82 FR 18152 - Determination and Declaration Regarding Emergency Use of Injectable Treatments for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 72 (April 17, 2017)

Page Range		18152-18153
FR Document		2017-07685

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.

Federal Register, Volume 82 Issue 72 (Monday, April 17, 2017)

[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18152-18153]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07685]


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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.

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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\
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    \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.
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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.
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    \3\ 42 U.S.C. 247d-6b(a).
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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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18152 Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices

reasonable accommodations, should Secretary for Preparedness and Based on any of these four
notify the Advisory Council at the Response, Office of the Secretary, determinations, the Secretary of HHS
address/telephone number listed above Department of Health and Human may then declare that circumstances
at least one week prior to the meeting. Services, 200 Independence Avenue exist that justify the EUA, at which
For those unable to attend in person, a SW., Washington, DC 20201, Telephone point the FDA Commissioner may issue
live webcast will be available. More (202) 205–2882 (this is not a toll free an EUA if the criteria for issuance of an
information on registration and number). authorization under section 564 of the
accessing the webcast can be found at SUPPLEMENTARY INFORMATION: FD&C Act are met.
http://www.hhs.gov/ash/carb/. The Centers for Disease Control and
Members of the public will have the I. Background Prevention (CDC) requested that the
opportunity to provide comments prior Under Section 564 of the FD&C Act, FDA issue an EUA for use of an
to the Advisory Council meeting by the Commissioner of the Food and Drug injectable treatment for nerve agent and
emailing CARB@hhs.gov. Public Administration (FDA), acting under certain insecticide (organophosphorus
comments should be sent in by delegated authority from the Secretary and/or carbamate) poisoning to support
midnight April 25, 2017, and should be of the U.S. Department of Health and preparedness and response to potential
limited to no more than one page. All Human Services (HHS), may issue an public health threats posed by these
public comments received prior to April Emergency Use Authorization (EUA) agents and compounds. At this time,
25, 2017, will be provided to Advisory authorizing (1) the emergency use of an FDA-approved injectable treatments for
Council members; comments are limited unapproved drug, an unapproved or nerve agent or certain insecticide
to two minutes per speaker. uncleared device, or an unlicensed (organophosphorus and/or carbamate)
Dated: April 12, 2017. biological product; or (2) an unapproved poisoning are not available to replenish
Jewel Mullen, use of an approved drug, approved or the Department’s Strategic National
cleared device, or licensed biological Stockpile 3 inventory when the products
Acting Director, National Vaccine Program
Office. product. Before an EUA may be issued, in the current inventory expire. Pending
the Secretary of HHS must declare that the availability of such products, an
[FR Doc. 2017–07708 Filed 4–14–17; 8:45 am]
circumstances exist justifying the EUA will facilitate ensuring that the
BILLING CODE 4150–44–P
authorization based on one of four products are available in the event of a
determinations: (1) A determination by public health emergency involving
DEPARTMENT OF HEALTH AND the Secretary of Homeland Security that nerve agent or certain insecticides
HUMAN SERVICES there is a domestic emergency, or a (organophosphorus and/or carbamate).
significant potential for a domestic The determination of a significant
Determination and Declaration emergency, involving a heightened risk potential for a public health emergency,
Regarding Emergency Use of of attack with a chemical, biological, and the declaration that circumstances
Injectable Treatments for Nerve Agent radiological, or nuclear (CBRN) agent or exist justifying the authorization of
or Certain Insecticide agents; (2) the identification of a emergency use of injectable treatments
(Organophosphorus and/or material threat by the Secretary of for nerve agent or certain insecticide
Carbamate) Poisoning Homeland Security pursuant to section (organophosphorus and/or carbamate)
319F–2 of the Public Health Service poisoning by the Secretary of HHS, as
AGENCY: Office of the Secretary, described below, enables the FDA
(PHS) Act 1 sufficient to affect national
Department of Health and Human Commissioner to issue an EUA for
security or the health and security of
Services. certain injectable treatments for
United States citizens living abroad; (3)
ACTION: Notice. a determination by the Secretary of emergency use under section 564 of the
SUMMARY: The Secretary of Health and Defense that there is a military FD&C Act.
Human Services (HHS) is issuing this emergency, or a significant potential for II. Determination by the Secretary of
notice pursuant to section 564 of the a military emergency, involving a Health and Human Services
Federal Food, Drug, and Cosmetic heightened risk to United States military
forces of attack with a CBRN agent or On April 11, 2017, pursuant to section
(FD&C) Act. On April 11, 2017, the 564 of the FD&C Act, I determined that
Secretary determined that there is a agents; or (4) a determination by the
Secretary of HHS that there is a public there is a significant potential for a
significant potential for a public health public health emergency that has a
emergency that has a significant health emergency, or a significant
potential for a public health emergency, significant potential to affect national
potential to affect national security or security or the health and security of
the health and security of United States that affects, or has a significant potential
to affect, national security or the health United States citizens living abroad and
citizens living abroad, and that involves that involves nerve agents or certain
nerve agents or certain insecticides and security of United States citizens
living abroad, and that involves a CBRN insecticides (organophosphorus and/or
(organophosphorus and/or carbamate). carbamate).1
On the basis of this determination, he agent or agents, or a disease or condition
also declared that circumstances exist that may be attributable to such agent or III. Declaration of the Secretary of
justifying the authorization of agents.2 Health and Human Services
emergency use of injectable treatments 1 42 On April 11, 2017, on the basis of my
U.S.C. 247d–6b(c).
for nerve agent or certain insecticide 2 As amended by the Pandemic and All-Hazards determination of a significant potential
(organophosphorus and/or carbamate) Preparedness Reauthorization Act, Public Law 113– for a public health emergency that has
mstockstill on DSK30JT082PROD with NOTICES

