Sol Doc 132197.pdf

Solicitation: 75F40126Q132197 (Page 1)

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR RFO Part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. The solicitation number is 75F40126Q132197. This solicitation is issued as a Request for Quote (RFQ) for Irradiated Sani-chip Bedding for primary enclosures used to house animal species at the research vivarium facilities.

This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul.

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

Schedule of Items (all shipping and handling shall be included in the price). Note: Quantities listed are for evaluation purposes only.

Contract

Line Item

Description Quantity Unit Unit Price Extended Price

Ordering Period 1:

Irradiated Sani-chip Bedding of 2.2 cu ft. per Bag as specified herein.

1,500 EA $ ______ $ _________

Ordering Period 2:

Irradiated Sani-chip Bedding of 2.2 cu ft. per Bag as specified herein.

1,500 EA $ ______ $ _________

Ordering Period 3:

Irradiated Sani-chip Bedding of 2.2 cu ft. per Bag as specified herein.

1,500 EA $ ______ $ _________

Ordering Period 4:

Irradiated Sani-chip Bedding of 2.2 cu ft. per Bag as specified herein.

1,500 EA $ ______ $ _________

Ordering Period 5:

Irradiated Sani-chip Bedding of 2.2 cu ft. per Bag as specified herein.

1,500 EA $ ______ $ _________

Total Evaluated Price (CLINs 0001 – 4001) $ ____________________ https://www.acquisition.gov/far-overhaul

Solicitation: 75F40126Q132197 (Page 2)

Contract Line Item

Description Quantity Unit Unit Price Extended Price

Solicitation: 75F40126Q132197 (Page 3)

Statement of Work Irradiated Sani-chip Bedding

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.

2.0 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.

3.0 Scope

This requirement is for the purchase of cube-cut, irradiated, heat-treated wood chip animal bedding substrate. The period of performance is five (5) year ordering periods. The purchase is an indefinite quantity up to a maximum of seven thousand five hundred (7,500) units over the 5 year ordering period.

4.0 Delivery to:

US Food and Drug Administration National Center for Toxicological Research (NCTR) 3900 NCTR Rd Jefferson, AR 72079-9501

5.0 Technical and performance specifications

Solicitation: 75F40126Q132197 (Page 4)

5.1 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.

5.2 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.

5.3 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.

5.4 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.

5.5 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

Solicitation: 75F40126Q132197 (Page 5)

Pesticide Residues Maximum Levels (ppm) 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) Lead < 0.5 Mercury < 0.1 Cadmium < 0.1 Arsenic < 0.2 Aflatoxins < 10 ppb

5.6 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.

5.7 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

Solicitation: 75F40126Q132197 (Page 6)

5.8 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;

5. The contractor will be required to deliver, unload, and haul the deliveries to specified locations as defined in the Delivery Orders;

6. The contractor is required to bring the necessary equipment to unload and haul the delivery which may involve delivery inside animal research facilities;

7. Other FDA Centers and locations may also receive deliveries as needed to meet the mission needs of the FDA and will be identified at the Delivery Order level; and

8. 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.

5.9 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.

5.10 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.

6.0 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.

6.1 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

Solicitation: 75F40126Q132197 (Page 7) 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.

6.2 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.

Solicitation: 75F40126Q132197 (Page 8)

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.

7.0 Minimum and Maximum Quantities

1. The contract guaranteed minimum will be $6,500.

2. Funding for this minimum guarantee will be obligated against the base contract award.

3. If the contractor is issued a Delivery Order off the IDIQ, then the Delivery order amount will be reduced by the minimum guarantee obligated on the IDIQ contract.

4. The contract maximum of all orders issued over five (5) year ordering periods and awarded under this contract is estimated not to exceed 10,000 units including any shipping costs though this ceiling can be increased via mutual agreement of the parties.

5. The estimated maximum anticipated under this contract is not intended to imply that it is an estimate of the total products that will be required.

6. The maximum amount in no way guarantees that the volume of purchases through this IDIQ will be higher or lower than the said estimate over the term of the IDIQ.

8.0 Ordering Procedures / Delivery Schedule

Ordering under this contract shall be accomplished by the issuance of written Delivery Orders.

The only individual authorized to process Delivery Orders for the FDA is an Office of Acquisitions & Grants Services (OAGS) Contracting Officer.

Solicitation: 75F40126Q132197 (Page 9)

All Delivery Orders issued hereunder are subject to the terms and conditions of this contract.

This contract shall control in the event of conflict with any Delivery Orders. The general process for individual Delivery Orders is as follows:

1. The FDA will prepare a Statement of Work (SOW). The SOW will include, at a minimum, the following elements:

a. Description of products required and quantity.

b. Delivery location.

c. Delivery schedule and Performance Period. (Each Delivery Order may have multiple shipment dates.)

d. Anything else necessary for the Delivery Order.

2. Delivery Orders shall only be issued by the FDA OAGS Contracting Officer or Specialist.

3. The Contractor shall acknowledge receipt of the Delivery Order and confirm acceptance of all requirements within the time period specified in the order.

