FDA-75F401-24-R-00119.pdf

Statement of Work

Project Title:

Programming and Panel Services for An Experimental Study Assessing Correction Strategies Addressing Medical Misinformation

1. Background

Social scientists at the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Communications (OCOMM) conduct social and behavioral science research studies to develop evidence-based knowledge and implementable recommendations to inform Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research’s (CDER’s) risk communications, regulatory actions, and policies; and to promote informed decision-making among patients, healthcare professionals, and the public. This research regularly includes online questionnaires and experimental studies on a variety of health topics, including opioids, biosimilars, medical countermeasures, medical misinformation, and drug safety. In order to effectively conduct research, access to participants as well as the ability to execute the studies is required in order to obtain data to inform communications, actions, and policies.

2. Purpose/Objective

The purpose of this requirement is to conduct an online experimental questionnaire study to test 5 types of correction strategies for addressing medical misinformation on social media by 1) obtaining access to a participant recruitment panel representative of the general United States population that must be linked and programmed in the Qualtrics questionnaire platform (to which CDER/OCOMM already has a license) and 2) conducting experimental research of at least 4,620 participants (4,200 main study and 420 sample pretest) representative of the U.S. population with specific oversampling of sub-samples of interest. More specifically, these research services include access to online participant panel(s); participant recruitment;

questionnaire programming; quality assurance checking of the programmed questionnaire; and data collection, cleaning and removing personal identifiers, and delivery to CDER/OCOMM researchers. The objectives of this study are to obtain needed evidence to inform the FDA’s communication decisions by identifying strategies for the agency to correct inaccurate or misleading medical information about FDA-regulated products that may occur during public health emergencies. This research aligns with FDA’s public health mission and is critically important to the agency’s obligation to provide accurate, trustworthy, and important information about regulated products, including vaccines and drug treatments, to the public during health emergencies.

3. Contract Tasks/Requirements

Independently and not as an agent of the Government, the Contractor shall furnish all necessary equipment/panel(s), and related services, personnel, materials, facilities, and otherwise do all things, except as provided in the schedule, necessary for or incident to the performance of the work as described in the Statement of Work (SOW). All work performed under this Contract shall be monitored by the Contracting Officer’s Representative (COR).

MANDATORY CRITERIA: The Contractor shall have ownership and management of a panel(s) of potential participants with an associated questionnaire platform that meets all the criteria listed in the Statement of Work (SOW) for Tasks 1 thru 5. In addition, the programming and administration of the questionnaire must be through the Qualtrics questionnaire platform.

The Contractor shall perform the following tasks:

Task 1: Questionnaire Programming

The Contractor shall program the English-language questionnaire on the Qualtrics platform for questionnaire administration. The Contractor shall manage the questionnaire programming of the web-based platform, including the programming of questionnaire items, block organization, logic, flow, randomization, and assigning values to questionnaire items. The Contractor shall perform the following:

• Initiate programming of the web-based questionnaire on the Qualtrics’ questionnaire platform based on the version CDER/OCOMM submitted for approval by FDA’s Institutional Review Board (IRB)/Office of the Chief Scientist Human Subjects Protection Executive Officer and the Office of Management and Budget (OMB) when notified to do so by the FDA COR. This programming may have to be updated if changes are required by IRB and/or OMB.

CDER/OCOMM expects the initial programming shall be completed within 10 business days.

However, if this is not possible, the Contractor shall state that in its proposal, providing the amount of additional time needed. If needed, updated programming shall be completed within three (3) business days.

• Program a screener questionnaire separately, or as part of the larger questionnaire, to identify eligible participants and remove those who do not fulfill the screening criteria.

• Program CDER/OCOMM developed informed consent text that allows only eligible participants who agree to the content to be taken to the questionnaire questions.

• Program a factorial experimental questionnaire, estimated to take approximately 25 minutes on average to complete, including a series of at least 30 individual, matrix, and ranking questions as well as nearly 10 demographic questions, and unobtrusive measures (e.g., time on page, questionnaire completion time).

