
[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21766-21767]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0120]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Cosmetic Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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.

DATES: Submit either electronic or written comments on the collection 
of information by June 16, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
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 (OMB Control Number 
0910-0599)--Extension

    The Federal Food, Drug, and Cosmetic Act (the 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, 331, 352, 361, 362, 363, 371, and 374, 
respectively) 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.
    FDA's cosmetic labeling regulations are published in part 701 (21 
CFR part 701). Four of the cosmetic labeling regulations have 
information collection provisions. 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.
    We estimate the annual burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
                                     Number of      disclosures    Total annual   Average burden
     21 CFR Section/Activity        respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
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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 contents.           1,518              24          36,432               1          36,432
    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 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 need to design

[[Page 21767]]

labels because they increase the number of label elements that 
establishments must take into account 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.
    The estimated annual third party disclosure is based on data 
available to the Agency, our knowledge of and experience with cosmetic 
labeling, and our communications with industry. We estimate there are 
1,518 cosmetic product establishments in the United States. We 
calculate label design costs based on stock keeping units (SKUs) 
because each SKU has a unique product label. Based on data available to 
the Agency and on communications with industry, we estimate that 
cosmetic establishments will offer 94,800 SKUs for retail sale in 2014. 
This corresponds to an average of 62 SKUs per establishment.
    One of the four provisions that we discuss in this information 
collection, Sec.  701.3, applies only to cosmetic products offered for 
retail sale. However, the other three provisions, Sec. Sec.  701.11, 
701.12, and 701.13, apply to all cosmetic products, including non-
retail professional-use-only products. We estimate that including 
professional-use-only cosmetic products increases the total number of 
SKUs by 15 percent to 109,020. This corresponds to an average of 72 
SKUs per establishment.
    Finally, based on the Agency's experience with other products, we 
estimate that cosmetic establishments may redesign up to one-third of 
SKUs per year. Therefore, we estimate that the number of disclosures 
per respondent will be 21 (31,878 SKUs) for Sec.  701.3 and 24 each 
(36,432 SKUs) for Sec. Sec.  701.11, 701.12, and 701.13.
    We estimate that each of the required label elements may add 
approximately 1 hour to the label design process. We base this estimate 
on the hour burdens the Agency has previously estimated for food, drug, 
and medical device labeling and on the Agency's knowledge of cosmetic 
labeling. Therefore, we estimate that the total hour burden on members 
of the public for this information collection is 141,174 hours per 
year.

    Dated: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08708 Filed 4-16-14; 8:45 am]
BILLING CODE 4160-01-P


