Cosmetic Labeling Regulations

Forms and Documents

Document Name	Status
0599 ss Part A 8-16-2017.docx Supporting Statement A	2017-08-16

IC Document Collections

IC ID	Document Title	Status
197278	21 CFR 701.13 Third Party Disclosure- Labeling requirement : Label odf A cosmetic Product Must Declare the Net Quantity Contents of the Product	Removed
197277	21 CFR 701.12 Third Party Disclosure - Labeling Requirement - Label of a Cosmetic Product Must Specify The Name and Place of Business of the Manufacturer , Packer or Distributor	Removed
178494	21 CFR 701.11 - Third Party Disclosure: Labeling Requirement , Principal Display Panel of Cosmetic Product Must Bear a Statement of The Identity of The Product	Removed
178493	Cosmetic Labeling Regulations	Modified

ICR Details

OMB Control No: 0910-0599	ICR Reference No: 201707-0910-007
Status: Historical Active	Previous ICR Reference No: 201406-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Cosmetic Labeling Regulations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/20/2017
	Date Received in OIRA: 08/17/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	141,174	0	141,174
Time Burden (Hours)	141,174	0	141,174
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection requires that cosmetic labeling include a list of ingredients in descending order of predominance; a statement of the identity of the product; the establishment's name and place of business; and the net quantity of contents. Respondents to the information collection are manufacturers, packers, and distributors of cosmetic products.

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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:
	82 FR 23576	05/23/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 37100	08/08/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
21 CFR 701.13 Third Party Disclosure- Labeling requirement : Label odf A cosmetic Product Must Declare the Net Quantity Contents of the Product
Cosmetic Labeling Regulations
21 CFR 701.11 - Third Party Disclosure: Labeling Requirement , Principal Display Panel of Cosmetic Product Must Bear a Statement of The Identity of The Product
21 CFR 701.12 Third Party Disclosure - Labeling Requirement - Label of a Cosmetic Product Must Specify The Name and Place of Business of the Manufacturer , Packer or Distributor

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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	141,174	141,174	0	0	0	0
Annual Time Burden (Hours)	141,174	141,174	0	0	0	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: This information collection remains unchanged. At the same time, we have revised the IC list appearing at omb.report by consolidating the previously itemized regulatory provisions. We believe this will assist the reader by more easily identifying the summary of cumulative fluctuations for the collection. At the same time, readers may still view estimated burden associated with individual provisions by referring to the agency’s 60-day and 30-day notices and in the burden tables found in Q.12: Estimates of Annualized Burden Hours and Costs of this supporting statement.

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Annual Cost to Federal Government: $953,472

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? Uncollected

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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: 08/17/2017

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