poisoning pursuant to section 564 of the 5, the Secretary may make determination of a public a significant potential to affect national
FD&C Act, subject to the terms of any health emergency, or a significant potential for a
public health emergency, under section 564 of the security or the health and security of
authorization issued under that section. FD&C Act. The Secretary is no longer required to United States citizens living abroad and
DATES: The determination and make a determination of a public health emergency that involves nerve agents or certain
declaration are effective April 11, 2017. in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
insecticides (organophosphorus and/or
FOR FURTHER INFORMATION CONTACT: declaration made under section 564 of the FD&C
George Korch, Ph.D., Acting Assistant Act. 3 42 U.S.C. 247d–6b(a).

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Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices 18153

carbamate), I declared that Place: National Institutes of Health, 6701 Dated: April 11, 2017.
circumstances exist justifying the Rockledge Drive, Room 7178, Bethesda, MD Michelle Trout,
authorization of emergency use of 20892 (Telephone Conference Call).
Program Analyst, Office of Federal Advisory
Contact Person: William J. Johnson, Ph.D.,
injectable treatments for nerve agent or Scientific Review Officer, Office of Scientific
Committee Policy.
certain insecticide (organophosphorus Review/DERA National Heart, Lung, and [FR Doc. 2017–07617 Filed 4–14–17; 8:45 am]
and/or carbamate) poisoning pursuant Blood Institute 6701 Rockledge Drive, Room BILLING CODE 4140–01–P
to section 564 of the FD&C Act, subject 7178, Bethesda, MD 20892–7924, 301–435–
to the terms of any authorization issued 0725, johnsonwj@nhlbi.nih.gov.
under that section. (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND
Notice of any EUAs issued by the Program Nos. 93.233, National Center for HUMAN SERVICES
FDA Commissioner pursuant to this Sleep Disorders Research; 93.837, Heart and
determination and declaration will be Vascular Diseases Research; 93.838, Lung National Institutes of Health
Diseases Research; 93.839, Blood Diseases
provided promptly in the Federal and Resources Research, National Institutes
Register as required under section 564 National Institute of Allergy and
of Health, HHS) Infectious Diseases; Notice of Closed
of the FD&C Act.
Dated: April 11, 2017. Meetings
Dated: April 11, 2017.
Thomas E. Price, Michelle Trout, Pursuant to section 10(d) of the
Program Analyst, Office of Federal Advisory Federal Advisory Committee Act, as
Secretary.
Committee Policy. amended (5 U.S.C. App.), notice is
[FR Doc. 2017–07685 Filed 4–14–17; 8:45 am]
[FR Doc. 2017–07618 Filed 4–14–17; 8:45 am] hereby given of the following meetings.
BILLING CODE P
BILLING CODE 4140–01–P The meetings will be closed to the
public in accordance with the
DEPARTMENT OF HEALTH AND provisions set forth in sections
DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
HUMAN SERVICES HUMAN SERVICES as amended. The grant applications and
National Institutes of Health National Institutes of Health the discussions could disclose
confidential trade secrets or commercial
National Heart, Lung, and Blood Center for Scientific Review; Notice of property such as patentable material,
Institute; Notice of Closed Meetings Closed Meeting and personal information concerning
individuals associated with the grant
Pursuant to section 10(d) of the Pursuant to section 10(d) of the applications, the disclosure of which
Federal Advisory Committee Act, as Federal Advisory Committee Act, as would constitute a clearly unwarranted
amended (5 U.S.C. App.), notice is amended (5 U.S.C. App.), notice is invasion of personal privacy.
hereby given of the following meetings. hereby given of the following meeting.
The meetings will be closed to the The meeting will be closed to the Name of Committee: National Institute of
public in accordance with the Allergy and Infectious Diseases Special
