NIA 21-011054

Submitted by mahonkg on Mon, 09/13/2021 - 08:40
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Generation of a novel mouse model to characterize the impact of NQO1 loss of function mutations on aging and common age-related diseases.
Contracting Office
National Institute on Aging (NIA)

Contact Points

Primary Contract Specialist

Taryn
Mabe
mabete@mail.nih.gov

Secondary Contracting Officer

Malita
Dyson
malita.dyson@nih.gov
NAICS Code Number
325414
Biological Product (Except Diagnostic) Manufacturing
Small Business Size Standard
1250
FPDS Classification Code
Q301
Estimated Period of Performance
September 27, 2021-September 26, 2022
Set-Aside Status
Not Set Aside
Competition Status
Non-Competitive
Vendor Name
Cyagen Biomodels LLC
Vendor Address
2255 Martin Avenue, Suite E
Santa Clara, CA 95050-2709
Single-Sole Source Determination
Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures and at a dollar value less than the simplified acquisition threshold are exempt from the requirements of FAR Part 6—Competition Requirements.

This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to Cyagen Biomodels, LLC. Cyagen has previously worked with NIA in the generation of other mouse models that will serve as controls for this study. These include a model that is deficient for NQO1 (mNQO1 KO) and a model that overexpresses human NQO1 (hNQO1 OE). These models have been extensively characterized by NIA's Translational Gerontology Branch (TGB), and this work has resulted in the publication of numerous peer reviewed scientific manuscripts. The vectors, cell lines, and other materials generated in the production of these prior models will be necessary for efficiently carrying out the work proposed and for ensuring consistency between the control and experimental (hNQO1*2 OE) mouse models. This includes Cyagen’s proprietary TurboKnockout technology. There are no agents or dealers authorized to represent this product. There is no other like item(s) or product(s) available for purchase that would serve the same purpose or function.

In conclusion Cyagen is the Sole Source vendor, as they are the only company with the available materials and institutional knowledge to generate this model in a manner that is consistent with the previous model that will serve as the control for these studies.
Background/Description of Requirement

This acquisition is being conducted under Federal Acquisition Regulations (FAR) Part 13 – Simplified Acquisition Procedures, and the resultant contract award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2021-07 dated September 10, 2021.

The Translational Gerontology Branch (TGB), National Institute on Aging (NIA) requires the generation of a novel mouse model is needed to better characterize the impact of NQO1 loss of function mutations on aging and common age related diseases.  

NQO1 is a multifaceted enzyme that plays an important role in anti-oxidant response, redox balance, and NAD metabolism, as well as other functions.  Overexpression of NQO1 has been shown to increase lifespan and healthspan in mice, and this enzyme may play a role in mediating some of the beneficial effects observed in response to caloric restriction.  In humans, the presence of a loss of function mutation in NQO1, NQO1*2, alters the risk of common age related diseases.  To better understand the effect of the NQO1*2 mutation on the regulation of different physiologic functions in vivo and assess how this impacts aging and the development of age related diseases, we will generate a mouse model in which the mutated form of human NQO1 (NQO1*2) is overexpressed in mice.  By comparing these mice to previously generated mouse models that are deficient for NQO1 or that overexpress an unmodified form of NQO1, we can directly determine the impact of this mutation.

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 Contractor is required to provide a novel mouse model generated in the C57BL/6N background in which a mutated form of the human NQO1 gene (P187S) will be conditionally expressed under the control of the ROSA26 promoter.  This model will allow for the selective overexpression of NQO1*2 in the presence of Cre-recombinase.  For direct comparison with other models that will serve as controls for this project, these mice must be generated with the same approach and materials used for generation of mNQO1 KO and hNQO1 OE mice.

LEVEL OF EFFORT:

The service will be provided by qualified technicians and project managers who have specific training and experience in the techniques needed to perform this work. This is anticipated to take between 30 and 49 weeks to complete.

GOVERNMENT RESPONSIBILITIES

The government will be expected to review and approve the project strategy and progress reports, and to verify the final products generated under the contract.  No access to government facilities will be required to complete this work. 

DELIVERY OR DELIVERABLES

The contractor would be required to ensure a timely delivery of a minimum of 3 TurboKnockout heterozygous mutant mice.

REPORTING REQUIREMENTS

The contractor will be required to provide written progress reports upon completion of each of the steps for this project as well as in the event of any problems encountered, problem resolutions, and unresolved problems.

KEY PERSONNEL

Experienced technicians and project manager to design and carry out the work.

Contract Type:

A Firm Fixed Price type order award not exceeding the Simplified Acquisition Threshold is anticipated to be awarded resulting from this requirement.

Summary Statement:

The Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response.

All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

Quoter Terms and Conditions (To be completed by the Offeror):

1. Period of Performance OR Delivery Date After Receipt of Order:

2. Shipping Point (F.O.B. OR Destination):

3. Payment Discount Terms:

4. NIH BPA Number, if applicable:

5. DUNS No:

6. Name of Company:

7. Street Address, City, State, Zip code:

8. Name of Person Authorized to Provide Quote:

9. Telephone Number and Email Address of Person Authorized to Provide Quote:

ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS
The FAR Clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/

1. The provisions of FAR clause at 52.212-4, Contract Terms and Conditions—Commercial Items (Oct 2018) are applicable to this solicitation.

2. The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jan 2021) are applicable to this solicitation:

52.222-3 Convict Labor (Jun 2003)
52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2020)
52.222-21 Prohibition of Segregated Facilities (Apr 2015)
52.222-26 Equal Opportunity (Sep 2016)
52.222-50 Combating Trafficking in Persons (Oct 2020)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020)
52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Oct 2018)
 

In addition, the following FAR provisions are applicable to this solicitation and incorporated by reference:

1) 52.204-13 System for Award Management Maintenance (Oct 2018),
2) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2018).

The following provisions and clauses apply to this acquisition.  Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their quotation.

1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)

2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)

3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)

4. NIH Invoice and Payment Provisions (February 2021)

5. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.