Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations and Voluntary Cosmetic Registration Program, 18993-18995 [2020-06982]
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0490]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Cosmetic Labeling
Regulations and Voluntary Cosmetic
Registration Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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,
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 and its Voluntary
Cosmetic Registration Program (VCRP).
DATES: Submit either electronic or
written comments on the collection of
information by June 2, 2020.
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 June 2, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 2, 2020. 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.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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
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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–
2008–N–0490 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Cosmetic
Labeling Regulations and Voluntary
Cosmetic Registration Program.’’
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
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18993
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.govinfo.gov/content/pkg/FR-201509-18/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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
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 and Voluntary Cosmetic
Registration Program—21 CFR Parts
710 and 720
OMB Control Number 0910–0599—
Revision
The Federal Food, Drug, and Cosmetic
Act (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.
Cosmetic Labeling Regulations
FDA’s cosmetic labeling regulations
are codified in part 701 (21 CFR part
701). 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. The information collection
provisions found in part 701 are
currently approved under OMB control
number 0910–0027. To improve the
efficiency of Agency operations, we are
consolidating these information
collection elements into OMB control
number 0910–0599.
Voluntary Cosmetic Registration
Program
Information collection associated with
our VCRP are found in parts 710 and
720 (21 CFR parts 710 and 720).
Participants have the option of
submitting information via paper forms
or via an online interface. The use of the
term ‘‘form’’ refers to both the paper
form and the online system.
Pursuant to part 710, we request that
establishments that manufacture or
package cosmetic products voluntarily
register with us using Form FDA 2511
entitled ‘‘Registration of Cosmetic
Product Establishment.’’ The online
version of Form FDA 2511 is available
on our VCRP website at https://
www.fda.gov/cosmetics/voluntarycosmetic-registration-program/onlineregistration-voluntary-cosmeticregistration-program-vcrp. We
encourage online registration of Form
FDA 2511 because it is faster and more
efficient for the filer and the Agency. A
registering facility will receive
confirmation of online registration,
including a registration number by
email. The online system also allows for
amendments to past submissions.
Because registration of cosmetic
product establishments is not
mandatory, voluntary registration
provides FDA with the best information
available about the locations, business
trade names, and types of activity
(manufacturing or packaging) of
cosmetic product establishments. We
store the registration information in a
computer database and use the
information to generate mailing lists for
distributing regulatory information and
for inviting firms to participate in
workshops on topics in which they may
be interested. Registration is permanent,
although we request that respondents
submit an amended Form FDA 2511 if
any of the originally submitted
information changes.
Pursuant to part 720, we request firms
that manufacture, pack, or distribute
cosmetics to file with the Agency an
ingredient statement for each of their
products. Filing of cosmetic product
ingredient statements is also voluntary.
Ingredient statements for new
submissions are reported on Form FDA
2512, ‘‘Cosmetic Product Ingredient
Statement,’’ and on Form FDA 2512a, a
continuation form. Amendments to
product formulations also are reported
on Forms FDA 2512 and FDA 2512a.
When a firm discontinues the
commercial distribution of a cosmetic,
we request that the firm notify FDA that
they have discontinued a cosmetic
product formulation by submitting an
amended Form FDA 2512. If any of the
information submitted on these forms is
confidential, the firm may submit a
request for confidentiality of a cosmetic
ingredient.
FDA’s use of an electronic submission
system has been designed to make it
easier for participants to provide
information to FDA about their
products. The online version of Forms
FDA 2512 and FDA 2512a are available
on our VCRP website at https://
www.fda.gov/cosmetics/voluntarycosmetic-registration-program/onlineregistration-voluntary-cosmeticregistration-program-vcrp.
Description of Respondents:
Respondents to this collection of
information include cosmetic
manufacturers, packers, and
distributors. Respondents are from the
private sector (for-profit businesses).
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
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21 CFR section; activity
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
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
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual third-party
disclosure burden is based on data
available to the Agency, our knowledge
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of and experience with cosmetics, and
communications with industry. The
hour burden is the additional or
PO 00000
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incremental time that establishments
need to design and print labeling that
includes the following required
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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 needed to
design labels because they increase the
number of label elements that
establishments must consider when
designing labels. These requirements do
not generate any recurring burden per
label because establishments must
18995
already print and affix labels to
cosmetic products as part of normal
business practices. We estimate that the
total third-party disclosure burden is
141,174 hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section or part
Form FDA No.
Number of
respondents
2 2511
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Part 710 (registrations) ......................
720.1 through 720.4 (new submissions).
720.6 (amendments) ..........................
720.6 (notices of discontinuance) ......
720.8 (requests for confidentiality) ....
