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BARDA CSN Q&As - 2019 DRAFT RFPs - CTPE, SDCC, BSIP

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19-BARDA-DRAFT-CSN-(CTPE-SDCC-BSIP)Federal

Contract Overview

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The contract pertains to the Biomedical Advanced Research & Development Authority's (BARDA) 2019 draft Requests for Proposals (RFPs) for its Clinical Studies Network (CSN), focusing on three key areas: Clinical Trial Planning and Execution (CTPE), Statistical and Data Coordinating Center (SDCC), and Biological Specimen and Investigational Product Storage Facility (BSIP). The purpose of releasing these draft RFPs was to facilitate early information exchange between the government and industry stakeholders, helping to clarify acquisition strategies, proposal requirements, evaluation criteria, and to address any concerns prior to final issuance. Interested parties were given an opportunity to submit questions or comments, which were then compiled into a comprehensive question and answer document addressing 116 inquiries related to the draft solicitations. The notice also provides references to archived versions of the draft RFPs for transparency and review. The government acknowledged the contributions from industry participants and indicated the final RFPs would be released soon following this draft phase. Correspondence related to the acquisition process is to be directed to the designated Contracting Officer, Enrique Mañan. The contract falls under NAICS code 541714, emphasizing research and development in biological testing, supporting the overarching goal of advancing clinical study capabilities through a well-defined, collaborative procurement process.

General Info

BARDA draft RFPs for Clinical Studies Network focus on clinical trials, data, specimen storage.

Agency

N/A

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Documents will appear here when they are available.

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyN/A
Contacts1 person available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Enrique Ma��nContracting Officer
contact@example.gov

Full Description

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BARDA Clinical Studies Network 2019 DRAFT RFPs - CTPE, SDCC, BSIP Questions & Answers A. Background The United States Government encourages agencies to promote early exchanges of information about future acquisitions. An early exchange of information, among industry and the Government, can identify and resolve concerns regarding the acquisition strategy, the feasibility of the requirement, the suitability of the proposal instructions and evaluation criteria, the availability of reference documents, and any other industry concerns or questions. For this reason, the Biomedical Advanced Research & Development Authority's (BARDA) Division of Contracts Management & Acquisition (DCMA) released three (3) DRAFT RFPs to the public on March 5, 2019. Questions/comments on the drafts were due on March 12, 2019. B. Purpose of Notice The purpose of this Special Notice is to provide the public with a consolidated list of questions and answers, resulting from the following Clinical Studies Network DRAFT RFPs: * 19-BARDA-DRAFT-CSN-CTPE: Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE) * 19-BARDA-DRAFT-CSN-SDCC: Clinical Studies Network (CSN) Statistical and Data Coordinating Center (SDCC) * 19-BARDA-DRAFT-CSN-BSIP: Clinical Studies Network (CSN) Biological Specimen and Investigational Product (BSIP) Storage Facility C. Attachment The attached PDF document includes 116 questions and answers related to the Draft RFPs listed in part B of this Special Notice. D. Historical Information Below are the FBO.gov links to the archived DRAFT RFPs: CTPE Draft RFP (Archived): https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-BARDA-DRAFT-CSN-BSIP/listing.html SDCC Draft RFP (Archived): https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-BARDA-DRAFT-CSN-SDCC/listing.html BSIP Draft RFP (Archived): https://www.fbo.gov/spg/HHS/OOS/OASPHEP/19-BARDA-DRAFT-CSN-BSIP/listing.html Thank you to all interested parties who participated in this Draft RFP process. The Government expects to release the final RFP within the next few weeks. Any further comments regarding this process should be submitted only to the Contracting Officer listed in this notice.

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