Evaluating NNMT Inhibitors in Metabolic Disorders

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 NAICS code 541380 should not submit a response to this notice.

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 and Objectives:  

NNMT is a methyltransferase, a metabolic enzyme that transfers a methyl group form SAM to nicotinamide. Its activity is upregulated in several diabetes and obesity models in preclinical studies and has also been observed in humans. Successful proof of concept experiments by silencing the gene and with unoptimized small molecule inhibitors has been demonstrated in literature. In collaboration with the NCI and University of Chicago, the National Center for Advancing Translational Sciences (NCATS) has developed exquisitely potent selective and orally bioavailable small molecule inhibitors of NNMT. We would like to demonstrate proof of concept with lead compounds in multi-week dosing studies in four different animal models (diabetes induced obesity, ob/ob, db/db, Zrucker rat models).

Project Requirements:

Contractor will be required to perform the following:

1. Receive compound from NCATS and conduct the following studies sequentially in predetermined dose, formulation, and route of administration for a period of 4 weeks:

Study-1: male C57 mice, n=8, 4 groups

Group 1 = normal diet

Group 2 = HFD + vehicle

Group 3 = HFD +TA@ low dose

Group 4 = HFD +TA@ high dose

Study-2: male ob/ob mice, n=8, 2 groups

Group 1 = ob/ob mice + vehicle

Group 2 = ob/ob mice + TA

Study-3: male db/db mice, n=8, 2 groups

Group 1 = db/db mice + vehicle

Group 2 = db/db mice + TA

Study-4: male ZDF rats, n=8, 2 groups

Group 1 = ZDF rat + Vehicle

Group 2 = ZDF rat+ TA

2. Provide periodic reports to NCATS with observations on food intake, body weight, glucose, and insulin.

3. Conduct histology on specific organs on a subset of animals at conclusion of study. 

4. Conduct test glucose tolerance test at the end of the study on a subset of animals on a specific arm of the study.

5. Monitor compound and metabolite in plasma liver and white adipose tissue in specific arms of the study.

6. The Contractor shall be required to have an active NIH OLAW Animal Welfare Assurance and AALAC accreditation. Do not provide the actual assurance with your response but indicate whether you possess these qualifications.

Note:  NCATS will supply compound, formulation, exposure study details and a study design to the Contractor.

Anticipated Period of Performance: 

The anticipated period of performance is 12 months from the date of award.

Capability Statement:

Small business concerns that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.  Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information.

Interested small businesses are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

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) pages.  The 10-page limit does not include the cover page, executive summary, or references, if requested.

All capability statements sent in response to this Sources Sought Notice must be submitted to Scott Bredow, Contracting Officer, via email at scott.bredow@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Facsimile responses are not acceptable.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response.  No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities.  However, responses to this notice will not be considered adequate responses to a solicitation.  The solicitation release date is pending. 

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).