[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Notices]
[Pages 5828-5829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3022]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0459]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
March 11, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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 No. 0910-0331)--
Extension

    Description: Section 403(r)(6) of the Federal Food, Drug, and 
Cosmetic 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: 
(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.
    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 for-profit 
organizations.
    In the Federal Register of October 25, 2001 (66 FR 54017), the 
agency requested comments on the proposed collection of information. 
Several comments were received that were not the subject of this 
information collection.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 5829]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Annual Frequency per    Total Annual
               21 CFR Section                   No. of Respondents            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 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 labeling or in its labeling. This 
estimate is based on the average number of notification submissions 
received by the agency in the preceding 18 months.

    Dated: January 31, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-3022 Filed 2-6-02; 8:45 am]
BILLING CODE 4160-01-S