Submission for OMB Review; Comment Request, 24496-24497 [2012-9759]
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Federal Register / Vol. 77, No. 79 / Tuesday, April 24, 2012 / Notices
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
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I. Background
Organ Procurement Organizations
(OPOs) are not-for-profit organizations
that are responsible for the
procurement, preservation, and
transport of organs to transplant centers
throughout the country. Qualified OPOs
are designated by the Centers for
Medicare & Medicaid Services (CMS) to
recover or procure organs in CMSdefined exclusive geographic service
areas, pursuant to section 371(b)(1) of
the Public Health Service Act (42 U.S.C.
273(b)(1)) and our regulations at 42 CFR
486.306. Once an OPO has been
designated for an area, hospitals in that
area that participate in Medicare and
Medicaid are required to work with that
OPO in providing organs for transplant,
pursuant to section 1138(a)(1)(C) of the
Social Security Act (the Act) and our
regulations at 42 CFR 482.45.
Section 1138(a)(1)(A)(iii) of the Act
provides that a hospital must notify the
designated OPO (for the service area in
which it is located) of potential organ
donors. Under section 1138(a)(1)(C) of
the Act, every participating hospital
must have an agreement only with its
designated OPO to identify potential
donors.
However, section 1138(a)(2)(A) of the
Act provides that a hospital may obtain
a waiver of the above requirements from
the Secretary under certain specified
conditions. A waiver allows the hospital
to have an agreement with an OPO other
than the one initially designated by
CMS, if the hospital meets certain
conditions specified in section
1138(a)(2)(A) of the Act. In addition, the
Secretary may review additional criteria
described in section 1138(a)(2)(B) of the
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Act to evaluate the hospital’s request for
a waiver.
Section 1138(a)(2)(A) of the Act states
that in granting a waiver, the Secretary
must determine that the waiver—(1) is
expected to increase organ donations;
and (2) will ensure equitable treatment
of patients referred for transplants
within the service area served by the
designated OPO and within the service
area served by the OPO with which the
hospital seeks to enter into an
agreement under the waiver. In making
a waiver determination, section
1138(a)(2)(B) of the Act provides that
the Secretary may consider, among
other factors: (1) cost-effectiveness; (2)
improvements in quality; (3) whether
there has been any change in a
hospital’s designated OPO due to the
changes made in definitions for
metropolitan statistical areas; and (4)
the length and continuity of a hospital’s
relationship with an OPO other than the
hospital’s designated OPO. Under
section 1138(a)(2)(D) of the Act, the
Secretary is required to publish a notice
of any waiver application received from
a hospital within 30 days of receiving
the application, and to offer interested
parties an opportunity to submit
comments during the 60-day comment
period beginning on the publication
date in the Federal Register.
The criteria that the Secretary uses to
evaluate the waiver in these cases are
the same as those described above under
sections 1138(a)(2)(A) and (B) of the Act
and have been incorporated into the
regulations at § 486.308(e) and (f).
II. Waiver Request Procedures
In October 1995, we issued a Program
Memorandum (Transmittal No. A–95–
11) detailing the waiver process and
discussing the information hospitals
must provide in requesting a waiver. We
indicated that upon receipt of a waiver
request, we would publish a Federal
Register notice to solicit public
comments, as required by section
1138(a)(2)(D) of the Act.
According to these requirements, we
will review the comments received.
During the review process, we may
consult on an as-needed basis with the
Health Resources and Services
Administration’s Division of
Transplantation, the United Network for
Organ Sharing, and our regional offices.
If necessary, we may request additional
clarifying information from the applying
hospital or others. We will then make a
final determination on the waiver
request and notify the hospital and the
designated and requested OPOs.
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III. Hospital Waiver Request
As permitted by 42 CFR 486.308(e),
the following hospital has requested a
waiver in order to enter into an
agreement with a designated OPO other
than the OPO designated for the service
area in which the hospital is located:
Transplant Institute at Methodist Le
Bonheur Healthcare of Memphis,
Tennessee, is requesting a waiver to
work with: Tennessee Donor Services,
1600 Hayes Street, Suite 300, Nashville,
TN 37203.
The Hospital’s Designated OPO is:
Mid-South Transplant Foundation, Inc.,
8001 Centerview Parkway, Suite 302,
Memphis, TN 38018.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; Program No. 93.774, Medicare—
Supplementary Medical Insurance, and
Program No. 93.778, Medical Assistance
Program)
Dated: April 18, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–9977 Filed 4–23–12; 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: TANF Quarterly Financial
Report, ACF–196.
OMB No.: 0970–0247.
Description: This information
collection is authorized under Section
411(a)(3) of the Social Security Act. This
request is for renewal of approval to use
the Administration for Children and
Families’ (ACF) 196 form for periodic
financial reporting under the Temporary
Assistance for Needy Families (TANF)
program. States participating in the
TANF program are required by statute to
report financial data on a quarterly
basis. This form meets the legal
standard and provides essential data on
the use of Federal funds. Failure to
collect the data would seriously
compromise ACF’s ability to monitor
program expenditures, estimate funding
needs, and to prepare budget
submissions required by Congress.
