[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Pages 18351-18352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06823]



Food and Drug Administration

[Docket No. FDA-2012-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.


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.

[[Page 18352]]

DATES: Fax written comments on the collection of information by April 
25, 2013.

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 0910-0331. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-5733, domini.bean@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.

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)) requires 
that FDA be notified by manufacturers, packers, and distributors of 
dietary supplements that they are marketing a dietary supplement 
product that bears on its label or in its labeling a statement provided 
for in section 403(r)(6). Section 403(r)(6) of the FD&C Act requires 
that FDA 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) a signature of a responsible 
individual 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.
    The procedural regulation for this program is codified at 21 CFR 
101.93. Section 101.93 provides submission procedures and identifies 
the information that must be included in order to meet the requirements 
of section 403 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.
    In the Federal Register of January 18, 2013 (78 FR 4153), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter in response to the 
notice. One comment in the letter suggested that electronic submission 
could potentially decrease the reporting burden. FDA agrees and is in 
the process of developing a method of receiving submissions 
    FDA estimates the burden of this collection of information as 

                                 Table 1--Estimated Annual Reporting Burden \1\
                                          Number of
  21 CFR section       Number of        responses per       Total annual      Average burden      Total hours
                      respondents         respondent         responses         per response
         101.93              2,200                  1              2,200               0.75              1,650
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    We believe that there will be minimal burden on the industry to 
generate information to meet the requirements of section 403 of the 
FD&C Act in submitting information regarding section 403(r)(6) 
statements on labels or in labeling of dietary supplements. 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 of the FD&C Act. We estimate that a firm will 
require 0.75 hours to gather the information needed and prepare a 
submission, for a total of 1,650 hours (2,200 x 0.75). This estimate is 
based on the average number of notification submissions received by us 
in the preceding 3 years.

    Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06823 Filed 3-25-13; 8:45 am]