Continued Stability on SP807 for ACT-1 Ophthalmic Solution

COMBINED SYNOPSIS / SOLICITATION

Title: Continued Stability on SP760 for ACT-1 Opthalmic Solution

(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 75N95019R00069 and the solicitation is issued as a request for proposals (RFP).

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 - NCATS Section, on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Particle Sciences Inc., 3894 Courtney St, Bethlehem, PA 18017, for one additional stability time point on the stability protocol outlined in SP807 under contract LBR1421.

The contracting officer has determined that only one source is reasonably available, as this is a minor amount of additional work under an existing research and development contract awarded by the National Cancer Institute on NCATS' behalf. The existing contract is no longer available for NCATS to modify, but NCATS requires two additional time points to be taken in the underlying study.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-02 dated June 5, 2019.

(iv) The associated NAICS code is 541715 and the small business size standard is 1000. This requirement is not set aside.

(v) Vendor will add add two additional stability time points on the stability protocol outlined in SP807 under contract LBR1421 in accordance with a statement of work provided by NCATS.

(vi) Delivery to be 3-6 months after receipt of order, FOB destination, to:

The National Center for Advancing Translational Sciences (NCATS)
9800 Medical Center Drive
Rockville, MD 20850

(vii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition.

(viii) Offers will be evaluated for technical criteria, price, and past performance. Technical evaluation will consider whether the work proposed is consistent with the stability protocol outlined in SP807 under contract LBR1421. Technical and past performance, when combined, are significantly more important than price.

(ix) Offerors are include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with offers.

(x) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition.

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)
HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015).
52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions (2/2014).

(xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition.

(xii) Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria.

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.

All responses must be received by 11:00 am Eastern time on Friday, July 12, 2019, and reference solicitation number 75N95019R00069. Responses must be submitted by email to Stuart Kern, Contract Specialist, stuart.kern@nih.gov, 301-402-3334.

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