Agency Information Collection Activities: Submission for OMB Review; Comment Request, 3818-3819 [2014-01208]
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3818
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
D. Pregnant women
E. The elderly (age greater than or
equal to 65 years)
II. What factors modify the test
performance and comparative test
performance of available diagnostic tests
in these populations?
E. Imaging tests (e.g., US;
multidetector or helical CT with or
without contrast administered orally,
rectally, or intravenously; MRI with or
without contrast; abdominal X-ray)
F. Nuclear imaging studies
G. Diagnostic laparoscopy
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
KQ 2
What is the comparative effectiveness
of alternative diagnostic tests, alone or
in combination, for patients with RLQ
pain and suspected acute appendicitis?
I. For the populations listed under
Key Question 1a, what is the effect of
alternative testing strategies on
diagnostic thinking, therapeutic
decision making, clinical outcomes, and
resource utilization?
II. What factors modify the
comparative effectiveness of testing for
patients with RLQ pain and suspected
acute appendicitis?
Comparators
Alternative tests or test combinations
(as listed above), clinical observation
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Outcomes
ACTION:
I. Test performance (e.g., sensitivity,
specificity, accuracy, proportion of
‘‘negative’’ appendectomies) using
pathology or clinical followup as the
reference standard
II. Intermediate outcomes
A. Impact on diagnostic thinking (e.g.,
change in diagnosis after testing; change
in subsequent diagnostic approach after
obtaining initial test results)
B. Impact on therapeutic decision
making (e.g., change in treatment plan
after testing; time from admission to
surgery)
III. Final health or patient-centered
outcomes
A. Bowel perforation (ruptured
appendix)
B. Fistula formation
C. Infectious complications (abscess
formation, peritonitis, sepsis, stump
appendicitis)
D. Delay in diagnosis (time from
presentation to definitive diagnosis;
time from presentation to initiation of
treatment; time from presentation to
resolution of pain)
E. Length of hospital stay
F. Fetal/maternal outcomes (for
pregnant women; including premature
labor, pregnancy loss, fetal morbidity,
fetal mortality, maternal morbidity,
maternal mortality)
G. Mortality
IV. Adverse effects of intervention(s)
A. Direct harms of testing (e.g., harms
from exposure to ionizing radiation,
allergic reactions/kidney injury caused
by contrast agents)
B. Harms of test-directed treatment
(indirect)
SUMMARY:
KQ 3
What are the harms of diagnostic tests
per se, and what are the treatmentrelated harms of test-directed treatment
for tests used to diagnose RLQ pain and
suspected acute appendicitis?
PICOTS (Population, Interventions,
Comparators, Outcomes, Timing,
Setting)
sroberts on DSK5SPTVN1PROD with NOTICES
Population(s)
I. Patients with acute RLQ abdominal
pain (less than or equal to 7 days
duration) for whom appendicitis is
considered in the differential diagnosis
II. Separate analyses will be
performed for the following
populations:
A. Children (age less than 18 years);
additional analyses will be performed
for younger children (less than 2 years
and 2–5 years of age)
B. Adults (age greater than or equal to
18 years)
C. Non pregnant women of
reproductive age
D. Pregnant women
E. Elderly (age greater than or equal to
65 years)
Interventions
I. Diagnostic tests (alone or in
combination) for diagnosing
appendicitis
A. Clinical signs (e.g., psoas sign,
obturator sign, Rovsing sign, McBurney
sign)
B. Clinical symptoms (e.g., fever,
migrating pain, guarding)
C. Laboratory tests (e.g., white blood
cell count, C-reactive protein
concentration, left shift)
D. Clinical prediction or decision
rules (e.g., Alvarado score, Pediatric
Appendicitis Score, other predictive
models)
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21:50 Jan 22, 2014
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Timing
Studies will be considered regardless
of duration of followup.
Setting
All health care settings will be
considered.
Dated: January 14, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–01241 Filed 1–22–14; 8:45 am]
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Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–308 and
CMS–10508]
Notice.
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
(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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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 on the collection(s) of
information must be received by the
OMB desk officer by February 24, 2014.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions:
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–5806
OR Email: OIRA_
submission@omb.eop.gov.
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,
E:\FR\FM\23JAN1.SGM
23JAN1
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).
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
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
Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3818-3819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01208]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-308 and CMS-10508]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by February 24, 2014.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions:
OMB, Office of Information and Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395-5806 OR Email: OIRA--
submission@omb.eop.gov.
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,
[[Page 3819]]
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).
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 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