Survey of Current Manufacturing Practices for the Cosmetics Industry

Forms and Documents

Document Name	Status
Appendix 4 Weighting.docx Supplementary Document	2018-11-26
Appendix 3 60 Day Publication.pdf Supplementary Document	2018-11-26
Supporting Statement B Cosmetic Survey 2019.docx Supporting Statement B	2019-03-11
Supporting Statement A Cosmetic Survey 2019.docx Supporting Statement A	2019-03-11

IC Document Collections

IC ID	Document Title	Status
234079	Survey Other-Mail Survey Instrument	New
234078	Invitation Other-Telephone Script	New

ICR Details

OMB Control No: 0910-0867	ICR Reference No: 201811-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Survey of Current Manufacturing Practices for the Cosmetics Industry
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/11/2019
	Date Received in OIRA: 11/29/2018
Terms of Clearance: Approved with the understanding that data collection will not be used to directly inform FDA enforcement activities or regulatory policy development.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2020	36 Months From Approved
Responses	1,462	0	0
Time Burden (Hours)	636	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration would like to improve its knowledge of the various manufacturing and quality management practices spanning the cosmetics industry. This Information Collection Request (ICR) collects information from cosmetic manufacturers on current manufacturing and quality management practices to estimate costs associated with achieving the industry baselines revealed by the survey. This ICR consists of a one-time survey which aims to provide FDA with information on the state of the industry.

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Authorizing Statute(s): None

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:
	83 FR 30940	07/02/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 58582	11/20/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Invitation
Survey

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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	1,462	0	0	1,462	0	0
Annual Time Burden (Hours)	636	0	0	636	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: This is a new data collection.

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Annual Cost to Federal Government: $328,134

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     Yes

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: 11/29/2018

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