[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12910-12912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05478]


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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; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice invites comments on the information collection 
provisions of the regulation requiring the manufacturer, packer, or 
distributor of a dietary supplement to notify us that it is marketing a 
dietary supplement product that bears on its label or in its labeling a 
statement provided for in the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act). The notice also invites comment on a new electronic form 
that allows manufacturers, packers, and distributors of dietary 
supplements to notify us via FDA's Unified Registration and Listing 
System (FURLS).

DATES: Submit either electronic or written comments on the collection 
of information by May 10, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 12911]]

     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-N-0221 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling; Notification 
Procedures for Statements on Dietary Supplements.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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 FDA via 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 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.
    We estimate the burden of this collection of information as 
follows:

[[Page 12912]]



                                 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........................           2,200               1           2,200  0.75 (45                   1,650
                                                                                 minutes).
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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: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05478 Filed 3-10-16; 8:45 am]
 BILLING CODE 4164-01-P