Information Collection

IC recommended in FDA guidance

IC 232749 under ICR 202501-0910-004 · OMB 0910-0686.

Documents and Forms

Documents and forms in this information collection
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IC Title:

IC recommended in FDA guidance

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 202.1(b), (c), and (d) 21 CFR 201.10(g) and (h)

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: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 747

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 Agency Discretion	Previously Approved
Annual Number of Responses for this IC	129,231	-35,845	165,076
Annual IC Time Burden (Hours)	56,249	-531,301	587,550
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

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

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