[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]
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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.
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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\
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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 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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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)
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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
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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.
[[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