PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
(CFSAN) Front-of-Package Nutrition Labeling Focus Groups 2
New
150
147
0
Other-Product mock-ups
Other-Screener
Other-Moderator guide
Other-
Other-Consent form
Advancing COVID-19 Health Equity Research
New
144
230
0
Other-AIM 1 focus group flyer
Other-AIM 1 screener
Other-AIM 1 focus group moderator guide
Other-AIM 2 community leaders focus group flyer
Other-AIM 2 community leaders screener
Other-AIM 2 community leader focus group moderator guide
Other-AIM 2 healthcare professionals focus group flyer
Other-AIM 2 healthcare professionals focus group screener
Other-AIM 2 healthcare professionals focus group moderator guide
Attitudes and Perceptions of People Living with Hepatitis B on Participation in Clinical Trials
New
47
71
0
Other-Consent form
Other-Eligibility Screening Questions
Other-Moderator's Guide
Other-Recruitment flyer African 1
Other-Recruitment flyer African 2
Other-Recruitment flyer Asian 1
Other-Recruitment flyer Asian 2
Other-IRB
Birth Control Options (Digital and Print Communication Focus Groups) OC
New
72
108
0
Other-Screener Guide in English
Other-Screener Guide in Spanish
Other-Survey Instrument in English
Other-Survey Instrument in Spanish
Other-Consent Form in English
Other-Consent Form in Spanish
Other-Confirmation Letter in English
Other-Confirmation Letter in Spanish
Other-Birth Control Chart in English
Other-Birth Control Chart in Spanish
Bridging Gaps: Recruiting African and Asian American Participants in Clinical Trials and Creating Culturally Competent Messages (OC)
New
100
150
0
Other-Screener
Other-Moderator Guide
Other-Invitation
Other-Consent
Other-Recruitment Flyer
Other-Advertisement
Bridging Gaps: Recruiting Asian and Black/African American Participants for COVID-19 Clinical Trials and Creating Culturally Competent Messages
New
100
150
0
Other-Informed consent
Other-Messages for testing
Other-Moderator guide
Co-creation of Digital Tools to Enhance Young Adult Minority Participation in COVID-19 Trials
New
352
352
0
Other-Screener
Other-Informed Consent
Other-Focus Group Guide
Other-Focus Group Debrief
Consumer Knowledge & Behavior Regarding Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed–Wave IV: Focus Groups Exploring Consumer Reactions to Educational Materials
New
384
224
0
Other-Screener
Other-Recruitment flyer
Other-Informed Consent
Other-Moderator Guide
Other-Environmental Impacts Infographic
Other-Genome Editing Fact Sheet
Other-GMOs 101 Fact Sheet
Other-Humanitarian Impacts Infographic
Dietary Supplement Education Focus Groups (Formative Research)
New
640
173
0
Other-Screener Older Adults
Other-Screener for Younger Adults
Other-Moderator Guide for Older Adults
Other-Moderator Guide for Young Adults
Other-Older Adult Fact Sheet
Other-Education Info for Young Adult Population
Other-Confirmation Email to Participants
Other-Consent Form
Dietary Supplement Education Focus Groups – Phase 2 (Formative Research) (CFSAN)
New
960
310
0
Other-Screener
Other-Consent Form
Other-Moderator Guide - Older Adults
Other-Moderator Guide - Young Adults
Other-Education Materials - Older Adults
Other-Education Materials - Young Adults
Other-Confirmation and Reminder Letters
End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women – WAVE II (CDER)
New
360
120
0
Other-Screener
Other-Recruitment Email
Other-Consent Forms
Other-Moderator Guide
Other-Labeling Examples with Infographic Mockup
Fish Focus Groups with those who are Pregnant, Breastfeeding, and Parents of Young Children
New
192
148
0
Other-Screener - Appendix A
Other-Moderator Guide (pregnant and breastfeeding) - Appendix B
Other-Moderator Guide (parents and caregivers)- Appendix C
Other-Consent Form - Appendix D
Other-Materials Referenced in Moderator Guides - Appendix E
Focus Groups Exploring Consumer Reactions to Nutrition Statements on Plant-Based Milk Alternatives (CFSAN)
New
256
213
0
Other-Screener
Other-Consent Form
Other-Moderator Guide
Other-Mock up Almond Milk
Other-Mock up Coconut Milk
Other-Mock up Oat Milk
Focus Groups on Consumer Perceptions of Genetically Engineered Salmon (CFSAN)
New
360
173
0
Other-Screener
Other-Recruitment Flyer
Other-Informed Consent
Other-Moderator's Guide
Other-GE Salmon Fact Sheet
Other-GE Salmon and the Environment
Focus Groups with Nutrition Educators (CFSAN)
New
600
326
0
Other-Screener
Other-Moderators Guide
Other-Nutrition Facts Label
Other-Consent Form
Other-Confirmation Email
Food Safety Focus Groups on Toxic Elements in Baby Food
New
288
173
0
Other-Participant screener
Other-Recruitment flyer
Other-Informed consent
Other-Moderator's guide
Other-Infographic toxic baby food
Other-Parents magazine article
Other-Harvard med school article
