0910-0360 Summaries of completed Gen ICs

United States Food and Drug Administration

Customer/Partner Service Surveys

OMB Control No. 0910-0360

SUMMARY OF GEN ICs

Title of Collection	Participants	Use of Information	Hours Used
(CDRH) Advisory Committee Satisfaction Survey	1,200 advisory committee meeting participants and stakeholders both internal and external, including the medical device industry, academia, patient groups, health professionals, consumers and anyone that interacts with CDRH.	Gathered satisfaction levels of meeting participants/stakeholders to: (1) determine stakeholder satisfaction ratings; (2) identify and help monitor trends around specific areas of satisfaction or dissatisfaction; and (3) identify areas for process improvement and improve them.	100
(CDER) Interviews with Applicants and Other External Stakeholders Regarding Use of Patient Experience Data in Regulatory Decision Making	130 medical product developers, patients, patient advocates, caregivers, and academic researchers participated in group interviews.	Helped inform FDA of stakeholders’ perceptions of how FDA is using patient experience data in regulatory decision making. More information can be found at: https://www.fda.gov/drugs/development-approval-process-drugs/assessment-use-patient-experience-data-regulatory-decision-making	195
(OC) FDA Food Industry Survey for Coronavirus Disease 2019 (COVID-19) Related Materials	15,000 FDA-registered food facilities in areas that are expected to or are experiencing a rise in COVID-19 cases.	Helped improve FDA resources for regulated food facilities that may be experiencing COVID-19 related impacts on operations as well as to enhance FDA’s outreach, improve engagement with stakeholders, and better disseminate information to food facilities during the COVID-19 pandemic. FDA submitted two gen ICs under this title. We began administering the initial survey on November 16, 2020; however, collection methods were limited against the implementation of public health safety practices. As a result, the survey was administered by telephone. We resubmitted the gen IC seeking to re-administer the survey to continue data collection.	2,500
(CDRH) 2021 Feedback #1 on Virtual Course Titled “IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes” (CDRH)	95 attendees of virtual course; medical device industry, universities, research organizations, and investment organizations.	Evaluated the quality of the March 9, 2021 virtual course on digital health technologies and patient outcomes titled “IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes” to properly plan future public engagement efforts around this topic; to gauge the level of satisfaction with the current course, as well as elicit feedback and recommendations on how to improve future courses to meet the needs of all attendees.	16
(CDRH) Feedback on Patient-Generated Health Data (PGHD) Workshop	300—Attendees of PGHD workshop; medical device industry, patient organizations, research organizations, health care professionals, and payors	Evaluated the quality of the May 4, 2021 public meeting on Patient-Generated Health Data, so that we can properly plan future public engagement efforts around this topic; to gauge the level of satisfaction with the current meeting, as well as elicit feedback and recommendations on how to improve future meetings to meet the needs of all attendees.	50
(ORA) State Program Satisfaction Survey for Remote Assessments	45 Manufactured Food Regulatory Program Standards (MFRPS) and Animal Feed Regulatory Program Standards (AFRPS) program coordinators.	Evaluated an alternative tool/process to assist in the oversight/assessment of MFRPS and AFRPS enrolled states as a continuation of and in addition to on-site assessments.	3.75
(CFSAN) FDA and the U.S. Department of Agriculture/FSA Produce Safety Presentation Series for Produce Stakeholders in Latin America Follow-up Survey	300 FDA stakeholders and importers of foreign produce.	Results from this follow-up customer satisfaction survey regarding imported fresh produce and foodborne illness were used to help FDA improve their communication, outreach, and training of stakeholders, particularly in the areas of these presentations will help inform future FDA communications, outreach, and training for stakeholders. Feedback on the presentation will also help improve future presentations.	25
(CTP) Scholastic Vaping Education Materials Survey	600-800 middle school and 600-800 high school teachers who meet the criteria. 3,000 were screened and 1,600 of those educators completed the survey.	Helped improve FDA’s The Real Cost of Vaping tobacco education and prevention materials to better serve the resource needs of middle and high school teachers across the United States.	766
(CDRH) Sponsor and Payor Feedback for the Early Payor Feedback Program (EPFP)	22 participants in the EPFP-- Medical device manufacturers (sponsors) and public and private organizations that pay for health care (payors).	Helped refine and demonstrate the impact of the program to stakeholders. More information on our Early Payor Feedback program can be found at: https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2.	15
