Cosmetic Product Voluntary Reporting Program

Forms and Documents

Document Name	Status
Form FDA2512 Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720 Form and Instruction	Modified
0030 comment ANA 9-29-08.doc Supplementary Document	2008-12-12
0030 ss 12-12-08.doc Supporting Statement A	2008-12-12

IC Document Collections

IC ID	Document Title	Status
5685	Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720 Form and Instruction	Modified
187596	Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720	New
187595	Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720	New
187594	Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720	New

ICR Details

OMB Control No: 0910-0030	ICR Reference No: 200812-0910-005
Status: Historical Active	Previous ICR Reference No: 200510-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Cosmetic Product Voluntary Reporting Program
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: 02/10/2009
	Date Received in OIRA: 12/18/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2012	36 Months From Approved	02/28/2009
Responses	7,390	0	1,503
Time Burden (Hours)	1,800	0	742
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) has the responsibility to regulate cosmetics. To assist the agency in carrying out its responsibiity, FDA requests under 21 CFR Part 720 that firms that manufacture, pack, or distribute cosmetics file with the agency an ingredient statement for each of their products. FDA uses the information for evaluation of cosmetic products currently on the market.

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Authorizing Statute(s): US Code: 21 USC 361 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:
	73 FR 53877	09/17/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 76360	12/16/2008
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720	FDA2512, FDA2512a, FDA2514	Cosmetic Product Ingredient Statement ,   Cosmetic Product Ingredient Statement ,   Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation
Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720
Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720
Cosmetic Product Voluntary Reporting Program - 21 CFR Part 720

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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	7,390	1,503	0	0	5,887	0
Annual Time Burden (Hours)	1,800	742	0	0	1,058	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:

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Annual Cost to Federal Government: $215,896

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: 12/18/2008

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