Determination and Declaration Regarding Emergency Use of Injectable Treatments for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning, 18152-18153 [2017-07685]
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Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
reasonable accommodations, should
notify the Advisory Council at the
address/telephone number listed above
at least one week prior to the meeting.
For those unable to attend in person, a
live webcast will be available. More
information on registration and
accessing the webcast can be found at
https://www.hhs.gov/ash/carb/.
Members of the public will have the
opportunity to provide comments prior
to the Advisory Council meeting by
emailing CARB@hhs.gov. Public
comments should be sent in by
midnight April 25, 2017, and should be
limited to no more than one page. All
public comments received prior to April
25, 2017, will be provided to Advisory
Council members; comments are limited
to two minutes per speaker.
Dated: April 12, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program
Office.
[FR Doc. 2017–07708 Filed 4–14–17; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination and Declaration
Regarding Emergency Use of
Injectable Treatments for Nerve Agent
or Certain Insecticide
(Organophosphorus and/or
Carbamate) Poisoning
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to section 564 of the
Federal Food, Drug, and Cosmetic
(FD&C) Act. On April 11, 2017, the
Secretary determined that there is a
significant potential for a public health
emergency that has a significant
potential to affect national security or
the health and security of United States
citizens living abroad, and that involves
nerve agents or certain insecticides
(organophosphorus and/or carbamate).
On the basis of this determination, he
also declared that circumstances exist
justifying the authorization of
emergency use of injectable treatments
for nerve agent or certain insecticide
(organophosphorus and/or carbamate)
poisoning pursuant to section 564 of the
FD&C Act, subject to the terms of any
authorization issued under that section.
DATES: The determination and
declaration are effective April 11, 2017.
FOR FURTHER INFORMATION CONTACT:
George Korch, Ph.D., Acting Assistant
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
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Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act,
the Commissioner of the Food and Drug
Administration (FDA), acting under
delegated authority from the Secretary
of the U.S. Department of Health and
Human Services (HHS), may issue an
Emergency Use Authorization (EUA)
authorizing (1) the emergency use of an
unapproved drug, an unapproved or
uncleared device, or an unlicensed
biological product; or (2) an unapproved
use of an approved drug, approved or
cleared device, or licensed biological
product. Before an EUA may be issued,
the Secretary of HHS must declare that
circumstances exist justifying the
authorization based on one of four
determinations: (1) A determination by
the Secretary of Homeland Security that
there is a domestic emergency, or a
significant potential for a domestic
emergency, involving a heightened risk
of attack with a chemical, biological,
radiological, or nuclear (CBRN) agent or
agents; (2) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act 1 sufficient to affect national
security or the health and security of
United States citizens living abroad; (3)
a determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces of attack with a CBRN agent or
agents; or (4) a determination by the
Secretary of HHS that there is a public
health emergency, or a significant
potential for a public health emergency,
that affects, or has a significant potential
to affect, national security or the health
and security of United States citizens
living abroad, and that involves a CBRN
agent or agents, or a disease or condition
that may be attributable to such agent or
agents.2
1 42
U.S.C. 247d–6b(c).
amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, the Secretary may make determination of a public
health emergency, or a significant potential for a
public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to
make a determination of a public health emergency
in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
declaration made under section 564 of the FD&C
Act.
2 As
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Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the FDA Commissioner may issue
an EUA if the criteria for issuance of an
authorization under section 564 of the
FD&C Act are met.
The Centers for Disease Control and
Prevention (CDC) requested that the
FDA issue an EUA for use of an
injectable treatment for nerve agent and
certain insecticide (organophosphorus
and/or carbamate) poisoning to support
preparedness and response to potential
public health threats posed by these
agents and compounds. At this time,
FDA-approved injectable treatments for
nerve agent or certain insecticide
(organophosphorus and/or carbamate)
poisoning are not available to replenish
the Department’s Strategic National
Stockpile 3 inventory when the products
in the current inventory expire. Pending
the availability of such products, an
EUA will facilitate ensuring that the
products are available in the event of a
public health emergency involving
nerve agent or certain insecticides
(organophosphorus and/or carbamate).
The determination of a significant
potential for a public health emergency,
and the declaration that circumstances
exist justifying the authorization of
emergency use of injectable treatments
for nerve agent or certain insecticide
(organophosphorus and/or carbamate)
poisoning by the Secretary of HHS, as
described below, enables the FDA
Commissioner to issue an EUA for
certain injectable treatments for
emergency use under section 564 of the
FD&C Act.
