[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65830-65832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22930]


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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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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.

DATES: Submit either electronic or written comments on the collection 
of information by December 15, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 15, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0878 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Premarket Notification for a New 
Dietary Ingredient.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-420-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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

[[Page 65831]]

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

    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.
    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; 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.

    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,

[[Page 65832]]

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: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22930 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P