Agency Information Collection Activities: Proposed Collection; Comment Request, 15014-15015 [2015-06408]
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15014
Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1180]
Draft Guidance for Industry on
Ensuring Safety of Animal Feed
Maintained and Fed On-Farm;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry #203 entitled ‘‘Ensuring Safety
of Animal Feed Maintained and Fed OnFarm.’’ This draft guidance is intended
to help animal producers (persons who
feed animals) develop and implement
on-farm practices to ensure the safety of
animal feed maintained and fed to
animals on the farm.
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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by June 3, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed 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for electronic access to the draft
guidance document.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draft guidance to https://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:
Phares Okelo, Center for Veterinary
Medicine (HFV–226), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6862,
email: phares.okelo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
FDA is announcing the availability of
a draft guidance for industry # 203
entitled ‘‘Ensuring Safety of Animal
Feed Maintained and Fed On-Farm.’’
This draft guidance is intended to help
animal producers (persons who feed
animals) develop and implement on-
VerDate Sep<11>2014
20:14 Mar 19, 2015
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farm practices to ensure the safety of
animal feed maintained and fed to
animals on the farm. In this document,
‘‘farm’’ means animal production units
such as integrated poultry grower
operations, swine finishing units, and
cattle feedlots. This document outlines
basic measures that may be taken to
maintain the safety of all types of feed
held on the farm for use in animal
production. This draft guidance
recommends establishing measures to
ensure the acquisition of safe feed and
maintenance of its safety until the feed
is offered to animals in the farm
environment. This document does not
address feed manufacture, which also
may occur on farms.
II. Significance of Guidance
This level 1 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.
III. Paperwork Reduction Act of 1995
FDA concludes that there are no
collections of information under the
Paperwork Reduction Act of 1995.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday and
will be posted to the docket at https://
www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: March 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06390 Filed 3–19–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10550 and CMS–
10551]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments must be received by
May 19, 2015.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development
Attention: Document Identifier/OMB
Control Number llll, Room C4–26–
DATES:
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Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10550 Hospital National
Provider Survey
mstockstill on DSK4VPTVN1PROD with NOTICES
CMS–10551 Nursing Home National
Provider Survey
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Hospital
National Provider Survey; Use: Section
3104 of the Patient and Protection and
Affordable Care Act (ACA) requires that
the Secretary of the Department of
Health and Human Services (HHS)
conduct an assessment of the quality
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Jkt 235001
and efficiency impact of the use of
endorsed measures in specific Medicare
quality reporting and incentive
programs. The ACA further specifies
that the initial assessment must occur
no later than March 1, 2012, and once
every 3 years thereafter. This planned
data collection activity was developed
and tested as part of the 2015 Impact
Report and data collection will be
conducted for reporting in the 2018
Impact Report.
There are two modes of data
collection with hospital quality leaders:
(1) A semi-structured qualitative
interview and (2) a standardized survey.
The data from the qualitative interviews
and standardized surveys will be
analyzed to provide us with information
on the quality and efficiency impact of
measures that we use to assess care in
the hospital inpatient and outpatient
settings. The surveys seek to understand
whether the use of performance
measures has led to changes in provider
behavior, and where undesired effects
are occurring as a result of
implementing quality and efficiency
measures. The survey will also help
identify characteristics associated with
high performance, which if understood,
could be used to leverage improvements
in care among lower performing
hospitals. The focus of the survey is to
assess the impacts of the measures that
we use in the context of public reporting
(pay-for-reporting) and value-based
purchasing programs. Form Number:
CMS–10550 (OMB control number:
0938–NEW); Frequency: Occasionally;
Affected Public: Private Sector (Business
or other for-profit and Not-for-profit
institutions); Number of Respondents:
940; Total Annual Responses: 940; Total
Annual Hours: 639. (For policy
questions regarding this collection
contact Noni Bodkin at 410–786–7837.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Nursing Home
National Provider Survey; Use: Section
3104 of the Patient and Protection and
Affordable Care Act (ACA) requires that
the Secretary of the Department of
Health and Human Services (HHS)
conduct an assessment of the quality
and efficiency impact of the use of
endorsed measures in specific Medicare
quality reporting and incentive
programs. The ACA further specifies
that the initial assessment must occur
no later than March 1, 2012, and once
every 3 years thereafter. This planned
data collection activity was developed
and tested as part of the 2015 Impact
Report and data collection will be
conducted for reporting in the 2018
Impact Report.
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15015
There are two modes of data
collection with nursing home quality
leaders: (1) A semi-structured
qualitative interview and (2) a
standardized survey. The data from the
qualitative interviews and standardized
surveys will be analyzed to provide us
with information on the quality and
efficiency impact of measures that we
use to assess care in nursing homes
delivering skilled nursing care. The
surveys seek to understand whether the
use of performance measures has led to
changes in provider behavior (both at
the nursing home-level and at the
frontline of care), and whether
undesired effects are occurring as a
result of implementing quality and
efficiency measures. The survey will
also help identify characteristics
associated with high performance,
which if understood, could be used to
leverage improvements in care among
lower performing nursing homes. The
focus of the survey is to assess the
impacts of the measures that we use in
the context of public reporting (pay-forreporting) and quality improvement.
Form Number: CMS–10551 (OMB
control number: 0938–NEW);
Frequency: Occasionally; Affected
Public: Private Sector (Business or other
for-profit and Not-for-profit
institutions); Number of Respondents:
940; Total Annual Responses: 940; Total
Annual Hours: 639. (For policy
questions regarding this collection
contact Noni Bodkin at 410–786–7837.)
Dated: March 17, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–06408 Filed 3–19–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse:
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
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]]>Agencies
[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Pages 15014-15015]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06408]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10550 and CMS-10551]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. 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 or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments must be received by May 19, 2015.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development Attention: Document Identifier/OMB
Control Number ____, Room C4-26-
[[Page 15015]]
05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10550 Hospital National Provider Survey
CMS-10551 Nursing Home National Provider Survey
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. The term
``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 requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Hospital National Provider Survey; Use: Section 3104 of the Patient and
Protection and Affordable Care Act (ACA) requires that the Secretary of
the Department of Health and Human Services (HHS) conduct an assessment
of the quality and efficiency impact of the use of endorsed measures in
specific Medicare quality reporting and incentive programs. The ACA
further specifies that the initial assessment must occur no later than
March 1, 2012, and once every 3 years thereafter. This planned data
collection activity was developed and tested as part of the 2015 Impact
Report and data collection will be conducted for reporting in the 2018
Impact Report.
There are two modes of data collection with hospital quality
leaders: (1) A semi-structured qualitative interview and (2) a
standardized survey. The data from the qualitative interviews and
standardized surveys will be analyzed to provide us with information on
the quality and efficiency impact of measures that we use to assess
care in the hospital inpatient and outpatient settings. The surveys
seek to understand whether the use of performance measures has led to
changes in provider behavior, and where undesired effects are occurring
as a result of implementing quality and efficiency measures. The survey
will also help identify characteristics associated with high
performance, which if understood, could be used to leverage
improvements in care among lower performing hospitals. The focus of the
survey is to assess the impacts of the measures that we use in the
context of public reporting (pay-for-reporting) and value-based
purchasing programs. Form Number: CMS-10550 (OMB control number: 0938-
NEW); Frequency: Occasionally; Affected Public: Private Sector
(Business or other for-profit and Not-for-profit institutions); Number
of Respondents: 940; Total Annual Responses: 940; Total Annual Hours:
639. (For policy questions regarding this collection contact Noni
Bodkin at 410-786-7837.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: Nursing
Home National Provider Survey; Use: Section 3104 of the Patient and
Protection and Affordable Care Act (ACA) requires that the Secretary of
the Department of Health and Human Services (HHS) conduct an assessment
of the quality and efficiency impact of the use of endorsed measures in
specific Medicare quality reporting and incentive programs. The ACA
further specifies that the initial assessment must occur no later than
March 1, 2012, and once every 3 years thereafter. This planned data
collection activity was developed and tested as part of the 2015 Impact
Report and data collection will be conducted for reporting in the 2018
Impact Report.
There are two modes of data collection with nursing home quality
leaders: (1) A semi-structured qualitative interview and (2) a
standardized survey. The data from the qualitative interviews and
standardized surveys will be analyzed to provide us with information on
the quality and efficiency impact of measures that we use to assess
care in nursing homes delivering skilled nursing care. The surveys seek
to understand whether the use of performance measures has led to
changes in provider behavior (both at the nursing home-level and at the
frontline of care), and whether undesired effects are occurring as a
result of implementing quality and efficiency measures. The survey will
also help identify characteristics associated with high performance,
which if understood, could be used to leverage improvements in care
among lower performing nursing homes. The focus of the survey is to
assess the impacts of the measures that we use in the context of public
reporting (pay-for-reporting) and quality improvement. Form Number:
CMS-10551 (OMB control number: 0938-NEW); Frequency: Occasionally;
Affected Public: Private Sector (Business or other for-profit and Not-
for-profit institutions); Number of Respondents: 940; Total Annual
Responses: 940; Total Annual Hours: 639. (For policy questions
regarding this collection contact Noni Bodkin at 410-786-7837.)
Dated: March 17, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2015-06408 Filed 3-19-15; 8:45 am]
BILLING CODE 4120-01-P
