SOURCES SOUGHT
A -- NIMH Toxicological Evaluation of Novel Ligands Program
- Notice Date
- 4/24/2013
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-DA-SBSS-13-272
- Point of Contact
- Craig Sager, Phone: 301-443-1193, Bruce E. Anderson, Phone: 301-443-2234
- E-Mail Address
-
csager@nida.nih.gov, banderso@mail.nih.gov
(csager@nida.nih.gov, banderso@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 the applicable NAICS code should not submit a response to this notice. Teaming and partnering arrangements among small businesses is encouraged. Background. The National Institute of Mental Health (NIMH) Toxicological Evaluation of Novel Ligands Program works to accelerate the discovery, development, and application of novel ligands for PET, SPECT, and MRI imaging in humans by providing toxicology and safety assessment of promising, target-selective compounds. The program also provides limited assessment of novel psychoactive agents for clinical research and as potential therapeutics. Toxicology and safety data generated by the program will be used to support an Investigational New Drug (IND) application to the Food and Drug Administration (FDA), or for Radioactive Drug Research Committee (RDRC) evaluation of a compound for human studies. The contract will evaluate toxicity and safety of compounds submitted for testing. This may include (but is not limited to) novel chemical entities, structural analogs of compounds with an IND, or analogs of FDA-approved drugs. Purpose and Objectives. NIMH is seeking information on all small businesses capable of providing toxicology and safety assessment services to continue the NIMH Toxicological Evaluation of Novel Ligands Program. The program provides assessment of promising, target-selective ligands for PET, SPECT, and MRI imaging in humans, as well as limited assessment of novel psychoactive agents for clinical research and as potential therapeutics. Toxicology and safety data generated by the program are used to support Investigational New Drug (IND) applications to the Food and Drug Administration, or for Radioactive Drug Research Committee (RDRC) evaluation of compound for human studies. Services to be provided under this program fall into five general areas: 1) bioanalytical chemistry; 2) in vitro absorption, distribution, metabolism, excretion, and toxicity (ADMET) assessments; 3) pharmacokinetics; 4) preliminary safety assessment; and 5) IND- directed toxicity assessments, including safety pharmacology. Capable sources will be required to (1) develop and validate analytical methods for quantitating drug concentrations in dosing solutions, biological fluids, and tissues and determine plasma drug levels in animals administered the agent under study and calculate pharmacokinetic parameters derived from these date; (2) determine the pharmacokinetics of a drug after different routes of administration; (3) conduct in vitro ADMET evaluation using industry-standard assays and (4) plan and conduct preclinical acute and chronic toxicity evaluations on lead compounds, including clinical observations, body weights, clinical pathology, and histopathology and plasma drug levels in rodents and non-rodent species, including safety pharmacology assessments. Project requirements. The NIMH is seeking sources that can provide toxicology and safety assessment services, as described above, to continue the NIMH Toxicological Evaluation of Novel Ligands Program. Interested small businesses must demonstrate they have the capacity/facilities to receive and test approximately 5 (but could range from 2-10) compounds per year, in a battery of toxicity and safety assessment tests (as listed above). The majority of these compounds will undergo limited assessment which may include analytical chemistry and pharmacokinetic assessment, dose range-finding studies and/or acute toxicity evaluation in rodents. Additional assessments of genotoxicity, safety pharmacology, repeat-dose, and chronic toxicity may be required in both rodent and non-rodent species (typically dog, rabbit, or primate). Institutions must be able to conduct GLP studies suitable for inclusion in IND applications submitted to the FDA and should have a current approved DHHS Animal Welfare Assurance. IACUC approval will be mandatory for this project prior to award of the contract. Anticipated period of performance. April 2014 - April 2019 Other important considerations. This contract is proposed to be a five (5) year Indefinite Delivery/Indefinite Quantity (IDIQ) type contract under which Task Orders will be issued. Additionally, all data provided to the Contractor and developed by the Contractor under this contract must be treated confidentially. The compound supplier may also request the Contractor to sign agreements, which could include Confidentiality and Nondisclosure Agreements (CDAs) and/or Material Transfer Agreements (MTAs). Capability statement/information sought. Any small business that believes it has the capability to fulfill this requirement should submit a narrative response indicating previous experience and capabilities related to the above work. You are encouraged to limit you response to fewer than 15 pages. Capability Statements should clearly state/describe: 1). The offerors experience and qualifications to perform this work; 2) your type of business or organization, its size (number of employees and gross annual revenue), your eligibility under 8(a) or other set-aside programs, as applicable (Note: the applicable NAICS code for this requirement is 541712, 500 employees; and 3) your management structure, history of your organization (e.g., number of years in business and DUNS #); and 4) other resources available to perform this work (e.g. scientific equipment, laboratory facilities, etc.). Generic marketing brochures will not be considered further. 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. Responses will be held in a confidential manner. 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 pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. If the Government decides to issue a solicitation, a Request for Proposal (RFP) will be available solely via the FEDBIZOPPS web page at http://www.fedbizopps.gov/. It will be the offeror's responsibility to monitor the FEDBIZOPPS web page for the release of any solicitation and amendments, and to download the RFP and all attachments. Responses to this notice should be received no later than the posted due date, and can be sent either by mail or e-mail ( csager@mail.nih.gov) to the point of contact listed. If using the U.S. Postal Service or commercial overnight services, please send an original plus five (5) copies of your response. Note: for commercial overnight services, use the Rockville, MD. 20852 address. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-DA-SBSS-13-272/listing.html)
- Place of Performance
- Address: United States
- Record
- SN03044655-W 20130426/130424234830-34511e4b73425dc9a09cd71b79f237f6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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