WOMEN-OWNED SMALL

BUSINESS (WOSB)

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NUMBER 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect calls)

8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

CODE

TELEPHONE NUMBER

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

OFFER

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

BELOW IS CHECKED

REQUEST

FOR QUOTE

(RFQ)

INVITATION

FOR BID

(IFB)

REQUEST

FOR

PROPOSAL

(RFP)

SEE ADDENDUM

19.

ITEM NUMBER

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Government Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NORTH AMERICAN

INDUSTRY CLASSIFICATION

STANDARD (NAICS):

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

THE DEFENSE PRIORITIES

AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

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

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

8(A)

ECONOMICALLY

DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

HT9426

DEFENSE HEALTH AGENCY

MEDICAL R&D CONTRACTING DIVISION 1, 808 SCHREIDER STREET

FORT DETRICK, MD 21702

UNITED STATES

Matthew Gembe, Email: matthew.w.gembe.civ@health.mil Telephone: 3016191350

HT942626QE022

Instructions, Conditions, & Notices to Offerors or Quoters

1.0 General Offerer Preparation Instructions (FAR 52.212-1-Addenda)

1.1 Submission Information: Quotes must be submitted electronically via email to the Contracting Officer at< terrie.l.bloom.civ@health.mil > and Contract Specialist at< matthew.w.gembe.civ@health.mil > no later than 10 June 2026 at 2:00PM Eastern Time.

1.2 Questions/Clarifications: All questions regarding this Request for Quote (RFQ) must be submitted in writing via email no later than 26 May 2026 at 2:00PM Eastern Time. The Government will not guarantee responses to questions received after this deadline.

1.3 Requirement is being solicited in accordance with FAR Subpart 12.201

1.4 Quote Organization: Offerer shall submit their response in three (3) separate volumes as detailed below:

Volume Title

Technical Capability

II Past Performance

Ill Price & Administrative

Maximum Page Limit

10 Pages

6 Pages

No Limit (Keep concise)

Formatting: Quote content shall be no smaller than Times New Roman font 12 point. Exhibits, graphics, charts, captions, etc., shall be no smaller than 1 O point.

2.0 Specific Volume Instructions: The Offeror's non-price proposal shall clearly reflect the Offeror's approach to execute and comply with the performance requirements identified in the PWS. The non-price proposal, including any supporting documentation, is to be clear and concise.

2.1 Volume I: Technical Capability

The Technical Volume must demonstrate the offeror's methodology and ability to meet the essential characteristics of the requirements without simply restating the (PWS). The offerer shall provide a narrative that specifically addresses:

• FDA ESG Gateway Expertise: Detailed approach to managing, processing, and validating XML-based electronic Structured Product Label (eSPL) submission via the FDA Electronic Submission Gateway.

• Quality Control & Validation: The specific tools and quality assurance processes used to ensure zero-error submissions and rapid resolution of any FDA portal rejections.

• Workflow Management: How the offerer tracks labeling changes, maintains version control, and communicates submission status to Government Stakeholders.

2.2 Volume II: Past Performance

The offeror shall submit up to three (3) recent and relevant past performance references. "Recent" is defined as performance within the last three (3) years from the issuance date of this RFQ. "Relevant" is defined as services of similar size, scope, and complexity (specifically managing FDA eSPL document submissions). The offerer shall utilize Past performance reference sheet (Attachment 3).

Information from Other Sources: The Government reserves the right to consider other past performance information at its disposal to include, but not limited to the Federal Awardee Performance and Integrity Information System (FAPIIS), the Contractor Performance Assessment Reporting System (CPARS), in addition to any information obtained from the references provided.

2.3 Volume Ill: Price and Administrative

This volume shall contain the offerer's Firm-Fixed-Price (FFP) quote and all required administrative information. The Offerer shall ensure mathematical computations are correct. Offerers shall propose on all contract line items. A line-item left blank will be considered nonresponsive to this request and the quote will not be considered for award. Offerers shall complete the Pricing Sheet (Attachment 4) inclusive of the offeror's total firm-fixed price quote for each line item.

• Pricing Schedule: The offerer shall provide a total FFP for the base year and all four (4) Option Years.

• System for Award Management (SAM): The offerer must explicitly state they have an active registration in SAM.gov (include UEI number and CAGE code).

• Representations and Certifications: The offerer shall include a completed copy of any required FAR provisions if not fully updated in SAM.gov. Please include any Representations that are not in SAM.gov.

FAR Clauses Incorporated by Reference

Number

52.203-18

52.204-7 52.212-1

Title

Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation.

System for Award Management-Registration. (Deviation 2026-00038) Instructions to Offerers-Commercial Products and Commercial Services. (Deviation 2026-00038)

DFARS Clauses Incorporated by Reference

Effective Date

Jan 2017

Feb 2026 Feb 2026

Effective

Alternate/ Deviation

Alternate/

Variation Effective Date

Variation