Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 27898-27899 [2023-09411]
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27898
Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Notices
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VerDate Sep<11>2014
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Jkt 259001
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09321 Filed 5–2–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by June 2,
2023.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0606. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements—21 CFR Part 111
OMB Control Number 0910–0606—
Extension
The Dietary Supplement Health and
Education Act (Pub. L. 103–417) added
section 402(g) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
342(g)), which provides, in part, that the
Secretary of Health and Human Services
may, by regulation, prescribe good
manufacturing practice for dietary
supplements. Section 402(g) of the
FD&C Act also stipulates that such
regulations will be modeled after
Current Good Manufacturing Practice
(CGMP) regulations for food and may
not impose standards for which there
are no current, and generally available,
analytical methodology. Section
402(g)(1) of the FD&C Act states that a
dietary supplement is adulterated if it
has been prepared, packed, or held
under conditions that do not meet
current good manufacturing practice
regulations.
Accordingly, we have issued
regulations in part 111 (21 CFR part
111) establishing minimum CGMP
requirements pertaining to the
manufacturing, packaging, labeling, or
holding of dietary supplements to
ensure their quality. Included among
the requirements is recordkeeping,
documenting, planning, control, and
improvement processes of a quality
control system. Implementation of these
processes in a manufacturing operation
serves as the backbone to CGMP. The
records must show what is being
manufactured and whether the controls
in place ensure the product’s identity,
purity, strength, and composition and
that limits on contaminants and
measures to prevent adulteration are
effective. Further, records must show
whether and what deviations from
control processes occurred, facilitate
evaluation and corrective action
concerning these deviations (including,
where necessary, whether associated
batches of product should be recalled
from the marketplace), and enable a
manufacturer to assure that the
corrective action was effective. We
believe the regulations in part 111
establish the minimum manufacturing
practices necessary to ensure that
dietary supplements are manufactured,
packaged, labeled, or held in a manner
E:\FR\FM\03MYN1.SGM
03MYN1
27899
Federal Register / Vol. 88, No. 85 / Wednesday, May 3, 2023 / Notices
that will ensure the quality of the
dietary supplements during
manufacturing, packaging, labeling, or
holding operations.
Specifically, the recordkeeping
requirements of the regulations in part
111 include establishing written
procedures and maintaining records
pertaining to: (1) personnel; (2)
sanitation; (3) calibration of instruments
and controls; (4) calibration, inspection,
or checks of automated, mechanical, or
electronic equipment; (5) maintaining,
cleaning, and sanitizing equipment and
utensils and other contact surfaces; (6)
water used that may become a
component of the dietary supplement;
(7) production and process controls; (8)
quality control; (9) components,
packaging, labels, and product received
for packaging and labeling; (10) master
manufacturing and batch production;
(11) laboratory operations; (12)
manufacturing operations; (13)
packaging and labeling operations; (14)
holding and distributing operations; (15)
returned dietary supplements; and (16)
product complaints.
Section 111.75(a)(1) (21 CFR
111.75(a)(1)) reflects FDA’s
determination that manufacturers that
test or examine 100 percent of the
incoming dietary ingredients for
identity can be assured of the identity
of the ingredient. However, we
recognize that it may be possible for a
manufacturer to demonstrate, through
various methods and processes in use
over time for its particular operation,
that a system of less than 100 percent
identity testing would result in no
material diminution of assurance of the
identity of the dietary ingredient as
compared to the assurance provided by
100 percent identity testing. Section
111.75(a)(1) provides an opportunity for
a manufacturer to make such a showing
and reduce the frequency of identity
testing of components that are dietary
ingredients from 100 percent to some
lower frequency. Section 111.75(a)(1)
also sets forth the information a
manufacturer is required to submit for
an exemption from the requirement of
100 percent identity testing when a
manufacturer petitions the Agency for
such an exemption to 100 percent
identity testing under 21 CFR 10.30 and
the Agency grants such exemption.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packagers and repackagers, labelers and
re-labelers, holders, distributors,
warehousers, exporters, importers, large
businesses, and small businesses
engaged in the dietary supplement
industry. Respondents are from the
private sector (for-profit businesses).
