[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54355-54357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24925]


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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 January 16, 2018.

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 January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 16, 2018. 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 ``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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD

[[Page 54356]]

20852, 301-796-7726, [email protected].

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

    This information collection supports Agency regulations. 
Specifically, 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, 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 System (FURLS). 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 invite comment on Form FDA 3880 
and the supplemental safety information form, which may be found on our 
Web site at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.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                      Average  burden
                           21 CFR section                               Number of      responses per     Total annual    per  response     Total hours
                                                                       respondents       respondent       responses        (in hours)
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190.6; Dietary Supplements.........................................              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.

    We have made no adjustments to the currently approved burden 
estimate for the information collection. While we have received 
previous comments suggesting our burden estimate may be too low, the 
comments did not discuss the basis for such a conclusion. We therefore 
specifically invite those commenters offering an alternative

[[Page 54357]]

burden estimate to include the methodology or reasoning used to do so.
    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 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 also 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: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24925 Filed 11-16-17; 8:45 am]
BILLING CODE 4164-01-P


