Amendment 0001-signed.pdf

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AMENDMENT #0001

RFP- NIHAI75N93022R00008

“DIAGNOSTICS PRE-CLINICAL SERVICES PROGRAM”

Amendment Number: 0001

This Amendment provides a lists questions submitted by interested parties and the responses provided by the National Institute of Allergy and Infectious Diseases (NIAID).

AMENDMENT ONE (0001)

Issued by: National Institute of Allergy and Infectious Diseases (NIAID)

Office of Acquisitions, MSC 9821 5601 Fishers Lane Rockville, MD 20852

Solicitation Number: NIHAI75N93022R00008

Date of Solicitation Issuance: April 15, 2022

Date of Amendment No.0001 Issuance: June 17, 2022

Number of Pages: 2 pages

NIAID Point of Contact: PRIMARY:

Ignacio Reyes, Contracting Officer Email: ignacio.reyes@nih.gov Phone: 301-435-7574

SECONDARY:

Charles H. Jackson, Jr. Contracting Officer Email: Charles.Jackson@nih.gov Phone: 240-669-5175

Offerors must acknowledge receipt of the posting of Amendment #0001, on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

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

mailto:ignacio.reyes@nih.gov

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THE FOLLOWING PAGES PROVIDE ANSWERS CONCERNING A NUMBER OF INQUIRIES

WE HAVE RECEIVED FOR THE ABOVE NUMBERED SOLICITATION:

Question

No.

Question / Response

1 Question: Is the government willing to allow offerors to provide technical approach write ups in separate sections in ONE volume, in order to make the sections that relate to facilities, management and other corporate level/general requirements not have to be repeated?

Response: The submitter must submit separate proposals for each Task Area.

2 Question: For Task Area A, please clarify if the required SOW by the offeror may include actual device development work with the Device Developers such as verification and validation activities.

Response: The intent of Task Area A is to support product developers through design control processes and documentation, utilizing an appropriate quality management system and document control system. Device development support, including e.g., advising on assay performance improvement or system integration activities, is out of scope.

3 Question: For Task Area A, under the Sample Task Order A attachment, in the Technical Requirements Item #4, Clarify if the offeror is required to define provisions for achieving any regulatory objectives with the development reviews (e.g., the output of the SOW is an FDA premarket submission). Additionally, clarify if the SOW scope is just the development of regulatory compliance documents, and the Device Developer will separately coordinate with NIAID on any further regulatory developments/expectations.

Response: The offeror is not required to define provisions for achieving any regulatory objectives with the development reviews. Supporting development of regulatory compliance documents, such as pre-submission documents, is in scope for the SOW.

4 Question: The sample task order B technical requirements, page2, 1.B references “Validate QC analysis, certifications guaranteeing yield and specific activity, if defined.”

a. Is this a requirement for validation of assays or to confirm the data is accurately annotated, given the 9-month period of performance?

b. Guaranteed yields are typically part of a commercial contract, post process validation where the process has been defined such that a CDMO is on contract for price/mass of released product delivery. Are guaranteed yields a requirement?

Response:

a. The purpose of this requirement is to ensure that the product developer is receiving what is claimed to be delivered. If the material is a protein reagent that has a specific activity, then that activity must be confirmed for the product developer.

b. The intent of this requirement is not to guarantee yields ahead of production, but rather to certify that the yield claimed to the product developer is confirmed through a validated analysis.

5 Question: The BASE SOW for Task Area B (Page 9, Technical Requirements, #5, #6 and #7) references cGMP compliant synthesis and manufacturing. The sample task order for Task Area B indicates offerors shall adhere to the BASE SOW requirements and to sample task order requirements. The product seems to be in a pre-GMP process development stage. Given the 9-month period of performance, please confirm that cGMP is not expected for this sample task order.

Response: A cGMP product is not required for Sample Task Order B if the product developer is in early stage development. A specific Task Order for cGMP material might

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6 Question: For sample task order B, regarding a recombinant protein, will there be a material transfer of cloned DNA in a desired expression system, or just the DNA sequence where the expression system would need to be determined?

Response: The product developer transfers cloned DNA to the contractor. The contractor subclones into whichever expression vector it prefers for overexpression.

7 Question: For sample task order B, if the cell line/expression system exists, what is it and has adventitious agent testing been performed?

Response: No specific cell line or expression system exists a priori for Sample Task Order B. However, the sample Task Orders are reviewed and evaluated based on Offerors proposed capabilities.

8 Question: For sample task order B, will reference materials be provided to support assay development and transfer?

Response: The Offeror shall provide the product developer with the material (recombinant protein or antibody) as part of Task Order B to support product developer’s assay development.

