BIOQUAL INC.NOTICE OF INTENT.NICHD-23-327.pdf

NICHD 23-327

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 Acquisition of Services for Lab Analysis for NIDDK Mice Studies.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380, Testing Laboratories and Services, and the Size Standard is $19.0.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2023-04 Effective June 2, 2023.

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

September 16, 2023– September 15, 2024 September 16, 2024– September 15, 2025 September 16, 2025– September 15, 2026 September 16, 2026– September 15, 2027

The Contractor shall provide the services contingent upon test system availability. Amounts for animal purchases are due at contract signing. Procedures and per diem will be billed each month as incurred.

Administration/Management will be billed monthly on a prorated basis until the end of in-life.

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 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.

Compounds: (1) GRFT, (2) Fc-mGRFT_opt, (3) gly_Fc-mGRFT_opt

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 INC tested the stability and toxicity of conjugates, Fc-mGRFT (opt and gly). 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.

This is a continuation of the studies done under:

POTS 18-009622 HHSN275201800419P

POTS 19-014157 HHSN75N94019P00897

POTS 22-012964 HHSN75N94022P00763

POTS 22-014644 HHSN75N94022P00775

POTS 23-009263 HHSN75N94023P00401

PURPOSE AND OBJECTIVES

The objective of this requirement 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 -3, 7, 14, and 21. Terminal Blood collections will be conducted on SD 28 for all mice. PCR and Luminex (flow cytometry) cytokine analyses will be conducted.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The purchase of specialized mice is required to determine HIV titers necessary for infection. The feature of this requirement include:

• (12) male CD34+NSG mice between the ages of 6-8 weeks old from an approved vendor.

• Mice (N=12) will be split into 4 groups of 3 mice each (N=3/group). All mice will be treated on SD -2, -1, and 0 (6h pre-challenge) through intravenous (IV) injection.

• Mice (N=12) will be challenged with HIV through intraperitoneal (IP) injection.

• In-life blood collections will occur on SD -3, 7, 14, and 21.

• Terminal Blood collections will occur on approximately SD 28 for all mice.

• Blood processing / serum isolation will be conducted.

• PCR and cytokine analyses by Luminex (flow cytometry) will be conducted.

TASKS AREAS

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

Areas listed below:

Task Area 1 – Serum Data. The Contractor shall provide data from PCR and Luminex (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.

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

DETERMINATION

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.

Compound: FcmGRFT (opt and gly)

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 INC tested the stability and toxicity of a conjugate called Fc-mGRFT (opt and gly). 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.

These in vivo animal studies are needed as a continuation of an ongoing project funded by the Office of AIDS Research to develop an antibody-protein conjugate as a potent HIV inhibitor. This study is a continuation of prior studies from the vendor all data must be comparable with the prior work.

POTS 18-009622 HHSN275201800419

POTS 19-014157 HHSN75N94019P00897

POTS 22-012964 HHSN75N94022P00763

POTS 22-014644 HHSN75N94022P00775

POTS 23-009263 HHSN75N94023P00401

This work must be completed by BIOQUAL INC, a company 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.

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. Any submitted capability statements must demonstrate relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger. 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 http://www.sam.gov/ considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

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.

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Friday, September 1, 2023 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov.

INVOICING PROCESSING PLATFORM (IPP)

Vendor/Contractor Must be able to accept payments via IPP (Invoice Processing Platform) The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause.

INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum "Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing" directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests" IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is:

https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at

(866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the contracting officer.

HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions. As used in this clause, Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE)

Assessment of Capability Lowest Price Technically Acceptable mailto:amber.harris@nih.gov https://www.ipp.gov/ mailto:IPPCustomerSupport@fiscal.treasury.gov