60 day notice

Appendix 3 60 Day Publication.pdf

Survey of Current Manufacturing Practices for the Cosmetics Industry

60 day notice

OMB: 0910-0867

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30940

Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices

Jeffrey M. Zirger,
Acting Chief, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2018–14172 Filed 6–29–18; 8:45 am]
BILLING CODE 4163–18–P

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.

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.

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SUMMARY:

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

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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

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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/201523389.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]
fda.hhs.gov.
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

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Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices
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
respondents

Activity

Total annual
responses

Average burden
per response

Total hours

Survey Invitation .........................................................
Survey ........................................................................

898
564

1
1

898
564

0.08 (5 minutes) ......
0.5 (30 minutes) ......

71.84
282.00

Total ....................................................................

........................

........................

........................

.................................

353.84

1 There

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Number of
responses per
respondent

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

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burden for this collection of information
to be 353.84 hours.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.

Health Resources and Services
Administration

[FR Doc. 2018–14158 Filed 6–29–18; 8:45 am]
BILLING CODE 4164–01–P

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Lists of Designated Primary Medical
Care, Mental Health, and Dental Health
Professional Shortage Areas
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

This notice informs the public
of the availability of the complete lists
of all geographic areas, population
groups, and facilities designated as
primary medical care, mental health,
and dental health professional shortage

SUMMARY:

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