National Cancer Institute; Notice of Closed Meetings, 68465-68466 [2019-27003]
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Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
by the Secretary of Health and Human
Services on September 25, 2019.
FOR FURTHER INFORMATION CONTACT:
Edwin Echegoyen, Acting Director,
Office of Management/Executive
Officer, Food and Drug Administration,
10903 New Hampshire Ave., Building
51, Silver Spring, MD 20993, 301–796–
3300.
lotter on DSKBCFDHB2PROD with NOTICES
I. Summary
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970; 60 FR 56606, November 9, 1995;
64 FR 36361, July 6, 1999; 72 FR 50112,
August 30, 2007; 74 FR 41713, August
18, 2009; and 76 FR 45270, July 28,
2011) is amended to reflect the
reorganization of the Center of Drug
Evaluation and Research.
This reorganization consists of the
following Offices: Office of New Drugs
(OND), Office of Translational Science
(OTS), and Office of Pharmaceutical
Quality (OPQ) within the Center for
Drug Evaluation and Research and
revises their functional statements. The
proposed organizational changes align
with the ReImagine HHS strategic shift
moving to the 21st century: Maximizing
Talent, Integrated Assessments, Benefit
Risk Monitoring, and Leveraging the
Power of Data. CDER will meet the
definition of Maximizing Talent by
focusing on growing our scientific
leadership. This will result in clearly
designed pathways to regulatory
approval and enhanced emphasis on
multidisciplinary teams. The proposed
reorganization will integrate
assessments to critically,
collaboratively, and consistently assess
whether information in submissions
meets statutory and regulatory
requirements. OND, OPQ, and OTS will
establish Benefit-Risk Monitoring to
unify the post-market safety
surveillance framework leading to
operational excellence by aligning the
therapeutic focus. Each of these offices
will incorporate Leveraging the Power
of Data to provide access to analytical
tools and systems to help the reviewers
evaluate and interpret submitted data,
thereby improving and streamlining the
processes which will impact the critical
analyses leading to efficiencies and
effectiveness in CDER’s scientific
regulatory review.
Under Part D, FDA, the Center for
Drug Evaluation and Research (CDER)
has been restructured as follows:
Standard Administrative Codes
(SAC). ORGANIZATION—CDER is
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headed by the Director and includes the
following organizational units:
Office of Regulatory Policy (SAC)
Office of Management (SAC)
Office of Communications (SAC)
Office of Compliance (SAC)
Office of Manufacturing Quality (SAC)
Office of Unapproved Drugs and
Labeling Compliance (SAC)
Office of Scientific Investigations (SAC)
Office of Program and Regulatory
Operations (SAC)
Office of Medical Policy (SAC)
Office of Prescription Drug Promotion
(SAC)
Office of Medical Policy Initiatives
(SAC)
Office of Translational Sciences (SAC)
Office of Biostatistics (SAC)
Office of Clinical Pharmacology (SAC)
Office of Computational Science (SAC)
Office of Study Integrity and
Surveillance (SAC)
Office of Administrative Operations
(SAC)
Office of Executive Programs (SAC)
Office of Surveillance and Epidemiology
(SAC)
Office of Medication Error Prevention
and Risk Management (SAC)
Office of Pharmacovigilance and
Epidemiology (SAC)
Office of New Drugs (SAC)
Office of Administrative Operations
(SAC)
Office of Cardiology, Hematology,
Endocrinology & Nephrology (SAC)
Office of Drug Evaluation Science (SAC)
Office of Immunology & Inflammation
(SAC)
Office of Infectious Diseases (SAC)
Office of Neuroscience (SAC)
Office of New Drug Policy (SAC)
Office of Nonprescription Drugs (SAC)
Office of Oncologic Diseases (SAC)
Office of Program Operations (SAC)
Office of Rare Diseases, Pediatrics,
Urology & Reproductive Medicine
(SAC)
Office of Regulatory Operations (SAC)
Office of Specialty Medicine (SAC)
Office of Therapeutic Biologics and
Biosimilars (SAC)
Office of Strategic Programs (SAC)
Office of Program and Strategic Analysis
(SAC)
Office of Business Informatics (SAC)
Office of Generic Drugs (SAC)
Office of Research Standards (SAC)
Office of Bioequivalence (SAC)
Office of Generic Drug Policy (SAC)
Office of Regulatory Operations (SAC)
Office of Pharmaceutical Quality (SAC)
Office of Administrative Operations
(SAC)
Office of Biotechnology Products (SAC)
Office of Lifecycle Drug Products (SAC)
Office of New Drug Products (SAC)
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68465
Office of Pharmaceutical Manufacturing
Assessment (SAC)
Office of Policy for Pharmaceutical
Quality (SAC)
Office of Program and Regulatory
Operations (SAC)
Office of Quality Surveillance (SAC)
Office of Testing and Research (SAC)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete SMG can find it on FDA’s
website at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/
StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Alex M. Azar, II,
Secretary.
