
[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68275-68277]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26998]


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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) 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 a new dietary ingredient or of a dietary 
supplement containing a new dietary ingredient is to submit to FDA 
information upon which it has based its conclusion that a dietary 
supplement containing the new dietary ingredient will reasonably be 
expected to be safe. The notice also invites comments on two new forms 
FDA is developing to allow manufacturers and distributors to submit 
this information electronically via FDA's Unified Registration and 
Listing System (FURLS).

DATES: Submit either electronic or written comments on the collection 
of information by January 13, 2015.

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

[[Page 68276]]

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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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, 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, the 
manufacturer or distributor of the dietary supplement or of the 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 the new dietary ingredient will reasonably be expected to be 
safe. FDA's implementing regulation, 21 CFR 190.6, requires this 
information to be submitted to the Office of Nutrition, Labeling, and 
Dietary Supplements (ONLDS) in the form of a notification. Under Sec.  
190.6(b), the notification must include the following: (1) The name and 
complete address of the manufacturer or distributor, (2) the name of 
the new dietary ingredient, (3) a description of the dietary 
supplement(s) that contain the new dietary ingredient, including the 
level of the new dietary ingredient in the dietary supplement and the 
dietary supplement's conditions of use, (4) the history of use or other 
evidence of safety establishing that the new dietary ingredient will 
reasonably be expected to be safe when used under the conditions 
recommended or suggested in the labeling of the dietary supplement, and 
(5) the signature of a responsible person designated by the 
manufacturer or distributor.
    These premarket notification requirements are designed to enable us 
to monitor the introduction into the marketplace of new dietary 
ingredients and dietary supplements that contain new dietary 
ingredients in order to protect consumers from ingredients and products 
whose safety is unknown. FDA is the information collected in new 
dietary ingredient notifications to evaluate the safety of new dietary 
ingredients in dietary supplements and to support regulatory action 
against ingredients and products that are potentially unsafe.
    FDA is developing an electronic portal that interested persons will 
be able to use to electronically submit their notifications to ONLDS 
via FURLS. Firms that prefer to submit a paper notification in a format 
of their own choosing will still have the option to do so; however, 
Form FDA 3880 prompts a submitter to input the elements of a new 
dietary ingredient notification (NDIN) in a standard format and helps 
the submitter organize its NDIN to focus on the information needed for 
FDA's safety review. Safety information will be submitted via a 
supplemental form entitled ``New Dietary Ingredient Safety 
Information.'' This form provides a standard format to describe the 
history of use or other evidence of safety on which the manufacturer or 
distributor bases its conclusion that the new dietary ingredient will 
be reasonably expected to be safe under the conditions of use 
recommended or suggested in the labeling of the dietary supplement, as 
well as related identity information that is necessary to demonstrate 
safety by showing that the new dietary ingredient and dietary 
supplement(s) that are the subject of the notification are the same or 
similar to the ingredients and products for which safety data and 
information have been provided. Draft screenshots of Form FDA 3880 and 
the supplemental safety information form are available for comment at 
http://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm356620.htm.
    Description of Respondents: The respondents to this collection of 
information are manufacturers and distributors in the dietary 
supplement industry; specifically, firms that manufacture or distribute 
new dietary ingredients or dietary supplements that contain a new 
dietary ingredient.
    FDA estimates the burden of this collection of information as 
follows:

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

    FDA believes that the burden of the premarket notification 
requirement on industry is limited and reasonable because FDA is 
requesting only safety and identity information that the manufacturer 
or distributor should already have developed to satisfy itself that a 
dietary supplement containing a new dietary ingredient is in compliance

[[Page 68277]]

with the FD&C Act. In the past, commenters have argued that FDA's 
burden estimate is too low. FDA carefully considered the issue and 
believes that burden estimates of greater than 20 hours are likely to 
include the burden associated with researching and generating safety 
data for a new dietary ingredient. Under section 413(a)(2) of the FD&C 
Act, a dietary supplement that contains a new dietary ingredient is 
deemed to be adulterated unless there is a history of use or other 
evidence of safety establishing that the new dietary ingredient will 
reasonably be expected to be safe under the conditions of use 
recommended or suggested in the labeling of the dietary supplement. 
This requirement is separate from and additional to the requirement to 
submit a premarket notification for the new dietary ingredient. FDA's 
regulation on new dietary ingredient notifications, Sec.  190.6(a), 
requires the manufacturer or distributor of the dietary supplement or 
of the new dietary ingredient to submit to FDA the information that 
forms the basis for its conclusion that a dietary supplement containing 
the new dietary ingredient will reasonably be expected to be safe. 
Thus, Sec.  190.6 only requires the manufacturer or distributor to 
extract and summarize information that should have already been 
developed to meet the safety requirement in section 413(a)(2) of the 
FD&C Act. FDA estimates that extracting and summarizing the relevant 
information from what exists in the company's files and presenting it 
in a format that meets the requirements of Sec.  190.6 will take 
approximately 20 hours of work per notification. However, FDA seeks 
comments on this estimate. FDA encourages comments offering alternative 
burden estimates to include documentation to support the alternative 
estimate.
    FDA further estimates that 55 respondents will submit 1 premarket 
notification each. FDA bases its estimate of the number of respondents 
on notifications received over the past 3 years, which averaged about 
55 notifications per year.

    Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26998 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P


