Information Collection

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule

IC 188335 under ICR 200901-0910-004 · OMB 0910-0572.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0572 can be found here:

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IC Title:	Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Final Rule	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 201.56

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 42	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 75 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	336	336
Annual IC Time Burden (Hours)	9,072	9,072
Annual IC Cost Burden (Dollars)	0	0

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