SUPPORTING STATEMENT
Terms of Clearance: None.
1.
Circumstances Making the Collection of Information Necessary
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 may, by regulation,
prescribe good manufacturing practices (CGMP) 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 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. In the Federal
Register of June
25, 2007 (72 FR 34752), FDA published a final rule (the 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.
We request OMB approval of the following information collection requirements:
21 CFR Part 111 -- Recordkeeping:
Requires firms to retain, and make available to regulatory officials, records regarding current good manufacturing practice for dietary supplements.
2.
Purpose and Use of the Information Collection
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 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. Respondents are from the private sector (for-profit businesses).
3.
Use of Improved Information Technology and Burden Reduction
The
regulation does not specifically prescribe the use of automated,
electronic, mechanical, or other technological techniques or other
forms of information technology as necessary for use by firms.
Companies are free to use whatever forms of information technology
may best assist them in retaining the appropriate records and making
them available to regulatory officials. FDA estimates that about
twenty-five percent (25%) of the records will be collected
electronically.
4.
Efforts to Identify Duplication and Use of Similar Information
No
duplication of Federal regulations concerning recordkeeping
requirements for the manufacturing, packaging, labeling or holding of
dietary supplements is likely because of the clear Congressional
authorization that FDA promulgate regulations pertaining to the
manufacture of dietary supplements as opposed to the jurisdiction of
the U.S. Department of Agriculture (meats and poultry) and the
Federal Trade Commission (advertising).
5.
Impact on Small Businesses or Other Small Entities
FDA
estimates that a substantial proportion (75%) of firms affected by
this regulation are small businesses, and has kept their particular
needs in mind throughout the implementation of these regulations.
Small businesses with
fewer than 20 employees were given an additional 2 years to comply
with the 2007 final rule. Small businesses with 20 to 499 employees
were given an additional year to comply with the final rule. FDA
aids small businesses in complying with its requirements through the
agency’s Regional Small Business Representatives and through
the administrative and scientific staffs within the agency. FDA has
provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6.
Consequences of Collecting the Information Less Frequently
Data
collection occurs daily. Less frequent collections of information
would reduce the documentation that is intended to ensure that
dietary supplements are manufactured, packaged, labeled, and held in
a manner that will ensure the quality of the dietary supplement and
that the dietary supplement is packaged and labeled as specified in
the master manufacturing record.
7.
Special Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There
are no special circumstances associated with this collection of
information.
8.
Comments in Response to the Federal Register Notice and Efforts to
Consult Outside the Agency
In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment on the
proposed extension of this collection of information
in the Federal
Register of
December 19, 2013 (78 FR 76836).
Although posted to its docket subsequent to the closing of the
60-day period, FDA received two letters in response to the notice
with one letter containing multiple comments.
The first letter supports FDA’s efforts and agrees with the proposed information collection request. The agency appreciates this comment and will continue to work 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 second letter maintains that FDA has used outdated information to determine its burden estimate and states that it was much too low. At the same time, the commenter did not provide alternative estimates upon which the agency might rely for a new determination. We are therefore retaining our original estimate, but we are open to considering and adjusting future estimates should new data be provided or become available to the agency. While the agency will continue to invite comment regarding its information collection activities, those directed at specific values for reporting and cost burden and methods of tabulation are most helpful.
The letter states also that the agency’s burden estimate omitted capital costs associated with the information collection burden; that costs to responsible parties for the purchase, lease, and maintenance of equipment for the purposes of fulfilling the CGMP requirements were capital costs to be included. FDA, however, believes that developing and maintaining written procedures and reporting systems are costs associated with meeting the requirements of 21 CFR part 111 established under the FD&C act, and are therefore costs associated with achieving regulatory compliance with agency regulations.
12.
Estimates of
Annualized Burden Hours and Costs
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. Respondents are from the private sector (for-profit businesses).
12
a. Annualized Hour Burden Estimate
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. 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 one as the default for the number of records per recordkeeper. For example, many of the records listed under §111.35 in Table 1, such as §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 §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 Table1, 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 §111.260 includes the burden for records listed under 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.
