National Center for Advancing Translational Sciences; Notice of Meetings, 22998-22999 [2016-08992]
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22998
ACTION:
Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Notices
Notice.
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7, that the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent license to
practice the following inventions
embodied in the following patent
applications, entitled ‘‘CB1 receptor
mediating compounds’’:
1. U.S. Provisional Patent Application
No.: 61/991,333, HHS Ref. No.: E–
140–2014/0–US–01, Filed: May 09,
2014.
2. PCT Application No.: PCT/US2015/
029946, HHS Ref. No.: E–140–2014/
0–PCT–02, Filed: May 08, 2015.
3. U.S. Provisional Patent Application
No.: 61/725,949, HHS Ref. No.: E–
282–2012/0–US–01, Filed:
November 13, 2012.
4. PCT Application No.: PCT/US2013/
069686, HHS Ref. No.: E–282–2012/
0–PCT–02, Filed: November 12,
2013.
5. U.S. Patent Application No.: 14/
442,383, HHS Ref. No.: E–282–
2012/0–US–03, Filed: May 12,
2015.
6. Canadian Patent Application No.:
2889697, HHS Ref. No.: E–282–
2012/0–CA–04, Filed: April 27,
2015.
7. European Patent Application No.:
13802153.0, HHS Ref. No.: E–282–
2012/0–EP–05, Filed: June 01, 2015.
8. Indian Patent Application No.: 3733/
DELNP/2015, HHS Ref. No.: E–282–
2012/0–IN–06, Filed: May 01, 2015.
9. Japanese Patent Application No.:
2015–542015, HHS Ref. No.: E–
282–2012/0–JP–07, Filed: May 11,
2015.
10. Chinese Patent Application No.:
201380069389.9, HHS Ref. No.: E–
282–2012/0–CN–08, Filed: July 3,
2015.
11. US Provisional Application No.: 62/
171,179, HHS Ref. No.: E–282–
2012/1–US–01, Filed: June 04,
2015.
to Kalytera Therapeutics Inc.,
(‘‘Kalytera’’), a company incorporated
under the laws of Delaware and having
an office in Hermosa Beach, California.
The patent rights in these inventions
have been assigned to the United States
of America. This license may be
worldwide. The field of use may be
limited to the use of the Licensed Patent
Rights to the development of select
compounds from the patents listed
above.
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SUMMARY:
Only written comments and/or
applications for a license which are
received by the Technology
DATES:
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Advancement Office, The National
Institute of Diabetes and Digestive and
Kidney Diseases on or before May 4,
2016 will be considered.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Requests for copies of the
patent application, patents, inquiries,
comments, and other materials relating
to the contemplated exclusive license
should be directed to: Betty Tong, Ph.D.,
Sr. Licensing and Patenting Manager,
Technology Advancement Office, The
National Institute of Diabetes and
Digestive and Kidney Diseases, 12A
South Drive, Bethesda, MD 20892;
Email: betty.tong@nih.gov. A signed
confidentiality non-disclosure
agreement will be required to receive
copies of any patent applications that
have not been published by the United
States Patent and Trademark Office or
the World Intellectual Property
Organization.
National Center for Advancing
Translational Sciences; Notice of
Meetings
ADDRESSES:
This
technology, and its corresponding
patent applications, is directed to
methods of treating fibrosis, obesity and
associated diseases such as type 2
diabetes by administering an agent that
reduces appetite, body weight, hepatic
steatosis, and insulin resistance. This
technology may be useful as a means for
treating various fibrotic diseases and
metabolic syndromes without serious
adverse neuropsychiatric side effects.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the Technology Advancement Office
receives written evidence and argument
that establishes that the grant of the
license would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.7.
Properly filed competing applications
for a license in response to this notice
will be treated as objections to the
contemplated license. Comments and
objections submitted in response to this
notice will not be made available for
public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
SUPPLEMENTARY INFORMATION:
Dated: April 13, 2016.
Anna Amar,
Acting Deputy Director, Technology
Advancement Office, National Institute of
Diabetes and Digestive and Kidney Diseases,
National Institutes of Health.
[FR Doc. 2016–08986 Filed 4–18–16; 8:45 am]
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National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Center for Advancing Translational
Sciences.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Cures Acceleration
Network Review Board.
Date: May 12, 2016.
Time: 8:30 a.m. to 2:45 p.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Advisory
Council.
Date: May 12, 2016.
Open: 8:30 a.m. to 2:45 p.m.
Agenda: Report from the Institute Director
and other staff.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
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22999
Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Notices
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: April 13, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–08992 Filed 4–18–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Opioid Drugs in
Maintenance and Detoxification
Treatment of Opioid Dependence—42
CFR part 8 (OMB No. 0930–0206) and
Opioid Treatment Programs (OTPs)—
Revision
42 CFR part 8 establishes a
certification program managed by
SAMHSA’s Center for Substance Abuse
Treatment (CSAT). The regulation
requires that Opioid Treatment
Programs (OTPs) be certified.
