Inactive

Description: This is a Small Business Sources Sought notice. This is NOT a solicitation or request for proposals, proposal abstracts, or quotations. It is not to be construed as a commitment by the Go... Description: This is a Small Business Sources Sought notice. This is NOT a solicitation or request for proposals, proposal abstracts, or quotations. 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 proposals or quotes. No award will be made as a result of this notice. The notice is issued to obtain information to help determine the availability of qualified small business sources technically capable of performing a future research and development (R&D) requirement for drug formulation and manufacturing (DMFP), and to determine the method of acquisition. The Government will NOT be responsible for any costs incurred by respondents to this notice. Once a determination is made regarding the method of acquisition, a separate pre-solicitation notice will be issued. Background: The National Institutes of Health (NIH) established the Blueprint Neurotherapeutics Network (BPN) to bridge the gap in drug development between academic and industry research. The BPN supports, through grants and contracts, every step of the drug development process, from validated hits through Phase I clinical trials. The Drug Manufacturing and Formulation Program (DMFP), a component of the BPN, will include contractors who will conduct the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. Purpose/Objective: The National Institute of Neurological Disorders and Stroke (NINDS) is seeking to determine the availability of small business organizations that have the capability to conduct process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, analytical method development and validation, stability studies; drug product manufacturing; packaging, labeling, storage, and distribution of drug products; conduct research in compliance with all current Federal Drug Administration (FDA), World Health Organization (WHO), and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines, and regulations; and prepare data and documentation in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), Investigational New Drug application, or New Drug Application (NDA). Capability statement /Information sought. Respondents must provide information and documentation clearly demonstrating that Respondent possesses the capabilities to meet the specific technical requirements and schedule of work for Performance Activity 2 - Active Pharmaceutical Ingredient (API) Development, Scale Up and Manufacture and Performance Activity 3 – Drug Product Formulation and Manufacture, which are described in the attached Statement of Work (SOW). Respondents must also provide their SAM Unique Entity ID (UEI), organization name, organization physical address, organization point of contact, and size and type of business (e.g., 8(a), HubZone, etc. under the applicable NAICS code), and any other information that may be helpful in developing or finalizing the acquisition requirements. Respondents must submit their capability statement/response in Microsoft Word or searchable Adobe PDF format using 11-point or 12-point font size and 8-1/2” x 11” (portrait layout). The response must be in an outline format and correspond to the specifically numbered activities under Performance Activity 2 and Performance Activity 3 in the attached SOW. A cover page and an executive summary may be included but is not required. Responses must include the respondent’ technical and administrative points of contact, including names, titles, office addresses, telephone numbers, and e-mail addresses. All responses must be submitted to Marlene Milgram, Contract Specialist, via e-mail at marlene.milgram@nih.gov. Faxed responses are NOT accepted. All responses must be received on or before the closing date and time of this notice and reference notice number: NIH-NINDS-SBSSN-75N95023R00031. “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 SAM. 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).”