Center for Scientific Review; Notice of Closed Meetings, 28243-28244 [2018-12920]
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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
ICH Assembly is responsible for the
endorsement of draft guidelines and
adoption of final guidelines. FDA
publishes ICH guidelines as FDA
guidances.
ICH S9 (2010) was a significant
advance in harmonizing anticancer drug
development. Implementation of ICH S9
(2010) has revealed areas that are open
to broad and divergent interpretation by
both regulatory authorities and industry.
For this reason, an Implementation
Working Group (IWG) was formed in
October 2014 to provide additional
clarity about anticancer pharmaceutical
development. The questions and
answers developed by the IWG are
intended to facilitate the
implementation of ICH S9 (2010), as
well as to continue progress in the 3Rs
of Reduction, Refinement, and
Replacement in the use of animals.
In the Federal Register of September
19, 2016 (81 FR 64178), FDA published
a notice announcing the availability of
a draft guidance entitled ‘‘S9
Nonclinical Evaluation for Anticancer
Pharmaceuticals—Questions and
Answers.’’ The notice gave interested
persons an opportunity to submit
comments by November 18, 2016.
After consideration of the comments
received and revisions to the guideline,
a final draft of the guideline was
submitted to the ICH Assembly and
endorsed by the regulatory agencies in
June 2016.
The guidance provides
recommendations on development of
anticancer pharmaceuticals, including
small molecule and biotechnologyderived products. The questions and
answers are intended to provide clarity
and to facilitate a harmonized approach
to the implementation of ICH S9 (2010).
Since the publication of the draft
questions and answers and receipt of
public comments, some questions were
combined for brevity and clarity or were
deleted as redundant or due to lack of
harmonization. Several areas of
particular importance include
additional clarity around the scope of
the guidance, additional
recommendations regarding
development of antibody-drug
conjugates, and the need for recovery
animals in general toxicology studies.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘S9 Nonclinical
Evaluation for Anticancer
Pharmaceuticals—Questions and
Answers.’’ 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
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requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12975 Filed 6–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 of
Allergy and Infectious Diseases Special
Emphasis Panel; Immunity in the Elderly
(R01).
Date: July 9–10, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, LD30,
5601 Fishers Lane, Rockville, MD 20892.
Contact Person: Julio Aliberti, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 5601
Fishers Lane, MSC–9823, Rockville, MD
20852, 301–761–7322, alibertijc@
niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Maintaining Immunity after
Immunization (U01).
Date: July 11–12, 2018.
Time: 8:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892.
Contact Person: Geetanjali Bansal, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G49, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9834,
Bethesda, MD 20892–9834, (240) 669–5073,
geetanjali.bansal@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project (P01).
Date: July 11, 2018.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Raymond R. Schleef,
Ph.D., Senior Scientific Review Officer,
Scientific Review Program, Division of
Extramural Activities, Room 3E61, National
Institutes of Health/NIAID, 5601 Fishers
Lane, MSC 9823, Bethesda, MD 20892–9823,
(240) 669–5019, schleefrr@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: June 12, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–12921 Filed 6–15–18; 8:45 am]
BILLING CODE 4140–01–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; PAR:
Selected Topics in Transfusion Medicine.
Date: June 28–29, 2018.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
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28244
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Katherine M. Malinda,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4140,
MSC 7814, Bethesda, MD 20892, 301–435–
0912, Katherine_Malinda@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: July 10, 2018.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Shalanda A. Bynum,
Ph.D., MPH, Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
Bethesda, MD 20892, 301–755–4355,
bynumsa@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Convergent
Neuroscience: From Genomic Association to
Causation.
Date: July 10, 2018.
Time: 11:00 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: Jana Drgonova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
Bethesda, MD 20892, 301–827–2549,
jdrgonova@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Neuroscience Assay, Diagnostics
and Animal Model Development.
Date: July 12–13, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Crown Plaza Seattle Hotel, 1113
6th Ave., Seattle, WA 98101.
Contact Person: Susan Gillmor, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301–
435–1730, susan.gillmor@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Center for
Neuroscience and Regenerative Medicine
Program.
Date: July 12, 2018.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Chittari V. Shivakumar,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Bethesda, MD
20892, 301–408–9098, chittari.shivakumar@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR
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Review: Understanding and Modifying
Temporal Dynamics of Coordinated Neural
Activity.