4. The Contractor shall adhere to the product pricing established in the contract and deliver in accordance with the specified schedule and requirements.

5. Other direct costs such as shipping shall be clearly identified, explained, and substantiated if not already included in the contract pricing.

6. The FDA Contracting Officer placing the Delivery Order shall issue either an OF347, SF1449 or other designated form to the Contractor.

7. Delivery Order performance periods may extend beyond the five (5) year ordering period provided the Delivery Order was issued prior to the ordering period expiration.

8. Delivery Order performance periods may extend up to and not longer than one (1) year after the end of the ordering period.

Delivery Orders issued against this contract vehicle will be Firm-Fixed-Price (FFP).

Specific delivery details will be provided in the delivery order, such as the delivery address, point of contact information, the feed required and delivery schedule and any specific local delivery requirements for security or loading dock delivery requirements. Changes to the delivery schedule may occur after issuance of the Delivery Order at the request of the FDA as long as adequate notice (minimum of two (2) weeks) is given to the contractor and as long as the changes are within the period of performance of the Delivery Order. Any changes that fall outside the period of performance of the Delivery Order will require the Contracting Officer to modify the Delivery Order. No one other than the Contracting Officer is authorized to change the terms and conditions of the Delivery Order.

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

Solicitation: 75F40126Q132197 (Page 10)

9.0 Period of Performance

All dates are approximate to be finalized upon award.

Ordering period 1: 3/30/2026 – 3/29/2027 Ordering period 2: 3/30/2027 – 3/29/2028 Ordering period 3: 3/30/2028 – 3/29/2029 Ordering period 4: 3/30/2029 – 3/29/2030 Ordering period 5: 3/30/2030 – 3/29/2031

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.

Delivery Orders may be issued up to the final day of this contract inclusive of any extensions thereto, and the contract shall remain in force to allow for the completion of all Delivery Orders issued. Delivery orders performance periods may go up to one (1) year past the IDIQ Ordering Period end date and products prices shall remain at the last ordering period rates.

10.0 Place of performance

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

Jefferson, AR 72079

11.0 Government Furnished Equipment (GFE)/Government Furnished Information

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

12.0 Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

• New Year’s Day

• Martin Luther King Day

• President’s Day

• Memorial Day

• Juneteenth Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veteran’s Day

• Thanksgiving Day

• Christmas Day

Solicitation: 75F40126Q132197 (Page 11)

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

13.0 Contract Administration

a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer Phone: 870-543-7370 Email: nick.sartain@fda.hhs.gov

b. Contracting Officer’s Representative (COR) – The following COR will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The COR is responsible for:

1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

2) Interpreting the statement of work and any other technical performance requirements;

3) Performing technical evaluation as required;

4) Performing technical inspections and acceptances required by this contract; and

5) Assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

1) Direct or negotiate any changes in the statement of work;

2) Modify or extend the period of performance;

3) Change the delivery schedule;

4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

5) Otherwise change any terms and conditions of this contract.

mailto:nick.sartain@fda.hhs.gov

Solicitation: 75F40126Q132197 (Page 12)

14.0 Inspection and Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the COR specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

15.0 Payments

Payment terms Net 30 days after government acceptance. No advance payments will be made.

16.0 Invoice Submission

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the

U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, 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, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

Solicitation: 75F40126Q132197 (Page 13) submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirects) - show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

1. List of all invoices submitted to date under the subject award, including the following:

1. Invoice number, amount, & date submitted

2. Corresponding payment amount & date received

2. Total amount of all payments received to date under the subject contract or order; and

3. For definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

Solicitation: 75F40126Q132197 (Page 14)

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301- 827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

17.0 Notice Regarding the Use of Macros in Submitted Documents

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

18.0 Designation of Task Order/Delivery Order Ombudsman

In accordance with FAR 16.505(b)(5) and HHSAR 316.505(b)(5), the Director, Office of Acquisitions and Grants Services, has been designated as the FDA Ombudsman for Task Order and Delivery Order contracts.

Leonard Grant Three White Flint North 11601 Landsdown Street Rockville MD 20852 Phone: 240-402-7584 Email: Leonard.Grant@fda.hhs.gov

(End of Clause) mailto:Leonard.Grant@fda.hhs.gov

Solicitation: 75F40126Q132197 (Page 15)

Solicitation Provisions

Contract Type: Commercial Item-Firm Fixed Price.

In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (Deviation) (RFO Aug 2025) The following addenda have been added to this provision:

Technical Acceptability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered products meet or exceed the technical requirements identified above. Proposed products may be supplemented with technical specifications, descriptive material, literature, brochures, publications, etc.

which the offeror believes will further demonstrate their technical product capabilities.

Any proprietary information shall be marked as such. The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure that the system meets the FDA’s stated needs.

• Price: Offerors shall provide a detailed price quote for each item proposed to meet the Schedule of Items. (Offerors shall fill in the schedule above with the total prices and provide a detailed quote in their own format.) Offerors shall include the firm’s SAM Unique Entity ID (UEI) number with their quote.

