Document ID: FDA-2010-N-0120-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cosmetic Labeling Regulations
Posted Date: 2010-05-28T04:00Z

[Federal Register: May 28, 2010 (Volume 75, Number 103)]
[Notices]               
[Page 30035-30036]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my10-93]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 oira_submission@omb.eop.gov. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency  of     Total Annual        Hours per
                    21 CFR Section                         Respondents          Disclosure          Disclosures         Disclosure        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
701.3                                                               1,518                    21             31,878                  1             31,878
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 30036]]

701.11                                                              1,518                    24             36,432                  1             36,432
--------------------------------------------------------------------------------------------------------------------------------------------------------
701.12                                                              1,518                    24             36,432                  1             36,432
--------------------------------------------------------------------------------------------------------------------------------------------------------
701.13                                                              1,518                    24             36,432                  1             36,432
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                   .................  ....................  .................  .................            141,174
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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