Voluntary Registration of Cosmetics Product Establishment

Forms and Documents

Document Name	Status
Form FDA 2511 Voluntary Registration of Cosmetics Product Establishment Form and Instruction	Modified
0027 21 CFR 710 5.doc Supplementary Document	2007-11-16
0027 21 CFR 710 4.doc Supplementary Document	2007-11-16
0027 Sections 601 and 602 of the FFDCA.doc Supplementary Document	2007-11-16
0027 21 CFR 710 1.doc Supplementary Document	2007-11-16
0027 ss 11-15-2007.doc Supporting Statement A	2007-11-16

IC Document Collections

IC ID	Document Title	Status
5681	Voluntary Registration of Cosmetics Product Establishment Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0027	ICR Reference No: 200711-0910-008
Status: Historical Active	Previous ICR Reference No: 200408-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Voluntary Registration of Cosmetics Product Establishment
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: 02/11/2008
	Date Received in OIRA: 11/21/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	02/29/2008
Responses	135	0	15
Time Burden (Hours)	27	0	6
Cost Burden (Dollars)	0	0	0

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Abstract: The voluntary registration of cosmetic product establishments 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:
	72 FR 39626	07/19/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 65041	11/19/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Voluntary Registration of Cosmetics Product Establishment	FDA 2511	Registration of Cosmetic Product Establishment

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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	135	15	0	0	120	0
Annual Time Burden (Hours)	27	6	0	0	21	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: $3,550

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: 11/21/2007

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