Request For Information for Structured Product Labeling Document Support.pdf

REQUEST FOR INFORMATION (RFI)

1.0 RFI TITLE: STRUCTURED PRODUCT LABELING (SPL) DOCUMENT SUPPORT

2.0 AGENCY: Defense Health Agency Research & Development Medical Research and Development Command

(DHA R&D – MRDC)

3.0 OFFICE: Office of Regulated Activities (ORA)

4.0 LOCATION: 1541 Porter St. Fort Detrick MD 21702

5.0 SUBJECT: The Office of Regulated Activities of the DHA R&D Medical Research and Development Command is conducting market research to determine whether a commercial solution can be provided to meet requirements for structured product labeling (SPL) document support or for the software and training needed to perform these updates internally to the organization. This market research may also assist with the further development and/or refinement of the requirements.

6.0 DISCLAIMER: In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time, and shall not be construed as a solicitation or as an obligation on the part of the DHA R&D – MRDC, or collaborative Department of Defense (DoD) activities. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

7.0 DESCRIPTION: Office of Regulated Activities of the DHA R&D – MRDC Medical Research and Development Command 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 3 licensed New Drug Application (NDA) products which require SPL submissions for up to 5 levels of primary and secondary labeling.

8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a CAPABILITIES STATEMENT. The subject header of the email for submission of questions and/or the RFI response shall be:

Structured Product Labeling (SPL)Document Support. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information:

• Consideration will be given to 3 types of SPL submission requests from the regulatory Sponsor:

1. Create new labels.

Draft labels.

Submit drafts to FDA review for approval.

Create final label.

2. Update existing labels Draft labels.

Submit drafts to FDA review for approval.

Create final label.

3. Submit final labels to FDA for specific product application.

• Information regarding adherence to the latest technical conformance criteria for SPL documents used by

FDA.

• Information regarding XML (eXtensible Markup Language) format, allowing for consistent, machine-readable data.

• Details on level of system validation and overall schema

• Details on processes and procedures to ensure quality and content consistency: The labeling must maintain consistency with the product's approval to ensure all information is accurate and up to date.

• Elements of Labeling covering SPL system capabilities: SPL should include specific elements such as:

1. Product Identification Information

2. Indications and Usage

3. Dosage and Administration

4. Warnings and Precautions

5. Adverse Reactions

6. Clinical Pharmacology

7. Other relevant sections based on the product type.

• Details on the procedure for sending content of Labeling to Regulatory Authorities.

• Details on managing system updates and maintenance.

• Details on managing data and records ensuring that the most current information is always accessible. It is essential to promptly update the SPL when any changes to the product labeling occur.

• Details on complying with US FDA and ICH Guidelines, as well as industry standards on SPL submissions requirements.

The ORA would also like to have responses from software companies that are capable of performing the above SPL updates along with training on how to use the software so ORA can perform these updates internally in our organization.

8.1 PROJECT COST Please consider the DHA R&D – MRDC currently has 3 licensed New Drug Application (NDA) products which require SPL submissions for up to 5 levels of primary and secondary labeling. Historical trends have required ~3 bundled SPL submissions per fiscal year. However, required labeling changes can occur at any time.

9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Alana M.

Sowers at alana.m.sowers.civ@health.mil no later than the close of business 17 April 2025. Telephonic communication will not be considered as submission nor receive response.

Responses shall be limited to five (5) pages, answer the questions posed in Section 8 and submitted via e-mail only.

The font shall be Times New Roman, size 12, single space. Electronic files shall not exceed 3 MB. All submissions become Government property and will not be returned.

10.0 REQUIRED INFORMATION: Fill in the below table when responding to this RFI.

Question Answer RFI Number Company Name Company Address Point of Contact

Phone Number E-mail Address Tax Identification Number (TIN) CAGE Code DUNS Number Company Web Page Company Location(s) Company is / is not a Small Business Company is / is not SAM Registered Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program