Agency Information Collection Activities; Proposed Collection; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities, 11132-11133 [2012-4289]
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Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
Conditions for Coverage and
Requirements for Outpatient Diabetes
Self-Management Training Services
The regulations specifying the
Medicare conditions for coverage for
outpatient diabetes self-management
training services are located in 42 CFR
parts 410, subpart H. These conditions
implement section 1861(qq) of the Act,
which provides for Medicare Part B
coverage of outpatient DSMT services
specified by the Secretary.
Under section 1865(a)(2) of the Act
and our regulations at § 410.142 (CMS
process for approving national
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§ 410.143 (Requirements for approved
accreditation organizations), we review
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necessarily limited to) the criteria set
forth in § 410.142(b).
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verify information in the organization’s
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organization’s compliance with its own
policies and procedures. The onsite
inspection may include, but is not
limited to, reviewing documents,
auditing documentation of meetings
concerning the accreditation process,
evaluating accreditation results or the
accreditation status decision making
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Notice Upon Completion of Evaluation
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a notice in the Federal
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evaluation.
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
srobinson on DSK4SPTVN1PROD with NOTICES
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
VerDate Mar<15>2010
18:34 Feb 23, 2012
Jkt 226001
(Catalog of Federal Domestic Assistance
Program No. 93.773 Medicare-Hospital
Insurance Program; and No. 93.774,
Medicare-Supplementary Medical Insurance
Program)
Dated: February 10, 2012.
Marilyn Tavenner,
Acting CMS Administrator, Centers for
Medicare & Medicaid Services.
[FR Doc. 2012–4277 Filed 2–23–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0145]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Improving Food
Safety and Defense Capacity of the
State and Local Level: Review of State
and Local Capacities
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 survey entitled ‘‘Improving Food
Safety and Defense Capacity of the State
and Local Level: Review of State and
Local Capacities.’’ The data collection
will obtain knowledge of State and local
capacities including food safety defense
staffing and expertise, laboratory
capacities, and information systems to
support food and feed safety and
defense.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 24, 2012.
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:
DATES:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Ila S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850,
301–796–7726,
Ila.Mizrachi@fda.hhs.gov.
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
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.
SUPPLEMENTARY INFORMATION:
Improving Food Safety and Defense
Capacity at the State and Local Level:
Review of State and Local Capacities—
(OMB Control Number 0910—New)
The Food Safety Modernization Act
(FSMA) (Pub. L. 111–353) states that a
review must be conducted to assess the
State and local capacities to show needs
for enhancement in the areas or staffing
levels, laboratory capacities, and
information technology systems. This
mandate is referenced again in FSMA
section 110 stating that a review of
current food safety and food defense
capabilities must be presented to
Congress no later than 2 years after the
date of enactment (enactment date
January 4, 2011). In order to facilitate
this review, this team must distribute a
E:\FR\FM\24FEN1.SGM
24FEN1
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Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
survey to State and local health and
agriculture agencies. In doing so, this
team will be able to analyze the gaps
and trends to occur at these respective
levels which will allow FSMA
counterparts to develop ways to
enhance food safety and food defense.
In developing these strategies, FDA will
be able to work with other Federal
Agencies to improve and expand food
safety and defense to ultimately reach a
state of an integrated food safety system.
FDA will conduct the survey
electronically which allows FDA to
conduct streamlines analysis while
creating a low-burden, user-friendly
environment for respondents to
complete the survey. Once the results
have been tabulated, a report will be
generated and given to FSMA section
110 to present to Congress as well as
FSMA section 205(c)1 to develop the
strategies to leverage and enhance
current State and local capacities.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
respondents
Activity
Current State and local government employees .................
1 There
Dated: February 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–4289 Filed 2–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0148]
Draft Guidance for Industry on
Complicated Urinary Tract Infections:
Developing Drugs for Treatment;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Complicated Urinary
Tract Infections: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of complicated urinary tract
infections (cUTIs). Specifically, this
guidance addresses FDA’s current
thinking regarding the overall drug
development program for the treatment
SUMMARY:
srobinson on DSK4SPTVN1PROD with NOTICES
1,400
Total annual
responses
1
1,400
Average
burden per
response
Total hours
1
1,400
are no capital costs or operating and maintenance costs associated with this collection of information.
