Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 66678-66680 [2019-26250]
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
adjustment to an increase in the number
HCT/P establishments and an increase
in the number HCT/Ps distributed over
the past few years.
Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26234 Filed 12–4–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by February 3, 2020.
DATES:
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.
jbell on DSKJLSW7X2PROD with NOTICES
ADDRESSES:
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17:38 Dec 04, 2019
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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
PO 00000
Frm 00030
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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/201523389.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
E:\FR\FM\05DEN1.SGM
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
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)
66679
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 § 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
Number of
recordkeepers
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR section; activity
111.14; records of personnel practices, including documentation of
training.
111.23; records of physical plant sanitation practices, including pest
control and water quality.
111.35; records of equipment and utensils calibration and sanitation
practices.
111.95; records of production and process control systems ..................
111.140; records that quality control personnel must make and keep ..
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17:38 Dec 04, 2019
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PO 00000
Frm 00031
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
15,000
4
60,000
1 ...................................
60,000
15,000
1
15,000
0.2 (12 minutes) ..........
3,000
400
1
400
12.5 ..............................
5,000
250
240
1
1,163
250
279,120
45 .................................
1 ...................................
11,250
279,120
Fmt 4703
Sfmt 4703
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section; activity
111.180; records associated with components, packaging, labels, and
product received for packaging and labeling as a dietary supplement.
111.210; requirements for what the master manufacturing record must
include.
111.260; requirements for what the batch record must include .............
111.325; records that quality control personnel must make and keep
for laboratory operations.
111.375; records of the written procedures established for manufacturing operations.
111.430; records of the written procedures for packaging and labeling
operations.
111.475; records of product distribution and procedures for holding
and distributing operations.
111.535; records for returned dietary supplements ................................
111.570; records regarding product complaints .....................................
Total .................................................................................................
1 There
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
240
1,163
279,120
1 ...................................
279,120
240
1
240
2.5 ................................
600
145
120
1,408
1
204,160
120
1 ...................................
15 .................................
204,160
1,800
260
1
260
2 ...................................
520
50
1
50
12.6 ..............................
630
15,000
1
15,000
0.4 (24 minutes) ..........
6,000
110
240
4
600
440
144,000
13.5 ..............................
0.5 (30 minutes) ..........
5,940
72,000
........................
........................
........................
......................................
929,140
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
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.
Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Quality Assurance Advisory Committee
in the Center for Devices and
Radiological Health. Nominations will
be accepted for upcoming vacancies
effective with this notice.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
[FR Doc. 2019–26250 Filed 12–4–19; 8:45 am]
DATES:
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.
Nominations received on or
before February 3, 2020, will be given
first consideration for membership on
the National Mammography Quality
Assurance Advisory Committee.
Nominations received after February 3,
2020, will be considered for nomination
to the committee as later vacancies
occur.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3207]
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the National Mammography
SUMMARY:
VerDate Sep<11>2014
17:38 Dec 04, 2019
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All nominations for
membership should be submitted
electronically by logging into the FDA
Advisory Nomination Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
ADDRESSES:
Request for Nominations of Voting
Members on a Public Advisory
Committee; National Mammography
Quality Assurance Advisory
Committee
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership: Sara Anderson, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5210,
Silver Spring, MD 20993, 301–796–
7047, email: Sara.Anderson@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the National Mammography Quality
Assurance Advisory Committee.
I. General Description of the Committee
Duties
The National Mammography Quality
Assurance Advisory Committee advises
the Commissioner of Food and Drugs
(the Commissioner) or designee on: (1)
Developing appropriate quality
standards and regulations for
mammography facilities; (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program; (3)
developing regulations with respect to
sanctions; (4) developing procedures for
monitoring compliance with standards;
(5) establishing a mechanism to
investigate consumer complaints; (6)
reporting new developments concerning
breast imaging that should be
E:\FR\FM\05DEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75; petition for exemption from 100 percent identity 1 1 1 8 8
testing.......................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