Financial reporting under the TANF
program is governed by 45 CFR part
265. This renewal removes columns for
reporting Emergency Contingency Fund
and Supplemental Grant expenditures,
as those funding streams are no longer
available, and includes a requirement to
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Federal Register / Vol. 77, No. 79 / Tuesday, April 24, 2012 / Notices
provide an addendum to the fourth
quarter report to describe estimates used
in deriving any expenditures reported in
any category.
Respondents: TANF Agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–196 ..........................................................................................................
51
4
8
1,632
Estimated Total Annual Burden
Hours: 1,632.
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 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, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–9759 Filed 4–23–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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17:40 Apr 23, 2012
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for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Small-Molecule Modulators of Lipid
Storage for Treatment of Obesity,
Atherosclerosis, Metabolic Syndrome
and Lipid Storage Diseases
Description of Technology: Lipid
droplets are key organelles involved in
lipid homeostasis. In normal
physiology, these droplets are formed in
response to elevated fatty acid levels,
and are broken down when needed for
energy production. Imbalances in lipid
homeostasis trigger compensatory
alterations in metabolism that can lead
to diseases such as obesity,
atherosclerosis, and metabolic
syndrome. There are also a number of
inherited lipid storage diseases that
result in harmful buildup of various
lipids, such as Gaucher disease, Fabry
disease, and others. Reducing the
accumulation of lipid droplets is a
promising potential strategy for
treatment of such disorders.
This technology describes three novel
structural classes of small-molecule
compounds that significantly reduce the
accumulation of lipid droplets. These
compounds hold promise for the
treatment of diseases associated with
aberrant lipid deposition.
Potential Commercial Applications:
• Treatment of inherited metabolic
diseases such as Gaucher disease, Fabry
disease, and Tay Sachs disease.
• Treatment of obesity and metabolic
disease.
• Treatment of atherosclerosis.
Competitive Advantages: Modulation
of lipid droplet accumulation is a novel
mechanism for treatment of lipid storage
diseases.
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Development Stage:
• Early-stage
• In vitro data available
Inventors: Matthew Boxer et al.
(NCATS).
Intellectual Property: HHS Reference
No. E–277–2011/0—U.S. Provisional
Patent Application No. 61/562,894 filed
22 Nov 2011.
Licensing Contact: Tara L. Kirby,
Ph.D.; 301–435–4426;
tarak@mail.nih.gov.
A Broadly Neutralizing Human AntiHIV Monoclonal Antibody (10E8)
Capable of Neutralizing Most HIV–1
Strains
Description of Technology: This
Human Anti-HIV Monoclonal Antibody
(10E8) has great potential to provide
passive protection from infection, as a
therapeutic vaccine, or as a tool for the
development of vaccine immunogens.
10E8 is one of the most potent HIVneutralizing antibodies isolated thus far
and it can potently neutralize up to 98%
of genetically diverse HIV–1 strains.
10E8 is specific to the membraneproximal external region (MPER) of the
HIV envelope protein, GP41. It is
anticipated that 10E8 could be used in
combination with another human antiHIV–1 monoclonal antibody to provide
an antibody response that neutralizes
nearly all strains of HIV–1.
Additionally, 10E8 is a useful tool for
the design of vaccine immunogens that
can elicit an adaptive immune response
to produces 10E8 like antibodies. This
technology also includes monoclonal
antibodies from the same germ line as
10E8.
Potential Commercial Applications:
• Passive protection to prevent HIV
infection
• Passive protection to prevent motherto-infant HIV transmission
• Topical microbicide to prevent HIV
infection
• Gene-based vectors for anti-gp41
antibody expression
• Therapeutic for the elimination of
HIV infected cells that are actively
producing virus
Competitive Advantages:
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[Federal Register Volume 77, Number 79 (Tuesday, April 24, 2012)]
[Notices]
[Pages 24496-24497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: TANF Quarterly Financial Report, ACF-196.
OMB No.: 0970-0247.
Description: This information collection is authorized under
Section 411(a)(3) of the Social Security Act. This request is for
renewal of approval to use the Administration for Children and
Families' (ACF) 196 form for periodic financial reporting under the
Temporary Assistance for Needy Families (TANF) program. States
participating in the TANF program are required by statute to report
financial data on a quarterly basis. This form meets the legal standard
and provides essential data on the use of Federal funds. Failure to
collect the data would seriously compromise ACF's ability to monitor
program expenditures, estimate funding needs, and to prepare budget
submissions required by Congress. Financial reporting under the TANF
program is governed by 45 CFR part 265. This renewal removes columns
for reporting Emergency Contingency Fund and Supplemental Grant
expenditures, as those funding streams are no longer available, and
includes a requirement to
[[Page 24497]]
provide an addendum to the fourth quarter report to describe estimates
used in deriving any expenditures reported in any category.
Respondents: TANF Agencies.
ANNUAL BURDEN ESTIMATES
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-196..................................... 51 4 8 1,632
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,632.
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 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, Email: OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-9759 Filed 4-23-12; 8:45 am]
BILLING CODE 4184-01-P
