[Federal Register Volume 64, Number 88 (Friday, May 7, 1999)]
[Notices]
[Pages 24660-24661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0124]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request and Correction; Premarket Notification for a 
New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.

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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). In addition, this 
document is correcting the information collection notice that appeared 
in the Federal Register of February 9, 1999 (64 FR 6364).
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.
Premarket Notification for a New Dietary Ingredient--21 CFR 190.6 (OMB 
Control Number 0910-0330--Extension)
    Description: Section 413(a) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350b(a)) provides for the notification of the 
Secretary of Health and Human Services (the Secretary) (and by 
delegation FDA) at least 75 days before the introduction or delivery 
for introduction into interstate commerce of a dietary supplement that 
contains a new dietary ingredient. The agency established 21 CFR 190.6 
as the procedural regulation for this program. This regulation provides 
details of the administrative procedures associated with the submission 
and identifies the information that must be included in the submission 
in order to meet the requirements of section 413(a) of the act and to 
show the basis on which a manufacturer or distributor of a new dietary 
ingredient or a dietary supplement containing a new dietary ingredient 
has concluded that the dietary supplement containing such dietary 
ingredient will reasonably be expected to be safe.
    Description of Respondents: Businesses or other for-profit 
organizations.
    In the Federal Register of February 9, 1999 (64 FR 6364), the 
agency requested comments on the proposed collections of information. 
No comments were received.

                                  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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190.6                                  11               1              11              20             220
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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 a minimal burden on the 
industry to generate data to meet the requirements of the premarket 
notification program because the agency is requesting only that 
information that the manufacturer or distributor should already have 
developed to satisfy itself that a dietary supplement containing a new 
dietary ingredient is in full compliance with the act. However, the 
agency estimates that extracting and summarizing the relevant 
information from the company's files, and presenting it in a format 
that will meet the requirements of section 413 of the act, will require 
a burden of approximately 20 hours of work per submission. This 
estimate is based on the average number of premarket notifications 
received by the agency in the last 3 years.
    Additionally, in FR Doc. 99-3014, appearing on page 6364 in the 
Federal Register of Tuesday, February 9, 1999, the following correction 
is made:
    1. On page 6365, in the first column, the title ``New Dietary 
Ingredient Premarket Notification--21 CFR 190.6 (OMB Control Number 
0910-0330--

[[Page 24661]]

Extension)'' is corrected to read ``Premarket Notification for a New 
Dietary Ingredient--21 CFR 190.6 (OMB Control Number 0910-0330--
Extension)''

    Dated: April 29, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-11454 Filed 5-6-99; 8:45 am]
BILLING CODE 4160-01-F