82 FR 50887 - National Institute of Nursing Research; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 211 (November 2, 2017)

Page Range		50887-50887
FR Document		2017-23865

Federal Register, Volume 82 Issue 211 (Thursday, November 2, 2017)

[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Page 50887]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

(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

Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50887

are set forth in 21 CFR 314.50, and one-fifth of which, or 2,000 hours, is these regulations of FDA’s criteria for
approved under OMB control number estimated to be spent preparing the evaluation of diagnostic
0910–0001. This information collection portions of the application that would radiopharmaceuticals is intended to
supports part 315, currently approved be affected by these regulations. The streamline overall information
under OMB control number 0910–0409. regulations do not impose any collection burdens, particularly for
Based on past submissions (human additional reporting burden for safety diagnostic radiopharmaceuticals that
drug applications and/or new indication and effectiveness information on may have well-established, low-risk
supplements for diagnostic diagnostic radiopharmaceuticals beyond safety profiles, by enabling
radiopharmaceuticals), we estimate two the estimated burden of 2,000 hours manufacturers to tailor information
submissions will be received annually. because safety and effectiveness submissions and avoid unnecessary
We estimate the time needed to prepare information is already required by
clinical studies.
a complete application for a diagnostic § 314.50 (collection of information
radiopharmaceutical to be approved under OMB control number FDA estimates the burden of this
approximately 10,000 hours, roughly 0910–0001). In fact, clarification in information collection as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual burden per
21 CFR section Total hours
respondents per responses response
respondent (in 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 Name of Committee: National Institute of FOR FURTHER INFORMATION CONTACT:
annual reporting burden for the Nursing Research Special Emphasis Panel; Licensing information and copies of the
preparation of the safety and NINR Clinical Trial Planning Grant. patent applications listed below may be
effectiveness sections of an application Date: November 17, 2017. obtained by emailing the indicated
Time: 1:00 p.m. to 3:00 p.m.
that are imposed by the applicable Agenda: To review and evaluate grant
licensing contact Michael Shmilovich,
regulations. This estimate does not applications. shmilovm@nih.gov at the National
include time needed to conduct studies Place: National Institutes of Health, Heart, Lung, and Blood, Office of
and clinical trials or other research from National Institute of Nursing Research, One Technology Transfer and Development
which the reported information is Democracy Plaza, 6701 Democracy Office of Technology Transfer, 31 Center
obtained. Boulevard, Room 703, Bethesda, MD 20892 Drive Room 4A29, MSC2479, Bethesda,
(Telephone Conference Call). MD 20892–2479; telephone: 301–402–
Dated: October 27, 2017. Contact Person: Weiqun Li, MD, Scientific 5579. A signed Confidential Disclosure
Anna K. Abram, Review Officer, National Institute of Nursing Agreement may be required to receive
Deputy Commissioner for Policy, Planning, Research, National Institutes of Health, 6701
Legislation, and Analysis. Democracy Boulevard, Room 710, Bethesda,
copies of the patent applications.
[FR Doc. 2017–23836 Filed 11–1–17; 8:45 am] MD 20892, (301) 594–5966, SUPPLEMENTARY INFORMATION: This
BILLING CODE 4164–01–P
wli@mail.nih.gov. notice is in accordance with 35 U.S.C.
(Catalogue of Federal Domestic Assistance 209 and 37 CFR 404 to achieve
Program Nos. 93.361, Nursing Research, commercialization of results of
DEPARTMENT OF HEALTH AND National Institutes of Health, HHS) federally-funded research and
HUMAN SERVICES Dated: October 30, 2017. development. Foreign patent
Sylvia L. Neal, applications are filed on selected
National Institutes of Health Program Analyst, Office of Federal Advisory inventions to extend market coverage
Committee Policy. for companies and may also be available
National Institute of Nursing Research; for licensing. A description of the
[FR Doc. 2017–23865 Filed 11–1–17; 8:45 am]
Notice of Closed Meeting technology follows.
BILLING CODE 4140–01–P

Pursuant to section 10(d) of the Endo-Cameral Closure Device
Federal Advisory Committee Act, as Description of Technology: Devices
amended, notice is hereby given of the DEPARTMENT OF HEALTH AND
HUMAN SERVICES and methods for closing a hole in the
following meeting. wall of a cardiovascular structure from
The meeting will be closed to the National Institutes of Health the inside using a self-assembling
public in accordance with the closure device. The closure device can
provisions set forth in sections Government-Owned Inventions; be delivered to the subject hole from the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Availability for Licensing inside of the cardiovascular chamber
asabaliauskas on DSKBBXCHB2PROD with NOTICES

as amended. The grant applications and using a transcatheter approach. The
the discussions could disclose AGENCY: National Institutes of Health, methods are techniques involve
confidential trade secrets or commercial HHS. deploying the closure device from the
property such as patentable material, ACTION: Notice. delivery device such that an endo-
and personal information concerning cameral portion of the closure device
individuals associated with the grant SUMMARY: The inventions listed below self-expands first to cover the hole from
applications, the disclosure of which are owned by an agency of the U.S. the inside, and then extra-cameral arms
would constitute a clearly unwarranted Government and are available for of the device are released to self-deploy
invasion of personal privacy. licensing in the U.S. against the outside of the wall by

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		November 17, 2017.
FR Citation		82 FR 50887

82 FR 50887 - National Institute of Nursing Research; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 211 (November 2, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health