Date: July 12, 2018.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jana Drgonova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
Bethesda, MD 20892, 301–827–2549,
jdrgonova@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Integrative Neuroscience.
Date: July 12, 2018.
Time: 1:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Jasenka Borzan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892–7814, 301–
435–1787, borzanj@csr.nih.gov.
Name of Committee: Biology of
Development and Aging Integrated Review
Group; International and Cooperative
Projects—1 Study Section.
Date: July 13, 2018.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@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: June 12, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–12920 Filed 6–15–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Chemical Facility Anti-Terrorism
Standards Personnel Surety Program
National Protection and
Programs Directorate (NPPD),
Department of Homeland Security
(DHS).
AGENCY:
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30-Day notice and request for
comments; revision of information
collection request: 1670–0029.
ACTION:
The DHS NPPD Office of
Infrastructure Protection (IP),
Infrastructure Security Compliance
Division (ISCD) will submit the
following information collection request
(ICR) to the Office of Management and
Budget (OMB) for review and clearance
in accordance with the Paperwork
Reduction Act of 1995. NPPD
previously published this ICR, in the
Federal Register on December 27, 2017,
for a 60-day public comment period.
In this notice NPPD is responding to
seven commenters that submitted
comments in response to the 60-day
notice previously published for this ICR
and soliciting public comment
concerning this ICR for an additional 30
days.
DATES: Comments are encouraged and
will be accepted until July 18, 2018.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, OMB. Comments should be
addressed to OMB Desk Officer,
Department of Homeland Security,
National Protection and Programs
Directorate and sent via electronic mail
to dhsdeskofficer@omb.eop.gov. All
submissions must include the words
‘‘Department of Homeland Security’’
and the OMB Control Number 1670–
0029.
Comments submitted in response to
this notice may be made available to the
public through relevant websites. For
this reason, please do not include in
your comments information of a
confidential nature, such as sensitive
personal information or proprietary
information. Please note that responses
to this public comment request
containing any routine notice about the
confidentiality of the communication
will be treated as public comments that
may be made available to the public
notwithstanding the inclusion of the
routine notice.
Comments that include trade secrets,
confidential commercial or financial
information, Chemical-terrorism
Vulnerability Information (CVI),
Sensitive Security Information (SSI), or
Protected Critical Infrastructure
Information (PCII) should not be
submitted to the public regulatory
docket. Please submit such comments
separately from other comments in
response to this notice. Comments
containing trade secrets, confidential
commercial or financial information,
CVI, SSI, or PCII should be
appropriately marked and packaged in
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28243-28244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12920]
-----------------------------------------------------------------------
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; PAR: Selected Topics in Transfusion Medicine.
Date: June 28-29, 2018.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
[[Page 28244]]
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Katherine M. Malinda, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD
20892, 301-435-0912, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: AIDS and AIDS Related Research.
Date: July 10, 2018.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shalanda A. Bynum, Ph.D., MPH, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206, Bethesda, MD 20892, 301-
755-4355, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Convergent Neuroscience: From Genomic Association to
Causation.
Date: July 10, 2018.
Time: 11:00 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: Jana Drgonova, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5213, Bethesda, MD 20892, 301-827-2549,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Neuroscience Assay, Diagnostics and Animal
Model Development.
Date: July 12-13, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Crown Plaza Seattle Hotel, 1113 6th Ave., Seattle, WA
98101.
Contact Person: Susan Gillmor, Ph.D., Scientific Review Officer,
National Institutes of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301-435-1730,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Center for Neuroscience and Regenerative Medicine Program.
Date: July 12, 2018.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Chittari V. Shivakumar, Ph.D., Scientific Review
Officer, National Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-408-9098,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Review: Understanding and Modifying Temporal Dynamics of
Coordinated Neural Activity.
Date: July 12, 2018.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jana Drgonova, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5213, Bethesda, MD 20892, 301-827-2549,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Integrative Neuroscience.
Date: July 12, 2018.
Time: 1:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Jasenka Borzan, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD
20892-7814, 301-435-1787, [email protected].
Name of Committee: Biology of Development and Aging Integrated
Review Group; International and Cooperative Projects--1 Study
Section.
Date: July 13, 2018.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Seetha Bhagavan, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD
20892, (301) 237-9838, [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: June 12, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-12920 Filed 6-15-18; 8:45 am]
BILLING CODE 4140-01-P