In the Federal Register of October 14,
2022 (87 FR 62429), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
111.14; records of personnel practices, including documentation of training ..
111.23; records of physical plant sanitation practices, including pest control
and water quality.
111.35; records regarding equipment and utensils, including calibration and
sanitation practices.
111.95; records of production and process control systems ............................
111.140; records that quality control personnel must make and keep ............
111.180; records associated with components, packaging, labels, and product received for packaging and labeling as a dietary supplement.
111.210; requirements for what the master manufacturing record must include.
111.260; requirements for what the batch production record must include .....
111.325; records that quality control personnel must make and keep for laboratory operations.
111.375; records of the written procedures established for manufacturing operations.
111.430; records of the written procedures for packaging and labeling operations.
111.475; records of product distribution and procedures for holding and distributing operations.
111.535; records for returned dietary supplements ..........................................
111.570; records regarding product complaints ...............................................
Total ...........................................................................................................
1 There
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
15,000
15,000
4
1
60,000
15,000
1 ........................
0.2 (12 minutes)
60,000
3,000
400
1
400
12.5 ...................
5,000
250
240
240
1
1,163
1,163
250
279,120
279,120
45 ......................
1 ........................
1 ........................
11,250
279,120
279,120
240
1
240
2.5 .....................
600
145
120
1,408
1
204,160
120
1 ........................
15 ......................
204,160
1,800
260
1
260
2 ........................
520
50
1
50
12.6 ...................
630
15,000
1
15,000
0.4 (24 minutes)
6,000
110
240
4
600
440
144,000
13.5 ...................
0.5 (30 minutes)
5,940
72,000
........................
........................
........................
...........................
929,140
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
111.75; petition for exemption from 100% identity testing ...................................
1
1
1
8
8
lotter on DSK11XQN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. We
base our estimates for the recordkeeping
and reporting burdens on our
VerDate Sep<11>2014
18:32 May 02, 2023
Jkt 259001
experience with the recordkeeping and
petition activities.
PO 00000
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09411 Filed 5–2–23; 8:45 am]
BILLING CODE 4164–01–P
Frm 00043
Fmt 4703
Sfmt 9990
E:\FR\FM\03MYN1.SGM
03MYN1
]]>Agencies
[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Notices]
[Pages 27898-27899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1619]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 2, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0606. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part
111
OMB Control Number 0910-0606--Extension
The Dietary Supplement Health and Education Act (Pub. L. 103-417)
added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practice for dietary supplements. Section 402(g) of the
FD&C Act also stipulates that such regulations will be modeled after
Current Good Manufacturing Practice (CGMP) regulations for food and may
not impose standards for which there are no current, and generally
available, analytical methodology. Section 402(g)(1) of the FD&C Act
states that a dietary supplement is adulterated if it has been
prepared, packed, or held under conditions that do not meet current
good manufacturing practice regulations.
Accordingly, we have issued regulations in part 111 (21 CFR part
111) establishing minimum CGMP requirements pertaining to the
manufacturing, packaging, labeling, or holding of dietary supplements
to ensure their quality. Included among the requirements is
recordkeeping, documenting, planning, control, and improvement
processes of a quality control system. Implementation of these
processes in a manufacturing operation serves as the backbone to CGMP.
The records must show what is being manufactured and whether the
controls in place ensure the product's identity, purity, strength, and
composition and that limits on contaminants and measures to prevent
adulteration are effective. Further, records must show whether and what
deviations from control processes occurred, facilitate evaluation and
corrective action concerning these deviations (including, where
necessary, whether associated batches of product should be recalled
from the marketplace), and enable a manufacturer to assure that the
corrective action was effective. We believe the regulations in part 111
establish the minimum manufacturing practices necessary to ensure that
dietary supplements are manufactured, packaged, labeled, or held in a
manner
[[Page 27899]]
that will ensure the quality of the dietary supplements during
manufacturing, packaging, labeling, or holding operations.
