GSA FEDSIM Issues RFI for Structured Product Labeling (SPL) IT System

RFI for Structured Product Labeling (SPL) Automated System

Structured Product Labeling (SPL) Automated System

Document Type: Sources Sought Notice
Solicitation Number: Reference-Number-SPL-05-01
Posted Date: Oct 20, 2004
Original Response Date: Nov 03, 2004
Current Response Date: Nov 03, 2004
Original Archive Date: Nov 18, 2004
Current Archive Date: Nov 18, 2004
Classification Code: 70 -- General purpose information technology equipment
Naics Code: 541512 -- Computer Systems Design Services

Contracting Office Address

General Services Administration
Federal Technology Service (FTS)
Federal Systems Integration & Management Center (TFM)
6354 Walker Lane Suite 200
Alexandria, VA, 22310

Description

1.1 INTRODUCTION.

The GSA Federal Systems Integration and Management Center (FEDSIM) on behalf of the Food and Drug Administration (FDA) are considering the introduction of state of the art technology into the FDA infrastructure to achieve a Structured Product Labeling (SPL) capability.

SPL is a strategic initiative for achieving FDA's mission to process labeling information electronically.

The Government is soliciting information to identify potential approaches to building the SPL IT system.

The Government is also seeking information from hardware and software vendors to ensure that all available commercial-off-the-shelf (COTS), government-off-the-shelf (GOTS), and custom/hybrid products that provide capabilities applicable to the SPL have been identified.

All manufacturers and suppliers of hardware and software technology that could be applied to support management of labels across their lifecycles are offered this opportunity to describe how the Government can best employ their products to meet SPL mission needs.

1.2 BACKGROUND.

The FDA wishes to automate current processes with IT systems that would automate and significantly improve the performance of the drug labeling review process and transfer of labeling data.

The FDA was recognized by the National Committee on Vital and Health Statistics (NCVHS) as the basic source for drug product terminology and information because of its regulatory responsibility for approving safe and effective drug products in the United States.

FDA, working with the industry, has developed SPL as a format for exchanging labeling information among computer systems.

In September 2004, industry began using the SPL document format to begin submitting labeling information to the FDA.

Currently, the FDA is reviewing this information manually to assess changes, make approval determinations, and share with other Government agencies.

The overall purpose of this project is to improve patient safety by ensuring that medication information is readily available to health care providers, patients and the public in its most up-to-date form.

The project is part of a larger initiative called the DailyMed.

The DailyMed Initiative is a partnership between the FDA, medication manufacturers and distributors, the National Library of Medicine (NLM), and healthcare information suppliers.

Additional information on the SPL background can be found in the High Level Requirements Document; [see section 1.5. below]

1.3 PROGRAM OBJECTIVES.

The overall objective of the FDA Structured Product Labeling project is to create a technological environment that will enable FDA to reliably generate up-to-date SPL for all drug products marketed in the United States.

Later phases can potentially address other FDA-regulated products including vaccines, animal drug products, dietary supplements and medical devices.

SPL file information contains the following medication data: (1) How to use medication - dosing recommendations and monitoring use; (2) When to use medication - indication, clinical effects (e.g., interactions and adverse events), activity (e.g., mechanism of action), other information about the use of the medication; (3) Description of the medication - names, ingredients, strength, appearance, dosage form; (4) How the medication is supplied - name, package type, quantity; and (5) Distributor of the medication.

Achieving this objective will require a new technical approach to reviewing, processing, and sharing label information.

Additional information on the SPL objectives can be found in the SPL High Level Requirements Document; [see section 1.5. below]

1.4 PROJECT SCOPE.

The scope of the expected work is developing the computer systems (hardware and software) that will enable FDA to realize the project objectives.

The computer system and a technical environment will support processing and managing of label information as well as labeling supplements in the SPL XML format.

Labeling reviewers will review and approve SPL submissions and disseminate the approved SPLs to Health Care Community/Public using the developed system.

A major system component of the SPL project is the Labeling System, which will be used to validate received SPL submissions and help to provide the most up-to-date information to the public, preventing medication errors and adverse events.

The system will also support the labeling review process performed by labeling reviewers.

In order to facilitate the labeling review process, the system will have interfaces with external systems (i.e., Tracking System for tracking information on new SPL submissions and Receiving Systems for receipt of incoming SPL submissions).

