[Federal Register Volume 71, Number 231 (Friday, December 1, 2006)]
[Notices]
[Pages 69569-69570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0277]


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 January 
2, 2007.

[[Page 69570]]


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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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--(OMB Control Number 0910-0331)--Extension

    Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the 
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) of the 
act. Section 403(r)(6) of the 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 the following: (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.
    FDA 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.
    Description of Respondents: Businesses or other for-profit 
organizations.
    In the Federal Register of July 24, 2006 (71 FR 41818), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received before the comment 
period closed.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                   No. of         Annual frequency
               21 CFR Section                   respondents         per response        Total annual responses    Hours per response      Total hours
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101.93                                                   2,500                     1                      2,500                   .75              1,875
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA 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) of the act 
statements on labels or in labeling of dietary supplements. FDA 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. This estimate 
is based on the average number of notification submissions received by 
FDA in the preceding 12 months.

    Dated: November 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20307 Filed 12-01-06; 8:45 am]
BILLING CODE 4160-01-S