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Structured Product Labeling (SPL) HT9426-26-Q-E022

Active
PANDHA-26-P-0000035401Federal

Contract Overview

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AI Contract Overview

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The contract issued by the Office of Regulated Activities within the DHA Research & Development Medical Research and Development Command focuses on managing, processing, and completing initial labeling and labeling changes for electronic Structured Product Label (SPL) document submissions to the FDA. SPL follows the Health Level Seven (HL7) standard, which is based on Clinical Document Architecture and the HL7 Reference Information Model and is accredited by ANSI for exchanging product information. The DHA R&D MRDC currently holds two licensed New Drug Application products necessitating SPL submissions covering up to five levels of primary and secondary labeling. This solicitation, titled "Structured Product Labeling (SPL)," was posted on May 15, 2026, with responses due by June 5, 2026. It is a combined contract type under NAICS code 541690, managed by the Army Medical Resources Acquisition Activity, a Department of Defense office located in Fort Detrick, Maryland. Performance will take place in Frederick, MD. The primary point of contact is Matthew Gembe, and the contracting officer is Terrie Bloom. The contract does not specify any set-aside provisions.

General Info

Manage and process electronic Structured Product Labeling submissions for FDA, under DHA R&D Medical command.

Agency

Department Of Defense → Army Medical Resources Acq Activity

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Frederick, MD, 21702, USA

Set-Aside

NONE

Documents

(8)

DHA R&D MRDC Organizational Conflict of Interest Certification Form

DOCXcertification-form

Attachment 3 - Past Performance References

PDFpast-performance

Solicitation HT942626QE022 Amendment 1 Structured Product Labeling

PDFamendment

B08.+Solicitation+-+HT942626QE022+Amendment+2.pdf

PDF

Solicitation HT942626QE022 for Structured Product Labeling Generation

PDFrfp

Non-Disclosure Agreement Attachment 1 for DHA R&D MRDC Contract

DOCXnon-disclosure-agreement

Performance Work Statement - ORA SPL Requirement

DOCXsow

Attachment 4 - Pricing Sheet for Structured Product Labeling Requirement

XLSXpricing-sheet

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Timeline

3 updates
PhaseCombined Synopsis
Amendment 0

Contract was updated

Amendment 2

Contract was updated

Posted

Combined Synopsis

Amendment 3

Contract was updated

Response Deadline

Submission deadline

Response Deadline

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Organization & Contact Information

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AgencyDepartment Of Defense → Army Medical Resources Acq Activity
Contacts2 people available
OfficeFORT DETRICK, MD, 21702, USA
Organization / Agency
Department Of Defense → Army Medical Resources Acq Activity
Office AddressFORT DETRICK, MD, 21702, USA
Contacts
Terrie Bloom Contracting Officer

Full Description

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Office of Regulated Activities of the DHA R&D – Medical Research and Development Command (MRDC) has a requirement to manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA. Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. The DHA R&D – MRDC currently has 2 licensed New Drug Application (NDA) products which require SPL submissions for up to 5 levels of primary and secondary labeling.

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