(CDER) U.S. President's Emergency Plan for AIDS Relief (PEPFAR) Database Customer Survey to Industry and External Stakeholders	75 respondents from FHI360, Global Fund, Bill & Melinda Gates Foundation, Clinton Health Access Initiative, Ethiopian Pharmaceuticals Supply Agency, Kenya Medical Supply Agency, Pan American Health, Organization, United Nations Children's Fund, United Nations Development Programme, Unitaid, South African Department of Health.	Informed the continued development of our PEPFAR Database and subsequent improvements for stakeholders.	14
(CDRH) Customer Satisfaction Survey	3,000 CDRH stakeholders both inside FDA/CDRH and external, including the medical device industry, academia, patient groups, health professionals, consumers and anyone that interacts with CDRH.	Gathered satisfaction levels associated with CDRH’s products and services from stakeholders to: (1) determine customer satisfaction ratings associated with CDRH products and services; (2) identify and help monitor trends around specific product or service areas of satisfaction or dissatisfaction; (3) identify areas for process improvement and improve them; and (4) identify areas where additional training and or resources may be necessary to provide excellent customer service.	250
(CDRH) 2022 Feedback #2 on Virtual Course Titled “IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes”	95 attendees of virtual course; medical device industry, universities, research organizations, and investment organizations.	Evaluated the quality of the January 26, 2022, virtual course on digital health technologies and patient outcomes titled “IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes” to properly plan future public engagement efforts around this topic; to gauge the level of satisfaction with the current course, as well as elicit feedback and recommendations on how to improve future courses to meet the needs of all attendees.	16
(ORA) Level 2 Training Course Evaluation	400 students required to attend FDA-sponsored courses from our state, local, tribal, and territorial partners.	Evaluated how well students are learning and using skills from FDA-sponsored course instruction.	34
(ORA) OTED Post-Course Satisfaction Evaluation	2600 students required to attend FDA-sponsored courses from our state, local, tribal, and territorial partners.	Evaluated student satisfaction with various aspects of FDA-sponsored course instruction, such as with the materials provided, the platform used for training and the pace of the course overall.	303
(CDER) Post-Event Survey for a Continuing Education (CE) Webinar on Pregnancy and Lactation Medication Information for the Healthcare Provider	500 respondents who registered for this webinar	Evaluated the quality of the course content, effectiveness of the speakers (faculty), and educational impact.	58
(CFSAN) Customer Satisfaction Surveys for FDA Food Safety Culture Webinar Series	5,000 respondents who registered for and attended the FDA Food Safety Culture Webinar. The respondents are from industry, government, academia, the media, and the general public.	Helped determine whether these webinars are informative to participants, whether any changes will be necessary, and if there are interests in a particular topic within Food Safety Culture which should be considered for future webinars in the series.	167
(ORA) Ombudsman Program External Stakeholder Satisfaction Survey	350 external stakeholders include consumers, third-party advocates, manufacturers, other federal and state government, trade associations, clinical professionals, importers, import industry and other stakeholders.	Informed future external stakeholder engagement strategy and to sustain and improve the quality, responsiveness, and accessibility of the FDA ORA Ombudsman Program. The data will not be used for the purposes of making policy or regulatory decisions.
(CFSAN) FDA Customer Satisfaction Survey for Self-Paced Online Teacher Training	160 teachers who will learn how to conduct school laboratory techniques related to microbiology so they will know how to teach students the underlying science principles of food safety.	Helped to improve the next year’s training, tailor our communication to inform teachers about next year’s training, and to make improvements in the communication and training based on responses and feedback shared by teachers on the content of this year’s course.	40
(ORA) Independent Course Delivery (ICD) Survey Not yet completed.	50 respondents from state, local, tribal, and territorial partners who applied for or attended OTED’s ICD Train the Trainer program.	Proposed use: This information will provide the Office of Training, Education and Development (OTED) a better understanding of how we might improve our Independent Course Delivery (ICD) program.	50 requested
(ORA) Train the Trainer Not yet completed.	190 respondents from state, local, tribal, and territorial partners who attended OTED’s ICD TTT courses.	Proposed use: This information will provide OTED a better understanding of how we might improve our Independent Course Delivery (ICD) Train the Trainer (TTT) courses.	22 requested
(ORA) Learning Transfer Evaluation Not yet completed.	1,000 respondents are regulators from our state, local, tribal, and territorial partners that are required to attend FDA-sponsored courses.	Proposed use: This information will provide OTED a better understanding of how well students are learning and using skills from FDA-sponsored course instruction.	80 requested

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