[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,
[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
[[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
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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