9 Question: For sample task order B, regarding a monoclonal antibody, will there be a material transfer of an immunogen in sufficient quantity to begin the immunization of animals for monoclonal antibody screening, or would the production of the immunogen be required based on the transfer of information and methods?

Response: The Offeror may receive immunogen from the product developer or from another source.

10 Question: For sample task order B, is a proposal being requested to target both a recombinant protein and a monoclonal antibody, or should only one target be selected for the purpose of the proposal?

Response: Offerors may choose to describe their capabilities at either or both recombinant protein expression, purification, and characterization, as well as monoclonal antibody production. Note: Offerors are not required to show capabilities for both.

11 Question: For [Task Area C: Nucleic Acids and Oligonucleotides] the DNA and RNA, we would like to know the fragment length and quantity and any required modifications.

Response: Contractors receiving a Task Area C award shall provide the product developer with DNA or RNA in the length required for the product developer to develop its assay.

The actual task order solicitation shall determine the requirements for product specifications.

12 Question: For the protein and antibody, we would like to know the quantity per batch and total quantity per year that NIAID would want supplied.

Response: Offerors propose how large a yield they can produce per batch and per year when they submit their proposals. The task order solicitation will identify the minimal yield and yield per year.

13 Question: Page limit for technical volume and whether CVs were included in the page count or not were blank in the solicitation – (Attachment for Packaging and Delivery of Proposals, Section II.B.1 and II.B.3) Response: On page 78, under Section 3: Technical plan/approach for each Task Area (20 page limit). Reference page 84 of 104 in the solicitation under “Section 4: Scientific and Technical Personnel”. This section reads, “Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the Task Order.” The CV’s are included in the 20 page limit.

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14 Question: Please confirm that reporting requirements are electronic through eRDS only and not paper copies (pg 5 and section L.1.c.1 pg 57) Response: Reporting requirements are to be submitted ONLY through eRDS.

15 Question: Is there missing information on page 76, for example the bullet points for the Enhancing Reproducibility through Rigor and Transparency, the section for Sharing Research Data, the section Obtaining and Disseminating Biomedical Research Resources, and what section should we add the Dual Use Research of Concern in?

Response:

Add the following information to page 76 of 104.

Compliance Factors

Describe the scientific premise for the Technical Proposal. The scientific premise is the research that is used to form the basis for the proposed research. Offerors should describe the general strengths and weaknesses of the prior research being cited by the offeror as crucial to support the proposal. It is expected that this consideration of general strengths and weaknesses could include attention to the rigor of the previous experimental designs, as well as the incorporation of relevant biological variables and authentication of key resources.

Describe the experimental design and methods proposed and how they will achieve robust and unbiased results.

Explain how relevant biological variables, including sex, [if deemed necessary by the IC, additional variables may be included here] are factored into research designs and analyses for studies in vertebrate animals and humans. For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for proposals proposing to study only one sex. If your proposal involves human subjects, the sections on the Inclusion of Women and Minorities and Inclusion of Children can be used to expand your discussion and justify the proposed proportions of individuals (such as males and females) in the sample. Refer to NOT-OD-15-102 for further consideration of NIH expectations about sex as a biological variable.

If applicable to the proposed science, briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposal. Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics.

Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals. If the Technical Proposal does not propose the use of key biological and/or chemical resources, a plan for authentication is not required, and the offeror should so state in its proposal.

16 Question: Can a company be a prime for some Task Areas and a [subcontractor] to another prime for an area they are not bidding as prime?

Response: A company can be a prime on a proposal for a specific Task Area and subcontractor to a prime on a proposal submitted for a different Task Area.

17 Question: Can the requirement for travel policies be removed as all of the sample task orders list travel as “None” (see pages 98, 100-101)?

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Response: Travel to NIAID’s facility for contract kickoff will be a part of the guaranteed minimum cost for each task area.

18 Question: The Sample Task Order for Task Area E does not indicate any work to be performed but lists monthly reports and meetings as deliverables. Does the Government only want the description of experience etc. without pricing? If the Government wants pricing, please provide a description of the work to be performed and priced.

Response: Under Technical Requirements, the offeror is to furnish all the necessary services, personnel, materials, equipment, and facilities, which includes a cost proposal for evaluation, to achieve delivery of the assay services listed: next-gen sequencing, proposed immunoassays, nucleic acid amplification services (e.g., PCR, qPCR, RT-PCR, etc.).

19 Question: The targets for small business participation on pages 85 and 90 do not match.

Please advise as to which small business targets are to be utilized.

Response: All large businesses submitting proposals are required to provide a subcontracting plan. On page 85 identifies the minimum targeted goals for small business categories.

