[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30035-30036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13075]
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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 (the PRA).
DATES: Fax written comments on the collection of information by June
28, 2010..
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 e-mailed 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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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--(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. 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
notice. FDA is publishing this notice in compliance with the PRA. This
notice does not represent any new regulatory initiative.
In the Federal Register of March 16, 2010 (75 FR 12546), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one letter, containing multiple
comments, in response to the notice. One comment expressed strong
support for the labeling of cosmetics. Additional comments were outside
the scope of the four collection of information topics on which the
notice solicits comments and, thus, will not be addressed here.
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 of Total Annual Hours per
21 CFR Section Respondents Disclosure Disclosures Disclosure Total Hours
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701.3 1,518 21 31,878 1 31,878
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[[Page 30036]]
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: May 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13075 Filed 5-27-10; 8:45 am]
BILLING CODE 4160-01-S