Government-Owned Inventions; Availability for Licensing, 50887-50888 [2017-23863]
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Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices
are set forth in 21 CFR 314.50, and
approved under OMB control number
0910–0001. This information collection
supports part 315, currently approved
under OMB control number 0910–0409.
Based on past submissions (human
drug applications and/or new indication
supplements for diagnostic
radiopharmaceuticals), we estimate two
submissions will be received annually.
We estimate the time needed to prepare
a complete application for a diagnostic
radiopharmaceutical to be
approximately 10,000 hours, roughly
one-fifth of which, or 2,000 hours, is
estimated to be spent preparing the
portions of the application that would
be affected by these regulations. The
regulations do not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours
because safety and effectiveness
information is already required by
§ 314.50 (collection of information
approved under OMB control number
0910–0001). In fact, clarification in
these regulations of FDA’s criteria for
evaluation of diagnostic
radiopharmaceuticals is intended to
streamline overall information
collection burdens, particularly for
diagnostic radiopharmaceuticals that
may have well-established, low-risk
safety profiles, by enabling
manufacturers to tailor information
submissions and avoid unnecessary
clinical studies.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Diagnostic Radiopharmaceuticals—315.4, 315.5, and 315.6 .................
2
1
2
2,000
4,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 contains estimates of the
annual reporting burden for the
preparation of the safety and
effectiveness sections of an application
that are imposed by the applicable
regulations. This estimate does not
include time needed to conduct studies
and clinical trials or other research from
which the reported information is
obtained.
Dated: October 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23836 Filed 11–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Closed Meeting
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
NINR Clinical Trial Planning Grant.
Date: November 17, 2017.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Nursing Research, One
Democracy Plaza, 6701 Democracy
Boulevard, Room 703, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Weiqun Li, MD, Scientific
Review Officer, National Institute of Nursing
Research, National Institutes of Health, 6701
Democracy Boulevard, Room 710, Bethesda,
MD 20892, (301) 594–5966,
wli@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: October 30, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–23865 Filed 11–1–17; 8:45 am]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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.
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FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
patent applications listed below may be
obtained by emailing the indicated
licensing contact Michael Shmilovich,
shmilovm@nih.gov at the National
Heart, Lung, and Blood, Office of
Technology Transfer and Development
Office of Technology Transfer, 31 Center
Drive Room 4A29, MSC2479, Bethesda,
MD 20892–2479; telephone: 301–402–
5579. A signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: This
notice is in accordance with 35 U.S.C.
209 and 37 CFR 404 to achieve
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing. A description of the
technology follows.
Endo-Cameral Closure Device
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S.
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Description of Technology: Devices
and methods for closing a hole in the
wall of a cardiovascular structure from
the inside using a self-assembling
closure device. The closure device can
be delivered to the subject hole from the
inside of the cardiovascular chamber
using a transcatheter approach. The
methods are techniques involve
deploying the closure device from the
delivery device such that an endocameral portion of the closure device
self-expands first to cover the hole from
the inside, and then extra-cameral arms
of the device are released to self-deploy
against the outside of the wall by
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Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices
withdrawal of a retaining element, such
as a guidewire, to secure the closure
device to the wall.
Potential Commercial Applications:
Endovascular interventions.
Inventors: Toby Rogers, Merdim
Sonmez, Robert Lederman, Ozgur
Kocaturk, (NHLBI).
Intellectual Property: HHS Reference
No. E–273–2015/0, U.S. Provisional
Patent Application 62/236,734 filed
October 2, 2015, International Patent
Application PCT/US2016/054961 filed
September 30, 2016.
Licensing Contact: Michael
Shmilovich, Esq, CLP; 301–435–5019;
shmilovm@nih.gov.
Dated: October 23, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
National Heart, Lung, and Blood Institute—
Factor VIII Immune Response (U54).
Date: November 30–December 1, 2017.
Time: 12:30 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Hotel, 1480 Crystal
Drive, Arlington, VA 22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–827–
7938, johnsonwj@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: October 27, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–23863 Filed 11–1–17; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2017–23819 Filed 11–1–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
National Institutes of Health
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
NHLBI Special Emphasis Panel
meetings.
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: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
T32: Institutional Training to Promote
Diversity.
