[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]



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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, 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

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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.....................
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    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

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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 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