[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58582-58583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25231]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2027]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Survey of Current 
Manufacturing Practices for the Cosmetics Industry

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 (PRA).

DATES: Fax written comments on the collection of information by 
December 20, 2018.

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--New and 
title ``Survey of Current Manufacturing Practices for the Cosmetics 
Industry.'' 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, 10A-12M, 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.

Survey of Current Manufacturing Practices for the Cosmetics Industry

OMB Control Number 0910--NEW

    FDA has the responsibility to protect public health and, as part of 
this broad mandate, oversees the safety of the nation's cosmetic 
products. The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits 
the introduction into interstate commerce of any cosmetic that is 
adulterated or misbranded; cosmetics are also to be safe and properly 
labeled.
    The FD&C Act defines cosmetics as articles intended to be rubbed, 
poured, sprinkled, or sprayed on, introduced into, or otherwise applied 
to the human body for cleansing, beautifying, promoting attractiveness, 
or altering the appearance. Among the products included in this 
definition are skin moisturizers, perfumes, lipsticks, fingernail 
polishes, eye and facial makeup, cleansing shampoos, permanent waves, 
hair colors, deodorants, and tattoo inks, as well as any substance 
intended for use as a component of a cosmetic product. Some cosmetic 
products are also regulated as drugs.
    As with other commodities FDA regulates, the safety of cosmetic 
products can be ensured in part through a manufacturer's approach to 
the management of cosmetic quality. To date, FDA has not identified in 
the published literature any systematic, detailed study of the 
diversity of the practices and standards employed across the cosmetic 
industry. This study is intended to fill this gap. FDA proposes to 
conduct a voluntary survey of cosmetics establishments to identify the 
current manufacturing practices in the cosmetic industry.
    The survey instrument will collect data, on a voluntary basis, from 
cosmetic product manufacturers on the following topics:
     Written Procedures and Documentation--including written 
procedures and records for manufacturing involving personnel, raw 
materials, processing, cleaning, maintenance, finished products, and 
training.
     Buildings and Equipment--including facility space, pest 
control, practices ensuring the cleanliness and sanitation, water usage 
and treatment, and the proper functioning and operation of equipment.
     Materials and Manufacturing--including practices for 
inventory management, labeling and storage of raw materials, closures, 
and in process materials, and in process standard operating procedures.
     Quality Control/Product Testing--including the scope of 
the quality control unit, laboratory testing, dealing with rejected or 
returned products and complaints, and corrective actions.
    In addition, FDA will obtain the characteristics of surveyed 
establishments such as the types of cosmetics produced, published 
standards and guidelines followed, the number of employees, the volume 
of production, and the approximate

[[Page 58583]]

revenue. The survey will be administered by web or by mail (respondent 
choice) and it will be directed to the Plant Manager of the cosmetics 
establishment.
    This is a new, one-time data collection. FDA does not plan to 
collect this data from the cosmetics industry on an ongoing basis.
    In the Federal Register of July 2, 2018 (83 FR 30940), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received three comments. FDA thanks the 
commenters for their comments and provides our responses below.
    The first comment expressed concern that the collection was 
voluntary, and a number of manufacturers may not participate, which 
will not inform FDA of manufacturers who are not observing good 
manufacturing practices. They also indicated that they feel the survey 
could help set future standards for the industry. In response to this 
comment, FDA notes that this survey is being conducted to inform FDA 
with updated information about the practices and standards employed 
across the cosmetics industry. With regard to identifying manufacturers 
who are not observing good manufacturing practices, the survey is 
structured to provide FDA with anonymized, updated cosmetic industry 
information, not individual response information about any of its 
participants.
    The second comment addressed specific PRA issues of necessity, 
burden estimate, quality and utility of the survey, and method of 
collection. The commenter feels that the survey is not necessary for 
proper FDA oversight of the industry because this information is 
already available to FDA through its facility inspections. They also 
indicated that they had not seen the actual questions on the survey, 
and therefore felt the burden estimate was not feasible. They suggested 
that FDA partner with outside sources to assist FDA in gathering 
information about the industry and thought that web or mail collection 
was reasonable.
    In response to the second comment, FDA noted in the Federal 
Register of July 2, 2018 that FDA has ``not identified in the published 
literature any systematic, detailed study of the diversity of the 
practices and standards employed across the cosmetic industry to ensure 
product quality and safety.'' FDA is conducting this survey to fill 
this gap in knowledge, and this survey is necessary to achieve this 
goal. With regard to the survey itself, it is (and has been) available 
at the FDA Docket assigned to this collection (FDA-2018-N-2027). We 
agree that the burden is likely greater than 30 minutes, and based on 
results of our pretest with six individuals, we have increased the 
burden estimate to 60 minutes. FDA's contractor did consult with 
industry stakeholders in the development of the survey instrument. 
Finally, FDA thanks the commenter for their comments and thoughts that 
our suggested method of web or collection method was reasonable.
    The third comment was not related to the PRA and will not be 
addressed at this time.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
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Survey Invitation............................             898               1             898  0.08 (5 minutes).........................           71.84
Survey.......................................             564               1             564  1........................................             564
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................          635.84
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We will select a sample of 898 establishments. After adjusting for 
ineligibility (i.e., firms that do not produce cosmetic products and 
those no longer in operation) and a response rate of 70 percent, we 
expect 564 completed surveys.
    We expect each individual survey invitation to take 5 minutes (0.08 
hour) to complete. Multiplying by the 898 establishments that will 
receive the survey invitation, we estimate the time burden of the 
survey invitation to be 71.84 hours. Previously, we estimated that the 
survey would take 30 minutes to complete. However, based on our pretest 
with six individuals, we now expect each individual survey to take, on 
average, 60 minutes (1 hour) to complete. Multiplying by the estimated 
564 establishments that will complete the survey, we estimate the time 
burden of the survey to be 564 hours. We estimate the total hourly 
reporting burden for this collection of information to be 635.84 hours.

    Dated: November 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25231 Filed 11-19-18; 8:45 am]
 BILLING CODE 4164-01-P


