Cosmetic Labeling Regulations

Forms and Documents

Document Name	Status
SS-0910-0599.doc Supporting Statement A	2010-05-25

IC Document Collections

IC ID	Document Title	Status
193079	21 CFR 701.13 - Third Party Disclosure- Labeling Requirement : Label of a Cosmetic Product Must Declare the Net Quanity of Contents of the Product	New
193078	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 Descending Order	Modified

ICR Details

OMB Control No: 0910-0599	ICR Reference No: 201005-0910-016
Status: Historical Inactive	Previous ICR Reference No: 200701-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
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OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 11/08/2010
	Date Received in OIRA: 05/28/2010
Terms of Clearance: In accordance with 5 CFR 1320, OMB is withdrawing this collection at the request of the agency.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	36 Months From Approved	11/30/2010
Responses	68,310	0	68,310
Time Burden (Hours)	141,174	0	141,174
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Food Drug and Cosmetic act (the act) and the Fair Packaging and Labeling act (the FPLA) require that cosmetic manufacturers, packers, and distributors disclose information about themselves or their products on labels or labeling of their products. Sections 201,502,601,602,603,701 and 704 of the act(21 U.S.C. 321,352,361,362,363,371,and 374) and sections 4and 5 of the FPLA ( 15 U.S.C. 1453 and 1454) provide authority to the FDA to regulate labeling of cosmetic products.. Failure to comply with the requirements for cosmetic labeling may render a cosmetic adulterated under section 601 of the act or misbranded under section 602 of thwe act.

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Authorizing Statute(s): US Code: 21 USC 371 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 352 Name of Law: FFDCA
   US Code: 21 USC 363 Name of Law: FFDCA
   US Code: 21 USC 374 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 701.3 -Third Party Disclosure: Labeling Requirement For Cosmetic Products to Bear a Declaration of Ingredients in Descending Order
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
21 CFR 701.13 - Third Party Disclosure- Labeling Requirement : Label of a Cosmetic Product Must Declare the Net Quanity of Contents of the Product

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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: 05/28/2010

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