Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient, 52773-52774 [2013-20711]
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Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
Form FDA 356v. FDA requests that an
applicant fills out and sends in a Form
FDA 356v with an ANADA, and with
requests for phased review of data to
support ANADAs, to ensure efficient
and accurate processing of information
to support the approval of a generic new
animal drug.
Records and reports that are required
post approval are described in 21 CFR
514.80, and that paperwork is already
covered by that rule in OMB control
number 0910–0284.
Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20712 Filed 8–23–13; 8:45 am]
BILLING CODE 4160–01–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 we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
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 invites comments on
the procedure by which a manufacturer
or distributor of dietary supplements or
of a new dietary ingredient is to submit
information to us upon which it has
based its conclusion that a dietary
supplement containing a new dietary
ingredient will reasonably be expected
to be safe.
DATES: Submit either electronic or
written comments on the collection of
information by October 25, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
13:45 Aug 23, 2013
Jkt 229001
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
301–796–3793, PRAStaff@fda.hhs.gov.
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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, FDA invite
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
Section 413(a) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
52773
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, a
manufacturer or distributor of dietary
supplements or of a 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 a new dietary ingredient will
reasonably be expected to be safe. Part
190 (21 CFR part 190) implements these
statutory provisions. Section 190.6(a)
requires each manufacturer or
distributor of a dietary supplement
containing a new dietary ingredient, or
of a new dietary ingredient, to submit to
the Office of Nutrition, Labeling, and
Dietary Supplements (ONLDS)
notification of the basis for their
conclusion that said supplement or
ingredient will reasonably be expected
to be safe. Section 190.6(b) requires that
the notification include the following:
(1) The complete name and address of
the manufacturer or distributor, (2) the
name of the new dietary ingredient, (3)
a description of the dietary supplements
that contain the new dietary ingredient,
and (4) the history of use or other
evidence of safety establishing that the
dietary ingredient will reasonably be
expected to be safe.
The notification requirements
described previously are designed to
enable us to monitor the introduction
into the food supply of new dietary
ingredients and dietary supplements
that contain new dietary ingredients, in
order to protect consumers from the
introduction of unsafe dietary
supplements into interstate commerce.
We use the information collected under
these regulations to help ensure that a
manufacturer or distributor of a dietary
supplement containing a new dietary
ingredient is in full compliance with the
FD&C Act. We are currently developing
an electronic means for submitting this
information.
Description of Respondents: The
respondents to this collection of
information are firms in the dietary
supplement industry, including dietary
supplement and dietary ingredient
manufacturers, packagers and repackagers, holders, labelers and relabelers, distributors, warehouses,
exporters, and importers.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\26AUN1.SGM
26AUN1
52774
Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
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
(in hours) 2
Total hours
190.6 ....................................................................................
55
1
55
20
1,100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
ehiers on DSK2VPTVN1PROD with NOTICES
We believe that there will be minimal
burden on the industry to generate data
to meet the requirements of the
premarket notification program because
we are requesting only that information
that the manufacturer or distributor
should already have developed to
satisfy itself that a dietary supplement
containing a new dietary ingredient is in
full compliance with the FD&C Act. In
the past, commenters argued that our
burden estimate is too low. We revisited
this issue and believe their burden
estimate included the time it takes to
research and generate safety data for a
new dietary ingredient. However, sec.
190.6(a) requires each manufacturer or
distributor of a dietary supplement
containing a new dietary ingredient, or
of a new dietary ingredient, to submit
notification of the basis for their
conclusion that said supplement or
ingredient will reasonably be expected
to be safe. Section 190.6 requests simply
the extraction and summarization of the
safety data that should have already
been developed by the manufacturer or
distributor. Thus, we estimate that
extracting and summarizing the relevant
information from the company’s files,
and presenting it in a format that will
meet the requirements of section 413 of
the FD&C Act will require a burden of
approximately 20 hours of work per
submission.
We estimate that 55 respondents will
submit one premarket notification each
and that it will take a respondent 20
hours to prepare the notification, for a
total of 1,100 hours. The estimated
number of premarket notifications and
hours per response is an average based
on our experience with notifications
received during the last 3 years and
information from firms that have
submitted recent premarket
notifications.
Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20711 Filed 8–23–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
13:45 Aug 23, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0973]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Feed
Network (Pet Event Tracking Network
and LivestockNET)—State, Federal
Cooperation To Prevent Spread of Pet
Food and Animal Feed Related
Diseases
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 paperwork burden to the public of
the Animal Feed Network, which
includes the Pet Event Tracking
Network (PETNet) and LivestockNET,
for reporting of pet food or animal feed
related instances, respectively.
