Sol Doc combined synopsis-solicitation 75F40126Q132721.pdf

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 75F40126Q132721. This solicitation is issued as a Request for Quote (RFQ) for multiple types of pharmaceutical drugs.

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- 325412 - Pharmaceutical Preparation Manufacturing; the applicable Small Business Size Standard is 1300 employees. This requirement is solicited as unrestricted full and open competition, any sized business may submit a quote.

Schedule of Items (all shipping and handling shall be included in the price)

Description Estimated Price for Evaluation purposes Ordering Period 1: Total evaluated price from Attachment 1 $___________

Ordering Period 2: Total evaluated price from Attachment 1 $___________

Ordering Period 3: Total evaluated price from Attachment 1 $___________

Ordering Period 4: Total evaluated price from Attachment 1 $___________

Ordering Period 5: Total evaluated price from Attachment 1 $___________

Grand Total: Evaluated Price for Ordering Periods 1-5 $___________

Statement of Work:

Background:

The U.S. Food and Drug Administration (FDA) is engaged in laboratory, animal and human research to develop tools and methodologies to evaluate generic drug equivalence. The Center for Drug Evaluation and Research (CDER), requires a Pharmaceutical Manufacturer/Supplier to provide brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics, drug-device combination products, and contrast agents. FDA collaborates with external investigators in industry and academia as well as internal investigators in various FDA laboratories to conduct research that will advance public health by providing access to safe and effective generic drugs. These research studies include: investigation of the quality of drug products associated with adverse events, comparison of branded and generic products in

75F40126Q132721 1 of 17 https://www.acquisition.gov/far-overhaul physicochemical characterization and in vitro release testing, analysis of methods to assay drugs of a particular class and surveillance of marketplace drug quality. Often the quantity and cost of these marketplace drugs exceeds the limit for orders by government credit card and are required as soon as practical. This is particularly true for peptide therapeutics, microsphere formulations, implants and products involving nanotechnology. Extramural and intramural generic drug research projects involve testing the marketed reference product and any marketed generic counterparts. Purchase of marketed drug products at the lowest possible price will enable the FDA to allocate financial resources towards other parts of the research program.

Objective and Scope

To obtain a reliable source of currently marketed pharmaceutical drug products for FDA research studies.

Description of Work

The contractor will fulfill orders from the FDA on an as-need basis for drug products listed in the schedule of items, Drug Products Schedule of the IDIQ contract.

The FDA may request both brand name and any available generic products. Requested drug products may include small molecule and peptide therapeutics, drug-device combination products, and contrast agents. An anticipated list of drug products and the required dosages that will be requested for purchase is given in the Attachment 1 – Comprehensive Drug Product List.

Other drug products not listed in the attachment may also be requested. The contractor must be able to supply a comprehensive list of pharmaceutical products to the FDA, including but not limited to those products listed in the Attachment 1. The contractor shall indicate what pharmaceuticals they can provide and the associated pricing.

Drug Product List Refresh: Additional Comprehensive Drug Products may be added to this list at any time throughout the life of the contract. These additional products, prices and descriptions of the products will be negotiated on a case-by-case basis. The additional categories, prices and descriptions quoted, upon determination by the Government that they are necessary for performance and are both fair and reasonable, can be issued in the order. The new product category may be incorporated by modification into the Schedule of Items tables of this contract.

The contractor shall provide a firm fixed price quote for the pharmaceuticals listed in Attachment #1.

The Contractor shall maintain a log of all pharmaceutical products purchased under this Contract and shall supply a copy to the FDA upon request

Immediately upon shipping pharmaceutical products, the Contractor shall provide all tracking information to the FDA COR (Identified at time of Contract award).

Location:

Pharmaceutical products shall be delivered to various FDA offices or laboratories; academic and industrial external research collaborators located throughout the U.S. and outside the U.S.

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The Contractor shall arrange direct shipment of pharmaceuticals as follows:

Location Delivery Date Domestic FDA Office/Laboratory Within 7 business days of order Domestic External Research Site Within 7 business days of order International External Research Site Within 14 business days of order Emergency Overnight Delivery

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.

Minimum and Maximum Quantities The contract guaranteed minimum will be $25,000. Funding for this minimum guarantee will be obligated against the base contract award. 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.

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

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.

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 order. The general process for individual Delivery orders is as follows:

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

1. Description of products required and quantity.

2. Delivery location.

3. delivery schedule and Performance Period. Each DO may have multiple shipment dates.

