Center for Scientific Review; Notice of Closed Meetings, 57454-57455 [2019-23278]
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
described in section 505(o)(3)(B) of the
FD&C Act.4
In April 2011, FDA issued a guidance
describing how it would implement
section 505(o) of the FD&C Act. At that
time, the ARIA system was still in early
development. The ARIA system is now
officially launched, and FDA must
consider the system’s sufficiency to
meet the purposes of section
505(o)(3)(B) of the FD&C Act to
determine if a postmarketing study or
clinical trial is necessary. This draft
guidance revises the guidance for
industry of the same name issued on
April 1, 2011 (76 FR 18226). Significant
changes from the 2011 version include
explaining how FDA considers the
reporting under section 505(k)(1) of the
FD&C Act and the ARIA system when
determining their sufficiency for the
purposes under section 505(o)(3)(B) of
the FD&C Act. The guidance is also
being revised to provide examples of
postmarketing requirements under
section 505(o)(3) of the FD&C Act to
assess a potential reduction in the
expected effectiveness of a drug under
certain circumstances. FDA’s authority
to require these types of studies or trials
was clarified by a modification to the
definition of adverse drug experience at
section 505–1(b)(1)(E) of the FD&C Act
(21 U.S.C. 505–1(b)(1)(E)) enacted under
section 3041 of the SUPPORT Act (Pub.
L. 115–271).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking on
implementation of section 505(o)(3)(B)
of the FD&C Act. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520).
The following collections of
information for postmarketing reports
and clinical data in 21 CFR 314.50,
314.80, 314.81, 314.98, 314.430, and
314.610(b), subpart I have been
approved under OMB control number
0910–0001: (1) Preparing and
submitting reports pertaining to safety,
postmarketing commitments and
4 Section
505(o)(3)(D)(ii) of the FD&C Act.
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preparing and submitting spontaneous
and periodic reports, including active
postmarket risk identification (using
electronic health care data) and any
milestones or submissions for which
projected dates were specified as part of
the postmarketing commitment; (2)
submitting a proposed timetable of the
postmarketing commitments; (3)
preparing registries and submitting
them when appropriate; (4) designing
meta-analyses to evaluate statistical
analyses of data; (5) preparing assay
procedures; and (6) prepare a plan or
approach for approval an NDA when
human efficacy studies are not ethical or
feasible.
The following collections of
information for postmarketing studies
and clinical trials (including various
patient populations) in 21 CFR 312.23
have been approved under OMB control
number 0910–0014: (1) Conducting in
vitro laboratory tests and studies to
compare pregnancy incidence an
pregnancy outcomes and/or child
outcomes for patients exposed to a drug;
(2) submitting an introductory statement
and general investigational plan,
including a drug’s pharmacological
class; and (3) submitting protocols for
drug safety and pharmacology and
toxicology information.
The collections of information in 21
CFR 310.305, 314.80, and 314.98 for
submitting adverse event information to
the FDA Adverse Event Reporting
System have been approved under OMB
control numbers 0910–0230 and 0910–
0291; the collections of information in
21 CFR 312.47 and 312.82 for
submitting a meeting request to appeal
the conduct of a postmarketing study or
clinical trial have been approved under
OMB control number 0910–0430 (and
guidance for industry and review staff
entitled ‘‘Formal Dispute Resolutions:
Appeals Above the Division Level’’
(available at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-drugsgen/documents/document/
ucm343101.pdf).
The following collection of
information in § 314.510 has been
approved under OMB control number
0910–0765: Requests for serious or lifethreatening diseases or conditions that
may be granted accelerated approval if
FDA determines the product has an
effect on a surrogate endpoint that is
reasonably likely to predict clinical
benefit or on a clinical endpoint that
can be measured earlier than
irreversible morbidity or mortality or
other clinical benefit.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
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https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23312 Filed 10–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Evidencebased Screening in Diverse Adult
Populations.
Date: November 15, 2019.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Karen Nieves Lugo, MPH,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health Bethesda, MD 20892, 301–594–9088,
karen.nieveslugo@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cancer Diagnostics and Treatments
(CDT).
Date: November 18–19, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Zhang-Zhi Hu, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6186,
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
MSC 7804, Bethesda, MD 20892, (301) 437–
8135, huzhuang@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Infectious
Diseases and Microbiology Research
Enhancement Review.
Date: November 18, 2019.
Time: 8:00 a.m. to 6:00 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: Liangbiao Zheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
MSC 7808, Bethesda, MD 20892, 301–996–
5819, zhengli@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Drug Discovery and Development.
