Information Collection

Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4)

IC 202639 under ICR 201810-0910-003 · OMB 0910-0719.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0719 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.2(a) and 601.60-601.65

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: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2	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	2	2
Annual IC Time Burden (Hours)	1,720	1,720
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.