Cosmetic Labeling Regulations

Forms and Documents

Document	Type	Status	Availability
CLRCoverMemotoOMB-Oct2006.doc	Supplementary Document	Uploaded 2006-12-05	Available
Cosmetic Labeling Attachment D 60day pubd.pdf	Supplementary Document	Uploaded 2006-12-05	Repair queued
Cosmetic Labeling Attachment C 21CFR701.pdf	Supplementary Document	Uploaded 2006-12-05	Available
Cosmetic Labeling Attachment B Fair Packaging and Labeling Act.doc	Supplementary Document	Uploaded 2006-12-05	Available
Cosmetic Labeling Attachment A FFDCA.doc	Supplementary Document	Uploaded 2006-12-05	Available
Cosmetic Labeling ss 2006.doc	Supporting Statement A	Uploaded 2006-12-18	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
178494	Cosmetic Labeling Regulations		New
178493	Cosmetic Labeling Regulations		New

ICR Details

OMB Control No: 0910-0599	ICR Reference No: 200701-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Cosmetic Labeling Regulations
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/04/2007
	Date Received in OIRA: 01/26/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	36 Months From Approved
Responses	68,310	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 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
   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:
	71 FR 2947	01/18/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 70411	12/04/2006
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Cosmetic Labeling Regulations
Cosmetic Labeling Regulations

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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	68,310	0	0	68,310	0	0
Annual Time Burden (Hours)	141,174	0	0	141,174	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: See item 15 in the supporting statement.

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Annual Cost to Federal Government: $748

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 12/18/2006

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