0606 part 111 SSA 2020 REV consolidating 0608

UNITED STATES FOOD & DRUG ADMINISTRATION
Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements
OMB Control No. 0910-0606 - Revision
SUPPORTING STATEMENT – Part A: Justification:

1. Circumstances Making the Collection of Information Necessary
The Dietary Supplement Health and Education Act (Pub. L. 103-417) added section 402(g) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that
the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing
practice for dietary supplements. Section 402(g) of the FD&C Act also stipulates that such
regulations will be modeled after current good manufacturing practice (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.” Accordingly, we have promulgated regulations in part 111 (21 CFR part 111)
establishing minimum CGMP requirements pertaining to the manufacturing, packaging, labeling, or
holding of dietary supplements to ensure their quality. Part 111 establishes the minimum CGMP
necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements
to ensure the quality of the dietary supplement.
Subpart E of 21 CFR Part 111 (21 CFR 111.55-111.95) covers certain quality control
specifications including component identity testing. Section 111.75(a)(1) provides for petitions
to request an exemption from certain testing requirements under the regulation. According to
§ 111.75(a)(1)(ii), manufacturers may request an exemption when a dietary ingredient is
obtained from one or more suppliers as identified in the petition. The regulation clarifies that
we are willing to consider, on a case-by-case basis, a manufacturer’s conclusion, supported by
appropriate data and information in the petition submission, that it has developed a system that it
would implement as a sound, consistent means of establishing, with no material diminution of
assurance compared to the assurance provided by 100 percent identity testing, the identity of the
dietary ingredient before use.
Part 111.75(a)(1) reflects FDA’s determination that manufacturers that test or examine 100
percent of the incoming dietary ingredients for identity can be assured of the identity of the
ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate,
through various methods and processes in use over time for its particular operation, that a system
of less than 100 percent identity testing would result in no material diminution of assurance of
the identity of the dietary ingredient as compared to the assurance provided by 100 percent
identity testing. To provide an opportunity for a manufacturer to make such a showing and
reduce the frequency of identity testing of components that are dietary ingredients from 100
percent to some lower frequency, we added to § 111.75(a)(1), an exemption from the

requirement of 100 percent identity testing when a manufacturer petitions the agency for such an
exemption to 100 percent identity testing under 21 CFR 10.30 and the agency grants such
exemption. Such a procedure would be consistent with FDA’s stated goal, as described in the
CGMP final rule, of providing flexibility in the CGMP requirements.
Part 111.75(a)(1)(ii) sets forth the information a manufacturer is required to submit in such a
petition. The regulation also contains a requirement to ensure that the manufacturer keeps
FDA’s response to a petition submitted under § 111.75(a)(1)(ii) as a record under § 111.95.
To increase our operational efficiency we are consolidating burden approved under OMB control
number 0910-0608, “Petition to Request an Exemption from 100 Percent Identity Testing of Dietary
Ingredients: CGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements,” which covers related information collection..
We therefore request OMB approval of the information collection provisions found in 21 CFR part
111 and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
Recordkeeping is 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
shows what is to be manufactured; what was manufactured; and whether the manufacturing controls
ensure the identity, purity, strength, and composition of the product and effectively limit
contaminants and prevent adulteration. Further, records 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, recordkeeping requirements helps to ensure industry adherence to CGMP. The regulations
in part 111 establish what we believe are 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 provide for 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.
The reporting is used to show whether a particular manufacturer of dietary supplements has
successfully, or unsuccessfully, petitioned FDA for an exemption from 100 percent identity
testing for ingredients used in supplement manufacture.

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Description of Respondents: Respondents to this collection of information include 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 regulations in part 111 do 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
recordkeeping and reporting. We estimate that about seventy-five percent (75%) of this information
collection will be done electronically.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
We estimate that a substantial proportion (75%) of firms subject to the regulation are small
businesses, however we believe the information collection requirements pose no undue burden on
these entities. At the same time, we assist small businesses in complying with FDA regulatory
requirements through our Regional Small Business Representatives and through the administrative
and scientific staffs within the agency. We also provide a Small Business Guide on our website at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entitycompliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling
6. Consequences of Collecting the Information Less Frequently
Data collection is ongoing. We believe maintaining accurate records results from daily information
collection activity. Less frequent information collection may reduce the reliability of documentation
that is intended to ensure that dietary supplements are manufactured, packaged, labeled, and held in a
manner that ensures 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), we published a 60-day notice for public comment in the
Federal Register of December 5, 2019 (84 FR 66658). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payment or gift to respondents.

