[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.14 15,000 4 60,000 1 60,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.23 15,000 1 15,000 0.2 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.35 400 1 400 12.5 5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.95 250 1 250 45 11,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.140 240 1,163 279,120 1 279,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.180 240 1,163 279,120 1 279,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.210 240 1 240 2.5 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.260 145 1,408 204,160 1 204,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.325 120 1 120 15 1,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.375 260 1 260 2 520
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.430 50 1 50 12.6 630
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.475 15,000 1 15,000 0.4 6,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.535 110 4 440 13.5 5,940
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.570 240 600 144,000 0.5 72,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 929,140
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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