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, 32215 [2011-13814]
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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
Jkt 223001
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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]
[Page 32215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0564]
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.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
Dated: May 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13814 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P
