Information Collection

21 CFR 1.283 (d);1.285(i);1.285(j) - Prior Notice Requests for Review & Post - Hold Submissions Under 801 (m)(1) of The Federal Food, Drug & Cosmetic Act.

IC 46713 under ICR 201312-0910-013 · OMB 0910-0520.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0520 can be found here:

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Information Collection (IC) Details

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IC Title:	21 CFR 1.283 (d);1.285(i);1.285(j) - Prior Notice Requests for Review & Post - Hold Submissions Under 801 (m)(1) of The Federal Food, Drug & Cosmetic Act.	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1.283(d) 21 CFR 1.285(j) 21 CFR 1.285 ( i )

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: 1	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	1	1
Annual IC Time Burden (Hours)	8	8
Annual IC Cost Burden (Dollars)	0	0

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