[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12546-12547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5657]
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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