[Federal Register Volume 64, Number 88 (Friday, May 7, 1999)]
[Notices]
[Pages 24659-24660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0123]


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.

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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 (the PRA).

DATES: Submit written comments on the collection of information by June 
7, 1999.
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: 
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 section 3507 of the PRA 
(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 101.93 (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 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 February 4, 1999 (64 FR 5664), the 
agency requested comments on the proposed collections of information. 
No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 24660]]



                                  Table 1.--Estimated Annual Reporting Burden1
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                                                          Annual
           21 CFR Section                 No. of       Frequency per   Total Annual     Hours per    Total Hours
                                        Respondents      Response        Responses      Response
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101.93                                    700               1             700            0.5 to 1    350 to 700
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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 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 last 3 years.

    Dated: April 29, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-11453 Filed 5-6-99; 8:45 am]
BILLING CODE 4160-01-F