Information Collection

CDER COVID-19 Critical Care Drug Monitoring Survey Portal

IC 259174 under ICR 202008-0910-019 · OMB 0910-0500.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0500 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Email Invitation final.docx	Other-Email invitation
COVID-19 Critical Care Drug Monitoring Survey Portal Reference Guide.pdf	Other-Reference guide
Survey Questions final.docx	Other-Survey
0500 OMB Memo COVID19 Critical Care 2023 FINAL.docx OMB Memo / Abbreviated Supporting Statement	IC Document
FDA PHE PRA Waiver Notice COVID-19 Surveys.pdf PHE waiver	IC Document

IC Title:

CDER COVID-19 Critical Care Drug Monitoring Survey Portal

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-Email invitation	Email Invitation final.docx	Yes	No	Printable Only
Other-Reference guide	COVID-19 Critical Care Drug Monitoring Survey Portal Reference Guide.pdf	Yes	No	Printable Only
Other-Survey	Survey Questions final.docx	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 300

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	15,600	15,600
Annual IC Time Burden (Hours)	3,900	3,900
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Memo / Abbreviated Supporting Statement	0500 OMB Memo COVID19 Critical Care 2023 FINAL.docx	03/16/2023
PHE waiver	FDA PHE PRA Waiver Notice COVID-19 Surveys.pdf	03/16/2023

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