0331 Diet Supps SSA 2019 Rev

UNITED STATES FOOD & DRUG ADMINISTRATION
Food Labeling: Notification Procedures for Statements on Dietary Supplements
OMB Control No. 0910-0331
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports implementation of the Dietary Supplement Health and
Education Act (DSHEA). The DSHEA amended the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) by adding section 403(r)(6) (21 U.S.C. 343(r)(6)), which requires the
notification to the Food and Drug Administration (FDA, the agency, us or we) (by
delegation of the Secretary of the Department of Health and Human Services) no later than
30 days after the first marketing of a dietary supplement product that bears a nutritional
support statement on its label or in its labeling. This requirement is codified in our food
labeling regulations at 21 CFR 101, subpart F.
Specifically, section 101.93 (21 CFR 101.93) establishes procedures for submitting
required information and notification to FDA no later than 30 days after first marketing a
dietary supplement that bears a statement of nutritional support. Information that is
required in the submission includes: (1) The name and address of the manufacturer, packer,
or distributor of the dietary supplement product; (2) the text of the statement that is being
made; (3) the name of the dietary ingredient or supplement that is the subject of the
statement; (4) the name of the dietary supplement (including the brand name); and (5) a
signature of a responsible individual who can certify the accuracy of the information
presented, and that the notifying firm has substantiation that the statement is truthful and
not misleading.
To assist respondents with the required reporting, we developed Form FDA 3955. Form
FDA 3955 allows interested persons to electronically submit notifications via an electronic
system. We are revising the information collection by upgrading the current electronic
system (FURLS) to the Food Applications Regulatory Management (FARM) system;
however, FARM requests no new or different information. Rather, it improves our
operational efficiency by its ability to interface with other agency systems. Screen shots of
the FARM system have been made available for comment through our website at:
https://www.fda.gov/Food/DietarySupplements/IndustryInfo/ucm485532.htm.
Respondents who prefer to submit a paper notification in a format of their own choosing
still have the option to do so. However, Form FDA 3955 prompts a respondent to include
certain elements in their notification described in § 101.93 in a standard format
electronically and helps the respondent organize their notification to include only the
information needed for our review of the claim. Notification, whether electronic or paper,
is used for all claims made pursuant to section 403(r)(6) of the FD&C Act.

We therefore request OMB approval of the information collection provisions found in 21
CFR 101.93, as well as the associated upgraded collection system FARM, as discussed in
this supporting statement.
2. Purpose and Use of the Information Collection
Notification to FDA is necessary for the review of nutrition claims made pursuant to 21
U.S.C. 343(r)(6). Food that is not compliant with labeling requirements of the FD&C Act
may be determined to be misbranded and subject to enforcement to protect consumers.
Description of Respondents: Respondents to this collection of information include
manufacturers, packers, or distributors of dietary supplements that bear section 403(r)(6) of
the FD&C Act statements on their labels or labeling. Respondents are from the private
sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
Respondents may choose to submit information by either electronic or traditional (paperbased) means, however we encourage the use of FARM. FARM is an upgraded collection
system that interfaces with other agency databases. At the same time, respondents who
prefer to submit a paper notification in a format of their own choosing still have the option
to do so. Since the electronic portal has allowed for a more efficient way to submit
information, we estimate that one-hundred percent (100%) of the notifications will be
submitted electronically over next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. While other collections support
food labeling provisions found in FDA regulations, this information collection supports the
notification requirement established under section 403(r)(6) of the act specific to dietary
supplements.
5. Impact on Small Businesses or Other Small Entities
We estimate that approximately seventy-five percent (75%) of the respondents are small
businesses, however we do not believe the information collection poses undue burden on
these entities. However, we aid small businesses in complying with regulatory
requirements through Regional Small Business Representatives and through scientific and
administrative staffs within the agency. We also provide resources, including a Small
Business Guide, on our website at www.fda.gov.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. Respondents submit the required information on an
occasional basis, associated with the marketing of their products, as required by section

