Solicitation.pdf

Request for Quote 134632

Title: Physiological Signal Dataset Development for AI/ML Wearable Device Research

DESCRIPTION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov. The solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular

(FAC 2026-01).

• NAICS Code: 541715 Research and Development in the Physical, Engineering, and Life

Sciences (except Nanotechnology and Biotechnology)

• PSC Code: R425

• Type of Contract: Firm Fixed Price (FFP)

• Acquisition Method: FAR Part 12– Acquisition of Commercial Products and Commercial

Services

SUPPLIES OR SERVICES AND PRICES/COSTS

PRICE SCHEDULE

DESCRIPTION COST

Base Period: Phase 1 $ Base Period: Phase 2 $ Option Period 1: Phase 1 $

TOTAL COST $

BACKGROUND

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires a contractor to support a two-phase research initiative aimed at advancing the development, evaluation, and benchmarking of AI/ML-enabled wearable medical devices that monitor cardiac physiological signals. This work will produce both a comprehensive inventory of publicly available physiological datasets and an original, annotated clinical dataset suitable for public dissemination and future AI/ML research.

All work performed under this SOW shall be conducted in close collaboration with FDA/CDRH subject matter experts (SMEs). The contractor shall maintain regular technical engagement with FDA, incorporate FDA feedback into all protocols, datasets, analyses, and manuscript drafts prior to finalization, and shall not release, publish, or publicly disseminate any work product without prior FDA review and written concurrence.

CONTRACT TYPE

This contract will be a Firm Fixed Price type contract.

SCOPE OF WORK

This statement of work (SOW) encompasses two phases of work and one option year:

• Phase 1 (Base Period): Systematic review and synthesis of publicly available cardiac physiological signal datasets, culminating in a peer-reviewed manuscript.

• Phase 2 (Base Period): Design and execution of a prospective clinical study to collect, annotate, and deliver a comprehensive, de-identified physiological dataset.

• Option Year 1 (if exercised): Manuscript preparation and publication support for the Phase 2 clinical dataset, including public dataset release activities.

Phase 1 — Systematic Review of Publicly Available Cardiac Physiological Signal Datasets

OVERVIEW

The contractor shall conduct a thorough, systematic review and synthesis of publicly available datasets containing cardiac physiological signals. The review shall be conducted in close collaboration with FDA/CDRH SMEs and shall result in a manuscript submitted to a peer-reviewed journal.

SCOPE OF THE DATASET REVIEW

The review shall encompass publicly available datasets that include, as available, the following data types:

• Wearable electrocardiography (ECG) signals

• Photoplethysmography (PPG) signals

• Accelerometry data

• Blood pressure or other physiological reference measures

• Posture and/or activity labels

• Repeated or longitudinal measurements

TASKS

A. Search Strategy Development The contractor shall work in close collaboration with FDA/CDRH SMEs to identify and finalize search keywords and search strategies appropriate for identifying relevant publicly available datasets.

B. Inclusion and Exclusion Criteria The contractor shall work with FDA/CDRH SMEs to define and document inclusion and exclusion criteria for dataset selection prior to initiating the formal review.

C. Dataset Identification The contractor shall identify all relevant datasets specific to cardiac physiological signals, including but not limited to PPG and ECG datasets, using the agreed-upon search strategy and criteria.

D. Critical Attribute Extraction For each identified dataset meeting inclusion criteria, the contractor shall extract and document the following attributes, at minimum:

• Dataset origin and provenance

• Access conditions (e.g., open access, credentialed access, restricted)

• Publication status

• Population characteristics, including subject count, demographic coverage (age, sex, race/ethnicity), and health status

• Device modality and sensor type(s)

• Availability of raw versus processed signals

• Sensor placement location(s)

• Sampling rates

• Study activities and protocol design

• Annotation characteristics (e.g., distinct points, segments, intervals, events) and annotation quality

• Reference standards used

• Data management characteristics (e.g., file formats, data dictionary availability)

E. Manuscript Preparation and Submission The contractor shall work closely with FDA/CDRH SMEs to prepare a manuscript collating and synthesizing the publicly available dataset inventory. The manuscript shall be suitable for submission to a peer-reviewed, high-impact journal. The manuscript shall not be submitted without FDA review and written concurrence.