II. Determination by the Secretary of
Health and Human Services
On April 11, 2017, pursuant to section
564 of the FD&C Act, I determined that
there is a significant potential for a
public health emergency that has a
significant potential to affect national
security or the health and security of
United States citizens living abroad and
that involves nerve agents or certain
insecticides (organophosphorus and/or
carbamate).1
III. Declaration of the Secretary of
Health and Human Services
On April 11, 2017, on the basis of my
determination of a significant potential
for a public health emergency that has
a significant potential to affect national
security or the health and security of
United States citizens living abroad and
that involves nerve agents or certain
insecticides (organophosphorus and/or
3 42
E:\FR\FM\17APN1.SGM
U.S.C. 247d–6b(a).
17APN1
Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
carbamate), I declared that
circumstances exist justifying the
authorization of emergency use of
injectable treatments for nerve agent or
certain insecticide (organophosphorus
and/or carbamate) poisoning pursuant
to section 564 of the FD&C Act, subject
to the terms of any authorization issued
under that section.
Notice of any EUAs issued by the
FDA Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
Register as required under section 564
of the FD&C Act.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7178, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, johnsonwj@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: April 11, 2017.
Thomas E. Price,
Secretary.
Dated: April 11, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–07685 Filed 4–14–17; 8:45 am]
[FR Doc. 2017–07618 Filed 4–14–17; 8:45 am]
BILLING CODE P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Center for Scientific Review; Notice of
Closed Meeting
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
mstockstill on DSK30JT082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 meeting.
The meeting 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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
TOPMed Informatics Research Center (IRC).
Date: May 9, 2017.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7178, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, johnsonwj@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
TOPMed Data Coordinating Center (DCC).
Date: May 9, 2017.
Time: 2:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–15–
276: Turkey-US Collaborative Program for
Affordable Medical Technologies (R01).
Date: May 5, 2017.
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: Careen K. Tang-Toth,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, (301) 435–
3504, tothct@csr.nih.gov.
VerDate Sep<11>2014
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(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)
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18153
Dated: April 11, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–07617 Filed 4–14–17; 8:45 am]
BILLING CODE 4140–01–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 (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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIH Support for
Conferences and Scientific Meetings (Parent
R13/U13).
Date: May 9–11, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health 5601
Fishers Lane, Rockville, MD 20892, (Virtual
Meeting).
Contact Person: J. Bruce Sundstrom, Ph.D.
Scientific Review Official, Scientific
Review Program, Division of Extramural
Activities, Room 3G11A, National Institutes
of Health/NIAID, 5601 Fishers Lane, MSC
9823, Bethesda, MD 20892–9823, (240) 669–
5045, sundstromj@niaid.nih.gov
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement
(U01/R01).
Date: May 10, 2017.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Yong Gao, Ph.D. Scientific
Review Officer Scientific Review Program,
Division of Extramural Activities, Room
#3G13B, National Institutes of Health/NIAID,
5601 Fishers Lane, MSC 9823, Rockville, MD
20892–7616, (240) 669–5048, yong.gao@
nih.gov.
E:\FR\FM\17APN1.SGM
17APN1
Agencies
[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18152-18153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07685]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Determination and Declaration Regarding Emergency Use of
Injectable Treatments for Nerve Agent or Certain Insecticide
(Organophosphorus and/or Carbamate) Poisoning
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564 of the Federal Food, Drug, and
Cosmetic (FD&C) Act. On April 11, 2017, the Secretary determined that
there is a significant potential for a public health emergency that has
a significant potential to affect national security or the health and
security of United States citizens living abroad, and that involves
nerve agents or certain insecticides (organophosphorus and/or
carbamate).
On the basis of this determination, he also declared that
circumstances exist justifying the authorization of emergency use of
injectable treatments for nerve agent or certain insecticide
(organophosphorus and/or carbamate) poisoning pursuant to section 564
of the FD&C Act, subject to the terms of any authorization issued under
that section.
DATES: The determination and declaration are effective April 11, 2017.
