[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10530-10532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04014]


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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.

[[Page 10531]]


DATES: Fax written comments on the collection of information by March 
27, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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 (CGMP) 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 methodologies. 
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 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 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 December 19, 2013 (78 FR 76836), FDA 
published a 60-day notice requesting public

[[Page 10532]]

comment on the proposed collection of information. No comments were 
received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                    Number of                     Average burden
         21 CFR Section             Number of      records per    Total annual         per          Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
111.14, records of personnel             15,000               4          60,000              1            60,000
 practices, including
 documentation of training.....
111.23, records of physical              15,000               1          15,000              0.2           3,000
 plant sanitation practices,
 including pest control and
 water quality.................
111.35, records of equipment                400               1             400             12.5           5,000
 and utensils calibration and
 sanitation practices..........
111.95, records of production               250               1             250             45            11,250
 and process control systems...
111.140, records that quality               240            1163         279,120              1           279,120
 control personnel must make
 and keep......................
111.180, records associated                 240            1163         279,120              1           279,120
 with components, packaging,
 labels, and product received
 for packaging and labeling as
 a dietary supplement..........
111.210, requirements for what              240               1             240              2.5             600
 the master manufacturing
 record must include...........
111.260, requirements for what              145            1408         204,160              1           204,160
 the batch record must include.
111.325, records that quality               120               1             120             15             1,800
 control personnel must make
 and keep for laboratory
 operations....................
111.375, records of the written             260               1             260              2               520
 procedures established for
 manufacturing operations......
111.430, records of the written              50               1              50             12.6             630
 procedures for packaging and
 labeling operations...........
111.475, records of product              15,000               1          15,000              0.4           6,000
 distribution and procedures
 for holding and distributing
 operations....................
111.535, records for returned               110               4             440             13.5           5,940
 dietary supplements...........
111.570, records regarding                  240             600         144,000              0.5          72,000
 product complaints............
                                --------------------------------------------------------------------------------
    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 standard 
operating procedures 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: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04014 Filed 2-24-14; 8:45 am]
BILLING CODE 4160-01-P