4. Anything else necessary for the delivery order.

b) The FDA will confirm pricing with the contractor.

c) The Contractor shall prepare and submit a price proposal if needed addressing all areas of the requirement. The Contractor shall submit the Task Order proposal within the time period specified in the request and adhere to the product ceiling rates established in the contract. Other

75F40126Q132721 3 of 17 direct costs such as shipping shall be clearly identified, explained, and substantiated. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a Delivery Order proposal. The Government will evaluate Delivery Order proposals as specified in the notice.

d) The FDA Contracting Officer placing the delivery order shall issue either an OF347, SF1449 or other designated form to the Contractor. Task orders performance period may extend beyond the five year ordering period provided the task order was issued prior to ordering period five year expiration, up to and not longer than one (1) year.

Delivery Orders issued against this contract vehicle will be a 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 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.

Contract Period of Performance The period of performance for this IDIQ contract shall consist of five (5), one-year ordering periods estimated to be:

Ordering period 1: September 1, 2026 through August 31, 2027 Ordering period 2: September 1, 2027 through August 31, 2028 Ordering period 3: September 1, 2028 through August 31, 2029 Ordering period 4: September 1, 2029 through August 31, 2030 Ordering period 5: September 1, 2030 through August 31, 2031

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 year past the IDIQ Ordering Period end date and products prices shall remain at the last ordering period rates.

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

Service/Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Labor Day Martin Luther King, Jr.’s Birthday Columbus Day Washington’s Birthday Veterans Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

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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

Required:

52.212-4, Contract Terms and Conditions-Commercial Items (Deviation SEP 2025) Applicable:

52.203-6 Alt I, Restrictions on Subcontractor Sales to the Government (Jun 2020) Alternate I (Nov 2021) 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

NOV 2025)

52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(DEVIATION) (RFO NOV 2025)

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

NOV 2025)

52.219-4, Notice of Price Evaluation preference for HUBZone Small Business Concerns

(DEVIATION) (RFO SEP 2025)

52.219-8, Utilization of Small Business Concerns (DEVIATION) (RFO SEP 2025) 52.219-9, Small Business Subcontracting Plan (DEVIATION) (RFO SEP 2025) Alt I (DEVIATION) (RFO SEP 2025) and Alt II, (DEVIATION) (RFO SEP 2025) 52.219-16, Liquidated Damages-Subcontracting Plan (DEVIATION) (RFO SEP 2025) 52.222-3, Convict Labor (DEVIATION) (RFO SEP 2025) 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) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(DEVIATION) (RFO SEP 2025)

52.222-50, Combating Trafficking in Persons (Deviation) (RFO Sep 2025) 52.222-90, Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026) 52.223-23, Sustainable Products and Services (Deviation) (RFO Sep 2025) 52.225-5, Trade Agreements (Nov 2023) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.229-12, Tax on Certain Foreign Procurements—Notice and Representation (DEVIATION)

(RFO SEP 2025)

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

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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.”

FAR Clause 52.216-19 Order Limitations (Oct 1995)

(a) “…$10,000.00 per Delivery order, …”

(b) (1) “… in excess of $1,000,000.00;”

(b) (2) “… in excess of $1,000,000.00;”

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

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

FAR Clause 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

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)

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(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 developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, 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 own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, 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 own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, 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 own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)]

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The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer’s Representative (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.

Contract Administration

a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer Phone: 301-796-1988 Email: nick.sartain@fda.hhs.gov

b. COR – The following COR will represent the Government for the purpose of this contract:

(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.

Payments

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

Invoice Submission

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

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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.

• 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;

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

Indirects)- show rate, base and total amount;

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

• 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;

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

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

• 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:

(a) 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

(b) total amount of all payments received to date under the subject contract or order

(c) and, 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.

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.

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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.

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.

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)

Solicitation provisions Contract Type: Commercial Item-Firm Fixed Price.

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. 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

FAR Provisions.

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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) 52.229-11 Tax on Certain Foreign Procurements—Notice and Representation (DEVIATION)

(RFO SEP 2025)

HHSAR Provisions 352.239-73[8] Electronic Information and [Communication] Technology Accessibility Notice (Dec 2015[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) 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

75F40126Q132721 12 of 17 https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html 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).

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 Capability: 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. In addition to identifying manufacturer or distributor of quoted products, it is incumbent of quoters that they unequivocally demonstrate that quoted products meet the requirements herein through the submission of technical specifications.

Past Performance: Provide recent (within the last 3 years of solicitation closing date) and relevant prior experience information for providing multiple types of pharmaceutical products (brand name and generic) similar to this requirement. Include period of performance, description (how is this relevant to current requirement), your role and responsibilities as either prime or subcontractor, dollar value, client name, client address, client point of contact name, client point of contact phone number, and client point of contact email address. Respondents who do not provide a valid email address for the client POC or without a relevant record of past performance or for whom information on current or past performance is not available will not be evaluated favorably or unfavorably. Favorable past performance is considered higher than neutral past performance.

