Solicatitation - RFP 75A50326R00007.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

CODE 16. ADMINISTERED BYCODE

X

X

325412

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORASPR/SNS

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

1700 ETLAMONICA NORWOOD

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75A50326R00007

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 26 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

ASPR/SNS WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The SNS has a need to procure a variety of FDA approved pharmaceuticals to maintain minimum stockpiling capabilities for responding to public health events.

The SNS Asset Management Team is tasked with the critical responsibility of replenishing pharmaceuticals to ensure the SNS maintains a high level of readiness. This readiness is essential for responding effectively to public health emergencies. To fulfill this

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

9/11/2026

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

responsibility, the team must regularly procure a diverse range of FDA-approved pharmaceuticals.

These acquisitions are vital to maintaining the minimum stockpiling levels necessary to support rapid response efforts during public health event.

The point of contact for information regarding this combined synopsis/solicitation is: Contract

Specialist:

LaMonica Norwood

SNS Contracting Program

Administration for Strategic Preparedness and

Response (ASPR)

U.S. Department of Health and Human Services (HHS)

Email: OSContracting@hhs.gov

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

262 of

SECTION A – SOLICITATION DESCRIPTION

(i) This is a combined synopsis/solicitation for commercial products. This announcement constitutes the only solicitation; a written solicitation will not be issued.

This solicitation will be conducted as a commercial acquisition competed on a full and open basis in accordance with the policies and procedures of Part 12 and Part 15 of the Revolutionary FAR Overhaul (RFO) Federal Acquisition Regulation (FAR).

(ii) The solicitation number is 75A50326R00007, which is being issued as a Request for Proposal (RFP). The United States Government (USG or Government) anticipates award of a Firm Fixed Price (FFP) type contract(s) as a result of this solicitation.

(iii) The solicitation document incorporates the FAR/RFO provisions and clauses identified in Section C. Federal Acquisition Circular (FAC) 2026-01 became effective July 01, 2026.

Applicable Revolutionary FAR Overhaul (RFO) model deviation text and HHS class deviations are identified in Section C. Current RFO materials are available through Acquisition.gov at www.acquisition.gov/far-overhaul.

(iv) This synopsis/solicitation is issued on the basis of full and open competition and is not set aside for small businesses. The NAICS code is 325412 (Pharmaceutical Preparation Manufacturing). The size standard is 1,300 (number of employees).

(v) The Center for the Strategic National Stockpile (SNS), of the U.S. Department of Health and Human Services (HHS) Office of the Administration for Strategic Preparedness and Response (ASPR), has a requirement for the replenishment of expired/expiring pharmaceuticals. See Section B below for line-item numbers and products, quantities, and units of measure.

(vi) See Section D, Statement of Work (SOW), below for description of requirements.

(vii) The contract duration will be twelve (12)-months beginning on the date of contract award.

Delivery of quantities ordered or scheduled during that period will occur in accordance with Sections B and D. Refer to Section D for delivery and acceptance requirements and the Free on Board (FOB) point(s).

(viii) The provision at RFO FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition. The Government intends to award without discussions, although it reserves the right to conduct discussions. Therefore, the submitted proposal should represent the Offeror's best offer.

(ix) The Government may accept any one item or group of items offered, unless the Offeror qualifies the offer by specific limitations. The Government anticipates making one or more awards, which may include award of any one item or any combination of items; however, the Government reserves the right to make a single award when determined to be in the Government's best interest.

(x) For each item awarded, the Government will award the full basic required quantity identified in Table B.3-1; the basic required quantity of an individual item will not be split among multiple contractors. Additional quantities, if needed, may be acquired only through the increased-quantity option described in Section B.5. For this solicitation, 'item' means an individual pharmaceutical product.

(xi) Provision 52.212-2, Evaluation-Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include evaluation factors and evaluation criteria.

(xii) The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition.

(xiii) There are no special contract requirements or terms and conditions related to contract financing arrangements, and the agency has no intention of entering into any agreements for contract financing arrangements.

(xiv) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A— Health Resources Priorities and Allocations System.

