Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities, 72727-72728 [2015-29663]
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices
offering of alternative non-opioid pain
management, discussion of safe storage
and proper disposal of opioids,
screening for overdose risk, and review
the history of substance use), discharge
planning, family training, rehabilitation
services, medical and nursing care,
interdisciplinary team goal setting and
care planning. We are also soliciting
information on publicly available
instruments for capturing patients’ and
family members’ experiences with IRF
care in a variety of formats (for example,
standardized, computer readable format)
that can be collected by providers or
CAHPS® survey vendors. We are
interested in suggested topic areas and
publicly available instruments that can
measure the quality of care from the
patients’ and/or family members’
perspective in IRFs within acute-care
hospitals, critical access hospitals, and
free-standing facilities; instruments that
can be used to track changes over time;
and items that are developed for and/or
can be modified to address low case
volume. Existing instruments are
preferred if they have been tested, have
been found to have a high degree of
reliability and validity, and for which
there is evidence of wide use in one or
more patient care settings, including
those in rural and frontier communities.
Instruments capable of risk adjustment,
and/or instruments that minimize
duplication of efforts and/or that utilize
common quality measures, where
available, are preferred. Whenever
possible, preference will be given to
quality measures identified by the
Secretary under section 1139A or 1139B
of the Act, or endorsed under section
1890 of the Act.
The following information would be
especially helpful in any comments
responding to this request for
information:
• A brief cover letter summarizing the
information requested for submitted
instruments and topic areas,
respectively, and how the submitted
materials could be used to help fulfil the
intent of the survey.
• (Optional) Information about the
person submitting the materials for the
purpose of follow-up questions about
the submission, which includes the
following:
++ Name.
++ Title.
++ Organization.
++ Mailing address.
++ Telephone number.
++ Email address.
• When submitting topic areas, we
encourage including, to the extent
available, the following information:
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17:39 Nov 19, 2015
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++ Detailed descriptions of the
suggested topic area(s) and specific
purpose(s).
++ Relevant peer-reviewed journal
articles or full citations.
• When submitting publicly available
instruments or survey questions, we
encourage including to the extent
available the following information:
++ Name of the instrument.
++ Indication that the instrument is
publicly available.
++ Copies of the full instrument in all
available languages.
++ Topic areas included in the
instrument.
++ Measures that can be derived from
data collected using the instrument.
++ Instrument reliability (internal
consistency, test-retest, etc.) and
validity (content, construct, criterion
related).
++ Results of cognitive testing (oneon-one testing with a small number of
respondents to ensure that they
understand the questionnaire.)
++ Results of field testing.
++ Current use of the instrument
(who is using it, what it is being used
for, what population it is being used
with, how instrument findings are
reported, and by whom the findings are
used).
++ Relevant peer-reviewed journal
articles or full citations.
++ CAHPS® trademark status.
++ NQF endorsement status.
++ Survey administration
instructions.
++ Data analysis instructions.
++ Guidelines for reporting survey
data.
If you wish to provide comments on
this information collection, please
submit your comments as specified in
the ADDRESSES section of this request for
information.
Comments must be received on/by
January 19, 2016.
III. Collection of Information
Requirements
This RFI does not impose any
information collection requirements. We
believe it is a solicitation of comments
from the general public. As stated in the
implementing regulations of the
Paperwork Reduction Act of 1995 (PRA)
at 5 CFR 1320.3(h)(4), it is exempt from
the requirements of the PRA (44 U.S.C.
3501 et seq.).
The data collected via this RFI will be
used to develop the IRF PEC Survey.
While surveys are generally subject to
the requirements of the PRA, we believe
the IRF PEC Survey is exempt. Section
I. of this RFI explains that we plan to
collect this information in support of
the NQS and, under sections 1886(j)(7)
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
72727
and 1890A(e) of the Act and develop the
IRF PEC Survey into a quality measure
that we may consider proposing for
adoption in the IRF Quality Reporting
Program (QRP). In accordance with
section 102 of the Medicare Access and
CHIP Reauthorization Act of 2015
(MACRA) (Pub. L. 114–110), the PRA
shall not apply to the collection of
information for the development of
quality measures.
