[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61430-61433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3456]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Recommended Recordkeeping for Cosmetic Good 
Manufacturing Practices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. Under the Paperwork Reduction Act of 1995 (the PRA), 
Federal Agencies must publish a notice in the Federal Register 
concerning each proposed collection of information, including 
collections of information in current guidance documents, and allow 60 
days for public comment. This notice invites comments on the 
recommended recordkeeping associated with our draft guidance entitled, 
``Draft Guidance for Industry: Cosmetic Good Manufacturing Practices.'' 
Our draft guidance remains unchanged by this notice. We are publishing 
this notice in compliance with the PRA. This notice does not represent 
any new regulatory initiative.

DATES: Submit either electronic or written comments on the collection 
of information by December 14, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-N-3456 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Recommended Recordkeeping for 
Cosmetic Good Manufacturing Practices.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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

[[Page 61431]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including 
collections of information in current guidance documents, before 
submitting the collection to OMB for approval. To comply with this 
requirement, we are publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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.

Recommended Recordkeeping for Cosmetic Good Manufacturing Practices OMB 
Control Number 0910-NEW

    The draft guidance, entitled ``Draft Guidance for Industry: 
Cosmetic Good Manufacturing Practices,'' (available at http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm353046.htm#Raw) provides guidance to industry and other stakeholders 
(e.g., consumer interest groups, academia, other regulatory groups) on 
our current thinking concerning what constitutes Good Manufacturing 
Practices (GMPs) for cosmetics. It is intended to assist industry and 
other stakeholders in identifying the standards and issues that can 
affect the quality of cosmetic products. In addition, as part of an 
international harmonization effort with the International Cooperation 
on Cosmetic Regulations (ICCR), we agreed to consider the current 
International Organization for Standardization (ISO) standard for 
cosmetic GMPs (ISO 22716:2007) when developing the draft guidance. We 
have incorporated elements of ISO 22716, as appropriate, and that are 
consistent with our regulations.
    Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 331) prohibits the introduction, or delivery for 
introduction, into interstate commerce of cosmetics that are 
adulterated or misbranded. Manufacturers of cosmetics can reduce the 
risk of adulterating or misbranding cosmetics by following the GMP 
recommendations in the draft guidance.
    The draft guidance recommends that manufacturers of cosmetics 
prepare written procedures and maintain records pertaining to: (1) 
Buildings and facilities; (2) equipment; (3) personnel; (4) raw 
materials; (5) production; (6) laboratory controls; (7) internal 
audits; and, (8) complaints, adverse events, and recalls.
    We expect that manufacturers of cosmetics that choose to follow the 
recommendations of this Cosmetic GMP draft guidance would maintain 
records of their written procedures as well as their test methods or 
other appropriate verification procedures. It is also possible that 
manufacturers would obtain and maintain records of Certificates of 
Analysis, test results, or other appropriate verification procedures 
from their suppliers.
    GMP is concerned with both manufacturing and quality control 
procedures. Manufacturers of cosmetics will use their written 
procedures and records as that part of quality assurance aimed at 
ensuring that products are consistently manufactured to a quality 
appropriate to their intended use. Records would be compiled and 
retained at each manufacturing facility.
    Description of Respondents: The respondents are manufacturers of 
cosmetic products.
    Our draft guidance remains unchanged by this notice. We are 
publishing this notice in compliance with the PRA. This notice does not 
represent any new regulatory initiative.
    We estimate the burden of this collection of information as 
follows:

                     Table 1--Estimated One-Time Burden to Establish Written Procedures \1\
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                                                  No. of records                  Average burden
    Section of draft guidance         No. of            per        Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Buildings and Facilities--                   607               1             607               1             607
 Development of written
 procedures regarding
 maintaining the buildings and
 facilities used for
 manufacturing in a clean and
 orderly manner.................
Equipment--Development of                    607               1             607              36          21,852
 written procedures regarding
 calibration and maintenance of
 equipment......................
Personnel--Development of                    607               1             607             3.6           2,185
 written procedures regarding
 personnel, including
 documentation of education,
 training, and/or experience of
 personnel, and preventing
 microbial contamination from
 sick or infected personnel, and
 for hygienic practices.........

[[Page 61432]]

 
Raw Materials--Development of                607               1             607              10           6,070
 written procedures for
 identifying, storing,
 examining, testing,
 inventorying, handling, and
 controlling raw materials to
 ensure they conform to
 appropriate standards and
 specifications.................
Production--Development of                   607               1             607              68          41,276
 written procedures regarding
 manufacturing operations.......
Laboratory Controls--Development             607               1             607              45          27,315
 of written procedures regarding
 laboratory controls............
Internal Audit--Development of               607               1             607            10.7           6,495
 written procedures regarding
 internal audits................
Complaints, Adverse Events, and              607               1             607              12           7,284
 Recalls \2\--Development of
 written procedures regarding
 product complaints and consumer
 adverse events.................
Complaints, Adverse Events, and              607               1             607               6           3,642
 Recalls \2\--Records regarding
 returned product...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         116,726
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ To avoid double-counting, the burden hour analysis in table 1 does not include burden hours already
  accounted for in the information collection approved under OMB control number 0910-0249 for our recall
  regulations (21 CFR part 7).


