Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program, 3819-3820 [2014-01221]
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sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
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: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: State Children’s
Health Insurance Program and
Supporting Regulations; Use: States
must submit title XXI plans and
amendments for approval by the
Secretary. We use the plan and its
subsequent amendments to determine if
the state has met the requirements of
title XXI. Information provided in the
state plan, state plan amendments, and
from the other information we are
collecting will be used by advocacy
groups, beneficiaries, applicants, other
governmental agencies, providers
groups, research organizations, health
care corporations, health care
consultants. States will use the
information collected to assess state
plan performance, health outcomes and
an evaluation of the amount of
substitution of private coverage that
occurs as a result of the subsidies and
the effect of the subsidies on access to
coverage. Form Number: CMS–R–308
(OCN: 0938–0841); Frequency: Yearly,
Once, and Occasionally; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 400; Total
Annual Hours: 1,473,817. (For policy
questions regarding this collection
contact Judith Cash at 410–786–4473).
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2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Evaluation of
the Rural Community Hospital
Demonstration (RCHD); Use: Section
10313 of the Affordable Care Act of
2010 (ACA) extended and expanded the
Rural Community Hospital
Demonstration (RCHD). Originally
authorized under the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), the
RCHD provides enhanced
reimbursement for inpatient services to
small rural hospitals that do not qualify
as critical access hospitals (CAHs). The
RCHD is intended to increase the
capability of these hospitals to meet the
health care needs of rural beneficiaries
in their service areas. As a
demonstration, the RCHD aims to
provide information that can be used to
assess the feasibility and advisability of
establishing a new category of rural
community hospitals for reimbursement
policy. As of January 2013, 23 hospitals
from 11 states are participating in the
RCHD. This number includes seven
hospitals continuing from the original
demonstration as authorized under the
MMA and 15 new hospitals that joined
under the expansion authorized under
the ACA.
For the original demonstration, the
MMA required a Report to Congress six
months after the end of the
demonstration, a requirement
unchanged by the ACA. An initial
evaluation was conducted between 2007
and 2011 toward preparing for a Report
to Congress and focused on the 17
hospitals that had participated at some
point between October 2004 and March
2011. Findings from this evaluation
were reported to the Centers for
Medicare and Medicaid Services (CMS)
in the Interim Evaluation Report of the
Rural Community Hospital
Demonstration (an unpublished report).
The current five-year evaluation of the
RCHD will extend and build on the
prior evaluation and produce the Report
to Congress required by the MMA. It
will assess the impact of the RCHD in
meeting its goals: to enable hospitals to
achieve community benefits such as
improved services for their communities
(especially Medicare beneficiaries),
meet their individual strategic goals,
and improve the financial solvency and
viability of the participating hospitals.
In addition, the evaluation will
determine if it is feasible and advisable
to create a new payment category of
rural hospitals. To achieve this
objective, the evaluation will examine
how RCHD hospitals responded to
payment options and assess how the
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3819
costs to Medicare under RCHD compare
to existing alternative payment options.
The evaluation will also summarize
the characteristics of the markets served
by RCHD hospitals, including
beneficiaries’ proximity to inpatient
providers and competition among
providers in the area. The information
will be used to assess the implications
of expanding the RCHD payment system
to hospitals in various market
environments. In addition, the
evaluation will examine the potential
costs of expanding the RCHD payment
methodology, accounting for alternative
approaches to targeting rural hospitals.
Form Number: CMS–10508 (OCN:
0938–NEW); Frequency: Annually;
Affected Public: State, Local or Tribal
Governments, Private sector (Business
or other for-profit and Not-for-profit
organizations); Number of Respondents:
57; Total Annual Responses: 101; Total
Annual Hours: 245. (For policy
questions regarding this collection
contact Woolton Lee at 410–786–4942.)
Dated: January 16, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–01208 Filed 1–22–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1064]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Application for
Participation in the Medical Device
Fellowship Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 February
24, 2014.
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:
SUMMARY:
E:\FR\FM\23JAN1.SGM
23JAN1
3820
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0551. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Application for Participation in the
Medical Device Fellowship Program—
(OMB Control Number 0910–0551)—
(Extension)
Sections 1104, 1302, 3301, 3304,
3320, 3361, 3393, and 3394 of Title 5 of
the United States Code authorize
Federal Agencies to rate applicants for
Federal jobs. Collecting applications for
the Medical Device Fellowship Program
will allow FDA’s Center for Devices and
Radiological Health (CDRH) to easily
and efficiently elicit and review
information from students and health
care professionals who are interested in
becoming involved in CDRH activities.
The process will reduce the time and
cost of submitting written
documentation to the Agency and lessen
the likelihood of applications being
misrouted within the Agency mail
system. It will assist the Agency in
promoting and protecting the public
health by encouraging outside persons
to share their expertise with CDRH.
In the Federal Register of September
10, 2013 (78 FR 55260), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA based these estimates on the
number of inquiries that have been
received concerning the program and
the number of requests for application
forms over the past 3 years.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
FDA form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Application Form (Form FDA 3608) ....................................
250
1
250
1
250
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01221 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0377]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Tobacco Health Document Submission
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01222 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Tobacco Health Document
Submission’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On August
28, 2013, the Agency submitted a
proposed collection of information
entitled ‘‘Tobacco Health Document
SUMMARY:
sroberts on DSK5SPTVN1PROD with NOTICES
Submission’’ 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 0910–0654. The
approval expires on December 31, 2016.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1089]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recommended
Glossary and Educational Outreach To
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use
AGENCY:
Food and Drug Administration,
HHS.
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Frm 00046
Fmt 4703
Sfmt 4703
ACTION:
Notice.
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.
SUMMARY:
Fax written comments on the
collection of information by February
24, 2014.
DATES:
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 0910–0553. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23JAN1.SGM
23JAN1
Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3819-3820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01221]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1064]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for
Participation in the Medical Device Fellowship Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
February 24, 2014.
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:
[[Page 3820]]
202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0551. 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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.
Application for Participation in the Medical Device Fellowship
Program--(OMB Control Number 0910-0551)--(Extension)
Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of
Title 5 of the United States Code authorize Federal Agencies to rate
applicants for Federal jobs. Collecting applications for the Medical
Device Fellowship Program will allow FDA's Center for Devices and
Radiological Health (CDRH) to easily and efficiently elicit and review
information from students and health care professionals who are
interested in becoming involved in CDRH activities. The process will
reduce the time and cost of submitting written documentation to the
Agency and lessen the likelihood of applications being misrouted within
the Agency mail system. It will assist the Agency in promoting and
protecting the public health by encouraging outside persons to share
their expertise with CDRH.
In the Federal Register of September 10, 2013 (78 FR 55260), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA based these estimates on the number of inquiries that have been
received concerning the program and the number of requests for
application forms over the past 3 years.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application Form (Form FDA 3608)................................... 250 1 250 1 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01221 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P