• Enable up to 10 iterations of branches to satisfy the experimental study design of up to 32 conditions concerning three (3) different FDA-regulated products. The programming of the questionnaire shall allow for the questionnaire item language to be specific to the targeted condition.

• Program questionnaire logic and flow that includes the randomization of conditions and the verification that the participant received that condition.

• Program the questionnaire such that data are exportable into correct numeric values (e.g., Likert Scales).

• Program the questionnaire to be accessible on both desktop and mobile devices.

• Provide back-end services such as providing numeric values to response options, data scrubbing, attention checks to exclude participants with replacement, analysis of device/IP addresses to avoid duplicate questionnaire submissions and/or bots.

• Conduct quality checking of the questionnaire to ensure all the questions are correct, no copyediting errors and the randomization within question functions as planned.

• Upon completion of programming the study elements described above into Qualtrics’ online questionnaire platform, provide the FDA Project Manager (PM) with a link(s) for CDER/OCOMM to test prior to the questionnaire being fielded. The contractor shall resolve any/all issues identified by CDER/OCOMM as possible or within three (3) business days of receiving comments from CDER/OCOMM. The contractor shall provide documentation that the questionnaire is programmed correctly and the numerical values will be represented correctly within the dataset. The Questionnaire Programming task is considered complete once the Contractor receives programming approval from the PM.

Task 2: Participant Recruitment and Small Sample Questionnaire Testing

The Contractor shall provide access to an online participant panel(s) that reflect the U.S. Census sociodemographic distributions and from which OCOMM can oversample target demographics that will result in at least 4,620 completed questionnaire participants with quality responses to the experimental study. CDER/OCOMM expects the questionnaire will be approximately 25 minutes on average in length.

The contractor shall perform the following:

• Recruit and screen panel respondents consisting of daily social media users 18 years or older who are able to read the English language, and in the last 3 years have not been employed by a federal government health agency, a health organization, a pharmaceutical company, a communications/marketing or research firm or the news media. Participants will be representative of the U.S population and align with the U.S. Census across sociodemographic distributions, including age, gender, states, income, urbanicity, and education levels of U.S. adults.

• Employ quota sampling to recruit participants with demographic characteristics of target audiences during screening of the questionnaire, including self-reported non-Hispanic African Americans/Blacks, Hispanics/Latinos, and education, to ensure diversity of traditionally harder-to-reach participants. The projected quota approach for the study will include:

o Self-reported race: Non-Hispanic Black/African American (25%), i.e., those who report ONLY Non-Hispanic Black/African American race (not in conjunction with other races).

o Self-reported ethnicity: Hispanic/Latino (25%) o Education: Less than high-school education (10%), highest degree a high-school diploma or equivalent (28%)

• Initiate recruitment of participants within five (5) business days upon notification by the PM that

OMB has approved the study.

• Ensure eligible participant data are private and securely stored and that participants’ personally identifiable information (PII) is not shared with CDER/OCOMM. Contractor shall remove all PII from any data or information provided to CDER/OCOMM.

• After the PM notifies the contractor the study has been approved by FDA IRB and OMB, conduct a small sample questionnaire test of the programmed questionnaire with a sample of 10% of eligible participants to test screener questions; question wording; timing; programming elements such as skip patterns, etc.; and any other issues as necessary. For planning purposes, the contractor shall complete the small sample questionnaire test data collection within 10 business days of launch; however, if more time is needed the contractor should note that in its proposal.

The Contractor shall submit a data summary (completion rates and frequencies of variables) of the small sample questionnaire test to the PM as well as an export of the dataset within three (3) days of completion of the small sample questionnaire test data collection. Participants in the small sample questionnaire test run shall have the same characteristics as the main questionnaire samples/subgroups. The contractor shall not count the 10% (n=420) small sample questionnaire test respondents as part of the 4,200 respondents to be included in the questionnaire study.

However, upon mutual agreement of the Contractor and FDA COR, the small sample questionnaire test data may be incorporated into the main questionnaire data if no significant issues are encountered during the small sample questionnaire test, in which case the total main study sample size may increase to 4,620.

