Attachment A - Draft Statement of Work.pdf

FDA Regulated Products Sampling Services

Draft Statement of Work

Ref No. 75F40125R00032

FDA REGULATED PRODUCTS SAMPLING SERVICES

DRAFT STATEMENT OF WORK

1. BACKGROUND

The U.S. Food and Drug Administration (FDA) intends to award an Indefinite Delivery-Indefinite Quantity (IDIQ) type contract to obtain Regulated Product Sampling Services. The anticipated performance period is five (5) years, a maximum ceiling of [To Be Determined], and a guaranteed minimum of [To Be Determined], which is anticipated to be funded with the first IDIQ task order award.

2. SERVICES AND PRICES

Labor Categories

Ordering Period I

Ordering Period II

Ordering Period III

Ordering Period IV

Ordering Period V

6 Month Option

Program Manager

Project Manager

Quality Assurance Specialist

Sampling Technician

Ordering Period I:

7/1/2025 – 6/30/2026

Ordering Period II: 7/1/2026 – 6/30/2027 Ordering Period III: 7/1/2027 – 6/30/2028 Ordering Period IV: 7/1/2028 – 6/30/2029 Ordering Period V: 7/1/2029 – 6/30/2030 6-Month Option: 7/1/2030 – 12/31/2030

The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly rates. The fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit. Hourly rates shall apply to services at both Governmental and non- Governmental sites.

3. CONTRACT TYPE

This is an Indefinite Delivery-Indefinite Quantity (IDIQ) type contract. It is anticipated that most of the task orders will be Time and Materials (T&M). At the discretion of the Contracting Officer (CO), Firm Fixed Price (FFP) and Labor-Hour (LH) task orders may be issued.

Single Order Minimum: $[To Be Determined] Single Order Maximum: $[To Be Determined] IDIQ Ceiling: $[To Be Determined]

4. CONTRACT REQUIREMENTS:

IDIQ STATEMENT OF WORK

1.1 INTRODUCTION

The FDA, or U.S. Food and Drug Administration, is responsible for ensuring the safety and efficacy of food, drugs, medical devices, and other products in the United States. The sample collection process is an important component of the FDA's regulatory oversight activities. The FDA collects samples of regulated products ready for consumption or sale, as well as in-process and raw ingredient samples, to monitor and evaluate these products for potential adulterants, or to verify the accuracy of product labeling.

Sample collection involves taking physical samples of products from warehouses, distributors, retail locations, ports of entry, or other designated holding facilities for laboratory analysis. The products being sampled may be produced in the U.S. or may be of foreign origin and have been imported into the U.S., including products originally produced in the U.S. before being exported and re-imported back into the U.S.

The results of sample collection and testing will be used by the FDA to ensure the safety and quality of products, expand knowledge of FDA regulated products and areas of concern through surveillance, and used to make regulatory decisions, such as pursuing voluntary recalls or initiating official FDA operations.

This IDIQ contract will provide direct support to FDA’s Programs by conducting sampling services on behalf of the FDA. All FDA Offices and Centers are stakeholders under this IDIQ Vehicle.

1.2 BACKGROUND

The FDA, inspects regulated products and manufacturers, conducts sample analyses and reviews imported products entering the U.S. This contract will provide supplemental sampling services to FDA, within the U.S., to allow the FDA inspectorate to focus on prioritized inspections, investigations, emergency response, and other high-risk activities.

1.3 ACCESS CONTROL & INFORMATION SECURITY

1.3.1 ACCESS

Contractor staff conducting sampling on behalf of the FDA may be credentialed as officers of the Department of Health and Human Services (DHHS), FDA, as set forth in section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act if access to the sampling location warrants credentials.

1.3.2 INFORMATION SECURITY

Non-disclosure Agreements will be required from the Contractor, from any proposed persons working on this contract, and between the Contractor and any other Contractors, where information may need to be shared in order to perform services under this contract. All individuals with access to FDA Information must undergo a background investigation initiated through FDA’s Office of Security Operations.

1.4 CONFLICT OF INTEREST

Contractors and contractor staff conducting the sampling on behalf of the FDA under this contract shall, during the course of this contract, recuse themselves from conducting sampling of any FDA regulated entity or product where they have a contractual or financial relationship. Per FAR Subpart 9.5, the FDA has determined that the contractor is expressly prohibited from performing any sampling of an FDA regulated entity or product where a contractual or financial relationship exists as this constitutes an unacceptable Conflict of Interest under this contract.

1.5 PURPOSE

The purpose of this IDIQ contract is to obtain Contractor services to conduct sampling activities on behalf of FDA. This contract will yield the following outcomes:

Allow the FDA inspectorate staff to focus on prioritized inspections, investigations, emergency response, and other high-risk activities.

