Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program; Correction, 62579-62580 [E9-28541]
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Federal Register / Vol. 74, No. 228 / Monday, November 30, 2009 / Notices
Licensing Contact: Suryanarayana
(Sury) Vepa, PhD, J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The NIEHS is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the ROR gamma mice or
related laboratory research interests.
Please contact Dr. Elizabeth Denholm at
denholme@niehs.nih.gov or 919–541–
0981 for more information.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Antibody Composition and Methods for
the Prevention and Treatment of Lupus
Nephritis
Description of Technology: This
technology identifies an antibody that
induces a protective effect in vivo in a
mouse model of lupus nephritis. Lupus
is a chronic autoimmune disease that
can damage various parts of the body,
especially the kidneys. The lupus
nephritis-model mice that were treated
with this antibody experienced a
dramatic increase in survival,
demonstrated a reduced immune
complex formation deposition in the
kidneys, and displayed low levels of
proteinuria as compared with untreated
mice. The antibody is an autospecific
anti-dsDNA IgM.
In addition, this invention may be
used as a component of a predictive
diagnostic kit. As lupus-related kidney
disease may be asymptomatic,
significant kidney damage may occur
before lupus is diagnosed (lupus.org).
The inventors are currently
investigating whether the ratio of
protective antibodies to nonprotective
or pathogenic antibodies in lupus
nephritis models is predictive of
disease. Currently available diagnostic
methods (proteinuria, creatine
clearance, or kidney biopsy) are not
predictive and test only for existing
kidney impairment or damage.
Applications:
• A preventative and therapeutic for
lupus nephritis.
• A component of a predictive
diagnostic kit for lupus nephritis.
• A research tool for investigation of
lupus nephritis in a mouse model.
Advantages:
• Therapeutic antibodies are unlikely
to elicit side effects in patient
populations, unlike many existing
therapies.
• The diagnostic would be predictive,
unlike existing diagnostics.
Development Status: Early stage, in
vivo (mouse).
Market:
• At least 1.5 million Americans have
lupus (lupus.org).
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14:58 Nov 27, 2009
Jkt 220001
• Up to 67% of children with lupus,
and approximately 40% of all
individuals with lupus, develop lupusrelated kidney complications
(lupus.org).
Inventors: Marilyn Diaz, Chuancang
Jiang, Ming-Lang Zhao (NIEHS).
Publication: In preparation.
Patent Status: U.S. Provisional
Application No. 61/176,615 filed 08
May 2009 (HHS Reference No. E–156–
2009/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Norbert Pontzer,
J.D., PhD; 301–435–5502;
pontzern@mail.nih.gov.
Collaborative Research Opportunity:
The NIEHS is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology or
related laboratory research interests.
Please contact Dr. Elizabeth Denholm at
denholme@niehs.nih.gov or 919–541–
0981 for more information.
P2Y1 Receptor Antagonists Useful for
the Study of Platelet Aggregation and
Clotting Conditions
Description of Technology: NIH
inventors have developed P2Y1 receptor
antagonists ((N)-Methanocarba 2′Deoxyadenosine 3′, 5′-Bisphosphate
Analogues) for inhibition of platelet
aggregation and treatment of clotting
conditions. On the platelet surface,
simultaneous activation of the P2Y1 and
P2Y12 receptors by ADP induces
aggregation. The P2Y1-mediated
response is associated with the initial
shape change and rapid aggregation, and
the P2Y12 receptor is associated with
amplification of the aggregation. P2Y12
receptor antagonists are both in clinical
use and under development as
antithrombotic agents. Potent and
selective P2Y1 receptor antagonists,
such as the conformationally locked
methanocarba nucleotide MRS2500 1
(Ki 0.79 nM), have been designed and
shown to have promise in preclinical
studies as antithrombotic agents. This
novel drug concept is also supported by
studies of mice in which the P2Y1
receptor has been genetically deleted,
wherein the initiation of clotting events
is markedly impaired.
