
[Federal Register: March 16, 2010 (Volume 75, Number 50)]
[Notices]               
[Page 12546-12547]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr10-60]                         

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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) 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 written or electronic comments on the collection of 
information by May 17, 2010.

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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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, 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 (OMB Control Number 
0910-0599)--Extension

    The Federal Food, Drug, and Cosmetic Act (the 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.

[[Page 12547]]

Sections 201, 502, 601, 602, 603, 701, and 704 of the 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 act or misbranded under section 602 of the 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.
    FDA's cosmetic labeling regulations remain unchanged by this 
document. FDA is publishing this document in compliance with the PRA. 
This document does not represent any new regulatory initiative.
    FDA estimates the annual burden of this collection of information 
as follows:

                           Table 1--Estimated Annual Third Party Disclosure Burden\1\
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                           No. of         Annual Frequency    Total Annual       Hours per
   21 CFR Section        Respondents       of Disclosure       Disclosures       Disclosure       Total Hours
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701.3                             1,518                 21            31,878                1             31,878
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701.11                            1,518                 24            36,432                1             36,432
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701.12                            1,518                 24            36,432                1             36,432
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701.13                            1,518                 24            36,432                1             36,432
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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 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.
    According to the 2001 census, there are 1,518 cosmetic product 
establishments in the United States (U.S. Census Bureau, http://
www.census.gov/epcd/susb/2001/us/US32562.HTM). FDA calculates label 
design costs based on stockkeeping units (SKUs) because each SKU has a 
unique product label. Based on data available to the agency and on 
communications with industry, FDA estimates that cosmetic 
establishments will offer 94,800 SKUs for retail sale in 2010. This 
corresponds to an average of 62 SKUs per establishment.
    One of the four provisions that FDA discusses 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. FDA estimates 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, FDA 
estimates that cosmetic establishments may redesign up to one-third of 
SKUs per year. Therefore, FDA estimates that the annual frequency of 
response 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.
    FDA estimates that each of the required label elements may add 
approximately 1 hour to the label design process. FDA bases 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, FDA estimates that the total hour 
burden on members of the public for this information collection is 
141,174 hours per year.

    Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5657 Filed 3-15-10; 8:45 am]
BILLING CODE 4160-01-S

