Question 1:

The BAA states it is required to carry out:

A. Direct immunologic comparisons of HIS mice derived from fetal and non-fetal sources of human cells/tissues, including:

a. HIS platform(s) selection and model characterization;

b. Evaluation of primary and secondary lymphoid tissue development, architecture, and function;

and

c. Systemic and tissue-specific innate and adaptive immune cell development and function.

The question is: Do we compare our new method directly with human fetal tissues as required by the contract, Or

Do we not include a human fetal tissue experiments as required by the Administration?

Response:

The June 5, 2019 Department of Health and Human Services (DHHS) Statement does not prohibit the use of human fetal tissue; but states that an ethics advisory board will be convened to assess applications that propose the use of human fetal tissue. Therefore, the original requirements of the BAA remain the same.

Question 2:

Would studies that propose the use and/or development of genetically-engineered fetal tissues derived from non-human animal models, adult-derived human stem cells, or human cord blood be considered responsive to this call for applications?

Response:

Yes, studies that include any or all these tissue sources are responsive.

Question 3:

Is having multiple PIs allowed?

Response:

Offeror proposing multiple PIs is required to submit a Leadership Plan as part of the Technical Proposal. The plan shall describe the governance and organizational structure of the research project including communication plans, process for making decisions on scientific direction, etc.

Question 4:

On page 5 of the Amendment 3, there is a NOTE that says “This contract will not provide funds to support…utilization/optimization of human fetal tissue for regenerative medicine or engraftment of cells/tissues that are not part of or required for optimal development/function of the human immune system.” Is creation of iPSCs allowable for use in functional transplant immunology studies?

Stem and progenitor cells may be used to create immune organs, tissues or cells. They also may be used to evaluate successful immune reconstitution, thymic or systemic immune function, or to optimize human immune responses in HIS mice. However, studies will not be supported that use engineered tissues (e.g. skin, bladder, cardiac, bone and connective tissue, etc) to repair, improve, or restore a non‐immune organ’s function.

Question 5:

If there are co-PIs at separate institutions, are there any considerations regarding submission of the application, i.e. which institution should submit the application?

The Institute considered as Prime Contractor will submit the contract proposal.