(xv) Offeror’s proposal must be submitted electronically to the contract specialist, LaMonica Norwood, via email to OSContracting@hhs.gov no later than the date and time provided herein under Section E, E.1 Proposal Submission Deadline. Late submissions must be treated in accordance with the solicitation provision at RFO FAR 52.212-1(c). When responding to the RFP, offeror must include RFP number 75A50326R00007 [company name] in the subject line.

a. All questions or clarification requests regarding any aspect of this RFP must be submitted to the contract specialist, LaMonica Norwood, via email at OSContracting@hhs.gov no later than the date and time provided below under Section E, E.2 Questions or Clarifications. Unless the Government otherwise determines that it is in its best interest to provide a response, questions received after the deadline will not be answered. When submitting questions or clarifications, offeror must include RFP number 75A50326R00007 in the subject line.

(xvi) The point of contact for information regarding this combined synopsis/solicitation is:

Contract Specialist:

LaMonica Norwood SNS Contracting Program Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: OSContracting@hhs.gov mailto:lamonica.norwood@hhs.gov

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: Firm-Fixed-Price.

B.1 Contract Structure and Contract Ceiling

The contract will include separate CLINs for the awarded pharmaceutical items and one aggregate contract ceiling. The contract ceiling will equal the total value of the awarded basic quantities plus the maximum value of the increased-quantity option authorized under Section B.5. The ceiling is a maximum contract value and does not reduce the Contractor's obligation to furnish the awarded basic quantities.

B.2 Ordering Period

The ordering period is twelve (12) months from the date of contract award. During the ordering period, the Government may issue written delivery instructions for awarded basic quantities and may exercise the increased-quantity option described in Section B.5. Use of an ordering period is intended to provide operational flexibility to authorize modifications in accordance with B.5.

B.3 Schedule of Pharmaceutical Items

Table B.3-1 is the authoritative schedule of pharmaceutical items and basic required quantities for this solicitation. Each awarded item will be incorporated into the resulting contract as a separate CLIN.

Offerors may propose one or more items. For each item offered, the Offeror must propose the full basic required quantity. The Government may make separate awards by item, and the basic required quantity of an individual item will not be split among multiple contractors.

For each item offered, the Offeror shall submit a firm-fixed unit price and extended price in RFP Attachment 5 – Price/Business Template. The awarded unit price will apply to the basic quantity and to any increased quantity exercised under Section B.5 and FAR 52.217-6.

CLIN Item ID Product Description UoM Basic Required

Quantity (Lowest UoM)

0001 A Dopamine Hydrochloride (HCL) injection, 400mg (40mg/ml) 10ml vial

VI 22,700

0002 B Levophed (Norepinephrine), solution for injection, 4mg (1mg/ml) 4ml vial

VI 10,080

0003 C Methylprednisolone Sodium Succinate for injection, 125mg in 2mL powder/diluent 2 chamber vial

VI 90

0004 D Vecuronium bromide for injection, 10mg (1mg/mL) 10mL powder vial

VI 206,000

0005 E Morphine Sulfate 10 mg/mL, 1 mL Luer- Lock prefilled syringe

VI 137,000

CLIN Item ID Product Description UoM Basic Required Quantity (Lowest UoM)

0006 F Amoxicillin Suspension 400mg/5ml in 100ml powder bottle

BT 250,920

0007 G Clindamycin phosphate solution for injection, 900mg (150mg/mL), 6mL vials

VI 1,958,100

0008 H Ciprofloxacin 250mg/5ml oral suspension, powder, 100ml bottle

BT 127,944

0009 I Ciprofloxacin in 5% dextrose solution for inj, 400mg in 200ml flexi-bag

EA 750,000

0010 J Gentamicin 800mg/20ml (40mg/ml) inj., multi-dose vial

VI 294,000

0011 K Lactated Ringers solution for injection, 1000mL flexible bag, latex free

EA 788,950

0012 L Sodium Chloride (NaCL) 0.9% for Injection, 1000 mL solution flexi-bag

EA 31,420

0013 M Bacitracin Zinc Ointment 30g TU 59,011 0014 N Midazolam HCl solution for injection 25mg (5mg/ml) 5ml multidose vial

