Drug Manufacturing and Formulation Program (DFMP)

The National Institute of Neurological Disorders and Stroke, (NINDS), under the auspices of the NIH Blueprint Neurotherapeutics Network, is seeking to increase the number of IDIQ awardees under its "Drug Manufacturing and Formulation Program (DMFP)" contract program. In January 2015, the NINDS made two 10-year IDIQ contract awards to Albany Molecular Research Inc. and MRIGlobal under the DMFP. These are the only two organizations currently under the DMFP contract program. NINDS has a need to increase the competition pool under this program through the current order period ending January 14, 2025. In an effort to identify small business concerns that might be capable of competing and performing under the DMFP, we are issuing this notice and asking small business concerns who believe that they have the capacity and ability to meet the "Statement of Work" requirements as currently in place under the DMFP as set forth in Attachment No. 1 hereto, and to submit a complete and detailed capability response. We are seeking capability responses from small business concerns to determine if re-solicitation of this requirement to increase our current IDIQ pool can be set aside exclusively for small business participation only. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS, and if your business concern is NOT a small business concern, there is no need to respond to this announcement. Once a determination is made regarding the suitability of this future requirement for a small business set-aside (or an open competition to include both large and small businesses), a separate Pre-Solicitation Announcement will be issued in advance of the release of a Request for Proposals. The applicable North American Industry Classification System (NAICS) code for this requirement is 325412. Therefore, the small business size standard for this announcement is 1,250 or fewer employees. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside (where large businesses would be excluded from competing), at least 50% of the direct labor cost must be "in-house". Specifically, FAR 52-219-14, "Limitations on Subcontracting," states that "at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern." Submitted Capability Statements must address how the business meets the applicable size standard. The following is a background statement and purpose of the BPN and the DMFP component in particular. In addition, provided as Attachment No. 1 to this notice is the current contract Statement of Work for DFMP. BACKGROUND AND PURPOSE: The NIH established the Blueprint Neurotherapeutics Network (BPN) to bridge the gap in drug development between academic and industry research (http://neuroscienceblueprint.nih.gov/dpdrugs/index.htm). 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 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. Contractors will 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, storage, and distribution of the drug products. The work will be conducted in accordance with Current Good Manufacturing Practices regulations (cGMPs) and as appropriate Good Laboratory Practice (GLP) regulations. Data and documentation will be prepared for example CMC regulatory documents in a form acceptable to the Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND application, or New Drug Application (NDA). Demonstrate the capability to perform the required work in-house, rather than through subcontractors. The design of the DMFP is to provide neuroscientists with drug manufacture and drug formulation services for the development of candidate molecules suitable for administration in preclinical efficacy studies, Investigational New Drug enabling studies, and clinical trials. The work of the Contractor will be divided into Performance Activities. In general, each candidate compound brought to the Contractor will include any or all of the following activities listed in the Statement of Work Attachment to this notice. The ultimate goal of the Blueprint program and of individual manufacturing projects is to bring new drugs to market. To this end, the NIH has approved a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations (FAR) for this contract. The DEC enables the Contributors to retain control of the intellectual property for compounds created through the DMFP. INFROMATION REQUESTED: Your response should demonstrate your capability, capacity and related experience in a requirement-specific Capability Statement addressing all performance requirements and activities in the attached Statement of Work. Your capability response must indicate how many staff members/employees of your organization would be available and dedicated for the contract. Should your organization need to involve other concerns/businesses in any capacity to perform/conduct any of the requisite SOW performance activities, these must be clearly identified and explained. In addition, your response must address your organization's ability to rapidly scale staffing capacity up or down in order to support the SOW anticipated workload. Small Businesses that meet the applicable size standard and believe that they have the capabilities described above are encouraged to submit a Capability Statement via email to: Laurie Leonard, Contracting Officer at LL44s@nih.gov; and Donna Morris, Contract Specialist at Donna.Morris@nih.gov by 4:00 PM local time February 21, 2017. Capability Statements should be limited to no more than 15 pages and should specifically address each of the performance activities specified in the attached SOW. Generic marketing brochures would not suffice for purposes of this notice and will not be evaluated. Only electronic responses will be accepted. This Small Business Sources Sought Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this Small Business Sources Sought announcement or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. All respondents are asked to indicate the type and size of your organization, e.g., Small Business, Veteran-Owned Small Business; Service Disabled Veteran-Owned Small Business; HUBZone Small Business, Women-Owned Small Business; Small Disadvantaged Business, or 8(a).