B08. Solicitation - HT942626QE022 Amendment 2.pdf
PDF 11 MB Posted
- Solicitation number
- PANDHA-26-P-0000035401
- Issued by
-
Defense Health Agency
About this file
This is a Request for Quote (RFQ) for structured product labeling services issued by the Defense Health Agency (DHA), Medical R&D Contracting Division at Fort Detrick, Maryland.
The solicitation seeks firm-fixed-price services for managing, processing, and validating electronic Structured Product Label (eSPL) submissions to the FDA Electronic Submission Gateway (ESG). The requirement covers initial labeling and labeling changes for up to five New Drug Application products requiring FDA submission. The base contract period runs from 30 July 2026 to 29 July 2027, with four (4) one-year option periods extending through 29 July 2031. The contract is set aside for Women-Owned Small Businesses (WOSB), with a North American Industry Classification System (NAICS) code of 541690 and a size standard of USD 19,000,000. Quotes must be submitted electronically by 29 June 2026 at 2:00 PM Eastern Time to the Contracting Officer and Contract Specialist. Offerors are required to provide a three-volume response addressing technical capability (10-page maximum), past performance references within the last three years (6-page maximum), and pricing with administrative information. Technical evaluation will assess FDA ESG Gateway expertise, quality control and validation processes, workflow management capabilities, and secure handling of sensitive product data. Award will be made to the responsible offeror offering the best value, considering technical capability, past performance, and price. The pricing is structured with a base year and four option years, with payments processed through the Wide Area Workflow (WAWF) system using firm-fixed-price invoicing.
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Text version
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/
LOC 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
29 June 2026
Deliveries or Performance
Line Item Delivery Schedule
Period of Performance From 30 July 2026 To 29 July 2027
Option Line Item
Period of Performance From 30 July 2026 To 29 July 2027
Option Line Item
Period of Performance From 30 July 2026 To 29 July 2027
Option Line Item
Period of Performance From 30 July 2026 To 29 July 2027
Option Line Item
Period of Performance From 30 July 2027
Quantity
2Job
1 Job
1 Job
1 Job
2Job
Address and POC
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
HT942626QE022
To 29 July 2028
Option Line Item
Period of Performance From 30 July 2027 To 29 July 2028
Option Line Item
Period of Performance From 30 July 2027 To 29 July 2028
Option Line Item
Period of Performance From 30 July 2027 To 29 July 2028
Option Line Item
Period of Performance From 30 July 2028 To 29 July 2029
Option Line Item
Period of Performance From 30 July 2028 To 29 July 2029
1 Job
1 Job
1 Job
2Job
1 Job
1 Job
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance
Option Line Item
Period of Performance From 30 July 2028 To 29 July 2029
Option Line Item
Period of Performance From 30 July 2028 To 29 July 2029
Option Line Item
Period of Performance From 30 July 2029 To 29 July 2030
Option Line Item
Period of Performance From 30 July 2029 To 29 July 2030
Option Line Item
Period of Performance From 30 July 2029 To 29 July 2030
1 Job
2Job
1 Job
1 Job
1 Job
DoDMC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDMC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDMC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDMC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDMC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDMC: HT0957 CountryCode: USA
USAMRD CMD - MM
Option Line Item
Period of Performance From 30 July 2029 To 29 July 2030
Option Line Item
Period of Performance From 30 July 2030 To 29 July 2031
Option Line Item
Period of Performance From 30 July 2030 To 29 July 2031
Option Line Item
Period of Performance From 30 July 2030 To 29 July 2031
Option Line Item
Period of Performance From 30 July 2030 To 29 July 2031
2Job
1 Job
1 Job
1 Job
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
Place of Performance DoDAAC: HT0957 CountryCode: USA
USAMRD CMD - MM
ATTN: MRDC / G4, 9200 AMBER DRIVE
FORT DETRICK, MD 21702-5011
UNITED STATES
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 29 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 17 June 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
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