BX 31,285

0015 O Oxycodone hydrochloride/ acetaminophen, 5mg/325mg (tablet, bottle, 100s)

BT 2,162,550

0016 P Proparacaine Hydrochloride Ophthalmic Solution 0.5%, 15mL bottle

EA 944

0017 Q Amoxicillin/Clavulanate 500mg/125mg tablets (100 tablets/bottle)

BT 570,000

0018 R Doxycycline for injection, 100mg (10mg/ml), powder vial

VL 1,473,685

0019 S Penicillin G Potassium 20MU VL 231,745 0020 T Diazepam soln. for inj., 5mg/ml, x

10ml multi-dose vial

VL 429,795

0021 U Potassium Iodide, 65mg tablets TAB 140,000

Table B.3-1

B.4 Delivery Schedule

For each item offered, the Offeror must provide a proposed month-by-month delivery schedule and corresponding quantities using RFP Attachment 3 – Technical Template Tab.

The Government will evaluate the proposed schedule in accordance with Section E.

The final delivery schedule for each awarded item will be incorporated into the resulting contract or established through written delivery instructions consistent with the awarded schedule. All basic and increased quantities must be ordered within the 12-month ordering period and delivered within the applicable delivery dates established by the contract or written delivery instruction.

B.5 Increased Quantity / Surge During the Ordering Period During the 12-month ordering period, the Government may exercise FAR 52.217-6 to increase an awarded CLIN by up to 20 percent of that CLIN's basic awarded quantity. Any increased quantity will be priced at the awarded unit price for that CLIN. The aggregate value of all basic quantities and all exercised increased quantities may not exceed the contract ceiling established at award. Exercise of the increased-quantity option does not extend the ordering period.

The contract contains no option period to extend its term. The increased-quantity option is the only option contemplated by this solicitation. Quantities above an awarded CLIN's basic quantity may be ordered only through the authorized increased-quantity option and within the aggregate contract ceiling.

SECTION C – PROVISIONS AND CONTRACT CLAUSES

www.acquisition.gov/far-overhaul https://www.acquisition.gov/browse/index/far

C.1 RFO Incorporation by Reference and Deviation Notice This solicitation incorporates by reference the applicable FAR/RFO provisions and clauses identified below. HHS contracting staff are required to use applicable RFO model deviation text and HHS class deviations. The FAR Overhaul section of Acquisition.gov is the controlling source for current RFO model deviation text; applicable HHS deviation memoranda control where an HHS deviation applies.

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 this solicitation. Contracting officers will rely on representations from offerors 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.

C.2 FAR/RFO Provisions and Clauses (Numerical Order)

FAR/RFO TITLE AND DATE

52.203-6 Alt 1 Restrictions on Subcontractor Sales to the Government (Jun 2020) 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal

Transactions (Sep 2024)) 52.203-13 Contractor Code of Business Ethics and Conduct (Nov 2021) 52.203-17 Contractor Employee Whistleblower Rights (Nov 2023) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal

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

Statements (Jan 2017) 52.204-7 System for Award Management—Registration (Aug 2025) (RFO Deviation

2025-9, Amendment 2) 52.204-13 System for Award Management—Maintenance (Aug 2025) (RFO Deviation

2025-9, Amendment 2) 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) 52.204-91 Contractor Identification (Aug 2025) (RFO Deviation 2025-09, Amendment 2) 52.209-6 Protecting the Government's Interest When Subcontracting With Contractors

Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (Apr 2026) (RFO Deviation 2025-10, Amendment 1)

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters (Apr 2026) (RFO Deviation 2025-10, Amendment 1)

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations (Apr 2026) (RFO Deviation 2025-10, Amendment 1)

52.209-12 Certification Regarding Tax Matters (Oct 2025) 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (RFO

Deviation 2025-09, Amendment 1) 52.212-2 Evaluation—Commercial Products and Commercial Services (RFO Deviation

2025-09, Amendment 1) http://www.acquisition.gov/far-overhaul https://www.acquisition.gov/browse/index/far

