[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18998-19000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07000]


-----------------------------------------------------------------------

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; 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 May 4, 2020.

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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--Revision

    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 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

[[Page 18999]]

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 (21 CFR 111.75) 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 
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 
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. This reporting burden is currently accounted for under OMB 
control number 0910-0608, Petition to Request an Exemption from 100 
Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, 
Packaging, Labeling or Holding Operations for Dietary Supplements. With 
this notice, we propose to consolidate information collection under 
Sec.  111.75 into the instant and related information collection.
    Description of Respondents: Manufacturers, dietary supplement 
manufacturers, packagers and repackagers, labelers and re-labelers, 
holders, distributors, warehousers, exporters, importers, large 
businesses, and small businesses engaged in the dietary supplement 
industry.
    In the Federal Register of December 5, 2019 (84 FR 66678), we 
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                     Average  burden
   21 CFR section; activity        Number of      records per    Total annual          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 of equipment               400               1             400  12.5............           5,000
 and utensils calibration and
 sanitation practices.
111.95; records of production              250               1             250  45..............          11,250
 and process control systems.
111.140; records that quality              240           1,163         279,120  1...............         279,120
 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 what             240               1             240  2.5.............             600
 the master manufacturing
 record must include.
111.260; requirements for what             145           1,408         204,160  1...............         204,160
 the batch record must include.
111.325; records that quality              120               1             120  15..............           1,800
 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 returned              110               4             440  13.5............           5,940
 dietary supplements.
111.570; records regarding                 240             600         144,000  0.5 (30 minutes)          72,000
 product complaints.

[[Page 19000]]

 
    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 percent identity testing.               1                1                1                  8                8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have made no changes to our estimate of the information 
collection based on our most recent review. However, in consolidating 
burden from information collection previously accounted for under OMB 
control number 0910-0608, the information collection reflects an 
increase of 8 hours and one response annually.

    Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07000 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P


