Information Collection

eSubmission: Promotional Labeling and Advertising Materials for Human Prescription Drugs

IC 236032 under ICR 201905-0910-003 · OMB 0910-0870.

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Information Collection (IC) Details

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IC Title:

eSubmission: Promotional Labeling and Advertising Materials for Human Prescription Drugs

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314 (subpart H) 21 CFR 601 (subpart E) 21 CFR 201, 202, 203 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

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Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

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: 277

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 New Statute
Annual Number of Responses for this IC	1,552	1,552
Annual IC Time Burden (Hours)	55,278	55,278
Annual IC Cost Burden (Dollars)	4,698,630	4,698,630

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