Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States

Forms and Documents

Document Name	Status
Supporting Statement Part A Allergy to Cosmetics 2019.docx Supporting Statement A	2019-12-06
Supporting Statement Part B Allergy to Cosmetics 2019.docx Supporting Statement B	2019-12-06

IC Document Collections

IC ID	Document Title	Status
238691	Survey Other-Survey Instrument	New
238690	Survey Invitation Other-Email Invitation and Reminder	New
238689	Pretest Other-Survey Instrument	New
238688	Pretest Invitation Other-Email Invitation and Reminder	New

ICR Details

OMB Control No: 0910-0881	ICR Reference No: 201911-0910-016
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States
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 without change	Conclusion Date: 01/06/2020
	Date Received in OIRA: 12/06/2019
Terms of Clearance: Any changes as a result of the pretest will need to be submitted and approved prior to fielding the main survey.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2021	36 Months From Approved
Responses	2,967	0	0
Time Burden (Hours)	428	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR is for a one-time data collection that is part of a broader research study. The broader research study includes these consumer surveys, OMB-approved consumer focus group studies, and cosmetics industry and local regulator interviews (of which there will be 9 or less interviews.) The overall objective of the study is to collect information from consumers to better understand the impact of allergens on cosmetic users. Study participants will be asked to answer questions via a Web-based survey regarding their use of cosmetic products, whether they have experienced an adverse event caused by allergens in their cosmetics, and actions, if any, taken to avoid the allergens. FDA will use the study results to help inform consideration for possible modifications to FDA’s policy on cosmetic product safety.

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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 55896	11/08/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 64322	11/21/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Pretest Invitation
Pretest
Survey 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	2,967	0	0	2,967	0	0
Annual Time Burden (Hours)	428	0	0	428	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: $440,263

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: 12/06/2019

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