Biological Therapeutics Product Development Subject Matter Expert Consulting Services to Support the Development of Therapeutic Biotechnology Products (Biologics)

(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 75N95024Q00016 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. See attached Statement of Work. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-05, with effective date September 22, 2023. (iv) The associated NAICS code 541690 and the small business size standard is $19 Million. This requirement is a small business set-aside. (v) DESCRIPTION/QUANTITY - See attached Statement of Work (vi) The Government anticipates award of a time and material award for this acquisition, and the anticipated period of performance is November 17, 2023, through November 16, 2024, with Option Line for 385 hours and Option Line for Travel NTE $1,200. Option Period of November 17, 2024, through November 16, 2024, with Option Line for 385 hours and Option Line for Travel NTE $1,200.00 month. (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 (Mar 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (Dec 2022) 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 52.212-4, Contract Terms and Conditions'Commercial Products and Commercial Services (Dec 2022). Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) FAR 52.216-31, Time-and-Materials/Labor-Hour Proposal Requirements'Commercial Acquisition. FAR 52.217-7, Option for Increased Quantity-Separately Priced Line Item (Mar 1989). The clause at FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). 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 52.204-24 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 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Sept 2023) NIH Invoice and Payment Provisions (March 2023) Service Contract Labor Standards / Wage Rate Determination. Area: State of Maryland, County of Montgomery; No. 2015-4269; Dated 06/30/2023, Revision 23. (ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items (Nov 2021), applies to this acquisition and is included as an attachment. (a) 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)]. Technical and past performance, when combined, are significantly more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) 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) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications'Commercial Products and Commercial Services (Dec 2022), 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 Items (Dec 2022), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) 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. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) 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 questions must be received by 4:00 p.m., Eastern Daylight/Standard Time, on Tuesday, October 31, 2023, and reference Solicitation Number 75N95024Q00016. Questions may be submitted electronically to Morgen Slager at morgen.slager@nih.gov and copy Michele Pastorek at michele.pastorek@nih.gov. All quotations must be received by 4:00 p.m., Eastern Daylight/Standard Time, on Friday, November 3, 2023, and reference Solicitation Number 75N95024Q00016. Responses must be submitted electronically to Michele Pastorek, Contract Specialist, at michele.pastorek@nih.gov Fax responses will not be accepted.