Phase 2 — Clinical Study: Collection, Annotation, and Delivery of a Physiological Signal Dataset

OVERVIEW

The contractor shall design and execute a prospective clinical study to collect, annotate, and deliver a comprehensive, synchronized physiological dataset from healthy human subjects. The resulting dataset shall be structured to support future AI/ML wearable device development, algorithm benchmarking, and public dissemination following de-identification and FDA review.

The clinical study design shall be developed in close collaboration with FDA/CDRH SMEs.

Study Population

A. Sample Size and Completion The contractor shall recruit and retain a cohort of healthy subjects sufficient to yield a complete, accepted dataset for 50 participants. Over-recruitment strategies may be employed to offset anticipated attrition; however, the final accepted dataset shall include data from exactly 50 subjects who complete the full four-session protocol.

B. Health Status Subjects shall be healthy adults with no prior diagnosis of cardiovascular disease or any other condition that would significantly affect cardiovascular function.

C. Demographic Requirements The completed cohort shall meet the following demographic specifications:

• Sex: Equally split between male and female subjects (25 male, 25 female)

• Age range: 22 to 60 years, with equal or nearly equal distribution of subjects across each decade of age within this range

D. Eligibility Screening — Required Measurements and Criteria The following measurements shall be obtained and documented for each subject during screening. Subjects not meeting all criteria shall be excluded:

• Height and weight

• Waist, neck, and arm circumference

• Medication use and medical history — subjects must not use any medications indicated for the treatment of cardiometabolic conditions

• Recent HbA1c measurement — subjects must have an HbA1c value of less than 5.3%

• Resting heart rate — must be less than 90 beats per minute at the time of screening

• Skin tone — must be quantified using a standardized, validated metric (e.g., the Fitzpatrick scale or an FDA-approved equivalent)

• Finger and body temperature — must be within normal limits and below 97.4°F at the time of each data collection session

Study Design And Session Protocol

A. Session Cadence Each enrolled subject shall complete one data collection session per week for four consecutive weeks, for a total of four sessions per subject.

B. Signal Collection Requirements Each session shall include concurrent, synchronized recording of all required signals and protocol activities as specified in Section 4.4. The contractor shall be responsible for safeguarding all collected data throughout acquisition, transfer, storage, and preparation for delivery.

C. Protocol Documentation The contractor shall develop and maintain a study protocol document that includes, at minimum:

• Observer training procedures

• Sensor placement specifications and procedures

• Signal synchronization procedures

• Quality-control checks and acceptance criteria

• Procedures for handling protocol deviations or unusable data segments

Required Signals and Data

The following signals and data shall be collected during each session for each subject:

A. Blood Pressure Double-observer auscultatory blood pressure measurements shall be performed in alignment with ISO 81060-2. All blood pressure measurements shall be time-aligned to the synchronized data record.

B. Photoplethysmography (PPG) Accurate PPG signal collection is required. Raw sensor signal access is required; processed-only output is not acceptable.

C. Electrocardiography (ECG) Accurate ECG signal collection is required. Raw sensor signal access is required; processed-only output is not acceptable.

D. Accelerometry Accurate three-axis accelerometer data shall be collected and synchronized with concurrent ECG and PPG data.

