[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4079-4080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1435]
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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 [email protected]. 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
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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