0497 Summaries of Focus Groups 2017

Summaries of Focus Groups Conducted by the Food and Drug Administration

0910-0497

FDA Center	Title of Focus Group	Use of Information
CDER	Spousal Influence on Consumer Understanding of and Response to DTC Prescription Drug Advertisements (Formative Research and Stimuli Testing)	Interviews examined spousal influence on consumer understanding of and response to DTC prescription drug advertising. This information collection request involved two qualitative phases of research that will be used to inform part of a larger quantitative project on the same topic, to be submitted for approval at a later time.
CFSAN	Food Safety Focus Groups	The information collected from this survey tracked consumers’ knowledge and attitudes about food safety, and why they perform certain behaviors. It also provided justification for adding additional questions to future Food Safety Surveys to help FDA to determine the prevalence for potential respondents performing safe food behaviors.
OC	Consumer Fact Sheet and Website Outreach Card on Medication Use during Pregnancy	The information collected was used to refine the messaging and layout FDA OWH print and electronic resources on medication use during pregnancy and pregnancy exposure registries.
OC	FDA Unified Consumer Communications Program	The results from the focus group were used to select a single concept to move forward with in the development of the new unified visual identity for the FDA.
OC	Focus Group Testing of Consumer Messaging on Participation of Diverse Women in Clinical Trials	The information collected was used to refine the messaging and layout of the FDA OWH print and electronic resources on women in clinical trials.
CFSAN	Menu Labeling Campaign	The information collected from this survey helped develop consumer messages about calorie information on menus to assist consumers who dine out in making food selections and manage calorie consumption.
OC	Logistics Evaluation for Implementation of Ultraviolet Decontamination and Reuse of Filtering Face Piece Respirators in Hospitals	The findings from these focus groups, individual interviews, and survey were used to explore the scope of any barriers to implementing decontamination and reuse of FFRs, and to identify key issues for further study.
CDRH	Upper Limb Prosthetic User Needs and Preferences Study: Focus Group Protocol	The findings from this survey were used to prepare for a study on the needs and preferences of upper limb amputees, specifically to: 1) Identify user needs, and common language used to articulate these needs, through a series of focus groups on activities affected by amputation and prosthesis use, and experiences with prosthesis use; and 2) Assessed preferences for emerging upper limb prosthesis technologies that interface with the peripheral nervous system, which will likely offer improved benefits, with increased risks. Findings will result in the development of a larger benefit-risk tradeoff survey.
CFSAN	Food Safety Focus Groups	The information collected from this survey assisted FDA in tracking consumers’ knowledge and attitudes about food safety and explored why consumers performed certain behaviors regarding food safety. It also helped FDA develop additional questions for possible inclusion in future Food Safety Surveys to determine the prevalence for performing certain safe food behaviors.
CFSAN	Listeria in Pasteurized Soft Cheese Focus Groups	FDA used the information from this survey to explore consumers’ understanding of the benefits and risks of pasteurized soft cheese consumption and to inform its informational content and approach with regard to Listeria and pasteurized soft cheese.
CFSAN	Focus Groups of Salon Professionals and Consumers to Determine Reactions to Labeling Statements on Cosmetic Labels	The information collected is being used to develop warning labels for products containing formaldehyde and formaldehyde-releasing agents to inform users about proper use and safety precautions when using these products.
CFSAN	Menu Labeling Campaign Focus Groups	The information collected is being used to further develop consumer messages regarding the use of calorie information for consumers making food selections and managing calorie consumption while dining out.
CFSAN	Healthy Claims Focus Groups	A CFSAN focus group study is collecting qualitative information to explore consumer’s interpretation of the term “healthy” on food labels. The purpose is to explore participants’ attitudes, beliefs, motivations, and reported behaviors related to foods that use a “healthy” claim. The study’s results will assist internal discussions about consumers’ understanding and use of the term “healthy” on the food label and examine consumers’ current understanding of “healthy” and the potential for misunderstanding if regulatory requirements change.
CDRH	Feasibility Study Using Hospitals Participating in the American Hernia Society Quality Collaborative (AHSQC) to Assess Patient Reported Outcomes after Ventral Hernia Repair with Mesh: Focus group protocol	The findings from the focus groups were used to further enhance the content of the existing PRO tool for regulatory use, determine the utility of the data captured by the PRO tool as real world evidence (RWE) for device surveillance and regulatory decision making, and contribute to the quality improvement process for stakeholders participating in the AHSQC.