[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19623-19625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07641]


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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, Agency, 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.

DATES: Submit written comments (including recommendations) on the 
collection of information by May 14, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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, 
PRAStaff@fda.hhs.gov.

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 19624]]

Premarket Notification for a New Dietary Ingredient

OMB Control Number 0910-0330--Extension

    This information collection supports Agency regulations. Under 
section 413(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 350b(a)), the manufacturer or distributor of a new dietary 
ingredient (NDI), or of the dietary supplement that contains the NDI, 
must submit a premarket notification to FDA (as delegate for the 
Secretary of Health and Human Services) at least 75 days before 
introducing the product into interstate commerce or delivering it for 
introduction into interstate commerce, unless the NDI and any other 
dietary ingredients in the dietary supplement ``have been present in 
the food supply as an article used for food in a form in which the food 
has not been chemically altered'' (21 U.S.C. 350b(a)(1)). The 
notification must contain the information which provides the basis on 
which the manufacturer or distributor of the NDI or dietary supplement 
has concluded that the dietary supplement containing the NDI will 
reasonably be expected to be safe (21 U.S.C. 350b(a)(2)).
    FDA's implementing regulation, Sec.  190.6 (21 CFR 190.6), 
specifies the procedure for submitting a premarket NDI notification and 
the information the manufacturer or distributor must include in the 
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 NDI; (3) a description of the dietary 
supplement(s) that contains the NDI, including the level of the NDI in 
the dietary supplement and the conditions of use recommended or 
suggested in the labeling of the dietary supplement, or if no 
conditions of use are recommended or suggested in the supplement's 
labeling, the ordinary conditions of use of the supplement; (4) the 
history of use or other evidence of safety establishing that the NDI 
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 NDIs and dietary 
supplements that contain NDIs in order to protect consumers from 
ingredients and products whose safety is unknown. We use the 
information collected in NDI notifications to evaluate the safety of 
NDIs in dietary supplements and to support regulatory action against 
ingredients and products that are potentially unsafe.
    FDA developed an electronic portal (Form FDA 3880) that respondents 
may use to electronically submit their notifications to us via the 
Center for Food Safety and Applied Nutrition (CFSAN) Online Submission 
Module (COSM). COSM was developed to assist respondents when filing 
regulatory submissions and is specifically designed to aid users 
wishing to file submissions with CFSAN. COSM allows safety and other 
information to be uploaded and submitted online via Form FDA 3880. 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 NDI is reasonably expected to be safe under the 
conditions of use recommended or suggested in the labeling of the 
dietary supplement, as well as a description of the ingredient and 
other information. Firms that prefer to submit a paper notification in 
a format of their own choosing have the option to do so; however, Form 
FDA 3880 prompts a submitter to input the elements of an NDI 
notification in a standard format that we will be able to review 
efficiently. Form FDA 3880 may be accessed at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.
    Description of Respondents: The respondents to this collection of 
information are certain manufacturers and distributors in the dietary 
supplement industry.
    In the Federal Register of October 16, 2020 (85 FR 65830), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. A number of comments were received 
expressing general interest in labeling requirements applicable to 
dietary supplements. Other comments were received pertaining to related 
Agency draft guidance, one suggesting 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) 
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.
    While we appreciate all feedback regarding Agency information 
collection activities, as we communicated in our notice of March 28, 
2018 (83 FR 13281), the data analysis offered by the comment does not 
provide a basis upon which we can revise our burden estimate under the 
PRA. Regulatory requirements regarding premarket notification for new 
dietary ingredients are set forth under 21 CFR 190.6 and were 
established by final rule of September 23, 1997 (62 FR 49886). 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 
applicable those requirements. Finally, notices of availability for 
Agency guidance documents are published consistent with regulations in 
21 CFR 10.115 (Good Guidance Practices), which provide for public 
comment at any time.
    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
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190.6; Dietary Supplements.........................................              55                1               55               20            1,100
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\1\ There are no operating and maintenance costs associated with this collection of information.


[[Page 19625]]

    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 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. We believe 
that the burden of the premarket notification requirement on industry 
is 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 the 
NDI is in compliance with the FD&C Act.
    If the required premarket notification is not submitted to FDA, 
section 413(a) of the FD&C Act provides that the dietary supplement 
containing the NDI is deemed to be adulterated under section 402(f) of 
the FD&C Act (21 U.S.C. 342(f)). Even if the notification is submitted 
as required, the dietary supplement containing the NDI is adulterated 
under section 402(f) of the FD&C Act unless there is a history of use 
or other evidence of safety establishing that the NDI, when used under 
the conditions recommended or suggested in the labeling of the dietary 
supplement, will reasonably be expected to be safe. This requirement is 
separate from and additional to the requirement to submit a premarket 
notification for the NDI. FDA's regulation on NDI notifications, Sec.  
190.6(a), requires the manufacturer or distributor of the dietary 
supplement or of the NDI to submit to FDA the information that forms 
the basis for its conclusion that a dietary supplement containing the 
NDI 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.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07641 Filed 4-13-21; 8:45 am]
BILLING CODE 4164-01-P


