80 FR 10121 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 37 (February 25, 2015)

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10121-10122]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by March 
27, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0330. 
Also include the FDA 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, [email protected].

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 
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 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 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. We use 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.
    We are developing an electronic portal that interested persons will 
be able to use to electronically submit their notifications to ONLDS 
via FDA Unified Registration and Listing System (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 our safety 
review. Safety information will be submitted via a supplemental form 
entitled ``New Dietary Ingredient (NDI) 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.
    In the Federal Register of November 14, 2014 (79 FR 68275), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. We received three comments 
in response to the notice. Two of the comments were unrelated to the 
PRA, and therefore we did not consider them.

[[Page 10122]]

    The third comment asserted that we underestimated the reporting 
burden of the NDIN procedures under Sec.  190.6 by failing to take into 
account the recommendations in the draft guidance entitled ``Dietary 
Supplements: New Dietary Ingredient Notifications and Related Issues'' 
(the 2011 draft guidance) (available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm257563.htm). FDA announced the availability of 
the 2011 draft guidance for comment in a notice published in the 
Federal Register of July 5, 2011 (76 FR 39111).
    Although we agree with the commenter that information collection 
recommendations in guidance are subject to the PRA, we intend to meet 
our PRA obligations in that regard separately at a later time. The 2011 
draft guidance was published solely for the purpose of seeking comment, 
and it has not been made final. Moreover, FDA intends to publish a 
revised draft guidance for comment later this year, and the revised 
draft guidance will supersede the 2011 draft guidance. Although we 
expect the revised draft guidance to be followed by a final guidance, 
there will be an interim period where no guidance on NDINs is in 
effect. The purpose of the current PRA proceeding is to seek comment on 
and obtain OMB approval for the NDIN collections of information in 
effect during this interim period, which are those found in the FDA's 
NDIN regulations at Sec.  190.6 and in the electronic NDIN submission 
forms that we have made available for comment. After publishing a 
revised draft guidance on NDINs and related issues, we intend to 
publish a 60-day notice inviting comment on the proposed collections of 
information associated with that document. At that time, we will 
carefully evaluate all comments we receive.
    We estimate 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6..............................................................              55                1               55               20            1,100
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\1\ There are no operating and maintenance costs associated with this collection of information.

    We believe that the burden of the premarket notification 
requirement on industry is limited and reasonable because we are 
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 
with the FD&C Act. In the past, commenters have argued that our burden 
estimate is too low. We carefully considered the issue and believe that 
burden estimates of greater than 20 hours per notification likely 
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 NDINs, 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. We estimate 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, we seek comments on this estimate. We 
encourage comments offering alternative burden estimates to include 
documentation to support the alternative estimate.
    We further estimate that 55 respondents will submit 1 premarket 
notification each. We base our estimate of the number of respondents on 
notifications received over the past 3 years, which averaged about 55 
notifications per year.

    Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03833 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P