Project scope also includes development and/or integrating supporting technology including the Listing System, Ingredients/UNII System, and Registration System.

All approved SPLs will need to be transmitted to the central repository NLM for dissemination to the Health Care Community/Public.

The Government perceives this project to be developed using a phased approach; the first release is scheduled to be implemented six months after project award and the final expected to be implemented eighteen months after project award.

The first increment will incorporate sufficient core functionality to achieve an Initial Operational Capability. Unimplemented requirements will be allocated to successive increments as needed to achieve Full Operational Capability.

The goals of the Phase 1 tentatively would be to develop systems that will register ingredients information and generate the UNII codes and process, review, approve, and disseminate electronic SPL submissions for approved prescription drugs.

The new systems will be integrated with the existing FDA systems.

The goals of the Phase 2 tentatively would be to develop systems that will process drug-listing information and create drug product codes and register information about manufactures, repackers, and relabelers.

The new systems will be integrated with the existing systems. After the Phase 2 is implemented, SPL submissions for all drug products will be processed.

The FDA expects the system to be capable of supporting 5,000 non-concurrent FDA users.

The system is expected to be capable of handling at least 1,000 SPL original submissions per year and 15,000 label modifications per year.

Indefinite data retention is expected for valid label information and archiving may be leveraged.

Response handling shall have performance of less than 10 seconds for up to 1,000 concurrent users and 15 seconds for greater numbers.

The system must be compliant with Section 508 and with applicable FDA and CDER policies.

Offers should review the CDER Technical Reference Model and Standards Profile and FDA policies 3250.26 and 3250.27 to understand the current list of approved technologies and applicable FDA security guidance; both resources can be located in the following section.

Additional functional and non-functional requirements and their applicable scope phase can be found in SPL High Level Requirements.

This document further defines the functional, technical, workflow, integration, and reporting requirements for each sub-system and system-level requirements for performance, security, and system administration.

1.5 REFERENCE SOURCES

RESOURCE: SPL High Level Requirements

DESCRIPTION: System requirements documentation

URL: http://www.fts.gsa.gov/fdaspl/

RESOURCE: Implementation Guide for Industry

DESCRIPTION: SPL file formatting guide published for Industry

URL: http://www.hl7.org/library/committees/rcrim/spl/SPL_implementation_guide_DRAFT.zip

RESOURCE: FDA/CDER Enterprise Architecture Technical Reference Model

DESCRIPTION: FDA/CDER Enterprise Architecture Technical Reference Model

URL: http://www.fts.gsa.gov/fdaspl/

RESOURCE: CDER Technical Reference Model and Standards Profile

DESCRIPTION: Lists current technologies acceptable for CDER/FDA implementation.

Modifications are made periodically.

URL: http://www.fts.gsa.gov/fdaspl/

RESOURCE: FDA 3250.26 and 3250.27

DESCRIPTION: Applicable FDA security policies

URL: http://www.fts.gsa.gov/fdaspl/

RESOURCE: Structured Product Labeling Resources

DESCRIPTION: Additional SPL resource information

URL: http://www.fda.gov/oc/datacouncil/spl.html

RESOURCE: RFI Advance Notice DESCRIPTION:

RFI Advance Notice posted to FedBizOpps on 1 October 2004

URL: http://www.fts.gsa.gov/fdaspl/

RESOURCE: Federal Rules and Regulations

DESCRIPTION: Amended regulations governing label file format submissions

URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-30641.pdf

RESOURCE: Draft Industry Guidance

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling

URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-2536.htm

1.6 RESPONSE INSTRUCTIONS

Businesses or other organizations with the capability of providing a technical solution are invited to submit in writing, sufficient information that demonstrates the ability to fulfill these requirements.

Briefly describe your company, your products and services, history, ownership, financial information, and other information you deem relevant.

Provide points of contact, including name, address, phone/fax number, and email.

There are no minimum or maximum restrictions in the number of pages for the response nor are there restrictions on document format.

Based on the understanding of the FDA?s needs, describe your conceptual technical and architectural approach to satisfy SPL mission needs including use of COTS, GOTS, or custom hardware and software components.

List which requirements from Table B-1 in the High Level Requirements are satisfied in existing technology (identifying that technology), and which would require development, configuration or customization.

Discuss technically feasible alternatives and provide non-binding order of magnitude cost and schedule estimates for the alternatives.