FOR FURTHER INFORMATION CONTACT: George Korch, Ph.D., Acting Assistant
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue SW.,
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act, the Commissioner of the Food and
Drug Administration (FDA), acting under delegated authority from the
Secretary of the U.S. Department of Health and Human Services (HHS),
may issue an Emergency Use Authorization (EUA) authorizing (1) the
emergency use of an unapproved drug, an unapproved or uncleared device,
or an unlicensed biological product; or (2) an unapproved use of an
approved drug, approved or cleared device, or licensed biological
product. Before an EUA may be issued, the Secretary of HHS must declare
that circumstances exist justifying the authorization based on one of
four determinations: (1) A determination by the Secretary of Homeland
Security that there is a domestic emergency, or a significant potential
for a domestic emergency, involving a heightened risk of attack with a
chemical, biological, radiological, or nuclear (CBRN) agent or agents;
(2) the identification of a material threat by the Secretary of
Homeland Security pursuant to section 319F-2 of the Public Health
Service (PHS) Act \1\ sufficient to affect national security or the
health and security of United States citizens living abroad; (3) a
determination by the Secretary of Defense that there is a military
emergency, or a significant potential for a military emergency,
involving a heightened risk to United States military forces of attack
with a CBRN agent or agents; or (4) a determination by the Secretary of
HHS that there is a public health emergency, or a significant potential
for a public health emergency, that affects, or has a significant
potential to affect, national security or the health and security of
United States citizens living abroad, and that involves a CBRN agent or
agents, or a disease or condition that may be attributable to such
agent or agents.\2\
---------------------------------------------------------------------------
\1\ 42 U.S.C. 247d-6b(c).
\2\ As amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act, Public Law 113-5, the Secretary may make
determination of a public health emergency, or a significant
potential for a public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to make a
determination of a public health emergency in accordance with
section 319 of the PHS Act, 42 U.S.C. 247d to support a
determination or declaration made under section 564 of the FD&C Act.
---------------------------------------------------------------------------
Based on any of these four determinations, the Secretary of HHS may
then declare that circumstances exist that justify the EUA, at which
point the FDA Commissioner may issue an EUA if the criteria for
issuance of an authorization under section 564 of the FD&C Act are met.
The Centers for Disease Control and Prevention (CDC) requested that
the FDA issue an EUA for use of an injectable treatment for nerve agent
and certain insecticide (organophosphorus and/or carbamate) poisoning
to support preparedness and response to potential public health threats
posed by these agents and compounds. At this time, FDA-approved
injectable treatments for nerve agent or certain insecticide
(organophosphorus and/or carbamate) poisoning are not available to
replenish the Department's Strategic National Stockpile \3\ inventory
when the products in the current inventory expire. Pending the
availability of such products, an EUA will facilitate ensuring that the
products are available in the event of a public health emergency
involving nerve agent or certain insecticides (organophosphorus and/or
carbamate). The determination of a significant potential for a public
health emergency, and the declaration that circumstances exist
justifying the authorization of emergency use of injectable treatments
for nerve agent or certain insecticide (organophosphorus and/or
carbamate) poisoning by the Secretary of HHS, as described below,
enables the FDA Commissioner to issue an EUA for certain injectable
treatments for emergency use under section 564 of the FD&C Act.
---------------------------------------------------------------------------
\3\ 42 U.S.C. 247d-6b(a).
---------------------------------------------------------------------------
II. Determination by the Secretary of Health and Human Services
On April 11, 2017, pursuant to section 564 of the FD&C Act, I
determined that there is a significant potential for a public health
emergency that has a significant potential to affect national security
or the health and security of United States citizens living abroad and
that involves nerve agents or certain insecticides (organophosphorus
and/or carbamate).\1\
III. Declaration of the Secretary of Health and Human Services
On April 11, 2017, on the basis of my determination of a
significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of United States citizens living abroad and that involves
nerve agents or certain insecticides (organophosphorus and/or
[[Page 18153]]
carbamate), I declared that circumstances exist justifying the
authorization of emergency use of injectable treatments for nerve agent
or certain insecticide (organophosphorus and/or carbamate) poisoning
pursuant to section 564 of the FD&C Act, subject to the terms of any
authorization issued under that section.
Notice of any EUAs issued by the FDA Commissioner pursuant to this
determination and declaration will be provided promptly in the Federal
Register as required under section 564 of the FD&C Act.
Dated: April 11, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017-07685 Filed 4-14-17; 8:45 am]
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