Information Collection

End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women - WAVE i

IC 241273 under ICR 201911-0910-015 · OMB 0910-0497.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0497 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Appendix 1 - Participant Screeners - Wave 1.docx	Other-Screener
Appendix 2 - Recruitment Email Wave 1.docx	Other-Recruitman Email
Appendix 3 - Informed Consent Wave 1.docx	Other-Consent Forms
Appendix 4 PLLR Moderators guide Wave 1.docx	Other-Moderator Guide
Appendix 5 Labeling examples with infographic mockup.docx	Other-Labeling Examples with Infogra
0497 OMB Approval Memo PLLR - Wave 1 2020.docx OMB Approval Memo	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women - WAVE i

Agency IC Tracking Number:

CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Screener	Appendix 1 - Participant Screeners - Wave 1.docx	Yes	Yes	Fillable Fileable
Other-Recruitman Email	Appendix 2 - Recruitment Email Wave 1.docx	Yes	No	Printable Only
Other-Consent Forms	Appendix 3 - Informed Consent Wave 1.docx	Yes	Yes	Fillable Fileable Signable
Other-Moderator Guide	Appendix 4 PLLR Moderators guide Wave 1.docx	Yes	No	Printable Only
Other-Labeling Examples with Infographics	Appendix 5 Labeling examples with infographic mockup.docx	Yes	No	Printable Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 360

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	360	360
Annual IC Time Burden (Hours)	143	143
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Approval Memo	0497 OMB Approval Memo PLLR - Wave 1 2020.docx	04/08/2020

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.