Information Collection

21 CFR 1.280, 1.281- New Prior Notice Submisions Submitted Through The ABI/ACS System. Regulation Sets Forth Information That the Prior Notice Is Required to Contain

IC 6237 under ICR 201312-0910-013 · OMB 0910-0520.

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Information Collection (IC) Details

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IC Title:	21 CFR 1.280, 1.281- New Prior Notice Submisions Submitted Through The ABI/ACS System. Regulation Sets Forth Information That the Prior Notice Is Required to Contain	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1.280, 1.281

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: 15,000	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	9,120,000	735,000	8,385,000
Annual IC Time Burden (Hours)	1,523,040	265,290	1,257,750
Annual IC Cost Burden (Dollars)	0	0	0

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