[Federal Register Volume 68, Number 141 (Wednesday, July 23, 2003)]
[Notices]
[Pages 43533-43534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18693]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0314]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the regulation requiring 
manufacturers, packers, and distributors of dietary supplements to 
notify FDA that they are marketing a dietary supplement product that 
bears on its label or in its labeling a statement provided for in the 
Federal Food, Drug, and Cosmetic Act (the act).

DATES: Submit written or electronic comments on the collection of 
information by September 22, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/ecomments. Submit written comments to the 
Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-305), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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 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: (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, 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 (21 U.S.C. 343).
    Description of Respondents: Businesses or other for-profit 
organizations.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 43534]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR                          Annual Frequency      Total Annual
   Section    No. of Respondents     per Response          Responses      Hours per 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: July 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18693 Filed 7-22-03; 8:45 am]
BILLING CODE 4160-01-S