Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), May 22, 2014; Corrections, 28524-28525 [2014-11380]
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28524
Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices
In the final rule for Stage 2 of
meaningful use (77 FR 53967), we
agreed that the burden on eligible
providers, public health agencies and
registries would be greatly reduced and
established that we would create such a
database and it would serve as the
definitive information source for
determining public health agency and
registry readiness to receive electronic
data associated with the public health
meaningful use objectives. The
information will be made publicly
available on the CMS Web site
(www.cms.gov/EHRincentiveprograms)
in order to provide a centralized
repository of this information to eligible
providers and eliminate there multiple
individual inquiries to multiple public
health agencies and registries. Form
Number: CMS–10499 (OMB control
number: 0938—New); Frequency:
Yearly; Affected Public: Private sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 250; Total Annual
Responses: 250; Total Annual Hours:
83. (For policy questions regarding this
collection contact Kathleen Connors de
Laguna at 410–786–2256.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Standards
Related to Reinsurance, Risk Corridors,
Risk Adjustment, and Payment Appeals;
Use: The Affordable Care Act provides
for three premium stabilization
programs—a reinsurance program, a risk
corridors program, and a risk
adjustment program—to mitigate the
negative impacts of adverse selection
and market uncertainty. On March 23,
2012, we published the Premium
Stabilization Rule (77 FR 17220) to
implement and set standards for these
premium stabilization programs. On
March 11, 2013, we published the final
Notice of Benefit and Payment
Parameters for 2014 (‘‘2014 Payment
Notice’’) (78 FR 15410), to implement
requirements for various programs
established by the Affordable Care Act,
establish standards for the cost-sharing
reduction program and the premium tax
credit program, to provide for the
collection of user fees from issuers to
fund operations of the Federallyfacilitated Exchange and the risk
adjustment program in States where
HHS operates risk adjustment, and to
expand on standards set forth in the
Premium Stabilization Rule. We
published a proposed Notice of Benefit
and Payment Parameters for 2015
(‘‘2015 Payment Notice’’) on December
02, 2013, to expand upon, modify, and
clarify the provisions of the Premium
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20:20 May 15, 2014
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Stabilization Rule, the 2014 Payment
Notice, and the first and second final
Program Integrity Rules (78 FR 54070
and 78 FR 65046).
The transitional reinsurance program
and the temporary risk corridors
program are designed to provide issuers
with greater payment stability as
insurance market reforms begin. The
reinsurance program serves to reduce
the uncertainty of insurance risk in the
individual market in each State by
making payments for high-cost
enrollees. The HHS-administered risk
corridors program serves to protect
against rate-setting uncertainty with
respect to qualified health plans by
limiting the extent of issuer losses (and
gains). The permanent risk adjustment
program is intended to protect health
insurance issuers that attract a
disproportionate number of higher risk
enrollees, that is, those with chronic
conditions. These programs will support
the effective functioning of the
American Health Benefit Exchanges
(‘‘Exchanges’’), which will become
operational by January 1, 2014. The
Exchanges are individual and small
group health insurance marketplaces
designed to enhance competition in the
health insurance market and to expand
access to affordable health insurance for
millions of Americans. Individuals who
enroll in qualified health plans (QHPs)
through individual market Exchanges
may receive premium tax credits to
make health insurance more affordable
and financial assistance to reduce cost
sharing for health care services. The
information collection requirements
contained in this information collection
request will enable States, HHS or both
States and HHS to implement these
programs, which will mitigate the
impact of adverse selection in the
individual and small group markets
both inside and outside the Exchange.
Form Number: CMS–10401 (OMB
control number: 0938–1155); Frequency:
Occasionally; Affected Public: State,
Local and Tribal governments, Private
sector—Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 2,520; Total Annual
Responses: 15,600,081,744; Total
Annual Hours: 17,469,624. (For policy
questions regarding this collection
contact Jaya Ghildyal at 301–492–5149.)
Dated: May 13, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–11388 Filed 5–15–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7032–CN]
Health Insurance Marketplace,
Medicare, Medicaid, and Children’s
Health Insurance Programs; Meeting of
the Advisory Panel on Outreach and
Education (APOE), May 22, 2014;
Corrections
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction notice.
AGENCY:
This notice corrects an error
in the notice of meeting that published
in the May 2, 2014 Federal Register
titled ‘‘Health Insurance Marketplace,
Medicare, Medicaid, and Children’s
Health Insurance Programs; Meeting of
the Advisory Panel on Outreach and
Education (APOE), May 22, 2014.’’
FOR FURTHER INFORMATION CONTACT:
Kirsten Knutson, (410) 786–5886.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In FR Doc. 2014- 09989, which
published in the May 2, 2014 Federal
Register (79 FR 25133) titled ‘‘Health
Insurance Marketplace, Medicare,
Medicaid, and Children’s Health
Insurance Programs; Meeting of the
Advisory Panel on Outreach and
Education (APOE), May 22, 2014’’, there
was an error that is identified and
corrected in the Correction of Errors
section of this correction notice.
II. Summary of Errors
On page 25134, we made an error in
providing information regarding the
public’s offsite participation in the May
22, 2014 APOE meeting.
