[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13281-13283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06155]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) 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 (PRA).

DATES: Fax written comments on the collection of information by April 
27, 2018.

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

[[Page 13282]]

Premarket Notification for a New Dietary Ingredient--21 CFR 190.6

OMB Control Number 0910-0330--Extension

    This information collection supports Agency regulations and 
accompanying guidance. Specifically, 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, 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, Sec.  190.6 (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 uses 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 has developed an electronic portal that respondents may use to 
electronically submit their notifications to ONLDS via FDA Unified 
Registration and Listing Systems. Firms that prefer to submit a paper 
notification in a format of their own choosing 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 respondent organize its NDIN to focus on the information 
needed for FDA's safety review. Safety information may 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 is 
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. We continue to invite comment on Form FDA 3880 and the 
supplemental safety information form, which may be found on our website 
at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.
    In the Federal Register of November 17, 2017 (82 FR 54355), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. One comment suggested ways 
FDA might assist respondents by developing ``specific guidance 
pertaining to the use and submission of master files to help determine 
whether a dietary ingredient should be the subject of an NDIN or 
exempted from notification.'' A second comment suggested that FDA: (1) 
Failed to account for the cost of removing from the market dietary 
supplements suddenly deemed New Dietary Ingredients for the first time 
in the Guidance \2\; (2) substantially underestimated the number and 
cost of New Dietary Ingredient submissions that must be filed to comply 
with the Guidance; and (3) grossly and dangerously undervalued the 
economic impact the Guidance will have on the dietary supplement 
industry and the economy as a whole.
---------------------------------------------------------------------------

    \2\ The ``Guidance'' refers to a draft guidance published for 
comment in August 2016 and available at: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm257563.htm.
---------------------------------------------------------------------------

    FDA appreciates this feedback. As noted, FDA has issued a draft 
guidance on Dietary Supplements: New Dietary Ingredient Notifications 
and Related Issues and will take the comment on additional guidance 
into consideration when finalizing the draft guidance. As resources 
allow, FDA may consider revised or additional guidance to assist 
respondents to the information collection. Relatedly, with regard to 
comments about costs or economic impact, FDA notes that, consistent 
with our regulations at 21 CFR part 10.115 (Good Guidance Practices), 
recommendations found in the draft guidance document are for comment 
only. In addition, the data analysis proffered regarding costs does not 
provide a basis upon which we can revise our burden estimate under the 
PRA. Notices published in the Federal Register in compliance with the 
PRA seek to improve information collection activities by evaluating our 
need for the information discussed in the notice and specific ways we 
might utilize technology and/or enhance our collection techniques and 
mechanisms to minimize burden on respondents who are subject to the 
applicable regulatory requirements.
    We therefore retain the following estimate:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Section              Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
190.6; Dietary Supplements......              55               1              55              20           1,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 13283]]

    We have made no adjustments to the currently approved burden 
estimate for the information collection. While we have received 
comments previously suggesting our burden estimate may be too low, the 
comments did not discuss the basis for such a conclusion. We therefore 
specifically invite individual respondent experience with the 
information collection and associated collection burden.
    Based on our experience with the information collection over the 
past 3 years, we estimate that 55 respondents will submit 1 premarket 
notification each. We assume that extracting and summarizing relevant 
information from existing files and presenting it in a format that 
meets the requirements of Sec.  190.6 will take approximately 20 hours 
of work per notification. We have carefully considered the burden 
associated with the premarket notification requirement and believe that 
estimates greater than 20 hours are likely to include burden associated 
with researching and generating safety data for a new dietary 
ingredient. We believe that the burden of the premarket notification 
requirement on industry is minimal 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. 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.

    Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06155 Filed 3-27-18; 8:45 am]
 BILLING CODE 4164-01-P