[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         929,140
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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