Applications: Potential new target for
treating intravascular clotting.
Development Status: Early-stage of
development.
Market: There is a very large potential
market for P2Y1 receptor antagonists.
For instance, P2Y1 receptor antagonists
may treat deep vein thrombosis, which
occurs in 80 of 100,000 individuals in
the U.S. annually.
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62579
Inventors: Kenneth A. Jacobson and
Sonia De Castro (NIDDK)
Patent Status:
• U.S. Provisional Application No.
61/061,309 filed 13 Jun 2008 (HHS
Reference No. E–235–2008/0–US–01).
• Patent Cooperation Treaty
Application PCT/US2009/47204 filed 12
Jun 2009 (HHS Reference No. E–235–
2008/0–PCT–03)
Licensing Status: Available for
licensing.
Licensing Contact: Steve Standley,
PhD; 301–435–4074; sstand@od.nih.gov.
Dated: November 23, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–28538 Filed 11–27–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–6023–CN]
Medicare Program; Solicitation of
Independent Accrediting Organizations
To Participate in the Advanced
Diagnostic Imaging Supplier
Accreditation Program; Correction
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction notice.
SUMMARY: This document corrects a
technical error in the notice entitled
‘‘Medicare Program; Solicitation of
Independent Accrediting Organizations
to Participate in the Advanced
Diagnostic Imaging Supplier
Accreditation Program’’ which was
posted for public inspection by the
Office of the Federal Register on October
30, 2009, and published in the Federal
Register on November 25, 2009.
FOR FURTHER INFORMATION CONTACT:
Sandra Bastinelli, (410) 786–3630.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. E9–26209, which was
posted for public inspection by the
Office of the Federal Register (OFR) on
October 30, 2009, and published in the
Federal Register on November 25, 2009,
we made a technical error that is
corrected in the Correction of Errors
section below. The provisions in this
correction notice are effective as if they
had been included in the November 25,
2009 notice.
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62580
Federal Register / Vol. 74, No. 228 / Monday, November 30, 2009 / Notices
II. Summary of Errors
In section II.B. of the November 25,
2009 notice, we list the criteria that an
accreditation organization must furnish
to CMS to be considered for approval as
a designated accreditation organization
for Medicare under 42 CFR 414.68 (as
issued in the ‘‘Medicare Program;
Payment Policies Under the Physician
Fee Schedule and Other Revisions to
Part B for CY 2010’’ final rule with
comment period, FR Doc. E9–26502,
posted for public inspection by OFR on
October 30, 2009). Due to a technical
error, the list of criteria does not
accurately reflect the requirements set
out at new § 414.68.
III. Correction of Errors
In FR Doc. E9–26502 published on
November 25, 2009 (74 FR 62189),
correct section II.B. to read as follows:
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
‘‘B. Application Requirements
To be considered for approval as a
designated accreditation organization for
Medicare requirements, an accreditation
organization must furnish CMS the
information and meet the criteria set out at
42 CFR 414.68, as issued in the ‘‘Medicare
Program; Payment Policies Under the
Physician Fee Schedule and Other Revisions
to Part B for CY 2010’’ final rule with
comment period, FR Doc. E9–26502, posted
for public inspection by OFR on October 30,
2009.’’
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register to provide a period for public
comment before the provisions of a rule
take effect in accordance with section
553(b) of the Administrative Procedure
Act (APA) (5 U.S.C. 553(b)). However,
we can waive this notice and comment
procedure if the Secretary finds, for
good cause, that the notice and
comment process is impracticable,
unnecessary, or contrary to the public
interest, and incorporates a statement of
the finding and the reasons therefore in
the notice.
Section 553(d) of the APA ordinarily
requires a 30-day delay in effective date
of final rules after the date of their
publication in the Federal Register.
This 30-day delay in effective date can
be waived, however, if an agency finds
for good cause that the delay is
impracticable, unnecessary, or contrary
to the public interest, and the agency
incorporates a statement of the findings
and its reasons in the rule issued.
