[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18652-18654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07965]
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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 (PRA).
DATES: Fax written comments on the collection of information by May 22,
2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0606.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
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
On October 25, 1994, the Dietary Supplement Health and Education
Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other
things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section
402(g)(2) of the FD&C Act provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practices 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.'' Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA may issue regulations necessary for
the efficient enforcement of the FD&C Act. In the Federal Register of
June 25, 2007 (72 FR 34752), (the June 25, 2007, final rule), FDA
published a final rule that established, in part 111 (21 CFR part 111),
the minimum CGMP necessary for activities related to manufacturing,
packaging, labeling, or holding dietary supplements to ensure the
quality of the dietary supplement.
Records are an indispensable component of CGMP. The records
required by FDA's regulations in part 111 provide the foundation for
the planning, control, and improvement processes that constitute a
quality control system. Implementation of these processes in a
manufacturing operation serves as the backbone to CGMP. The records
show what is to be manufactured; what was, in fact, manufactured; and
whether the controls that the manufacturer put in place to ensure the
identity, purity, strength, and composition and limits on contaminants
and to prevent adulteration were effective. Further, records will 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. In addition, by
establishing recordkeeping requirements, FDA can ensure that industry
follows CGMP during manufacturing, packaging, labeling, or holding
operations. 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.
The recordkeeping requirements of the regulations 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.
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.
The recordkeeping requirements of the regulations in part 111 are
set forth in each subpart. In table 1, we list the annual burdens
associated with recordkeeping, as described in the June 25, 2007, final
rule. For some provisions listed in table 1, we did not estimate the
number of records per recordkeeper because recordkeeping occasions
consist of frequent brief entries of dates, temperatures, monitoring
results, or documentation that specific actions were taken. Information
might be recorded a few times a day, week, or month. When the records
burden involves frequent brief entries, we entered 1 as the default for
the number of records per recordkeeper. For example, many of the
records listed under Sec. 111.35 in table 1, such as Sec.
111.35(b)(2) (documentation, in individual equipment logs, of the date
of the use, maintenance, cleaning, and sanitizing of equipment),
involve many
[[Page 18653]]
short sporadic entries over the course of the year, varying across
equipment and plants in the industry. We did not attempt to estimate
the actual number of recordkeeping occasions for these provisions, but
instead entered an estimate of the average number of hours per year. We
entered the default value of 1 as the number of records per
recordkeeper for these and similar provisions. For Sec. 111.35, the
entry for number of records is 1 as a default representing a large
number of brief recordkeeping occasions.
In many rows of table 1, we list a burden under a single provision
that covers the written procedures or records described in several
provisions. For example, the burden of the batch production records
listed in table 1 under Sec. 111.260 includes the burden for records
listed under Sec. 111.255 because the batch production records must
include those records.
The number of records for batch production records (and other
records kept on a batch basis in table 1) equals the annual number of
batches. The estimated burden for records kept by batch includes both
records kept for every batch and records kept for some but not all
batches. We use the annual number of batches as the number of records
that will not necessarily be kept for every batch, such as test results
or material review and disposition records, because such records are
part of records, if they are necessary, that will be kept for every
batch.
In the Federal Register of September 29, 2016 (81 FR 66967), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from two commenters.
(Comment 1) One commenter had concerns about whether the processes
being used to assess the contents of supplements are genuine and
accurate and how this is regulated; whether records regarding labeling
indicate what is actually contained in a supplement; and whether these
records will be available to the public.
These comments appear to address PRA issues of practical utility
and ways to enhance the quality, utility, and clarity of the
information to be collected.
(Response 1) In this collection of information, FDA is evaluating
the burden of retaining records and making them available to regulatory
officials, but not the burden for proactively submitting them to FDA.
FDA reviews the records maintained while conducting an investigation
(e.g., during a facility inspection and during the followup
communication until a particular investigation is closed out). The
investigation of a particular firm by FDA is exempt from the PRA and is
not included as part of the burden estimate. The required elements of
labeling are part of different regulations and do not apply to this
collection of information. The commenter also discussed the safety of a
particular product but CGMP regulations deal with establishing a
quality product, not necessarily a safe product. Finally, the commenter
discussed allowing the records maintained to be made public. These
records are required to be maintained by the firm and are not
proactively submitted to FDA, but they are required to be made
available to FDA during inspections. If FDA obtains these records
during the investigation of a firm, the public can submit a Freedom of
Information Act request but the document they would typically receive
would be redacted because the records are the property of the firm.
(Comment 2) The second commenter stated that the labeling on
dietary supplement products should be consistent and FDA regulated, the
term ``healthy'' should be required to have a standard meaning, and
``healthy'' should not be allowed to be used unless it meets FDA
requirements of the term.
(Response 2) The recordkeeping for CGMPs has nothing to do with the
required elements of food and dietary supplement labeling, which are
covered under FDA's labeling regulations. FDA recently published, on
May 27, 2016, a final rule for Nutrition (and Supplement) Facts Labels
(81 FR 33741), and is currently reviewing new requirements for labeling
your food ``healthy''. This information collection for CGMP addresses
recordkeeping for specifications for a label and labeling operations.
FDA estimates 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 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.
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.
[[Page 18654]]
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.
The average burden per recordkeeping estimates in table 1 are based
on those in the June 25, 2007, final rule, which were based on our
institutional experience with other CGMP requirements and on data
provided by Research Triangle Institute in the ``Survey of
Manufacturing Practices in the Dietary Supplement Industry'' cited in
that rule.
The estimates in table 1 of the number of firms affected by each
provision of part 111 are based on the percentage of manufacturers,
packagers, labelers, holders, distributors, and warehousers that
reported in the survey that they have not established written SOPs or
do not maintain records that were later required by the June 25, 2007,
final rule. Because we do not have survey results for general
warehouses, we entered the approximate number of facilities in that
category for those provisions covering general facilities. For the
dietary supplement industry, the survey estimated that 1,460 firms
would be covered by the final rule, including manufacturers, packagers,
labelers, holders, distributors, and warehousers. The time estimates
include the burden involved in documenting that certain requirements
are performed and in recordkeeping. We used an estimated annual batch
production of 1,408 batches per year to estimate the burden of
requirements that are related to the number of batches produced
annually, such as Sec. 111.260, ``What must the batch production
record include?'' The estimate of 1,408 batches per year is near the
midpoint of the number of annual batches reported by survey firms.
The length of time that CGMP records must be maintained is set
forth in Sec. 111.605. Table 1 reflects the estimated burdens for
written procedures, record maintenance, periodically reviewing records
to determine if they may be discarded, and for any associated
documentation for that activity for records that are required under
part 111. We have not included a separate estimate of burden for those
sections that require maintaining records in accordance with Sec.
111.605, but have included those burdens under specific provisions for
keeping records. For example, Sec. 111.255(a) requires that the batch
production records be prepared every time a batch is manufactured, and
Sec. 111.255(d) requires that batch production records be kept in
accordance with Sec. 111.605. The estimated burdens for both Sec.
111.255(a) and (d) are included under Sec. 111.260, what the batch
record must include.
Dated: April 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-07965 Filed 4-19-17; 8:45 am]
BILLING CODE 4164-01-P