Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient, 10121-10122 [2015-03833]
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Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices
10121
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Total ..................................
1 There
Number of records
per recordkeeper
Total annual
records
Average burden per
recordkeeping
............................
21 CFR Section
..............................
............................
..................................................
Premarket Notification for a New
Dietary Ingredient—21 CFR 190.6
(OMB Control Number 0910–0330)—
Extension
[FR Doc. 2015–03881 Filed 2–24–15; 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; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification for a New Dietary
Ingredient
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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
(the PRA).
DATES: Fax written comments on the
collection of information by March 27,
2015.
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 oira_
submission@omb.eop.gov. 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE—14526, Silver
Spring, MD 20993–0002, 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.
SUMMARY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
882,203
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Total hours
VerDate Sep<11>2014
18:05 Feb 24, 2015
Jkt 235001
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 us (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, 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 § 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. We
use 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
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
ingredients and products that are
potentially unsafe.
We are developing an electronic
portal that interested persons will be
able to 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 will 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 submitter organize its
NDIN to focus on the information
needed for our safety review. Safety
information will be submitted via a
supplemental form entitled ‘‘New
Dietary Ingredient (NDI) 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 will be 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. Draft
screenshots of Form FDA 3880 and the
supplemental safety information form
are available for comment at https://
www.fda.gov/Food/Dietary
Supplements/NewDietaryIngredients
NotificationProcess/ucm356620.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.
In the Federal Register of November
14, 2014 (79 FR 68275), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. We
received three comments in response to
the notice. Two of the comments were
unrelated to the PRA, and therefore we
did not consider them.
E:\FR\FM\25FEN1.SGM
25FEN1
10122
Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices
The third comment asserted that we
underestimated the reporting burden of
the NDIN procedures under § 190.6 by
failing to take into account the
recommendations in the draft guidance
entitled ‘‘Dietary Supplements: New
Dietary Ingredient Notifications and
Related Issues’’ (the 2011 draft
guidance) (available at https://
www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/
DietarySupplements/ucm257563.htm).
FDA announced the availability of the
2011 draft guidance for comment in a
notice published in the Federal Register
of July 5, 2011 (76 FR 39111).
Although we agree with the
commenter that information collection
recommendations in guidance are
subject to the PRA, we intend to meet
our PRA obligations in that regard
separately at a later time. The 2011 draft
guidance was published solely for the
purpose of seeking comment, and it has
not been made final. Moreover, FDA
intends to publish a revised draft
guidance for comment later this year,
and the revised draft guidance will
supersede the 2011 draft guidance.
Although we expect the revised draft
guidance to be followed by a final
guidance, there will be an interim
period where no guidance on NDINs is
in effect. The purpose of the current
PRA proceeding is to seek comment on
and obtain OMB approval for the NDIN
collections of information in effect
during this interim period, which are
those found in the FDA’s NDIN
regulations at § 190.6 and in the
electronic NDIN submission forms that
we have made available for comment.
After publishing a revised draft
guidance on NDINs and related issues,
we intend to publish a 60-day notice
inviting comment on the proposed
collections of information associated
with that document. At that time, we
will carefully evaluate all comments we
receive.
We estimate 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 ....................................................................................
55
1
55
20
1,100
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1 There
are no operating and maintenance costs associated with this collection of information.
We believe that the burden of the
premarket notification requirement on
industry is limited 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. In the past,
commenters have argued that our
burden estimate is too low. We carefully
considered the issue and believe that
burden estimates of greater than 20
hours per notification likely include the
burden associated with researching and
generating safety data for a new dietary
ingredient. 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
NDINs, § 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, § 190.6 only requires the
VerDate Sep<11>2014
18:05 Feb 24, 2015
Jkt 235001
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. 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
§ 190.6 will take approximately 20
hours of work per notification.
However, we seek comments on this
estimate. We encourage comments
offering alternative burden estimates to
include documentation to support the
alternative estimate.
We further estimate that 55
respondents will submit 1 premarket
notification each. We base our estimate
of the number of respondents on
notifications received over the past 3
years, which averaged about 55
notifications per year.
Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03833 Filed 2–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0230]
Technical Performance Assessment of
Digital Pathology Whole Slide Imaging
Devices; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Technical Performance Assessment of
Digital Pathology Whole Slide Imaging
Devices.’’ This draft guidance provides
industry and Agency staff with
recommendations regarding the
technical performance assessment data
that should be provided for regulatory
evaluation of a digital whole slide
imaging (WSI) system. This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 26, 2015.
ADDRESSES: An electronic copy of the
guidance document is available for
SUMMARY:
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10121-10122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03833]
-----------------------------------------------------------------------
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 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 (the PRA).
DATES: Fax written comments on the collection of information by March
27, 2015.
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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE--14526, Silver
Spring, MD 20993-0002, 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.
Premarket Notification for a New Dietary Ingredient--21 CFR 190.6 (OMB
Control Number 0910-0330)--Extension
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 us (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, 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. We use 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.
We are developing an electronic portal that interested persons will
be able to 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
will 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 submitter
organize its NDIN to focus on the information needed for our safety
review. Safety information will be submitted via a supplemental form
entitled ``New Dietary Ingredient (NDI) 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 will be 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.
Draft screenshots of Form FDA 3880 and the supplemental safety
information form are available for comment at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm356620.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.
In the Federal Register of November 14, 2014 (79 FR 68275), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. We received three comments
in response to the notice. Two of the comments were unrelated to the
PRA, and therefore we did not consider them.
[[Page 10122]]
The third comment asserted that we underestimated the reporting
burden of the NDIN procedures under Sec. 190.6 by failing to take into
account the recommendations in the draft guidance entitled ``Dietary
Supplements: New Dietary Ingredient Notifications and Related Issues''
(the 2011 draft guidance) (available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm257563.htm). FDA announced the availability of
the 2011 draft guidance for comment in a notice published in the
Federal Register of July 5, 2011 (76 FR 39111).
Although we agree with the commenter that information collection
recommendations in guidance are subject to the PRA, we intend to meet
our PRA obligations in that regard separately at a later time. The 2011
draft guidance was published solely for the purpose of seeking comment,
and it has not been made final. Moreover, FDA intends to publish a
revised draft guidance for comment later this year, and the revised
draft guidance will supersede the 2011 draft guidance. Although we
expect the revised draft guidance to be followed by a final guidance,
there will be an interim period where no guidance on NDINs is in
effect. The purpose of the current PRA proceeding is to seek comment on
and obtain OMB approval for the NDIN collections of information in
effect during this interim period, which are those found in the FDA's
NDIN regulations at Sec. 190.6 and in the electronic NDIN submission
forms that we have made available for comment. After publishing a
revised draft guidance on NDINs and related issues, we intend to
publish a 60-day notice inviting comment on the proposed collections of
information associated with that document. At that time, we will
carefully evaluate all comments we receive.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6.............................................................. 55 1 55 20 1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
We believe that the burden of the premarket notification
requirement on industry is limited 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. In the past, commenters have argued that our burden
estimate is too low. We carefully considered the issue and believe that
burden estimates of greater than 20 hours per notification likely
include the burden associated with researching and generating safety
data for a new dietary ingredient. 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 NDINs, 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. 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. However, we seek comments on this estimate. We
encourage comments offering alternative burden estimates to include
documentation to support the alternative estimate.
We further estimate that 55 respondents will submit 1 premarket
notification each. We base our estimate of the number of respondents on
notifications received over the past 3 years, which averaged about 55
notifications per year.
Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03833 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P
