Drug Formulation and Manufacturing Program

This notice is being amended to provide questions and answers and provide the amened solicitation. As a result of this amendment the proposal submission deadline has been extended..

This notice is being updated to inform interested vendors that email address, cmssda@od.nih.gov, has been experiencing outages. The submission email address has been changed to Robert.Burdette@nih.gov. As a result of these circumstances, the submission date for questions and proposal intent response forms has been extended. If you previously submitted questions or forms and have not received confirmation that your submissions were received, you are encouraged to resubmit to the new address.

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This Notice is being updated to incorporate the solicitation document and its attachments. We are requesting that interested offerors complete and return the proposal intent response form by 22 March 2019..

Pursuant to FAR subpart 5.2, "Synopsis of Proposed Contract Actions", this is a pre-solicitation notice of a proposed contract Action.

Acquisition Authority: This acquisition is being conducted under Federal Acquisition Regulations (FAR) 15, Contracting by Negotiation.

North American Classification System (NAICS) Code: The intended procurement is classified under NAICS code 325412 -- Pharmaceutical Preparation Manufacturing with a size standard of 1,250 employees.

Set-Aside Status: This acquisition is intended to be a partial small business set-aside. Additional information will be provided with the solicitation release. This information will not be provided to individual vendors prior to the solicitation release.

Description of Requirement: The NIH Clinical Center (CC), Pharmacy Department, Investigational Drug Management and Research Service (IDMRS); the Office of Research Support and Compliance (ORSC); and the Office of Logistics and Acquisition Operations (OLAO) are partnering to establish a suite of multiple award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts that, together, will constitute the Drug Formulation and Manufacturing Contracts (DFMC). The DFMC will allow NIH ICs to hire contractors to conduct the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials.

The goal of the contracts is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug compounds. Throughout the period of performance of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. Additionally, unless otherwise requested any assigned research must be performed in compliance with, all current FDA, World Health Organization (WHO), and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to current good manufacturing practices (cGMP) as may be applicable.

This is a reposting of previous presolicitation notice NIHOD201800029..