[Federal Register Volume 71, Number 11 (Wednesday, January 18, 2006)]
[Notices]
[Pages 2947-2948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-443]



[[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