Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations, 23576-23578 [2017-10532]
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23576
Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section or activity
CDER:
202.1(e)(6); waiver request ..............................
202.1(j)(1); submission of advertisement .........
202.1(j)(1)(iii); assuring that adverse information be publicized ..........................................
202.1(j)(4); voluntary submission of ad to FDA
CBER:
202.1(e)(6); waiver request ..............................
202.1(j)(1); submission of advertisement .........
202.1(j)(1)(iii); assuring that adverse information be publicized ..........................................
202.1(j)(4); voluntary submission of ad to FDA
CVM:
202.1(e)(6); waiver request ..............................
202.1(j)(1); submission of advertisement .........
202.1(j)(1)(iii); assuring that adverse information be publicized ..........................................
202.1(j)(4); voluntary submission of ad to FDA
Total ...........................................................
1 There
Total annual
responses
Hours per
response
Total hours
1
1
1
1
1
1
12
2
12
2
1
71
1
6.97
1
495
12
20
12
9,900
0
0
0
0
0
0
12
2
0
0
0
9
0
8
0
72
12
20
0
1,440
0
0
0
0
0
0
12
2
0
0
0
5
0
1
0
5
12
20
0
100
....................................
........................
........................
........................
11,466
are no capital costs or operating and maintenance costs associated with this collection.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
CDER:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................
202.1(j)(1); info. included re. fatalities or serious damage ..................................................
CBER:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................
202.1(j)(1); info. included re. fatalities or serious damage ..................................................
CVM:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................
202.1(j)(1); info. included re. fatalities or serious damage ..................................................
Total ...........................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section or activity
Hours per
response
Total hours
394
105.3
41,494
400
16,597,600
1
1
1
40
40
47
63.4
2,984
400
1,193,600
0
0
0
40
0
25
36
900
400
360,000
0
0
0
40
0
....................................
........................
........................
........................
18,151,240
are no capital costs or operating and maintenance costs associated with this collection.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–10533 Filed 5–22–17; 8:45 am]
[Docket No. FDA–2017–N–1848]
BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with NOTICES
Total annual
responses
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Cosmetic Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
21:15 May 22, 2017
Jkt 241001
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection provisions in FDA’s cosmetic
labeling regulations.
DATES: Submit either electronic or
written comments on the collection of
information by July 24, 2017.
ADDRESSES: You may submit comments
as follows:
E:\FR\FM\23MYN1.SGM
23MYN1
Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2017–N–1848 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Cosmetic
Labeling Regulations.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management 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
VerDate Sep<11>2014
21:15 May 22, 2017
Jkt 241001
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 Division of Dockets
Management. 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/201523389.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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, FDA PRA Staff, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
7726, PRAStaff@fda.hhs.gov.
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,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
PO 00000
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Fmt 4703
Sfmt 4703
23577
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.
Cosmetic Labeling Regulations—21 CFR
Part 701; OMB Control Number 0910–
0599—Extension
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) and the Fair
Packaging and Labeling Act (the FPLA)
require that cosmetic manufacturers,
packers, and distributors disclose
information about themselves or their
products on the labels or labeling of
their products. Sections 201, 301, 502,
601, 602, 603, 701, and 704 of the FD&C
Act (21 U.S.C. 321, 352, 361, 362, 363,
371, and 374) and sections 4 and 5 of
the FPLA (15 U.S.C. 1453 and 1454)
provide authority to FDA to regulate the
labeling of cosmetic products. Failure to
comply with the requirements for
cosmetic labeling may render a cosmetic
adulterated under section 601 of the
FD&C Act or misbranded under section
602 of the FD&C Act.
FDA’s cosmetic labeling regulations
are published in part 701 (21 CFR part
701). Four of the cosmetic labeling
regulations have information collection
provisions. Section 701.3 requires the
label of a cosmetic product to bear a
declaration of the ingredients in
descending order of predominance.
Section 701.11 requires the principal
display panel of a cosmetic product to
bear a statement of the identity of the
product. Section 701.12 requires the
label of a cosmetic product to specify
the name and place of business of the
manufacturer, packer, or distributor.
