RFP FDA SOL 75F40124R00103.docx

FDA - SOL: 75F40124R00103

Consumer Survey Platform and Participant Recruitment

REQUEST FOR PROPOSAL

US Food and Drug Administration Request for Proposal (RFP)

FDA-SOL- 75F40124R00103

Consumer Survey Platform and Participant Recruitment

Date Posted: June 14, 2024 Response Date: July 5, 2024, 3:00PM EST Classification Code: R703 Support- Management: Accounting NAICS Code: 541990 - All Other Professional, Scientific, and Technical Services

SECTION 1 – PRODUCT LIST AND DELIVERY INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Time and Materials Purchase Order in accordance with FAR Part 13.

The solicitation number is FDA-SOL-75F40124R00103. This solicitation is issued as a Request for Proposal (RFP).

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2023-04, effective 02 June 2023. FAR and HHSAR provisions and clauses referenced in this RFP can be found on the following website: https://www.acquisition.gov/browse/index/far

BASIS FOR AWARD AND EVALUATION CRITERIA

The Government will evaluate proposals against the following technical evaluation factors listed below in order of importance. The Government will also evaluate the proposed pricing and discounts. This evaluation will be conducted using the trade-off best value methodology. When combined, the technical factors considered are significantly more important than price, which means the lowest priced technically acceptable quote may not necessarily be awarded the Order. However, the Government will evaluate all price proposals to determine whether the pricing is fair and reasonable. In the event multiple Offerors’ technical proposals are deemed to be of similar merit, price will be the determining factor.

· Factor 1 – Technical Understand and Approach

· Factor 2 – Similar/Relevant Experience

· Factor 3 – Price

Factors 1 and 2 are more important than Factor 3.

Confidence levels will be either “High confidence,” Some Confidence,”, or “Low Confidence” and are defined as follows:

Price will be used as a deciding factor with quotations that are essentially equally technically rated.

All questions in response to this solicitation shall be submitted on or June 28, 2024, 3:00PM, Washington DC Local Time. All questions shall be submitted via email to Sheron Johnson, Contracting Specialist, sheron.johnson@fda.hhs.gov and copied to Ian Weiss, Contracting Officer, ian.weiss@fda.hhs.gov.

All quotes are due no later than July 5, 2024, 3:00PM Washington DC Local Time. Vendors shall submit quotes electronically to Sheron Johnson, sheron.johnson@fda.hhs.gov and copied to Ian Weiss, ian.weiss@fda.hhs.gov.

Volume I - Technical Quote

i. Factor 1 – Technical Understanding and Approach

ii. Factor 2 – Similar/Relevant Experience

iii. Factor 3 – Price

Factor 1: Technical Understanding and Approach

In this section of the technical proposal, the Offeror shall provide a well-organized and easy-to-read Technical Narrative that shall clearly describe their understanding of the requirements; technical approach to performing the work in compliance with applicable standards and guidelines; project responsibilities; communication and coordination, scheduling of all tasks and subtasks, meetings, and deliverables; how the work will be performed, including detailed explanations of the procedures and techniques to be followed and any assumptions upon which the Offeror’s approach is based. The Offeror’s Proposal shall demonstrate the following:

· Ownership and management of an online research panel of at least 100,000 adults in the United States that reflects the U.S. Census sociodemographic distributions, and the methodological approach involved in fulfilling the scope of work to recruit target populations for online surveys, administer surveys, and deliver quality survey data to the government.

· An established process for identifying and recruiting target populations for a survey and associated performance objectives under the contract, particularly for topics related to health, regulated and unregulated drug products such as opioids, drug safety, public health misinformation, or a related, relevant area. The Offeror’s shall demonstrate the ability to conduct surveys at varying scales (i.e., from fewer than 100 respondents to more than 2,500 respondents), and to recruit specialized populations, particularly vulnerable and at-risk participants who are typically difficult to recruit and are not often accessible via survey platforms’ online panel(s) (e.g., those who use certain FDA-approved medications of identified interest for each specific study, who use certain drugs and/or substances non-medically of identified interest, who co-use several drugs of identified interest, and/or who meet specific diagnostic criteria).

· Demonstration that their online research panel has a reasonable degree of demographic diversity of participants’ gender, race, and age. The Offeror’s shall demonstrate the ability to oversample sociodemographic subgroup populations, such as specific age ranges, race, ethnicity, education, income, and/or geographic location to ensure diversity of traditionally harder-to-reach participants.

· Demonstration that if the Offeror needs to recruit outside of their panel members for a specific survey, that they have a plan and ability to recruit for the specific sample of need.

· Demonstrated evidence of the ability to customize recruitment materials for surveys, including the ability to tailor communications to participants, adjust compensation for participants, or related, relevant recruitment strategies.

