2018-24441. Agency Information Collection Activities; Proposed Collection; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a pilot study entitled “Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.”

DATES:

Submit either electronic or written comments on the collection of information by January 7, 2019.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 7, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2018-N-3442 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [e-mail].

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States; OMB Control Number 0910—New

I. Background

In the past 40 years, the cosmetics industry, as well as consumer behaviors and expectations related to cosmetics, have evolved. Technological and scientific advances have been made in cosmetics production, manufacturing, marketing, and usage, while consumer access to information about cosmetic products and ingredients has expanded, because of the internet and social media influences. Most notably, multiple cosmetic products such as lotions, perfume, body wash, hand wash, shampoo, deodorant, hair spray, baby wipes, nail polish, etc. are used daily by nearly everyone in the United States, including infants, children, adults, geriatric populations, healthy people, and individuals with medical conditions.

Evidence indicates that the prevalence of allergies in the U.S. population is increasing (Ref. 1). However, no publicly available data has been collected on the prevalence of adverse reactions to cosmetic products since 1975 (Ref. 2). FDA proposes a pilot study to collect the data needed for a current and detailed understanding of the impact of allergens on consumer use of cosmetics. In addition to updating our knowledge about cosmetics, this new information collection is consistent with FDA's efforts to improve public awareness of adverse events associated with FDA-regulated products. In December 2016, FDA decided to make public the adverse event data in the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS). CAERS (and its imminent successor the CFSAN Adverse Events Management System or CAEMS) provides the public with transparent access to all food and cosmetic related adverse events reported to FDA. However, the information that we have collected and which will be collected through CAERS is an underestimate of adverse events to cosmetics in the United States, as not every adverse event is reported by consumers through CAERS because some consumers are not aware of CAERS or some choose not to report.

To obtain additional relevant data, FDA proposes to conduct a pilot study. “Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.” The objective of the current effort is to collect information needed for a more current understanding of the prevalence of adverse reactions to cosmetics. FDA proposes to conduct an exploratory consumer web-based survey to collect data on consumer use of cosmetic products, the frequency of adverse events believed to be caused by allergens in cosmetics, consumer awareness of the problem, and actions (if any) taken to avoid the allergens.

The proposed survey will use a 20-minute web-based questionnaire to collect information from 1,000 English-speaking adult members of a probability-based web-enabled research panel maintained by a contractor. Selected panel members will be sent an email invitation to participate in the survey. After clicking on the link in the email invitation, panelists will be directed to the online instrument. On the first screen, panelists will provide disclosure information which includes informed consent and be asked if they would like to proceed with the survey. Consenting respondents will be prompted to complete the survey. After OMB approval of this collection and prior to the full-scale survey, a pretest will be conducted with 100 respondents randomly selected from the panel.

The web-based panel is designed to be representative of the U.S. adult population. This representation is achieved through address-based sampling where every U.S. adult with an address (including those who do not have a landline phone number) has an equal probability of being selected for participation.

This pilot study is part of the Agency's continuing effort to understand the impact of allergens on cosmetics.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

Study component	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Pretest invitation	200	1	200	0.033 (2 minutes)	7
Pretest	100	1	100	0.333 (20 minutes)	33
Survey invitation	1,667	1	1,667	0.033 (2 minutes)	55
Survey	1,000	1	1,000	0.333 (20 minutes)	333
Total					428
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

The following references are on display with the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these are not available electronically at https://www.regulations.gov as these references are copyright protected.

1. Peiser, M., T. Traulau, J. Heidler, et al., “Allergic Contact Dermatitis: Epidemiology, Molecular Mechanisms, In Vitro Methods and Regulatory Aspects. Current Knowledge Assembled at an International Workshop at BfR, Germany.” Cellular and Molecular Life Sciences, 69:763-781, 2012.

2. Westat, Inc. “An Investigation of Consumers' Perceptions of Adverse Reactions to Cosmetic Products.” Final report submitted to U.S. Department of Health, Education, and Welfare, Food and Drug Administration. June 1975.

Dated: November 5, 2018.

Leslie Kux,

Associate Commissioner for Policy.