83 FR 30940 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Current Manufacturing Practices for the Cosmetics Industry

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 127 (July 2, 2018)

Page Range		30940-30941
FR Document		2018-14158

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.

Federal Register, Volume 83 Issue 127 (Monday, July 2, 2018)

[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Notices]
[Pages 30940-30941]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14158]

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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.

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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.thefederalregister.org/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,
PRAStaff@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

[[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
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Total.................................... .............. .............. .............. ......................................... 353.84
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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. 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

Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices 30941

utility; (2) the accuracy of FDA’s makeup, cleansing shampoos, • Buildings and Equipment—
estimate of the burden of the proposed permanent waves, hair colors, including facility space, pest control,
collection of information, including the deodorants, and tattoo inks, as well as practices ensuring the cleanliness and
validity of the methodology and any substance intended for use as a sanitation, water usage and treatment,
assumptions used; (3) ways to enhance component of a cosmetic product. Some and the proper functioning and
the quality, utility, and clarity of the cosmetic products are also regulated as operation of equipment.
information to be collected; and (4) drugs. • Materials and Manufacturing—
ways to minimize the burden of the As with other commodities FDA including practices for inventory
collection of information on regulates, the safety of cosmetic management, labeling and storage of
respondents, including through the use products can be ensured in part through raw materials, closures, and in process
of automated collection techniques, a manufacturer’s approach to the materials; and in process standard
when appropriate, and other forms of management of cosmetic quality. To operating procedures.
information technology. date, FDA has not identified in the • Quality Control/Product Testing—
published literature any systematic, including the scope of the quality
Survey of Current Manufacturing
detailed study of the diversity of the control unit, laboratory testing, dealing
Practices for the Cosmetics Industry—
practices and standards employed with rejected or returned products and
OMB Control Number 0910—New
across the cosmetic industry to ensure complaints, and corrective actions.
FDA has the responsibility to protect product quality and safety. This study is In addition, FDA will obtain the
public health and, as part of this broad intended to fill this gap. FDA proposes characteristics of surveyed
mandate, oversees the safety of the to conduct a voluntary survey of establishments such as the types of
nation’s cosmetic products. The Federal cosmetics establishments to identify the cosmetics produced, published
Food, Drug, and Cosmetic Act (FD&C current quality management and safety standards and guidelines followed, the
Act) prohibits the introduction into practices in the cosmetic industry. number of employees, the volume of
interstate commerce of any cosmetic production, and the approximate
that is adulterated or misbranded. The survey instrument will collect revenue. The survey will be
The FD&C Act defines cosmetics as data, on a voluntary basis, from administered by web or by mail
articles intended to be rubbed, poured, cosmetic product manufacturers on the (respondent choice) and it will be
sprinkled, or sprayed on, introduced following topics: directed to the Plant Manager of the
into, or otherwise applied to the human • Written Procedures and cosmetics establishment.
body for cleansing, beautifying, Documentation—including written This is a new, one-time data
promoting attractiveness, or altering the procedures and records for collection. FDA does not plan to collect
appearance. Among the products manufacturing involving personnel, raw this data from the cosmetics industry on
included in this definition are skin materials, processing, cleaning, an ongoing basis.
moisturizers, perfumes, lipsticks, maintenance, finished products, and FDA estimates the burden of this
fingernail polishes, eye and facial training. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent

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 burden for this collection of information DEPARTMENT OF HEALTH AND
establishments. After adjusting for to be 353.84 hours. HUMAN SERVICES
ineligibility (i.e., firms that do not Dated: June 26, 2018.
produce cosmetic products and those no Health Resources and Services
longer in operation) and a response rate Leslie Kux, Administration
of 70 percent, we expect 564 completed Associate Commissioner for Policy.
surveys. [FR Doc. 2018–14158 Filed 6–29–18; 8:45 am] Lists of Designated Primary Medical
BILLING CODE 4164–01–P
Care, Mental Health, and Dental Health
We expect each individual survey Professional Shortage Areas
invitation to take 5 minutes (0.08 hour)
to complete. Multiplying by the 898 AGENCY: Health Resources and Services
establishments that will receive the Administration (HRSA), Department of
survey invitation, we estimate the time Health and Human Services (HHS).
burden of the survey invitation to be ACTION: Notice.
daltland on DSKBBV9HB2PROD with NOTICES

71.84 hours. We expect each individual
survey to take 30 minutes (0.5 hour) to SUMMARY: This notice informs the public
complete. Multiplying by the estimated of the availability of the complete lists
564 establishments that will complete of all geographic areas, population
the survey, we estimate the time burden groups, and facilities designated as
of the survey to be 282 hours. We primary medical care, mental health,
estimate the total hourly reporting and dental health professional shortage

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Document Created: 2018-06-30 00:18:07
Document Modified: 2018-06-30 00:18:07

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 31, 2018.
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]
FR Citation		83 FR 30940

83 FR 30940 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Current Manufacturing Practices for the Cosmetics Industry

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 127 (July 2, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration