RFI_SOW.pdf

REQUEST FOR INFORMATION (RFI)

FOR: Human Foods Program (HFP)

DEPT/AGENCY INFORMATION: Department of Health and Human Services U.S. Food and Drug Administration (FDA)

Requiring Offices: Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDFI)

GENERAL INFORMATION

The U.S. Food and Drug Administration (FDA) is issuing this request for information (RFI) as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of business and information technology support services (ITSS) for on-going operations and maintenance (O&M) and IT system development support using the current and enhanced infrastructure to various Human Foods Program (HFP) IT systems.

This is a REQUEST FOR INFORMATION ONLY, not a Request for Proposal (RFP) and does not commit the Government to award a contract now or in the future. The purpose of this RFI is to identify SMALL BUSINESS sources with the capabilities to provide the services stated herein.

Submission of any information in response to this market survey is purely voluntary and FDA welcomes responses from all interested parties; the Government assumes no financial responsibility for any costs incurred. Small businesses are encouraged to submit a response.

The FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the objectives described in this notice.

The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

INSTRUCTIONS

Responses should not exceed 15 pages in length. A complete response should include answers to all the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (i.e., the response must go beyond the statement that, "XYZ company can provide technical support").

Respondents will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

While the Government anticipates establishing a contract for supporting and developing information technology systems which require contractual support, A SOLICITATION IS NOT CURRENTLY AVAILABLE. The Government is not obligated and will not pay for any information received from potential sources as a result of this RFI.

Companies are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business are encouraged to respond to this notice.

However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required.

Responses should be emailed to Brian Wodzisz Contract Specialist, at Brian.Wodzisz@fda.hhs.gov by 2pm ET, Monday, January 13th, 2025.

Please include the RFI number FDA-RFI-75F40125R00031 Food Applications Regulatory Management (FARM) system and Interfacing IT systems in the subject line. No phone calls will be accepted for this notice.

CAPABILTY STATEMENTS

Interested, capable vendors (parties) shall submit a Capability Statement in response to this notice with the following information:

A. Contact information:

1) Company Name

2) Mailing Address

3) Name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

4) UEI

5) Business size for NAICS 541519 with size limitation standards of $34,000,000.00 and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages).

6) Company structure (Corporation, LLC, partnership, joint venture, etc.).

Companies also must be registered in the SAM (www.sam.gov) to be considered as potential sources.

mailto:Brian.Wodzisz@fda.hhs.gov

7) Any Governmentwide Acquisition contract number(s) with period of performance to include option periods.

8) If a small business, demonstrate the firm’s capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting.

9) If a large business, identify the subcontracting opportunities that would exist for small business concerns.

10) Proposed NAICS for this effort if different from the code listed in bullet #5.

B. We are interested in learning from you whether the following Scope of Work is reasonable based on what a vendor like yours might generally agree to. Please provide responses to the following questions regarding capability/experience relevant to providing Business and Information Technology Support Services (ITSS) for on-going operations and maintenance (O&M) and IT system development support using the current and enhanced infrastructure to various HFP IT systems.

1. Experience: Provide a brief narrative to demonstrate your company’s experience offering this type of product in the context of Food Applications Regulatory Management (FARM) system and Interfacing IT systems.

2. What are the most cost-effective solutions you or your organization are aware of?

3. Does your organization have any publicly available pricing?

4. How have you in the past managed information from files to incorporate metadata to seamlessly integrate with the current electronically created documents to search and find relevant information by reviewers?

5. What solutions have you provided previously to make systems interoperable and search across the systems for metadata and regulatory information from a centralized user interface?

6. What solutions and intelligent toolsets have your organization utilized or seen to modernize critical IT systems and support the premarket and post market program areas?

