Center for Scientific Review; Notice of Closed Meetings, 50946-50947 [2018-21898]
Download as PDF
50946
Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Diana Solana-Sodeinde, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 2724,
Silver Spring, MD 20993–0002, 240–
402–3908.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Assessing the Irritation and
Sensitization Potential of Transdermal
and Topical Delivery Systems for
ANDAs.’’
The components and composition of
a TDS formulation, including the nature
of the drug substance and/or the
occlusivity of the TDS materials, in
conjunction with other factors such as
the environmental humidity or the
condition of the skin, may have the
potential to irritate the skin or lead to
a sensitization reaction. Such reactions
can be unpleasant to the patient and
may affect patient compliance, skin
permeability, and/or adhesion of the
TDS to the skin. The collective
consequence of these potential effects
could create uncertainty about the
resulting drug delivery profile and
uncertainty about the rate and extent of
drug absorption from the TDS.
Therefore, applicants should perform a
comparative assessment of the test (T)
and reference (R) TDS products using an
appropriately designed skin I/S study
with human subjects to demonstrate
that the potential for a skin irritation or
sensitization reaction with the T TDS is
no worse than the reaction observed
with the R TDS.
This draft guidance provides
recommendations for the design and
conduct of studies to evaluate the in
vivo skin I/S potential of a proposed
TDS. The recommendations in this draft
guidance relate exclusively to studies
submitted in support of an ANDA.
The Agency is seeking comments on
the recommendations reflected in the
draft guidance announced in this notice.
In addition, FDA invites comments on
the scales and any alternative
approaches, including those
recommended by international
regulatory agencies, that may have been
used with success for the comparative
assessment of the I/S potential for
VerDate Sep<11>2014
21:20 Oct 09, 2018
Jkt 247001
proposed generic TDS products. FDA
also specifically invites comments
regarding the comparative assessment of
sensitization itself, i.e., whether there
are clinical scenarios where a
comparative sensitization assessment
may be uninformative when done in
addition to a comparative irritation
assessment.
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 of FDA
on ‘‘Assessing the Irritation and
Sensitization Potential of Transdermal
and Topical Delivery Systems for
ANDAs.’’ 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. This guidance is not
subject to Executive Order 12866.
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 collections
of information in 21 CFR 314.94 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21958 Filed 10–9–18; 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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
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;
Neurobiology of Learning and Memory.
Date: October 24, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW, Washington, DC 20037.
Contact Person: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785, kondratyevad@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Health Disparities in and Caregiving for
Alzheimer’s Disease.
Date: November 2, 2018.
Time: 8:00 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: Gabriel B. Fosu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
MSC 7808, Bethesda, MD 20892, (301) 435–
3562, fosug@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Infectious Diseases and Microbiology.
Date: November 5–6, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Palomar, 2121 P Street NW,
Washington, DC 20037.
Contact Person: Tamara Lyn McNealy,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3188,
Bethesda, MD 20892, 301–827–2372,
tamara.mcnealy@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Risk, Prevention and Health
Behavior.
Date: November 5–6, 2018.
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: Martha M. Faraday, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
MSC 7808, Bethesda, MD 20892, (301) 435–
3575, faradaym@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Bioengineering Sciences and
Technologies.
E:\FR\FM\10OCN1.SGM
10OCN1
amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
Date: November 5, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Nitsa Rosenzweig, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152,
MSC 7760, Bethesda, MD 20892, (301) 404–
7419, rosenzweign@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Nephrology.
Date: November 5, 2018.
Time: 1:00 p.m. to 4:00 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: Julia Spencer Barthold,
MD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, julia.barthold@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Traumatic Brain Injury.
Date: November 5, 2018.
Time: 1:00 p.m. to 5:00 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: Alexander Yakovlev,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206,
MSC 7846, Bethesda, MD 20892–7846, 301–
435–1254, yakovleva@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Healthcare Delivery and
Methodologies.
Date: November 5, 2018.
Time: 12:00 p.m. to 3:00 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: Jacinta Bronte-Tinkew,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3164,
MSC 7770, Bethesda, MD 20892, (301) 806–
0009, brontetinkewjm@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 2, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–21898 Filed 10–9–18; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
21:20 Oct 09, 2018
Jkt 247001
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4396–
DR; Docket ID FEMA–2018–0001]
Commonwealth of the Northern
Mariana Islands; Major Disaster and
Related Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This is a notice of the
Presidential declaration of a major
disaster for the Commonwealth of the
Northern Mariana Islands (FEMA–4396–
DR), dated September 29, 2018, and
related determinations.
DATES: The declaration was issued
September 29, 2018.