Indicate whether your product is commercially available or is on the General Services Administration Federal Supply Schedule.

Indicate the maturity level of your software or systems engineering processes, e.g., SEI CMM, CMMI, etc.

If a level has been achieved, indicate what evaluation or assessment method was used and what organizational units were covered.

It is desired that the system be implemented on a schedule consistent with the Release matrix identified in the High Level Requirements document, but early implementation is desirable.

Intermediate milestones between contract award and implementation are encouraged.

Also, a prototype is desirable to mitigate risk.

1.7 CONTACT INFORMATION.

Interested parties are invited to go to the SPL Acquisition website: http://www.fts.gsa.gov/fdaspl/

Technical matters regarding this RFI should be submitted via email to: jeff.williamGSA FEDSIM, Attn: Nat Harrison, 6354 Walker Lane, Suite 200, Alexandria, VA 22310

The Government may elect not to discuss submissions received in response to this RFI with individual responders. The SPL project goal is to start the system development by February 2005.

1.8 DISCLAIMER.

This RFI is issued for information and planning purposes only and does not constitute a solicitation. The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for information received in response to this RFI.

All information received in response to this RFI that is marked Proprietary will be handled accordingly.

Responses to the RFI will not be returned.

Information provided in response to this RFI will be used to assess tradeoffs and alternatives available for determining how to proceed in the acquisition process for the SPL and may lead to the development of a specification for the SPL.

In accordance with FAR 15.201(e), responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract.

Responders are solely responsible for all expenses associated with responding to this RFI.

Point of Contact

Nat Harrison, Contract Specialist, Phone 703-306-7606, Fax 703-306-7710, Email nat.harrison@gsa.gov
Jeff Williams, Project Manager, Phone 703-392-9975, Fax null, Email jeffrey.williams@gsa.gov

[Source: http://www2.eps.gov/spg/GSA/FTS/TFM/Reference%2DNumber%2DSPL%2D05%2D01/SynopsisR.html]

Prepared by Robin Cover for The XML Cover Pages archive. See general references in "Structured Product Labeling (SPL)", part of "XML in Clinical Research and Healthcare Industries."