                   Table 2--Estimated Annual Recordkeeping Burden for Records Maintenance \1\
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                                                  No. of records                  Average burden
    Section of draft guidance         No. of            per        Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Buildings and Facilities--                 1,518               1           1,518               2           3,036
 Records regarding maintaining
 the buildings and facilities
 used for manufacturing in a
 clean and orderly manner.......
Equipment--Records regarding               1,518               1           1,518             3.3           5,009
 calibration and maintenance of
 equipment......................
Personnel--Records regarding               1,518               1           1,518            41.1          62,390
 personnel, including
 documentation of education,
 training and/or experience of
 personnel, and preventing
 microbial contamination from
 sick or infected personnel, and
 for hygienic practices.........
Raw Materials--Records regarding           1,518               1           1,518           231.5         351,417
 identifying, storing,
 examining, testing,
 inventorying, handling, and
 controlling raw materials to
 ensure they conform to
 appropriate standards and
 specifications.................
Production--Records regarding              1,518               1           1,518             7.7          11,689
 manufacturing operations.......
Laboratory Controls--Records               1,518               1           1,518             1.2           1,822
 regarding laboratory controls..
Internal Audit--Records of                 1,518               1           1,518           231.5         351,417
 internal audits................
Complaints, Adverse Events, and            1,518               1           1,518            60.3          91,535
 Recalls \2\--Records regarding
 product complaints and consumer
 adverse events.................
Complaints, Adverse Events, and            1,518               1           1,518             5.1           7,742
 Recalls \2\--Records regarding
 returned product...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         886,057
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ To avoid double-counting, the burden hour analysis in table 1 does not include burden hours already
  accounted for in the information collection approved under OMB control number 0910-0249 for our recall
  regulations (21 CFR part 7).

    In table 1 we list the one-time burdens associated with 
establishing written procedures. In table 2 we list the annual burdens 
associated with recordkeeping. We base our estimates of the number of 
recordkeepers reported in column 2 of tables 1 and 2 on data available 
to us, our knowledge of and experience with the cosmetics industry, and 
our communications with industry, as well as our estimate of the number 
of recordkeepers subject to cosmetic labeling regulations, published in 
the Federal Register of June 25, 2014 (79 FR 36069). We estimate there 
are 1,518 cosmetic product establishments in the United States (79 FR 
36069 at 36070). We estimate that 20 percent of these (304 
establishments) are large businesses and 80 percent (1,214 
establishments) are small businesses. We further estimate that large 
businesses are likely to have established written procedures and that 
about half of the small businesses (607 establishments) may not have 
established written procedures. Thus, for purposes of this analysis, we 
assume that these 607 establishments will undertake to establish 
written procedures recommended by the draft guidance, when it is 
finalized, as reported in table 1, column 2. We

[[Page 61433]]

further assume that the 1,518 cosmetic product establishments may not 
maintain all of the records recommended by the draft guidance. Thus, 
for purposes of this analysis, we assume that 1,518 establishments will 
keep the records recommended by the draft guidance, when it is 
finalized, as reported in table 2, column 2. We further assume that if 
multiple products are produced in the same facility, the written 
procedures and recordkeeping will be shared among the multiple 
products.
    We base our estimates of the number of records per recordkeeper and 
the average burden per recordkeeping reported in columns 3 and 5 of 
tables 1 and 2 on our experience with good manufacturing practices used 
to control the identity and composition of food and dietary supplements 
and to limit contaminants and prevent adulteration, as well as our 
estimate of the burden of similar recordkeeping activities described in 
the dietary supplement final rule published in the Federal Register of 
June 25, 2007 (72 FR 34752 at 34916) (the June 25, 2007, final rule), 
that established, in part 111 (21 CFR part 111), the minimum good 
manufacturing practices necessary for dietary supplements. For the 
recordkeeping recommendations listed in table 2, the recordkeeping 
occasions consist of frequent brief entries of dates, temperatures, 
monitoring results, or documentation that specific actions were taken. 
Information might be recorded a few times a day, week, or month. 
Because the records burden involves frequent brief entries, we did not 
attempt to estimate the actual number of recordkeeping occasions for 
these activities. We entered one as the default for the number of 
records per recordkeeper and we calculated the average burden per 
recordkeeping in column 5 based on the reported burden of similar 
provisions estimated in the June 25, 2007, final rule, averaged across 
the 1,460 firms covered by that final rule.
    The estimates for the recordkeeping burdens presented here are 
averages. We anticipate that the time spent to develop written 
procedures and recordkeeping would vary based on the type of cosmetic 
product manufactured. The estimated burdens for developing 
recordkeeping includes record maintenance, periodically reviewing 
records to determine if they may be discarded, and any associated 
documentation for that activity.
    This draft guidance also refers to previously approved collections 
of information found in our regulations. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the PRA (44 U.S.C. 3501-3521). The collections of 
information in our recall regulations in 21 CFR part 7 have been 
approved under OMB control number 0910-0249. The collection of 
information in 21 CFR 70.25, which requires that color additives 
subject to certification be labeled with the lot number assigned by the 
Color Certification Branch, has been approved under OMB control number 
0910-0016.

    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25957 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P