[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Pages 37100-37101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16649]



Food and Drug Administration

[Docket No. FDA-2017-N-1848]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Cosmetic Labeling 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) 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 (PRA).

DATES: Fax written comments on the collection of information by 
September 7, 2017.

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 emailed 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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--21 CFR Part 701

OMB Control Number 0910-0599--Extension

    The Federal Food, Drug, and Cosmetic Act (the FD&C 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, 301, 502, 601, 602, 603, 701, and 704 of the 
FD&C 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 FD&C Act or misbranded under 
section 602 of the FD&C 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.
    In the Federal Register of May 23, 2017 (82 FR 23576), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received which described 
ingredients used in the creation of cosmetics but was not PRA-related 
and will not be addressed here.
    FDA estimates the burden of this collection of information as 

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
                                                     Number of
                                     Number of      disclosures    Total annual       Average
     21 CFR section/activity        respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
701.3--Ingredients in order of             1,518              21          31,878               1          31,878
701.11--Statement of identity...           1,518              24          36,432               1          36,432

[[Page 37101]]

701.12--Name and place of                  1,518              24          36,432               1          36,432
701.13--Net quantity of contents           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

    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 
    The estimated annual third-party disclosure is based on data 
available to the Agency, our knowledge of and experience with cosmetic 
labeling, and our communications with industry. We estimate there are 
1,518 cosmetic product establishments in the United States. We 
calculate label design costs based on stock keeping units (SKUs) 
because each SKU has a unique product label. Based on data available to 
the Agency and on communications with industry, we estimate that 
cosmetic establishments will offer 94,800 SKUs for retail sale in 2017. 
This corresponds to an average of 62 SKUs per establishment.
    One of the four provisions that we discuss 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. We estimate 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, we 
estimate that cosmetic establishments may redesign up to one-third of 
SKUs per year. Therefore, we estimate that the number of disclosures 
per respondent 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.
    We estimate that each of the required label elements may add 
approximately 1 hour to the label design process. We base 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, we estimate that the total hour burden on members 
of the public for this information collection is 141,174 hours per 

    Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16649 Filed 8-7-17; 8:45 am]