[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