3 2512
1,702
6,843
1
1
1,702
6,843
0.20 (12 minutes)
0.33 (20 minutes)
340
2,258
2512
2512
........................
2,477
232
1
1
1
1
2,477
232
1
0.17 (10 minutes)
0.10 (6 minutes) ..
2 ...........................
421
23
2
Total ............................................
........................
........................
........................
........................
..............................
3,044
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
The term ‘‘Form FDA 2511’’ refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP,
which is available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
3 The term ‘‘Form FDA 2512’’ refers to the paper Forms FDA 2512 and 2512a and online Form FDA 2512 in the online system known as the
VCRP, which is available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
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2
We base our estimate on information
from cosmetic industry personnel and
FDA experience entering data submitted
on paper Forms FDA 2511, 2512, and
2512a into the online system. We
estimate that, annually, 1,702
establishments that manufacture or
package cosmetic products will each
submit 1 registration on Form FDA
2511, for a total of 1,702 annual
responses. Each submission is estimated
to take about 0.20 hour per response for
a total of 340.4 hours, rounded to 340.
We estimate that, annually, firms that
manufacture, pack, or distribute
cosmetics will file 6,843 ingredient
statements for new submissions on
Forms FDA 2512 and FDA 2512a. Each
submission is estimated to take about
0.33 hour per response for a total of
2,258.19 hours, rounded to 2,258. We
estimate that, annually, firms that
manufacture, pack, or distribute
cosmetics will file 2,477, amendments
to product formulations on Forms FDA
2512 and FDA 2512a. Each submission
is estimated to take about 0.17 hour per
response for a total of 421.09 hours,
rounded to 421. We estimate that,
annually, firms that manufacture, pack,
or distribute cosmetics will file 232
notices of discontinuance on Form FDA
2512. Each submission is estimated to
take about 0.10 hour per response for a
total of 23.2 hours, rounded to 23. We
estimate that, annually, one firm will
file one request for confidentiality. Each
such request is estimated to take 2 hours
to prepare for a total of 2 hours. Thus,
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the estimated total reporting burden is
3,044 hours.
Our estimated burden for the
information collection reflects an
overall increase of 3,044 hours and a
corresponding increase of 11,255
responses. We attribute this adjustment
to an increase in the number of hours
and responses due to the consolidation
of OMB control numbers 0910–0027 and
0910–0599. Total burden for the
combined collection of information is
therefore, 144,218 hours (141,174 hours
from OMB control number 0910–0599
and 3,044 hours from OMB control
number 0910–0027).
Dated: March 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06982 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1119]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00083
Fmt 4703
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ACTION:
Notice.
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,
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 the information
collection provisions of reporting and
recordkeeping requirements for firms
that process acidified foods and
thermally processed low-acid foods in
hermetically sealed containers.
DATES: Submit either electronic or
written comments on the collection of
information by June 2, 2020.
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 June 2, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 2, 2020. 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.
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18993-18995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06982]
[[Page 18993]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0490]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Cosmetic Labeling Regulations and Voluntary Cosmetic
Registration Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, 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 and its Voluntary Cosmetic Registration
Program (VCRP).
DATES: Submit either electronic or written comments on the collection
of information by June 2, 2020.
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 June 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 2, 2020. 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-2008-N-0490 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Cosmetic Labeling Regulations and
Voluntary Cosmetic Registration Program.'' 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.govinfo.gov/content/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. 3501-3521), 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
[[Page 18994]]
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 and Voluntary Cosmetic
Registration Program--21 CFR Parts 710 and 720
OMB Control Number 0910-0599--Revision
The Federal Food, Drug, and Cosmetic Act (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.
Cosmetic Labeling Regulations
FDA's cosmetic labeling regulations are codified in part 701 (21
CFR part 701). 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. The information collection
provisions found in part 701 are currently approved under OMB control
number 0910-0027. To improve the efficiency of Agency operations, we
are consolidating these information collection elements into OMB
control number 0910-0599.
Voluntary Cosmetic Registration Program
Information collection associated with our VCRP are found in parts
710 and 720 (21 CFR parts 710 and 720). Participants have the option of
submitting information via paper forms or via an online interface. The
use of the term ``form'' refers to both the paper form and the online
system.
Pursuant to part 710, we request that establishments that
manufacture or package cosmetic products voluntarily register with us
using Form FDA 2511 entitled ``Registration of Cosmetic Product
Establishment.'' The online version of Form FDA 2511 is available on
our VCRP website at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp. We encourage online registration of Form FDA
2511 because it is faster and more efficient for the filer and the
Agency. A registering facility will receive confirmation of online
registration, including a registration number by email. The online
system also allows for amendments to past submissions.