[FR Doc. 2019–26952 Filed 12–13–19; 8:45 am]
BILLING CODE 4164–01–P
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, 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; NCI SPORE
(P50) III Review.
Date: January 29–30, 2020.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
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lotter on DSKBCFDHB2PROD with NOTICES
68466
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washington
Blvd., Gaithersburg, MD 20878.
Contact Person: Anita T. Tandle, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W248,
Bethesda, MD 20892, 240–276–5085,
tandlea@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Program Project (P01) Review III.
Date: February 6–7, 2020.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Jennifer C. Schiltz, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, National Institutes
of Health, Rockville, MD 20850, 240–276–
5864, jennifer.schiltz@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP 7: NCI
Clinical and Translational R21 and Omnibus
R03.
Date: February 12–13, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Robert Stephen Coyne,
Ph.D., Scientific Review Officer, National
Cancer Institute, NIH, Division of Extramural
Activities, Special Review Branch, 9609
Medical Center Drive, Room 7W236,
Rockville, MD 20850, 240–276–5120,
coyners@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–3: NCI
Clinical and Translational R21 and Omnibus
R03.
Date: February 13–14, 2020.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Hasan Siddiqui, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W240, Rockville, MD
20850, 240–276–5122, hasan.siddiqui@
nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; TEP–1:
SBIR Contract Review.
Date: February 19–20, 2020.
Time: 6:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Marriott Bethesda North Hotel &
Conference Center, 5701 Marinelli Road,
Rockville, MD 20850.
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
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Technology and Contract Review Branch,
Division of Extramural Activities, 9609
Medical Center Drive, Room 7W260, National
Cancer Institute, NIH, Bethesda, MD 20892–
9745, 240–276–5856, nadeem.khan@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Research Specialist Award R50.
Date: February 27–28, 2020.
Time: 5:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Zhiqiang Zou, M.D., Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, 7W242, Bethesda, MD 20892,
240–276–6372, zouzhiq@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Transition
to Independence SEP.
Date: March 10, 2020.
Time: 10:30 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
7W602, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Delia Tang, M.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W602,
Bethesda, MD 20892, 240–276–6456, tangd@
mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Quantitative Imaging Methods and Resources
(UG3/UH3, U24).
Date: March 13, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
6W030, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Saejeong J. Kim, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W640, Rockville, MD
20850, 240–276–7684, saejeong.kim@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; HIVAssociated Malignancy Research.
Date: March 26–27, 2020.
Time: 5:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Bethesda North Hotel &
Conference Center, 5701 Marinelli Road,
Rockville, MD 20852.
Contact Person: Nadeem Khan, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, 9609
Medical Center Drive, Room 7W260, National
Cancer Institute, NIH, Bethesda, MD 20892–
9745, 240–276–5856, nadeem.khan@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
PO 00000
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93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: December 10, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–27003 Filed 12–13–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: The Development of
Siglec-6-Specific Chimeric Antigen
Receptor (CAR) for the Treatment
Acute Myeloid Leukemia (AML),
Chronic Lymphocytic Leukemia (CLL),
and Other Forms of Acute and Chronic
B- and T-Cell Leukemia and
Lymphoma
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this notice to T–CURX GmbH
(T–CURX), located in Wu¨rzburg,
Germany.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before December 31, 2019 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: Abritee Dhal, Ph.D.,
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 3W610, MSC
9702, Bethesda, MD 20892–9702, (for
business mail), Rockville, MD 20850–
9702, Telephone: (240) 276–6154;
Facsimile: (240) 276–5504; Email:
abritee.dhal@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
U.S. Provisional Patent Application
61/178,688 entitled ‘‘A Panel Of Fully
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]]>Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68465-68466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27003]
-----------------------------------------------------------------------
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, 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; NCI SPORE (P50) III Review.
