Amendment_1_to_RFP_NIH-NICHD-2019-01.pdf

Amendment 1 to RFP NIH-NICHD-2019-01, “Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder – Contract Research Organization”

AMENDMENT 1

Request for Proposal (RFP) NIH-NICHD-2019-01 entitled, “Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder – Contract Research Organization”

Amendment Number: One (1)

Amendment Issue Date: December 6, 2018

Proposal Intent Response Sheet Due Date: December 3, 2018

Proposal Due Date: December 17, 2018 (unchanged)

Issued By: Daniel Federline

DHHS, NIH, NICHD

Office of Acquisitions

NIAAA CMB

Point of Contact: Daniel Federline Contact Email: daniel.federline@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:

1. To provide answers to the RFP questions submitted by November 26, 2018. Specifically, the answers are below:

General & Technical Questions

1. In the Solicitation, on page 86, Section 1, paragraph 2, the last sentence states the following: “The system must be capable of handling rapidly and efficiently the volume of data likely to be generated by the attached generic protocol.” Can you point out where the attached generic protocol resides in the solicitation or provide the generic protocol?

ANSWER:

There could be up to 400 subjects in other studies, but for Task Order 1, there will be 27 subjects per site, with 4 sites anticipated. You can also make the following assumptions:

mailto:hanacekp@mail.nih.gov

Amendment 1 to RFP NIH-NICHD-2019-01, “Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder – Contract Research Organization”

A. 27 subjects per clinical site – 4 clinical sites B. Five (5) week study- weekly in clinic visits C. 3-arm treatment study, 2 doses of active and 1 placebo group D. Placebo and active drug provided by Pharmaceutical Company E. Begin recruitment in March 2019

2. Attachment 3a, Task Order 1 describes the SOW for the Alcohol Cue Human Laboratory Testing ANS-6637 (HLAB 002). Could the number of subjects to be enrolled in this study be provided for costing purposes?

ANSWER:

See answer to Question 1

3. In the Solicitation, on page 21, Section 3 Information Security Categorization, the No PII box is checked. However, page 71 Section J Information Security Categorization, Yes PII box is checked. Can you clarify which is correct?

ANSWER:

The CRO will have access to PII at the clinical sites. Page 21, Section 3 is incorrectly missing the check in the correct checkbox.

General & Technical Questions