• If a programming error is discovered during the small sample questionnaire testing, the contractor will be responsible for reprogramming and collecting replacement data.

Task 3: Associated Research Services

The Contractor shall provide the following questionnaire-related research services and administration:

• Upon approval of the small sample questionnaire testing data summary, the Contractor will notify the FDA PM that the questionnaire has been launched within 3 business days.

• CDER/OCOMM expects the main questionnaire will be fielded for up to 45 days to satisfy completion of at least 4,620 respondents. However, if this is not possible, the Contractor shall state that in its proposal, providing the amount of additional time needed.

• Provide recruitment and questionnaire completion updates to CDER/OCOMM every three (3) business days that include the number of recruited participants satisfying the predetermined quotas and sociodemographic characteristics, number of completes in each condition, number that failed the attention checks, and number that completed a minimum threshold of questionnaire items to be considered complete questionnaire response. The specific criteria for a complete survey will be defined before the survey programming, e.g., those who pass the attention checks, are not found to straight-line their answers, and who complete the survey in shorter-than-acceptable timeframes.

• Perform regular random quality-control checks of respondents through appropriate panel or individual procedures and report the outcomes of these checks to CDER/OCOMM at least weekly. These checks should include, but are not limited to, removing straight liners, attention check failures and response times deviating significantly from the mean. Problems or issues should be reported to the FDA Project Manager immediately (i.e., within 24 hours/one (1) business day of being identified).

• Deliver a table that describes completions rates for the questionnaire across different denominators (i.e.., percent completes among # of panelists recruited, # of panelists who initiated the screening process, # of panelists who successfully cleared screening, # of panelists who started the questionnaire, sociodemographic breakdown of recruited participants, deemed eligible, completed the survey and non-responders) as well as across quota and prescreened characteristics (i.e., percent of respondents who are non-Hispanic Black, Hispanic, less than HS educated, HS educated, social media use, ineligibility). The contractor shall close the questionnaire within (one) 1 business day of FDA PM approval of the completion table.

• The contractor is responsible for providing incentives directly to participants to facilitate study recruitment.

Task 4: Questionnaire Data Delivery

The Contractor shall code variables and items into datasets and provide CDER/OCOMM with de-identified questionnaire data and supporting documents that describe how the questionnaire data were finalized. The supporting documents shall also provide a breakdown of the overall sociodemographic makeup of the panel(s) and provide questionnaire completion rates based on the prescreened characteristics. The Contractor shall perform the following:

• Securely transfer a final dataset to the FDA Project Manager and COR in an electronic spreadsheet format (e.g., csv, xlxs, etc.) within 5 business days of the questionnaire closing.

• Provide a data dictionary that catalogs and communicates the structure and content of data and provides meaningful descriptions of the variables that are understandable to CDER/OCOMM delivered simultaneously with the final dataset. Ensure and verify that no PII in any form is provided to CDER/OCOMM, including that physical or electronic consent forms.

• CDER/OCOMM will have complete ownership of and control over all data collected as part of the questionnaire.

Task 5: Project Administration

The Contractor shall perform all aspects of the described tasks according to the listed time frames and maintain communication with FDA throughout the contract as described. The Contractor shall perform the following:

• Coordinating and hosting a virtual initial project kickoff meeting within 10 business days of contract effective date with the CDER/OCOMM Project Manager and COR.

• Hosting virtual project meetings with OCOMM team members and other stakeholders within 5 business days of a request from the FDA COR or Project Manager.

• Provide an initial demonstration/training of the questionnaire recruitment and administration platform at a date and time acceptable to OCOMM.

• Manage project invoices and contracts through FDA’s Invoice Processing Platform (IPP).

• CDER/OCOMM will be responsible for obtaining clearance from OMB and the FDA IRB. The

Contractor shall provide information for submission of the OMB and IRB package(s) (e.g., confidentiality, questionnaire record-keeping, recruitment procedures and response rates, confidentiality, and consent procedures) and provide additional documentation as needed to facilitate these processes. The Contractor shall not make any changes to the protocol as approved by OMB or FDA IRB without consulting with nor proceed with any data collection without written authorization from the FDA COR.

5. Deliverables

All deliverables shall be provided to the CDER/OCOMM COR and Project Manager, unless otherwise specified. Due dates are based on calendar days with the understanding that any due dates that fall on a federal holiday or weekend, deliverable(s) are due on the next business day.

All deliverables submitted under this contract shall be complete, clear, concise, technically accurate, well organized, and properly referenced. The Contractor shall deliver data in a mutually agreed upon format.

Deliverables are to be transmitted via email with a description of the content, including which deliverables are included.

Deliverables include:

Task Deliverable Due Date 1 Cost projections and projected timelines for study recruitment, completion, and delivery of questionnaire data

Within 5 business days of request from CDER/OCOMM

1 Recruitment Updates on Quota Completion Rates

Every 3 business days during recruitment

1 Link for OCOMM to Test Online Questionnaire

Within 5 business days of OMB approval

1 Final Programmed Questionnaire Within 5 business days of receiving comments from

CDER/OCOMM

1 Access to Questionnaire Development via Qualtrics

Within 5 business days of OMB approval

2 Small Sample Questionnaire Test Data Summary

Within 3 business days of completion of the small sample pretesting of the questionnaire

2 Recruitment and Questionnaire Completion Updates

Every 3 business days during recruitment.

3 Notification of Launched Questionnaire

Within 3 business days of final resolution of the small sample questionnaire testing data summary

3 Quality Control Check Reports Weekly during recruitment.

Problems or issues should be reported to CDER/OCOMM immediately.

3 Notification of Closure of Questionnaire

Within 1 business day of CDER/OCOMM approval of the completion table.

4 Final Dataset Withing 5 business days of the questionnaire closing

4 Final Completion Table Withing 5 business days of the questionnaire closing

4 Data Dictionary Withing 5 business days of the questionnaire closing

5 Kick off Meeting [1 hr.];

Detailed kick-off agenda

Within 10 business days of Task Order Effective Date or Option Period Start Date

5 Virtual project meetings As directed by the SOW

5 Questionnaire Recruitment and Platform administration training

As directed by the SOW

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents 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). Document submissions required throughout the award period(s) 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.

6. Contract Type

The government anticipates award of a firm fixed price contract.

7. Period of Performance

The anticipated period of performance shall be July 1, 2024, to June 30, 2025.

8. Place of Performance

Any contractor work under this Contract shall be performed at the Contractor’s facility.

9. Contract Administration

CDER/OCOMM Contracting Officer’s Representative (COR):

TBD at the time of award

OCOMM Project Manager:

TBD at the time of award

10. Special Contract Requirements

Government Property

All materials, media, data, etc., gathered and developed in the course of this contract become the property of the U.S. Government and cannot be used or distributed in any form without the express written permission of the FDA Project Manager and COR. Request for use will not necessarily result in approval.

If for some reason, work under this contract is incomplete, all materials and media under development will be transferred to the FDA Project Manager and COR. Similarly, at the conclusion of this contract, all materials, media, data, etc., developed and gathered in the course of this contract shall be transferred to the FDA Project Manager and COR.

SAFEGUARDING OF INFORMATION

The contractor and its employees shall exercise the utmost discretion in regard to all matters relating to their duties and functions. They shall not communicate to any person any information known to them by reason of their performance of services under this contract which has not been made public, except in the course of their duties or by written authorization of the Contracting Officer. Furthermore, no article, book, pamphlet, recording, broadcast, speech, television appearance, film, or photographs concerning any aspect of the contract shall be published or disseminated through any media without the prior written authorization of the Contracting Officer. These obligations do not cease upon termination of this contract.

The contractor shall include the substance of this provision in all contracts for employment and in all subcontracts hereunder.

CONFIDENTIALITY

The contractor shall comply with standard FDA and professional safeguards to ensure participant confidentiality, limiting use of participant personally identifiable or contact information (PII). Consistent to ensure participant confidentiality, the contractor shall (1) never use last names of any participant on any materials (e.g., lists of participants, name plates, transcripts, and draft or final reports); and (2) not attribute to an individual quotes used in reports.

