[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Notices]
[Pages 40840-40842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17054]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0355]
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) 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 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 September 13, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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
[[Page 40841]]
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) (Public Law 103-417) was signed into law. DSHEA, among
other things, amended the Federal Food, Drug, and Cosmetic Act (the
act) by adding section 402(g) of the act (21 U.S.C. 342(g)). Section
402(g)(2) of the 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 act also
stipulates that such regulations shall 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 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 act (21 U.S.C. 371(a)), FDA may issue regulations
necessary for the efficient enforcement of the 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
will show what is to be manufactured; what was, in fact, manufactured;
and whether the controls that the manufacturer put in place to control
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 requiring records, FDA will be able to 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 records requirements of the regulations include written
procedures and 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.
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. In the table, where the
same records are mentioned in more than one provision of a subpart, we
list the burden under the provisions corresponding to the heading in
the June 25, 2007, final rule, ``Under this subpart, what records must
you make and keep?'' For some provisions listed in table 1, we did not
estimate the annual frequency of recordkeeping 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 one as
the default for the annual frequency of recordkeeping. 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 annual
frequency of recordkeeping for these and similar provisions. For Sec.
111.35, the entry for annual frequency 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 annual frequency 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
frequency for 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:
[[Page 40842]]
Table 1.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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111.14 15,000 4 60,000 1 60,000
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111.23 15,000 1 15,000 0.2 3,000
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111.35 400 1 400 12.5 5,000
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111.95 250 1 250 45 11,250
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111.140 240 1,163 279,120 1 279,120
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111.180 240 1,163 279,120 1 279,120
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111.210 240 1 240 2.5 600
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111.260 145 1,408 204,160 1 204,160
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111.325 120 1 120 15 1,800
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111.375 260 1 260 2 520
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111.430 50 1 50 12.6 630
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111.475 15,000 1 15,000 0.4 6,000
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111.535 110 4 440 13.5 5,940
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111.570 240 600 144,000 0.5 72,000
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Total 929,140
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
The burden 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: July 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17054 Filed 7-13-10; 8:45 am]
BILLING CODE 4160-01-S