National Institute of Nursing Research; Notice of Closed Meeting, 50887 [2017-23865]
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50887
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.
VerDate Sep<11>2014
22:28 Nov 01, 2017
Jkt 244001
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 Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Page 50887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23865]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research; 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 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]
BILLING CODE 4140-01-P
