B_Sources Sought Notice.pdf

Title: GMP Synthesis of Bulk Drug Testing Notice ID: N01DA-24-8915

Notice Type:

Sources Sought

Posted Date:

September 1, 2023

Response Date:

September 30, 2023, 3:00 pm Eastern

Classification Code:

A -- Research & Development

NAICS Code:

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Notice Information Agency/Office:

National Institutes of Health

Location:

National Institute on Drug Abuse

Title:

GMP Synthesis of Bulk Drug Testing

Description(s):

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). Offerors must provide the Good Manufacturing Practices (GMP) synthesis of bulk drug substances to the medications development program of NIDA for toxicological and clinical trials. Offerors must 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 must 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 must 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 must 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. 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 to V controlled substances and demonstrate the capability to obtain DEA Research and Manufacturing Registrations for Schedule I controlled substances.

The established NAICS code is 541715. 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.

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.).

THIS IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to a contractual agreement. This is not a request for proposals. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. Small business concerns that believe they possess the capability necessary to successfully undertake the work described above should submit an original and two copies of their capability statement which minimally includes the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s) under which company business is conducted, 5) business type (i.e., women-owned, HUBZONE, etc.), size and status, and 6) capability information in response to the requirement and qualifications identified in this notice. Please submit written capability statements by September 30, 2023 to the NIDA Contracting Officer. Electronic copies of capability statements can be emailed to Polina Klimenkova, Contract Specialist at polina.klimenkova@nih.gov mailto:polina.klimenkova@nih.gov