7. What potential risks do you foresee and how might you mitigate them?

8. What (if any) additional resources would be required to make your project successful?

9. Any feedback on the scope of work that would be beneficial to the overall requirement.

Attachment 1: Statement of Work (SOW)

1. Background

1.1 Introduction

The FDA is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, biological products, medical devices, cosmetics, the nation’s food supply, and certain other products. In total, the FDA regulates more than $1 trillion of consumer goods, or about 25% of consumer expenditures in the United States.

The FDA’s optimal performance has significant public health and economic benefits. The Agency can speed innovations to market, leading to more affordable medicines and foods. It protects public health, ensuring that people have access to accurate, science-based information about their medicines and foods. The FDA also coordinates with several international organizations to enable global investigations of potential health risks from products, to respond to emerging new diseases, and to help address the challenges faced by public health officials and individuals around the world.

The Human Foods Program (HFP) oversees all FDA activities related to food safety and nutrition, organized in a single group working under the Deputy Commissioner of Human Foods. The mission of the HFP is to ensure that food is a source of wellness for all U.S. consumers, and our day-to-day activities are focused at protecting and promoting the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet related chronic disease, and ensure chemicals in food are safe.

The HFP has many interfacing IT systems that support its mission. These include the Food Applications Regulatory Management (FARM), the Chemical Evaluation and Risk Estimation System (CERES), and the Scientific Terminology and Regulatory Information (STARI), and Warp Intelligent Learning Engine (WILEE). The HFP- Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI) uses those multiple systems to access and visualize data to support the review and assessment of food ingredients and packaging.

The HFP’s Food Applications Regulatory Management (FARM) system and Interfacing IT systems currently support the work of staff across Human Foods Program (HFP) Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI) that includes HFP-OFCSDSI Office of PreMarket Additive Safety (OPMAS), HFP-OFCSDSI PostMarket Assessment (OPMA), HFP-OFCSDSI Office of Dietary Supplement Programs (ODSP), , HFP-OFCSDSI-Innovative Foods Staff, HFP-OFCSDSI-Operations Staff. and the HFP-Nutrition Center of Excellence (NCE)- Office of Nutrition and Food Labeling (ONFL).. In addition to HFP, the IT systems support other FDA centers such as FARM supporting the Office of Chief Scientist, Office of Color and Cosmetics (OCS-OCAC), and the Center for Veterinary Medicine (CVM)’s Ingredient Safety Team, Division of Animal Feeds and other scientific reviewers in the Center for Drug Evaluation and Research (CDER). FARM was initiated in 1995 to support premarket and post market safety review of petitions and notifications received from the regulated industry. FARM is the primary system available to HFP reviewers to access and review industry submissions and conduct analysis with regards to chemical, toxicological, and environmental analysis and other issues, regarding specific ingredients. The following submissions/petitions are supported by the FARM system: Food Additive Petitions (FAPs), Color Additive Petitions (CAPs),Generally Recognized as Safe notices (GRNs), Food Contact Notifications (FCNs), Biotechnology Consultations (BNFs), New Protein Consultations (NPCs), Infant Formula Notifications (IFNs), Notifications for Food Allergens (NFAs), Petitions for Food Allergens (PFAs), Citizen Petitions (CZPs), Cell Culture Consultation (CCC), and Cell Culture Ingredients (CCI), New Dietary Ingredient Notifications (NDIs), Structure Function Claims (SFCs) and Health Claims (HC).

In addition to providing information technology support to the scientific review of submissions, the FARM System is used to support critical regulatory functions for processing and documenting agency actions pertaining to pre-submission meetings, Prenotification Consultations, Prepetition Consultations, Inquiries/correspondences and Freedom of

Information Act (FOIA) requests for information sent to OFCSDFI, OFCSDFI-ODSP, NCE-ONFL and

OCS-OCAC

The purpose of this ID/IQ is to establish a contracting vehicle for operations and maintenance and IT development services to support the mission of the various program areas. The contractor will work with multiple IT systems and interfaces to support the regulatory goals and objectives of each program area.