Allow for collection of domestic and import surveillance samples when low on resources or geographic challenges make it difficult to meet targets.

1.6 OBJECTIVES

The FDA has several business objectives for sampling activities under this contract, such as:

Collect samples as part of FDA’s surveillance sampling program used to gather data on FDA-regulated products.

Aid FDA’s sampling efforts of items offered for import, while in import status or after release.

Provide FDA’s laboratories with a reliable and consistent stream of samples for analysis.

1.7 PROJECT SCOPE

The scope of this IDIQ contract entails sample collection, documentation, maintenance of the chain of custody, and sample shipping related activities. Documentation shall include, but not be limited to, the following:

Sample log Digital photographs or photocopies of specific information, detailed in the Statement of Work Chain of Custody Shipping paperwork

1.8 GENERAL AND SPECIFIC TASKS AREAS

1.8.1 CONTRACT-LEVEL PROGRAM MANAGEMENT TASKS

The Contractor shall provide contract-level program management to establish communication channels and quality control functions necessary to successfully execute the sampling goals throughout the contract’s period of performance and achieve the mission to manage submissions received by the FDA. This person’s duties shall include, but not be limited to, the following:

Coordinate sampling events with FDA

Prepare reports required under the contract

Ensure quality control of documentation and sample collection

Aid in training of key personnel

Identify and address internal protocol issues

1.8.2 REPORTING

Be advised that the FDA does not accept documents which contain the use of “macros.” Document submissions required throughout the period of performance of this contract including any task orders under this contract shall not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

1.8.2.1 IDIQ Monthly Status Report

The Contractor’s Program Manager (PM) shall electronically provide a monthly contract level status report to the IDIQ Contracting Officer’s Representative (COR) on the last business day of each month, incorporating all tasks at a high level and their progress.

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

A cover page containing:

• Contract Number and Title

• Task Order Number

• Type of and sequence number of the report

• Period of Performance covered by the report

• Contractor’s Name, Address, and Phone Number

• Name and contact information for the Author(s)

• Date of report

• Issues encountered while collecting samples

An Excel, or other electronically sortable document, which includes a listing of each Sample Identification Number (as defined by the FDA), product collected, and targeted analyte(s).

Copies of all chain of custody documents for samples submitted during the period of performance.

1.8.3 Escalation Procedures

The Contractor PM shall escalate issues related to any impediment to progress towards any deliverables defined in the IDIQ contract or an individual Task Order. The Contractor shall follow escalation procedures consistent with the line of command in FDA. The Contractor shall follow this order of escalation when reporting to FDA personnel:

1. Task Order Contracting Officer’s Representative (COR)

2. IDIQ COR

3. Contracting Officer

1.9 QUALITY MANAGEMENT

The Contractor shall provide Quality Management activities as identified in individual task orders. Quality Management activities for this contract include, but is not limited to, ensuring proper handling and chain of custody of each sample; identifying and mitigating risks; resolving issues; and adhering to processes and procedures.

The Contractor shall develop and implement a proactive Quality Assurance Plan (QAP) based on American Society for Quality (ASQ) standards, detailing its methodology and processes for measuring and attaining quality of performance under this contract. The Contractor’s QAP shall be submitted within thirty (30) calendar days of IDIQ contract award. The QAP shall be updated on an annual basis. The Contractor shall be responsible for the quality of products and services provided under the terms of this contract, to include those provided by subcontractors.

The Contractor shall develop Quality Control Plans (QCP) for individual task orders issued under this contract. Specific contents of the QCP will be detailed in individual task orders.

The Contractor may also be tasked to provide guidance on proper quality assurance methods related to document control, records or information activities.

The Contractor, and any applicable subcontractors, may be subject to periodic onsite audits of their sampling procedures to be conducted by FDA personnel while a sample collection is being completed. The audits will be prescheduled, and the FDA auditor will work with the Contractor and subcontractor to determine a date and time for the audit.

1.10 TASK ORDER MANAGEMENT

The Contractor shall provide task order level project management to effectively manage tasks, monitor task order performance, manage Contractor staff and provide subcontractor management; and establish notification mechanisms to ensure the individual task orders stay on track to meet the important milestones and performance measures within the awarded task order.

Representative activities include:

Status and progress of all tasks Cost Management Comply with reporting requirements as stipulated in the task orders.

Follow escalation procedures for problems, issues, and recommendations as specified in individual task orders.

Participate in FDA’s program/project reviews and document lessons learned as directed by the TO

COR.

Ensure proper exit criteria are followed when Contractor employees leave projects. This may be subject to change based on individual Task Order requirements.

1.11 TASK AREA: SAMPLE COLLECTION

The majority of effort under this IDIQ contract involves collection of FDA regulated item samples from non-Governmental facilities (retail sites, warehouses, ports of entry, manufacturing sites, farms, etc.). The Contractor shall perform the following activities under this task area, to include sampling of FDA regulated items or components using appropriate techniques, documentation of the sample(s) collection, packaging the sample(s) for transport, and shipping the sample(s) to the designated laboratory.