As applicable, the offerors shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239- 74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the VPAT - Information Technology Industry Council (MS Word) provided by the Industry Technology Industry Council (ITIC). For this requirement we anticipate only invoices to be applicable to the requirement

NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.itic.org/policy/accessibility/vpat http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility

Solicitation: 75F40126Q132197 (Page 16) of the Government. The Government reserves the right to request additional information from a quoter at any time.

Microsoft Suite Documents Containing Macros

The offeror shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

Buy American Act and Executive Order 14005

If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required.

Line Item No. Country of Origin

The provision at FAR 52.212-2 Evaluation-Commercial Items (Deviation) (RFO Aug 2025). The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

• The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is the lowest price technically acceptable. Offers will be evaluated on their ability to meet the minimum requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined. The following factors shall be used to evaluate offers:

o Technical Acceptability o Price

Solicitation: 75F40126Q132197 (Page 17)

The Government reserves the right to request additional information or conduct discussions at any time. Once the Government determines the offeror that is the best-suited (i.e., the apparent successful offeror), the Government reserves the right to communicate with only that offeror to address any remaining issues, if necessary, and finalize a contract with that offeror. These issues may include technical, price or other issues.

Options (if applicable). The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s).

Quote Validity Period. Submitted quotations shall be valid, at a minimum, through September 30, 2026.

Notice of award. A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

• 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (SEP 2024)

• 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017)

• 52.204-7 System for Award Management (Deviation) (RFO Aug 2025)

• 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products

(Feb 2021)

• 52.225-6 Trade Agreements-Certificate (FEB 2021)

• 52.240-90 Security Prohibitions and Exclusions Representations and Certifications

(Deviation) (RFO AUG 2025)

HHSAR Provisions

352.239-7[8] Information and [Communication] Technology Accessibility Notice [Feb 2024] [(Deviation)]

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html

Solicitation: 75F40126Q132197 (Page 18) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://section508.gov/.

(e) In order to facilitate the Government's determination whether proposed ICT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria.

Checklist for various formats are available at https://section508.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(END OF PROVISION).

Notice to Offerors:

• System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not https://www.itic.org/policy/accessibility/vpat https://section508.gov/ https://section508.gov/

Solicitation: 75F40126Q132197 (Page 19) included in this solicitation. Contracting officers will rely on representations from offers based on provisions in the solicitation. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

• Notice to Offerors or Quoters: Funds are not presently available for this effort. No award will be made under this solicitation until adequate funds are available for it. The Government reserves the right to cancel this solicitation, either before or after the closing date of it. If the Government cancels this solicitation, the Government has no obligation to reimburse an offeror or quoter for any costs associated with it, including proposal or quote preparation costs.

• One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements.

Solicitation: 75F40126Q132197 (Page 20)

Contract clauses

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The following contract clauses apply to this acquisition.

Required:

52.212-4, Contract Terms and Conditions-Commercial Items (Deviation NOV 2025)

Applicable:

52.203-17, Contractor Employee Whistleblower Rights (Nov 2023)

52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

52.204-13 System for Award Management and Maintenance (Deviation) (RFO Aug 2025)

52.209-6, Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Deviation) (RFO Aug 2025)

52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Deviation) (RFO Aug 2025)

52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Deviation) (RFO Sep 2025)

52.222-3, Convict Labor (Jun 2003)

52.222-19, Child Labor—Cooperation with Authorities and Remedies (Deviation) (RFO Sep 2025)

52.222-35, Equal Opportunity for Veterans (Deviation) (RFO Sep 2025)

52.222-36, Equal Opportunity for Workers with Disabilities (Deviation) (RFO Sep 2025)

52.222-37, Employment Reports on Veterans (Deviation) (RFO Sep 2025)

52.222-50, Combating Trafficking in Persons (Deviation) (RFO Sep 2025)

52.223-23, Sustainable Products and Services (Deviation) (RFO Sep 2025) https://www.acquisition.gov/far-overhaul https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Solicitation: 75F40126Q132197 (Page 21)

52.225-5, Trade Agreements (NOV 2023)

52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024)

52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018)

52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

52.233-3, Protest After Award (Deviation) (RFO Aug 2025)

52.233-4, Applicable Law for Breach of Contract Claim (Deviation) (RFO Aug 2025)

52.240-91 Security Prohibitions and Exclusions (Deviation) (RFO Aug 2025)

52.244-6, Subcontracts for Commercial Products and Commercial Services (Deviation) (RFO Sep 2025)

Other applicable clauses:

52.216-18 Ordering (Aug 2020)

(a) “ … from effective date of contract award through and including the last date of the contract including any extensions thereto.”

52.216-19 Order Limitations (Oct 1995)

(a) “…$3,000.00 per Delivery Order, …”

(b) (1) “… in excess of $100,000.00;”

(b) (2) “… in excess of $200,000.00;”

(b) (3) “… within five (5) calendar days…”

(d) “… within five (5) calendar days…”

52.216-22 Indefinite Quantity (Deviation) (RFO Sep 2025)

(d) “…after three (3) years from date of contract expiration.”

Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Solicitation: 75F40126Q132197 (Page 22)

HHSAR Clause 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(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)

HHSAR Clause 352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support…