Submission for OMB Review; Comment Request, 56809-56810 [2014-22598]
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56809
Federal Register / Vol. 79, No. 184 / Tuesday, September 23, 2014 / Notices
to an advance written agreement;
however, for the meetings, CMS
reimburses travel, meals, lodging, and
related expenses in accordance with
standard Government travel regulations.
CMS has a special interest in ensuring,
while taking into account the nominee
pool, that the Panel is diverse in all
respects of the following: Geography;
rural or urban practice; race, ethnicity,
sex, and disability; medical or technical
specialty; and type of hospital, hospital
health system, or other Medicare
provider subject to the OPPS.
Based upon either self-nominations or
nominations submitted by providers or
interested organizations, the Secretary,
or her designee, appoints new members
to the Panel from among those
candidates determined to have the
required expertise. New appointments
are made in a manner that ensures a
balanced membership under the FACA
guidelines.
II. Criteria for Nominees
The Panel must be fairly balanced in
its membership in terms of the points of
view represented and the functions to
be performed. Each Panel member must
be employed full-time by a hospital,
hospital system, or other Medicare
provider subject to payment under the
OPPS. All members must have technical
expertise to enable them to participate
fully in the Panel’s work. Such expertise
encompasses hospital payment systems;
hospital medical care delivery systems;
provider billing systems; APC groups;
Current Procedural Terminology codes;
and alpha-numeric Health Care
Common Procedure Coding System
codes; and the use of, and payment for,
drugs, medical devices, and other
services in the outpatient setting, as
well as other forms of relevant expertise.
For supervision deliberations, the Panel
shall have members that represent the
interests of Critical Access Hospitals
(CAHs), who advise CMS only regarding
the level of supervision for hospital
outpatient services.
It is not necessary for a nominee to
possess expertise in all of the areas
listed, but each must have a minimum
of 5 years experience and currently have
full-time employment in his or her area
of expertise. Generally, members of the
Panel serve overlapping terms up to 4
years, based on the needs of the Panel
and contingent upon the rechartering of
the Panel. A member may serve after the
expiration of his or her term until a
successor has been sworn in.
Any interested person or organization
may nominate one or more qualified
individuals. Self-nominations will also
be accepted. Each nomination must
include the following:
• Letter of Nomination stating the
reasons why the nominee should be
considered.
• Curriculum vitae or resume of the
nominee that includes an email address
where the nominee can be contacted.
• Written and signed statement from
the nominee that the nominee is willing
to serve on the Panel under the
conditions described in this notice and
further specified in the Charter.
• The hospital or hospital system
name and address, or CAH name and
address, as well as all Medicare hospital
and or Medicare CAH billing numbers
of the facility where the nominee is
employed.
III. Copies of the Charter
To obtain a copy of the Panel’s
Charter, we refer readers to our Web site
at the following: https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonAmbulatory
PaymentClassificationGroups.html.
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
Dated: September 15, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–22634 Filed 9–22–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Annual Statistical Report on
Children in Foster Homes and Children
in Families Receiving Payment in
Excess of the Poverty Income Level from
a State Program Funded Under Part A of
Title IV of the Social Security Act.
OMB No.: 0970–0004.
Description
The Department of Health and Human
Services is required to collect these data
under section 1124 of Title I of the
Elementary and Secondary Education
Act, as amended by Public Law 103–
382. The data are used by the U.S.
Department of Education for allocation
of funds for programs to aid
disadvantaged elementary and
secondary students. Respondents
include various components of State
Human Service agencies.
Respondents
The 52 respondents include the 50
States, the District of Columbia, and
Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Annual Statistical Report on Children in Foster Homes and Children Receiving Payments in Excess of the Poverty Level From a State Program
Funded Under Part A of Title IV of the Social Security Act ........................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
52
1
264.35
13,746.20
Estimated Total Annual Burden
Hours: 13,746.20
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
VerDate Sep<11>2014
17:55 Sep 22, 2014
Jkt 232001
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
E:\FR\FM\23SEN1.SGM
23SEN1
56810
Federal Register / Vol. 79, No. 184 / Tuesday, September 23, 2014 / Notices
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–22598 Filed 9–22–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1359]
Development and Regulation of AbuseDeterrent Formulations of Opioid
Medications; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting to discuss the
development, assessment, and
regulation of abuse-deterrent
formulations of opioid medications. The
meeting will focus on scientific and
technical issues related to the
development and in vitro assessment of
these products, as well as FDA’s
approach towards assessing the benefits
and risks of all opioid medications,
including those with abuse-deterrent
properties.
FDA is seeking input on these issues
from all stakeholders, including
patients, health care providers, the
pharmaceutical industry, patient
advocates, academics, researchers, and
other governmental entities.
DATES: The public meeting will be held
on October 30, 2014, from 8:30 a.m. to
5 p.m. and October 31, 2014, from 8:30
a.m. to 3 p.m. The public meeting may
be extended or may end early
depending on the level of public
participation. Individuals who wish to
present at the meeting must register by
October 14, 2014. Individuals who wish
to attend the meeting but do not wish
to make a presentation should register
by October 24, 2014. See section III
under the SUPPLEMENTARY INFORMATION
section for information on how to
register to speak at the meeting. Submit
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:55 Sep 22, 2014
Jkt 232001
either electronic or written comments
by January 9, 2015.