Date: January 29-30, 2020.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
[[Page 68466]]
Place: Gaithersburg Marriott Washingtonian Center, 9751
Washington Blvd., Gaithersburg, MD 20878.
Contact Person: Anita T. Tandle, Ph.D., Scientific Review
Officer, Research Programs Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W248, Bethesda, MD 20892, 240-276-5085,
[email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; NCI Program Project (P01) Review III.
Date: February 6-7, 2020.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center,
Montgomery County Conference Center Facility, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Jennifer C. Schiltz, Ph.D., Scientific Review
Officer, Special Review Branch, Division of Extramural Activities,
National Cancer Institute, National Institutes of Health, Rockville,
MD 20850, 240-276-5864, [email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; SEP 7: NCI Clinical and Translational R21 and Omnibus R03.
Date: February 12-13, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Robert Stephen Coyne, Ph.D., Scientific Review
Officer, National Cancer Institute, NIH, Division of Extramural
Activities, Special Review Branch, 9609 Medical Center Drive, Room
7W236, Rockville, MD 20850, 240-276-5120, [email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; SEP-3: NCI Clinical and Translational R21 and Omnibus R03.
Date: February 13-14, 2020.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center,
Montgomery County Conference Center Facility, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Hasan Siddiqui, Ph.D., Scientific Review
Officer, Special Review Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical Center Drive, Room
7W240, Rockville, MD 20850, 240-276-5122, [email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; TEP-1: SBIR Contract Review.
Date: February 19-20, 2020.
Time: 6:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: Marriott Bethesda North Hotel & Conference Center, 5701
Marinelli Road, Rockville, MD 20850.
Contact Person: Nadeem Khan, Ph.D., Scientific Review Officer,
Research Technology and Contract Review Branch, Division of
Extramural Activities, 9609 Medical Center Drive, Room 7W260,
National Cancer Institute, NIH, Bethesda, MD 20892-9745, 240-276-
5856, [email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; NCI Research Specialist Award R50.
Date: February 27-28, 2020.
Time: 5:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center, 5701
Marinelli Road, Bethesda, MD 20852.
Contact Person: Zhiqiang Zou, M.D., Ph.D., Scientific Review
Officer, Special Review Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical Center Drive, 7W242,
Bethesda, MD 20892, 240-276-6372, [email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; Transition to Independence SEP.
Date: March 10, 2020.
Time: 10:30 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 7W602, Rockville, MD 20850 (Telephone Conference
Call).
Contact Person: Delia Tang, M.D., Scientific Review Officer,
Research Programs Review Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical Center Drive, Room
7W602, Bethesda, MD 20892, 240-276-6456, [email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; Quantitative Imaging Methods and Resources (UG3/UH3, U24).
Date: March 13, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Cancer Institute Shady Grove, 9609 Medical
Center Drive, Room 6W030, Rockville, MD 20850 (Telephone Conference
Call).
Contact Person: Saejeong J. Kim, Ph.D., Scientific Review
Officer, Special Review Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical Center Drive, Room
7W640, Rockville, MD 20850, 240-276-7684, [email protected].
Name of Committee: National Cancer Institute Special Emphasis
Panel; HIV-Associated Malignancy Research.
Date: March 26-27, 2020.
Time: 5:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Marriott Bethesda North Hotel & Conference Center, 5701
Marinelli Road, Rockville, MD 20852.
Contact Person: Nadeem Khan, Ph.D., Scientific Review Officer,
Research Technology and Contract Review Branch, Division of
Extramural Activities, 9609 Medical Center Drive, Room 7W260,
National Cancer Institute, NIH, Bethesda, MD 20892-9745, 240-276-
5856, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: December 10, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-27003 Filed 12-13-19; 8:45 am]
BILLING CODE 4140-01-P
