Document ID: FDA-2009-N-0221-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
Posted Date: 2010-01-26T05:00Z

[Federal Register: January 26, 2010 (Volume 75, Number 16)]
[Notices]               
[Page 4079-4080]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja10-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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.

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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 
February 25, 2010.

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 e-mailed 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: Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 act (21 U.S.C. 343(r)(6)) requires that 
the agency 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

[[Page 4080]]

section 403(r)(6) of the act. Section 403(r)(6) of the act requires 
that the agency 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 the 
following items: (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 agency established Sec.  101.93 (21 CFR 101.93) as the 
procedural regulation for this program. Section 101.93 provides details 
of the procedures associated with the submission and identifies the 
information that must be included in order to meet the requirements of 
section 403 of the act.
    In the Federal Register of June 2, 2009 (74 FR 26406), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two letters in response, each 
containing one or more comments. One of these letters was received 
several months after the close of the comment period. The comments that 
were timely filed were outside the scope of the comment request.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                No. of       Annual Frequency   Total Annual       Hours per
      21 CFR Section          Respondents      per Response       Responses         Response        Total Hours
----------------------------------------------------------------------------------------------------------------
101.93                               2,200                  1           2,200               0.75           1,650
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The agency believes that there will be minimal burden on the 
industry to generate information to meet the requirements of section 
403 of the act in submitting information regarding section 403(r)(6) 
statements on labels or in labeling of dietary supplements. The agency 
is 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. FDA estimates 
that, each year, approximately 2,200 firms will submit the information 
required by section 403 of the act. We estimate that a firm will 
require 0.75 hours to gather the information needed and prepare a 
communication to FDA, 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 the agency in the preceding 2 years.

    Dated: January 20, 2010.
David Dorsey
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1435 Filed 1-25-10; 8:45 am]
BILLING CODE 4160-01-S