Cosmetic Labeling and Cosmetic Registration

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 5067 Cosmetic Product Listing	Form and Instruction	Modified	Available
Form FDA 5066 Registration of Cosmetic Product Facility	Form and Instruction	Modified	Available
0599 Cosmetic Product Requirements SSA 2026 REV.docx	Supporting Statement A	Uploaded 2026-10-16	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
262241	Cosmetic recordkeeping requirements for Adverse Events		Modified
243117	Cosmetic registration and listing	Form and Instruction	Modified	Cosmetic Product Listing
243117	Cosmetic registration and listing	Form and Instruction	Modified	Registration of Cosmetic Product Facility
243117	Cosmetic registration and listing	Other-Statutory Authority	Modified
178493	Cosmetic disclosure requirements		Modified

ICR Details

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

table that charts list comparision

	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

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Abstract: This information collection supports implementation of statutory and regulatory provisions that govern cosmetics. Respondents to the collections of information include cosmetic manufacturers and processors.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: FFDCA
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 328 3501 Name of Law: Modernization of Cosmetics Regulation Act of 2022

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 44850	07/17/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 65219	10/14/2026
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Cosmetic disclosure requirements
Cosmetic recordkeeping requirements for Adverse Events
Cosmetic registration and listing	FDA 5066, FDA 5067	Registration of Cosmetic Product Facility ,   Cosmetic Product Listing

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ICR Summary of Burden

table that charts list of burden

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

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/16/2026

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