[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55896-55898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3442]


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.

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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, 
[email protected].

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.

[[Page 55897]]

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


[[Page 55898]]

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.
[FR Doc. 2018-24441 Filed 11-7-18; 8:45 am]
 BILLING CODE 4164-01-P