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Contract Opportunity

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Abbreviated Testing for the Feasibility of Developing a Solid Dosage Form for Metarrestin

(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 75N95024Q00104 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), Office of Acquisition (OA), on behalf of the 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 University of Kansas Center for Research, Inc. 2097 Constant Avenue, Lawrence, KS 66047 for Abbreviated Testing for the Feasibility of Developing a Solid Dosage Form for Metarrestin.

This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).

Only this suggested source can furnish the requirements, to the exclusion of other sources, to ensure the integrity of NCATS ongoing research study remains intact. NCATS must employ the same formulation of tablets that was developed by the University Of Kansas Center For Research, Inc that was previously used to generate prior tablets on the program, in order to maintain consistency in the use of the lead compound, and allow a direct, apples-to-apples comparison of newly generated and previously generated results based on the use of tablets manufactured and supplied by University Of Kansas Center For Research, Inc. In addition, the tablets must be delivered by 02/01/2024. If the required delivery date is not met, the patients currently enrolled in the study would not receive the adequate exposure to metarrestin to study its potential therapeutic effect in delaying the progress of the pancreatic cancer. A new contractor would take at least 6 months to acquire the competency that has been developed by KU BIOC. The government would have to pay an additional $19,500 in order for the new contractor to be up to speed in delivering the required tablets of adequate potency.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-06 dated 12/04/2023.

(iv) The associated NAICS code is 541380 Testing Laboratories and the small business size standard is $19 M. Not set aside restriction applicable.

(v) This requirement is for the following Abbreviated Testing for the Feasibility of Developing a Solid Dosage Form for Metarrestin

(vi) 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 National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

Statement of Work

The vendor shall:

1. Analytical method for Potency and impurities

Modify existing potency and impurity assays by HPLC along with external standard calibration curves, apply to screening of alternate dosage forms with various excipients

2. Physicochemical testing including solubility

Evaluation of TGA, DVS, Tm, Tg, Tc by mDSC of the metarrestin provided; solubility in aqueous media (pH 2, 5.5, 6.5 and FaSSIF, FeSSIF), solubility with CDs (β, SBE-β, HPB-β)

3. Feasibility of Attrition Milling to reduce particle size

API will be milled via dry powder milling with various size screens, mDSC, particle size by light scattering

4. Feasibility Testing for Propensity to Precipitate

Assess the potential for Precipitation with dilution into non-solvent, screen 4 polymers as precipitation inhibitors, screen CDs if warranted from Task 2 (test in PBS and FeSSIF)

5. Feasibility Testing for an Amorphous Solid Dispersion (ASD)

(if warranted by data in task 2 either) prepare spray-dried ASD with polymers and/or CD as selected in Task 4, mDSC, DVS, SEM, precipitation inhibition

6. Intrinsic dissolution rate comparisons

Carry out intrinsic dissolution rates of unmilled, milled, ASDs, physical mixtures with CD

7. Prepare surrogate formulations of top 3 strategies for rodent bioavailability

Taking the top 2-3 strategies, prepare surrogate formulation of each which can be shipped for testing of bioavailability in rodents, ship supplies

8. Monthly meetings with slide updates

Provide an ongoing slide deck with monthly updates added to the deck and provided to NIH

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is 02/01/2024.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. 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 solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)


• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)


• FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023)


• 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)


• FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (Nov 2023)


• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses 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. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)


• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)


• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video

Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services-

Representation (Oct 2020)

• FAR 52.204–27, Prohibition on a ByteDance Covered Application (Jun 2023)

• FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2023).


• HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (Dec 2023)


• NIH Invoice and Payment Provisions

(ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].

(x) Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Sep 2023), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Products and

Commercial Services (Nov 2023), applies to this acquisition. Addendum to this FAR

clause applies to this acquisition and is attached.

(xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii) 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.

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. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

The Unique Entity ID from SAM.gov, 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 offers must be received by 3:00p.m., Eastern Daylight/Standard Time, on January 12, 2024, and reference solicitation number 75N95024Q00067. Responses must be

submitted electronically to Claudia Ventola, Contract Specialist at

claudia.ventola@nih.gov, cc michelle.cecilia@nih.gov.

Fax responses will not be accepted.

Attachments/Links