This survey is slated to be a one-time
survey. Through testing on six FDA
employees who were formerly State
employees, the survey development
team has come to the conclusion that it
should take no longer than 1 hour for
the 1,400 current State and local
government employees to complete the
survey. FDA is requesting this data
collection burden so as not to restrict
the Agency’s ability to gather
information on public sentiment for its
proposals in its regulatory and
communications programs.
AGENCY:
No. of
responses per
respondent
VerDate Mar<15>2010
18:34 Feb 23, 2012
Jkt 226001
of cUTIs, including clinical trial designs
to support approval of drugs.
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 on 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 24, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Complicated Urinary Tract Infections:
Developing Drugs for Treatment.’’ The
purpose of this draft guidance is to
assist sponsors and investigators in the
development of drugs for the treatment
of cUTIs. This draft guidance revises
and replaces the draft guidance for
industry entitled ‘‘Complicated Urinary
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Tract Infections and Pyelonephritis—
Developing Antimicrobial Drugs for
Treatment’’ published in 1998.
Infections of the urinary tract
occurring in patients with underlying
functional or anatomic abnormalities of
the urinary tract are defined as cUTIs.
Infections of the kidney, called
pyelonephritis, can occur in persons
without underlying abnormalities of the
urinary tract, but are also considered to
be a subset of cUTI. Different types of
bacteria can cause cUTI, but Gramnegative bacteria are most often
associated with cUTI.
This draft guidance includes
recommendations for an efficacy
endpoint and noninferiority trial design.
The efficacy endpoint, based on
resolution of clinical symptoms and
eradication of bacteria from the urinary
tract, was derived from previously
conducted trials for the treatment of
cUTI. The draft guidance provides a
scientific justification for a
noninferiority margin based on
historical observational data compared
to the results of previously conducted
clinical trials. The draft guidance also
provides a discussion about patients
with unmet need who have an infection
caused by bacterial pathogens that show
resistance to most antibacterial drugs on
in vitro susceptibility testing.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11132-11133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4289]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0145]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Improving Food Safety and Defense Capacity of the
State and Local Level: Review of State and Local Capacities
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a survey entitled ``Improving Food Safety
and Defense Capacity of the State and Local Level: Review of State and
Local Capacities.'' The data collection will obtain knowledge of State
and local capacities including food safety defense staffing and
expertise, laboratory capacities, and information systems to support
food and feed safety and defense.
DATES: Submit either electronic or written comments on the collection
of information by April 24, 2012.
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:
Ila S. Mizrachi, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-
796-7726, Ila.Mizrachi@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 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.
Improving Food Safety and Defense Capacity at the State and Local
Level: Review of State and Local Capacities--(OMB Control Number 0910--
New)
The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) states
that a review must be conducted to assess the State and local
capacities to show needs for enhancement in the areas or staffing
levels, laboratory capacities, and information technology systems. This
mandate is referenced again in FSMA section 110 stating that a review
of current food safety and food defense capabilities must be presented
to Congress no later than 2 years after the date of enactment
(enactment date January 4, 2011). In order to facilitate this review,
this team must distribute a
[[Page 11133]]
survey to State and local health and agriculture agencies. In doing so,
this team will be able to analyze the gaps and trends to occur at these
respective levels which will allow FSMA counterparts to develop ways to
enhance food safety and food defense. In developing these strategies,
FDA will be able to work with other Federal Agencies to improve and
expand food safety and defense to ultimately reach a state of an
integrated food safety system.
FDA will conduct the survey electronically which allows FDA to
conduct streamlines analysis while creating a low-burden, user-friendly
environment for respondents to complete the survey. Once the results
have been tabulated, a report will be generated and given to FSMA
section 110 to present to Congress as well as FSMA section 205(c)1 to
develop the strategies to leverage and enhance current State and local
capacities.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Average
Activity No. of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current State and local government employees............................ 1,400 1 1,400 1 1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
This survey is slated to be a one-time survey. Through testing on
six FDA employees who were formerly State employees, the survey
development team has come to the conclusion that it should take no
longer than 1 hour for the 1,400 current State and local government
employees to complete the survey. FDA is requesting this data
collection burden so as not to restrict the Agency's ability to gather
information on public sentiment for its proposals in its regulatory and
communications programs.
Dated: February 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4289 Filed 2-23-12; 8:45 am]
BILLING CODE 4160-01-P
