View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0599
ICR Reference No:
202312-0910-013
Status:
Historical Inactive
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
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
02/27/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/26/2024
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2026
36 Months From Approved
12/31/2026
Responses
253,211
0
253,211
Time Burden (Hours)
224,056
0
224,056
Cost Burden (Dollars)
0
0
0
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.
Authorizing Statute(s):
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
PL:
Pub.L. 117 - 328 3501
Name of Law: Modernization of Cosmetics Registration Act of 2022
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AI82
Proposed rulemaking
89 FR 105490
12/27/2024
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
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
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.
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
Agency Contact:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov
Common Form ICR:
No
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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