0606 SS A 2017 Extension

Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements
OMB Control No. 0910-0606
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
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

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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 seventy-five percent (75%) 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).

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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
in the Federal Register of September 29, 2016 (81 FR 66967). FDA received comments
from two commenters.
(Comment) One commenter had concerns about whether the processes being used to
assess the contents of supplements are genuine and accurate and how this is regulated;
whether records regarding labeling indicate what is actually contained in a supplement;
and whether these records will be available to the public.
These comments appear to address PRA issues of practical utility and ways to enhance
the quality, utility, and clarity of the information to be collected.
(Response) In this collection of information, FDA is evaluating the burden of retaining
records and making them available to regulatory officials, but not the burden for
proactively submitting them to FDA. FDA reviews the records maintained while
conducting an investigation (e.g., during a facility inspection and during the follow up
communication until a particular investigation is closed out). The investigation of a
particular firm by FDA is exempt from the Paperwork Reduction Act and is not included
as part of the burden estimate. The required elements of labeling are part of different

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regulations and do not apply to this collection of information. The commenter also
discussed the safety of a particular product but current good manufacturing practice
(CGMP) regulations deal with establishing a quality product, not necessarily a safe
product. Finally, the commenter discussed allowing the records maintained to be made
public, but these records are required to be maintained by the firm and are not proactively
submitted to FDA, they are required to be made available to FDA during inspections. If
FDA obtains these records during the investigation of a firm, the public can submit a
Freedom of Information Act (FOIA) request but the document they would typically
receive would be redacted because the records are the property of the firm.
(Comment) The second commenter stated that the labeling on dietary supplement
products should be consistent and FDA regulated, the term “healthy” should be required
to have a standard meaning, and “healthy” should not be allowed to be used unless it
meets FDA requirements of the term.
(Response) The recordkeeping for current good manufacturing practices (CGMP) has
nothing to do with the required elements of food and dietary supplement) labeling, which
are covered under FDA’s labeling regulations. FDA has recently published a new final
rule for Nutrition (and Supplement) Facts Labels, and is currently reviewing new
requirements for labeling your food “healthy”. This information collection for CGMP
addresses recordkeeping for specifications for a label and labeling operations.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gift to respondents.
10. Assurance of Confidentiality Provided to Respondents
Company records describing manufacturing procedures, which may be consulted during
FDA plant inspections, and records that the Agency may copy or take possession of,
often contain trade secret and commercial confidential information. Confidential
commercial information is protected from disclosure under the Freedom of Information
Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), by Section 301(j) of
the FD&C Act, and by part 20 of the Agency’s regulations (21 CFR part 20).
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive
nature.
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

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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:
21 CFR Section/Activity

No. of Recordkeepers

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

(12 minutes)

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

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21 CFR Section/Activity

No. of Recordkeepers

No. of
Records per
Recordkeeper

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
111.210, requirements for
what the master
manufacturing record must
include
111.260, requirements for
what the batch record must
include

240

1163

279,120

1

279,120

240

1

240

2.5

600

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

50

1

50

12.6

630

15,000

1

15,000

0.4

6,000

111.430, records of the
written procedures for
packaging and labeling
operations
111.475, records of product
distribution and procedures
for holding and distributing
operations
111.535, records for returned
dietary supplements
111.570, records regarding
product complaints

Total
Annual
Records

Average
Burden per
Recordkeeping

Total Hours

(24 minutes)

110

4

440

13.5

5,940

240

600

144,000

0.5

72,000

(30 minutes)

Total

929,140

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

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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).
12b. 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 WashingtonBaltimore in 2017, approximately $17.38/hour. Doubling this wage to account for
overhead costs, FDA estimates the average hourly cost to respondents to be $34.76/hour.
The overall estimated cost incurred by the respondents is $32,296,906 (929,140 burden
hours x $34.76/hr = $32,296,906).
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 $45.42 per hour, the GS-13/Step-1 rate for the Washington-

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Baltimore locality pay area for the year 2017. To account for overhead, this cost is
increased by 100 percent, making the total cost $90.84 per hour. FDA estimates the cost
to the Federal Government for the review of records to be $454.20 per review
($90.84/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 $45,420
($454.20 x 100 inspections).
15. Explanation for Program Changes or Adjustments
There are no changes in the burden estimate for this collection.
The previously approved ICR submitted to OMB in 2014 consolidated fourteen ICs
entered in ROCIS into thirteen ICs. We continued to maintain this consolidation in
ROCIS with this submission. However, the information collection activities and the
burden associated with each IC remain separated into fourteen ICs in this supporting
statement and in the table in Item 12.
16. Plans for Tabulation and Public 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.

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