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This amendment modifies a request for proposal issued by the National Institute of Child Health and Human Development on behalf of the National Institute on Alcohol Abuse and Alcoholism. The solicitation seeks proposals for multiple clinical research sites to conduct Phase I and Phase II alcohol use disorder medication trials over seven years. Key details include:

  • Proposals are due July 28, 2020. The amendment provides a corrected link for the cost summary attachment but does not change the response date.

  • Awards are anticipated to be made on or around December 18, 2020 to approximately ten clinical research sites through indefinite delivery/indefinite quantity contracts with a seven year ordering period. Task orders issued against the contracts may include options but the parent contracts do not.

  • Each site will enroll an average of 35 to 40 subjects per trial over 1.5 to 2 year periods to support testing one compound every 1.5 to 2 years. Previous clinical sites for this network included major academic medical centers.

  • The network is coordinated by Fast Track Drugs and Biologics, LLC under a separate contract awarded in 2019 to serve as the clinical research organization and coordinating center through January 2031. This solicitation separates those coordination functions from the direct clinical research at multiple sites.

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Amendment 1 to RFP NIH-NICHD-NIAAA-2020-04, “Clinical Research Sites for the NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder”

AMENDMENT 1

Request for Proposal (RFP) NIH-NICHD-NIAAA-2020-04 entitled, “Clinical Research Sites for the NIAAA Medications Development Clinical Investigations Network for the Treatment of Alcohol Use Disorder”

Amendment Number: One (1)

Amendment Issue Date: June 8, 2020

Proposal Due Date: July 28, 2020 (unchanged)

Issued By: Jason Williams Contracting Officer

DHHS, NIH, NICHD

Office of Acquisitions

NIAAA CMB

Point of Contact: Jason Williams Contact Email: jason.williams2@nih.gov

THIS AMENDMENT IS ISSUED TO ALL POTENTIAL OFFERORS:

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals has NOT been extended. Offerors must acknowledge receipt of this amendment by identifying this amendment number and date on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer.

Except as provided herein, all terms and conditions of the RFP remain unchanged and in full force and effect.

PURPOSE OF AMENDMENT:

To provide the correct link for Attachment No. 8, entitled “Technical Proposal Cost Summary”, found in Section J, “List of Attachments”, on page 79.

The correct link is as follows:

ATTACHMENT 8: Technical Proposal Cost Summary http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost- Summ.pdf mailto:jason.williams2@nih.gov http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

File details come from the government source that posted it. Updated .