Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient, 65830-65832 [2020-22930]
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
6. written confirmation that the
facility meets the selection criteria in
section II.A, including agreement to
items 3a–c;
7. written confirmation that the
facility can handle a visit of up to 10
FDA staff and contractors; and
8. a brief description of prior
experiences undergoing an assessment
related to the maturity of the facility’s
quality culture, including the name of
the organization that conducted the
assessment and date of the assessment.
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22977 Filed 10–15–20; 8:45 am]
BILLING CODE 4164–01–P
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.
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,
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SUMMARY:
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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
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
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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, § 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 § 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/NewDietary
IngredientsNotificationProcess/
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
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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
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and presenting it in a format that meets
the requirements of § 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
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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,
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
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,
§ 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, § 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3179]
Request for Nominations on Public
Advisory Panels of the Medical
Devices Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on certain panels of the Medical
Devices Advisory Committee (MDAC or
Committee) in the Center for Devices
and Radiological Health (CDRH) notify
FDA in writing. FDA is also requesting
nominations for nonvoting industry
representatives to serve on certain
device panels of the MDAC in the
CDRH. A nominee may either be selfnominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current and
upcoming vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by November 16, 2020 (see
sections I and II of this document for
further details). Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
November 16, 2020.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives
should be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
SUMMARY:
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring,
MD 20993, 301–796–5960, email:
margaret.ames@fda.hhs.gov.
The
Agency is requesting nominations for
nonvoting industry representatives to
the panels listed in the table in this
document.
SUPPLEMENTARY INFORMATION:
I. Medical Devices Advisory Committee
The Committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational devices
and makes recommendations for their
regulation. The panels engage in a
number of activities to fulfill the
functions the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) envisions
for device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, advises
the Commissioner of Food and Drugs
(the Commissioner) regarding
recommended classification or
reclassification of devices into one of
three regulatory categories; advises on
any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the FD&C Act; advises on the
necessity to ban a device; and responds
to requests from the Agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
the Commissioner on issues relating to
the design of clinical studies regarding
the safety and effectiveness of marketed
and investigational devices. The
Committee also provides
recommendations to the Commissioner
or designee on complexity
categorization of in vitro diagnostics
under the Clinical Laboratory
Improvement Amendments of 1988.
Panels
Function
Anesthesiology and Respiratory Therapy Devices Panel.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in anesthesiology and respiratory therapy and makes appropriate
recommendations to the Commissioner.
Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational products for use in dentistry, endodontics or bone physiology relative to the oral
and maxillofacial area and makes appropriate recommendations to the Commissioner.
Dental Products Panel (one representative—to
represent the dental drug industry).
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
