Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient, 32214-32215 [2011-13815]
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Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–13768 Filed 6–2–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0410]
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) 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 procedure by which a manufacturer
or distributor of dietary supplements or
of a new dietary ingredient is to submit
information to FDA 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 August 2, 2011.
ADDRESSES: Submit electronic
comments on the collection of
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:49 Jun 02, 2011
Jkt 223001
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
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
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Sfmt 4703
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 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 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 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 FDA 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.
FDA uses 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.
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.
FDA estimates the burden of this
collection of information as follows:
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03JNN1
32215
Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response (in
hours)
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.
The Agency believes that there will be
minimal burden on the industry to
generate data to meet the requirements
of the premarket notification program
because the Agency is 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. However, the Agency
estimates 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.
The estimated number of premarket
notifications and hours per response is
an average based on the Agency’s
experience with notifications received
during the last 3 years and information
from firms that have submitted recent
premarket notifications. FDA received
77 notifications in 2008, 39 notifications
in 2009, and 48 notifications in 2010,
for an average of 55 notifications.
Accordingly, 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.
Dated: May 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
ACTION:
Notice.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Restaurant Menu and Vending Machine
Labeling: Registration for Small Chains
Under Section 4205 of the Patient
Protection and Affordable Care Act of
2010’’ has been approved by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 31, 2011 (76
FR 5384), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0664. The
approval expires on April 30, 2013. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUMMARY:
Dated: May 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13815 Filed 6–2–11; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2011–13814 Filed 6–2–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jlentini on DSK4TPTVN1PROD with NOTICES
[Docket No. FDA–2010–N–0564]
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Restaurant Menu and Vending Machine
Labeling; Registration for Small
Chains Under Section 4205 of the
Patient Protection and Affordable Care
Act of 2010
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
[Docket No. FDA–2011–N–0403]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Substantiation for
Dietary Supplement Claims Made
Under the Federal Food, Drug, and
Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
17:08 Jun 02, 2011
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PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
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 information collection provisions of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) and the guidance
entitled ‘‘Guidance for Industry:
Substantiation for Dietary Supplement
Claims Made Under Section 403(r)(6) of
the Federal Food, Drug, and Cosmetic
Act.’’
DATES: Submit either electronic or
written comments on the collection of
information by August 2, 2011.
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUMMARY:
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03JNN1.SGM
03JNN1
]]>Agencies
[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32214-32215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13815]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0410]
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) 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 procedure by which a
manufacturer or distributor of dietary supplements or of a new dietary
ingredient is to submit information to FDA 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 August 2, 2011.
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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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
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, a
manufacturer or distributor of dietary supplements or of a 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 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 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 FDA 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. FDA uses 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.
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.
FDA estimates the burden of this collection of information as
follows:
[[Page 32215]]
Table 1--Estimated Annual Reporting Burden1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden per
21 CFR Section Number of responses per Total annual response (in Total hours
respondents respondent responses 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.
The Agency believes that there will be minimal burden on the
industry to generate data to meet the requirements of the premarket
notification program because the Agency is 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. However,
the Agency estimates 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.
The estimated number of premarket notifications and hours per
response is an average based on the Agency's experience with
notifications received during the last 3 years and information from
firms that have submitted recent premarket notifications. FDA received
77 notifications in 2008, 39 notifications in 2009, and 48
notifications in 2010, for an average of 55 notifications. Accordingly,
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.
Dated: May 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13815 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P