We note that section 1834(e) of the
Act requires us to designate
organizations to accredit suppliers
furnishing the technical component
(TC) of advanced diagnostic imaging
services by January 1, 2010. Given the
VerDate Nov<24>2008
14:58 Nov 27, 2009
Jkt 220001
statutory deadline to designate
organizations and the timing of the
publication of this final rule with
comment period, we believe it is
impracticable to provide a notice and
comment period or to delay the effective
date of these criteria for designating
organizations to accredit suppliers
furnishing the TC of advanced
diagnostic imaging services. In addition,
it is unnecessary to provide a period for
notice and comment or delay the
effective date of this correction, because
this correction notice does not change
our policies regarding the application
process, but merely clarifies that the
application process is subject to a
regulation that has already been the
subject of notice and comment
rulemaking. Therefore, we believe that
we have good cause for waiving a notice
and comment period, and making the
imaging accreditation application
process correction effective upon
publication.
Authority: Section 1834(e) of the Act.
(Catalog of Federal Domestic Assistance
Program No. 93.774, MedicareSupplementary Medical Insurance Program)
Dated: November 23, 2009.
Dawn L. Smalls,
Executive Secretary to the Department.
[FR Doc. E9–28541 Filed 11–25–09; 11:15
am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3218–N]
Medicare Program; Meeting of the
Medicare Evidence Development and
Coverage Advisory Committee
January 27, 2010.
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
SUMMARY: This notice announces that a
public meeting of the Medicare
Evidence Development & Coverage
Advisory Committee (MEDCAC)
(‘‘Committee’’) will be held on
Wednesday, January 27, 2010. The
Committee generally provides advice
and recommendations concerning the
adequacy of scientific evidence needed
to determine whether certain medical
items and services can be covered under
the Medicare statute. This meeting will
focus on the sufficiency of currently
available evidence to determine whether
the results of pharmacogenomic testing
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affect health outcomes of patients with
cancer when used as a guide for certain
drug treatments. This meeting is open to
the public in accordance with the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)).
DATES: Meeting date: The public
meeting will be held on Wednesday,
January 27, 2010 from 7:30 a.m. until
4:30 p.m., Eastern Standard Time
(E.S.T.).
Deadline for Submission of Written
Comments: Written comments must be
received at the address specified in the
ADDRESSES section of this notice by 5
p.m., E.S.T. on December 28, 2009.
Once submitted all comments are final.
Deadlines for Speaker Registration
and Presentation Materials: The
deadline to register to be a speaker and
to submit powerpoint presentation
materials and writings that will be used
in support of an oral presentation, is 5
p.m., E.S.T. on Monday, December 28,
2009. Speakers may register by phone or
via e-mail by contacting the person
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Presentation materials must be received
at the address specified in the
ADDRESSES section of this notice.
Deadline for All Other Attendees
Registration: Individuals may register
via e-mail at
MEDCAC_Registration@cms.hhs.gov or
by phone by contacting the person listed
in the FOR FURTHER INFORMATION
CONTACT section of this notice by 5 p.m.,
E.S.T. on Wednesday, January 20, 2010.
Deadline for Submitting a Request for
Special Accommodations: Persons
attending the meeting who are hearing
or visually impaired, or have a
condition that requires special
assistance or accommodations, are
asked to contact the Executive Secretary
as specified in the FOR FURTHER
INFORMATION CONTACT section of this
notice no later than 5 p.m., E.S.T,
Friday, January 8, 2010.
ADDRESSES: Meeting Location: The
meeting will be held in the main
auditorium of the Centers for Medicare
& Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244.
Submission of Presentations and
Comments: Presentation materials and
written comments that will be presented
at the meeting must be submitted via email to
MedCACpresentations@cms.hhs.gov or
by regular mail to the contact listed in
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date
specified in the DATES section of this
notice.