Section 701.13 requires the label of a
cosmetic product to declare the net
quantity of contents of the product.
FDA estimates the annual burden of
this collection of information as follows:
E:\FR\FM\23MYN1.SGM
23MYN1
23578
Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per respondent
Number of
respondents
21 CFR section/activity
Average
burden per
disclosure
Total annual
disclosures
Total hours
701.3—Ingredients in order of predominance ...................
701.11—Statement of identity ...........................................
701.12—Name and place of business ..............................
701.13—Net quantity of contents ......................................
1,518
1,518
1,518
1,518
21
24
24
24
31,878
36,432
36,432
36,432
1
1
1
1
31,878
36,432
36,432
36,432
Total ............................................................................
........................
..........................
........................
........................
141,174
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The hour burden is the additional or
incremental time that establishments
need to design and print labeling that
includes the following required
elements: A declaration of ingredients
in decreasing order of predominance, a
statement of the identity of the product,
a specification of the name and place of
business of the establishment, and a
declaration of the net quantity of
contents. These requirements increase
the time establishments need to design
labels because they increase the number
of label elements that establishments
must take into account when designing
labels. These requirements do not
generate any recurring burden per label
because establishments must already
print and affix labels to cosmetic
products as part of normal business
practices.
The estimated annual third party
disclosure is based on data available to
the Agency, our knowledge of and
experience with cosmetic labeling, and
our communications with industry. We
estimate there are 1,518 cosmetic
product establishments in the United
States. We calculate label design costs
based on stock keeping units (SKUs)
because each SKU has a unique product
label. Based on data available to the
Agency and on communications with
industry, we estimate that cosmetic
establishments will offer 94,800 SKUs
for retail sale in 2017. This corresponds
to an average of 62 SKUs per
establishment.
One of the four provisions that we
discuss in this information collection,
§ 701.3, applies only to cosmetic
products offered for retail sale.
However, the other three provisions,
§§ 701.11, 701.12, and 701.13, apply to
all cosmetic products, including nonretail professional-use-only products.
We estimate that including professionaluse-only cosmetic products increases
the total number of SKUs by 15 percent
to 109,020. This corresponds to an
average of 72 SKUs per establishment.
Finally, based on the Agency’s
experience with other products, we
estimate that cosmetic establishments
VerDate Sep<11>2014
21:15 May 22, 2017
Jkt 241001
may redesign up to one-third of SKUs
per year. Therefore, we estimate that the
number of disclosures per respondent
will be 21 (31,878 SKUs) for § 701.3 and
24 each (36,432 SKUs) for §§ 701.11,
701.12, and 701.13.
We estimate that each of the required
label elements may add approximately 1
hour to the label design process. We
base this estimate on the hour burdens
the Agency has previously estimated for
food, drug, and medical device labeling
and on the Agency’s knowledge of
cosmetic labeling. Therefore, we
estimate that the total hour burden on
members of the public for this
information collection is 141,174 hours
per year.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–10532 Filed 5–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0349]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Providing WaiverRelated Materials in Accordance With
the Guidance for Industry on Providing
Post-Market Periodic Safety Reports in
the International Conference on
Harmonisation E2C(R2) Format
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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, including each proposed
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information associated
with the Guidance ‘‘Providing Postmarket Periodic Safety Reports in the
ICH E2C(R2) Format (Periodic BenefitRisk Evaluation Report).’’
DATES: Submit either electronic or
written comments on the collection of
information by July 24, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 24, 2017.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 24, 2017. 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.
ADDRESSES: You may submit comments
as follows:
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
E:\FR\FM\23MYN1.SGM
23MYN1
Agencies
[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23576-23578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10532]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1848]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Cosmetic Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
provisions in FDA's cosmetic labeling regulations.
DATES: Submit either electronic or written comments on the collection
of information by July 24, 2017.
