National Cancer Institute; Amended Notice of Meeting, 62747 [2016-21786]
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Federal Register / Vol. 81, No. 176 / Monday, September 12, 2016 / Notices
260 submissions of 510(k)s for third
party review per year.
Proposed revisions to the currently
approved information collection:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
• Reporting
National Cancer Institute; Amended
Notice of Meeting
National Institutes of Health
Æ Requests for rerecognition: The
Agency anticipates an average annual
receipt of four applications for
rerecognition for third party 510(k)
review. The Agency reached this
estimate by reviewing the number of
existing recognized firms under the TP
Review Program and anticipating the
number of firms applying for
rerecognition every 3 years.
• Recordkeeping
Æ The Agency expects TP Review
Organizations to retain and maintain
documentation related to recognition
and rerecognition.
The respondents for this information
collection are private sector, for-profit
firms seeking recognition and
rerecognition.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 807, subpart E have been
approved under OMB control number
0910–0120; collections of information
for the device appeals processes have
been approved under OMB control
number 0910–0738.
V. References
sradovich on DSK3GMQ082PROD with NOTICES
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are
also available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register but Web sites are subject to
change over time.
1. International Medical Device Regulators
Forum’s Medical Device Single Audit
Program documents, available at https://
imdrf.org/documents/documents.asp.
2. FDA Draft Guidance entitled
‘‘Accreditation and Reaccreditation Process
for Firms under the Third Party Review
Program: Part I,’’ February 15, 2013, available
at https://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM339697.pdf.
Dated: September 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21876 Filed 9–9–16; 8:45 am]
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Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel,
October 26, 2016, 11:00 a.m. to October
26, 2016, 5:00 p.m., National Cancer
Institute Shady Grove, 9609 Medical
Center Drive, 4W034, Rockville, MD
20850 which was published in the
Federal Register on August 25, 2016, 81
FR 58524.
The meeting notice is amended to
change the date of the meeting to
November 15, 2016 from 11:00 a.m. to
5:00 p.m. The meeting is closed to the
public.
Dated: September 6, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–21786 Filed 9–9–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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 Cancer
Institute Special Emphasis Panel R13
Conference Grant Review.
Date: October 11, 2016.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W556, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Bratin K. Saha, Ph.D.,
Scientific Review Officer, Program
Coordination and Referral Branch, Division
of Extramural Activities, National Cancer
PO 00000
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62747
Institute, 9609 Medical Center Drive, Room
7W556, Rockville, MD 20892–9750, 240–
276–6411 sahab@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel Cancer
Tissue Engineering Collaborative: Enabling
Biomimetic Tissue-Engineered Technologies
for Cancer Research (U01).
Date: October 14, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, 9609 Medical Center Drive,
Room 7W260, Rockville, MD 20892–9750
240–276–5856, nadeem.khan@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel Cooperative
Agreement to Develop Targeted Agents for
use with Systemic Agents Plus Radiotherapy
(U01).
Date: October 21, 2016.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Thomas A. Winters, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, 9609 Medical
Center Drive, Room 7W412, Rockville, MD
20892–9750, 240–276–6386, twinters@
mail.nih.gov.
Name of Committee: National Cancer
Institute Initial Review Group Subcommittee
F—Institutional Training and Education.
Date: October 24–25, 2016.
Time: 7:30 p.m. to 3:45 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Timothy C. Meeker, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W606, Rockville, MD 20892–9750, 240–
276–6464, meekert@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, NCI
Clinical and Translational, R21: SEP–7.
Date: October 27, 2016.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rockville,
MD 20850 (Telephone Conference Call).
Contact Person: Caron A. Lyman, Ph.D.,
Chief, Scientific Review Officer, Research
Programs Review Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W126, Rockville, MD 20892–9750, 240–
276–6348, lymanc@mail.nih.gov.
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[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Notices]
[Page 62747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Cancer Institute Special Emphasis Panel, October 26, 2016, 11:00 a.m.
to October 26, 2016, 5:00 p.m., National Cancer Institute Shady Grove,
9609 Medical Center Drive, 4W034, Rockville, MD 20850 which was
published in the Federal Register on August 25, 2016, 81 FR 58524.
The meeting notice is amended to change the date of the meeting to
November 15, 2016 from 11:00 a.m. to 5:00 p.m. The meeting is closed to
the public.
Dated: September 6, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-21786 Filed 9-9-16; 8:45 am]
BILLING CODE 4140-01-P
