Inactive

This is a Research and Development (R&D) 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... This is a Research and Development (R&D) 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 as proposals or quotes. No award will be made as a result of this notice. This notice is strictly for the purpose of obtaining information and identifying small business concerns with the capability to perform a prospective research and development requirement which is described in the attached Statement of Work. 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 identify organizations with the requisite qualifications and capabilities to provide services including 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 clear and convincing documentation of their capability of providing the required services described in this notice and attached Statement of Work (SOW). Respondents must also provide their SAM Unique Entity ID (UEI), organization name and address, 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 response in Microsoft Word or searchable Adobe PDF format using 11-point or 12-point font size, single or double spacing, and 8-1/2” x 11” paper size. The response must be in an outline format and address each of the specific activities listed under Performance Activity 2 and Performance Activity 3 in the SOW. A cover page and an executive summary may be included but is not required. Responses are limited to ten (10) pages not including cover page and executive summary page. Responses must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses. All responses must be submitted via email to Marlene Milgram, Contract Specialist, at marlene.milgram@nih.gov. Faxed responses are not accepted. All responses must reference notice number: NIH-NINDS-RD-75N95023R00031 and be received on or before the closing date and time of this notice. “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).