GMP Synthesis of Bulk Drug Testing

Introduction: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) should not submit a response to this notice. Description: The National Institute on Drug Abuse (NIDA) seeks capability statements from Small Businesses (e.g., 8(a), veteran-owned, service-disabled veteran-owned, HUBZone, small disadvantaged, and woman-owned small businesses) having the capability to provide the Good Manufacturing Practices (GMP) synthesis of bulk drug substances to the medications development program of NIDA for toxicological and clinical trials. Offerors should demonstrate the ability to manufacture bulk drug substances under both GMP following relevant Food and Drug Administration (FDA) guidance and regulations (e.g. Code of Federal Regulations Title 21) and non-GMP. Offerors should indicate experience in producing GMP and non-GMP drug substances in batch sizes of at least one kilogram or larger, appropriately store GMP and non-GMP materials on site, and maintain a facility in good standing with the FDA. Offerors should have onsite access to state-of-the-art equipment for analytical testing (high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), isotope ratio (IR), circular dichroism (CD) and nuclear magnetic resonance (NMR)). Offerors should show experience in preparing reports acceptable in format and substance for adaptation into a Chemistry, Manufacturing and Control (CMC) section for each drug substance for submission to the FDA in support of Investigational New Drug (IND) and New Drug Application (NDA) applications. Mandatory Criteria: 1. Due to the nature of the bulk drug substances being used to support NIDA preclinical safety testing and subsequent safety and efficacy clinical trials, it is mandatory that offerors' facilities are in good standing with the FDA and meet all FDA Good Manufacturing Practice (GMP) requirements. 2. To handle substances or starting materials under the Controlled Substance Act of 1970, offerors must possess Drug Enforcement Administration (DEA) Research and Manufacturing Registrations for Schedules II, III, IV orV controlled substances and demonstrate the capability to obtain DEA Research and Manufacturing Registrations for Schedule I controlled substances. Capability Statement/Information Sought: The established NAICS code is 541715. Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous project, specific GMP work and any in-house research and development efforts; (2) Personnel: Name, professional qualifications and specific experience of scientists, engineers and technical personnel who may be assigned as principal investigator and/or project director; (3) Facilities: Availability and description of special facilities required to perform synthesis, analysis, and storage of drug substances under GMP conditions, including security. (4) Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented should be included. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts, both Government and commercial, that the organization has performed, references (i.e., names, titles, telephone numbers), and any other information serving to document the organization's capabilities (e.g., awards, commendation, etc.) (5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their 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 numbers 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. Point of Contact: Renu Simon, Contract Specialist, NIDA Section, Contracts Management Branch, Phone (301) 443-6677, Fax (301) 443-7595. Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Office of Acquisitions, 6001 Executive Blvd, Room 4211 Bethesda, MD, 20892-7902, UNITED STATES. Submission Instructions: Interested parties shall submit capability statements via email to Renu Simon, Contract Specialist at renu.simon@nih.gov and reference the Sources Sought Number 75N95019Q00094. The due date for receipt of statements is March 15, 2019 Eastern Time on 10:00 am. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.