· Demonstration of the technological functionality of the web-based survey platform, including, but not limited to, question formats (i.e., matrix, rankings, open-ended, etc.), skip pattern logic, sliders, rank order, semantic differentials, hot spot measures, progress bars, collecting metadata (e.g., device type, browser type, length to complete survey) and embedding visual and video media.

· Demonstrated evidence of the ability to perform quality checks of survey data, have fraud detection and checks in place to validate data integrity, and produce a quality data set containing no personally identifiable information.

· Demonstrate evidence of the ability to provide adequate documentation on item coding and dataset codebooks. Demonstrated ability to export a variety of file types, including SPSS, STATA, SAS, and Microsoft Excel.

· A management approach that describes the organization, processes, and application of best practices to performing project management support, including related to the recruitment of eligible panel participants; manage the survey administration through a web-based platform and deliver the completed de-identified clean data.

· Quality control measures that will be used to ensure quality and timeliness of services/deliverables, any issues or risks it anticipates (in particular with respect to timelines, deliverables, and proposing specific amounts of additional time where they expect it may be needed for certain tasks/activities), and a detailed plan to manage or mitigate the anticipated issues or risks (i.e., revised deliverable schedule).

· Justifications for all proposed participant incentives that reflect the true cost(s) of participating for that participant group/population. Incentive justifications should include labor rates approved by the Department of Labor, examples of the same/similar OMB-approved incentives for other FDA projects or those approved for other federal government agencies, and a detailed explanation of why incentives are required for the success of this project specifically. There should be examples of incentives to recruit from specific populations, as these incentives may differ from incentives used to recruit from the general adult population. As noted above, incentives for government-funded research are significantly lower than market rates, which should not be used for their justification.

Evaluation: The Government will evaluate the extent to which the quote:

· Describes the capabilities of its proprietary panel forum and survey platform.

· Describes the demographics and sub-samples available in the panel.

· Provides a technical approach that is technically sound, logical, and effective and clearly explains how it will meet the requirements identified in the performance work statement.

· Demonstrates its understanding of the scope and complexity of the work involved with an effective implementation approach, understanding of Federal business practices and ability to analyze, evaluate, and document those processes.

· Demonstrates identified risks associated with the technical approach and how they will be mitigated.

Factor 2: Similar/Relevant Experience

The Offeror shall submit summaries of three (3) examples of similar, relevant work experience in the past three (3) years, particularly similar research projects conducted for FDA or other federal government public health agencies. Those for non-governmental organizations or commercial entities may also be included.

For each of these summaries, the Offeror shall specifically describe how the similar projects are relevant to the current FDA project described in the SOW, as well as whether those projects were completed or are ongoing.

The Offeror shall adhere to the following guidelines for each of the three (3) summaries:

Evaluation: The FDA will evaluate the extent to which the Offeror’s narrative description of its relevant experience demonstrates it has experience in performing work similar and relevant in technical nature and the project tasks cited. For work to be deemed “similar in nature,” it must involve quantitative research related to health and involving special target populations similar to those described in the SOW, which will be used to demonstrate the Offeror’s capability to fulfill the Government’s requirement.

Volume II - Price Proposal Pricing data showing a breakdown of survey rates by total number of respondents with complete surveys and population type shall be submitted as part of the proposal for verification and evaluation purposes. A total price for all phases of the project must be submitted. In addition, all pricing formulas, links between cells, and the basis of estimates shall be shown to support the Offeror’s derivation of their proposed pricing.

Factor 3: Price

In this section, the Offeror shall submit a Price Schedule that presents the Time and Materials proposed for the completion of each task. The Offeror shall also include a total cumulative price for the entire project.

All other direct costs, to include materials, supplies, etc. shall be supported with estimated units and unit prices.

Specific pricing per survey respondent shall be provided as part of the Offeror’s price proposal. For the participant recruitment panel(s):

· The Offeror shall state in its proposal a description of all costs to conduct Tasks 1-4 for the following sample populations for a 20-minute survey:

· 1000 US adults 18 years and older who have used a prescription opioid for any reason other than for which it was prescribed. (Approximately 3.3% of the US population age 26+)

· 2000 US adults 18 years and older from a general population (i.e., those not required to meet other specific requirements).

· If various cost levels are available (e.g., the per-respondent cost changes based on the overall number of respondents or costs per type of service (i.e., statistical, and administrative costs) or other factors vary), the Offeror shall provide these factors and costs as part of its proposal.

· If cost varies based on screening criteria (e.g., special population(s) as described previously), the Offeror shall provide an explanation of the pricing variability in its proposal.

· If up-front “bulk” payment (akin to a retainer) is available and/or required, Offeror shall provide a detailed explanation of such a mechanism to include its benefits to CDER/OCOMM, minimum starting cost, and handling of any potential unused funds.

No travel costs are associated with this acquisition. Travel is not required as part of this contract.