Front-of -Pack Focus Groups
New
120
118
0
Other-Graphic: FOP schemes to test
Other-FOP screener
Other-FOP Moderator's guide
Other-Graphic: FOP product mock-ups
Other-FOP email for qualifying participant
Other-FOP participant consent
Health Care Provider Testing Associated with the Pregnancy and Lactation Labeling Rule to Improve Health Communications Related to Lactation (CDER)
New
600
238
0
Other-Screener
Other-Recruitment Email
Other-Informed Consent
Other-Moderator Guide
Other-Labeling Examples and Infographic Mockup
Hispanic, Black and Pacific Islander Perspectives on COVID-19 Outreach Strategies and Patient Centered Outcomes (HeAR US))
New
165
248
0
Other-Focus Group Questionnaire (ENGLISH)
Other-Focus Group Questionnaire (SPANISH)
Other-Focus Group Moderator Interview Guide (ENGLISH)
Other-Focus Group Moderator Interview Guide (SPANISH)
Other-Recruitment Script Phone (ENGLISH)
Other-Recruitment Script Phone (SPANISH)
Other-Recruitment Script Email (ENGLISH)
Other-Recruitment Script Email (SPANISH)
Other-Informed Consent (ENGLISH)
Other-Informed Consent (SPANISH)
Other-Study Flyer (ENGLISH)
Other-Study Flyer (SPANISH)
Other-FDA graphics for use with Moderator Guide (ENGLISH)
Other-FDA graphics for use with Moderator Guide (SPANISH)
Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in COVID-19 Clinical Trials
New
60
120
0
Other-Recruitment email
Other-Demographic screener
Other-Focus group guide
Other-IRB information sheet
Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in COVID-19 Clinical Trials
New
1
0
0
Other-Recruitment email
Other-Screener
Other-Moderator guide
Other-IRB information sheet
MUltimorbidity and Medications: the unheard perspective of older Under-Represented Racial and Ethnic Minority Adults
New
250
169
0
Other-Invitation letter
Other-Invitation letter (Traditional Chinese)
Other-Invitation letter (Simplified Chinese)
Other-Information sheet
Other-Information sheet (Traditional Chinese)
Other-Information sheet (Simplified Chinese)
Other-Phone Recruitment and Screening
Other-Phone Recruitment and Screening (Traditional Chinese)
Other-Phone Recruitment and Screening (Simplified Chinese)
Other-Recruitment Flyer
Other-Recruitment Flyer (Traditional Chinese)
Other-Recruitment Flyer (Simplified Chinese)
Other-Newsletter Advertisement
Other-Newsletter Advertisement (Traditional Chinese)
Other-Newsletter Advertisement (Simplified Chinese)
Other-Newspaper Recruitment Advertisement
Other-Newspaper Recruitment Advertisement (Traditional Chinese)
Other-Newspaper Recruitment Advertisement (Simplified Chinese)
Other-Verbal Presentation Script Recruitment
Other-Verbal Presentation Script Recruitment (Traditional Chinese)
Other-Verbal Presentation Script Recruitment (Simplified Chinese)
Other-Moderator Guide
Other-Moderator Guide (Traditional Chinese)
Other-Moderator Guide (Simplified Chinese)
Nutrition Facts Label Education and Outreach Initiative – Qualitative Evaluation of Educational Materials (CFSAN)
New
240
104
0
Other-Screener
Other-Consent Form
Other-Moderator Guide
Other-Overview Fact Sheet
Other-Educational Video
Other-Stimuli - Visual Images of Cereal Food Products
Other-Stimuli - Visual Images of Entree Products
Online Focus Groups with Low-Income Primary Caregivers on Childhood Obesity
New
600
295
0
Other-Recruitment email
Other-Screener
Other-Moderator Guide
Other-Consent Form
Provider Decision-Making about Pain Management and Opioid Prescribing Focus Group
New
80
43
0
Other-Email invitation
Other-Verbal consent
Other-Focus group guide
Safety Alert and Outbreak Advisory Templates Testing Focus Group (CFSAN)
New
300
133
0
Other-Message Templates
Other-Screener
Other-Moderator Guide
Skin Lightening Products: Understanding Consumer Perspectives and Effective Educational Messages (OC)
New
60
90
0
Other-Screener
Other-Moderator Guide
Other-Consent Form
Teratogenic Risk Impact and Mitigation (TRIM): An Evidence-based Decision Framework
New
30
90
0
Other-TRIM Invitation E-mail
Other-TRIM Focus Group Questions
Teratogenic Risk Impact and Mitigation (TRIM): An Evidence-based Decision Framework: Follow-Up
New
30
60
0
Other-Focus group questionnaire
The Shades of Beauty: Understanding African American and Asian American Women's Perception and Use of Skin Lightening Products and the Potential Health Risks (OC)
New
220
160
0
Other-Attachment A: Recruitment Flyer
Other-Attachment B: Prescreening Questionnaire
Other-Attachment C: Consent Form
Other-Attachment D: Moderator Guide
Total Burden Actually Used for Information Collections Under Currently Approved ICR:
7761
4936
0
Total Burden Currently Requested for Information Collections Under Currently Approved ICR:
0
0
0
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