CBER-2026-134085 SSN.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Center for Biologics Evaluation & Research

Provision of Bordetella-Free Baboons for Pertussis Infection and Vaccination Studies

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for baboons for studies to be conducted at FDA/CBER Facility in Silver Spring, Maryland.

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 following 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: 112990 All Other Animal Production. The applicable Small Business Size Standard is $2.75M.

Statement of Work

Center for Biologics Evaluation & Research Provision of Bordetella-Free Baboons for Pertussis Infection and Vaccination Studies

1. Background

Pertussis is an acute, highly contagious, potentially life-threatening respiratory disease, caused by the Gram-negative bacterium Bordetella pertussis. The underlying factors leading to the failure of public health measures to control pertussis disease using currently licensed vaccines are poorly understood. A more complete understanding of this disease and of the mechanisms of vaccine-mediated protection is a critical public health need.

The baboon model of pertussis, developed in the laboratories of the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), is the only animal model of pertussis that recapitulates the disease as observed in human patients.

Refinement of the baboon model to include establishment of infection by means of natural transmission will enable a more refine evaluation of the differences between the licensed acellular pertussis vaccines that fail to prevent infection and the whole cell vaccines that reduce infection. The performance of this study requires the purchase and delivery of twenty, Bordetella-free baboons.

2. Purpose The purpose of this solicitation is to obtain baboons for studies to be conducted at FDA/CBER Facility in Silver Spring, Maryland.

3. Requirements The contractor(s) shall provide and deliver twenty baboons and shall meet the specifications below:

1. Twenty (20) six to eight-month-old, Bordetella-free, unvaccinated baboons delivered to CBER in one shipment.

2. The vendor will draw blood and perform nasopharyngeal washes prior to shipment. The nasopharyngeal washes will be plated to confirm absence of Bordetella and sera will be sent to CBER laboratories for serology. Only animals that test negative for Bordetella exposure, as determined by the CBER principal investigator, will be included in the shipment.

3. All baboons shall be examined by a licensed veterinarian, Doctor of Veterinary Medicine (DVM) as defined by the Animal Welfare Act Regulations (9 CFR, Subchapter A, Part 1 - Definition of Terms), experienced in Non-Human Primates (NHP) medicine and surgery, and found to be in good health prior to shipping.

4. The vendor will coordinate with USDA-licensed carriers and the CBER division of veterinary services for the delivery of baboons into quarantine at the CBER primate facility on the FDA White Oak Campus in Silver Spring Maryland.

5. The contractor shall maintain liaison with carrier personnel to ensure the animals receive proper care in accordance with USDA standards and guidelines during transit.

6. Shipping, quarantine, and animal handling procedures comply with the CBER Institutional Animal Care and Use Committee (IACUC) and are detailed in the approved animal safety protocol (ASP#2009-19) The CBER Animal Assurance Number is A4295-01.

7. Contractors must commit to accept return of animals that clear infection and return to good health following conclusion of B. pertussis studies at CBER.

4. Special Requirements: Animal Welfare The shipment of animals to CBER and the conduct of animal studies at CBER will be performed under approval of the CBER institutional IACUC as outlined in the approved animal study protocol ASP#2009-19.

Delivery acceptance criteria are that the animals be of the age, gender and weight specified in the animal order, the animals be free of exposure to Bordetella, and that the animals arrive in good health. Acceptance of the animals will be made by the supervising veterinarian at the quarantine facility upon completion of a quarantine entry physical.

The contractor shall be responsible for meeting all requirements associated with shipment and delivery of animals.

5. Delivery Delivery must be coordinated with the COR in advance.

FDA White Oak Campus 10903 New Hampshire Avenue Silver Spring, MD 20993 Bldg. 72 CBER Vivarium

POC: To be provided at time of award

6. Contract Type The required products and supplies will be provided on a Firm Fixed Price basis.

7. Period of Performance

a. Dates are approximate to be finalized upon award.

b. Delivery is expected to be completed within ninety (90) calendar days of contract award.

c. Estimated award date: 07/02/2026

d. The period of performance (estimated) is 09/30/2026 to 09/29/2027.

e. There are no option periods.

8. Government Furnished Equipment/Government Furnished Information (GFI) No government-furnished property or government-furnished information will be provided in the scope of this acquisition.

9. 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

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.

10. Contract Administration

a. Contract Specialist David Kramer, Contract Specialist Phone: 703-447-2694 Email: david.kramer@fda.hhs.gov mailto:david.kramer@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.

11. Inspection and Acceptance

The supplies delivered hereunder shall be inspected and accepted at destination by the COR specified at award. If the supplies are deemed acceptable in no more than ninety (90) calendar days, the COR shall promptly forward a report of inspection and acceptance to the paying office.

If the supplies are not acceptable, the COR shall document the nonconforming items and immediately notify the contracting officer.

12. Payments

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

13. 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 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.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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 task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

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.

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 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 of a small business manufacturer or producer all interested parties may respond.

At a minimum, responses shall include the following:

1. Part 1: Company/Organization Overview

a. Business/organization name;

b. SAM Unique Entity ID number;

c. Business/organization address;

d. Business/organization website;

e. Business/organization 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: Product Information

a. Please indicate whether your product will meet all of the requirements stated in the Statement of Work. Please identify any requirements that your product does not meet and recommend an alternative.

b. Please provide sufficient descriptive literature that unequivocally demonstrates that your offered product can meet the requirements articulated in the Statement of Work (SOW).

c. Please include descriptive material necessary for the government to determine whether the product offered meets the technical requirements including technical specifications, ISO certifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the organization to meet the requirement.

d. Please provide three (3) years of past performance information, where the respondent has provided same or substantially similar product/service solutions on the same or near-same requirements. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact phone number, client point of contact email address.

3. Part 3: 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 product is available on.

c. Section 508: Demonstrate the capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

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

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

f. Informational Pricing: Though this is not a request for quote, but 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 29 May 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov. Reference CBER-2026-134085.

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility 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.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

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).

Sources Sought Response Instructions