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, 64322-64324 [2019-25274]
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Federal Register / Vol. 84, No. 225 / Thursday, November 21, 2019 / Notices
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regarding their request to speak by
November 27, 2019.
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16:41 Nov 20, 2019
Jkt 250001
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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.
Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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
[FR Doc. 2019–25247 Filed 11–20–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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).
SUMMARY:
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,
DATES:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
Web-Based Pilot Survey To Assess
Allergy to Cosmetics in the United
States
OMB Control Number 0910–NEW
E:\FR\FM\21NON1.SGM
21NON1
Federal Register / Vol. 84, No. 225 / Thursday, November 21, 2019 / Notices
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 20minute web-based questionnaire to
collect information from 1,000 Englishspeaking 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
VerDate Sep<11>2014
16:41 Nov 20, 2019
Jkt 250001
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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
64323
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 ‘Fragrancefree?’ ’’.
• 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:
E:\FR\FM\21NON1.SGM
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64324
Federal Register / Vol. 84, No. 225 / Thursday, November 21, 2019 / Notices
• 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/skinallergies/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
Number of
responses per
respondent
Number of
respondents
Study component
Total annual
responses
Pretest invitation ...............................
Pretest ...............................................
Survey Invitation ...............................
Survey ...............................................
200
100
1,667
1,000
1
1
1
1
200
100
1,667
1,000
Total ...........................................
........................
........................
........................
1 There
Average burden per response
0.033
0.333
0.033
0.333
Total hours
(2 minutes) .............................
(20 minutes) ...........................
(2 minutes) .............................
(20 minutes) ...........................
7
33
55
333
...........................................................
428
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
VerDate Sep<11>2014
16:41 Nov 20, 2019
Jkt 250001
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 9990
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
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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,
[email protected].
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