FAR/RFO TITLE AND DATE

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (Nov

2025) (Deviation 2025-9, Amendment 1) 52.217-5 Evaluation of Options (Nov 2025) (RFO Deviation 2025-12) 52.219-8 Utilization of Small Business Concerns (Feb 2026) (RFO Deviation 2026-01, Amendment 3) 52.219-9 Small Business Subcontracting Plan (Feb 2026) (RFO Deviation 2026-01, Amendment 3) 52.219-16 Liquidated Damages-Subcontracting Plan (Feb 2026) (RFO Deviation 2026-01, Amendment 3) 52.222-3 Convict Labor (Apr 2026) (RFO Deviation 2026-01, Amendment 3) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (Apr 2026) (RFO

Deviation 2026-01, Amendment 3) 52.222-35 Equal Opportunity for Veterans (Apr 2026) (RFO Deviation 2026-01, Amendment 3) 52.222-36 Equal Opportunity for Workers with Disabilities (Apr 2026) (RFO Deviation

2026-01, Amendment 3) 52.222-37 Employment Reports on Veterans (Apr 2026) (RFO Deviation 2026-01, Amendment 3) 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (Apr

2026) (RFO Deviation 2026-01, Amendment 3) 52.222-50 Combating Trafficking in Persons (Apr 2026) (RFO Deviation 2026-01, Amendment 3) 52.222-54 Employment Eligibility Verification (Apr 2026) (RFO Deviation 2026-01, Amendment 3) 52.222-90 Addressing DEI Discrimination by Federal Contractors (Apr 2026) (RFO

Deviation 2026-01, Amendment 3) 52.225-1 Buy American-Supplies (Mar 2026) (RFO Deviation 2026-01, Amendment 3) 52.225-2 Buy American Certificate (Apr 2026) (RFO Deviation 2026-01, Amendment 3);

paired with 52.225-1) 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 (Sep 2025) (RFO Deviation 2025-10, Amendment 1) 52.233-4 Applicable Law for Breach of Contract Claim (Sep 2025) (RFO Deviation 2025-

10, Amendment 1) 52.240-90 Security Prohibitions and Exclusions Representations and Certifications (Aug

2025) (RFO Deviation 2025-09, Amendment 1) 52.240-91 Security Prohibitions and Exclusions (Aug 2025) (RFO Deviation 2025-09, Amendment 1) 52.240-93 Basic Safeguarding of Covered Contractor Information Systems (Aug 2025)

(RFO Deviation 2025-09, Amendment 1) 52.244-6 Subcontracts for Commercial Products and Commercial Services (Nov 2025)

(RFO Deviation 2025-11) 52.252-5 Authorized Deviations in Provisions (Nov 2020) 52.252-6 Authorized Deviations in Clauses (Nov 2020)

C.3 HHSAR Provisions and Clauses

HHSAR TITLE AND DATE

352.203-70 Anti-Lobbying (Jun 2026) (RFO Deviation 2026-11) 352.204-74 Supply Chain Risk Assessment (OCT 2024 (Deviation)) 352.204-75 Supply Chain Risk Assessment During Contract Performance (OCT 2024

(RFO Deviation)) 352.208-70 Printing and Duplication (Feb 2026) (RFO Deviation 2026-2) 352.223-70 Safety and Health (Dec 2015) 352.227-72 Publications and Publicity (Jun 2026) (RFO Deviation 2026-14) 352.233-71 Litigation and Claims (Dec 2015)

C.4 FAR 52.217-6 – Option for Increased Quantity The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor at any time during the 12-month ordering period. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.5 Contracting Officer’s Authority The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

No information, other than that which may be contained in an authorized modification to this contract and duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, must be considered grounds for deviation from any stipulation of this contract.

C.6 Contracting Officer’s Representative (COR) Appointment and Authority Performance of work under this contract is subject to the technical direction of the COR or a representative designated by the contracting officer in writing. The term "technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily. Technical direction must be within the scope of the contract specification(s)/work statement.

The COR does not have authority to issue technical direction that: (a) Constitutes additional work outside the contract specification(s)/work statement; (b) Constitutes a change as defined in the “Changes" clause of this contract; (c) Causes an increase or decrease in the contract price, or the time required for contract performance interferes with the contractor's right to perform under the terms and conditions of the contract; or (d) Directs, supervises or otherwise controls the actions of the contractor' s employees.