Because registration of cosmetic product establishments is not
mandatory, voluntary registration provides FDA with the best
information available about the locations, business trade names, and
types of activity (manufacturing or packaging) of cosmetic product
establishments. We store the registration information in a computer
database and use the information to generate mailing lists for
distributing regulatory information and for inviting firms to
participate in workshops on topics in which they may be interested.
Registration is permanent, although we request that respondents submit
an amended Form FDA 2511 if any of the originally submitted information
changes.
Pursuant to part 720, we request firms that manufacture, pack, or
distribute cosmetics to file with the Agency an ingredient statement
for each of their products. Filing of cosmetic product ingredient
statements is also voluntary. Ingredient statements for new submissions
are reported on Form FDA 2512, ``Cosmetic Product Ingredient
Statement,'' and on Form FDA 2512a, a continuation form. Amendments to
product formulations also are reported on Forms FDA 2512 and FDA 2512a.
When a firm discontinues the commercial distribution of a cosmetic, we
request that the firm notify FDA that they have discontinued a cosmetic
product formulation by submitting an amended Form FDA 2512. If any of
the information submitted on these forms is confidential, the firm may
submit a request for confidentiality of a cosmetic ingredient.
FDA's use of an electronic submission system has been designed to
make it easier for participants to provide information to FDA about
their products. The online version of Forms FDA 2512 and FDA 2512a are
available on our VCRP website at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
Description of Respondents: Respondents to this collection of
information include cosmetic manufacturers, packers, and distributors.
Respondents are from the private sector (for-profit businesses).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section; activity Number of disclosures per Total annual burden per Total hours
respondents 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 estimated annual third-party disclosure burden is based on data
available to the Agency, our knowledge of and experience with
cosmetics, and communications with industry. The hour burden is the
additional or incremental time that establishments need to design and
print labeling that includes the following required
[[Page 18995]]
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 needed to design labels because they
increase the number of label elements that establishments must consider
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. We
estimate that the total third-party disclosure burden is 141,174 hours.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section or part Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 710 (registrations).................. \2\ 2511 1,702 1 1,702 0.20 (12 minutes)........... 340
720.1 through 720.4 (new submissions)..... \3\ 2512 6,843 1 6,843 0.33 (20 minutes)........... 2,258
720.6 (amendments)........................ 2512 2,477 1 2,477 0.17 (10 minutes)........... 421
720.6 (notices of discontinuance)......... 2512 232 1 232 0.10 (6 minutes)............ 23
720.8 (requests for confidentiality)...... .............. 1 1 1 2........................... 2
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. .............. ............................ 3,044
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 2511'' refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP, which is
available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
\3\ The term ``Form FDA 2512'' refers to the paper Forms FDA 2512 and 2512a and online Form FDA 2512 in the online system known as the VCRP, which is
available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
We base our estimate on information from cosmetic industry
personnel and FDA experience entering data submitted on paper Forms FDA
2511, 2512, and 2512a into the online system. We estimate that,
annually, 1,702 establishments that manufacture or package cosmetic
products will each submit 1 registration on Form FDA 2511, for a total
of 1,702 annual responses. Each submission is estimated to take about
0.20 hour per response for a total of 340.4 hours, rounded to 340. We
estimate that, annually, firms that manufacture, pack, or distribute
cosmetics will file 6,843 ingredient statements for new submissions on
Forms FDA 2512 and FDA 2512a. Each submission is estimated to take
about 0.33 hour per response for a total of 2,258.19 hours, rounded to
2,258. We estimate that, annually, firms that manufacture, pack, or
distribute cosmetics will file 2,477, amendments to product
formulations on Forms FDA 2512 and FDA 2512a. Each submission is
estimated to take about 0.17 hour per response for a total of 421.09
hours, rounded to 421. We estimate that, annually, firms that
manufacture, pack, or distribute cosmetics will file 232 notices of
discontinuance on Form FDA 2512. Each submission is estimated to take
about 0.10 hour per response for a total of 23.2 hours, rounded to 23.
We estimate that, annually, one firm will file one request for
confidentiality. Each such request is estimated to take 2 hours to
prepare for a total of 2 hours. Thus, the estimated total reporting
burden is 3,044 hours.
Our estimated burden for the information collection reflects an
overall increase of 3,044 hours and a corresponding increase of 11,255
responses. We attribute this adjustment to an increase in the number of
hours and responses due to the consolidation of OMB control numbers
0910-0027 and 0910-0599. Total burden for the combined collection of
information is therefore, 144,218 hours (141,174 hours from OMB control
number 0910-0599 and 3,044 hours from OMB control number 0910-0027).
Dated: March 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06982 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P
