NCTR-2026-132197 Sources Sought Notice.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Irradiated Sani-chip Bedding

The Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) needs contact bedding for primary enclosures used to house animal species (mostly rodents) at the research vivarium facilities.

The FDA is seeking to identify capable small business sources to determine the availability and capability of small businesses equipped to provide the required products. Businesses that are ‘Other than small’ business concerns are also encouraged to submit capability statements. The information is requested to assist the FDA in conducting Market Research to identify potential sources for this effort.

The associated North American Industry Classification System (NAICS) Code is: 334517 – Irradiation Apparatus Manufacturing; the applicable Small Business Size Standard is 1,200 employees.

Statement of Work

Irradiated Sani-chip Bedding

1.0 INTRODUCTION

1.0 Background

The Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) needs contact bedding for primary enclosures used to house animal species (mostly rodents) at the research vivarium facilities. The bedding allows absorption of urine and feces to facilitate cleaning and sanitation. This bedding will:

1. Provide substrate for resting and sleeping;

2. Absorb moisture, minimize the growth of microorganisms, and dilute and limit animals’ contact with excreta, and reduce the accumulation of intracage ammonia;

3. Enhance animal well-being by providing animals with sensory and motor stimulation, and providing opportunities for species-specific behavior such as foraging, digging and burrowing; and

4. Facilitate in-animal thermoregulation.

1.1 Objectives

The objectives for this requirement are as follows. The bedding:

1. Must be composed of heat-treated, cube-cut type hardwood chip bedding, free of splinters, shavings, slivers, excessive dust, and all foreign matter;

2. Must be treated with high heat (kiln drying or autoclaving) reduces the concentration of volatile organic compounds;

3. Must be irradiated and free of microbial contamination;

4. Must be free of contamination from toxins and other substances, bacteria, fungi, parasites and vermin; and

5. Will be part of the essential animal husbandry material used in the NCTR animal housing facilities located on the Jefferson Laboratories campus that is supporting the needs of the studies conducted under the National Toxicology Program.

2.0 SCOPE

This requirement is for the purchase of cube-cut, irradiated, heat-treated wood chip animal bedding substrate. The period of performance includes a base period of one (1) year followed by four (4) option years. The purchase is an indefinite quantity up to a maximum of two thousand (2,000) units.

3.0 DELIVERY TO:

Food and Drug Administration National Center for Toxicological Research (NCTR)

3900 NCTR Rd Jefferson, AR 72079-9501

4.0 TECHNICAL AND PERFORMANCE SPECIFICATIONS

4.1 Material:

1. The raw material processed for the product covered by this specification shall be from beech, birch, aspen, or maple or any mixture thereof;

2. The raw material processed for the product covered by this specification shall be free of bark, dirt, trash, metal, stones or other foreign materials;

3. No other species of wood will be acceptable, nor will the presence of other species be permitted with any single species or mixture of the acceptable species;

4. Decayed raw materials or raw materials that have been used for other purposes (i.e., used lumber) shall not be used in products covered by this specification; and

5. Respondents shall state in their bid the species or combination of species to be furnished.

4.2 Form:

1. The finished product shall be a cube cut type and shall be free of shavings and slivers as described below;

2. The finished product shall meet the following specification. After a 100 gram sample is shaken in a Ro-Tap machine (Ro-Tap RX-812) for three (3) minutes, not more than 10± 1% (by weight) shall be retained on a #8 U.S. Standard Sieve (ASTM specifications), nor will more than 0.2± 0.5% dust pass through a #20 sieve (ASTM specifications). No more than .7% of the original sample weight of the original sample shall remain in the receiver pan; and

3. The particle size of bedding shall fit within these testing parameters and pass particle size testing as summarized by the following:(see attached NCTR SOP OSC CHEM 316.03 for particle size limit testing):

a. #8 Sieve – no more than 10% of the original sample weight.

b. Receiver Pan – no more than 0.7% of the original sample weight.

4.3 Processing/Heat-Treatment:

1. Materials shall be rotary drum dried, with a maximum temperature of 1200 degrees Fahrenheit, for twenty (20) minutes; and

2. The moisture content shall be reduced to eight percent, with a two percent variance, a process that kills most harmful bacteria.

4.4 Irradiation:

1. Bedding shall receive a minimum dose of fifteen (15) kGy irradiation; and

2. Each bag shall be marked with an indicator proving that irradiation complying with this specification has been affected.

4.5 Chemical Contaminant Restrictions:

1. The finished product shall contain no harmful resins or volatile oils which may stain animal fur or otherwise cause irritation to the animal;

2. If at any time a shipment of bedding contains any of the contaminants listed below in excess of the concentration designated, that shipment shall be replaced by the contractor within thirty (30) calendar days at no expense to the Government.