Technical direction may be oral or in writing. The COR must confirm oral directions in writing within five working days, with a copy to the contracting officer. The contractor must proceed promptly with performance resulting from the technical direction issued by the COR, if the opinion of the contractor, any direction of the COR or the designated representative falls within the limitations above, the Contractor must immediately notify the Contracting Officer no later than the beginning of the next Government workday. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract must be subjected the terms of the "Disputes" clause of this contract.

C.7 Non-Disclosure Agreement

All Contractor employees that will have access to non-public and procurement-sensitive information (photos, drawings, specifications, statements of work requirements, location data, etc.) or access to non-public ASPR facilities must sign a Non-Disclosure Agreement (NDA). The NDA will be made part of the contract file. The NDA requires contractor employees properly identify themselves as employees of a contractor when communicating or interacting with ASPR employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with ASPR/SNS), and members of the public. The Federal Acquisition Regulation (FAR) 37.114(c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

a. The Contractor must inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

b. During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractor employees sign an NDA, and it is submitted to the Contracting Officer prior to commencement of their work with ASPR/SNS.

c. Contractor employees in designated positions or functions that have not signed the appropriate NDA must not have access to any non-public, procurement sensitive information or participate in government meetings where sensitive information may be discussed.

d. The Contractor must prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list must at a minimum contain: contract number, employee’s name, position, date of hire and NDA requirement.

C.8 Contractor Publicity

The Contractor, or any entity or representative acting on behalf of the Contractor, must not refer to the supplies or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the CO. Should any reference to such equipment or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government must consider institution of all rights and remedies available under the contract and applicable law, including the recovery of damages. Further, any violation of this requirement may be considered as part of the evaluation of past performance.

C.9 HHSAR 352.232-71 Electronic Submission of Payment Requests (Apr 2026) (Deviation 2026- 07)

(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 in FAR 32.905(b), and the applicable payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor must 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.

(d) If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officers’ written authorization with each payment request.

Electronic Invoicing and Payment Requirement - Invoice Processing Platform (IPP)

• All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

• 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 the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services included in commercial items contracts. The IPP website address is:

https://www.ipp.gov.

• Contractors are responsible for enrolling in the 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.

o 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.

o 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.

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

o 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.

Invoice Elements.

In accordance with FAR 32.905 Payment documentation and process, Contractor must submit an electronic invoice to the email addresses designated in the contract to receive invoices. Payment will be based on receipt of a proper invoice and satisfactory contract performance.

(a) Content of invoices.

(1) A proper invoice must include the following items (except for interim payments on cost reimbursement contracts for services):

i. Name and address of the contractor.

ii. Invoice date and invoice number. (Contractors must date invoices as close as possible to the date of mailing or transmission.)

iii. Contract number or other authorization for supplies delivered or services performed (including order number and line-item number).

iv. Description, quantity, unit of measure, unit price, and extended price of supplies delivered, or services performed.

https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

v. Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading.

vi. Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).

vii. Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

viii. Taxpayer Identification Number (TIN). The contractor must include its TIN on the invoice only if required by agency procedures. (See 4.9 TIN requirements.)

ix. Electronic funds transfer (EFT) banking information.

(A) The contractor must include EFT banking information on the invoice only if required by agency procedures.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the contractor must have submitted correct EFT banking information in accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by

EFT.

(x) Any other information or documentation required by the contract (e.g., evidence of shipment).

(2) An interim payment request under a cost-reimbursement contract for services constitutes a proper invoice for purposes of this subsection if it includes all of the information required by the contract.

(3) If the invoice does not comply with these requirements, the designated billing office must return it within 7 days after receipt (3 days on contracts for meat, meat food products, or fish; 5 days on contracts for perishable agricultural commodities, dairy products, edible fats or oils, and food products prepared from edible fats or oils), with the reasons why it is not a proper invoice. If such notice is not timely, then the designated billing office must adjust the due date for the purpose of determining an interest penalty, if any.

(b) Authorization to pay. All invoice payments, with the exception of interim payments on cost-reimbursement contracts for services, must be supported by a receiving report or other Government documentation authorizing payment (e.g., Government certified voucher).