III. Correction of Errors
In FR Doc. 2014–09989 of May 2,
2014 (79 FR 25133), make the following
correction:
1. On page 25134, first column,
second paragraph (ADDRESSES section),
line 21, the phrase ‘‘engage virtually in
the open meetings, this APOE meeting
will be available to view via live Web
streaming by visiting the link
www.cms.gov/live during the designated
time of the meeting.’’ is corrected to
read ‘‘engage in the open meeting, this
APOE meeting will be available for
listening only via a conference call. To
listen to the meeting, the public may
dial 1–877–267–1577, then follow the
instructions on the phone and enter the
following meeting ID number, 996 925
940, followed by the pound sign.’’
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Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance, Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: May 13, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–11380 Filed 5–15–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fax written comments on the
collection of information by June 16,
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 0910–0540. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
[Docket No. FDA–2007–N–0037]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Drug User
Fee Act Waivers and Reductions
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
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.
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Animal Drug User Fees and Fee
Waivers and Reductions (OMB Control
Number 0910–0540)—Extension
Enacted on November 18, 2003, the
Animal Drug User Fee Act (ADUFA)
(Pub. L. 108–130) amended the Federal
Food, Drug, and Cosmetic Act and
requires FDA to assess and collect user
fees for certain applications, products,
establishments, and sponsors. It also
requires the Agency to grant a waiver
from, or a reduction of those fees in
certain circumstances. Thus, to
implement this statutory provision of
ADUFA, FDA developed a guidance
entitled ‘‘Guidance for Industry: Animal
Drug User Fees and Fee Waivers and
Reductions.’’ This document provides
guidance on the types of fees FDA is
authorized to collect under ADUFA, and
how to request waivers and reductions
from FDA’s animal drug user fees.
Further, this guidance also describes the
types of fees and fee waivers and
reductions; what information FDA
recommends be submitted in support of
a request for a fee waiver or reduction;
how to submit such a request; and
FDA’s process for reviewing requests.
Respondents to this collection of
information are new animal drug
sponsors. Requests for waivers or
reductions may be submitted by a
person paying any of the animal drug
user fees assessed including application
fees, product fees, establishment fees, or
sponsor fees.
In the Federal Register of February
25, 2014 (79 FR 10532) FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
response
Total annual
responses
Total hours
740(d)(1)(A); significant barrier to innovation.
740(d)(1)(B); fees exceed cost .........
740(d)(1)(C); free choice feeds ........
740(d)(1)(D); minor use or minor
species.
740(d)(1)(E); small business .............
Request for reconsideration of a decision.
Request for review—(user fee appeal officer).
45
1 time for each application ...............
45
2
90
8
5
76
3.75 ..................................................
1 time for each application ...............
1 time for each application ...............
30
5
76
2 0.5
2
2
15
10
152
3
2
1 time for each application ...............
1 time for each application ...............
3
2
2
2
6
4
0
1 time for each application ...............
0
0
0
Total ...........................................
........................
...........................................................
........................
........................
277
1 There
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2 30
are no capital costs or operating and maintenance costs associated with this collection of information.
minutes.
Based on FDA’s database system, from
fiscal years 2010 to 2012 there were an
estimated 173 sponsors subject to
ADUFA. However, not all sponsors will
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have any submissions in a given year
and some may have multiple
submissions. The total number of
waiver requests is based on the average
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number of submission types received by
FDA in fiscal years 2010 to 2012.
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Agencies
[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Pages 28524-28525]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11380]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-7032-CN]
Health Insurance Marketplace, Medicare, Medicaid, and Children's
Health Insurance Programs; Meeting of the Advisory Panel on Outreach
and Education (APOE), May 22, 2014; Corrections
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Correction notice.
-----------------------------------------------------------------------
SUMMARY: This notice corrects an error in the notice of meeting that
published in the May 2, 2014 Federal Register titled ``Health Insurance
Marketplace, Medicare, Medicaid, and Children's Health Insurance
Programs; Meeting of the Advisory Panel on Outreach and Education
(APOE), May 22, 2014.''
FOR FURTHER INFORMATION CONTACT: Kirsten Knutson, (410) 786-5886.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2014- 09989, which published in the May 2, 2014 Federal
Register (79 FR 25133) titled ``Health Insurance Marketplace, Medicare,
Medicaid, and Children's Health Insurance Programs; Meeting of the
Advisory Panel on Outreach and Education (APOE), May 22, 2014'', there
was an error that is identified and corrected in the Correction of
Errors section of this correction notice.
II. Summary of Errors
On page 25134, we made an error in providing information regarding
the public's offsite participation in the May 22, 2014 APOE meeting.
III. Correction of Errors
In FR Doc. 2014-09989 of May 2, 2014 (79 FR 25133), make the
following correction:
1. On page 25134, first column, second paragraph (ADDRESSES
section), line 21, the phrase ``engage virtually in the open meetings,
this APOE meeting will be available to view via live Web streaming by
visiting the link www.cms.gov/live during the designated time of the
meeting.'' is corrected to read ``engage in the open meeting, this APOE
meeting will be available for listening only via a conference call. To
listen to the meeting, the public may dial 1-877-267-1577, then follow
the instructions on the phone and enter the following meeting ID
number, 996 925 940, followed by the pound sign.''
[[Page 28525]]
Authority: (Catalog of Federal Domestic Assistance Program No.
93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: May 13, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2014-11380 Filed 5-15-14; 8:45 am]
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