Date: November 30, 2017.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Suite 7189, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Lindsay M. Garvin, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Suite 7189, Bethesda, MD
20892, 301–827–7911, lindsay.garvin@
nih.gov.
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National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; NIAMS
Ancillary Studies Review Meeting.
Date: November 15, 2017.
Time: 10:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health/NIAMS,
6701 Democracy Blvd., Suite 824, Bethesda,
MD 20892 (Teleconference).
Contact Person: Yin Liu, Ph.D., MD,
Scientific Review Officer, Scientific Review
Branch, National Institute of Health/NIAMS,
6701 Democracy Blvd., Suite 824, Bethesda,
PO 00000
Frm 00034
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MD 20892, 301–594–4952, liuy@
exchange.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: October 30, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–23864 Filed 11–1–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–6044–N–01]
Notice of Certain Operating Cost
Adjustment Factors for 2018
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Notice.
AGENCY:
This notice establishes
operating cost adjustment factors
(OCAFs) for project-based rental
assistance contracts issued under
Section 8 of the United States Housing
Act of 1937 and renewed under the
Multifamily Assisted Housing Reform
and Affordability Act of 1997 (MAHRA)
with an anniversary date on or after
February 11, 2018. OCAFs are annual
factors used primarily to adjust the rents
for contracts renewed under section 515
or section 524 of MAHRA. OCAFs are
distinct from, and do not apply to the
same properties as Annual Adjustment
Factors (AAFs). AAFs are used to adjust
contract rents for units assisted in
certain Section 8 housing assistance
payment programs during the initial
(i.e., pre-renewal) term of the HAP
contract and for all units in the ProjectBased Certificate program.
DATES: Applicable: February 11, 2018.
FOR FURTHER INFORMATION CONTACT:
Carisa L. Janis, Program Analyst, Office
of Asset Management and Portfolio
Oversight, Department of Housing and
Urban Development, 451 7th Street SW.,
Washington, DC 20410; telephone
number 202–402–2487 (this is not a tollfree number). Hearing- or speechimpaired individuals may access this
number through TTY by calling the tollfree Federal Relay Service at 800–877–
8339.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. OCAFs
Section 514(e)(2) and section 524(c)(1)
of MAHRA (42 U.S.C. 1437f note)
require HUD to establish guidelines for
the development of OCAFs for rent
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]]>Agencies
[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Pages 50887-50888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23863]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the patent applications listed below may be obtained by emailing the
indicated licensing contact Michael Shmilovich, shmilovm@nih.gov at the
National Heart, Lung, and Blood, Office of Technology Transfer and
Development Office of Technology Transfer, 31 Center Drive Room 4A29,
MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed
Confidential Disclosure Agreement may be required to receive copies of
the patent applications.
SUPPLEMENTARY INFORMATION: This notice is in accordance with 35 U.S.C.
209 and 37 CFR 404 to achieve commercialization of results of
federally-funded research and development. Foreign patent applications
are filed on selected inventions to extend market coverage for
companies and may also be available for licensing. A description of the
technology follows.
Endo-Cameral Closure Device
Description of Technology: Devices and methods for closing a hole
in the wall of a cardiovascular structure from the inside using a self-
assembling closure device. The closure device can be delivered to the
subject hole from the inside of the cardiovascular chamber using a
transcatheter approach. The methods are techniques involve deploying
the closure device from the delivery device such that an endo-cameral
portion of the closure device self-expands first to cover the hole from
the inside, and then extra-cameral arms of the device are released to
self-deploy against the outside of the wall by
[[Page 50888]]
withdrawal of a retaining element, such as a guidewire, to secure the
closure device to the wall.
Potential Commercial Applications: Endovascular interventions.
Inventors: Toby Rogers, Merdim Sonmez, Robert Lederman, Ozgur
Kocaturk, (NHLBI).
Intellectual Property: HHS Reference No. E-273-2015/0, U.S.
Provisional Patent Application 62/236,734 filed October 2, 2015,
International Patent Application PCT/US2016/054961 filed September 30,
2016.
Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019;
shmilovm@nih.gov.
Dated: October 23, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood
Institute, Office of Technology Transfer and Development.
[FR Doc. 2017-23863 Filed 11-1-17; 8:45 am]
BILLING CODE 4140-01-P