The agency receiving official should forward the receiving report or other Government documentation to the designated payment office by the 5th working day after Government acceptance or approval, unless other arrangements have been made. This period of time does not extend the due dates prescribed in this section. Acceptance should be completed as expeditiously as possible. The receiving report or other Government documentation authorizing payment must, as a minimum, include the following:

(1) Contract number or other authorization for supplies delivered or services performed.

(2) Description of supplies delivered, or services performed.

(3) Quantities of supplies received and accepted, or services performed, if applicable.

(4) Date supplies delivered, or services performed.

(5) Date that the designated Government official-

(i) Accepted the supplies or services; or https://www.acquisition.gov/far/subpart-4.9#FAR_Subpart_4_9 https://www.acquisition.gov/far/52.232-38#FAR_52_232_38 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 https://www.acquisition.gov/far/52.232-34#FAR_52_232_34

(ii) Approved the progress payment request, if the request is being made under the clause at 52.232-5, Payments Under Fixed-Price Construction Contracts, or the clause at 52.232-10, Payments Under Fixed-Price Architect-Engineer Contracts.

(6) Signature, printed name, title, mailing address, and telephone number of the designated Government official responsible for acceptance or approval functions.

(c) Billing office. The designated billing office must immediately annotate each invoice with the actual date it receives the invoice.

(d) Payment office. The designated payment office will annotate each invoice and receiving report with the actual date it receives the invoice.

The Administration for Strategic Preparedness and Response (ASPR) additional requirements:

(i) The contractor must submit monthly invoices under this contract unless otherwise agreed upon by all parties. For indefinite delivery and blanket purchase agreement vehicles, separate invoices must be submitted for each order.

(ii) Invoices must break-out price/cost by contract line-item number (CLIN) as specified in the pricing section of the contract.

C.10 Post Award Evaluation of Contractor Performance

a. Contractor Performance Evaluations

A final Contractor Performance Assessment Reporting System (CPARS) evaluation will be prepared at or around completion of contract performance in accordance with applicable FAR Part 42 requirements. Any interim evaluation will be prepared only if required by the applicable FAR/agency procedures for the period of performance. The Contractor will be provided the evaluation for review and comment in accordance with the applicable procedures.

b. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov.

https://www.acquisition.gov/far/52.232-5#FAR_52_232_5 https://www.acquisition.gov/far/52.232-10#FAR_52_232_10 http://www.cpars.gov/

SECTION D – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

FY 26 SNS Pharmaceutical Logistic Replenishment

D.1 Background:

The Center for the Strategic National Stockpile (SNS) of the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local medical supplies and equipment during public health emergencies. The supplies, medicines, and devices for lifesaving care contained in the SNS can be used as a short-term, stopgap buffer when the immediate supply of these materials may not be available or sufficient.

The mission of the SNS is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical authorities request federal assistance to support their response efforts, the SNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

D.2 Purpose:

The SNS has a need to procure a variety of FDA approved pharmaceuticals to maintain minimum stockpiling capabilities for responding to public health events.

The SNS Asset Management Team is tasked with the critical responsibility of replenishing pharmaceuticals to ensure the SNS maintains a high level of readiness. This readiness is essential for responding effectively to public health emergencies. To fulfill this responsibility, the team must regularly procure a diverse range of FDA-approved pharmaceuticals. These acquisitions are vital to maintaining the minimum stockpiling levels necessary to support rapid response efforts during public health events, ensuring that the SNS is fully equipped to protect and serve the public in times of need.

D.3 Scope of Work:

A. The Contractor, as an independent organization and not as an agent of the Government, must furnish all labor, materials, supplies, facilities, equipment, and transportation necessary to deliver the acceptable pharmaceuticals. The contractor must provide brand name or equal product for the pharmaceuticals listed in Table B.3-1 above.

B. The quantities listed below in Table B.3-1 above are in the lowest unit of measure, each, which reflects the overall requirement that is defined as a single tablet, capsule, vial, bag, tube, bottle, packet, ampule, etc. Unless expressly authorized by solicitation amendment, each offered product must match the drug/active ingredient, strength, dosage form, formulation, and material packaging requirements stated in Sections B and D. Different manufacturers or NDCs may be offered when the offered product otherwise meets all solicitation requirements. The Contractor must ship all pharmaceuticals in the unit of measure of cases.

