[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62429-62432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1619]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements
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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of FDA's regulations regarding current good
[[Page 62430]]
manufacturing practice (CGMP) for dietary supplements.
DATES: Either electronic or written comments on the collection of
information must be submitted by December 13, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 13, 2022. 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-2013-N-1619 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Operations
for Dietary Supplements.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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: 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
each proposed extension of an existing 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
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.
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 (DSHEA) (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 CGMP regulations for food and may not impose standards for which
there are no current, and generally available,
[[Page 62431]]
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 promulgated 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 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).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section; activity Number of records per Total annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
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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.
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[[Page 62432]]
Total................... .............. .............. .............. ....................... 929,140
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
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111.75; petition for exemption 1 1 1 8 8
from 100 percent identity
testing........................
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\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: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22303 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P