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This document contains an amendment to a request for proposals from the National Institute of Allergy and Infectious Diseases for a Clinical Site Monitoring Center. The amendment extends the proposal due date to May 24, 2021 and allows Section 508 PATs to be exempt from the 150-page limit for technical proposals. The RFP seeks a contractor to provide comprehensive clinical site and study monitoring services for NIAID-sponsored clinical research, including clinical trials, for both domestic and international sites. The selected contractor will be responsible for maintaining a clinical site monitoring system; developing training programs; managing a centralized data management and reporting system; coordinating with other NIAID contractors and grantees; engaging in risk-based monitoring innovation; implementing a quality assurance plan; and providing qualified clinical, scientific, and technical personnel as well as necessary facilities and equipment.

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Amendment 4 to RFP Final.pdf PDF
Amendment 3 to RFP Final.pdf PDF
Amendment 1 to RFP Final.pdf PDF
RFP 75N93020R00021 Final 2_23.pdf PDF

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Amendment # 2 to RFP-NIH-NIAID-DAIT-75N93020R00021

Amendment to Solicitation No.:

RFP-NIH-NIAID-DAIT-75N93020R00021

Amendment No. 2

Issue Date: April 23, 2021

Effective Date:

Proposal Due Date:

April 23, 2021

May 24, 2021 3:00 pm (Unchanged)

Issued By: Deborah Blyveis Contracting Officer

NIH/NIAID/DEA

Office of Acquisitions 5601 Fishers Lane Room 3B6* MSC 9821 Rockville, MD 20852

Point of Contact: Deborah Blyveis, Contracting Officer blyveisd@niaid.nih.gov

Name and Address of Offeror: To All Potential Offerors

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment(s). Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

The deadline for submitting questions is April 26, 2021.

SECTION 1- QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to all previous amendments for additional questions and clarification.

1. We ask the Government to reconsider exempting the required Section 508 PATs from the page limits (per the response in RFP Amendment 1 dated April 7, 2021, Question 8). Offerors will need to provide multiple Section 508 PATs for systems proposed to support the scope of work. By virtue of format and length of these technical reports, it would be prohibitive to include all of these and still have adequate space for fully responsive technical proposal narrative and supporting appendices within the allotted 150-page limit.

Answer: The Government will allow the Section 508 PAT’s to be exempt from the page count. Please include them as a technical appendix in the technical proposal.

Amendment # 2 to RFP-NIH-NIAID-DAIT-75N93020R00021

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