Cosmetic Labeling Regulations

Forms and Documents

Document Name	Status
SS-0910-0599.rev 04-01-11.doc Supporting Statement A	2011-04-04

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	New
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	New
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	Modified
178493	21 CFR 701.3 Third Party Disclosure: Labeling Requirement For Cosmetic Products to Bear a Declaration of Ingredients in A Descending Order	Modified

ICR Details

OMB Control No: 0910-0599	ICR Reference No: 201104-0910-004
Status: Historical Active	Previous ICR Reference No: 200701-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Cosmetic Labeling Regulations
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/27/2011
	Date Received in OIRA: 04/12/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved
Responses	141,174	0	0
Time Burden (Hours)	141,174	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Under the authority of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, the Food & Drug Administration has the authority to regulate the labeling of cosmetic products. The cosmetic labeling regulations in 21 CFR Part 701 require that cosmetic manufacturers, packers, and distributors label their products with 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.

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Authorizing Statute(s): US Code: 21 USC 374 Name of Law: FFDCA
   US Code: 21 USC 352 Name of Law: FFDCA
   US Code: 21 USC 361 Name of Law: FFDCA
   US Code: 21 USC 362 Name of Law: FFDCA
   US Code: 21 USC 363 Name of Law: FFDCA
   US Code: 21 USC 371 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:
	75 FR 12546	03/16/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 30035	05/28/2010
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
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
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 701.13 Third Party Disclosure- Labeling requirement : Label odf A cosmetic Product Must Declare the Net Quantity Contents of the Product
21 CFR 701.3 Third Party Disclosure: Labeling Requirement For Cosmetic Products to Bear a Declaration of Ingredients in A Descending Order

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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	0	0	0	72,864	68,310
Annual Time Burden (Hours)	141,174	0	0	0	0	141,174
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:

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Annual Cost to Federal Government: $895,565

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 04/12/2011

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