SOURCES SOUGHT
Q -- Genetic Toxicology Studies for 3 Novel Compounds under Non-GLP conditions
- Notice Date
- 5/19/2020 8:22:08 AM
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-20-006937
- Response Due
- 6/2/2020 12:00:00 PM
- Archive Date
- 06/17/2020
- Point of Contact
- Rashiid Cummins
- E-Mail Address
-
rashiid.cummins@nih.gov
(rashiid.cummins@nih.gov)
- Description
- 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 and to determine the method of acquisition.� 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. Background:�The Drug Design & Development Section (DDDS), TGB, NIA, NIH has been developing drugs to treat neurodegenerative diseases in humans for several decades. There are three novel drugs that require the performance of pre-clinical toxicology studies to be undertaken before an agent can be selected for development of a new Investigational New Drug (IND) Application for submission to the US Food and Drug Administration. All new drugs must undergo the assessment of potential genetic toxicology and cardiac arrhythmia analysis before they will be considered for development as treatments for clinical disease. Data generated by these toxicology screens will be used to decide which experimental drug should be developed into human evaluation and preparation of an IND application. This is vital to the DDDS, TGB, NIA and NIH and the US Government. Purpose and Objectives: The Drug Design & Development Section, TGB, NIA, NIH, requires the performance of in vitro genetic toxicology studies for the screening of 3 compounds under non-GLP conditions. The government requires the assessment of 3 novel drugs to be undertaken to allow the Government to generate an Investigational New Drug (IND) Application for the US Food and Drug Administration (US FDA). These genetic toxicology screens are vital to the development of all novel drugs and need to be performed prior to clinical development. The screens will include (1) the AMES Assay by Microtitre Fluctuation Method; (2) the chromosome aberration assay using human peripheral blood lymphocytes (HPBL), and (3) In vitro cardiac safety assessment by the performance of the hERG patch clamp studies to assess for possible proarrhythmic risks caused by novel drugs. Project requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the�Statement of Work below: The AMES Assay by Microtitre Fluctuation Method - Eurofins Discovery offers a miniaturized screening version of the Ames test that requires a very small amount of compound (typically 5 mg). Our Ames fluctuation assay is high-throughput, being performed in 384-well plates and uses four Salmonella strains to detect multiple mutations including frameshift mutations and base-pair substitutions as well as to identify certain mutagenic compounds which are not detected by specific bacterial strains. The chromosome aberration assay using human peripheral blood lymphocytes (HPBL). In vitro cardiac safety assessment by the performance of the hERG patch clamp studies to assess for possible proarrhythmic risks caused by novel drugs. Anticipated period of performance: 3 months after receipt of the award. Capability statement /information sought. Respondents must provide, as part of their responses, a capability statement clearly identifying their ability to provide the requested service. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit.� The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.� Facsimile responses are NOT accepted. The response must be submitted to Rashiid Cummins at e-mail address rashiid.cummins@nih.gov.�� The response must be received on or before June 2, 2020, 3:00 pm, Eastern Time. � ��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. 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 presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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
-
SAM.gov Permalink
(https://beta.sam.gov/opp/dcbe5342316449c4939e39f46dc96fdd/view)
- Place of Performance
- Address: Baltimore, MD, USA
- Country: USA
- Country: USA
- Record
- SN05663253-F 20200521/200519230158 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |