[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66678-66680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26250]


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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 or Agency) 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 manufacturing practice (CGMP) 
for dietary supplements.

DATES: Submit either electronic or written comments on the collection 
of information by February 3, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 3, 2020. 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.
     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.gpo.gov/fdsys/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.

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: 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

[[Page 66679]]

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--Revision

    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, 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 (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.
    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 recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
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111.14; records of personnel practices,                15,000               4          60,000  1........................................          60,000
 including documentation of training.
111.23; records of physical plant sanitation           15,000               1          15,000  0.2 (12 minutes).........................           3,000
 practices, including pest control and water
 quality.
111.35; records of equipment and utensils                 400               1             400  12.5.....................................           5,000
 calibration and sanitation practices.
111.95; records of production and process                 250               1             250  45.......................................          11,250
 control systems.
111.140; records that quality control                     240           1,163         279,120  1........................................         279,120
 personnel must make and keep.

[[Page 66680]]

 
111.180; records associated with components,              240           1,163         279,120  1........................................         279,120
 packaging, labels, and product received for
 packaging and labeling as a dietary
 supplement.
111.210; requirements for what the master                 240               1             240  2.5......................................             600
 manufacturing record must include.
111.260; requirements for what the batch                  145           1,408         204,160  1........................................         204,160
 record must include.
111.325; records that quality control                     120               1             120  15.......................................           1,800
 personnel must make and keep for laboratory
 operations.
111.375; records of the written procedures                260               1             260  2........................................             520
 established for manufacturing operations.
111.430; records of the written procedures                 50               1              50  12.6.....................................             630
 for packaging and labeling operations.
111.475; records of product distribution and           15,000               1          15,000  0.4 (24 minutes).........................           6,000
 procedures for holding and distributing
 operations.
111.535; records for returned dietary                     110               4             440  13.5.....................................           5,940
 supplements.
111.570; records regarding product complaints             240             600         144,000  0.5 (30 minutes).........................          72,000
                                              ----------------------------------------------------------------------------------------------------------
    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  per    Total hours
                                                                   respondents       respondent       responses           response
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111.75; petition for exemption from 100 percent identity                      1                1                1                    8                8
 testing.......................................................
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\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: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26250 Filed 12-4-19; 8:45 am]
 BILLING CODE 4164-01-P


