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

Notice of Intent to Sole Source

FDA-75F401-24-R-00119

Programming and Panel Service for An Experimental Study

Synopsis – Notice of Intent to Sole Source

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This synopsis is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13 for the following, under simplified acquisition procedures. The Government intends to negotiate and solicit with only one source:

Qualtrics, Office of Research & Innovation 333 W. River Park Dr., Provo, UT., 84604.

The NAICS code is 541990 - All Other Professional, Scientific, and Technical Services.

Social scientists at the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Communications (OCOMM), is conducting a social and behavioral science research study to develop evidence-based knowledge and implementable recommendations. 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.

The objective of this acquisition 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.

This order shall be within scope, issued within ordering period, and be within the maximum total dollar value of approximately $35,00.00 for a one-year period for the base period beginning July 1, 2024, to June 30, 2025.

Programming and Panel Service for An Experimental Study

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

Programming and Panel Service for An Experimental Study

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

The proposed contract is for the supplies and services for which the Government intends to solicit and negotiate with one source, American Society for Quality, under authority of FAR 6.302-1 (statutory authority 10 U.S.C. 2304(c)(1)), Only One Responsible Source.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. However, a determination by the Government not to compete this proposed action based upon responses to this draft agreement is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.

All responses are due by 12:00pm ET on Friday, June 28, 2024, due via email to the Primary Point of Contact: Ryan Alexander by email at: ryan.alexander@fda.hhs.gov.

Attachments:

Attachment A: Statement of Work mailto:ryan.alexander@fda.hhs.gov

The NAICS code is 541990 - All Other Professional, Scientific, and Technical Services.