C. Contractor must ensure the National Drug Code (NDC) is identified on the external case or box packaging upon delivery. The NDC will be the same as identified on the contract, packing slip, and case packaging. Contractor must inform the Government about a plan to identify product NDC, when it is not reflected on the external case packaging during proposal and at the kick-off meeting (e.g. NDC listed on the packing slip per product line).

D.3.1 Pharmaceutical Products The pharmaceutical products, units of measure, and required quantities applicable to this requirement are identified in Table B.3-1, Schedule of Pharmaceutical Items. The requirements of this SOW apply to each awarded item, as applicable.

D.3.2 Special Requirements:

A. The products produced and stored under this contract must be Food and Drug Administration (FDA) approved and must be manufactured in accordance with the conditions approved by the FDA under appropriate patents for the medication. The current Good Manufacturing Practice regulations (cGMP's) (21CFR Parts 210 211) will be the standard to be applied for manufacturing, processing, and packing of pharmaceuticals.

B. At the time of delivery, product must have no less than 90% of total FDA approved shelf-life remaining. Contractor must ensure shelf-life is represented by an expiration date that is identified on the external case or box packaging upon delivery. Contractor must inform the Government about a plan to identify product expiration date, when it is not reflected on the external case or box packaging during proposal and at the kick-off meeting (e.g. expiration listed on the packing slip per product line).

C. The contractor must be an authorized manufacturer, distributor, or reseller with a current FDA license for such. If proposing on a controlled substance pharmaceutical, the contractor must also have the appropriate Drug Enforcement Administration (DEA) licenses to procure, store, and distribute such drugs.

D. The contractor must comply with Drug Enforcement Administration and State Controlled Substance Requirements:

1. The contractor is required to submit a Form 222 or use the DEA’s Controlled Substance

Ordering System (“CSOS”) for physical transfer of Scheduled II controlled substances from manufacturer or other source (which must be a DEA registered location) to contractor’s facilities.

2. The contractor must ensure that any delivery location(s) receiving a pharmaceutical that is a Scheduled II controlled substance, submits a DEA 222 Form or CSOS order, unless DEA provides an exemption or alternative process.

E. The Contractor must store Schedule II controlled substances in a vault and keep these products physically segregated in a separate space from non-controlled substances.

F. The Contractor must comply with all DEA and state recordkeeping and reporting regulations related to receiving controlled substances, inventories, shipping, Automation of Reports and Consolidated Orders System (ARCOS) reporting and Suspicious Order Monitoring reporting.

These requirements may be modified or limited pursuant to agreement with DEA, ASPR, and the authorities. The Contractor will require guidance from DEA and states as to the extent to which these requirements will be applicable to the pharmaceuticals. The DEA regulation governing controlled substances imposes strict requirements for recordkeeping and reporting to ensure compliance and to prevent the diversion of these substances. Key areas of compliance include:

1) Receiving Controlled Substances: When controlled substances are received, the Contractor must document and verify the receipt of the shipment. This includes maintaining accurate records of the quantities received, the date of receipt, the supplier, and any discrepancies. The DEA requires these records to be maintained in a manner that is readily retrievable for inspection.

2) Inventories: The Contractor must conduct initial and biennial inventories of all controlled substances in their possession. This inventory must include a complete and accurate count of all substances on hand, with separate records maintained for Schedule I and II substances and Schedule III, IV, and V substances. The inventory records must include the date of the inventory, whether it was taken at the beginning or close of business, and the signatures of the individuals responsible for conducting the inventory.

3) Shipping Controlled Substances: When shipping controlled substances, the Contractor must ensure that all shipments are documented and tracked. Shipping records must include the quantities shipped, the date of shipment, the recipient, and any discrepancies noted during the shipping process. These records are essential for maintaining the integrity of the supply chain and ensuring that controlled substances are not diverted.

4) Automation of Reports and Consolidated Orders System (ARCOS) Reporting: ARCOS is an automated system that monitors the flow of controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level. The Contractor must submit regular reports to ARCOS, detailing the quantities of controlled substances that have been manufactured, imported, exported, or distributed. These reports are critical for maintaining oversight of the controlled substances and ensuring that they are being used appropriately.