Pesticide Residues Maximum Levels (ppm)

Alpha BHC < 0.02

Beta BHC < 0.02

Lindane < 0.02

Adlrin < 0.02

Hepatachlor Epoxide < 0.02

Dieldrin < 0.02

Endrin < 0.02

DDT < 0.03

DDD < 0.02

DDE < 0.02

Diazinon < 0.10

Ethyl Parathion < 0.03

Methyl Parathion < 0.03

Malathion < 0.05

Ethion < 0.02

Ronnel < 0.03

Triothion < 0.03

Polychlorinated Biphenyls < 0.20

Pentachlorophenol < 0.10

Heavy Metals Maximum Levels (ppm)

Pesticide Residues Maximum Levels (ppm)

Lead < 0.5

Mercury < 0.1

Cadmium < 0.1

Arsenic < 0.2

Aflatoxins < 10 ppb

4.6 Particle Size Limits:

1. Particle size of bedding shall fit within these testing parameters and pass particle size testing (see attached NCTR Laboratory Standard Operating Procedures (SOP) for particle size limit testing).

a. #8 Sieve – no more than 10% of the original sample weight.

b. Receiver Pan – no more than 0.7% of the original sample weight.

4.7 Packaging

1. Bags and materials used in packaging the bedding shall comply with the requirements in NIH Standard No. 4, latest issue in unless otherwise stated;

2. Bedding will be packaged in 2.2 cu. ft. bags measuring approximately 8”X16”X24”;

3. Each bag shall be marked (either on the bag or via tag) with the lot number and the date of manufacture;

4. Other markings are restricted to the trade name of the product, the name and address of the manufacturer, the net weight, and the bag manufacturer’s trademark or identification;

5. The finished product shall be palletized and stretch wrapped (a minimum of 2 times) using a 4-way entry pallet made of hardwood or plastic and to industry standard of 40” x 48”; and

6. A standard pallet will be packed with fifty (50) bags per pallet, stacked five (5) bags/layer and ten (10) layers high

4.8 Delivery and Shipping

1. The frequency of shipments is anticipated to be quarterly; however, the frequency of shipments will vary to meet the needs of NCTR’s research program

2. NCTR will notify the vendor each time a shipment is needed via formal communication from the Contracting Officer/Specialist;

3. The number of bags needed for each shipment may vary and will be specified at the time of the order;

4. The minimum order will be five hundred (500) bags with a maximum order of one thousand five hundred (1,500) bags per order; and

5. All bags to be shipped in the first half of each year of the contract shall be from the same lot; all bags shipped in the second half of each year of the contract shall be from the same lot.

4.9 Bedding Analysis:

1. Each shipment of bedding is subject to analysis by NCTR or other testing facilities for particle size, moisture content, and chemical contaminants as specified in above sections of this document; and

2. Testing results found to be noncompliant with these specifications will be rejected.

4.10 Approval Recall and Replacement:

1. A shipment of bedding will be rejected or accepted by the Government within sixty (60) calendar days after receipt;

2. The contractor shall remove a shipment of bedding from the NCTR premises within thirty (30) calendar days of receipt of notification of the rejection by the Government;

and

3. Replacement shipment will be delivered within ten (10) calendar days of the Government request.

5.0 TECHNICAL AND PERFORMANCE SPECIFICATIONS

This standard establishes the requirements in the following areas of laboratory animal bedding processing (1) raw material, manufacturing facility and warehouse sanitation (2) treatment for product processing and (3) product packaging.

5.1 Plant Sanitation:

1. The Manufacturer shall have a written Standard Operating Procedure (SOP) for the maintenance and sanitation of the receiving, production, and storage areas;

2. These SOP's shall provide, in detail, methods that are used to ensure these areas remain orderly, sanitary, properly maintained and pest free to comply with the standards herein;

3. These SOP's shall also contain a schedule for the maintenance and sanitation of the aforementioned areas;

4. A copy of these SOP's with the name and title of person(s) responsible for ensuring that these duties are performed shall be provided to the Government Inspector at time of inspection of the facility; and

5. To prevent contamination of raw materials and product, plant sanitation methods at a minimum shall include the following:

a. Daily cleaning and removal of all loose raw material and debris from floors around production apparatus; and

b. Periodic removal of trash, dirt, and other debris lodged on floors, walls, I- beams, pipes, and ceilings of the production facilities and warehouses.

5.2 Pest Management:

1. The Manufacturer shall have in place a documented integrated pest management program provided by a licensed pest control company;

2. The pest control company shall adhere to all applicable local, State, and Federal regulations;

3. The program shall consist of regularly scheduled pest management services, including monitoring for pests (pests include invertebrate and vertebrate animals), and surveying facilities for conditions that promote pest activity;

4. The program shall emphasize the use of non-chemical pest management methods such as traps, exclusion, harborage reduction, and strive to provide corrective actions/recommendations that will provide long lasting control while reducing pesticide usage;

5. The manufacturer shall maintain accurate and complete records of all pest management activities and shall provide these records to the Government Inspector at the time of facility inspection;

6. Manufacturing and product storage areas shall be effectively rodent and bird proofed.

These areas shall be free of insects, rodents, and birds at all times;