CONFLICT OF INTEREST

Organizational Conflict of Interest

a) The purpose of this section is to ensure that the Contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language of section VII applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest

Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501).

(d) Contractor’s Conflict of Interest Responsibilities

The individual contractor must be free of interest prior to performing under this contract. Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the FDA. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the contract officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

Prior to award, contractors that disclose potential or actual conflicts of interest shall submit a mitigation of conflicts of interest plan along with their technical and business proposals.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities.– The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

HUMAN SUBJECTS PROTECTION

All research conducted, supported, or regulated by any U.S. Government Agency is subject to certain uniform requirements of the Federal Policy for the Protection of Human Subjects including Institutional Review Board (IRB) membership, IRB review and approval criteria, IRB operations and record keeping, and informed consent. The contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The contractor further agrees that research involving human subjects and funded by the Food and Drug Administration shall receive approval from an IRB prior to enrolling human subjects. The contractor shall understand and comply with ethical principles and regulatory requirements involving human subjects research as specified in the Federal regulations for the Protection of Human Subjects, 45 CFR 46. The contractor shall remain in compliance with the Health and Human Services (HHS) policies and procedures that concern the conduct of human subjects research. The contractor shall work with FDA throughout the process of IRB approval to coordinate activities. The contractor further agrees to provide all amendments as well as an annual application for renewal to the IRB for review and approval prior to implementation. In addition the contractor shall provide certification at least annually that the Institutional Review Board of record has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

For HSR exempt from the requirements of 45 CFR part 46:

(a) The Contractor will submit to FDA a letter from their IRB or HSP entity that the proposed research is exempt (see 45 CFR 46.104).

(b) In accordance with SMG 9001.4, FDA will follow its procedures for making the exempt research determination. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination.

For HSR that is not exempt from the requirements of 45 CFR part 46 (nonexempt research):

(a) The Contractor agrees to protect the rights and welfare of human subjects involved in research under this contract by complying with 45 CFR part 46 and the clause at HHSAR 352.270-4b.

(b) Initial proof of compliance with 45 CFR Part 46 shall consist of the following:

(1) A copy of a current Federalwide Assurance on file with OHRP http://ohrp.cit.nih.gov/search/. The copy of a current Federal–wide Assurance shall be included with the Contractor’s proposal.

(2) A letter from the Contractor’s local IRB (specified in the Offeror’s Assurance of Compliance) stating that it has reviewed and approved the proposed research protocol. The letter from the local IRB shall be submitted to the COR.

http://ohrp.cit.nih.gov/search/

(3) In accordance with SMG 9001.4, FDA will determine if FDA is considered engaged in the research for purposes of 45 CFR part 46. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination. When that determination is made, FDA will confirm the extent to which the terms of 352.270-11 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required apply.

The contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract in a proper manner and as safely as is feasible. Nothing in this contract shall be deemed to constitute the contractor or any subcontractor, agent or employee of the contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for acts of the contractor or its employees.

If at any time during performance of this contract, the Contracting Officer determines that the contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing by the Contracting Officer. If the contractor fails to complete the corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Department of Health and Human Services Human Subject Assurances.

IRB and OMB APPROVAL:

Clearance from an IRB and OMB must be obtained prior to any type of recruitment or data collection. No recruiting or data collection is to begin until FDA receives clearance of the research protocol from the Office of Management and Budget (OMB), FDA’s Office of the Chief Scientist Human Subject Protection Executive Officer, and an accredited external Institutional Review Board. The contractor shall not deviate from the approved OMB, Office of the Chief Scientist Human Subject Protection Executive Officer, and IRB research protocol without prior written authorization from the FDA Project Manager and COR. In the event that a change must be made to the research protocols, no matter how small the change appears, the contractor must seek and receive approval from the FDA Project Manager and COR. If the FDA IRB has not made the determination of exempt status, non-engaged status, or has not deferred its review authority to an external IRB, the FDA will be responsible for submitting the final study materials to the FDA IRB. The contractor shall be responsible for providing FDA the necessary information for a complete IRB study package and a complete OMB study package. Additional information to be provided by the contractor may include information such as confidentiality and record-keeping procedures and personnel qualifications, such as resumes and human subjects protection training.