5) Suspicious Order Monitoring Reporting: The Contractor is required to implement a system to identify and report suspicious orders of controlled substances. Suspicious orders may include orders of unusual size, orders that deviate substantially from a normal pattern, and orders of unusual frequency. When a suspicious order is identified, the contractor must report it to the DEA in accordance with regulatory requirements.

D.3.3 Returns and Recalls:

A. The Contractor is responsible for returns and replacements. If there are any discrepancies, including damages, shortages, overages, or inconsistencies identified during transport or upon delivery, the Contractor must provide full replacements for the affected units of measure (e.g., box, case, pallet) at no additional cost to the Government. Within five (5) business days of receiving notice, the Contractor must submit a revised delivery schedule specifying the anticipated delivery date(s). All costs associated with returns and replacements, including shipping and handling, must be the sole responsibility of the Contractor.

B. The Contractor is responsible for coordinating the recall of any distributed products provided by the manufacturer. This includes managing logistics, communication, and other actions associated with the recall process. Additionally, the Contractor is responsible for shipping any recalled Government Furnished Property (GFP) back to ASPR/SNS. The Contractor must ensure that all such shipments are completed in compliance with applicable regulations and guidelines. The Contractor is responsible for any cost involving the recall process i.e. returning and replacement of product, including shipping and handling, with no additional cost to the Government.

D.4 Ordering Period, Delivery Period, and Delivery Locations:

The contract ordering period is twelve (12) months from the date of award. Delivery locations and the distribution plan will be provided after award because SNS site information is sensitive. Deliveries may be required to up to nine SNS locations in the 48 contiguous states and Hawaii. Delivery dates for awarded basic quantities and any exercised increased quantities will be established consistent with the awarded schedule, written delivery instructions, and this SOW.

Exact delivery locations and the distribution plan will be provided by the Contracting Officer’s Representative (COR) after award. Final delivery dates will be established consistent with the awarded month-by-month delivery schedule and the requirements of this SOW.

D.5 Proposed Delivery Schedule:

The Offeror shall include a proposed month-by-month delivery schedule in RFP Attachment 3 Tab, Technical Template. After award, the COR will provide SNS delivery addresses and receiving-site points of contact. The Contractor must contact the receiving-site POC at least 48 hours before shipment to coordinate access and delivery. Deliveries may be required monthly to up to nine SNS locations in the 48 contiguous states and Hawaii.

D.6 Shipping Requirements:

All contracts for delivery to an SNS location must have the following shipping requirements:

a. Products must be stored and maintained in a controlled room where temperature conditions are kept within the range of 20°C to 25°C (68°F to 77°F) both during storage and transit to SNS locations.

b. Product will be shipped in accepted UoM of case.

c. No partial case or box quantities will be accepted.

d. No mixed lot numbers per case or per packages will be accepted.

e. No mixed sizes (e.g., small, medium, large, extra-large mixed in on one pallet) will be accepted.

f. No mixed product per pallet will be accepted.

g. Shelf-life and storage requirements must be included on all packing list, inner packaging, and outer case.

h. One lot number will be used per pallet. Each individual lot number must have a single expiration date. Different expiry dates for the same Lot number will not be accepted.

i. Lot numbers and part numbers must be included on the inner packaging and clearly identified.

j. Lot numbers, part numbers, and case quantity must be listed on the outer packaging.

k. Labels must adhere to applicable FDA labeling regulations.

l. Case labels must be securely affixed and durable throughout the product's lifespan. Case labels must face outward on pallet to enable material handlers the ability to view on both open ends of the pallet.

m. All shipments will include packing slips containing the contract number, item description, NDC or part number, lot numbers, and quantities. Contractor must ensure the NDC is identified on the external case or box packaging upon delivery. Contractor must inform the Government about a plan to identify product NDC, when it is not reflected on the external case or box packaging during proposal and at the kick-off meeting (e.g. NDC listed on the packing slip per product line). The Contractor must ensure the NDC is the same that is identified on the contract, packing slip, and case or box packaging.

n.