Specifically, the recordkeeping requirements of the regulations in
part 111 include establishing written procedures and maintaining
records pertaining to: (1) personnel; (2) sanitation; (3) calibration
of instruments and controls; (4) calibration, inspection, or checks of
automated, mechanical, or electronic equipment; (5) maintaining,
cleaning, and sanitizing equipment and utensils and other contact
surfaces; (6) water used that may become a component of the dietary
supplement; (7) production and process controls; (8) quality control;
(9) components, packaging, labels, and product received for packaging
and labeling; (10) master manufacturing and batch production; (11)
laboratory operations; (12) manufacturing operations; (13) packaging
and labeling operations; (14) holding and distributing operations; (15)
returned dietary supplements; and (16) product complaints.
Section 111.75(a)(1) (21 CFR 111.75(a)(1)) reflects FDA's
determination that manufacturers that test or examine 100 percent of
the incoming dietary ingredients for identity can be assured of the
identity of the ingredient. However, we recognize that it may be
possible for a manufacturer to demonstrate, through various methods and
processes in use over time for its particular operation, that a system
of less than 100 percent identity testing would result in no material
diminution of assurance of the identity of the dietary ingredient as
compared to the assurance provided by 100 percent identity testing.
Section 111.75(a)(1) provides an opportunity for a manufacturer to make
such a showing and reduce the frequency of identity testing of
components that are dietary ingredients from 100 percent to some lower
frequency. Section 111.75(a)(1) also sets forth the information a
manufacturer is required to submit for an exemption from the
requirement of 100 percent identity testing when a manufacturer
petitions the Agency for such an exemption to 100 percent identity
testing under 21 CFR 10.30 and the Agency grants such exemption.
Description of Respondents: Respondents to this collection of
information include manufacturers, packagers and repackagers, labelers
and re-labelers, holders, distributors, warehousers, exporters,
importers, large businesses, and small businesses engaged in the
dietary supplement industry. Respondents are from the private sector
(for-profit businesses).
In the Federal Register of October 14, 2022 (87 FR 62429), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
111.14; records of personnel 15,000 4 60,000 1................. 60,000
practices, including
documentation of training.
111.23; records of physical 15,000 1 15,000 0.2 (12 minutes).. 3,000
plant sanitation practices,
including pest control and
water quality.
111.35; records regarding 400 1 400 12.5.............. 5,000
equipment and utensils,
including calibration and
sanitation practices.
111.95; records of 250 1 250 45................ 11,250
production and process
control systems.
111.140; records that 240 1,163 279,120 1................. 279,120
quality control personnel
must make and keep.
111.180; records associated 240 1,163 279,120 1................. 279,120
with components, packaging,
labels, and product
received for packaging and
labeling as a dietary
supplement.
111.210; requirements for 240 1 240 2.5............... 600
what the master
manufacturing record must
include.
111.260; requirements for 145 1,408 204,160 1................. 204,160
what the batch production
record must include.
111.325; records that 120 1 120 15................ 1,800
quality control personnel
must make and keep for
laboratory operations.
111.375; records of the 260 1 260 2................. 520
written procedures
established for
manufacturing operations.
111.430; records of the 50 1 50 12.6.............. 630
written procedures for
packaging and labeling
operations.
111.475; records of product 15,000 1 15,000 0.4 (24 minutes).. 6,000
distribution and procedures
for holding and
distributing operations.
111.535; records for 110 4 440 13.5.............. 5,940
returned dietary
supplements.
111.570; records regarding 240 600 144,000 0.5 (30 minutes).. 72,000
product complaints.
-----------------------------------------------------------------------------------
Total................... .............. .............. .............. .................. 929,140
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75; petition for exemption from 100% identity testing.......... 1 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. We base our estimates for the recordkeeping and reporting
burdens on our experience with the recordkeeping and petition
activities.
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09411 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P