Evaluation: The Government will evaluate:

· The proposed level of effort for each task area to determine the Offeror’s understanding of the SOW requirements.

· Validate overall pricing calculations.

· The total Evaluated Price will be the total of the base period plus all option periods as presented in the Price Schedule.

The PDF is the version of record. An authorized individual who can contractually bind the Offeror shall sign the cover page of each volume. Digital signatures are acceptable.

· Volume 1 shall be submitted in PDF format.

· Volume 2 shall be submitted in PDF and Microsoft Word formats. The PDF shall be the version signed by the Offeror.

ALL quotes shall include a statement on the cover page of each volume regarding the terms and conditions herein: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

FDA is not responsible for informing a Offeror that their emailed quotation was not received, or received late, or not accepted due to the email containing high-risk file types or being flagged as a security risk.

FDA is not responsible for technical difficulties associated with the transmission of any electronic files to the FDA. Accordingly, Offerors may break down their quotation into smaller sections to stay well below the individual email size limitation. In this case, Offerors shall number multiple emails appropriately to ensure all emails are received (i.e. 1 of 2).

Quote information submitted over the page limitation (see below) will not be evaluated.

General Formatting Instructions Offerors shall use the following page setup parameters:

· Margins – top, bottom, left, right – 1”

· Gutter – 0”

· From edge – header, footer – 0.25”

· Page size – 8.5” width x 11” height

· Exceptions

· Price Schedule

· Tables and Illustrations may use landscape layout (11” width x 8.5” height)

Each paragraph shall be separated by at least one blank line. Responses shall utilize a minimum of 1.15 spacing between lines using no less than a 10-point font size. Offerors are encouraged to use Calibri 11-point font size. Tables and illustrations may use a reduced font size no less than 8-point.

Page Limitation

Volume I is limited to 25. Any pages exceeding the maximum allowable pages will not be evaluated. The following are excluded from the total page count limitation but must be clearly labeled:

· Cover Page

· Table of Contents

· Glossary

· Divider Pages

· Offeror Teaming Arrangements (if applicable)

Volume II has no page limitation.

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 a 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. It is the Offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

1. Background Social scientists in 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. These studies include online surveys and experimental studies about a variety of health topics, such as emerging infectious diseases; regulated and unregulated drug products such as opioids, biosimilars, and medical countermeasures; and drug safety.

2. Purpose/Objective The purpose of this requirement is to obtain access to participant recruitment panel(s) of more than 100,000 US adults that are subsequently linked and administered through a web-based survey platform to enable OCOMM to conduct public health surveys with members of specific target audiences as needed to address CDER and FDA priorities. This may include adult members of the general public as well as those in specialized and/or vulnerable populations, such as those who use regulated drugs non-medically or other substances recreationally. To address emergent issues and research questions of importance to CDER, OCOMM has a need to conduct surveys that can promptly generate quantitative, evidence-based findings that are generalizable across various consumer populations of interest.

3. Contract Tasks/Requirements Independently and not as an agent of the Government, the Contractor shall furnish all necessary equipment/platform(s)/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 of potential participants with an associated survey platform that meets all the criteria listed in the Statement of Work (SOW) for Tasks 1 thru 3.

The Contractor shall perform the following tasks:

Task 1: Participant Recruitment The Contractor shall provide annual access to an online participant panel(s) of more than 100,000 US adults that reflect the U.S. Census sociodemographic distributions and from which OCOMM can recruit a variety of general and specific target populations based on the topic and research questions for each specific survey study. The Contractor shall perform the following:

· Recruit unique samples for each survey study which will range between one to four studies each annual period of performance.

· For each survey study, project the number of eligible participants within the panel who meet the selection screen criteria designed by CDER/OCOMM (e.g., sociodemographics, drugs taken, diagnosed diseases or conditions) within five (5) business days of a study request from CDER/OCOMM. These projections shall include cost estimates, along with projected timelines for study recruitment, completion, and delivery of survey data once notified by FDA PM that OMB has approved the survey study.

· Oversample sociodemographic subgroup populations, such as specific age ranges, race, ethnicity, education, income, and/or geographic location to ensure diversity of traditionally harder-to-reach participants, when requested by CDER/OCOMM.

· Initiate recruitment of participants within 5 business days upon notification by the FDA PM that OMB has approved the study.

· Employ quota sampling to recruit participants with demographic characteristics of target audiences (e.g., lower income and lower literacy consumers, patients, racial/ethnic minorities, prescribers in rural locations, those who speak English as a second language). CDER/OCOMM expects that most survey studies will be approximately 15 to 25 minutes in length.

· Ensure that eligible participant data is private, securely stored and that participants’ personally identifiable information are not shared with CDER/OCOMM. The contractor shall provide consent forms to potential participants that include as many sections and are as long as needed to address FDA Institutional Review Board (IRB) requirements.

