[Federal Register: December 1, 2006 (Volume 71, Number 231)]
[Notices]
[Page 69569-69570]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de06-82]
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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