Raw Signal Access and Synchronization

A. Raw Signal Access The contractor shall identify all sensors used in the study and shall implement a validated method to obtain raw signals directly from each sensor, rather than relying solely on final or processed output signals. The raw-signal access methodology shall be documented and provided as part of the final deliverables. This documentation shall include, at minimum:

• Device brands and models used

• Hardware and software interfaces employed

• Signal extraction workflow

• File structures and formats

• Known limitations of the raw signal access approach

• Any preprocessing applied to signals prior to delivery

B. Synchronization Methodology The contractor shall implement and document a robust synchronization methodology. This documentation shall describe, at minimum:

• The common time base used across all signals

• Synchronization markers or triggers employed

• Procedures for detecting and handling clock drift

• Alignment procedures for physiological signals, reference measurements, and protocol events

Study Activities and Protocol

The contractor shall ensure that all required equipment is available and appropriate for the activities listed below. All activities shall be fully annotated and synchronized with cardiac and accelerometer signals. The following activities shall be included in each session:

• Postural transition — seated to supine: Blood pressure measurements collected during the transition from a seated to a lying (supine) position.

• Postural transition — seated to standing: Blood pressure measurements collected during the transition from a seated to a standing position.

• Quiet standing: Blood pressure measurements collected during stationary standing for 30 seconds to 1 minute, without hand movement.

• Treadmill walking at 2 mph: Cardiac signal and associated accelerometer data collected during treadmill walking at a constant speed of 2 miles per hour.

• Treadmill walking at 3.5 mph: Cardiac signal and associated accelerometer data collected during treadmill walking at a constant speed of 3.5 miles per hour.

• Stair climbing: Cardiac signal and associated accelerometer data collected during ascent and descent of a flight of five stairs.

The contractor shall ensure that all specialized equipment necessary to support these activities is procured and maintained in proper working order throughout the study.

Dataset Annotation, De-identification, and Delivery

A. Annotation Requirements The contractor shall ensure that the final dataset is fully annotated, with all events and measurements clearly labeled and time-stamped. Annotations shall identify, at minimum:

• Visit number and subject identifier

• Signal start and stop times

• Posture changes

• Treadmill activity intervals and speeds

• Stair-climbing intervals

• Blood pressure reference measurements and associated timestamps

• Protocol deviations or data quality flags

B. De-identification and Public Dissemination Preparation The complete dataset shall be de-identified in accordance with applicable legal and ethical requirements and prepared for public dissemination, subject to FDA review and written concurrence prior to any release.

C. Delivery Format and Documentation The dataset shall be delivered in a standard, non-proprietary format (e.g., CSV or HDF5) and shall include the following accompanying documentation:

• Data dictionary

• Annotation schema

• README file

• Any additional documentation necessary to support reuse by third parties

D. Secure Transfer The secure digital transfer method used for dataset delivery shall be compliant with applicable FDA cybersecurity requirements.

DELIVERABLES AND SCHEDULE

All deliverables shall be provided according to the schedule below unless otherwise adjusted in writing by FDA. The contractor shall not finalize public-facing materials or submit manuscripts for publication without prior FDA review and written concurrence.

# Deliverable Due Date

Project management plan, including project timeline, milestones, staffing plan, recruitment and retention plan, risk management approach, data management and cybersecurity plan, and FDA engagement cadence

Within 30 days of contract award

Phase 1 deliverables: public dataset inventory, critical-attribute framework, comparative matrix, narrative synthesis, and manuscript-ready text suitable to support Journal Paper #1

Within 90 days of

# Deliverable Due Date

Complete clinical study design, developed in collaboration with FDA/CDRH SMEs

Within 180 days of mpletion of all clinical data collection

Within 335 days of

Complete study report, including the full de-identified dataset (all required physiological signals, metadata, annotations, data dictionary, annotation guide, and README), delivered in a standard non-proprietary format via secure digital transfer compliant with FDA cybersecurity requirements

Within 365 days of

Option Year 1 — Manuscript Preparation and Public Dataset Release Support

If Option Year 1 is exercised, the contractor shall convert the Phase 2 clinical study data and findings into a publishable journal article and shall provide full publication support in close collaboration with FDA/CDRH SMEs. All activities under Option Year 1 are subject to FDA review and written concurrence prior to submission or public release.