FOR FURTHER INFORMATION CONTACT:
Dean Webster, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street SW,
Washington, DC 20472, (202) 646–2833.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that, in a letter dated
September 29, 2018, the President
issued a major disaster declaration
under the authority of the Robert T.
Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq.
(the ‘‘Stafford Act’’), as follows:
SUMMARY:
I have determined that the damage in
certain areas of the Commonwealth of the
Northern Mariana Islands resulting from
Typhoon Mangkhut during the period of
September 10 to September 11, 2018, is of
sufficient severity and magnitude to warrant
a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (the
‘‘Stafford Act’’). Therefore, I declare that such
a major disaster exists in the Commonwealth
of the Northern Mariana Islands.
In order to provide Federal assistance, you
are hereby authorized to allocate from funds
available for these purposes such amounts as
you find necessary for Federal disaster
assistance and administrative expenses.
You are authorized to provide Individual
Assistance and Public Assistance in the
designated areas and Hazard Mitigation
throughout the Commonwealth. Consistent
with the requirement that Federal assistance
be supplemental, any Federal funds provided
under the Stafford Act for Hazard Mitigation
and Other Needs Assistance will be limited
to 75 percent of the total eligible costs.
Federal funds provided under the Stafford
Act for Public Assistance also will be limited
to 75 percent of the total eligible costs, with
the exception of projects that meet the
eligibility criteria for a higher Federal costsharing percentage under the Public
Assistance Alternative Procedures Pilot
Program for Debris Removal implemented
pursuant to section 428 of the Stafford Act.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
50947
Further, you are authorized to make
changes to this declaration for the approved
assistance to the extent allowable under the
Stafford Act.
The time period prescribed for the
implementation of section 310(a),
Priority to Certain Applications for
Public Facility and Public Housing
Assistance, 42 U.S.C. 5153, shall be for
a period not to exceed six months after
the date of this declaration.
The Federal Emergency Management
Agency (FEMA) hereby gives notice that
pursuant to the authority vested in the
Administrator, under Executive Order
12148, as amended, Benigno Bern Ruiz,
of FEMA is appointed to act as the
Federal Coordinating Officer for this
major disaster.
The following areas of the
Commonwealth of the Northern Mariana
Islands have been designated as
adversely affected by this major disaster:
The islands of Rota, Saipan, and Tinian for
Individual Assistance.
The islands of Rota, Saipan and Tinian for
Public Assistance.
All areas within the Commonwealth of the
Northern Mariana Islands are eligible for
assistance under the Hazard Mitigation Grant
Program.
The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034,
Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to
Individuals and Households In Presidentially
Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance—
Disaster Housing Operations for Individuals
and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals
and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
Brock Long,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2018–21927 Filed 10–9–18; 8:45 am]
BILLING CODE 9111–11–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4366–
DR; Docket ID FEMA–2018–0001]
Hawaii; Amendment No. 4 to Notice of
a Major Disaster Declaration
Federal Emergency
Management Agency, DHS.
AGENCY:
E:\FR\FM\10OCN1.SGM
10OCN1
Agencies
[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50946-50947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21898]
-----------------------------------------------------------------------
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; Neurobiology of Learning and Memory.
Date: October 24, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The Fairmont Washington, DC, 2401 M Street NW,
Washington, DC 20037.
Contact Person: Alexei Kondratyev, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD
20892, 301-435-1785, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Health Disparities in and Caregiving for
Alzheimer's Disease.
Date: November 2, 2018.
Time: 8:00 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: Gabriel B. Fosu, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108, MSC 7808, Bethesda, MD
20892, (301) 435-3562, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowship: Infectious Diseases and Microbiology.
Date: November 5-6, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hotel Palomar, 2121 P Street NW, Washington, DC 20037.
Contact Person: Tamara Lyn McNealy, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3188, Bethesda, MD 20892, 301-
827-2372, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowships: Risk, Prevention and Health Behavior.
Date: November 5-6, 2018.
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: Martha M. Faraday, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD
20892, (301) 435-3575, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Bioengineering Sciences and Technologies.
[[Page 50947]]
Date: November 5, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20817, (Telephone Conference Call).
Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD
20892, (301) 404-7419, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Topics in Nephrology.
Date: November 5, 2018.
Time: 1:00 p.m. to 4:00 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: Julia Spencer Barthold, MD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Traumatic Brain Injury.
Date: November 5, 2018.
Time: 1:00 p.m. to 5:00 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: Alexander Yakovlev, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD
20892-7846, 301-435-1254, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Healthcare Delivery and Methodologies.
Date: November 5, 2018.
Time: 12:00 p.m. to 3:00 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: Jacinta Bronte-Tinkew, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3164, MSC 7770, Bethesda, MD
20892, (301) 806-0009, [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 2, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-21898 Filed 10-9-18; 8:45 am]
BILLING CODE 4140-01-P