SEARCH Advanced Search ABOUT Site Map CP RSS Channel Contact Us Sponsoring CP About Our Sponsors NEWS Cover Stories Articles & Papers Press Releases CORE STANDARDS XML SGML Schemas XSL/XSLT/XPath XLink XML Query CSS SVG TECHNOLOGY REPORTS XML Applications General Apps Government Apps Academic Apps EVENTS LIBRARY Introductions FAQs Bibliography Technology and Society Semantics Tech Topics Software Related Standards Historic	GSA FEDSIM Issues RFI for Structured Product Labeling (SPL) IT System RFI for Structured Product Labeling (SPL) Automated System Structured Product Labeling (SPL) Automated System Document Type: Sources Sought Notice Solicitation Number: Reference-Number-SPL-05-01 Posted Date: Oct 20, 2004 Original Response Date: Nov 03, 2004 Current Response Date: Nov 03, 2004 Original Archive Date: Nov 18, 2004 Current Archive Date: Nov 18, 2004 Classification Code: 70 -- General purpose information technology equipment Naics Code: 541512 -- Computer Systems Design Services Contracting Office Address General Services Administration Federal Technology Service (FTS) Federal Systems Integration & Management Center (TFM) 6354 Walker Lane Suite 200 Alexandria, VA, 22310 Description 1.1 INTRODUCTION. The GSA Federal Systems Integration and Management Center (FEDSIM) on behalf of the Food and Drug Administration (FDA) are considering the introduction of state of the art technology into the FDA infrastructure to achieve a Structured Product Labeling (SPL) capability. SPL is a strategic initiative for achieving FDA's mission to process labeling information electronically. The Government is soliciting information to identify potential approaches to building the SPL IT system. The Government is also seeking information from hardware and software vendors to ensure that all available commercial-off-the-shelf (COTS), government-off-the-shelf (GOTS), and custom/hybrid products that provide capabilities applicable to the SPL have been identified. All manufacturers and suppliers of hardware and software technology that could be applied to support management of labels across their lifecycles are offered this opportunity to describe how the Government can best employ their products to meet SPL mission needs. 1.2 BACKGROUND. The FDA wishes to automate current processes with IT systems that would automate and significantly improve the performance of the drug labeling review process and transfer of labeling data. The FDA was recognized by the National Committee on Vital and Health Statistics (NCVHS) as the basic source for drug product terminology and information because of its regulatory responsibility for approving safe and effective drug products in the United States. FDA, working with the industry, has developed SPL as a format for exchanging labeling information among computer systems. In September 2004, industry began using the SPL document format to begin submitting labeling information to the FDA. Currently, the FDA is reviewing this information manually to assess changes, make approval determinations, and share with other Government agencies. The overall purpose of this project is to improve patient safety by ensuring that medication information is readily available to health care providers, patients and the public in its most up-to-date form. The project is part of a larger initiative called the DailyMed. The DailyMed Initiative is a partnership between the FDA, medication manufacturers and distributors, the National Library of Medicine (NLM), and healthcare information suppliers. Additional information on the SPL background can be found in the High Level Requirements Document; [see section 1.5. below] 1.3 PROGRAM OBJECTIVES. The overall objective of the FDA Structured Product Labeling project is to create a technological environment that will enable FDA to reliably generate up-to-date SPL for all drug products marketed in the United States. Later phases can potentially address other FDA-regulated products including vaccines, animal drug products, dietary supplements and medical devices. SPL file information contains the following medication data: (1) How to use medication - dosing recommendations and monitoring use; (2) When to use medication - indication, clinical effects (e.g., interactions and adverse events), activity (e.g., mechanism of action), other information about the use of the medication; (3) Description of the medication - names, ingredients, strength, appearance, dosage form; (4) How the medication is supplied - name, package type, quantity; and (5) Distributor of the medication. Achieving this objective will require a new technical approach to reviewing, processing, and sharing label information. Additional information on the SPL objectives can be found in the SPL High Level Requirements Document; [see section 1.5. below] 1.4 PROJECT SCOPE. The scope of the expected work is developing the computer systems (hardware and software) that will enable FDA to realize the project objectives. The computer system and a technical environment will support processing and managing of label information as well as labeling supplements in the SPL XML format. Labeling reviewers will review and approve SPL submissions and disseminate the approved SPLs to Health Care Community/Public using the developed system. A major system component of the SPL project is the Labeling System, which will be used to validate received SPL submissions and help to provide the most up-to-date information to the public, preventing medication errors and adverse events. The system will also support the labeling review process performed by labeling reviewers. In order to facilitate the labeling review process, the system will have interfaces with external systems (i.e., Tracking System for tracking information on new SPL submissions and Receiving Systems for receipt of incoming SPL submissions). Project scope also includes development and/or integrating supporting technology including the Listing System, Ingredients/UNII System, and Registration System. All approved SPLs will need to be transmitted to the central repository NLM for dissemination to the Health Care Community/Public. The Government perceives this project to be developed using a phased approach; the first release is scheduled to be implemented six months after project award and the final expected to be implemented eighteen months after project award. The first increment will incorporate sufficient core functionality to achieve an Initial Operational Capability. Unimplemented requirements will be allocated to successive increments as needed to achieve Full Operational