Table 1. Recent submission data stored in the FARM system (2015 to 2024).

Submission Type 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

BNF 6 5 6 6 6 4 5 9 6 2

COR 154 126 98 103 31 18 180 357 427 442

FCN 112 113 122 97 79 82 4 74 67 76

EFOIA / FOI 222 207 205 232 280 235 266 234 264 316

GRN 52 73 64 85 72 86 58 82 49 52

GNF 33 35 33 21 37 28 28 24

GMT 0 1 0 1 0 0 0 0

NDI 0 0 0 0 2 65 57 56 51 71

PETITION 8 8 5 6 3 6 6 5 7 12

PNC 203 187 174 174 157 131 143 151 157 160

NPC 4 1 0 0 0 0 0 1 0 1

IFN 18 18 30 29 20 44 49 24 23

PMR 3 5 3 5 6 3 3 15

CZP -OFCSDFI (CZP) 15 0 0 1 4 0 5 0

CZP-OFCSDFI-ODSP

(OCZ) 0 0 0 0 0 0

COR-OFCSDFI-

ODSP (CORDS) 167 459 180 272 366 168

SFC-OFCSDFI-ODSP 44 1432 1634 1482 1861 2542

TOR 2 5 6 2 1 0

FALCPA 39 72 0 66 2 0

GBFP 105 8 72 110 78 100

GRAS

(GRN+GNF+GMT)

6 4 95 110 77 76

2. Technical Background Human Foods Program (HFP) has iteratively upgraded the FARM System to its current configuration, an integrated system that supports online submission, content management, search/retrieval, workflows, account management, reporting, forms management, and indexing activities.

Exhibit 1 - FARM Features

FARM supporting software stack is provided in Table 2.

Table 2. Current FARM System technology stack

FARM Component / Software

FARM Component Software Version

Input/PDF Forms Management

Adobe Experience Manager (AEM) 6.5

Application Server Oracle WebLogic 12C (12.2.1.4/12.2.1.4), Java jdk-8u271-linux-x64 Java JDK/JRE jdk-8u271 Java J2EE 2.2 Spring Boot 2.6.2 Log4j 2.17.1 Apache PDF Box 2.0.4 Hibernate 4.3.8 (FARM Web); 5.2.17 (FARM API) Jersey 2.25.1 Single Sign On (SSO) Oracle SSO (12.2.1.4) DB Storage Oracle RDS 19c (Version 19.18.0.0.0) Search Apache Solr 6.6.0 (Zookeeper 3.4.10)

FARM Component / Software

FARM Component Software Version

Content Management System

Documentum DFC 22.4

Appian/Workflow Appian 24.3

FARM Web Application UI PrimeFaces 11.0.0 Business Object Reports SAP BusinessObjects BI Platform 4.2 Support Pack 7 Patch 5 Version:

14.2.7.3248 Electronic Submissions MOVEit/file transfer version 14.1;

Public facing Internet UI Management

Angular 11.2.14, JWT, Angular Material, Bootstrap 4+, Prime NG 6+

Apache Kafka 2.12-2.7.0 Kafdrop 3.10.0 Swagger 2.8.0

3. Objectives and Scope

As a direct result of contract performance, the FDA expects to achieve the following outcomes:

Management of the IT configuration, security requirements, upgrades and programming of software processes associated with the front-end processing of submissions and the back-end integrating with HFP Food Applications Regulatory Management system workflows and HFP interfacing IT systems.

Optimize the Food Applications Regulatory Management system content management, workflow processes towards Intelligent Business Management (support content creation, review and authorization, categorization, reusability, storage and archiving, and retrieval of data); and finally fulfill the reporting needs of HFP.

