Inactive

Description: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availabilit... Description: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). Background: 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. Purpose and Objectives: Contractor will manufacture matching dutasteride 0.5 mg and placebo by over-encapsulation of the commercial product. Project requirements: 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). 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 Anticipated period of performance: The period of performance will be one year from the award of the contract including delivery in January 2025 and January 2027. Other important considerations: The National Institutes of Health (NIH) Clinical Center (CC) Pharmacy/Investigational Drug Outsourcing Unit will provide the vendor with access to the information in the existing IND # 69,632, including information on formulation development and drug product stability. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Christopher Halstead, Contract Specialist at e-mail address Christopher.Halstead@nih.gov The response must be received on or before July 25, 2022, 5:00pm, Eastern Time. “Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”