Document ID: FDA-2013-N-0878-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Notification for a New Dietary Ingredient
Posted Date: 2013-08-26T04:00Z

[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52773-52774]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20711]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0878]

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 or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. 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 
invites comments on the procedure by which a manufacturer or 
distributor of dietary supplements or of a new dietary ingredient is to 
submit information to us 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 October 25, 2013.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 301-796-3793, PRAStaff@fda.hhs.gov.

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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA invite 
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 (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 us (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 (ONLDS) 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 us 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. We use 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. We are 
currently developing an electronic means for submitting this 
information.
    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.
    We estimate the burden of this collection of information as 
follows:

[[Page 52774]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of                       Average burden
                           21 CFR section                               Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses      (in hours) \2\
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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.

    We believe that there will be minimal burden on the industry to 
generate data to meet the requirements of the premarket notification 
program because we are 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. In the past, commenters argued 
that our burden estimate is too low. We revisited this issue and 
believe their burden estimate included the time it takes to research 
and generate safety data for a new dietary ingredient. However, sec. 
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 notification of the basis for their conclusion 
that said supplement or ingredient will reasonably be expected to be 
safe. Section 190.6 requests simply the extraction and summarization of 
the safety data that should have already been developed by the 
manufacturer or distributor. Thus, we estimate 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.
    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. The estimated 
number of premarket notifications and hours per response is an average 
based on our experience with notifications received during the last 3 
years and information from firms that have submitted recent premarket 
notifications.

    Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20711 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P