Mixed Gender Human Liver Microsomes for NCATS Tox21 program

SOURCES SOUGHT NOTICE

1. Sources Sought Number: 75N95019Q00293

2. Title: Mixed Gender Human Liver Microsomes" for NCATS Tox21 program.

3. Classification Code: 99- Miscellaneous

4. NAICS Code: 325413 - In-Vitro Diagnostic Substance Manufacturing

5. 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.

6. Statement of Need and Purpose: The Tox21 group of the National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) requires a reagent named "Mixed Gender Human Liver Microsomes". The "Mixed Gender Human Liver Microsomes" will be used in a p53-bla assay to identify the compounds with metabolic activation/inactivation on P53 induction. The purpose of the purchase is to screen Tox21 library collections (10,000 compounds) in a 1536-well high-throughput format. This project is one of the cross partner projects in the Tox21 collaboration between NCATS and NTP/EPA/FDA.

7. Purpose and Objectives: The mission of the Tox21 group of NCATS at the National Institutes of Health (NIH) is to develop better toxicity assessment methods to quickly and efficiently test chemicals for their potential disrupt processes in the human body that may lead to negative health effects.
Genotoxicity potential is a critical component within comprehensive toxicological profiles. Since P53 is often upregulated in cells subjected to physiological stresses and particularly to DNA damage, P53 activation can be used as an indicator of genotoxicity. Thus, identifying compounds which activate p53 is directly related to the Tox21 mission.

At present, NCATS has completed the Tox21 10k screenings for p53-bla project in the absence of metabolism. This purchase-needed metabolic project is to identify the compounds that require metabolism to activate/inactivate p53. The assay using human liver microsomes will be one of the powerful methods for identifying these kind of compounds. The p53-bla with human liver microsomes assay has been optimized and validated in 1,536 well plate formats.

8. Salient Characteristics
Microsomes are subcellular fractions, which are derived from the endoplasmic reticulum of liver containing a rich variety of metabolic enzymes for assessing the in vitro metabolism of drug candidates. They are effective tools for the in vitro evaluation of metabolism, drug-drug interactions, hepatotoxicity, and transporter activity.

Human liver microsomes are required by Tox21 groups to complete this project. "Mixed Gender Human Liver Microsomes" are prepared from fresh human liver tissue which ensures a higher retention of enzyme levels. This product has large pool of 50 donors with mixed gender that provides representation of population average of drug metabolism activity. Every donor used in the pool has a quality tested enzyme profile.

Quantity: 300 vials (1mL each) of "Mixed Gender Human Liver Microsomes"

Anticipated period of performance: NCATS expects to issue a purchase order in FY19 (no later than September 30, 2019). Delivery date will be 4 weeks ARO.

9. REQUESTED RESPONSE:

The intent of this sources sought notice is to define the procurement strategy (e.g. set-aside, sole source, unrestricted) for a solicitation that NCATS intends to post soon. Interested contractors are requested to respond by (1) identifying how their proposed product meets or exceeds each of the seven salient charactistics listed above, by number; and (2) providing product literature, white papers, or capability statements that demonstrate their bona fide ability to supply such an instrument within the time frame described above.

In addition, please state your business size status and whether you are the manufacturer or authorized distributor of the device you propose.

Please note that NCATS is particularly interested in small business sources. If you are a small business, please state the type of small business (small business; HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged businesses) and your 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.

Please note that if no responses to this notice are received from either authorized distributors or providers of potentially equivalent items, then this action will be sole-sourced to the provider cited above.

Please provide your DUNS number, organization name, address, point of contact, other information described above, and any other information that may be helpful in developing or finalizing the acquisition requirements.

The information submitted must be must be in an outline format that addresses each of the elements of the project requirement. A cover page and an executive summary may be included but is not required.

The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

10. All responses to this notice must reference number 75N95019Q00293 and be submitted by email to Jessica Adams, Contract Specialist at jessica.adams@nih.gov.

Responses must be received on or before August 8, 2019, at 5:00pm. Eastern Standard time.

11. 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).

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