Improve data quality, data profiling, governance and data integration between HFP Food Applications Regulatory Management system and interfacing IT systems with other FDA data sets to facilitate the search and retrieval and sharing of information

Improve information reporting from various data resources to support various program areas

The purpose of this Statement of Work is to obtain business and information technology support services (ITSS) for on-going operations and maintenance (O&M) and IT system development support using the current and enhanced infrastructure to various HFP IT systems The contract will allow the Agency to seek the full range of Information technology services including online submission, content management, database administration, customizations and process automation of workflows and reports; performance tuning and monitoring; system administration; help desk support and end-user training; infrastructure configuration, EPLC and security documentation management, user account administration for existing Food Applications Regulatory Management system and other HFP IT system components.

3.1 Task Area - Project Management, Firm Fixed Price (Task 1) The Contractor shall provide project management oversight the scope, schedule, quality, and cost are properly monitored and controlled throughout the duration of the contract.

Specifically, the Contractor PM shall perform these project management activities described in the following sections:

3.1.1 Meetings

The Contractor PM shall participate in the regular status meetings, technical and process improvement meetings. The Contractor PM shall prepare meeting agendas, minutes, issues, risks and action items.

3.1.2 Project Management Plan (PMP)

For the task orders released under this contract, the Contractor shall provide task order level PMP to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. For each task order, the Contractor shall prepare a Management Plan describing the technical approach, organizational resources, risk management and other management controls to be employed to meet the cost, performance and schedule requirements throughout the task order execution.

The Contractor shall provide monthly status reports on all awarded task orders and their progress to the IDIQ Task Order Contracting Officer Representative (COR).

Within the first thirty (30) days after contract award, the Government and the Contractor will design and agree upon a standard reporting format that includes the following information at a minimum:

• Status and progress of tasks,

• Cost and schedule variances,

• Significant risks to scheduled deliverables and plans to mitigate them,

• Progress against service level metrics and

• Recommendations for changes or additional activities to ensure that the tasks support progress on the overall contract objectives.

In addition to progress reporting, the Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Representatives of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA staff, or other Contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.

3.1.3 Reporting and Documentation

Weekly/Monthly/Annual Progress Reports: The Contractor PM shall submit Weekly, Monthly and Annual Reports and Project Schedule updates

3.1.4 EPLC Support and Documentation

The Contractor PM shall follow the FDA Enterprise Performance LiveCycle (EPLC) process and EPLC artifacts/deliverables

3.1.5 Release Management

The Contractor PM shall document the underlying software components and follow release management

3.2 Task Area - Operations and Maintenance Support, Firm Fixed

Price (Task 2) The Contractor shall perform technical upgrades and refreshes as directed, required and/or mandated by the FDA. The contractor will work with multiple HFP IT systems and interfaces to provide continuous IT solution support on a wide range of operations and maintenance services. For instance, FDA security classifies FARM as a ‘Mission Critical’ system with a 24/7 operational requirement, excluding planned outages.

Representative activities under this task area may include:

Provide user production support (such as Helpdesk), training and responses to Data

Calls Coordinate, plan, develop, test, and implement all releases (major, minor, emergency) following FDA EPLC standard with the FDA data center and Cloud environment contractors. Fix defects and perform minor enhancements (less than 200 hours for each enhancement ), incorporate them into releases

Develop all documentation for EPLC intake processes and save all documents pertaining to the requirements, technical documents, user manuals, online help guides, etc., in the FDA document repository

Implement infrastructure configuration and increase the scalability of system servers, keep updated software stack within two versions from the latest release and perform annual operational analysis of the IT systems

Implement mandated Security Scan, such as Continuity of Operations (COOP) Information Systems Contingency Plan (ISCP) Exercise events that require Contractor support to meet all security requirements.

3.3 Task Area – Information Technology System Development, Labor hour (Task 3)

The contractor will work on HFP IT systems and interfaces to perform on the development, modernization and enhancements (DME) tasks on a wide range of IT modernization services.

The specific IT system development tasks will provide the details about the existing IT systems to be changed or modified to substantively improve their capability or performance.

