
[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32214-32215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0410]


Agency Information Collection Activities; Proposed Collection; 
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 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 procedure by which a 
manufacturer or distributor of dietary supplements or of a new dietary 
ingredient is to submit information to FDA upon which it has based its 
conclusion that a dietary supplement containing a new dietary 
ingredient will reasonably be expected to be safe.

DATES: Submit either electronic or written comments on the collection 
of information by August 2, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 these topics: (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.

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 
FD&C Act) (21 U.S.C. 350b(a)) provides that at least 75 days before the 
introduction or delivery for introduction into interstate commerce of a 
dietary supplement that contains a new dietary ingredient, a 
manufacturer or distributor of dietary supplements or of a new dietary 
ingredient is to submit to FDA (as delegate for the Secretary of Health 
and Human Services) information upon which the manufacturer or 
distributor has based its conclusion that a dietary supplement 
containing a new dietary ingredient will reasonably be expected to be 
safe (part 190 (21 CFR part 190)) implements 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 Nutrition, 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 the 
following: (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 the introduction of 
unsafe dietary supplements into interstate commerce. 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 FD&C Act.
    Description of Respondents: The respondents to this collection of 
information are firms in the dietary supplement industry, including 
dietary supplement and dietary ingredient manufacturers, packagers and 
re-packagers, holders, labelers and re-labelers, distributors, 
warehouses, exporters, and importers.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 32215]]



                                                       Table 1--Estimated Annual Reporting Burden1
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                                                                               Number of                          Average burden per
                   21 CFR Section                          Number of         responses per       Total annual        response (in         Total hours
                                                          respondents         respondent           responses            hours)
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190.6...............................................                 55                   1                  55                  20               1,100
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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 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 FD&C 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 FD&C Act will 
require a burden of approximately 20 hours of work per submission.
    The estimated number of premarket notifications and hours per 
response is an average based on the Agency's experience with 
notifications received during the last 3 years and information from 
firms that have submitted recent premarket notifications. FDA received 
77 notifications in 2008, 39 notifications in 2009, and 48 
notifications in 2010, for an average of 55 notifications. Accordingly, 
we estimate that 55 respondents will submit one premarket notification 
each and that it will take a respondent 20 hours to prepare the 
notification, for a total of 1,100 hours.

    Dated: May 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13815 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P


