Voluntary Cosmetic Registration Program

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 2511 Reporting (21 CFR Part 710) Voluntary Registration of Cosmetics Product Establishment	Form and Instruction	Unchanged	Available
Form 2514 Reporting (21CFR 720.6) Voluntary Registration (Notices of Discontinuance)	Form and Instruction	Unchanged	Available
Form 2512a Reporting (21 CFR 720.6) Voluntary Registration (Amendments)	Form and Instruction	Unchanged	Available
Form 2512 a Reporting (21 CFR- 720.1-720.4) Voluntary Registration (New submissions)	Form and Instruction	Unchanged	Available
0027 SS Part A 2014 Voluntary Cosmetic Registration.doc	Supporting Statement A	Uploaded 2014-07-07	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0910-0027	ICR Reference No: 201407-0910-005
Status: Historical Active	Previous ICR Reference No: 201404-0910-019
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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: 08/27/2014
	Date Received in OIRA: 07/08/2014
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	7,827	0	7,525
Time Burden (Hours)	1,987	0	1,827
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 participating establishments. 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:
	79 FR 7196	02/06/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 23981	04/29/2014
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

table that charts list 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	7,827	7,525	0	302	0	0
Annual Time Burden (Hours)	1,987	1,827	0	160	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is an approval request in which both the total annual number of responses and the total annual hour burden are being increased. The total annual number of responses reflects an overall increase from 7,525 to 7,827 responses (an increase of 302) and a total annual hour burden increase from 1,827 to 1,987 hours (an increase of 160). The overall increase was due to industry growth and is discussed more fully at Q15. of the supporting statement Part A.

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Annual Cost to Federal Government: $429,253

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: 07/08/2014

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