Representative activities under this task area may include:

Perform planning, analyzing and gathering requirements:

o Analyze existing business processes, scenarios, activities, architecture, and information flow o Perform impact analysis scenarios and gap analysis activities to identify inefficiencies, redundancies, obsolescence, and technology gaps

Design and develop IT application system per the requirements o Provide business and technology roadmaps to include blueprints, to-be business processes, information flow and data flow diagram, conceptual, data models, and system architectures that will transform the current state to the designed future state of business processes, web application and systems

Test and Implement IT application system per the requirements into production

3.3.1 Development of FARM Workflows and Reports in Appian Cloud The FARM System provides information management tools for Agency reviewers and is the key enabler of the electronic document review process and expedites the ingredient safety review process and subsequent safety decision-making effort to maximize productivity. Currently, FARM has 25 workflows:

Collect new requirements, design, develop and implement enhancements to the existing workflows for HFP offices of Pre-Market Additive Safety, Post-Market and Assessment, Dietary Supplement Programs, Nutrition and Food Labeling and the Office of Color and Cosmetics.

Collect new requirements, design, develop and implement enhancements to reports for the HFP offices of Pre-Market Additive Safety, Post-Market and Assessment, Dietary Supplement Programs, Nutrition and Food Labeling and the Office of Color and Cosmetics.

Development of public facing online submissions and data transferring to FDA internal components and Advanced Search Enhance public facing online submissions to accommodate existing submission types in alignment with office hierarchies under the Human Foods Program.

Enhance FARM Federated Search Integration of HFP IT systems in AWS Cloud

• Enhance data sharing among the HFP IT components (public facing interface, Search, Workflow, Reports, etc.)

3.3.2 Integration with Interfacing Systems in AWS Cloud

• Enhance the integration of FARM with other HFP interfacing IT systems such as EASE, TRAM/CERES, STARI, G-SRS, CDW, WILEE, etc.

3.4 Transition in and Transition out, Labor hour (Task 4)

3.4.1 Transition-In Support

The Contractor shall provide Transition-In support in order to provide an orderly transition from the incumbent Contractor to the successor Contractor. The successor Contractor shall work toward the Government’s goal of ensuring minimal disruption to the current system and operational activities.

Working with the incumbent Contractor and the COR, the successor Contractor shall develop a plan to take over on-going work from the incumbent Contractor as required in the Task Orders released under this IDIQ.

Representative activities may include:

Develop a Transition-In plan, Participate in Transition-In meetings, Conduct and coordinating all on-boarding activities with the Government and obtaining secure badging for team personnel, Ensure staff identified as key personnel are available to work with Subject Matter

Experts (SME) from the Government and the incumbent Contractor immediately after IDIQ Task Order awards, Engage in regularly scheduled meetings.

3.4.2 Transition-Out Support

As tasked, the Contractor shall facilitate the transition of contracted FARM related activities and services to the Federal Government or to a follow-on Contractor at the end of the contract period of performance.

Representative activities under this task area may include:

• Provide the FDA with current versions of all system and user documentation;

• Provide FDA all licensing and renewal information, asset management records, software documentation, and training materials;

• Provide FDA with a current inventory of all Government-owned assets used by the

Contractor along with full support in the reconciliation of this inventory;

• Provide FDA with current versions of all CONOPS, operational procedures, standard operating procedures, guidelines, performance reports, specifications for hardware and software, and other pertinent information needed to continue the services being performed by the Contractor;

• Provide “shadowing” and other knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor;

• Provide full source code sets (not COTS source code) with configuration management information; and,

• Provide up to date-EPLC and program/project management documents.

3.5 Deliverables

Deliverables shall be specified at the task order level released under this contract.

Deliverable products shall be reviewed, validated and tested as appropriate to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

Draft versions of the contract level Program Management Plan (PMP) shall be submitted with the Offeror’s proposal. Final versions of the PMP shall be delivered within 30 days of contract award. When approved by the IDIQ COR, the Contractor shall operate under the PMP.

