Litron Multiflow and Microflow Kits

Single Source Acquisition Notification 75F40125Q130500

The Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR intends to award a Purchase Order on a Single Source basis to Litron Laboratories LTD, 3500 Winton Pl, Rochester, NY 14623, under the authority of FAR 13.106-1(b)(1), Only one Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

The FDA/NCTR requires four (4) MicroFlow In-vitro-1,000/200 kits and six (6) MultiFlow DNA Damage – p53, yH2AX, and Phospho-Histone H3 kits, which will be used for assessing potential genotoxicity of FDA-regulated products (ICH guideline approved).

The associated North American Industry Classification System (NAICS) Code 325414 - Biological Product (except Diagnostic) Manufacturing; with a Small Business Size Standard of 1,250 employees

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1).

Any firm that believes they can provide the required item(s) as stated herein may submit their capability statement referencing Solicitation 75F40125Q130500 to document their ability on or before July 16, 2025 by 1:00 PM Central Time - Local Prevailing Time in Jefferson, Arkansas by e-Mail to howard.nesmith@fda.hhs.gov. A determination to compete this procurement based on

a response to this notice is solely within the discretion of the government.

Minimum Technical Requirements:

• In-vitro Micronucleus Kit shall be capable of being used to analyze in vitro samples via flow cytometer using a Becton Dickinson FACSCanto II with a High Throughput auto Sampler (HTS).

o Each kit shall contain sufficient quality assured reagents and supplies to analyze 1,000 samples in 96-well plate format or 200 samples in larger microtube format.

o Each kit shall allow automated scoring by flow cytometry.

o Each kit shall be compatible with 96 well plates, as well as autosamplers and robotics.

o Each kit shall be compatible with many different cell lines (more than one type).

o Each kit shall be compatible with cells which grow in attachment or suspension.

o Supplier shall provide unlimited technical support.

o Each kit shall be compatible for use with a variety of attachment and suspension cell lines including L5178Y, CHO-K1, TK6, V79, WIL-2, and HepG2, among others.

o Each kit shall be capable of detecting multiple Modes-of-Action.

• Each MultiFlow DNA Damage Kit shall contain all of the quality assured supplies and reagents to study multiple endpoints associated with DNA damage response pathways.

o Endpoints shall include p53 as an indicator of nuclear p53, γH2AX as a measure

of DNA double strand breaks, and phospho-histone H3 to label mitotic cells.

• Kits shall arrive in multiple boxes due to the various temperature requirements (some on

dry ice, some on wet ice, and some at room temperature).

• Kits shall be delivered in a single delivery to NCTR within 90 days of contract award

using the required shipping method to ensure safe and proper arrival of item.

Single Source Determination Based Upon:

• The required kits have been used for more than 10years to assess the genotoxicity of

various chemicals or chemical mixtures in several protocols.

• Litron Laboratories is the owner and manufacturer of the assay kits and is the only known

seller of the kits.

• No additional sources have been identified as being capable of providing the required

kits.

• Data generated from associated projects have been used to support other FDA Centers for

regulatory decision-making and published in peer-reviewed journals.

• Competing this requirement would result in significant detrimental delays in fulfilling

Agency’s requirement.

• Acquisition of these kits are essential for the continuity of the data collection; past,

present, and future.

• A change in provider would compromise the integrity of future study and impact the

entire research program.

• In an effort to maintain continuity and consistency, FDA/NCTR intends to purchase the

required kits from Litron Laboratories.