ADDRESSES: The public meeting will be
held at the Sheraton Silver Spring Hotel,
8777 Georgia Ave., Silver Spring, MD
20910, 301–589–0800, FAX: 301–587–
4791.
Submit electronic comments 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. Identify all
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Mary C. Gross, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20903, 301–796–3519, FAX: 301–796–
9899, email: mary.gross@fda.hhs.gov; or
Brutrinia D. Cain, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–4633, email:
Brutrinia.cain@fda.hhs.gov; or
Georgiann Ienzi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–3515, FAX: 301–847–
8737, email: Georgiann.Ienzi@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
Opioid analgesics are important
medications that are widely prescribed
for the treatment of pain, and certain
opioids are also used in drug treatment
programs. When used properly, opioid
drugs provide significant benefits for
patients. However, they also carry a risk
of misuse, abuse, addiction, overdose,
and death. According to an analysis
from the Centers for Disease Control and
Prevention (CDC), in 2010, opioid
analgesics were involved in 16,651
overdose deaths, which represented a
313 percent increase over the past
decade (Ref. 1). The Substance Abuse
and Mental Health Services
Administration (SAMHSA) reports that
for each overdose death, there were an
additional 11 treatment admissions (Ref.
2), 33 emergency department visits (Ref.
3), and 880 non-medical users of these
drugs (Ref. 4).
The development of and transition to
use of opioids with meaningful abusedeterrent properties is one important
component of a multipronged approach
to addressing abuse of opioid
medications. FDA looks forward to a
future in which most or all opioid
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Fmt 4703
Sfmt 4703
medications are available in
formulations that are less susceptible to
abuse than the formulations that are on
the market today.
To achieve this goal, FDA is taking
steps to incentivize and support the
development of opioid medications
with progressively better abusedeterrent properties. These steps
include working with individual
sponsors on promising abuse-deterrent
technologies, developing appropriate
testing methodologies for both innovator
and generic products, and publishing
guidance on the development and
labeling of abuse-deterrent opioids.
FDA understands that the iterative
innovation in abuse-deterrent
technologies we envision could have
implications for generic opioid
medications. It is important that generic
options remain available to ensure
widespread access to effective
analgesics for patients who need them.
The transition to abuse-deterrent
formulations of opioid medications
presents a number of complex scientific
and regulatory challenges. The purpose
of this public meeting is to share and
solicit comments on the Agency’s
ongoing work to identify and address
these challenges.
II. Background
Opioid analgesics (e.g., hydrocodone,
oxycodone, morphine, and fentanyl)
play a vital role in treating both chronic
and acute pain. The Institute of
Medicine reports that millions of
Americans are living with chronic pain,
including those suffering from back
pain, neuropathic pain, and pain
associated with cancer, with an annual
economic cost of approximately $600
billion in health care expenses and lost
productivity (Ref. 5). Millions more
suffer from acute pain following
common medical procedures performed
every day across the country, such as
dental and orthopedic procedures.
While FDA is working to support the
efficient development of safer, nonopioid alternatives for treating pain,
opioids are currently an indispensable
component of the pain treatment
armamentarium, and will remain so for
some time to come.
Unfortunately, the abuse and misuse
of opioid medications has become a
public health crisis. Opioid-involved
drug overdose death rates in the United
States have increased four-fold from
1999 to 2008 (Ref. 6). Emergency
department visits, substance abuse
treatment admissions, and economic
costs associated with opioid abuse have
also increased dramatically over the
same period (Ref. 7). This rise in
adverse events has largely paralleled the
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56809-56810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22598]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Annual Statistical Report on Children in Foster Homes and
Children in Families Receiving Payment in Excess of the Poverty Income
Level from a State Program Funded Under Part A of Title IV of the
Social Security Act.
OMB No.: 0970-0004.
Description
The Department of Health and Human Services is required to collect
these data under section 1124 of Title I of the Elementary and
Secondary Education Act, as amended by Public Law 103-382. The data are
used by the U.S. Department of Education for allocation of funds for
programs to aid disadvantaged elementary and secondary students.
Respondents include various components of State Human Service agencies.
Respondents
The 52 respondents include the 50 States, the District of Columbia,
and Puerto Rico.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Annual Statistical Report on Children in 52 1 264.35 13,746.20
Foster Homes and Children Receiving
Payments in Excess of the Poverty Level
From a State Program Funded Under Part A of
Title IV of the Social Security Act........
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 13,746.20
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn:
ACF Reports Clearance Officer. All requests should be identified by the
title of the information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect
[[Page 56810]]
if OMB receives it within 30 days of publication. Written comments and
recommendations for the proposed information collection should be sent
directly to the following: Office of Management and Budget, Paperwork
Reduction Project, Fax: 202-395-7285, Email:
OIRASUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-22598 Filed 9-22-14; 8:45 am]
BILLING CODE 4184-01-P
