
[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70237-70238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28788]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0564]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Dietary Supplement 
Labeling Requirements and Recommendations Under the Dietary Supplement 
and Nonprescription Drug Consumer Protection Act

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.

DATES: Fax written comments on the collection of information by 
December 14, 2015.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0642. 
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, PRAStaff@fda.hhs.gov.

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.

Dietary Supplement Labeling Requirements and Recommendations Under the 
Dietary Supplement and Nonprescription Drug Consumer Protection Act--
(OMB Control Number 0910-0642)-Extension

    In 2006, the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act (the DSNDCPA) amended the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) with respect to serious adverse event 
reporting for dietary supplements and nonprescription drugs marketed 
without an approved application. The DSNDCPA also amended the FD&C Act 
to add section 403(y) (21 U.S.C. 343(y)), which requires the label of a 
dietary supplement marketed in the United States to include a domestic 
address or domestic telephone number through which the product's 
manufacturer, packer or distributor may receive a report of a serious 
adverse event associated with the dietary supplement.
    In the Federal Register of September 1, 2009 (74 FR 45221), we 
announced the availability of a guidance document entitled, ``Guidance 
for Industry: Questions and Answers Regarding the Labeling of Dietary 
Supplements as Required by the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act.'' The guidance document contains 
questions and answers related to the labeling requirements in section 
403(y) of the FD&C Act and provides guidance to industry on the use of 
an explanatory statement before the domestic address or telephone 
number. The guidance document provides our interpretation of the 
labeling requirements for section 403(y) of the FD&C Act and our views 
on the information that should be included on the label. We believe 
that the guidance will enable persons to meet the criteria for labeling 
that are established in section 403(y) of the FD&C Act.
    In the Federal Register of August 24, 2015 (80 FR 51278), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
            Activity                 Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
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Domestic address or phone number           1,700            3.27           5,560             0.2           1,112
 labeling requirement (21 U.S.C.
 343(y))........................
FDA recommendation for label               1,700            3.27           5,560             0.2           1,112
 statement explaining purpose of
 domestic address or phone
 number.........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,224
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

The labeling requirements of section 403(y) of the FD&C Act became 
effective on December 22, 2007, although we exercised enforcement 
discretion until September 30, 2010, to enable all firms to meet the 
labeling requirements for dietary supplements. At this time, therefore, 
we expect that all labels required to include the domestic address or 
telephone number issued in section 403(y) have been revised 
accordingly. Thus our current burden estimate for this information 
collection applies only to new product labels.
    In row 1 of Table 1 we estimate the total annual hourly burden 
necessary to comply with the requirement under section 403(y) of the 
FD&C Act (21 U.S.C. 343(y)) to be 1,112 hours. Using historical A.C. 
Nielson Sales Scanner Data, we estimate the number of dietary 
supplement SKUs for which product sales are greater than zero to be 
55,600. Assuming that the flow of new products is 10 percent per year, 
then each year approximately 5,560 new dietary supplement products are 
projected to enter the market. Estimating that there are 1,700 dietary 
supplement manufacturers, re-packagers, re-labelers, and holders of 
dietary supplements subject to the information collection requirement 
(using the figure 1,460 as

[[Page 70238]]

provided in our final rule of June 25, 2007 (72 FR 34752) on the 
Current Good Manufacturing Practice in Manufacturing, Packaging, 
Labeling, or Holding Operations for Dietary Supplements, and factoring 
for a two percent annual growth rate), we calculate an annual 
disclosure burden of 3.27 disclosures (labels) per firm. Last, we 
expect that firms prepare the required labeling for their products in a 
manner that takes into account at one time all information required to 
be disclosed and therefore believe that less than 0.2 hours (12 
minutes) per product label would be expended to fulfill this 
requirement.
    In row 2 of Table 1 we estimate the total burden associated with 
the recommendation to include an explanatory statement on dietary 
supplement product labels letting consumers know the purpose of the 
domestic address or telephone number to be 1,112 hours. Based upon our 
knowledge of food and dietary supplement labeling, we estimate it would 
require less than 0.2 hours (12 minutes) per product label to include 
such a statement.

    Dated: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28788 Filed 11-12-15; 8:45 am]
BILLING CODE 4164-01-P