Capability. The goals of the Phase 1 tentatively would be to develop systems that will register ingredients information and generate the UNII codes and process, review, approve, and disseminate electronic SPL submissions for approved prescription drugs. The new systems will be integrated with the existing FDA systems. The goals of the Phase 2 tentatively would be to develop systems that will process drug-listing information and create drug product codes and register information about manufactures, repackers, and relabelers. The new systems will be integrated with the existing systems. After the Phase 2 is implemented, SPL submissions for all drug products will be processed. The FDA expects the system to be capable of supporting 5,000 non-concurrent FDA users. The system is expected to be capable of handling at least 1,000 SPL original submissions per year and 15,000 label modifications per year. Indefinite data retention is expected for valid label information and archiving may be leveraged. Response handling shall have performance of less than 10 seconds for up to 1,000 concurrent users and 15 seconds for greater numbers. The system must be compliant with Section 508 and with applicable FDA and CDER policies. Offers should review the CDER Technical Reference Model and Standards Profile and FDA policies 3250.26 and 3250.27 to understand the current list of approved technologies and applicable FDA security guidance; both resources can be located in the following section. Additional functional and non-functional requirements and their applicable scope phase can be found in SPL High Level Requirements. This document further defines the functional, technical, workflow, integration, and reporting requirements for each sub-system and system-level requirements for performance, security, and system administration. 1.5 REFERENCE SOURCES RESOURCE: SPL High Level Requirements DESCRIPTION: System requirements documentation URL: http://www.fts.gsa.gov/fdaspl/ RESOURCE: Implementation Guide for Industry DESCRIPTION: SPL file formatting guide published for Industry URL: http://www.hl7.org/library/committees/rcrim/spl/SPL_implementation_guide_DRAFT.zip RESOURCE: FDA/CDER Enterprise Architecture Technical Reference Model DESCRIPTION: FDA/CDER Enterprise Architecture Technical Reference Model URL: http://www.fts.gsa.gov/fdaspl/ RESOURCE: CDER Technical Reference Model and Standards Profile DESCRIPTION: Lists current technologies acceptable for CDER/FDA implementation. Modifications are made periodically. URL: http://www.fts.gsa.gov/fdaspl/ RESOURCE: FDA 3250.26 and 3250.27 DESCRIPTION: Applicable FDA security policies URL: http://www.fts.gsa.gov/fdaspl/ RESOURCE: Structured Product Labeling Resources DESCRIPTION: Additional SPL resource information URL: http://www.fda.gov/oc/datacouncil/spl.html RESOURCE: RFI Advance Notice DESCRIPTION: RFI Advance Notice posted to FedBizOpps on 1 October 2004 URL: http://www.fts.gsa.gov/fdaspl/ RESOURCE: Federal Rules and Regulations DESCRIPTION: Amended regulations governing label file format submissions URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-30641.pdf RESOURCE: Draft Industry Guidance Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-2536.htm 1.6 RESPONSE INSTRUCTIONS Businesses or other organizations with the capability of providing a technical solution are invited to submit in writing, sufficient information that demonstrates the ability to fulfill these requirements. Briefly describe your company, your products and services, history, ownership, financial information, and other information you deem relevant. Provide points of contact, including name, address, phone/fax number, and email. There are no minimum or maximum restrictions in the number of pages for the response nor are there restrictions on document format. Based on the understanding of the FDA?s needs, describe your conceptual technical and architectural approach to satisfy SPL mission needs including use of COTS, GOTS, or custom hardware and software components. List which requirements from Table B-1 in the High Level Requirements are satisfied in existing technology (identifying that technology), and which would require development, configuration or customization. Discuss technically feasible alternatives and provide non-binding order of magnitude cost and schedule estimates for the alternatives. Indicate whether your product is commercially available or is on the General Services Administration Federal Supply Schedule. Indicate the maturity level of your software or systems engineering processes, e.g., SEI CMM, CMMI, etc. If a level has been achieved, indicate what evaluation or assessment method was used and what organizational units were covered. It is desired that the system be implemented on a schedule consistent with the Release matrix identified in the High Level Requirements document, but early implementation is desirable. Intermediate milestones between contract award and implementation are encouraged. Also, a prototype is desirable to mitigate risk. 1.7 CONTACT INFORMATION. Interested parties are invited to go to the SPL Acquisition website: http://www.fts.gsa.gov/fdaspl/ Technical matters regarding this RFI should be submitted via email to: jeff.williamGSA FEDSIM, Attn: Nat Harrison, 6354 Walker Lane, Suite 200, Alexandria, VA 22310 The Government may elect not to discuss submissions received in response to this RFI with individual responders. The SPL project goal is to start the system development by February 2005. 1.8 DISCLAIMER. This RFI is issued for information and planning purposes only and does not constitute a solicitation. The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for information received in response to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. Information provided in response to this RFI will be used to assess tradeoffs and alternatives available for determining how to proceed in the acquisition process for the SPL and may lead to the development of a specification for the SPL. In accordance with FAR 15.201(e), responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Point of Contact Nat Harrison, Contract Specialist, Phone 703-306-7606, Fax 703-306-7710, Email nat.harrison@gsa.gov Jeff Williams, Project Manager, Phone 703-392-9975, Fax null, Email jeffrey.williams@gsa.gov [Source: http://www2.eps.gov/spg/GSA/FTS/TFM/Reference%2DNumber%2DSPL%2D05%2D01/SynopsisR.html] Prepared by Robin Cover for The XML Cover Pages archive. See general references in "Structured Product Labeling (SPL)", part of "XML in Clinical Research and Healthcare Industries."