BIOQUAL INC.NOTICE OF INTENT.75N94024Q00110.pdf

RFQ# 75N94024Q00110

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to BIOQUAL INC for the Services for Humanized Mice Studies.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size Standard of $19.00.

PRIMARY PRODUCT/SERVICE CODE

Q301 - LABORATORY TESTING SERVICES

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 2024-04 Effective May 1, 2024.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

PERIOD OF PERFORMANCE

June 1, 2024 – May 31, 2025

Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 8 Center Drive Bethesda, MD 20892

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

DESCRIPTION OF REQUIREMENT

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

The NIDDK supports a wide range of medical research through grants to universities and other medical research institutions across the country. The Institute also supports government scientists who conduct basic, translational, and clinical research across a broad spectrum of research topics and serious, chronic diseases and conditions related to the Institute's mission. In addition, the NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public.

The Natural Products Chemistry Section requires studies to determine the in vivo anti-HIV activity of our novel APC’s. These studies are being done on optimized antibody-lectin conjugates (APC) that prevent HIV infection.

The research study is to expand viral particles and measure infectious virus titers, required to determine the viral load necessary for robust infection in humanized mice. Infection will be measured by PCR and flow cytometry of T-cells in infected and control mice. In-life blood collections will be conducted on SD -1, 7, 14, 21, 28, 35, 42, and 49. Terminal Blood collections will be conducted on SD 56 for all mice. Blood processing / serum isolation will be conducted. Additionally, PCR and flow cytometry will be conducted.

Compounds: (1) GRFT, (2) mGRFT-Fc(glyc) (3) Vehicle

The NPCS carries out research aimed at developing anti-HIV and antiviral antibody-protein conjugates. This is a long-term project that has been funded by the Office of AIDS Research. Previous studies with BioQual tested the stability and toxicity of conjugates, mGRFT-Fc(glyc) The research has advanced to a point where testing for in vivo anti-HIV activity is necessary for further development. To do this, we will use a humanized mouse model (that has human CD4 T-cells, a host cell for the HIV virus) and challenge with HIV virions.

PURPOSE AND OBJECTIVES

The objective of this requirement is to procure two (2) mice challenge studies to determine HIV titers necessary for infection.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The required features for the mice challenge studies are:

Study one

(1560.2) NDDK-24-01

Contractor shall provide 15 male CD34+NSG mice between the ages of 6-8 weeks old from an approved vendor.

The mice (N=15) will be split into 3 groups of 5 mice each. All mice will be treated on SD 0 (6h pre-challenge) through intravenous (IV) injection. The mice will be challenged with HIV through intraperitoneal (IP) injection on SD 0.

In-life blood collections will occur on SD -1, 7, 14, 21, 28, 35, 42, and 49. Terminal blood collections will occur on approximately SD 56 for all mice. Blood processing / serum isolation will be conducted. Additionally, PCR and flow cytometry will be conducted. Weights and clinical observations will be recorded on days of procedures.

There will no QC or final report.

Study two

(1561.2) NDDK-24-02

Contractor shall provide 15 male CD34+NSG mice between the ages of 6-8 weeks old from an approved vendor.

The mice (N=15) will be split into 3 groups of 5 mice each. All mice will be treated on SD 1 (24h post-challenge) through intravenous (IV) injection. The mice will be challenged with HIV through intraperitoneal (IP) injection on SD 0.

In-life blood collections will occur on SD -1, 7, 14, 21, 28, 35, 42, and 49. Terminal Blood collections will occur on approximately SD 56 for all mice. Blood processing / serum isolation will be conducted. Additionally, PCR and flow cytometry will be conducted. Weights and clinical observations will be recorded on days of procedures. There will no QC or final report.

TASK AREAS:

Independently, and not as an agent of the Government, the contractor shall perform all the detailed Task Areas listed below:

Task Area 1 – Serum Data – The Contractor shall provide data from PCR and flow cytometry of T-cells in infected mice from each bleed to the NPCS by either electronic transfer or hard copy mail as needed.

Task Area 2 – Final Report – The Contractor shall provide a final report via email (to be scheduled by Project Officer); billed upon receipt of the first draft.

Task Area 3 – Testing – The Contractor shall provide the services contingent upon test system availability.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME)

DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined BIOQUAL INC to be the only reasonable available source to provide Services for Humanized Mice Studies.

This acquisition was pursued on a sole source basis centered on the following: BioQual, Inc., is the sole entity that specializes in pre-clinical and clinical evaluation of pharmaceuticals and has successfully completed NIH studies in the past. With respect to this purchase order, BioQual, Inc., has worked extensively on HIV/AIDS drugs in cooperation with NIH researchers including NIDDK, NCI, NIAID, and the Vaccine Research Center. They have shown great care and reliability in carrying out these very important and sensitive animal studies. BioQual, Inc., holds AAALAC accreditation (file # 624) and is Animal Welfare Assurance compliant with an OLAW-approved Assurance Number A-3086-01. The NIDDK must continue using this vendor in the project for scientific continuity. That continuity will help the NIDDK to avoid the introduction of new variables into its research and to avoid long delays and additional costs resulting from retesting products from other potential suppliers.

Failure to procure these deliverables from BIOQUAL INC would result in a significant loss of research. Based on the proposal received, it was determined that BIOQUAL INC is the best source able to meet the requirements for this order.

The Natural Products Chemistry Section requires studies to determine the in vivo anti-HIV activity of our novel APC’s. These studies are being done on optimized antibody-lectin conjugates (APC) that prevent HIV infection.

The in vivo animal studies are needed as a continuation of an ongoing and long-term project that has been funded by the Office of AIDS Research to develop an antibody-protein conjugate as a potent HIV inhibitor. The continuation of prior studies and data must be comparable with the prior work. Previous studies with BioQual tested the stability and toxicity of a conjugate called mGRFT-Fc(glyc). The research has advanced to a point where testing for in vivo anti-HIV activity is necessary for further development. To do this, we will use a humanized mouse model (that has human CD4 T-cells, a host cell for the HIV virus) and challenge with HIV virions.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (UEI), 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.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, May 22, 2024 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov .

Assessment of Capability Lowest Price Technically Acceptable http://www.sam.gov/ mailto:amber.harris@nih.gov