[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64322-64324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by 
December 23, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Web-Based Pilot Survey to Assess Allergy to Cosmetics in the 
United States.'' Also include the FDA docket number in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 64323]]

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 that 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.
    In the Federal Register of November 8, 2018 (83 FR 55896), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received 82 comments. Several addressed 
issues not related to the PRA, while others were PRA related. Of the 
comments received, several described the commenter's reactions to 
cosmetics, and while important, these comments do not address the PRA 
and will not be discussed here.
    Several comments discussed the necessity and practical utility of 
the collection. This survey represents an ongoing effort by FDA to 
better understand cosmetic ingredients that may be potential allergens, 
and this survey constitutes the third contract over the last few years 
to address allergens in cosmetics. A few comments thought the proposed 
information collected by the survey does not appear to be necessary for 
proper performance of FDA's functions because of the small size of the 
number of respondents but several comments described how the collection 
was important and needed to be conducted so that we can better 
understand consumer's perception of skincare and beauty products. 
Several comments supported the survey because they agreed with the 
intention and methods being proposed and because of the topic's growing 
interest and concern to consumers. We appreciate these comments 
supporting our undertaking this survey of reactions to allergens in 
cosmetics.
    This survey is part of an ongoing effort by FDA to better 
understand cosmetic ingredients that may be potential allergens, and 
this constitutes the third contract over the last few years to address 
allergens in cosmetics. The first contract in 2015-2016 conducted a 
comprehensive literature review of 26 fragrances that the European 
Union has identified as allergens. The second contract in 2016-2017 
expanded the inquiry to other cosmetic ingredients, and it tested the 
criteria that were developed from the earlier contract on the 26 
fragrance allergens. We appreciate comments of support for undertaking 
this survey of reactions to allergens in cosmetics.
    A few comments had concerns about the study population of the 
survey and its size. With respect to the statistical power of the 
study, FDA notes that the relevant questions are binary (e.g., do you 
have an allergy or not, has it been medically confirmed or not, etc.), 
which allows precise estimates for the fraction of adults reporting an 
allergy and the fraction having had the allergy medically confirmed 
with a relatively smaller sample. Based on the power calculations 
performed for this study, 1,000 completed surveys will allow detection 
of differences of 6.6 percentage points in the estimates of allergy or 
not with 95% confidence, 80% power, and a Design Effect of 1.1. With 
respect to the study group composition, the sampling frame for the 
survey is the GfK Custom Research, Inc. (GfK) online consumer panel, 
KnowledgePanel (KP), which is a probability-based consumer panel that 
is designed to be representative of the U.S. adult population. Because 
the purpose of this survey is limited to obtaining nationally 
representative estimates of the U.S. population that have a medically 
diagnosed allergy and to obtain descriptive statistics on cosmetics use 
by U.S. citizens and other questions, suggested oversampling of 
specific groups (e.g. women, new cosmetics users and so on) would 
result in unequal weighting effects that would reduce our precision for 
the national estimates.
    Several comments noted that the survey might be improved by 
including additional questions, rephrasing existing questions to 
improve accuracy, avoid potential confusion, improve the flow of the 
survey, and ultimately reduce time to complete the survey. Thanks to 
these comments, FDA has modified the survey in the following manner:
     In the introduction to the survey, we have added text that 
describes how the collection of this data will benefit the participant, 
and that data will only be presented in aggregate form to maintain 
confidentiality. We also added a definition of allergy and text that 
describes how the collection will benefit the participant, and only be 
presented in aggregate format to maintain confidentiality.
     After Question (Q) 7, we added the question, ``How often 
do you buy cosmetic products labeled as `Fragrance-free?' ''.
     In Q14 we added additional reactions that people might 
suffer, such as burning eyes or eyelid rash.
     In Qs 1, 11, 14 and 15, to products numbers 39-41 and 
45,''excluding sunscreens'' has been added to prevent reporting of 
allergies to over the counter drug regulated products.
     In Q18, we added clarifying definitions for mobility, 
self-care, etc.
     In Q27, ``fragrance mix ingredients'' was changed to 
``fragrance mix allergens''.
     Qs 23-27 were moved to immediately follow Q13 for a more 
logical flow.
    In addition to these changes, we have carefully considered and 
decided not to make revisions based on the following suggestions:

[[Page 64324]]

     Suggestion to add feminine products to product list: We 
recognize that the product list given in the survey is fairly 
aggregated. However, adding more products (or splitting existing 
products) may make the survey longer and more difficult to complete. A 
primary limitation to the length of the survey is that the survey 
should be short-enough so that it can be completed in 20 minutes or 
less. The desired sample size would be more difficult to achieve by 
lengthening the survey.
     Suggestion to omit questions regarding expiration dates: 
Although cosmetic products are not required to have an expiration date 
printed on them (as pointed out by commenters), we have determined that 
some products do include expiration dates. The purpose of these 
questions is to determine whether this information, when available, is 
used by the consumer.
     Suggestions to use another list of allergens (Q26): 
Commenters are correct that other lists of allergens are available 
(such as the American Contact Dermatitis Society (ACDS)), in addition 
to the one provided in our survey. However, it is important to note 
that the ACDS is only one of many patch tests that could be used and is 
not actually the standard patch test in the United States (TRUE test is 
the only patch test approved for use by FDA). FDA chose the list 
included in the survey based on an independent review of sensitization 
data for various cosmetics ingredients and found these ingredients to 
be of most interest.
     Suggestion to clarify the terms ``product'', ``cosmetic'', 
and ``cosmetic product'': We conducted several cognitive interviews and 
the use of these terms did not seem to create any problems for the 
participants.
     Symptoms and clinical signs of skin allergies: For 
question 14, the following reactions were listed: Burning, Blistering, 
Hair Loss, Itchiness, Scabs or Scales, Skin Rash or Redness, and 
Swelling. These reactions are in agreement with the American College of 
Allergy, Asthma, & Immunology list of the symptoms for cosmetic 
dermatitis: Red, irritated skin, itching, swelling, bumps or blisters, 
hot or tender skin (https://acaai.org/allergies/types/skin-allergies/contact-dermatitis). Further, research suggests that allergic contact 
dermatitis of the scalp can be a cause of hair loss (https://jamanetwork.com/journals/jamadermatology/fullarticle/478194).
     Linking allergic reaction to a single product or 
ingredient: We agree that it may be difficult to isolate an allergic 
reaction to a single product or causative ingredient. Still, some 
consumers are able to accurately pinpoint the ingredient. Asking first 
whether a person has an allergy (Q12) and then following it up with 
questions about whether it has been medically confirmed (Q23) should 
allow one to adequately estimate the fraction of adults that believe 
they have an allergy (based on data from Q12) and the fraction that 
have actually confirmed this allergy (based on data from Q23). This 
should provide a more complete picture of the incidence of allergies to 
cosmetics that is currently lacking.
     Suggestions to include additional questions: Allergic 
reactions to cosmetics worn by other individuals, caused by other 
products (e.g., laundry detergents), health conditions beyond 
allergies, and economic costs, are beyond the scope of this survey. A 
primary limitation is that the survey needs to be short-enough so that 
it can be completed in 20 minutes or less and making the survey longer 
would likely make it more difficult to achieve the desired sample size.
    Finally, a few comments indicated that the estimated time to 
complete the survey is too low and that a reduction in survey length 
could positively improve survey results. These comments also believe 
the survey will reflect inadequacies and access which will impact 
respondent input and FDA discovery. As discussed earlier, the survey 
will be conducted using the GfK online consumer panel, KP. GfK 
routinely conducts surveys of this length using their panel and we are 
confident we will achieve 1,000 completes.
    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
----------------------------------------------------------------------------------------------------------------
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.

II. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852 and 
are available for viewing by interested persons between 9 a.m. and 4 
p.m., Monday through Friday; they are also available electronically at 
https://www.regulations.gov. References without asterisks are not on 
public display at https://www.regulations.gov because they have 
copyright restriction. Some may be available at the website address, if 
listed. References without asterisks are available for viewing only at 
the Dockets Management Staff. FDA has verified the website addresses, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

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 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25274 Filed 11-20-19; 8:45 am]
 BILLING CODE 4164-01-P