In addition, the contractor shall obtain all necessary internal approvals, such as determination from its own IRB, if required, prior to any human subject data collection. The contractor shall obtain the determination from its own IRB no later than 40 business days after the FDA COR approval of the final study materials package. All staff working with human subjects or having access to human subjects’ data must complete human subjects training appropriate for this type of social behavioral study.

PRIVACY, PUBLICATIONS, AND PRESENTATIONS

The contractor shall hold all discussions and deliberations under this order as confidential. The contractor shall secure facilities and communications to limit the access and distribution of any materials, documents, data, findings, analysis, or conclusions arising out of the order. The contractor shall not present, publish, or otherwise release any information arising out of this order without the express prior written permission of the COR. The COR will determine what, if any, information may be releasable for publication, presentation, or through another means and will determine the content of the released information, including any authorship decisions. The intended purpose of this order is to conduct research to evaluate stimuli that will inform refinement and further development for later research and other projects. No papers may be published by the contractor on the work provided herein. If CDER/OCOMM determines it is appropriate for development of a paper to publish, this will be done in collaboration with the contractor through the CDER/OCOMM clearance process.

PROPRIETARY DATA

The contractor shall provide a descriptive list of the data that is considered confidential, commercial value, and/or trade secret information.

SECTION 508 REQUIREMENTS

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards.

This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services. These 508 standards were revised in January 2018. These revised standards, which consist of 508 Chapters 1 and 2 (Appendix A), along with Chapters 3 through 7 (Appendix C), contain scoping and technical requirements for information and communication technology (ICT) to ensure accessibility and usability by individuals with disabilities. Compliance with these standards is mandatory for Federal agencies subject to Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d).

The following Section 508 standards apply to this acquisition:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping

Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping

Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance

Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. Appropriate Scoping Requirement from Appendix A

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) Appropriate Technical Performance and Technical Requirement from Appendix C

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

Additional Clauses, terms, and Provisions FAR 52.252-2 – Clauses Incorporated by Reference (Feb 1998)

This purchase order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained in full text at:

https://www.acquisition.gov/far/ and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (Jan 2017)

52.204–23 Prohibition on Contracting for Hardware, Software, and Services Developed or

Provided by Kaspersky Lab or Other Covered Entities (Jul 2018)

52.204-25 Prohibition on Contracting For Certain Telecommunications And Video

Surveillance Services or Equipment (Aug 2020)

52.212-4 Contract Terms and Conditions—Commercial Products and Commercial

Services (NOV 2021).

http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.acquisition.gov/far/ https://www.acquisition.gov/far/

52.227-17 Rights in Data—Special Works (DEC 2007).

52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)

HHSAR Clauses

HHSAR Clause 352.203-70 Anti-lobbying DEC 2015

HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

DEC 2015

HHSAR Clause 352.224-71 Confidential Information. (December 18, 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: All data related to this procurement is restricted.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are:

The national security risk to the Government that process Americans’ plasma samples, genome or exome data in any foreign country or entity or potentially provide that information to a foreign country or other foreign entities. The Federal Bureau of Investigation (FBI) has identified national security risks that could undermine U.S. companies and steal intellectual property and trade secrets related to sharing genomic data, and recognizes foreign countries and entities as a primary source of those risks.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

HHSAR Clause 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 shall 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 shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

HHSAR Clause 352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

*For this requirement we anticipate only invoices to be applicable to the requirement

Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

• E206 Hardware (Appendix A, Application and Scoping Requirements)

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 4 Hardware (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 5 Software, (Appendix C, Functional Performance Criteria and Technical Requirements)

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the contracting officer.

(End of Clause)

(End of Solicitation)

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