[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2528-2530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01380]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0032]
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 solicits comments on the information collection provisions of
the regulation
[[Page 2529]]
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).
DATES: Submit either electronic or written comments on the collection
of information by April 8, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 8, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 8, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2013-N-0032 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling; Notification
Procedures for Statements on Dietary Supplements.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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: 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, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comment on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's 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 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
[[Page 2530]]
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 the FDA Unified Registration 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
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 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.
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 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 FURLS 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 hours 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 hours).
Dated: February 1, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01380 Filed 2-6-19; 8:45 am]
BILLING CODE 4164-01-P