Items to be sampled may include:

Human foods or ingredients

Animal foods or ingredients

Cosmetics or cosmetic ingredients

1.11.1 SAMPLE COLLECTION TASKS, AT A MINIMUM, SHALL INCLUDE:

Thoroughly review the sampling assignment including: sample schedule, sampling technique, appropriate sampling location, laboratory being used for analysis, storage and shipping conditions.

Collect sample as required, Prepare and ship sample per assignment requirements via approved transportation company and shipping method.

Maintain chain of custody at all times.

Collection of items specified in task order from designated locations (i.e. retail sites, manufacturing environments, warehouses, ports of entry, farms, etc.)

Following all personal protective equipment and facility requirements for entry

Complete chain of custody documentation

Preparation of sample(s) for shipping, including composite sample preparation as required

Maintaining appropriate temperatures for the sample until receipt by the designated laboratory

Preparation of shipping documentation, as required

If required for purposes of FDA enforcement actions or other regulatory decisions informed by the results of the sampling, be prepared to provide all relevant documentation and testimony to FDA.

1.12 TRAINING

The Contractor staff shall be trained in aseptic techniques for sample collection and appropriate documentation for sample integrity, including training on chain of custody and documentation practices.

Additional training requirements will be specified in specific task orders and may include Current Good Manufacturing Practices (cGMP). All training content must conform to agency and center regulations, policies, and procedures. The Contractor shall provide copies of training certificates for FDA recognized courses and materials for all classes not recognized by the FDA.

1.13 IDIQ LABOR CATEGORIES AND MINIMUM QUALIFICATIONS

The Contractor staff for each task order will include positions selected from the following labor categories.

Not all categories may be used for each task order. The labor categories specify minimum qualifications, and there may be additional requirements for any labor category on an individual task order.

1.13.1 PROGRAM MANAGER

The Program Manager must have a bachelor’s degree in a scientific or quality assurance related discipline.

The individual must have a minimum of 10 years of project management experience, preferably in a federal environment. This must include directing, managing, and coordinating resources and staff across multiple task orders/projects and locations. The Program Manager must have demonstrated knowledge of compliance with FDA regulations and sampling techniques. The Program Manager must demonstrate the ability to effectively communicate with Federal CORs and ensure timely response for all communications and deliverables across all task orders. Professional certification in Project Management should be noted.

1.13.2 PROJECT MANAGER

The Project Manager must have a bachelor’s degree in a scientific or quality assurance related field. The individual must have demonstrated abilities in the management of similar projects for a minimum of six (6) years, preferably in a contract environment. This individual’s past experience must contain a significant amount of client customer service. The Project Manager must have demonstrated ability to manage field staff sampling and documentation efforts. The project manager must have the ability to effectively communicate with Federal COR’s, management, user organizations, and technical staff. The individual must have an extensive knowledge of regulatory compliance and sampling techniques.

1.13.3 SAMPLING TECHNICIAN

The Sampling Technician must possess a minimum of a bachelors’ degree or higher, with coursework in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field with no comparable experience. Alternatively, to qualify without a qualifying bachelor’s degree, the sampling technician must have or at least two (2) years of comparable experience. Comparable experience is defined as experience with FDA, a state or federal partner agency, or in an FDA-regulated industry or organization providing investigative or compliance services to an FDA-regulated industry, focused on evaluating or ensuring compliance with FDA or related public health laws and regulations.

1.13.4 QUALITY ASSURANCE SPECIALIST

The Quality Assurance Specialist must possess a high school education and a minimum of three (3) years of experience of quality assurance and control. This position establishes and maintains procedures for adhering to performance metrics and SOPs. Additionally, this position: creates and / or updates workflow diagrams to identify when quality control will be conducted; identifies quality issues and recommends solutions;

submits quality control reports, verifies the accuracy of data entry activities, and inspects each worksite, as required, to ensure compliance with the requirements of orders issued against the contract; requires limited supervision; proofreads documentation and graphics for accuracy and adherence to original content and provides quality control checking for documents received from copying and word processing. Professional certification in Project Management or Quality Processes and Systems is preferred.

1.14 SAMPLE RELATED COSTS AND FEES

All costs related to Postage Fees, Sampling Supplies, Personal Protective Equipment (PPE), Mileage/Transportation Costs, Vehicle/Transportation Maintenance, Storage Fees, Shipping Containers and Refrigeration Materials (dry ice, wet ice, cooler packs), shall be paid by the Contractor.

All fees related to distribution of deliverables, including forms, reports, etc. shall be paid by the Contractor.