Page 90, because of the nature of this procurement method (IDIQ), funding is provided via task orders based on competition. Therefore, the language identified on page 90 can be removed.

20 Question: For the general task order requirements within the Base Contract Statement of Work, should each of the requirements be its own section within the overall technical volume, or does the Government expect each section (i.e., Program Management, Quality Management and Quality Assurance, Storage and Shipping, Transition) be included in each task area to which the Offeror will respond?

Response: A separate proposal is required for each Task Area the offeror(s) submit a proposal.

21 Question: Can the assumption be made that a IVD product development plan should target clinical trials as end point?

Response: It is not required that a product developer’s IVD product development plan target clinical trials as an end point. The product developer provides the starting content of its product development plan. The contractor and the product developer determine the appropriate content of the product development plan as it relates to ensuring compliance with a quality management system and design control procedures.

22 Question: As regulatory documentation is not within scope of this Task Area, what kind of regulatory guidance will be required? E.g., General regulatory pathway/ requirements for the IVD in question?

Response: The contractor shall have the capabilities to assist the product developer on what regulatory content needs to be included in the product development plan. Note: The product developer must comply with FDA guidance on regulatory requirements for submission of an IVD.

23 Question: What level of quality oversight will be required for Task Area A?

Response: The contractor shall assist the PD to develop an acceptable quality management system with quality plan, quality statement, quality documentation, etc.

24 Question: Should the contractor assume that projects under Task Area A encompass full product development, or only aspects thereof e.g., reagent production, or a regulatory roadmap?

Response: The contractor shall assume that the breadth of needs for product development processes under Task Area A depends on the needs of the product developer seeking assistance via the IDIQ.

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25 Question: Should the contractor assume that the scope of Task Area A includes the organization of educational training workshops on IVD development topics, for example regulatory requirements, quality oversight, etc.?

Response: A candidate contractor should assume that the scope of Task Area A could include, for example, training workshops on IVD product development including, but not limited to, regulatory requirements, quality oversight, etc.

26 Question: Could DMID/NIAID provide more detail on the scope of the Sample Task Order for Task Area A. In particular, what services are requested, that will enable us to provide a more tailored and relevant proposal.

Response: Contractors shall have a broad understanding of the stages of IVD product development, processes and documentation necessary to navigate these stages as well as provide expertise to product developers.

27 Question: Can more details on the IVD be provided for which a product development plan is requested e.g., Immuno-based assay, PCR-based etc.?

Response: When Task Area A, Task Order, solicitations are issued, the details/requirements on the IVD under development will be provided. Offerors that have capabilities to accelerate the product development program, of a product developer, need to promote these capabilities for providing this expertise in their proposals.

28 Question: Could you provide an assumption regarding the stage of development for which the IVD is, for which the product development plan is intended for?

Response: When Task Area A, Task Order, solicitations are issued, the details/requirements of the product developer’s needs based on its stage of development will be provided.

29 Question: Could DMID/NIAID provide more detail on the scale of the expected production of the Sample Task Order for Task Area B?

Response: When Task Order B solicitation(s) are issued, details of the requirements including scale needs for the requested material, shall be provided.

30 Question: What are the quantities of recombinant proteins or monoclonal antibodies this Task Order are looking for?

Response: Sample Task Orders are provided in this solicitation for evaluation purposes to determine technical capabilities and cost reasonableness. Task Order solicitations shall list requirements for quantities of desired product, based on the inquiring of the requirement needs. Offerors responding to any of the sample Task Order solicitation need to describe their capabilities for producing such materials.

31 Question: Could DMID/NIAID provide more detail on the extent of the expected product testing of the Sample Task Order for Task Area B?

Response: Sample Task Orders are provided in this solicitation for evaluation purposes to determine technical capabilities and cost reasonableness. Task Order solicitations will list the requirements for product testing, based on the inquiring of the requirement needs.

Offerors responding to this sample Task Order solicitation need to describe their capabilities for performing these types of services, including product testing.

32 Question: What level of quality oversight is expected for Sample Task Order Task Area B?

Response: Sample Task Orders are provided in this solicitation for evaluation purposes to determine technical capabilities and cost reasonableness. Task Order solicitations will list the requirements for quality oversight based on the inquiring Governments’ needs.

Offerors responding to this sample Task Order solicitation needs are describing their capabilities for advising of the requirement on quality oversight as part of FDA-compliant IVD product development processes.

33 Question: In “Characterization and certification of activity and/or structure of recombinant protein” what do they mean by “certification”?

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Response: “Certification” means confirmation through established, validated means that the product to be delivered is exactly what it is claimed to be in its content, performance, amount, stability, etc.