Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, 34083 [2011-14411]
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34083
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
of automated collection techniques,
when appropriate, and other forms of
information technology.
State Petitions for Exemption From
Preemption—21 CFR 100.1(d) (OMB
Control Number 0910–0277)—Extension
Under Section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (the
determine whether the State food
labeling or standard of identity
requirement satisfies the criteria of
section 403A(b) of the FD&C Act for
granting exemption from Federal
preemption.
FDA estimates the burden of this
collection of information as follows:
FD&C Act) (21 U.S.C. 343–1(b)), States
may petition FDA for exemption from
Federal preemption of State food
labeling and standard of identity
requirements. Section 100.1(d) (21 CFR
100.1(d)) sets forth the information a
State is required to submit in such a
petition. The information required
under section 100.1(d) enables FDA to
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
100.1(d) ............................................................
1
1
1
40
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the last 3 years,
FDA has not received any new petitions
for exemption from preemption;
therefore, the Agency estimates that one
or fewer petitions will be submitted
annually. Although FDA has not
received any new petitions for
exemption from preemption in the last
3 years, it believes these information
collection provisions should be
extended to provide for the potential
future need of a State or local
government to petition for an exemption
from preemption under the provisions
of section 403(A) of the FD&C Act.
Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14412 Filed 6–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0008]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
AGENCY:
Federal Food, Drug, and Cosmetic Act’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2011–N–0401]
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Communications Usability Testing, as
Used by the Food and Drug
Administration
In the
Federal Register of December 15, 2010
(75 FR 78249) 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 0910–0679. The
approval expires on April 30, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14411 Filed 6–9–11; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
SUMMARY:
VerDate Mar<15>2010
14:33 Jun 09, 2011
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Food and Drug Administration
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a generic clearance to collect
information that will provide tools to
test the usability of FDA
communications on specific topics and
to assist in the development and
modification of communication
messages to promote public health and
compliance with regulations.
DATES: Submit either electronic or
written comments on the collection of
information by August 9, 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
SUMMARY:
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Page 34083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0008]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on Citizen
Petitions and Petitions for Stay of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry on Citizen
Petitions and Petitions for Stay of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic Act'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 15, 2010
(75 FR 78249) 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 0910-0679.
The approval expires on April 30, 2014. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: June 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14411 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P
