RFQ-NIAID-23-2175814_JOFOC REDACTED.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: OROV peptide pool order

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID, LVD, BI

Requestors name:

Requestors phone number:

Requestors email address:

Address of the requesting lab/office: 4 Memorial Drive, Bldg. 4, Bethesda, MD 20892

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value)

A. Type of action: (check the appropriate box) ☒ New requirement

B. AMBIS Sequence number for this requirement: _#2175814 C. Total estimated dollar value of the requirement (including options, if applicable):

D. Period of performance, inclusive of options: N/A

E. Project Background:

The section of Barrier Immunity (BI) within the Laboratory of Viral Diseases (LVD) conducts research to better understand the mechanisms of HIV/SIV disease progression and help facilitate therapeutic interventions aimed at decreasing disease progression. The LVD conducts a comprehensive program of research on the NIH intramural campus and works with scientists in academic and clinical laboratories through a program of national collaborations. Following the SARS-CoV2 pandemic, there has been an emphasis on researching viruses with “pandemic potential”, one of which is the Oropouche virus (OROV). There has been minimal OROV research done in non-human primate species.

F. Project Description:

The laboratory of Dr. Jason Brenchley requires the purchase of 408 peptides as outlined in quote # KBP230503 DY (KareBay Biochem, Inc) to assess the immunity from T cells in rhesus macaques against segments of the Oropouche virus. These peptides are designed from the protein sequences of two segments of the Oropouche viral assembly from previous studies. These peptides will be used to determine if Oropouche targets T cells and if so, which segment is prompting responses in rhesus macaques.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) ☒ 41 USC 253(c)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source ☐ 41 USC 501 a n d F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 253(c)(2) a n d F A R P a r t 6 . 3 0 2 - 2 : Unusual & compelling urgency ☐ 41 USC 253(c)(3) a n d F A R P a r t 6 . 3 0 2 - 3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services ☐ 41 USC 253(c)(4) a n d F A R P a r t 6 . 3 0 2 - 4 : International agreement ☐ 41 USC 253(c)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute ☐ 41 USC 253(c)(6) a n d F A R P a r t 6 . 3 0 2 - 6 : National security ☐ 41 USC 253(c)(7) a n d F A R P a r t 6 . 3 0 2 - 7 : Public interest

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited A. Name and address of the proposed contractor(s):

KareBay Biochem, Inc.

11 Deer Park Drive, Suite 102A Monmouth Junction, NJ 08852 USA Phone: 732-823-1545 Fax: 732-823-1349 Email: service@karebaybio.com

B. Describe why only the requested supply/service will meet the government’s needs

Using overlapping peptides specific to the Oropouiche virus is the simplest and most straightforward way to assess the immune response as the Brenchley lab has already developed a workflow to use them in study.

C. Describe why only the proposed contractor is capable of providing the requested supply/service

As these are for a newly studied virus, there are no readily available commercial options for the peptides and must be custom synthesized. The lowest acceptable quality and amount of peptides for these experiments would be 1 milligram of each peptide with at least 90% purity. The peptides can be synthesized by other companies, but other quoted costs (attached) for these peptides have been more expensive - KareBay Bio can provide them at the lowest cost at no expense to the purity/quality to try and lower the costs.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable

The price has been determined by the Contracting Officer to be fair and reasonable based on the comparison with similar services in this industry. Comparable vendors/services include:

A. 408 peptides KareBay Biochem, Inc. Quote # KBP230503 DY $10,435.00 B. 408 peptides Genscript Quote #U0498RUWG0 $42,529.08 C. 408 peptides JPT Quote #OF-13371 $89,656.00

Option A is the vendor with the cheapest pricing and best purity for this peptide order.

VI. Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.

Official Name & Title Signature Date

Requestor Certification Jason Brenchley, senior investigator

6/15/23

Contracting Officer Approval