[Federal Register: October 14, 2003 (Volume 68, Number 198)]
[Notices]
[Page 59189-59190]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc03-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0314]
Agency Information Collection Activities; Submission for the
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
November 13, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 Part 101.93 (OMB Control Number 0910-0331)--
Extension
Section 403(r)(6) of the Federal Food, Drugs, and Cosmetics Act
(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 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: (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) the signature of a responsible
individual who can certify the accuracy of the information presented,
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.
Description of Respondents: Businesses or other forprofit
organizations.
In the Federal Register of July 23, 2003 (68 FR 43533), FDA
published a 60-day notice requesting public comment on the information
collection provisions. One firm submitted a comment stating that it
believed that the burden of making the required submission could be
slightly reduced by enabling the electronic submission of the required
information, perhaps submitted through the Agency's Web
[[Page 59190]]
site. The comment also suggested that FDA consider amending its
information requirements to provide that an electronic submission
include a notifier-assigned reference number.
The Center for Food Safety and Applied Nutrition (CFSAN) is working
with other FDA units toward developing the necessary technology
infrastructure, namely a public key infrastructure (PKI)-capable
system, to enable it to accept these submissions electronically in the
future. The requirement for a PKI-capable system for these
notifications derives, in part, from the certification requirement in
Sec. 101.93(a)(3) and the significant legal consequences attendant to
it. CFSAN lacks a PKI-capable system, but is working with other FDA
units toward putting it in place. In the meantime, the agency believes
that other forms of electronic submission that the agency might be able
to accept present unacceptable risks that provide a basis to not accept
these submissions electronically until an acceptable infrastructure is
in place.
With respect to the comment's request that FDA provide for the
notifier to include a reference number in its submission, as we develop
and implement an electronic submission system, we intend to consider
what changes, if any, in the information required to be submitted is
needed to ensure that the notification requirements and process meet
the agency's needs and those of the regulated industry.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Numeber of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses 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.
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) of
the act 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. This estimate
is based on the average number of notification submissions received by
the agency in the preceding 12 months.
Dated: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25846 Filed 10-10-03; 8:45 am]
BILLING CODE 4160-01-S