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1 |
|||||
21 CFR Section/Activity |
No. of Record-keepers |
No. of Records per Recordkeeper |
Total Annual Records |
Average Burden per Recordkeeping |
Total Hours |
111.14, records of personnel practices, including documentation of training |
15,000 |
4 |
60,000 |
1 |
60,000 |
111.23, records of physical plant sanitation practices, including pest control and water quality |
15,000 |
1 |
15,000 |
0.2 |
3,000 |
111.35, records of equipment and utensils calibration and sanitation practices |
400 |
1 |
400 |
12.5 |
5,000 |
111.95, records of production and process control systems |
250 |
1 |
250 |
45 |
11,250 |
111.140, records that quality control personnel must make and keep |
240 |
1163 |
279,120 |
1 |
279,120 |
111.180, records associated with components, packaging, labels, and product received for packaging and labeling as a dietary supplement |
240 |
1163 |
279,120 |
1 |
279,120 |
111.210, requirements for what the master manufacturing record must include |
240 |
1 |
240 |
2.5 |
600 |
111.260, requirements for what the batch record must include |
145 |
1408 |
204,160 |
1 |
204,160 |
111.325, records that quality control personnel must make and keep for laboratory operations |
120 |
1 |
120 |
15 |
1,800 |
111.375, records of the written procedures established for manufacturing operations |
260 |
1 |
260 |
2 |
520 |
111.430, records of the written procedures for packaging and labeling operations |
50 |
1 |
50 |
12.6 |
630 |
111.475, records of product distribution and procedures for holding and distributing operations |
15,000 |
1 |
15,000 |
0.4 |
6,000 |
111.535, records for returned dietary supplements |
110 |
4 |
440 |
13.5 |
5,940 |
111.570, records regarding product complaints |
240 |
600 |
144,000 |
0.5 |
72,000 |
Total |
929,140 |
||||
1There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates in Table 1 are based on those in the June 25, 2007 final rule, and include the agency’s 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 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 §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 §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 §111.605, but have included those burdens under specific provisions for keeping records. For example, §111.255(a) requires that the batch production records be prepared every time a batch is manufactured, and §111.255(d) requires that batch production records be kept in accordance with §111.605. The estimated burdens for both §111.255(a) and (d) are included under §111.260 (what the batch record must include).
12 b. Annualized Cost Burden Estimate
FDA estimates that the average hourly wage for respondents’ workers involved in recordkeeping is equivalent to a GS-5-1 level in the locality pay area of Washington-Baltimore in 2014, approximately $16.49/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to respondents to be $32.98/hour. The overall estimated cost incurred by the respondents is $30,643,037 (929,140 burden hours x $32.98/hr = $30,643,037.20).
13.
Estimates of Other Total Annual Costs to Respondents and/or
Recordkeepers/Capital Costs
There are no capital,
start-up, operating, or maintenance costs associated
with this collection.
14.
Annualized Cost
to the Federal Government
FDA’s
review of the retained records would generally occur as part of its
routine or for cause establishment inspection activities. FDA
estimates that its review of the retained records would take five
hours per inspection. FDA estimates the hourly cost for review and
evaluation to be $43.09 per hour, the GS-13/Step-1 rate for the
Washington-Baltimore locality pay area for the year 2014. To account
for overhead, this cost is increased by 100 percent, making the total
cost $86.18 per hour. FDA estimates the cost to the Federal
Government for the review of records to be $430.90 per review
($86.18/hour x 5 hours) and that it reviews records for an average of
100 inspections per year. Thus, FDA estimates the total annual cost
to the Federal Government to be $43,090 ($430.90 x 100 inspections).
15.
Explanation for Program Changes or Adjustments
There
are no changes in the burden estimate for this collection.
16. Plans for Tabulation and Publication and Project Time Schedule
The
results of this information collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There
are no reasons why display of the expiration date for OMB approval of
the information collection would be inappropriate.
18.
Exceptions to Certification for Paperwork Reduction Act
Submissions
There
are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Bean, Domini |
| File Modified | 2014-02-27 |
| File Created | 2014-02-27 |