IC recommended in FDA guidance

Prescription Drug Advertisements; Presentation of Advertisements in Television and Radio - Final Rule

⚠️ Notice: This information collection may be referencing outdated material.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 Quant Info 2023.docx Other-Agency Guidance

Information Collection (IC) Details

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

Is this a Common Form? No		IC Status: Unchanged

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	Form No.	Form Name	Instrument File	URL	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

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	Previously Approved
Annual Number of Responses for this IC	156,064	156,064
Annual IC Time Burden (Hours)	448,197	448,197
Annual IC Cost Burden (Dollars)	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.