[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36069-36070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14768]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Cosmetic Labeling 
Regulations

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: Fax written comments on the collection of information by July 
25, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0599. 
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 (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

[[Page 36070]]

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.
    In the Federal Register of April 17, 2014 (79 FR 21766), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates 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    Total annual     burden per      Total hours
                                    respondents   per 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 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 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 burden hours 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 burden hours on members 
of the public for this information collection are 141,174 hours per 
year.

    Dated: June 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14768 Filed 6-24-14; 8:45 am]
BILLING CODE 4164-01-P