[Federal Register Volume 75, Number 186 (Monday, September 27, 2010)]
[Notices]
[Pages 59266-59268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0355]


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.

DATES: Fax written comments on the collection of information by October 
27, 2010.

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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 (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 
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 (the Secretary) may, by regulation, 
prescribe good manufacturing practices for dietary supplements. Section 
402(g) of the FD&C Act also stipulates that such regulations shall be 
modeled after current good manufacturing practices (CGMPs) 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. FDA published a final 
rule on June 25, 2007 (72 FR 34752) (the final rule) that established, 
in part 111 (21 CFR part 111), the minimum CGMPs 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 CGMPs. 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 CGMPs. 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 CGMPs 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

[[Page 59267]]

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 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.
    In the Federal Register of July 14, 2010 (75 FR 40840), FDA 
published a 60-day notice requesting public 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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                                                     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 costs or operating and maintenance costs associated with this collection of information.


[[Page 59268]]

    The burden estimates in table 1 of this document are based on those 
in the final rule, which were based on our institutional experience 
with other CGMP requirements and on data provided by Research Triangle 
Institute (RTI) 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 (SOPs) or do not maintain records that were later 
required by the 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 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24105 Filed 9-24-10; 8:45 am]
BILLING CODE 4160-01-P