Date: November 18, 2019.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Sergei Ruvinov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4158,
MSC 7806, Bethesda, MD 20892, 301–435–
1180, ruvinser@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AI19–024/
025: US South Africa Program for
Collaborative Biomedical Research.
Date: November 18, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Marci Scidmore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, 301–435–
1149, marci.scidmore@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Electronic Nicotine Delivery Systems
(ENDS): Population, Clinical and Applied
Prevention Research.
Date: November 18, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Miriam Mintzer, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
Bethesda, MD 20892, 301–523–0646,
mintzermz@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Medical Imaging Investigations.
Date: November 19, 2019.
Time: 10:00 a.m. to 5:30 p.m.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Guo Feng Xu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5122,
MSC 7854, Bethesda, MD 20892, 301–237–
9870, xuguofen@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cancer Biology.
Date: November 19, 2019.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Charles Morrow, MD,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202,
MSC 7804, Bethesda, MD 20892, 301–451–
4467, morrowcs@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Retinopathies, Cornea Regeneration
and Strabismus.
Date: November 19, 2019.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Alessandra C. Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205,
MSC7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Health Services Organization and
Delivery.
Date: November 19, 2019.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Jessica Bellinger, Ph.D.,
Scientific Review Administrator, Center for
Scientific of Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
Bethesda, MD 20892, 301–827–4446,
bellingerjd@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 21, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–23278 Filed 10–24–19; 8:45 am]
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57455
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 Board of Scientific
Counselors for Clinical Sciences and
Epidemiology National Cancer Institute,
November 4, 2019, 9:00 a.m. to 3:45
p.m., National Institutes of Health,
Building 45, Natcher Building,
Conference Room D, 45 Center Drive,
Bethesda, MD 20892, which was
published in the Federal Register on
February 15, 2019, 84 FR 4487.
This meeting notice is amended to
add an open session from 9:05 a.m. to
9:35 a.m. to present Remarks from the
Acting Director, NCI and to change the
meeting end time from 3:45 p.m. to 5:00
p.m. The meeting is partially closed to
the public.
Dated: October 21, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–23282 Filed 10–24–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 Institute on
Drug Abuse Special Emphasis Panel;
Identification of Genetic and Genomic
Variants by Next-Gen Sequencing in Nonhuman Animal Models (U01).
Date: November 1, 2019.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
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]]>Agencies
[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57454-57455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific Review Special Emphasis
Panel; Evidence-based Screening in Diverse Adult Populations.
Date: November 15, 2019.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Karen Nieves Lugo, MPH, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of Health
Bethesda, MD 20892, 301-594-9088, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Cancer Diagnostics and Treatments (CDT).
Date: November 18-19, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: Zhang-Zhi Hu, MD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6186,
[[Page 57455]]
MSC 7804, Bethesda, MD 20892, (301) 437-8135, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Infectious Diseases and Microbiology Research Enhancement
Review.
Date: November 18, 2019.
Time: 8:00 a.m. to 6:00 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: Liangbiao Zheng, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD
20892, 301-996-5819, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Drug Discovery and Development.
Date: November 18, 2019.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: Sergei Ruvinov, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4158, MSC 7806, Bethesda, MD
20892, 301-435-1180, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AI19-024/025: US South Africa Program for Collaborative
Biomedical Research.
Date: November 18, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Marci Scidmore, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192, MSC 7808, Bethesda, MD
20892, 301-435-1149, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Electronic Nicotine Delivery Systems (ENDS):
Population, Clinical and Applied Prevention Research.
Date: November 18, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Miriam Mintzer, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108, Bethesda, MD 20892, 301-
523-0646, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Medical Imaging Investigations.
Date: November 19, 2019.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Guo Feng Xu, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5122, MSC 7854, Bethesda, MD 20892, 301-237-
9870, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Cancer Biology.
Date: November 19, 2019.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Charles Morrow, MD, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD
20892, 301-451-4467, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Retinopathies, Cornea Regeneration and
Strabismus.
Date: November 19, 2019.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Alessandra C. Rovescalli, Ph.D., Scientific
Review Officer, National Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205, MSC7846, Bethesda, MD 20892,
(301) 435-1021, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Health Services Organization and Delivery.
Date: November 19, 2019.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Jessica Bellinger, Ph.D., Scientific Review
Administrator, Center for Scientific of Review, National Institutes
of Health, 6701 Rockledge Drive, Room 3158, Bethesda, MD 20892, 301-
827-4446, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: October 21, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-23278 Filed 10-24-19; 8:45 am]
BILLING CODE 4140-01-P
