SUPPORTING STATEMENT
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
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 (the Secretary) may, by regulation, prescribe good
manufacturing practices (CGMP) 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), FDA may issue
regulations necessary for the efficient enforcement of the 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
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 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. 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. The agency estimates that
about 25 percent (25%) of the records would 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 development 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 in the Federal Register of July 14, 2010 (75 FR
40840). FDA received no comments.
12. Estimates
of Annualized Burden Hours and Costs
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. 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 § 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 annual frequency of recordkeeping for these and similar provisions. For § 111.35, the entry for annual frequency is 1 as a default representing a large number of brief recordkeeping occasions.
In many rows of table1 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 § 111.260 includes the burden for records listed under § 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:
Table 1.--Estimated Annual Recordkeeping Burden1 |
|||||
21 CFR Section |
No. of Record-keepers |
Annual Frequency per Record-keeping |
Total Annual 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 |
1163 |
279,120 |
1 |
279,120 |
111.180 |
240 |
1163 |
279,120 |
1 |
279,120 |
111.210 |
240 |
1 |
240 |
2.5 |
600 |
111.260 |
145 |
1408 |
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 |
1There are no capital costs 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 (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 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 § 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 2010, approximately $16.33/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to respondents to be $32.66/hour. The overall estimated cost incurred by the respondents is $30,345,712 (929,140 burden hours x $32.66/hr = $30,345,712).
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 $42.66 per hour, the GS-13/Step-1 rate for the
Washington-Baltimore locality pay area for the year 2010. To account
for overhead, this cost is increased by 100 percent, making the total
cost $85.32 per hour. Thus, FDA estimates the cost to the Federal
Government for the review of records to be $426.60 per review
($85.32/hour x 5 hours). FDA estimates that it reviews records for
an average of 100 inspections per year. Thus, FDA estimates that the
total annual cost to the Federal Government would be $42,660 ($426.60
x 100 inspections).
15. Explanation
for Program Changes or Adjustments
FDA
estimates that total burden hours are reduced from 1,085,570 to
929,140. This decrease in the burden estimate is a program change
due to agency discretion, i.e. occurs as a result of the
discontinuation of the one-time burden hours associated with the
June 25,2007 final rule
( 72 FR 34752)
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 | DPresley |
| File Modified | 2010-09-28 |
| File Created | 2010-09-27 |