[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]


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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.

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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\
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                                                 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
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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 hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75; petition for exemption from 100% identity testing..........               1                1                1                8                8
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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: 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