Manuscript Scope

The manuscript shall describe, at minimum:

• Study design and rationale

• Participant cohort characteristics

• Instrumentation and device selection

• Synchronization approach and methodology

• Activity protocol

• Dataset structure and organization

• Annotation approach and schema

• Key findings relevant to future AI/ML wearable device development

Publication Support Activities

The contractor shall provide support for all activities associated with manuscript preparation and submission, including:

• Drafting and revision of manuscript text

• Preparation of figures and tables

• Response to co-author comments and review cycles

• Additional analyses required to support publication

• Activities associated with public release of the dataset, including preparation of the public release package

Dataset Delivery for Publication

As part of the manuscript submission package, the contractor shall provide the complete de-identified dataset, including all required physiological signals, metadata, annotations, data dictionary, annotation guide, and README, in a standard non-proprietary format (e.g., CSV or HDF5), delivered via secure digital transfer compliant with FDA cybersecurity requirements.

Additional Collaboration

At the Government's discretion, the contractor shall collaborate with FDA on additional data analysis, manuscript preparation and submission activities, and public-release support for the dataset.

FDA Oversight and Collaboration Requirements

All work developed under this SOW shall be performed in close collaboration with FDA/CDRH SMEs. The contractor shall maintain regular technical engagement with FDA and shall incorporate FDA feedback into all protocols, datasets, analyses, and manuscript drafts prior to finalization.

At a minimum, FDA shall have the opportunity to review and provide concurrence on the following prior to finalization:

• Project management plan

• Clinical study protocol

• Critical-attribute framework from Phase 1

• Raw-signal access plan

• Annotation and de-identification approach

• Final dataset package

• All manuscript drafts

Any public dissemination of data, public release package, conference abstract, or journal submission generated under this SOW shall be contingent upon FDA review and written concurrence.

The contractor shall support periodic status meetings at a minimum frequency of once every two weeks and shall provide written progress updates in a format and cadence agreed upon with FDA during project kickoff.

Contractor Qualifications and Minimum Requirements

Offerors must demonstrate that they meet all of the following minimum qualifications at the time of proposal submission:

1. Federal Collaboration and Publication Record: Demonstrated ability to collaborate with federal laboratories, supported by a recent record of publication in prestigious or high-impact peer-reviewed journals within the last ten (10) years.

2. Clinical Study Experience: Demonstrated successful execution of at least five (5) clinical studies involving healthy and/or patient subject populations.

3. Hospital Affiliation: Established affiliation with a hospital located within ten (10) miles of the contractor's primary study site or laboratory.

4. AI/ML Expertise: Demonstrated history of working in artificial intelligence and machine learning applied to health or biomedical data for more than ten (10) years.

5. Wearable Dataset Analysis Expertise: Demonstrated extensive history of working in the analysis of wearable physiological datasets for more than seven (7) years.

6. Authorized Laboratory and Medical Personnel: Possession of authorized laboratory space and appropriate involvement of qualified medical professionals to perform the clinical study safely and in compliance with applicable regulations.

7. Equipment Acquisition Capability: Demonstrated willingness and financial capacity to acquire all equipment necessary for conducting the specified clinical study activities.

8. Raw Signal Access from Wearable Devices: Access to at least three (3) distinct ECG/PPG wearable device brands, with demonstrated ability to download raw signals directly from each device rather than relying solely on processed output signals.

9. Invasive Blood Pressure Measurement Capability (Preferred): The contractor should have the capability to perform invasive blood pressure measurements via arterial line under the direct supervision of a licensed physician and a nurse or nurse practitioner. This capability is preferred but not required.

General Terms

• All work shall be performed in accordance with applicable federal regulations, FDA guidance documents, and ethical standards governing human subjects research.

• The contractor shall comply with all applicable data security, privacy, and cybersecurity requirements throughout the performance of this contract.

