[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18993-18995]
[FR Doc No: 2020-06982]

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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.

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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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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

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\
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                                                    Number of                         Average
   21 CFR section; activity        Number of     disclosures per   Total annual     burden per      Total hours
                                  respondents      respondent       disclosures     disclosure
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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
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\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\
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                                                                               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
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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
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\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


[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Rules and Regulations]
[Pages 19498-19499]
[FR Doc No: 2016-07792]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2016-0002]

Final Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: Base (1% annual-chance) Flood Elevations (BFEs) and modified
BFEs are made final for the communities listed below. The BFEs and
modified BFEs are the basis for the floodplain management measures that
each community is required either to adopt or to show evidence of being
already in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: The date of issuance of the Flood Insurance Rate Map (FIRM)
showing BFEs and modified BFEs for each community. This date may be
obtained by contacting the office where the maps are available for
inspection as indicated in the table below.

ADDRESSES: The final BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified elevations have been
published in newspapers of local circulation and ninety (90) days have
elapsed since that publication. The Deputy Associate Administrator for
Mitigation has resolved any appeals resulting from this notification.
    This final rule is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the proof Flood Insurance Study and FIRM available at the
address cited below for each community. The BFEs and modified BFEs are
made final in the communities listed below. Elevations at selected
locations in each community are shown.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Dated: March 10, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.
    Accordingly, 44 CFR part 67 is amended as follows:

PART 67--[AMENDED]

0
1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.11  [Amended]

0
2. The tables published under the authority of Sec.  67.11 are amended
as follows:

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                                                                      * Elevation in
                                                                      feet (NGVD) +
                                                                    Elevation in feet
                                           Location of referenced   (NAVD) # Depth in
           Flooding source(s)                    elevation          feet above ground     Communities affected
                                                                    [caret] Elevation
                                                                     in  meters (MSL)
                                                                         Modified
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                   Morehouse Parish, Louisiana, and Incorporated Areas Docket No.: FEMA-B-1145
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Horse Bayou............................  Just upstream of Cherry                  +98  City of Bastrop,
                                          Ridge Road.                                   Unincorporated.
                                         Approximately 140 feet                  +122  Areas of Morehouse
                                          upstream of Louisiana                         Parish.
                                          Highway 830-4.
Staulking Head Creek...................  Approximately 489 feet                   +84  City of Bastrop,
                                          downstream of Henry                           Unincorporated.
                                          Avenue.
                                         Approximately 520 feet                  +114  Areas of Morehouse
                                          upstream of Cleveland                         Parish.
                                          Street.
W-10 Canal.............................  Approximately 4,330 feet                 +91  City of Bastrop,
                                          downstream of the dam.                        Unincorporated.
                                         Approximately 2,382 feet                +102  Areas of Morehouse
                                          upstream of the dam.                          Parish.
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* National Geodetic Vertical Datum.
+ North American Vertical Datum.
# Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES
City of Bastrop
Maps are available for inspection at the City Hall, 200 East Jefferson Avenue, Bastrop, LA 71220.
Unincorporated Areas of Morehouse Parish
Maps are available for inspection at the Morehouse Parish Police Jury Building, 125 East Madison Avenue,
 Bastrop, LA 71220.
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[FR Doc. 2016-07792 Filed 4-4-16; 8:45 am]
 BILLING CODE 9110-12-P