Any proprietary information shall be marked as such.

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Price: Offerors shall complete Attachment 1 by entering, for each quoted item, the manufacturer/distributor information, NDC number if available, and unit price for Ordering Periods 1 through 5. Attachment 1 shall serve as the offeror’s price quote for evaluation purposes. Offerors shall include their SAM Unique Entity ID (UEI) with the quotation.

Small Business Subcontracting Plan If the Offeror determines that there will not be subcontracting opportunities, the Offeror shall still submit a subcontracting plan and include a statement of circumstances supporting this determination. Failure to submit and then negotiate an acceptable subcontracting plan within the time specified by the Contracting Officer (CO) when the CO notifies the offeror of issues and concerns with the subcontracting plan will render the offeror, notwithstanding any other decision made from the above-listed criteria, ineligible for award. The resulting subcontracting plan will be made a part of the resulting contract and the Contractor shall comply with the reporting requirements of FAR Clause 52.219-9(I). Small businesses are exempt from this requirement.

*Note: If offeror already has an approved Commercial Plan, submit that in lieu of Attachment 2.

In accordance with FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and price proposals. An offeror’s subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to contract award. An offeror is to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at:

https://osdbu.hhs.gov/subcontracting/3610b9f3-00dc-49da-b5f3-c80d402fc1ca. The offeror shall follow the instructions outlined in the SBCX Industry Guide (https://sbcm-acqtools.s3.amazonaws.com/SBCX+Industry+Subcontracting+Guide.pdf) to successfully submit their subcontracting plan by the proposal submission deadline.

The official point of receipt for determining timely submission of an offeror’s subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission.

If an offeror’s subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late.

Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

Failure to submit and then negotiate an acceptable subcontracting plan within the time specified by the Contracting Officer (CO) when the CO notifies the apparently successful offeror(s) of issues and concerns with the subcontracting plan will render the offeror(s), notwithstanding any other decision made from the above-listed criteria, ineligible for award. If the Offeror determines that there will not be subcontracting opportunities, the

75F40126Q132721 14 of 17 https://osdbu.hhs.gov/subcontracting/3610b9f3-00dc-49da-b5f3-c80d402fc1ca https://sbcm-acqtools.s3.amazonaws.com/SBCX+Industry+Subcontracting+Guide.pdf

Offeror shall still submit a subcontracting plan and include a statement of circumstances supporting this determination. The resulting subcontracting plan will be made a part of the resulting contract and the Contractor shall comply with the reporting requirements of FAR Clause 52.219-9(I). Negotiating an acceptable subcontracting plan is part of responsibility and does not open up negotiations with all offerors.

Small businesses are exempt from this requirement of submitting a small business subcontracting plan.

The Quoter 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 Voluntary Product Accessibility Template Version 2.0 (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 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 or applicant 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 or applicant’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

75F40126Q132721 15 of 17 http://www.itic.org/policy/accessibility nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required.

Line Item No. Country of Origin

Period for Acceptance of Offers. The offeror agrees to hold the prices in its quote firm through September 30, 2026.

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:

Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

- Technical Capability

- Past Performance

- Price

Technical capability and past performance, when combined, are more important than price.

However, if the Government determines non-price factors to be essentially equal among competing offerors price becomes more important as a discriminating factor.

The Small Business Subcontracting Plan is not part of the best value trade-off decision but rather if the Government and offeror can negotiate an acceptable plan. The plan is rated on an acceptable/ unacceptable level. It will be evaluated based on the Offeror’s proposed subcontracting plan related to this effort. Evaluation will reflect the extent to which the contractor has committed to utilizing small businesses. Failure to submit and negotiate an acceptable subcontracting plan by the time of award or other time specified may render the Offeror ineligible for award of a contract. The small business subcontracting plan will become part of the contract. The Offeror must clearly document circumstances where no small business subcontracting opportunities exist which may be considered acceptable to the Government based on the information submitted. Negotiating an acceptable subcontracting plan is part of responsibility and does not open up negotiations with all offerors.

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.

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(c) 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.

A single award IDIQ contract is anticipated from this solicitation.

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 included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

- 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 included in agency solicitations, including 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals—Representation, and paragraph (t) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Agencies will not consider or use these representations. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

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

It is the offeror's responsibility to monitor sam.gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc. Offerors that fail to complete the required representations and certifications or reject the terms and conditions of the solicitation may be excluded from consideration.

All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 75F40126Q132721. The offers are due by email to nick.sartain@fda.hhs.gov on or before May 15, 2026 by 1:00 P.M. (Central Time in Jefferson, Arkansas).

For information regarding this solicitation, please contact Nick Sartain at (301) 796-1988 or email nick.sartain@fda.hhs.gov.

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