Cosmetic Labeling and Cosmetic Registration

Forms and Documents

Document	Type	Status	Availability
PRA-0599-SupportingStatement-AsbestosinTalcNPRM 12-20-24 ROCIS.docx	Supporting Statement A	Uploaded 2024-12-20	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
264102	PROPOSED RULE: Talc-containing cosmetic products; recordkeeping requirements		New
262241	Cosmetic recordkeeping requirements, including Adverse Event records		Unchanged
243117	Cosmetic registration and listing	Form and Instruction	Unchanged
178493	Cosmetic disclosure requirements		Unchanged

ICR Details

OMB Control No: 0910-0599	ICR Reference No: 202312-0910-013
Status: Received in OIRA	Previous ICR Reference No: 202309-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
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: 12/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2026
Responses	267,172	253,211
Time Burden (Hours)	475,354	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. FDA is proposing to require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc. We are also proposing corresponding adulteration provisions. Asbestos is a potential contaminant in talc, which is used in certain cosmetic products, and is a known human carcinogen. This proposed rule, if finalized, will help protect users of talc-containing cosmetic products from harmful exposure to asbestos given the potential for contamination of these products. The proposed rule would add 21 CFR part 730 to subchapter G to require manufacturers of a talc-containing cosmetic product to make and keep written records of testing for asbestos to verify that talc-containing cosmetic products comply with requirements of the FD&C Act.

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Authorizing Statute(s): PL: Pub.L. 117 - 328 3501 Name of Law: Modernization of Cosmetics Registration Act of 2022
   PL: Pub.L. 117 - 328 3505 Name of Law: Modernization of Cosmetics Registration Act of 2022
   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
PL: Pub.L. 117 - 382 3505 Name of Law: Modernization of Cosmetics Registration Act of 2022

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI82	Proposed rulemaking

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Cosmetic disclosure requirements
Cosmetic recordkeeping requirements, including Adverse Event records
Cosmetic registration and listing	FDA 5066, FDA 5067	Registration of Cosmetic Product Facility ,   Cosmetic Product Listing
PROPOSED RULE: Talc-containing cosmetic products; recordkeeping requirements

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ICR Summary 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	267,172	253,211	0	13,961	0	0
Annual Time Burden (Hours)	475,354	224,056	0	251,298	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: If finalized, the rulemaking would add 13,961 responses and 251,298 hours annually to the information collection. We are submitting this in accordance with 5 CFR 1320.11. The Office of the Federal Register has provided a scheduled publication date of December 27, 2024.

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Annual Cost to Federal Government: $2,720,010

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: 12/26/2024

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