Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Cosmetic Good Manufacturing Practices, 61430-61433 [2015-25957]
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 089238 .........
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/60 mg.
Amitriptyline HCl Tablets USP, 150 mg ................................
Oxaliplatin for Injection USP, 50 mg/vial and 100 mg/vial ....
Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318.
ANDA 089244 .........
ANDA 089423 .........
ANDA 090849 .........
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)) and under authority
delegated to the Director of Food and
Drugs, Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective
November 12, 2015. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in table 1 that
are in inventory on the date that this
notice becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: October 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25922 Filed 10–9–15; 8:45 am]
BILLING CODE 4164–01–P
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.
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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Do.
Mutual Pharmaceutical Co., Inc.
Sandoz Inc., 506 Carnegie Center, Suite 400, Princeton,
NJ 08540.
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: 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): Division of
PO 00000
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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
https://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
https://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
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
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.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 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 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, PRAStaff@
fda.hhs.gov.
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
https://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
No. of
recordkeepers
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Section of draft guidance
Buildings and Facilities—Development of written procedures regarding maintaining the buildings and facilities
used for manufacturing in a clean and orderly manner ...
Equipment—Development of written procedures regarding
calibration and maintenance of equipment ......................
Personnel—Development of 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 ................................................
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No. of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total
hours
607
607
1
607
607
1
607
36
21,852
607
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1
1
607
3.6
2,185
Sfmt 4703
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
TABLE 1—ESTIMATED ONE-TIME BURDEN TO ESTABLISH WRITTEN PROCEDURES 1—Continued
No. of
recordkeepers
Section of draft guidance
Raw Materials—Development of 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 written procedures regarding
manufacturing operations .................................................
Laboratory Controls—Development of written procedures
regarding laboratory controls ...........................................
Internal Audit—Development of written procedures regarding internal audits .............................................................
Complaints, Adverse Events, and Recalls 2—Development
of written procedures regarding product complaints and
consumer adverse events ................................................
Complaints, Adverse Events, and Recalls 2—Records regarding returned product ..................................................
Total ..............................................................................
No. of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total
hours
607
1
607
10
6,070
607
1
607
68
41,276
607
1
607
45
27,315
607
1
607
10.7
6,495
607
1
607
12
7,284
607
1
607
6
3,642
........................
........................
........................
........................
116,726
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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).
2 To
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR RECORDS MAINTENANCE 1
No. of
recordkeepers
Section of draft guidance
Buildings and Facilities—Records regarding maintaining
the buildings and facilities used for manufacturing in a
clean and orderly manner ................................................
Equipment—Records regarding calibration and maintenance of equipment ..........................................................
Personnel—Records 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 .....
Raw Materials—Records regarding identifying, storing, examining, testing, inventorying, handling, and controlling
raw materials to ensure they conform to appropriate
standards and specifications ............................................
Production—Records regarding manufacturing operations
Laboratory Controls—Records regarding laboratory controls ...................................................................................
Internal Audit—Records of internal audits ...........................
Complaints, Adverse Events, and Recalls 2—Records regarding product complaints and consumer adverse
events ...............................................................................
Complaints, Adverse Events, and Recalls 2—Records regarding returned product ..................................................
Total ..............................................................................
No. of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total
hours
1,518
1
1,518
2
3,036
1,518
1
1,518
3.3
5,009
1,518
1
1,518
41.1
62,390
1,518
1,518
1
1
1,518
1,518
231.5
7.7
351,417
11,689
1,518
1,518
1
1
1,518
1,518
1.2
231.5
1,822
351,417
1,518
1
1,518
60.3
91,535
1,518
1
1,518
5.1
7,742
........................
........................
........................
........................
886,057
1 There
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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Jkt 238001
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
PO 00000
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Fmt 4703
Sfmt 4703
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
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
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
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21:23 Oct 09, 2015
Jkt 238001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3543]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Quantitative
Information in Direct-to-Consumer
Television Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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
research entitled ‘‘Quantitative
Information in Direct-to-Consumer
Television Advertisements.’’ The
objective of this research is to test
consumers’ understanding of
quantitative information about
prescription drugs in DTC television
advertisements (ads).
DATES: Submit either electronic or
written comments on the collection of
information by December 14, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
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61433
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): 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–3543 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Quantitative Information in Direct-toConsumer Television Advertisements.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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): 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 https://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 https://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: https://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 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 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, PRAStaff@fda.hhs.gov.
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 https://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\
----------------------------------------------------------------------------------------------------------------
No. of records Average burden
Section of draft guidance No. of per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
