Contact Points
(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.
(ii) The solicitation number is 75N95020Q00056 and the solicitation is issued as a request for quotation (RFQ).
This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.
THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).
The National Institute on Drug Abuse (NIDA), NIDA Office of Acquisitions – National Center for Advancing Translational Sciences (NCATS) Section, on behalf of NCATS, intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Arc Trinova, Taylor Drive, Alnwick, Northumberland, NE66 2DH, United Kingdom for Extended IND Regulatory Support services.
This acquisition is conducted as non-competitive for a commercial item or service and is conducted under the authority of the FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items and 13.501 Special documentation requirements and the authority of 41 U.S.C. 1901 and the FAR Subpart 13.106-1(b) Soliciting from a single source.
Pursuant to FAR Subpart 13.501 (a) (1) (iv) the rationale for the brand name justification: Arcinova has been working extensively on Chemistry, Manufacturing, and Controls (CMC) regulatory support services for the NCATS toward advancing a molecule towards Investigational New Drug (IND) status. The services required are dedicated toward the preparation and revision of CMC dossier of the key molecule for IND status.
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-04 dated January 15, 2020.
(iv) No set-aside restriction is applicable.
(v) The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The NCATS is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people’s lives. NCATS is currently interested in additional CMC support services towards advancing the molecule of interest towards IND status. The services are dedicated toward the preparation and revision of CMC dossier of the key molecule for IND status.
(vi) The purpose of this solicitation is to obtain extended IND regulatory support services.
Specific Requirements: 1. Contractor will prepare a revised CMC regulatory dossier for a single small molecule drug, for incorporation into a Phase 1 IND. 2. Contractor will engage in 10 hours of consultative regulatory support with NCATS.
Reporting Requirements: 1. Contractor will be required to stay in email contact with the government representative with reports issued at least monthly. 2. One report on the revised CMC section for the small molecule, or the CMC regulatory dossier itself.
Technical Requirements: 1. Contractor must have the capability to do Good Laboratory Practices (GLP) work 2. Contractor must have the capability to do Good Manufacturing Practices (GMP) work 3. Contractor must have previous experience in regulatory support for IND.
Level of Effort:
1. One CMC regulatory support expert: 10 hours 2. One CMC scientific writer: 20 hours
Data Rights The Government retains all right to data produced. Contractor will not write, publish articles, except with the written permission of the Government.
Confidentiality of Information Contractor will keep information strictly confidential. Any information the contractor is to release must be authorized by the Government before release.
(vii) Delivery shall be to:
National Center for Advancing Translational Sciences (NCATS) 9800 Medical Center Drive Building C Rockville, MD 20850
Delivery shall be 24 months after receipt of order
(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.
(ix) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:
(i) technical capability of the item offered to meet the Government requirement; (ii) price; (iii) past performance [see FAR 13.106-2(b)(3)];
Technical and past performance, when combined, are significantly more important than cost or price.
(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.
(x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with offers.
(xi) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The following addendum applies:
SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)
This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a clause may be accessed electronically at these addresses:
For FAR clauses: https://www.acquisition.gov/browsefar
For HHSAR clauses: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html
(end of clause)
The following FAR provisions or clauses are incorporated by reference:
52.204-7, System for Award Management (Oct 2018) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Entity Code Reporting (Jul 2016) 52.204-18, Commercial and Entity Code Maintenance (Jul 2016) 52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions (2/2014).
(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition:
52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018) 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Sep 2016) 52.222-50 Combating Trafficking in Persons (Mar 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.225-5 Trade Agreements (Aug 2018) 52.225-13 Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) 52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Jul. 2013)
(xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices.
(xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
(xv) This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service.
The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.
Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.
In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
A determination by the Government whether to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered to determine whether to proceed on a non-competitive basis as indicated above, or to conduct a competitive procurement.
All responses must be received by March 13, 2020 at 3:00pm Eastern Standard Time and reference solicitation number 75N95020Q00056. Responses must be submitted electronically to Scott Bredow at scott.bredow@nih.gov.
Fax responses will not be accepted.
(xvi) The name and email address of the individual to contact for information regarding the solicitation: Scott Bredow, scott.bredow@nih.gov.
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.