public in accordance with the
provisions set forth in sections Emphasis Panel; NIH Support for
provisions set forth in sections Conferences and Scientific Meetings (Parent
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., R13/U13).
as amended. The contract proposals and as amended. The grant applications and Date: May 9–11, 2017.
the discussions could disclose the discussions could disclose Time: 8:30 a.m. to 5:00 p.m.
confidential trade secrets or commercial confidential trade secrets or commercial Agenda: To review and evaluate grant
property such as patentable material, property such as patentable material, applications.
and personal information concerning and personal information concerning Place: National Institutes of Health 5601
individuals associated with the contract individuals associated with the grant Fishers Lane, Rockville, MD 20892, (Virtual
proposals, the disclosure of which Meeting).
applications, the disclosure of which
would constitute a clearly unwarranted Contact Person: J. Bruce Sundstrom, Ph.D.
would constitute a clearly unwarranted Scientific Review Official, Scientific
invasion of personal privacy. invasion of personal privacy. Review Program, Division of Extramural
Name of Committee: National Heart, Lung, Name of Committee: Center for Scientific Activities, Room 3G11A, National Institutes
and Blood Institute Special Emphasis Panel; Review Special Emphasis Panel; PAR–15– of Health/NIAID, 5601 Fishers Lane, MSC
TOPMed Informatics Research Center (IRC). 276: Turkey-US Collaborative Program for 9823, Bethesda, MD 20892–9823, (240) 669–
Date: May 9, 2017. Affordable Medical Technologies (R01). 5045, sundstromj@niaid.nih.gov
Time: 1:00 p.m. to 2:30 p.m. Date: May 5, 2017. Name of Committee: National Institute of
Agenda: To review and evaluate contract Time: 1:00 p.m. to 3:30 p.m. Allergy and Infectious Diseases Special
proposals. Agenda: To review and evaluate grant Emphasis Panel; NIAID Clinical Trial
Place: National Institutes of Health, 6701 applications. Implementation Cooperative Agreement
Rockledge Drive, Room 7178, Bethesda, MD Place: National Institutes of Health, 6701 (U01/R01).
20892 (Telephone Conference Call). Rockledge Drive, Bethesda, MD 20892 Date: May 10, 2017.
Contact Person: William J. Johnson, Ph.D., (Telephone Conference Call). Time: 1:00 p.m. to 4:00 p.m.
Scientific Review Officer, Office of Scientific Contact Person: Careen K. Tang-Toth, Agenda: To review and evaluate grant
Review/DERA National Heart, Lung, and Ph.D., Scientific Review Officer, Center for applications.
Blood Institute 6701 Rockledge Drive, Room Scientific Review, National Institutes of Place: National Institutes of Health
7178, Bethesda, MD 20892–7924, 301–435– Health, 6701 Rockledge Drive, Room 6214, Rockville, MD 20892 (Telephone Conference
mstockstill on DSK30JT082PROD with NOTICES

0725, johnsonwj@nhlbi.nih.gov. MSC 7804, Bethesda, MD 20892, (301) 435– Call).
Name of Committee: National Heart, Lung, 3504, tothct@csr.nih.gov. Contact Person: Yong Gao, Ph.D. Scientific
and Blood Institute Special Emphasis Panel; (Catalogue of Federal Domestic Assistance Review Officer Scientific Review Program,
TOPMed Data Coordinating Center (DCC). Program Nos. 93.306, Comparative Medicine; Division of Extramural Activities, Room
Date: May 9, 2017. 93.333, Clinical Research, 93.306, 93.333, #3G13B, National Institutes of Health/NIAID,
Time: 2:30 p.m. to 5:00 p.m. 93.337, 93.393–93.396, 93.837–93.844, 5601 Fishers Lane, MSC 9823, Rockville, MD
Agenda: To review and evaluate contract 93.846–93.878, 93.892, 93.893, National 20892–7616, (240) 669–5048, yong.gao@
proposals. Institutes of Health, HHS) nih.gov.

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Document Created: 2018-08-25 11:26:33
Document Modified: 2018-08-25 11:26:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The determination and declaration are effective April 11, 2017.
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).
FR Citation		82 FR 18152