Information Collection

IC recommended in FDA guidance

IC 232749 under ICR 202406-0910-002 · OMB 0910-0686.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0686 can be found here:

Documents and Forms

Document Name Document Type
GFI CDER PNP in Promotional Labeling.pdf Other-Agency Guidance
GFI CDER PNP in Promotional Labeling.pdf Other-Agency Guidance
GFI Quant Info 2023.docx Other-Agency Guidance
GFI Quant Info 2023.docx Other-Agency Guidance
0857 GFI Payor communications q-and-a JUNE 2018.pdf Other-Agency Guidance
0857 GFI Payor communications q-and-a JUNE 2018.pdf Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	IC recommended in FDA guidance	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 201.10(g) and (h) 21 CFR 202.1(b), (c), and (d)

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	GFI CDER PNP in Promotional Labeling.pdf	No		Printable Only
Other-Agency Guidance	GFI Quant Info 2023.docx	Yes	Yes	Fillable Fileable
Other-Agency Guidance	0857 GFI Payor communications q-and-a JUNE 2018.pdf	No		Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,181	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	165,076	9,012	156,064
Annual IC Time Burden (Hours)	587,550	139,353	448,197
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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