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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).
Privacy Act
This information collection request (ICR) is collecting personally identifiable information (PII) or
other data of a personal nature. Recordkeeping requirements pertaining to quality control operations
require the signatures of quality control personnel when certain specified, quality control procedures
are performed or when certain information is provided. See 21 CFR 111.140(b)(2)(ii) and (b)(3)(vii).
The recordkeeping requirements pertaining to training require documentation of training, including
the person(s) trained. See 21 CFR 111.14(b)(2). The complaints recordkeeping requirements require
a written record of every product complaint that is related to good manufacturing practice. This
written record must include the name, address, or telephone number of the complainant, if available.
See 21 CFR 111.570(b)(2)(ii)(C). This collection of information asks the respondents to maintain
records at their site. Therefore, no records are stored with FDA.
In preparing this supporting statement our Privacy Office was consulted to ensure appropriate
handling of information collected. We determined that although PII is collected, the collection is not
subject to the Privacy Act of 1974 and the particular notice and other requirements of the Act do not
apply. Specifically, we do not use name or any other personal identifier to routinely retrieve records
from the information collected.
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 Cost
12a. Annualized Hour Burden Estimate
The recordkeeping and reporting requirements of the regulations in part 111 are set forth
in each subpart. In Table 1, 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

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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 many brief
recordkeeping occasions.
In many rows of Table 1, 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.
We estimate the burden of this collection of information as follows:
Table 1 – Estimated Annual Recordkeeping Burden1
No. of
Recordkeepers

No. of
Records per
Recordkeeper

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
(12 mins.)

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
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

1,163

279,120

1

279,120

240

1,163

279,120

1

279,120

240

1

240

2.5

600

145

1,408

204,160

1

204,160

120

1

120

15

1,800

260

1

260

2

520

21 CFR Section; Activity

111.325; records that quality
control personnel must make and
keep for laboratory operations.
111.375; records of the written
procedures established for
manufacturing operations

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Total
Annual
Records

Average
Burden per
Recordkeeping

Total
Hours

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

50

1

50

12.6

630

15,000

1

15,000

0.4
(24 mins.)

6,000

110

4

440

13.5

5,940

240

600

144,000

0.5
(30 mins.)

72,000

TOTAL
1

929,140

There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimates in Table 1 are based on the agency’s institutional experience and other
CGMP requirements.
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 (e.g., what the batch record must include).
Table 2 – Estimated Annual Reporting Burden1
21 CFR Section; Activity

No. of
Respondents

111.75; petition for exemption
from 100 percent identity testing
1

1

No. of
Responses per
Respondent
1

Total
Annual
Responses
1

Average
Burden per
Response
8

Total
Hours
8

There are no capital costs or operating and maintenance costs associated with this collection of information.

In the last 3 years, we have received one new petition to request an exemption from 100 percent
identity testing of dietary ingredients; therefore, the agency estimates that one or fewer petitions will
be submitted annually. Based on our experience with petition processes, we estimate that the
assembly of information in support of the petition required by § 111.75(a)(1)(ii) will take about 8
hours.
12b. Annualized Cost Burden Estimate
We estimate 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 2020,
approximately $18.83/hour. Doubling this wage to account for overhead costs, we estimate the

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average hourly cost to respondents to be $37.66/hour. Therefore, the overall estimated cost incurred
by the respondents is $34,991,713.68 (929,148 burden hours x $37.66/hour = $34,991,713.68).

Activity
Recordkeeping

Table 3.--Estimate of Annualized Cost Burden
Total Burden Hours
Hourly Wage Rate
Total Respondent
Costs
929,148
$37.66
$34,991,713.68

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or 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. We estimate that review of the retained records would take five
hours per inspection. We estimate the hourly cost for review and evaluation to be $49.19 per hour,
the GS-13/Step-1 rate for the Washington-Baltimore locality pay area for the year 2020. To account
for overhead, this cost is increased by 100 percent, making the total cost $98.38 per hour. We
estimate the cost to the Federal Government for the review of records to be $491.90 per review
($98.38/hour x 5 hours) and that we review records for an average of 100 inspections per year. Thus,
we estimate the total annual cost to the Federal Government to be $49,190 ($491.90 x 100
inspections).
15. Explanation for Program Changes or Adjustments
We have made no changes to our estimate of the information collection based on our most recent
review. However, in consolidating burden from OMB control number 0910-0608, the information
collection reflects an increase of 8 hours and one response annually applicable to petitions under 21
CFR 111.75. We have also consolidated previously itemized elements found at Question 12 of this
supporting statement into a single, cumulative estimate we attribute to the recordkeeping
requirements found in 21 CFR part 111.
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.

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