
[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Pages 66967-66970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23521]


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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 we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 invites 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 November 28, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you

[[Page 66968]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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--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 
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), 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

[[Page 66969]]

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 of this document, 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 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 of this document, 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 of this document) 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.
    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 personnel             240           1,163         279,120  1......................................         279,120
 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 record             145           1,408         204,160  1......................................         204,160
 must include.
111.325, Records that quality control personnel             120               1             120  15.....................................           1,800
 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 for               50               1              50  12.6...................................             630
 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.

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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 of this 
document 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 of this document 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: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23521 Filed 9-28-16; 8:45 am]
 BILLING CODE 4164-01-P