• Any modifications to the scope, schedule, or deliverables described in this SOW shall be made only through written agreement between the contractor and the FDA Contracting Officer.

PLACE OF PERFORMANCE

The place of performance is the contractor’s site.

CONTRACT ADMINISTRATION

The contact information for the FDA Contracting Officer’s Representative (COR) is the following: TBD

The contact information for the FDA Contracting Officer (CO)is the following: TBD

The contact information for the FDA Contract Specialist (CS)is the following: TBD

The contact information for the Contractor (KTR)is the following: TBD

CLAUSES AND PROVISIONS

Federal Acquisition Regulation (FAR) Clauses and Provisions

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (Nov 2025)

(DEVIATION)

52.203-17 Contractor Employee Whistleblower Rights (Nov 2023) 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-13 System for Award Management-Maintenance (Nov 2025) (DEVIATION) 52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (Nov 2025) (DEVIATION) 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (Nov 2025)

(DEVIATION)

52.222-3 Convict Labor (Jun 2003)

52.222-19 Child Labor—Cooperation with Authorities and Remedies (Nov 2025) (DEVIATION) 52.222-35 Equal Opportunity for Veterans (Nov 2025) (DEVIATION) 52.222-36 Equal Opportunity for Workers with Disabilities (Nov 2025) (DEVIATION) 52.222-37 Employment Reports on Veterans (Nov 2025) (DEVIATION) 52.222-41 Service Contract Labor Standards (Aug 2018) 52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) 52.222-50 Combating Trafficking in Persons (Nov 2025) (DEVIATION) 52.222-54 Employment Eligibility Verification (Nov 2025) (DEVIATION) 52.222-62 Paid Sick Leave Under Executive Order 13706 (Jan 2022) 52.224-3 Privacy Training (Jan 2017) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-3 Protest After Award (Nov 2025) (DEVIATION) 52.233-4 Applicable Law for Breach of Contract Claim (Nov 2025) (DEVIATION) 52.240-91 Security Prohibitions and Exclusions (Nov 2025) (DEVIATION) 52.240-92 Security Requirements (Nov 2025) 52.240-93 Basic Safeguarding of Covered Contractor Information Systems (Nov 2025) 52.217-9 Option to Extend the Term of the Contract (Mar 2000) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government The total duration of this contract, including the exercise of any options under this clause, must not exceed the identified period of performance, inclusive of any options if exercised. Gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract must be considered to include this option clause.

52.212-1 Instructions to Offerors — Commercial Products and Commercial Services (Nov 2025)

(DEVIATION)

52.212-2 Evaluation — Commercial Products and Commercial Services (Nov 2025) (DEVIATION)52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2024) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017) 52.204-7 System for Award Management (Nov 2025) (DEVIATION) 52.217-5 Evaluation of Options (Nov 2025) (DEVIATION) 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications JUN 2020 52.240-90 Security Prohibitions and Exclusions Representations and Certifications (Nov 2025)

(DEVIATION

Health and Human Services Acquisition Regulation (HHSAR) Clauses

352.224-70 Notification of System of Records Notice (Feb 2024) (DEVIATION)

352.224-71 Confidential Information (Feb 2024) (DEVIATION) 352.227-70 Publications and Publicity (Dec 2015) 352.237-75 Key Personnel (Dec 2015) 352.232-71 Electronic submission of payment requests (FEB 2022)

(a) Definitions. As used in this clause - Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause FAR 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts.

The IPP website address is: https://www.ipp.gov.

c. 1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to

(1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information must be included, in addition to supporting documentation to substantiate costs incurred:

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs must also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which must include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments must be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor must not be paid, or must be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

INSTRUCTIONS TO OFFERORS

The quote must be prepared and submitted in three parts: “Volume I – Executive Summary,” “Volume II -Technical Quote,” and “Volume III – Business Quote.” All parts shall be separate attachments and complete so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The FDA is not responsible for any costs incurred in preparing the documents described in this email.