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403(r)(6) of the FD&C Act. The information is only collected if a manufacturer of a
dietary supplement is making a statement of nutritional support on its label or in its
labeling. If the collection is not conducted or is conducted less frequently, the
manufacturers of the dietary supplement making the statement of nutritional support will
not be in compliance with section 403(r)(6) of the FD&C Act.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for 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 February 7, 2019 (84 FR 2528). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents of the information collection.
10. Assurance of Confidentiality Provided to Respondents
Information collected is not confidential. However, regulations concerning confidentiality
in 21 CFR 20.61 apply to all information received. In consultation with our Privacy
Office, we have concluded that, although the name and address of the manufacturer,
packer, or distributor of the dietary supplement product is included in the submission, it
does not request any personally identifiable information. Therefore, under 5 U.S.C.
§ 552a(e)(3) we have determined that a Privacy Act Statement is not required.
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
12a. Annualized Hour Burden Estimate
The total estimated hour burden associated with this collection is 2,767.5 hours
annually. We believe that there is minimal burden on respondents to gather information to
meet the requirements of section 403 of the FD&C Act in submitting information
regarding nutritional support statements on labels or in labeling of dietary supplements.
We are requesting only information that is immediately available to the manufacturer,
packer, or distributor of the dietary supplement that bears such a statement on its label or in
its labeling. We estimate that listing the information required by section 403 of the FD&C
Act and presenting it in a format that will meet the procedures listed in § 101.93, requires a

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burden of approximately 45 minutes (0.75 hour) per submission. We base our estimate on
our experience with similar notification programs. We estimate that the manufacturers,
packers, or distributors will submit approximately 3,690 notifications a year. This estimate
is based on the average number of notification submissions received in the preceding 12
months.
Table 1.--Estimated Annual Reporting Burden1
21 CFR
Section
101.93
1

No. of
Respondents
3,690

No. of
Responses per
Respondent
1

Total Annual
Responses
3,690

Average
Burden per
Response
0.75
(45 mins.)

Total
Hours
2,767.5

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

12b. Annualized Cost Burden Estimate
We estimate the annualized burden hour cost to respondents for this collection of
information to be approximately $196,824.60. We estimate that this notification will be
prepared by an employee making an average wage similar that of a Federal government
employee at the GS-11/Step-3 rate for the Washington-Baltimore locality pay area for the
year 2019, which is $35.56 per hour. To account for overhead, this cost is increased by
100 percent, which is $71.12 per hour. Thus, the annual wage cost for completion and
submission of these notifications is $196,824.60 (2,767.5 hours x $71.12 per hour).
Table 2. --Estimated Annual Burden Cost
Activity and CFR
cite
101.93

Total Burden
Hours

Hourly Wage Rate

2,767.5

$71.12

Total
Respondent
Costs
$196,824.60

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
information collection.
14. Annualized Cost to the Federal Government
The estimated cost to the Federal Government is $39,536.64. We base our estimate on the
salary of one (1) full-time employee (FTE) at GS-13/Step 1, in the Washington-Baltimore
locality pay area for the year 2019 who spends an estimated 416 hours (416 hours x
$47.52/hour = $19,768.32) reviewing the notifications. To account for overhead, this cost
is increased by 100 percent, making the total estimated cost to the Federal Government
$39,536.64.

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15. Explanation for Program Changes or Adjustments
The information collection reflects a revision to the collection mechanism. Specifically,
we are implementing an updated IT system, FARM, that improves our operational
efficiency by interfacing with other agency systems. As explained in Question 1, no new
information is collected, however we characterize the change as a revision. We have also
adjusted our estimates to reflect an increase in submissions. Specifically, our estimated
burden for the information collection reflects an overall increase of 1,117.5 hours (from
1650 to 2767.5 hours) and a corresponding increase of 1,490 responses (from 2,200 to
3,690 responses).
16. Plans for Tabulation and Publication and Project Time Schedule
The information from this 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 this
information collection would be inappropriate. We will display the OMB expiration date
as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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