[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29867-29868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0221]


Agency Information Collection Activities; Proposed Collection; 
Submission for Office of Management and Budget Review; 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) 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 (the PRA).

DATES: Fax written comments on the collection of information by June 
13, 2016.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 FD&C Act (21 U.S.C. 343(r)(6)) and its 
implementing regulation, 21 CFR 101.93, require that 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. These provisions require that we be notified, with a 
submission about such statements, no later than 30 days after the first 
marketing of the dietary supplement. 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) 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.
    We have developed an electronic form (Form FDA 3955) that 
interested persons will be able to use to electronically submit their 
notifications to us via FDA's Unified Registration and Listing System 
(FURLS). Firms that prefer to submit a paper notification in a format 
of their own choosing will still have the option to do so, however. 
Form FDA 3955 prompts a respondent to include certain elements in their 
structure/function claim notification (SFCN) described in Sec.  101.93 
in a standard format electronically and helps the respondent 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 that would be prepared as attachments to the form (e.g., 
label), can be submitted in electronic format via FURLS. Submissions of 
SFCNs will continue to be allowed in paper format. We use this 
information to evaluate whether statements made for dietary

[[Page 29868]]

ingredients or dietary supplements are permissible under section 
403(r)(6) of the FD&C Act. Draft screenshots of Form FDA 3955 and 
instructions are available for comment at http://www.fda.gov/Food/DietarySupplements/IndustryInfo/ucm485532.htm.
    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.
    In the Federal Register of March 11, 2016 (81 FR 12910), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment in support of the 
information collection.
    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 per response           Total hours
                                                respondents     respondent       responses
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101.93......................................           2,200               1           2,200  0.75 (45 minutes).........................           1,650
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We believe that there will be minimal burden on the industry to 
generate information to meet the notification requirements of section 
403(r)(6) of the FD&C Act by submitting information regarding section 
403(r)(6) of the FD&C Act statements on labels or in labeling of 
dietary supplements. We also believe that submission via FURLS will not 
affect the burden estimates. 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, each year, approximately 2,200 firms 
will submit the information required by section 403(r)(6) of the FD&C 
Act. This estimate is based on the average number of notification 
submissions received by us in the preceding 3 years. We estimate that a 
firm will require 0.75 hours to gather the information needed and 
prepare a communication to us, for a total of 1,650 hours (2,200 x 
0.75).

    Dated: May 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11272 Filed 5-12-16; 8:45 am]
 BILLING CODE 4164-01-P