Volume I - Contains the Executive Summary, which includes the following information:

Cover Letter – Must be signed by an individual that has the authority to bind the company. The cover letter must include the following, at a minimum:

• Name of Offeror and Address

• Unique Entity ID (UEI)

• Point of Contact – Name, telephone number and email address

Volume II –Technical Quote

The Technical Quote must include information on resources required, such as labor categories and hours, subcontractors, travel, etc., but no associated costs should be provided in Volume II -- Technical Quote.

The Technical Quote shall disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the Technical Quote instructions and the technical evaluation criteria listed below. The Technical Quote (Volume II) shall be limited to fifteen (15) pages. This limitation excludes resumes (if provided) and any commitment documentation. The technical quote shall include a table of contents.

The Technical Quote is the most important item in the evaluation of your capability to perform the desired services. Therefore, your quote must present sufficient information to reflect a thorough understanding of the work requirements and a detailed technical approach for achieving project objectives as set forth in the Statement of Work (SOW).

To permit a thorough and effective evaluation, the technical portion of your quote must be as concise, complete and clear as possible to enable the Government to make a sound determination of your ability to successfully complete the requirements set forth in the SOW. The inclusion of any important considerations not covered by this request is encouraged.

Statements to the effect that the Offeror “understands and will comply” with the SOW (in whole or in part) or phrases such as “standard procedures will be used” or “well- known techniques will be utilized,” and other such generalities will not constitute compliance with the requirements. It is essential that you present in your quote, information in sufficient detail to permit the Government to make an evaluation of the technical quote without further information being required. The

Government reserves the right to award based upon initial quotes received. The Offeror shall clearly state any areas in which assumptions are based or clearly state areas that deviate from the requirements stated in the SOW.

Volume III –Business Quote

The Business Quote shall consist of a cover page, a table of contents, and the information requested in the Business Quote Instructions set forth below. There is no page limitation for the business quote.

Authorized Official and Submission of Quote: The quote must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this solicitation.

The Offeror shall submit a Business Quote fully supported by underlying cost information (i.e., price breakdown) adequate for the Government to determine the reasonableness of the unit pricing proposed, and to evaluate whether the proposed costs are consistent with the technical quote and the Offeror’s effort to perform the requirement.

The Offeror must submit a payment schedule, which should be based upon the deliverables for this requirement.

Volume III shall not include any notes or assumptions not described elsewhere in the quote.

Formatting Instructions

Specific formatting instructions for each volume are as follows:

General Formatting Instructions:

Offerors shall use the following page setup parameters:

• Margins – Top, Bottom, Left, Right – 1”

• Gutter – 0”

• From Edge – Header, Footer – 0.5”

• Page Size, Width – 8.5”

• Page Size, Height – 11”

• Each paragraph shall be separated by at least one blank line

Offerors are encouraged to use Calibri 11-point font. However, a font of equivalent size may be used (such as Arial or Times New Roman).

Tables and illustrations may use a reduced font size not less than 10-point and may be landscape.

Page limitations shall be treated as maximums. The following items are not included in the stated page limitations:

• Cover Sheet;

• Executive Summary;

• Table of Contents;

• Dividers;

• Glossary;

• Resumes, each no more than three (3) pages in length

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award.

BASIS FOR AWARD

The Government will award a contract resulting from this RFQ to the responsible offeror whose proposal conforming to the RFP will be most advantageous to the Government, price and other factors considered. The following non-price factors (Factors 1 & 2 are the equally important and are more important than Factor 3-Technical Capability), shall be used to evaluate offers: Relevant Experience, Relevant Past Performance and Technical Capability.

All non-price factors, when combined, are approximately equal price. When making its best value determination, if the Government determines non-price factors to be essentially equal amongst competing Offerors, price becomes more important as the discriminating factor.

