Amend 3 .pdf

Amendment 3

RFP 75N93020R00011

NIAID Clinical Data and Safety Management Center (CDSMC)

1. Please clarify the period of performance. RFP p. 16 states that the base period begins 9/30/2020 and last option period ends 9/29/2025. RFP p. 50 indicates that an award will be made around 9/30/20121 [sic]. Is the actual period of performance for the Base plus 4 Options 9/30/2021–9/29/2026?

Answer:

ARTICLE F.1. PERIOD OF PERFORMANCE is modified to read:

1. The period of performance of this contract shall be from September 30, 2021 through September 29, 2022.

2. If the Government exercises its options pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Period of Performance

Option 1, Year 2 09/30/2022 - 09/29/2023 Option 2, Year 3 09/30/2023 - 09/29/2024 Option 3, Year 4 09/30/2024 - 09/29/2025 Option 4, Year 5 09/30/2025 - 09/29/2026

2. Please confirm that all the required attachments per p. 43 Section J are exempt from the

150-page limit, as noted below. In particular, the Section 508 PATs are long reports, and we’ll need to provide multiple PATs on electronic systems in support of the CDSMC.

• Attachment 8: Planned Enrollment Report, PHS-398/2590 (Rev. 08/12)

• Attachment 9: Technical Proposal Cost Summary

• Attachment 10: Summary of Related Activities

• Attachment 11: Protection of Human Subject Assurance Identification/IRB

Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310)

• Attachment 12: HHS Section 508 Product Assessment Template

Answer: Attachment 1, Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website of the RFP states that the “[t]otal page count [of the Technical Proposal] does not include: Title and Back Page; Table of Contents; and Section Dividers that do not contain information other than title of Section.

CVs shall not exceed 3 pages. Attachments 9-11 are included in the page limitations.

Attachments 8 and 12 are removed and offerors are no longer required to submit.

3. Given that the CDSMC supports a portfolio of studies, the IRB approval for individual studies is outside of the scope of the CDSMC. What is the government’s expectation for the CDSMC obtaining IRB approval?

Answer: The Government would expect an IRB review of any events and subsequent corrective actions that are related to the mishandling of data that compromises the study integrity or study participant’s rights. An example of mishandling of data would be a security breach exposing PII, PHI, or other confidential study data to the public domain.

4. We request that you reevaluate the designation in Section M.3 (RFP p. 90) that this research involves human subjects as well as the applicability of the associated human subjects proposal requirement in Section L.2.b.4 Human Subjects (RFP p. 68). This request is based both on the CDSMC Attachment 3 Statement of Work and the fact that CDSMC supports an entire portfolio of studies and many of the requirements for the Human Subjects plan can only be addressed in the context of a specific study. Please consider the following:

• Risks to subjects are minimized: The CDSMC does not design the studies and will have no role in subject care nor in the administration of the studies at a subject level.

• Risks to subjects are reasonable in relation to anticipated benefits: The CDSMC will not make risk determination to subjects at a study level. That responsibility lies with the investigators, site IRBs, and NIAID.

• Selection of subjects is equitable: The sites are wholly responsible for subject selection and recruitment, and the CDSMC will have no contact with study subjects.

• Informed consent will be obtained and documented by methods that are adequate and appropriate: The CDSMC will provide tools to the sites for use in obtaining and documenting informed consent but will not have direct subject contact and will not conduct the activity of obtaining informed consent.

Answer: Offerors are only required to respond to the instructions provided in Section L.2.b.4 Human Subjects (RFP p. 68) to the extent applicable to the CDSMC Attachment 3 Statement of Work. Offerors will need to have access to an IRB for instances identified in response to the question within bullet #1.

5. If you choose not to change the designation that this research involves human subjects (as noted in the previous question), we request clarification that the Offeror is only required to respond to the instructions provided in Section L.2.b.4 Human Subjects (RFP p. 68) to the extent applicable to the CDSMC Attachment 3 Statement of Work.

Answer: Offerors are only required to respond to the instructions provided in Section L.2.b.4 Human Subjects (RFP p. 68) to the extent applicable to the CDSMC Attachment 3 Statement of Work. Offerors will need to have access to an IRB for instances identified in response to the question within bullet #1.

6. Regardless of the designation, we request that the Attachment 8, Planned Enrollment Report, be removed as a required attachment for the CDSMC response. No Offeror can accurately complete this table, as the CDSMC does not design the studies nor control the enrollment. Further, the table is designed to describe an individual study, and the CDSMC will support an entire portfolio of studies.

Answer: Attachment 8, Planned Enrollment Report is removed.

7. The link for Attachment 12, HHS Section 508 Product Assessment Template does not work.

Answer: Attachment 12 has been removed.

ATTACHMENTS SECTION J - LIST OF ATTACHMENTS

Changes to Section J attachments are shown below:

TECHNICAL PROPOSAL ATTACHMENTS

Attachment No. Title Location Attachment 8 Planned Enrollment

Report, PHS398/2590 (Rev. 08/12)

This attachment is no longer required and is removed.

Attachment 12 HHS Section 508 Accessibility

This attachment is not longer required and is removed.

INFORMATIONAL ATTACHMENTS

Attachment No. Title Location Attachment 18 Privacy Act System of Records https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html

Attachment 19 Safety and Health, HHSAR Clause 352.223-70 https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files

Attachment 20 Research Patient Care Costs, NIH(RC)-11

Attachment 21 PHS HUMAN

SUBJECTS AND

CLINICAL TRIALS

INFORMATION

FORM

Attachment 22 Cumulative Inclusion Enrollment Report

Included as an Attachment to this Amendment.

Attachment 25 Employee Separation Checklist

Included as an Attachment to this Amendment.

https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files