[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25282-25283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0032]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Labeling; 
Notification Procedures for Statements on Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 1, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0331. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Labeling; Notification Procedures for Statements on Dietary 
Supplements--21 CFR 101.93

OMB Control Number 0910-0331--Extension

    Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 343(r)(6)) and Sec.  101.93 (21 CFR 101.93) of our 
regulations require that, no later than 30 days after the first 
marketing, we be notified by the manufacturer, packer, or distributor 
of a dietary supplement that it is marketing a dietary supplement 
product that bears on its label or in its labeling a statement provided 
for in section 403(r)(6) of the FD&C Act. In accordance with these 
requirements, submissions must include: (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) the signature of a responsible individual or the person who can 
certify the accuracy of the information presented, and who must certify 
that the information contained in the notice is complete and accurate, 
and that the notifying firm has substantiation that the statement is 
truthful and not misleading.
    Our electronic form (Form FDA 3955) allows respondents to the 
information collection to electronically submit notifications to FDA 
via an electronic system. We are upgrading our current system (the FDA 
Unified Registration Listing System known as FURLS) to deploy the Food 
Applications Regulatory Management (FARM) system. FARM is modeled after 
FURLS and collects the same information, but improves our operational 
efficiency. A web link of the FARM system can be found here: https://www.fda.gov/Food/DietarySupplements/IndustryInfo/ucm485532.htm. Firms 
that 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 
respondents to include certain elements in their structure/function 
claim notification (SFCN) described in Sec.  101.93 in a standard 
electronic format and helps respondents organize their SFCN to include 
only the information needed for our review of the claim. Note that the 
SFCN, whether electronic or paper, is used for all claims made pursuant 
to section 403(r)(6) of the FD&C Act, including nutrient deficiency 
claims and general well-being claims in addition to structure/function 
claims. The electronic form, and any optional elements prepared as 
attachments to the form (e.g., label), can be submitted in electronic 
format. Submissions of SFCNs will continue to be allowed in paper 
format. We use this information to evaluate whether statements made for 
dietary ingredients or dietary supplements are permissible under 
section 403(r)(6) of the FD&C Act.
    In the Federal Register of February 7, 2019 (84 FR 2528), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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.
    We estimate the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                   Number of
        21 CFR Section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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101.93........................           3,690               1           3,690  0.75 (45                 2,767.5
                                                                                 minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our burden estimate reflects an overall increase of 1,117.5 hours 
(from 1,650 hours) and a corresponding increase of 1,490 responses 
(from 2,200 responses). We attribute this adjustment to an increase in 
the average number of notification submissions we received over the 
preceding 12 months, which we expect will continue over the next 3 
years. We believe gathering information to satisfy the notification 
requirements of section 403(r)(6) of the FD&C Act by

[[Page 25283]]

submitting information regarding section 403(r)(6) of the FD&C Act 
statements on labels or in labeling of dietary supplements imposes 
minimal burden on respondents. We expect the information needed 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 believe also that submission via the FARM system will 
facilitate reporting for respondents. We estimate that, each year, 
approximately 3,690 firms will submit the information required by 
section 403(r)(6) of the FD&C Act. Assuming firms require 0.75 hour to 
gather the information needed and prepare a communication, we calculate 
a total of 2,767.5 hours (3,690 total annual responses x 0.75 hour).

    Dated: May 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11419 Filed 5-30-19; 8:45 am]
BILLING CODE 4164-01-P