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)

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, 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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