Task 2: Survey Administration The Contractor shall facilitate the linkage of recruited participants from the panel(s) to a web-based platform for survey administration. The Contractor shall manage the survey administration of the web-based platform, including programming the survey, monitoring survey responses and in survey completion progress. The Contractor shall perform the following:

· Initiate programming of the web-based survey on the survey platform based on the version submitted to OMB and after approval by FDA IRB and notified by the FDA COR. This programming may have to be updated if required by OMB. FDA expects this programming should be able to be completed within 5 business days. However, if this is not possible, the Contractor shall state that in its proposal, providing the amount of additional time needed.

· Upon completion of programming the online platform, provide a link(s) to the online surveys for CDER/OCOMM to test prior to the survey being fielded. Any unaddressed/additional issues identified by CDER/OCOMM shall be completed as soon as possible or within five (5) business days of receiving comments from CDER/OCOMM. The contractor shall provide documentation that the survey is programmed correctly and the numerical values will be represented correctly within the dataset.

· Conduct a test run of the programming with a small sample of eligible participants (e.g., 50) to test screener questions; question wording; timing; programming elements such as skip patterns, etc.; and any other issues as necessary. Participants in the test run shall have the same characteristics as the main survey samples/subgroups. The Contractor shall analyze these pretest data separately from fielded survey, and for planning purposes, the Offeror shall not count the pretest respondents in the power calculation of the number of respondents to be included in the survey study. However, upon mutual agreement of the Contractor and FDA COR, the pretest data may be incorporated into the main survey data if no significant issues are encountered during the pretest.

· Submit a report of the results of small sample pre-test to CDER/OCOMM as well as an export of the dataset within 3 days of completion of the small sample pretesting of the survey

· Notify the FDA COR that the survey is launched within 3 business days of final resolution of the small sample pretesting of the survey.

· Provide recruitment and survey completion updates every 3 business days that include the number of recruited participants that satisfy the predetermined quotas with CDER/OCOMM.

· 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. Problems or issues should be reported to the FDA Project Manager immediately.

· Deliver a completion table of recruited participants that have satisfied the quota requirements and have completed the survey. The contractor shall close the survey within 1 business day of FDA COR approval of the completion table.

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

Task 3: Survey Data Delivery The Contractor shall code variables and items into datasets and provide CDER/OCOMM with de-identified survey data and supporting documents that describe how the survey data was finalized. The supporting documents shall also provide a breakdown of the overall makeup of the panel(s) and provide survey 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 10 business days of the survey closing.

· Deliver a final completion table of recruited participants that meet quota requirements and completed the survey. The final completion table shall provide a breakdown of recruited study participants at the end of data collection, including prescreened characteristics (e.g., sociodemographics, social media use, and health-relevant attributes) and available data on study participants that screened out within 10 business days of the survey 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. within 10 business days of the survey closing.

· Ensure and verify, that no personally identifiable information (PII) in any form will be available or provided to CDER/OCOMM, or that CDER/OCOMM as receive any physical or electronic consent forms.

· Be responsible for acquiring prior approval from the FDA COR before using or sharing the study data with any sub-contractors or other third parties. CDER/OCOMM will have complete control over and ownership of all resulting data under this SOW.

Task 4: Project Administration The Contractor shall perform all aspects of the SOW according to an agreed upon timeline and maintain communication with FDA throughout the contract. 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 FDA 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 survey 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 the FDA IRB and the Office of Management and Budget (OMB). The Contractor shall prepare materials (e.g., confidentiality, survey record-keeping, recruitment procedures and response rates, confidentiality, and consent procedures) for submission of the OMB package(s) and provided additional documentation as needed to facilitate the OMB and FDA IRB processes. The Contractor shall not make any changes to the protocol as approved by OMB or FDA IRB without consulting with the FDA COR.

5. Deliverables All deliverables shall be provided to the 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 with a cover letter, on the prime contractor’s letterhead, describing the contents.

The FDA shall have exclusive ownership of all deliverables and products developed under this Contract as well as material produced by the Contractor and subcontractors. Deliverables include:

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 time and materials contract.

7. Period of Performance The anticipated period of performance shall be July 15, 2024 to July 14, 2025 with four (4) additional option years. Option years will be exercised at the government's discretion and depending on funding availability.

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

9. Contract Administration OCOMM Contracting Officer’s Representative (COR) Dionne Brown dionne.brown@fda.hhs.gov Phone: 301-348-1848

OCOMM Project ManagerTBD

Contracting Officer Ian Weiss ian.weiss@fda.hhs.gov

Contracting Specialist Sheron Johnson sheron.johnson@fda.hhs.gov

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.

(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 one of 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.

Procurements Requiring Information Security and/or Physical Access Security

1) Baseline Security Requirements

a) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

i) Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

ii) Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

b) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

c) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for…