Factor 1- Relevant Experience: Relevant Experience is the extent to which the Offeror’s quote demonstrates it has relevant experience in performing similar projects in terms of size, scope, and complexity. Offerors shall describe, in detail, 2-3 projects they believe to be relevant to the requirements effort described in the Statement of Work. Projects should be recent, completed, or substantially completed projects for which the Offeror is the prime Contractor (preferred) or subcontractor. The description should include at a minimum: brief description, contract amounts, dates completed, and contract numbers. Through the description of previous projects, the Contractor should demonstrate that it has the requisite experience, knowledge, and skillset necessary in order to successfully provide all services as described in the SOW and that is has the ability to effectively manage them.

The Contractor shall demonstrate that it has:

• Knowledge and understanding of each task area.

• Sufficient experience performing all of the tasks/procedures listed in the SOW;

• Experience performing like services at multiple geographic locations around the country under the same contract.

• Ability to quickly fill positions in remote locations where it may not have a geographic presence

Processes and procedures that:

• Exceed or reflect current industry best practices; and

• Meet all FDA requirements and other standards referenced in SOW.

Factor 1: Relevant Experience

Relevant Experience is used to demonstrate the Offeror’s technical experience as it relates to the requirements of the Statement of Work. The Offeror should reference projects showing they have experience in performing the same types of work in terms of size, scope, and complexity as required in this project. Qualifications, educational levels, degrees, experience, licenses, certificates, technical skills, and availability of individuals will also be considered in the evaluation for Factor 1.

Offeror shall limit Relevant Experience to 10 pages in the quote. Offeror shall use Times New Roman font and font size shall not be less than 12 anywhere in the quote, including tables etc.

Factor 2: Relevant Past Performance

The Relevant Past Performance factor is intended to measure how well a Contractor has performed on its previous, relevant projects that were similar in size and scope to the existing requirement (projects cited in response to Factor 1- Relevant Experience).

The distinction between relevant experience and past performance is relevant experience pertains to the types of work and volume of work completed by an Offeror that are comparable to the types of work covered by this requirement, in terms of size, scope, and complexity; Past Performance relates to how well the Offeror has performed on those efforts. The Offeror shall provide a POC (name, phone number, email address, best time to contact) for each project that the Offeror cited under the Relevant Experience factor. During the proposal review process, the Government will interview these individuals asking questions from a standardized questionnaire in order to assess the Contractor’s performance on the project.

The Government may review any other sources of information for evaluating past performance.

Other sources may include, but are not limited to: past performance information retrieved through the Contractor Performance Assessment Reporting System (CPARS) using all CAGE/DUNS numbers of team members (partnership, joint venture, teaming arrangements, or parent company/subsidiary/affiliate) identified in the Offeror’s quote, inquiries of owner representative(s), and any other known sources not provided by the Offeror.

While the Government may elect to consider data from other sources, the burden of providing current, accurate and complete past performance information rests with the Offeror.

Offerors without a record of relevant past performance or for who information on past performance is not available; the Offeror will neither be evaluated favorably or unfavorably on the past performance factor.

Offeror shall limit Relevant Past Performance 7 pages in the quote. Offeror shall use Times New Roman font and font size shall not be less than 12 anywhere in the quote, including tables etc.

Factor 3: Technical Capability

This factor will measure the Offeror’s understanding of the requirement as set forth in the Statement of Work. Offerors should seek to make the Government feel confident in the Offeror’s proposed technical approach and its potential to fulfill the TASKS outlined in the SOW. Factor 3 is the medium by which the Government evaluates how well an Offeror: understands technical problems, is able to provide technical solutions, and how likely the Contractor will be at successfully providing competitive, accurate pricing estimates commensurate with technical requirements. Simply restating the Statement of Work is not sufficient for meeting the criteria for this evaluation factor. The Offeror’s Quote should demonstrate that they are competent in performing the various types of work and need to show how the work is to be accomplished.

