This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. 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. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond . The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks capability statements from interested and qualified potential sources for the NICHD Chemical Screening and Optimization Facility (CSOF). As an NIH Institute, NICHD is the lead Federal agency that fulfills a unique role in bridging the discovery of contraceptive and/or reproductive health-related targets to the development and approval of the contraceptive and/or reproductive health-related products. The goal of the CSOF is to provide meritorious investigators a contract research facility with the capability to carry out the production of active recombinant protein, assay development, chemical screening, identification and optimization of chemical series and production of milligram to kilogram quantities of materials suitable for in vitro and in vivo testing for contraception and/or reproductive health-related therapeutic indications. Purpose and Objectives: This initiative will provide overall project management and the capabilities to support all phases of Chemical Screening and Optimization Services to include, but are not limited to, the following: Target Screening and Identification of Active Molecules Biological/biochemical assay development High throughput screening performance Confirmatory studies of active molecules identified from high throughput screens Evaluation and selection of confirmed active molecules for further development Medicinal chemistry services for the development and identification of lead series Chemical Lead Series Optimization Medicinal chemistry campaigns (e.g., structure activity relationships) Chemical and protein expression and structural analysis Computational molecular modeling services Intellectual property analysis (e.g., prior art and landscape evaluation ) Drug metabolism and Pharmacokinetic analysis The Contractor shall provide the following expertise, as specified in task orders for all activities related to: Protein production and/or purification Activity demonstration of purified protein Biological/biochemical assay development for high throughput screening, including cell culture facilities High throughput compound screening Assay hit verification Intellectual property evaluation summary by qualified legal expert(s) Medicinal chemistry activities including, but not limited to; Compound synthesis on the milligram to kilogram scale Bioisostere knowledge and execution Purification and characterization including but not limited to: Compound purification, as required, using: Chromatography (e.g., HPLC) Structural confirmation, as required, using: Infrared spectroscopy (IR) 1H and 13C nuclear magnetic resonance (NMR) Ultraviolet and/or mass spectroscopy data (i.e., LC-MS) Optical rotation and enantiomeric excess (where necessary) Elemental analysis and/or X-ray structure confirmation Computational molecular modeling X-ray crystallography In vitro biological characterization (e.g., cellular permeability) Absorption, distribution, metabolism, excretion studies One or more reproductive scientists skilled in the science of male and/or female gametogenesis/fertilization for consultation Radiochemical synthesis Peptide synthesis The following services shall also be provided: Label, catalogue, and store synthesized compounds under proper laboratory storage conditions Maintain current records of compound identification, quantity, purity, and all associated analytical data Provide access to the Government for all information directly related to the contract including, but not limited to, all bound laboratory notebooks or e-notebooks (which must be used to record all data), spectral, analytical and chromatographic data All work shall be performed in accordance with all local, state, and federal laws and regulations. Anticipated period of performance: 09/25/2023 – 9/24/2028 Responses: Capability statements in response to this announcement should be no longer than 15 pages inclusive of all material. Responses will be evaluated on the basis of experience, expertise, and capabilities in the areas cited above. The anticipated contract type will be a cost reimbursement IDIQ . The RFP is anticipated to be posted on or about April 30, 2023 on SAM.gov Businesses that believe they possess the capabilities necessary to undertake this project should submit electronic copies of their capability statement, addressing the areas above. Please limit responses to fifteen (15) pages or less. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by no later than 12:00 PM(noon) Eastern Time on March 16, 2023. Capability statements must identify the business status of the organization (i.e. educational institution, non- profit, large business, small business, 8 (a), or other corporate or non-corporate entity). Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project officer: (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, and a statement regarding industrial security clearance. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. Inquiries should be directed to: Adelola St John, Contracting Officer, DHHS/NIH, National Institute of Child Health and Human Development, email:
[email protected] or
[email protected].