[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\
----------------------------------------------------------------------------------------------------------------
                                                      Number of
    21 CFR section; activity         Number of      responses per     Total annual    Average burden     Total
                                    respondents       respondent       responses       per response      hours
----------------------------------------------------------------------------------------------------------------
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