DATES: Submit either electronic or
written comments on the collection of
information by October 25, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, 1350
Piccard Dr., PI50–400T, Rockville, MD
SUMMARY:
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
20850, 301–796–5733, domini.bean@
fda.hhs.gov.
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.
Pet Event Tracking Network—State,
Federal Cooperation To Prevent Spread
of Pet Food Related Diseases—and
Livestock.NET—21 U.S.C. 342, 21
U.S.C. 343, Section 1002(b) of the FDA
Amendments Act of 2007 (Pub. L. 110–
85, 121 Stat. 823) (2007)—OMB Control
Number 0910–0680
On August 1, 2011, the Pet Event
Tracking Network (PETNet) was
launched by FDA and its partners in the
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52773-52774]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20711]
-----------------------------------------------------------------------
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 we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the 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
invites comments on the procedure by which a manufacturer or
distributor of dietary supplements or of a new dietary ingredient is to
submit information to us upon which it has based its conclusion that a
dietary supplement containing a new dietary ingredient will reasonably
be expected to be safe.
DATES: Submit either electronic or written comments on the collection
of information by October 25, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 301-796-3793, PRAStaff@fda.hhs.gov.
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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA invite
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
Section 413(a) of the Federal Food, Drug, and Cosmetic Act (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, a
manufacturer or distributor of dietary supplements or of a 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 a new dietary ingredient will reasonably be expected to be
safe. Part 190 (21 CFR part 190) implements these statutory provisions.
Section 190.6(a) requires each manufacturer or distributor of a dietary
supplement containing a new dietary ingredient, or of a new dietary
ingredient, to submit to the Office of Nutrition, Labeling, and Dietary
Supplements (ONLDS) notification of the basis for their conclusion that
said supplement or ingredient will reasonably be expected to be safe.
Section 190.6(b) requires that the notification include the following:
(1) The complete name and address of the manufacturer or distributor,
(2) the name of the new dietary ingredient, (3) a description of the
dietary supplements that contain the new dietary ingredient, and (4)
the history of use or other evidence of safety establishing that the
dietary ingredient will reasonably be expected to be safe.
The notification requirements described previously are designed to
enable us to monitor the introduction into the food supply of new
dietary ingredients and dietary supplements that contain new dietary
ingredients, in order to protect consumers from the introduction of
unsafe dietary supplements into interstate commerce. We use the
information collected under these regulations to help ensure that a
manufacturer or distributor of a dietary supplement containing a new
dietary ingredient is in full compliance with the FD&C Act. We are
currently developing an electronic means for submitting this
information.
Description of Respondents: The respondents to this collection of
information are firms in the dietary supplement industry, including
dietary supplement and dietary ingredient manufacturers, packagers and
re-packagers, holders, labelers and re-labelers, distributors,
warehouses, exporters, and importers.
We estimate the burden of this collection of information as
follows:
[[Page 52774]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours) \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6.............................................................. 55 1 55 20 1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal burden on the industry to
generate data to meet the requirements of the premarket notification
program because we are requesting only that information that the
manufacturer or distributor should already have developed to satisfy
itself that a dietary supplement containing a new dietary ingredient is
in full compliance with the FD&C Act. In the past, commenters argued
that our burden estimate is too low. We revisited this issue and
believe their burden estimate included the time it takes to research
and generate safety data for a new dietary ingredient. However, sec.
190.6(a) requires each manufacturer or distributor of a dietary
supplement containing a new dietary ingredient, or of a new dietary
ingredient, to submit notification of the basis for their conclusion
that said supplement or ingredient will reasonably be expected to be
safe. Section 190.6 requests simply the extraction and summarization of
the safety data that should have already been developed by the
manufacturer or distributor. Thus, we estimate that extracting and
summarizing the relevant information from the company's files, and
presenting it in a format that will meet the requirements of section
413 of the FD&C Act will require a burden of approximately 20 hours of
work per submission.
We estimate that 55 respondents will submit one premarket
notification each and that it will take a respondent 20 hours to
prepare the notification, for a total of 1,100 hours. The estimated
number of premarket notifications and hours per response is an average
based on our experience with notifications received during the last 3
years and information from firms that have submitted recent premarket
notifications.
Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20711 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P