3.6 Personnel

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to task orders awarded.

3.7 Key Personnel

Pursuant to HHSAR Clause 352.270-5, “Key Personnel” will be designated at the task order level.

3.8 Place of Performance

The primary place of performance will be the FDA facilities within the Washington DC metropolitan area. Specific locations will be specified in each individual Task Order. Alternate locations may be approved on a Task Order basis.

Due to FDA-wide limited space availability, the Contractor may be expected to perform most contract development activities off-site, at the Contractor’s proposed location. This can be near the Food and Drug Administration HFP, CPK2, 4300 River Road, University Station, College Park, MD, or it can be on/via Contractor’s existing office spaces.

On-site meetings, supports and operations shall be performed at 4300 River Road, College Park, MD 20740 or other local FDA locations. Other contract-related technical works may be performed off-site via Virtual Private Network (VPN) using FDA-issued laptops, personal identity verification (PIV) cards (badges) and appropriate network accounts. The Contractor shall be responsible for providing internet access so Contractor-assigned computers can connect to the FDA network via VPN.

The Contractor may be required to move frequently while working at the various campuses.

The Contractor may be required to utilize conference rooms, hoteling space, common areas, libraries, cafeterias, existing offices, or other shared space at the campus. The Contractors will need to be extremely mobile with no expectation of occupying the same work area for an extended period.

Additional requirements may also be specified within each task order.

3.9 Government Furnished Property (GFP)/Government Furnished

Information (GFI)

GFP/GFI will be provided at the task order level. In general, the FDA will provide laptops Identity Verification (PIV) cards (badges) and appropriate network accounts.

The Government Project Manager shall provide information and access to subject matter experts in both the business and technical areas as necessary.

3.10 IDIQ Administration Information

The following sections detail the administrative information relevant to this IDIQ.

3.11 Period of Performance

The period of performance will be determined at the task order level.

3.12 IDIQ Ceiling

The total value of services purchased under this IDIQ shall not exceed $25,000,000.00 over the entire ordering period.

Appendix I The FARM System provides information management tools for Agency reviewers and is the key enabler of the electronic document review process and expedites the ingredient safety review process and subsequent safety decision-making effort to maximize productivity. Currently, FARM has 25 workflows:

Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDFI) BioTech Notification Files (BNF) Workflow Cell Culture Consultation (CCC) Workflow Cell Culture Consultation (CCI) Workflow Citizen Petition Workflow Correspondence Workflow Electronic Freedom of Information Act (EFOIA) Workflow Food Allergen Labeling and Consumer Protection Act (FALCPA) Workflow Food Contact Notification (FCN) Workflow BPS-Biotechnology Pre-Submission Review, GPS-GRAS Pre-Submission Review, FPS-FALCPA Pre- Submission Review (GBFP) Workflow Generally Recognized as Safe (GRAS) Workflow Infant Formula Notification (IFN) Workflow New Protein Consultation (NPC) Workflow New Protein Consultation (PMR) Workflow Petition Workflow Pre-Notification Consult (PNC) Workflow Pre-Petition Consultation (PRP) Workflow Threshold of Regulation File (TOR) Workflow Office of Chief Scientist (OCS)

OCS-OCAC:

OCS-OCAC Correspondence Workflow

OFCSDFI-ODSP:

OFCSDFI-ODSP Citizen Petition Workflow OFCSDFI-ODSP Correspondence Workflow OFCSDFI-ODSP New Dietary Ingredient Notification (NDI) Workflow OFCSDFI-ODSP Structure Function Notification (SFCN) Workflow Nutritional Center of Excellence (NCE)

NCE-ONFL:

NCE-ONFL Citizen Petition Workflow NCE-ONFL Health Claims Workflow

NCE-ONFL Inquiry and Correspondence Workflow