Voluntary Cosmetic Registration Program

Forms and Documents

Document Name	Status
Form FDA 2511 Reporting - 21 CFR Part 710 - Voluntary Registration of Cosmetics Product Establishment Form and Instruction	Modified
Form 2514 Reporting 21CFR 720.6 Voluntary Registration ( Notices of Discontinuance) Form and Instruction	New
Form 2512a Reporting 21 CFR 720.6 Voluntary Registration ( Amendments) Form and Instruction	New
Form 2512 a Reporting - 21 CFR- 720.1 - 720.4 - Voluntary Registration ( New submissions Form and Instruction	New
SS-0910-0027 ( #2).doc Supporting Statement A	2011-02-28

IC Document Collections

IC ID	Document Title	Status
5681	Reporting - 21 CFR Part 710 - Voluntary Registration of Cosmetics Product Establishment Form and Instruction	Modified
196428	Reporting 21 CFR 720.8 Voluntary Registration ( Request for Confidentiality)	New
196427	Reporting 21CFR 720.6 Voluntary Registration ( Notices of Discontinuance) Form and Instruction	New
196426	Reporting 21 CFR 720.6 Voluntary Registration ( Amendments) Form and Instruction	New
196425	Reporting - 21 CFR- 720.1 - 720.4 - Voluntary Registration ( New submissions Form and Instruction	New

ICR Details

OMB Control No: 0910-0027	ICR Reference No: 201102-0910-012
Status: Historical Active	Previous ICR Reference No: 200711-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Voluntary Cosmetic Registration Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/29/2011
	Date Received in OIRA: 02/28/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved	04/30/2011
Responses	7,525	0	135
Time Burden (Hours)	1,827	0	27
Cost Burden (Dollars)	0	0	0

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Abstract: The "Voluntary Cosmetic Registration Program" provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing and packaging) of establishment that participate in this program. FDA uses the registration to estimate the size of the cosmetic industry and for conducting on site establishment inspections.

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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:
	75 FR 78257	12/15/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 10607	02/25/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Reporting - 21 CFR Part 710 - Voluntary Registration of Cosmetics Product Establishment	FDA 2511	Registration of Cosmetic Product Establishment
Reporting - 21 CFR- 720.1 - 720.4 - Voluntary Registration ( New submissions	2512 a, 2512	Cosmetic Product Ingredient ,   Cosmetic Product Ingredient Statement
Reporting 21 CFR 720.6 Voluntary Registration ( Amendments)	2512a, 2512	Cosmetic Product Ingredient ,   Cosmetic Product Ingredient statement
Reporting 21CFR 720.6 Voluntary Registration ( Notices of Discontinuance)	2514	Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation
Reporting 21 CFR 720.8 Voluntary Registration ( Request for Confidentiality)

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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	7,525	135	0	7,390	0	0
Annual Time Burden (Hours)	1,827	27	0	1,800	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: There was a program change increase due to agency discretion. The change involved the consolidation of two ICRs. Please refer to item # 15 of the supporting statement for further details.

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Annual Cost to Federal Government: $425,186

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: 02/28/2011

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