SOURCES SOUGHT
A -- Toxicological Evaluations of Potential Medications
- Notice Date
- 12/4/2017
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800011
- Point of Contact
- Lisa Bielen, Phone: (301) 443-6677, Andrew Hotaling, Phone: (301) 443-6677
- E-Mail Address
-
lisa.bielen@nih.gov, hotalingar@mail.nih.gov
(lisa.bielen@nih.gov, hotalingar@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from qualified Small Business organizations (NAICS code 541715, small business size standard is 1000 employees). For details of Small Business Size Standards see http://www.SBA.gov). This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, women-owned small businesses, and other small businesses) to fulfill the needs of NIH and NIDA for this future requirement. A. General Requirements: Offerors must conduct systematic preclinical toxicology and safety pharmacology studies, and preclinical cardiovascular safety studies that support the development of pharmacotherapies as medications to reduce substance abuse. The preclinical studies shall adhere to Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) guidelines as set forth by relevant Food and Drug Administration (FDA) guidance and regulations (Code of Federal Regulations Title 21, Chapter 1, Subchapter A, Part 58). B. Specific Requirements: 1.Offerors must have on-site in vivo toxicology (rodent, rabbit, guinea pig, canine and non-human primate) and in vivo cardiovascular safety testing facilities with telemetric recording capability in conscious, unrestrained animals (rat, dog and non-human primate); 2.Offerors must have access to state-of-the-art equipment for performing in vitro tests on cardiac muscle (hERG channel assays and action potential duration tests), access to state-of-the-art equipment for performing mutagenicity and genotoxicity tests and access to state-of-the-art equipment for performing analytical testing of dosing solutions; 3.Offerors must be able to verify the identity of the bulk substance through High Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Infrared Spectroscopy (IR) and Nuclear Magnetic Resonance Spectroscopy (NMR); 4.Offerors must possess experience conducting rodent, dog and non-human primate GLP studies designed to evaluate the safety of test compounds in the presence of common drugs of abuse, including ethanol, cocaine, methamphetamine and opiates; 5.Offerors must possess experience in preparing reports acceptable in format for both paper and electronic submission to the FDA; 6.After the Request for Proposals (RFP) is issued, and prior to award, each offeror must: • Be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). •Demonstrate its understanding and compliance with the NIH Guide for the Care and Use of Laboratory Animals. •Show that it has an Animal Welfare Assurance on file with the Office of Extramural Research, Office of Laboratory Affairs (OLAW; see http://grants.nih.gov/grants/olaw/olaw.htm). C. Mandatory Evaluation Criteria: To handle test substances under the Controlled Substances Act of 1970, and prior to award, each offeror must possess a U.S. Drug Enforcement Administration (DEA) Registration for Schedules II to V. In addition, each offeror must either possess, or demonstrate the ability to obtain prior to award, DEA Registration for Schedule I controlled substances. D. Information Required for Sources Sought: 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 projects, specific GLP work performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientists 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 toxicological and cardiovascular studies that support the development of potential pharmacotherapies for the reduction of substance abuse. (4) Any other specific and relevant information about this procurement that would improve our consideration and evaluation of the information presented is desirable. 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 is not limited to, contracts both Government and commercial organizations performed, references, i.e., names, titles, telephone numbers, and any other information serving to document the organizations capability, e.g. awards, commendations, etc. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type(s) of business, if any (e.g.: small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone). Written capability statements must be submitted to Lisa Bielen, whose contact information is included, NO LATER THAN December 19, 2017. Hardcopy or electronic capability statements will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIHDA201800011/listing.html)
- Record
- SN04756267-W 20171206/171204231227-b52896ed4775b64a75cff0e48f075245 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |