Information Collection

Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications

IC 211858 under ICR 201706-0910-017 · OMB 0910-0771.

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IC Title:

Applicants That Do Not Have a Periodic Safety Update Report Waiver For an Approved Applications

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.80(c)(2) 21 CFR 600.80(c)(2)

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 29

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	67	67
Annual IC Time Burden (Hours)	134	134
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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