Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations and Voluntary Cosmetic Registration Program, 44539-44541 [2020-15996]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 142 / Thursday, July 23, 2020 / Notices
For CMS https://www.cms.gov/
Medicare/Coding/
ICD9ProviderDiagnosticCodes/meetings.
FOR FURTHER INFORMATION CONTACT:
Traci Ramirez, Program Specialist, CDC,
3311 Toledo Road, Hyattsville,
Maryland 20782, Telephone (301) 458–
4454; TRamirez@cdc.gov.
SUPPLEMENTARY INFORMATION: Purpose:
The ICD–10 Coordination and
Maintenance (C&M) Committee is a
public forum for the presentation of
proposed modifications to the
International Classification of Diseases,
Tenth Revision, Clinical Modification
and ICD–10 Procedure Coding System.
Matters To Be Considered: The
tentative agenda will include
discussions on ICD–10–CM and ICD–
10–PCS topics listed below. Agenda
items are subject to change as priorities
dictate.
Please refer to the posted agenda for
updates one month prior to the meeting.
ICD–10–PCS Topics
Vertebral Body Tethering
Removal of a Transplanted/Rejected
Kidney
Isotope Administration
Administration of Lifileucel
Administration of Narsoplimab
Insertion of Implantable Bone Void
Filler
Single-Use Duodenoscope
Administration of Immune Effector Cell
Therapy
Spinal Stabilization
Administration of Idecabtagene
Vicleucel (ide-cel)
Restriction of Coronary Sinus
Embolic Protection
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
jbell on DSKJLSW7X2PROD with NOTICES
[Docket No. FDA–2008–N–0490]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Cosmetic Labeling
Regulations and Voluntary Cosmetic
Registration Program
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by August 24,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0599. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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.
Complications of immune effector
cellular (IEC) therapy
Endometriosis
Immune Effector Cell Associated
Neurotoxicity Syndrome (ICANS)
Addenda
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–16000 Filed 7–22–20; 8:45 am]
BILLING CODE 4163–18–P
17:10 Jul 22, 2020
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
ICD–10–CM Topics:
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 250001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 (FPLA) require that
cosmetic manufacturers, packers, and
distributors disclose information about
themselves or their products on the
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
44539
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, 331, 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.
I. 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.
II. Voluntary Cosmetic Registration
Program
Information collection associated with
our Voluntary Cosmetic Registration
Program (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
E:\FR\FM\23JYN1.SGM
23JYN1
44540
Federal Register / Vol. 85, No. 142 / Thursday, July 23, 2020 / Notices
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).
In the Federal Register of April 3,
2020 (85 FR 18993), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
communicating general support for the
information collection.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures per
respondent
Number of
respondents
21 CFR section; activity
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
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
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
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR section or part
Number of
respondents
Form FDA No.
Number of
responses per
respondent
Total annual
responses
Part 710 (registrations) ............................
2 2511
1,702
1
1,702
720.1
720.6
720.6
720.8
3 2512
Average
burden per
response
(minutes)
through 720.4 (new submissions)
(amendments) ................................
(notices of discontinuance) ............
(requests for confidentiality) ..........
2512
2512
........................
6,843
2,477
232
1
1
1
1
1
6,843
2,477
232
1
0.20
(12)
0.33 (20)
0.17 (10)
0.10 (6)
2
Total ..................................................
........................
........................
........................
........................
........................
1 There
Total hours
340
2,258
421
23
2
3,044
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
2 The
VerDate Sep<11>2014
17:10 Jul 22, 2020
Jkt 250001
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
E:\FR\FM\23JYN1.SGM
23JYN1
Federal Register / Vol. 85, No. 142 / Thursday, July 23, 2020 / Notices
44541
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.
jbell on DSKJLSW7X2PROD with NOTICES
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: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–15996 Filed 7–22–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:10 Jul 22, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1648]
Pediatric Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pediatric Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
September 15, 2020, from 10 a.m. to
4:30 p.m.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–1648.
The docket will close on September 14,
2020. Submit either electronic or
written comments on this public
meeting by September 14, 2020. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before September 14, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 14, 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.
Comments received on or before
August 31, 2020, will be provided to the
committee. Comments received after
that date will be taken into
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
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
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–
2020–N–1648 for ‘‘Pediatric Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
E:\FR\FM\23JYN1.SGM
23JYN1
]]>Agencies
[Federal Register Volume 85, Number 142 (Thursday, July 23, 2020)]
[Notices]
[Pages 44539-44541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15996]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0490]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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.
DATES: Submit written comments (including recommendations) on the
collection of information by August 24, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0599. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (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, 331, 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.
I. 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.
II. Voluntary Cosmetic Registration Program
Information collection associated with our Voluntary Cosmetic
Registration Program (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
[[Page 44540]]
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).
In the Federal Register of April 3, 2020 (85 FR 18993), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received communicating
general support for the information collection.
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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section or part Form FDA No. respondents responses per responses response Total hours
respondent (minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 710 (registrations)................................ \2\ 2511 1,702 1 1,702 0.20 340
(12)
720.1 through 720.4 (new submissions)................... \3\ 2512 6,843 1 6,843 0.33 (20) 2,258
720.6 (amendments)...................................... 2512 2,477 1 2,477 0.17 (10) 421
720.6 (notices of discontinuance)....................... 2512 232 1 232 0.10 (6) 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.
[[Page 44541]]
\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: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15996 Filed 7-22-20; 8:45 am]
BILLING CODE 4164-01-P