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, Executive Secretary for
E:\FR\FM\30NON1.SGM
30NON1
Agencies
[Federal Register Volume 74, Number 228 (Monday, November 30, 2009)]
[Notices]
[Pages 62579-62580]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-6023-CN]
Medicare Program; Solicitation of Independent Accrediting
Organizations To Participate in the Advanced Diagnostic Imaging
Supplier Accreditation Program; Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Correction notice.
-----------------------------------------------------------------------
SUMMARY: This document corrects a technical error in the notice
entitled ``Medicare Program; Solicitation of Independent Accrediting
Organizations to Participate in the Advanced Diagnostic Imaging
Supplier Accreditation Program'' which was posted for public inspection
by the Office of the Federal Register on October 30, 2009, and
published in the Federal Register on November 25, 2009.
FOR FURTHER INFORMATION CONTACT: Sandra Bastinelli, (410) 786-3630.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. E9-26209, which was posted for public inspection by the
Office of the Federal Register (OFR) on October 30, 2009, and published
in the Federal Register on November 25, 2009, we made a technical error
that is corrected in the Correction of Errors section below. The
provisions in this correction notice are effective as if they had been
included in the November 25, 2009 notice.
[[Page 62580]]
II. Summary of Errors
In section II.B. of the November 25, 2009 notice, we list the
criteria that an accreditation organization must furnish to CMS to be
considered for approval as a designated accreditation organization for
Medicare under 42 CFR 414.68 (as issued in the ``Medicare Program;
Payment Policies Under the Physician Fee Schedule and Other Revisions
to Part B for CY 2010'' final rule with comment period, FR Doc. E9-
26502, posted for public inspection by OFR on October 30, 2009). Due to
a technical error, the list of criteria does not accurately reflect the
requirements set out at new Sec. 414.68.
III. Correction of Errors
In FR Doc. E9-26502 published on November 25, 2009 (74 FR 62189),
correct section II.B. to read as follows:
``B. Application Requirements
To be considered for approval as a designated accreditation
organization for Medicare requirements, an accreditation
organization must furnish CMS the information and meet the criteria
set out at 42 CFR 414.68, as issued in the ``Medicare Program;
Payment Policies Under the Physician Fee Schedule and Other
Revisions to Part B for CY 2010'' final rule with comment period, FR
Doc. E9-26502, posted for public inspection by OFR on October 30,
2009.''
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register to provide a period for public comment before the
provisions of a rule take effect in accordance with section 553(b) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we
can waive this notice and comment procedure if the Secretary finds, for
good cause, that the notice and comment process is impracticable,
unnecessary, or contrary to the public interest, and incorporates a
statement of the finding and the reasons therefore in the notice.
Section 553(d) of the APA ordinarily requires a 30-day delay in
effective date of final rules after the date of their publication in
the Federal Register. This 30-day delay in effective date can be
waived, however, if an agency finds for good cause that the delay is
impracticable, unnecessary, or contrary to the public interest, and the
agency incorporates a statement of the findings and its reasons in the
rule issued.
We note that section 1834(e) of the Act requires us to designate
organizations to accredit suppliers furnishing the technical component
(TC) of advanced diagnostic imaging services by January 1, 2010. Given
the statutory deadline to designate organizations and the timing of the
publication of this final rule with comment period, we believe it is
impracticable to provide a notice and comment period or to delay the
effective date of these criteria for designating organizations to
accredit suppliers furnishing the TC of advanced diagnostic imaging
services. In addition, it is unnecessary to provide a period for notice
and comment or delay the effective date of this correction, because
this correction notice does not change our policies regarding the
application process, but merely clarifies that the application process
is subject to a regulation that has already been the subject of notice
and comment rulemaking. Therefore, we believe that we have good cause
for waiving a notice and comment period, and making the imaging
accreditation application process correction effective upon
publication.
Authority: Section 1834(e) of the Act.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare-Supplementary Medical Insurance Program)
Dated: November 23, 2009.
Dawn L. Smalls,
Executive Secretary to the Department.
[FR Doc. E9-28541 Filed 11-25-09; 11:15 am]
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