[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Notices]
[Pages 30940-30941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14158]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Survey of Current Manufacturing Practices for the 
Cosmetics Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a new information collection: A survey of 
the cosmetics industry on their current manufacturing practices.

DATES: Submit either electronic or written comments on the collection 
of information by August 31, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 31, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-2027 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Survey of Current Manufacturing 
Practices for the Cosmetics Industry.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: 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 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.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical

[[Page 30941]]

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.

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.
    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 to ensure product quality and safety. This study is intended 
to fill this gap. FDA proposes to conduct a voluntary survey of 
cosmetics establishments to identify the current quality management and 
safety 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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey Invitation............................             898               1             898  0.08 (5 minutes).........................           71.84
Survey.......................................             564               1             564  0.5 (30 minutes).........................          282.00
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................          353.84
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. We expect each individual survey 
to take 30 minutes (0.5 hour) to complete. Multiplying by the estimated 
564 establishments that will complete the survey, we estimate the time 
burden of the survey to be 282 hours. We estimate the total hourly 
reporting burden for this collection of information to be 353.84 hours.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14158 Filed 6-29-18; 8:45 am]
BILLING CODE 4164-01-P


