RFQ 75D301-22-Q-74545 QA posted March 25 2022.docx

RFP 75D301-22-Q-74545

RFP 75D301-22-Q-74545

Questions and Answers

1. Q: As this proposal/program does not involve the development, acquisition or maintenance of electronic and information technology supplies or services, please clarify the applicability of HHSAR 352.239-74 Electronic and Information Technology Accessibility, or kindly remove as it is inapplicable.

A: The Section 508 accessibility requirements apply to all Information and Communication Technology (ICT) deliverables, such as electronic documents, which in this contract include the interim and final reports.

2. Q: We assume CDC100_0004 Data Management Plan (Instructions) (Nov 2018) applies to contracts involving human collections. As our portion of this effort will not involve human collections, we assume this paragraph would not be incorporated into the resultant contract. Please confirm.

A: The Data Management Plan is required for contracts that involve the collection or generation of public health data. “Public health data,” for the purpose of this provision, is defined in the clause at CDC100_0003 Public Access To CDC Funded Digital Public Health Data (Nov 2018) as digitally recorded factual material commonly accepted in the scientific community as a basis for public health findings, conclusions, and implementation. The data that will be generated by this contract meet the definition of public health data for the purposes of the Data Management Plan, and therefore a Data Management Plan will be required for this project. The Data Management Plan may be submitted with the business volume.

3. Q: The outline lists euthanasia dates after the second administration, but there are four administrations. Can CDC please clarify the correct number?

A: The draft study outline attached to the Statement of Work indicates that euthanasia is “2 days and 2 weeks after the fourth administration (to be confirmed),” not after the second administration.

4. Q: Please provide more detail as to what the immunogenicity work entails. The presumption is serum, please clarify what is correct.

A: Correct, CDC is asking for collection of serum samples at designated dates. CDC will perform assays and analysis.

5. Q: Requirement (j)(1) Experience – This states that the experience factor will be evaluated based on a vendor’s experience with the testing of vaccines for use in humans in animals, vaccine research and development, preclinical toxicology services, the preparation of documentation related to animal toxicology, and evidence of accreditation by the American Association for Accreditation of Laboratory Animal Care (AAALC), if applicable. Would the CDC please provide detail as to what is required for the preparation of documentation related to animal toxicology?

A: Paragraph (j)(1) is the evaluation criteria which we will use to evaluate a vendor’s experience. The experience evaluation factor will be evaluated based on the vendor’s experience with different facets of research similar to this project, including the preparation of documentation related to animal toxicology. Examples of experience preparing documentation related to animal toxicology could include but is not limited to development of study protocols, execution of studies, and preparation of reports in accordance with regulatory requirements.