Information Collection

Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use - Form FDA 356h

IC 5933 under ICR 200002-0910-002 · OMB 0910-0338.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0338 can be found here:

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Information Collection (IC) Details

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IC Title:	Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use - Form FDA 356h	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

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

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 826	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 5 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	21,252	9,115	12,137
Annual IC Time Burden (Hours)	602,856	117,376	485,480
Annual IC Cost Burden (Dollars)	0	0	0

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