7. Pest management records shall be maintained in a logbook and at a minimum contain the following sections:

a. Program Information - this section shall contain pest management company contacts and service personnel information;

b. Client Pest Sighting- this section is intended for facility personnel to record pest sightings and to communicate that to the pest management professional servicing the facility;

c. Pesticides - this section shall include a list of primary pesticides to be applied at the manufacturing facility. A current copy of each pesticide label and MSDS, (material safety data sheets) shall be included in the order it was listed;

d. Facility Map - a floor plan(s) shall be used to indicate the location of any type of pest management device. i.e., sticky trap, pheromone trap, light trap, rodent trap etc. used in the integrated pest management (IPM) program. The locations of pest control and monitoring devices shall be maintained and kept current;

e. Service Reports - Pest management services performed at the facility shall be placed in this section. Service report records shall include but not be limited to:

i. Results of monitoring and inspections, including accepted common/generic names of all pests, numbers of each pest, and the location in the facility they were trapped or observed.

ii. Pest sightings and conditions conducive to pest infestation shall be reported on pest management data sheets.

iii. Specific written recommendations evaluating sanitation conditions, structural repairs i.e., caulking, sealing, and harborage reduction as well as operational changes that will prevent and/or reduce pest problems and enhance the effectiveness of the pest management program.

iv. Control products applied, the concentrations and quantities of all pesticides applied, including the accepted Environmental Protection Agency common names (generic names), method(s) of application, area of application in the feed mill, warehouse and other surrounding grounds.

8. “Restricted Use” pesticide application will be undertaken by a certified pesticide applicator or licensed pest control contractor or under the direct supervision of same in accordance with label directions and local, State and Federal regulations;

9. “General Use” pesticides, in states not requiring certification, may be undertaken by a person who has attended a pesticide seminar or been trained by a licensed applicator and who has demonstrated to have expertise and knowledge in the correct and safe use of pesticides or is under direct supervision of a Certified Pesticide Applicator. All applications shall be made in compliance with label directions;

10. Outside bait stations designed for mouse and rat control using EPA registered rodenticide baits shall be tamper resistant, labeled, locked, and secured in place around the facility’s perimeter. Bait station covers should be secured by mate that cannot be easily severed;

11. Internal measures for rodent control monitoring programs shall include device such as glue boards, mechanical traps, extended trigger traps, but not feeding stations; and

12. No domestic animals or fowl, wild animals or birds shall be confined in or have entry to building(s) housing production equipment, delivery site of and provide storage for feed ingredients or storage for the finished product. Provide, when necessary, effective screening or other protection against pests.

6.0 PERIOD OF PERFORMANCE

All dates are approximate to be finalized upon award.

Base period: 1/10/2026 – 1/9/2027

Option Year 1: 1/10/2027 – 1/9/2028

Option Year 2: 1/10/2028 – 1/9/2029

Option Year 3: 1/10/2029 – 1/9/2030

Option Year 4: 1/10/2030 – 1/9/2031

Each Order against this IDIQ shall be funded at the time the Order is placed; Orders will be placed based on funds availability and the needs of the Federal Government.

7.0 PLACE OF PERFORMANCE

National Center for Toxicological Research (NCTR) 3900 NCTR Rd.

Jefferson, AR 72079

8.0 GOVERNMENT FURNISHED EQUIPMENT (GFE)/GOVERNMENT

FURNISHED INFORMATION

No government-furnished property or government-furnished information will be provided in the scope of this acquisition.

END OF STATEMENT OF WORK

SOURCES SOUGHT RESPONSE INSTRUCTIONS

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond.

At a minimum, responses shall include the following:

1. Part 1: Company Overview

a. Business name;

b. SAM Unique Entity ID number;

c. Business address;

d. Business website;

e. Business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB); and

f. Point of contact name and mailing address (if different from business address), phone number and email address.

2. Part 2: Descriptive Literature

a. Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the requirements articulated in the Statement of Work (SOW).

b. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, ISO certifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the contractor to meet the requirement.

3. Part 3: Past Performance

a. Three (3) years of past performance product/service information, where the respondent has provided same or substantially similar products/service solutions on the same or near-same brand name equipment.

b. For each past performance reference include:

i. Date of sale;

ii. Description;

iii. Dollar value;

iv. Client name and client address;

v. Client point of contact name, mailing address (if different from that provided for client), phone number, and email address; and

vi. Name of the manufacturer (to include SAM Unique Entity ID number and size status) if not the respondent.

4. Part 4: Requirements Response

a. Please indicate if any of the above specifications are too restrictive and recommend an alternative.

5. Part 5: Other Information

a. GSA Schedule contract(s): If applicable, identify the respondent’s GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Include a detailed list of items included and not included on the GSA contract to meet this requirement.

b. Best in Class (BIC) contracts: If applicable, identify the respondent’s Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

c. Subcontracting Opportunities: If a large business, identify the subcontracting opportunities that would exist for small business concerns.

d. Warranty and Terms: Include your standard commercial warranty and payment terms.

e. Place of Manufacture: Indicate the place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed; and

f. Informational Pricing: Though this is not a request for quote, informational pricing is encouraged.

Response Date and Time

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before December 15, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov. Reference NCTR-2026-132197.

mailto:david.kramer@fda.hhs.gov

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).