‘‘Certification’’ is the process by which
SAMHSA determines that an OTP is
qualified to provide opioid treatment
under the Federal opioid treatment
standards established by the Secretary
of Health and Human Services. To
become certified, an OTP must be
accredited by a SAMHSA-approved
accreditation body. The regulation also
provides standards for such services as
individualized treatment planning,
increased medical supervision, and
assessment of patient outcomes. This
submission seeks continued approval of
the information collection requirements
in the regulation and of the forms used
in implementing the regulation.
SAMHSA currently has approval for
the Application for Certification to Use
Opioid Drugs in a Treatment Program
Under 42 CFR 8.11 (Form SMA–162);
the Application for Approval as
Accreditation Body Under 42 CFR 8.3(b)
(Form SMA–163); and the Exception
Request and Record of Justification
Under 42 CFR 8.12 (Form SMA–168),
which may be used by physicians when
there is a patient care situation in which
the physician must make a treatment
decision that differs from the treatment
regimen required by the regulation.
Form SMA–168 is a simplified,
standardized form to facilitate the
documentation, request, and approval
process for exceptions.
SAMHSA believes that the
recordkeeping requirements in the
regulation are customary and usual
practices within the medical and
rehabilitative communities and has not
calculated a response burden for them.
The recordkeeping requirements set
forth in 42 CFR 8.4, 8.11, and 8.12
include maintenance of the following: 5year retention by accreditation bodies of
certain records pertaining to
accreditation, and documentation by an
OTP of the following: A patient’s
medical examination when admitted to
treatment, a patient’s history, a
treatment plan, any prenatal support
provided to the patient, justification of
unusually large initial doses, changes in
a patient’s dosage schedule, justification
of unusually large daily doses, the
rationale for decreasing a patient’s clinic
attendance, and documentation of
physiologic dependence.
The rule also includes requirements
that OTPs and accreditation
organizations disclose information. For
example, 42 CFR 8.12(e)(1) requires that
a physician explain the facts concerning
the use of opioid drug treatment to each
patient. This type of disclosure is
considered to be consistent with the
common medical practice and is not
considered an additional burden.
Further, the rule requires, under Sec.
8.4(i)(1) that accreditation organizations
shall make public their fee structure;
this type of disclosure is standard
business practice and is not considered
a burden.
A number of changes have been made
to the forms. Forms have been reworded
for clarification, updated with current
SAMHSA mailing and web-submission
information, and a few additional fields
have been provided for clarity and for
providers to best explain their services
(e.g., expanding the former global
patient census in the SMA–162 to
request patient census by drug type—
methadone, buprenorphine, naltrexone,
or other) and the needs of their patients
(e.g., including urinalysis results on the
SMA–168 and adding ‘‘weather crisis’’
as a standard option for physician
justification of the requested exception).
Amendments also include the removal
of information pertaining to faxing the
forms to SAMHSA, as this is no longer
an acceptable form of submission. The
burden hours have increased slightly
(by 28% or approximately 639 hours)
due to an increase in the number of
facilities accredited and certified by
SAMHSA since the previous
submissions of these forms. The forms
are available online with a unique
feature for both the SMA–162 and
SMA–168 that pre-populates certain
information within the form. This in
turn reduces the program’s time spent
filling out the forms as well as the staff
time spent on processing it.
The tables that follow summarize the
annual reporting burden associated with
the regulation, including burden
associated with the forms.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES
Number of
respondents
42 CFR citation
Purpose
8.3(b)(1–11) .........
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[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Notices]
[Pages 22998-22999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08992]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Advancing Translational Sciences; Notice of
Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of meetings of the
National Center for Advancing Translational Sciences.
The meetings will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Cures Acceleration Network Review Board.
Date: May 12, 2016.
Time: 8:30 a.m. to 2:45 p.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive
Secretary, National Center for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809,
anna.ramseyewing@nih.gov.
Name of Committee: National Center for Advancing Translational
Sciences Advisory Council.
Date: May 12, 2016.
Open: 8:30 a.m. to 2:45 p.m.
Agenda: Report from the Institute Director and other staff.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, Conference
Room 10, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive
Secretary, National Center for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809,
anna.ramseyewing@nih.gov.
[[Page 22999]]
(Catalogue of Federal Domestic Assistance Program Nos. 93.859,
Pharmacology, Physiology, and Biological Chemistry Research; 93.350,
B--Cooperative Agreements; 93.859, Biomedical Research and Research
Training, National Institutes of Health, HHS)
Dated: April 13, 2016.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-08992 Filed 4-18-16; 8:45 am]
BILLING CODE 4140-01-P