Also, as stated earlier in section I. of
this RFI, we will develop the CMS IRF
PEC Survey in accordance with
CAHPS® Survey Design Principles and
are developing this survey and plans to
submit the resulting instrument to
AHRQ for recognition as a CAHPS®
survey. Upon receiving recognition as a
CAHPS® survey and prior to
implementation, CMS will submit the
CAHPS recognized IRF PEC Survey
through the OMB approval process. At
that time, the public will have the
opportunity to review, comment, or
review and comment on the proposed
information collection request prior to
its submission to OMB for review and
approval.
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.
Dated: November 6, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–29623 Filed 11–19–15; 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; Submission for Office of
Management and Budget Review;
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:
E:\FR\FM\20NON1.SGM
Notice.
20NON1
72728
Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
21, 2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0726. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT:
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Improving Food Safety and Defense
Capacity at the State and Local Level:
Review of State and Local Capacities
OMB Control Number 0910–0726—
Extension
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 referenced 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). This
review was completed in 2013 through
this information collection request.
This collection provided a baseline
measurement of the nation’s current
food safety and food defense
capabilities; FDA wants to renew this
information collection to gather more
data. By renewing this collection, FDA
will be able to analyze the gaps and
trends at the State and local levels,
allowing FDA and its partners to
develop ways to create a national
integrated food safety system.
FDA will conduct the survey
electronically, allowing FDA to conduct
streamlined analysis while creating a
low-burden, user-friendly environment
for respondents to complete the survey.
Once the results have been tabulated,
FDA and its partners can assess the
current progress towards an integrated
food safety system.
In the Federal Register of August 31,
2015 (80 FR 46025), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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.
Dated: November 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
(mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg,
and 10 mg/80 mg, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
ezetimibe and atorvastatin tablets, 10
mg/10 mg, 10 mg/20 mg, 10 mg/40 mg,
and 10 mg/80 mg, if all other legal and
regulatory requirements are met.
[FR Doc. 2015–29663 Filed 11–19–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
Determination That LIPTRUZET
(Ezetimibe and Atorvastatin) Tablets,
10 Milligrams/10 Milligrams, 10
Milligrams/20 Milligrams, 10
Milligrams/40 Milligrams, and 10
Milligrams/80 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that LIPTRUZET (ezetimibe
and atorvastatin) tablets, 10 milligrams
SUMMARY:
VerDate Sep<11>2014
17:39 Nov 19, 2015
Jkt 238001
Kate
Greenwood, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6217, Silver Spring,
MD 20993–0002, 240–402–1748.
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2015–P–3404]
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72727-72728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0145]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
-----------------------------------------------------------------------
[[Page 72728]]
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 21, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0726.
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Improving Food Safety and Defense Capacity at the State and Local
Level: Review of State and Local Capacities OMB Control Number 0910-
0726--Extension
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 referenced 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). This review was completed in 2013 through this
information collection request.
This collection provided a baseline measurement of the nation's
current food safety and food defense capabilities; FDA wants to renew
this information collection to gather more data. By renewing this
collection, FDA will be able to analyze the gaps and trends at the
State and local levels, allowing FDA and its partners to develop ways
to create a national integrated food safety system.
FDA will conduct the survey electronically, allowing FDA to conduct
streamlined analysis while creating a low-burden, user-friendly
environment for respondents to complete the survey. Once the results
have been tabulated, FDA and its partners can assess the current
progress towards an integrated food safety system.
In the Federal Register of August 31, 2015 (80 FR 46025), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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.
Dated: November 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29663 Filed 11-19-15; 8:45 am]
BILLING CODE 4164-01-P
