[Federal Register Volume 67, Number 111 (Monday, June 10, 2002)]
[Notices]
[Page 39728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0062]


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

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.

DATES:  Submit written comments on the collection of information by 
July 10, 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.

Premarket Notification for a New Dietary Ingredient--21 CFR 190.6 (OMB 
Control Number 0910-0330)--Extension

    Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 350b(a)) provides that a manufacturer or distributor of 
dietary supplements or of a new dietary ingredient is to submit 
information to FDA (as delegate for the Secretary of Health and Human 
Services) upon which it has based its conclusion that a dietary 
supplement containing a new dietary ingredient will reasonably be 
expected to be safe at least 75 days before the introduction or 
delivery for introduction into interstate commerce of a dietary 
supplement that contains a new dietary ingredient. FDA's regulations at 
part 190, subpart B (21 CFR part 190, subpart B) implement these 
statutory provisions. Section 190.6(a) requires each manufacturer or 
distributor of a dietary supplement containing a new dietary 
ingredient, or of a new dietary ingredient, to submit to the Office of 
Nutritional Products, Labeling, and Dietary Supplements notification of 
the basis for their conclusion that said supplement or ingredient will 
reasonably be expected to be safe. Section 190.6(b) requires that the 
notification include: (1) The complete name and address of the 
manufacturer or distributor, (2) the name of the new dietary 
ingredient, (3) a description of the dietary supplements that contain 
the new dietary ingredient, and (4) the history of use or other 
evidence of safety establishing that the dietary ingredient will 
reasonably be expected to be safe.
    The notification requirements described previously are designed to 
enable FDA to monitor the introduction into the food supply of new 
dietary ingredients and dietary supplements that contain new dietary 
ingredients, in order to protect consumers from unsafe dietary 
supplements. FDA uses the information collected under these regulations 
to help ensure that a manufacturer or distributor of a dietary 
supplement containing a new dietary ingredient is in full compliance 
with the act.
    In the Federal Register of March 19, 2002 (67 FR 12570), the agency 
requested comments on the proposed collection of information. One 
comment was received, but it did not pertain to the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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   21 CFR                          Annual Frequency      Total Annual
   Section    No. of Respondents     per Response          Responses      Hours per Response      Total Hours
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190.6                        35                   1                  35                  20                 700
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA believes that there will be minimal burden on the industry to 
generate data to meet the requirements of the premarket notification 
program because FDA 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 annual average number of premarket 
notifications FDA received during the last 3 years (i.e., 1999-2001), 
which was 23. Twenty-three represents 12 more notifications than the 
agency received as an annual average during the previous 3-year period 
(i.e.,1996-1998). Therefore, FDA anticipates a similar upward trend 
will be seen in the annual average number of notifications it receives 
during 2002-2004, which is estimated to be 35 (23 + 12 = 35).

    Dated: May 31, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-14456 Filed 6-7-02; 8:45 am]
BILLING CODE 4160-01-S