Cosmetic Labeling and Voluntary Cosmetic Registration

Forms and Documents

Document Name	Status
Form FDA 2511 Voluntary Cosmetic Registration Form and Instruction	New
0599 Cosmetics including 0027 SSA 2020 REV.pdf Supporting Statement A	2020-08-12

IC Document Collections

IC ID	Document Title	Status
243117	Voluntary Cosmetic Registration Form and Instruction	New
178493	Cosmetic Labeling Regulations	Modified

ICR Details

OMB Control No: 0910-0599	ICR Reference No: 202008-0910-008
Status: Active	Previous ICR Reference No: 201707-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Cosmetic Labeling and Voluntary Cosmetic Registration
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/14/2020
	Date Received in OIRA: 08/12/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2023	36 Months From Approved	09/30/2020
Responses	152,429	0	141,174
Time Burden (Hours)	144,218	0	141,174
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports Food and Drug Administration (FDA, the agency, us or we) regulations pertaining to cosmetic labeling and voluntary cosmetic registration. These regulations are codified in FDA regulations at 21 CFR parts 701, 710, and 720.

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

Citations for New Statutory Requirements: None

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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:
	85 FR 18993	04/03/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 44539	07/23/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Cosmetic Labeling Regulations
Voluntary Cosmetic Registration	FDA 2512, FDA 2512a, FDA 2511	Registration of Cosmetic Product Establishment ,   Cosmetic Product Ingredient Statement (Labeling information) ,   Cosmetic Product Ingredient Statement (Continuation - Ingredients)

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ICR Summary of Burden

	Total Approved	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	152,429	141,174	0	0	11,255	0
Annual Time Burden (Hours)	144,218	141,174	0	0	3,044	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: The burden for this information collection reflects an overall increase of 3,044 burden hours and a corresponding increase of 11,255 burden responses due to a revision to consolidate two similar collections of information. We have consolidated the information collection provisions from OMB control number 0910-0027 into this collection. Once this collection has been approved by OMB, we will request for OMB control no. 0910-0027 to be discontinued.

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Annual Cost to Federal Government: $1,522,746

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.     No

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: 08/12/2020

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