(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 HHS-NIH-NIDA-CSS-20-006937 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; FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; 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 National Institute on Aging (NIA), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Eurofins Advinus for Genetic Toxicology Studies for 3 Novel Compounds under NON-GLP conditions.

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

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2020-05, with effective date March 30, 2020.

(iv) The associated NAICS code is 621511 and the small business size standard is $35,000,000.00.  This requirement has no set-aside restrictions.

(v) This requirement is for the following services:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the requirements below:

(vi) Specific Requirements:

1. The contractor must have extensive experience at performing genetic toxicology and cardiac arrhythmia testing of pre-clinical investigational drugs.
2. The contractor must have the technology and expertise to complete the studies three different genetic toxicology screens no longer than 3 months after receiving the test compounds.
3. The tasks can be performed in a sequential order or at the same time.
4. The contractor must complete the three different genetic toxicology screens with no more than 40 mg of each test compound.
5. The contractor must be able to demonstrate that it has successfully generated multiple (10) clinical candidates that are undergoing clinical trials across the globe by the parent company.

LEVEL OF EFFORT:

The contractor must provide the scientific technical expertise to design, perform and interpret the data obtained from the genetic toxicology and cardiac arrhythmia tests.

GOVERNMENT RESPONSIBILITIES:

The Government must provide the contractor with the pre-clinical test compounds (40 mg of each) to allow the contractor to perform the genetic toxicology and cardiac arrhythmia assessments. The Government will provide the contractor with basic safety advice of working with the test compounds. The Government will not be required to provide other resources to the contractor.

DELIVERY OR DELIVERABLES:

The contractor to perform the genetic toxicology and cardiac arrhythmia assessments of the 3 Government drugs, the work shall be completed in 3 months after receipt of the award and test drugs.

REPORTING REQUIREMENTS:

The contractor shall provide the Government an electronic report on the completion of the assessments.

(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance should be approximately 3 months from the time of the receipt of the award and test compounds.

(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 (JUL 2016)
• FAR 52.212-1, Instructions to Offerors--Commercial Items (MAR 2020)
• FAR 52.212-3, Offeror Representations and Certifications – Commercial Items (MAR 2020)
• 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 (JUL 2016)
• 52.212-4 Contract Terms and Conditions Commercial Items (OCT 2018)
• HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)
• 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (MAR 2020)

The following clauses within 52.212-5 apply to this acquisition:

• 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (OCT 2018)
• 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)
• 52.219-28 Post Award Small Business Program Representation (2020)
• 52.222-3 Convict Labor (JUNE 2003)
• 52.222-19 Child Labor-Cooperation with Authorities and Remedies (JAN 2020)
• 52.222-21 Prohibition of Segregated Facilities (APR 2015)
• 52.222-26 Equal Opportunity (SEPT 2016)
• 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014)
• 52.222-50 Combating Trafficking in Persons (JAN 2019)
• 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)
• 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008)
• 52.232-33 Payment by Electronic Funds Transfer—System for Award Management (OCT 2018)

The following provisions and clauses apply to this acquisition and is attached in full text:

• Standard NIH Invoice and Payment Provisions (FEB 2014)
• Interim NIH Invoice and Payment Provisions (APR 2020)

(ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition.

(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; and (ii) price. Technical capability is significantly more important than 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 shall include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer.

(xi) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

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

(xiii) 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 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 quotations must be received by Friday, June 12th, 2020 at 3:00 pm Eastern Daylight/Standard Time and must reference solicitation number HHS-NIH-NIDA-CSS-20-006937. Responses must be submitted electronically to Rashiid Cummins, Contract Specialist, at [email protected]

Fax responses will not be accepted.

(xiv) The name and of the individual to contact for information regarding the solicitation:

Rashiid Cummins

Contract Specialist

[email protected]