2.0 INFORMATIONAL DATA

2.0.1 FDA GLOSSARY OF TERMS

Glossary / Terms

Acronym Term

CBER Center for Biologics Evaluation and Research

CCB Change Control Board

CDER Center for Drug Evaluation & Review

CER2 CBER Electronic Records Repository

CFSAN Center for Food Safety and Applied Nutrition

CO Contacting Officer

COR Contacting Officer Representative

CSO Consumer Safety Officer (Government Employee)

CST Consumer Safety Technician (Government Employee)

Glossary / Terms

Acronym Term

CTP Center for Tobacco Products

CVM Center for Veterinary Medicine

EIR Establishment Inspection Report

EUA Emergency Use Authorization

FDA Food and Drug Administration

FOIA Freedom of Information Act

HFP Human Food Program

LOA Letter of Authorization

NPI Non-Public Information

QA Quality Assurance

QC Quality Control

OIO Office of Imports

OII Office of Inspections and Investigations

RCS Records Control Schedule

SOP Standard Operating Procedure

2.1 DEFINITIONS

Non-public Information (NPI) - The term "non-public information" refers to all information which is exempt from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. § 552b (1)-(9) or the Privacy Act (5 U.S.C. § 552a). Examples of such NPI include a business’s trade secret or confidential commercial information, an intra-agency or inter-agency memorandum or letter, an individual’s private personal information, and the Government’s law enforcement records.

Unauthorized Disclosure -- A communication (oral, written, electronic or otherwise) or the physical transfer of NPI to an unauthorized recipient or a communication which fails to comply with established procedures.

5. ORDERING PROCEDURES

A request for task order proposal (RFTOP) will be issued via email to the Contractor IAW the procedures of FAR 16.505. The RFTOP will clearly describe the services required and the anticipated task order type.

The Contractor will typically have five (5) – ten (10) calendar days to respond to any RFTOP. At a minimum, the following required documents must be submitted with any proposal in response to a RFTOP:

Technical proposal

Resumes for key personnel identified in the RFTOP.

Training certificates or certifications, as applicable, for key personnel identified in the RFTOP.

Commitment letters for each identified key personnel position, signed by the recommended candidate and the point of contact at the company that has the authority to offer employment.

Commitment letters must include the following information:

• Title of position

• Name of company

• Name of individual offered position.

Price proposal

The Government reserves the right to require additional training for key personnel in response to a RFTOP.

Labor rates proposed in response to each RFTOP issued must be in accordance with the labor categories and fixed labor rates in effect for the performance start dates within the IDIQ ordering period. The Contractor may propose lower labor rates in response to a RFTOP. During the performance period of this IDIQ contract, by mutual agreement of the parties, additional labor categories may be added to support the objectives in the SOW.

If a task order’s stated period of performance must be extended because of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period for LH and/or T&M task orders.

LH and T&M task orders will include a ceiling price.

FDA is the only agency authorized to place task orders against this IDIQ contract.

All task orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order.

This IDIQ contract will have an ordering period of five (5) years from the effective date of the contract.

Each task order issued under this contract will specify:

Date of order.

Contract number and order number.

For supplies and services, contract line-item number (CLIN) and description, quantity, and unit price.

Specific tasks to be performed.

Specific deliverables and deliverable due dates.

Task Order Contracting Officer Representative (COR), if different from the IDIQ COR.

Delivery or performance schedule.

Place of delivery or performance (including consignee).

Any applicable packaging, packing, and shipping instructions.

Accounting and appropriation data.

Method of payment and payment office, to include invoicing instructions, if not specified in the contract.

Task Order Transmission

Task orders will be issued by email.

The Contractor is required to perform on any signed task order transmitted by the above authorized means.

6. SCHEDULE OF DELIVERABLES

Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the period of performance of this contract must not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Specific deliverables will be defined at the task order level.

7. PLACE OF PERFORMANCE

The Contractor will conduct sampling nationwide and location information will be specified in each Task Order. Locations will include retail facilities (online and onsite), warehouse/distribution facilities, ports of entry, farms, etc.

8. PERIOD OF PERFORMANCE

Ordering Period I: 7/1/2025 – 6/30/2026

Ordering Period II: 7/1/2026 – 6/30/2027

Ordering Period III: 7/1/2027 – 6/30/2028

Ordering Period IV: 7/1/2028 – 6/30/2029

Ordering Period V: 7/1/2029 – 6/30/2030

6-Month Option Period (IAW FAR 52.217-8)

9. FOOD & DRUG ADMINISTRATION (FDA) REQUIREMENTS

Federal Holidays generally observed by Government personnel include:

New Year’s Day

Martin Luther King, Jr. Day

Washington’s Birthday

Memorial Day

Juneteenth National Independence Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Christmas Day

Any other day designated by Federal statue

Any other day designated by Executive Order

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, except as set forth in the contract.