Contractors should also discuss contract management as well as the resources they intend to utilize in the accomplishment of the work. Resources include: facilities, personnel, subcontractors, etc.

Offeror shall limit Relevant Experience to 10 pages in the quote. Offeror shall use Times New Roman font and font size shall not be less than 12 anywhere in the quote, including tables etc.

Factor 4: Price

The pricing volume shall be completely separate from the Contractor’s technical quote. The technical volume of the quote shall not include ANY pricing information whatsoever.

The Government anticipates adequate price competition; therefore, cost or pricing data will not be required. There is also significant historical information from past projects of a similar nature to estimate the types and quantities of labor that will be required over the life of the contract. In the event that adequate competition is not present, information other than cost or pricing data may be requested.

Price Analysis will be performed by the following techniques to ensure a fair and reasonable price:

• Comparison to other Bidder’s proposed prices received in response to the RFQ;

• Comparison of proposed prices of individual elements with available historical information; and

• Comparison of proposed prices of individual elements and total price with the independent Government estimate.

• Price proposal demonstrates and clearly describe an effective and efficient cost approach for accomplishing stated requirements.

EVALUATION FACTORS

Factor 1: Relevant Experience

The Government will evaluate the degree to which the Offeror’s cited experience is relevant based on the aforementioned criteria. A high degree of relevancy for previous work performed will increase the Government’s level of confidence that the Offeror is likely to achieve successful contract performance in relation to this requirement.

Factor 2: Relevant Past Performance

The government will evaluate the degree to which information submitted by the Offeror reflect a trend of acceptable performance considering:

• A pattern of successful completion of tasks;

• A pattern of deliverables that are timely and of good quality;

• A pattern of cooperativeness and teamwork with the Government at all levels (task managers, contracting officers, auditors, etc.);

Factor 3: Technical Capability

The Government will evaluate the clarity and effectiveness of the Offeror’s approach to how it intends to manage and operate all aspects of the contract and multiple complex Task Orders with overlapping performance periods.

The Offeror will be evaluated on its proposed personnel and staffing. Personnel will be evaluated based on their demonstrated experience in performing or managing similar requirements to those stated in the SOW.

Factor 4: Price

The Government will evaluate the total price to determine if they are fair and reasonable and submitted in accordance with the pricing price schedule.

Offerors shall complete the pricing tables for all 5 years.

Offeror Price Quotes shall include completed tables from PART 2-SUPPLIES OR SERVICES AND PRICES/COSTS. This is a Firm Fixed Price contract. Additional costs beyond those listed in the PART 2 tables are not anticipated, but if there are other price components that must be factored in that are unique to the offeror they shall be noted and included in the Price Quote and must also be fixed price. The Government must be able to quickly and easily discern the Bidder’s annual proposed Firm Fixed Price amounts.

No technical information shall be included in the Pricing Volume.

EVALUATION CRITERIA

The evaluation system used by the Government to rank competitive proposals under this RFQ is as follows: Acceptable and Unacceptable.

Acceptable: The Offeror demonstrates that the RFQ requirements have been analyzed, evaluated, and synthesized into proposed approaches, plans, and techniques that, when implemented, should result in adequate performance. The proposal has modest strengths. The weaknesses in the proposal are offset by the strengths.

Unacceptable: The Offeror demonstrates a superficial, incomplete, or incorrect understanding of the RFQ requirements, resulting in proposed approaches, plans, and techniques that are deficient and should result in poor performance when implemented. The proposal has few strengths.

The proposal has significant weaknesses and/or many minor weaknesses that are not offset by strengths.

OFFERORS RESPONSE DATE AND TIME

All quotes shall be submitted via email to Telisha.Wilson@fda.hhs.gov with the subject titled

“ALP-134632”.

Questions are due by 10Am EST on July 31, 2026.

Responses are due by 10Am EST on August 07, 2026.

Quotes must be valid through September 30, 2026