Dutasteride Double-blind Phase II Clinical Trial

STREAMLINED SOLICITATION FOR COMMERCIAL SERVICE COMBINED SYNOPSIS / SOLICITATION COMPETITIVE Title: Dutasteride Double-blind Phase II Clinical Trial (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. (ii) The solicitation number is NIMH22005185RFQ 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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 dated 4/26/2022. (iv) The associated NAICS code 325412 and the small business size standard is 1250 employees. This requirement is full and open with no set-aside restrictions. (v) The National Institutes of Health (NIH) Clinical Center (CC) Pharmacy/Investigational Drug Outsourcing Unit will have a double-blind, placebo-controlled, parallel design, phase II clinical trial of the 5-alpha reductase inhibitor, dutasteride for three consecutive menstrual cycles in women with Premenstrual Dysphoric Disorder (PMDD) This study is a double blind, placebo controlled, parallel design, Phase II clinical trial, to determine the efficacy of inhibition of 5-alpha-reductase activity with dutasteride, an inhibitor of both 5-alpha-reductase types 1 and 2, for three consecutive menstrual cycles in women with premenstrual dysphoric disorder (PMDD). This is a randomized study of 48 women diagnosed with PMDD assigned blindly to either dutasteride 2.5 mg per day or placebo for three menstrual cycles. The study will allow us to determine the efficacy over three menstrual cycles (compared with a single menstrual cycle in our previous pilot study) of the inhibition of 5-alpha reductase activity and the suppression of allopregnanolone levels in the mitigation of luteal phase symptoms in women with PMDD. (vi) Purchase Description: 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 Statement of Work (attached). Per the SOW the contractor will: Manufacture 12,000 placebo capsules and 12,000 over-encapsulated Dutasteride 0.5mg gelatin capsules. Objective 1: The active and placebo must match for the double-blind study. Placebo should match the dutasteride 0.5mg capsules in size, color, and odor. Objective 2: Test the finished product upon release and establish a stability study for a Phase II study as outlined in cGMP regulations and FDA guidance. Salient characteristics: Refer to Attachment 1: Statement of Work for a complete description of salient characteristics. Quantity: Manufacture 12,000 placebo capsules and 12,000 over-encapsulated Dutasteride 0.5mg gelatin capsules. Objective 1: The active and placebo must match for the double-blind study. Placebo should match the dutasteride 0.5mg capsules in size, color, and odor. Objective 2: Test the finished product upon release and establish a stability study for a Phase II study as outlined in cGMP regulations and FDA guidance. (vii) Delivery Date: The contractor will provide: 12,000 placebo capsules for the Dutasteride 0.5 mg capsule in 3 separate batches made every 2 years. 2) 12,000 Dutasteride 0.5 mg capsule in 3 separate batches made every 2 years. Requesting completion of manufacturing and delivery of the first of three batches of the investigational products by January 2023 to NIH Clinical Center/IDCU. The second and third batches will be delivered by January 2025 and January 2027, respectively Place of Delivery/Acceptance: Attn: Tiffany Jones NIH - IDMRS - CLINICAL CENTER PHARMACY DEPT 10 CENTER DRIVE BUILDING 10, ROOM 1C230, MSC 1196 BETHESDA MD 20892-1196 FOB: Destination (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. 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) price; (ii) technical capability of the item offered to meet the Government requirement. The agency will first evaluate offerors prices, and then evaluate the apparent lowest-priced quote to determine if it is technically acceptable. If the lowest-price quote is evaluated as unacceptable, then the agency will consider the acceptability of the next lowest-price quote, continuing this process as necessary. 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 Attachment 2: FAR Provisions 52.204-24, 52.204-26 and 52.212-3 with its quote. (xi) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items, applies to this acquisition. See Attachment 3 for FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 that are applicable to this acquisition and Additional Terms and Conditions (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. Warranty: (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) 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. In addition the Unique Entity Identifier (UEI), 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. (xvi) Closing Information All responsible sources may submit a quotation which will be considered by the agency. All responses must be received by 5:00 PM, August 25, 2022 and reference number NIMH22005185RFQ. Responses must be submitted electronically (e-mail) to Christopher.halstead@nih.gov Fax responses will not be accepted. Any questions must be submitted by 5:00 PM EST on August 20, 2022. All questions must be submitted electronically (e-mail) to Christopher.halstead@nih.gov and reference number NIMH22005185RFQ. Telephone inquiries will not be honored. (xvii) Attachments Attachment 1 - Statement of Work Attachment 2 - Reps and Certs Attachment 3 - FAR Clauses 52.212-4, 52.212-5, and Additional Terms and Conditions Attachment 4 - Invoice Instructions