[Federal Register: October 14, 2003 (Volume 68, Number 198)]
[Page 59189-59190]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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)--

    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 
    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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                             Numeber of        Annual Frequency     Total Annual     Hours per
    21 CFR Section          Respondents          per Response        Responses       Response      Total Hours
101.93                                2,500                   1            2,500         .75              1,875
\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]