View Information Collection Request (ICR) Package

View ICR - Agency Submission

OMB Control No: 0910-0599	ICR Reference No: 202610-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202309-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Cosmetic Labeling and Cosmetic Registration
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 10/16/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2026
Responses	1,093,868	253,211
Time Burden (Hours)	1,043,947	224,056
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	1,093,868	253,211	840,657
Annual Time Burden (Hours)	1,043,947	224,056	819,891
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Cumulatively, the information collection reflects an increase of 819,891 burden hours and 840,657 responses annually. We have characterized this request as a revision because we have added instructional information for Forms FDA 5066 and 5067 to include tutorials. The increase in burden and respondents reflects continued implementation of program requirements mandated by the FD&C Act for cosmetic products as amended by the Consolidated Appropriations Act of 2023. Since the previous renewal of this information collection, more facilities have registered and undertaken applicable requirements.

Annual Cost to Federal Government: $3,005,595

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.