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 FDA 2512 Reporting (21CFR 720.6) Voluntary Registration (Notices of Discontinuance) Form and Instruction	Modified
Form FDA 2512 Reporting (21 CFR 720.6) Voluntary Registration (Amendments) Form and Instruction	Modified
Form FDA 2512 Reporting (21 CFR- 720.1-720.4) Voluntary Registration (New submissions) Form and Instruction	Modified
0027 ss 8-18-2017.docx Supporting Statement A	2017-08-18

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)	Modified
196427	Reporting (21CFR 720.6) Voluntary Registration (Notices of Discontinuance) Form and Instruction	Modified
196426	Reporting (21 CFR 720.6) Voluntary Registration (Amendments) Form and Instruction	Modified
196425	Reporting (21 CFR- 720.1-720.4) Voluntary Registration (New submissions) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0027	ICR Reference No: 201707-0910-006
Status: Historical Active	Previous ICR Reference No: 201407-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Voluntary Cosmetic Registration 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: 09/22/2017
	Date Received in OIRA: 08/22/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	12,187	0	7,827
Time Burden (Hours)	3,233	0	1,987
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports agency regulations regarding voluntary registration for cosmetic firms and FDA's Voluntary Cosmetic Registration Program (VCRP). The VCRP provides FDA with information about the locations, business trade names, and types of activity (manufacturing and packaging) of participating establishments. FDA uses the information to support implementation of the cosmetic regulatory provisions under the Federal Food, Drug, and Cosmetic Act.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	82 FR 24977	05/31/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 39795	08/22/2017
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 Establishments
Reporting (21 CFR- 720.1-720.4) Voluntary Registration (New submissions)	FDA 2512a, FDA 2512	Cosmetic Product Ingredient Statement ,   Cosmetic Product Ingredient Statement
Reporting (21 CFR 720.6) Voluntary Registration (Amendments)	FDA 2512a, FDA 2512	Cosmetic Product Ingredient Statement ,   Cosmetic Product Ingredient Statement
Reporting (21CFR 720.6) Voluntary Registration (Notices of Discontinuance)	FDA 2512, FDA 2512a	Cosmetic Product Ingredient Statement ,   Cosmetic Product Ingredient Statement
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	12,187	7,827	0	0	4,360	0
Annual Time Burden (Hours)	3,233	1,987	0	0	1,246	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: This information collection reflects agency adjustments. The total annual number of responses reflects an overall increase from 7,827 to 12,187 responses (an increase of 4,360 responses) and a total annual hour burden increase from 1,987 to 3,233 hours (an increase of 1,246 hours). We attribute the increase to industry growth, specifically an increase in the number of respondents. Specific fluctuations to the individual information collections are summarized in Q15.

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Annual Cost to Federal Government: $452,593

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 08/22/2017

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