Amendment 0001-signed.pdf

RFP- NIHAI75N93023R00003 Page 1 of 4

AMENDMENT #0001

RFP- NIHAI75N93023R00003

“PRE-CLINICAL MODELS OF INFECTIOUS DISEASES”

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: NIHAI75N93023R00003

Date of Solicitation Issuance: February 15, 2023

Date of Amendment No.0001 Issuance: March 10, 2023

Number of Pages: 4 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, Team Lead 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 AND STATEMENTS CONCERNING A

NUMBER OF INQUIRIES WE HAVE RECEIVED FOR THE ABOVE CITED SOLICITATION:

INCLUSION OF SECTION H.

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH

PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated August 25, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.5. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990- 0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self-designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310).

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

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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. If an Offeror chooses to respond to more than one Task Area, proposals responding to each task area must be complete in and of themselves. Each proposal will be reviewed on its own merit by a Technical Evaluation Panel in accordance with the Technical Evaluation Factors found in Section M, on page 105 of the solicitation.

2 Question: Would it be considered responsive if for each animal replacement model, we provided a sample task order for each model and one research question? We could then provide for each model a listing of the research questions that are suitable for each model.

Response: The Technical Proposal Instructions, found in Attachment 5 of the solicitation, indicates that proposals should include: a Technical Overview section of no more than 20 pages to describe the qualifications of the Offeror, the models that the Offeror can provide, proposed personnel, and proposed facilities. Attachment 5 also provides general instructions on how to address the requirements of the Sample Task Order(s). The purpose of the Sample Task Order(s) is to demonstrate the proposed approach the Offeror would take in conducting the study that is outlined in the Sample Task Order statement of work.

3 Question: The RFP did not list the gamma-herpesviruses, but did list the other 6 human herpesviruses?

Response: The list of areas of emphasis reflects the models for which NIAID has received product evaluation requests as well as several groups of pathogens/agents that are noted priorities at NIAID. As this list is not exhaustive, Gamma-herpesvirus models would be within scope.

4 Question: Can we apply our co-infection model to test potential compounds targeting either or both pathogens [identified in the solicitation] under your contract.

Response: Yes, combination infection models are within scope. For the purposes of the sample task order, the offerors are to develop or refine one animal model for one pathogenic agent to test one candidate countermeasure.

5 Question: Are foreign entities eligible to apply for this opportunity Response: Yes, as long as you comply with the FAR Part 25 - Foreign Acquisition (Subparts 25.3- Contracts Performed Outside the United States, 25.4- Trade Agreements, 25.7- Prohibited Sources, 25.8- Other International Agreements and Coordination, 25.10- Additional Foreign Acquisition Regulations, 25.11- Solicitation Provisions and Contract Clauses).

6 Question: Our company was acquired by a foreign based company. Are we eligible to apply for the RFP?

Response: See response to question 5.

7 Question: What is the amount of details to be provided for each Task Area/ Cost?

Response: Sample Task Orders are provided in this solicitation for evaluation purposes

RFP- NIHAI75N93023R00003 Page 4 of 4 to determine technical capabilities and cost reasonableness applied to a specific set of study requirements. Offerors need to describe their approach and capabilities, relevant to any of the Sample Task Order(s) proposed, in sufficient detail to demonstrate an understanding of and complying with the Sample Task Order requirements.

8 Question: What is the page limitation for the Technical proposal and Curriculum Vitae?

Response: The technical proposal limit is 100 pages. The CV limit is 3 pages per individual.

9 Question: Please confirm that reporting requirements are electronic through eRDS only and not paper copies Response: Reporting requirements are to be submitted ONLY through eRDS and/or via secure emails as instructed in the task order solicitation(s).

10 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: The purpose of the overall PCMID program is to provide the capacity and capability needed to develop, refine and use animal and animal replacement models to assess candidate therapeutics, vaccines and diagnostics targeted at infectious diseases and to generate difficult-to-source reagents requiring an in vivo model.

The purpose of sample Task Orders A-C is to demonstrate the Offeror’s approach to establishment or refinement of an animal or animal replacement model, as well as the evaluation of a test article in a proof-of-concept experiment to test the validity of the model.

Statement:

This is an IDIQ contract, as described in FAR 16.504, where the Offerors received a base Task Area award and are given the chance to compete for task order requirements. The contractors receiving a base awards, under this solicitation, will obtain a guaranteed minimum funding amount with a maximum funding amount cite for the task area/contract identified. Offerors need to respond to the sample task order appropriate to their companies’ abilities. Once the proposals are received, NIAID conducts a scientific review by Task Area to determine if submitted proposals are deemed technically acceptable or not.