[Federal Register: January 18, 2006 (Volume 71, Number 11)]
[Notices]
[Page 2947-2948]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja06-59]
[[Page 2947]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0494]
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 collections of information in current rules, 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. FDA's cosmetic labeling regulations, as published
in the Federal Register on March 15, 1974 (39 FR 10054 at 10056) and
subsequently amended, most recently on March 17, 1999 (64 FR 13254 at
13297), remain unchanged by this notice. FDA is publishing this notice
in compliance with the PRA. This notice does not represent any new
regulatory initiative.
DATES: Submit written or electronic comments on the collection of
information by March 20, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. 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: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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
collections of information in current rules, 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.
Under section 3506(c)(2)(A) of the PRA and 5 CFR 1320.8(d)(1), FDA
invites comments on: (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)
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, as published in the Federal
Register on March 15, 1974 (39 FR 10054 at 10056) and subsequently
amended, most recently on March 17, 1999 (64 FR 13254 at 13297), remain
unchanged by this notice. FDA is publishing this notice in compliance
with the PRA. This notice does not represent any new regulatory
initiative.
FDA estimates the annual burden of this collection of information
as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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701.3 1518 21 31,600 1.00 31,600
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701.11 1518 24 36,340 1.00 36,340
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701.12 1518 24 36,340 1.00 36,340
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701.13 1518 24 36,340 1.00 36,340
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Total 140,620
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 2948]]
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 2005. 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 (31,600 SKUs) for Sec. 701.3 and 24 each (36,340
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
140,620 hours per year.
Dated: January 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-443 Filed 1-17-06; 8:45 am]
BILLING CODE 4160-01-S