ADDRESSES: You may submit comments as follows:
[[Page 23577]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2017-N-1848 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Cosmetic Labeling Regulations.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, FDA PRA Staff, Office
of Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
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, including
each proposed extension of an existing 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.
Cosmetic Labeling Regulations--21 CFR Part 701; OMB Control Number
0910-0599--Extension
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the
Fair Packaging and Labeling Act (the FPLA) require that cosmetic
manufacturers, packers, and distributors disclose information about
themselves or their products on the labels or labeling of their
products. Sections 201, 301, 502, 601, 602, 603, 701, and 704 of the
FD&C Act (21 U.S.C. 321, 352, 361, 362, 363, 371, and 374) and sections
4 and 5 of the FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA
to regulate the labeling of cosmetic products. Failure to comply with
the requirements for cosmetic labeling may render a cosmetic
adulterated under section 601 of the FD&C Act or misbranded under
section 602 of the FD&C Act.
FDA's cosmetic labeling regulations are published in part 701 (21
CFR part 701). Four of the cosmetic labeling regulations have
information collection provisions. Section 701.3 requires the label of
a cosmetic product to bear a declaration of the ingredients in
descending order of predominance. Section 701.11 requires the principal
display panel of a cosmetic product to bear a statement of the identity
of the product. Section 701.12 requires the label of a cosmetic product
to specify the name and place of business of the manufacturer, packer,
or distributor. Section 701.13 requires the label of a cosmetic product
to declare the net quantity of contents of the product.
FDA estimates the annual burden of this collection of information
as follows:
[[Page 23578]]
Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section/activity Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
701.3--Ingredients in order of 1,518 21 31,878 1 31,878
predominance..................
701.11--Statement of identity.. 1,518 24 36,432 1 36,432
701.12--Name and place of 1,518 24 36,432 1 36,432
business......................
701.13--Net quantity of 1,518 24 36,432 1 36,432
contents......................
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 141,174
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The hour burden is the additional or incremental time that
establishments need to design and print labeling that includes the
following required elements: A declaration of ingredients in decreasing
order of predominance, a statement of the identity of the product, a
specification of the name and place of business of the establishment,
and a declaration of the net quantity of contents. These requirements
increase the time establishments need to design labels because they
increase the number of label elements that establishments must take
into account when designing labels. These requirements do not generate
any recurring burden per label because establishments must already
print and affix labels to cosmetic products as part of normal business
practices.
The estimated annual third party disclosure is based on data
available to the Agency, our knowledge of and experience with cosmetic
labeling, and our communications with industry. We estimate there are
1,518 cosmetic product establishments in the United States. We
calculate label design costs based on stock keeping units (SKUs)
because each SKU has a unique product label. Based on data available to
the Agency and on communications with industry, we estimate that
cosmetic establishments will offer 94,800 SKUs for retail sale in 2017.
This corresponds to an average of 62 SKUs per establishment.
One of the four provisions that we discuss in this information
collection, Sec. 701.3, applies only to cosmetic products offered for
retail sale. However, the other three provisions, Sec. Sec. 701.11,
701.12, and 701.13, apply to all cosmetic products, including non-
retail professional-use-only products. We estimate that including
professional-use-only cosmetic products increases the total number of
SKUs by 15 percent to 109,020. This corresponds to an average of 72
SKUs per establishment.
Finally, based on the Agency's experience with other products, we
estimate that cosmetic establishments may redesign up to one-third of
SKUs per year. Therefore, we estimate that the number of disclosures
per respondent will be 21 (31,878 SKUs) for Sec. 701.3 and 24 each
(36,432 SKUs) for Sec. Sec. 701.11, 701.12, and 701.13.
We estimate that each of the required label elements may add
approximately 1 hour to the label design process. We base this estimate
on the hour burdens the Agency has previously estimated for food, drug,
and medical device labeling and on the Agency's knowledge of cosmetic
labeling. Therefore, we estimate that the total hour burden on members
of the public for this information collection is 141,174 hours per
year.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10532 Filed 5-22-17; 8:45 am]
BILLING CODE 4164-01-P