
[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29867-29883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3224]


Authorization of Emergency Use of an Injectable Treatment for 
Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) 
Poisoning; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of an Emergency Use Authorization (EUA) (the Authorization) 
for an injectable treatment for nerve agent or certain insecticide 
(organophosphorus and/or carbamate) poisoning. FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by the U.S. Centers for Disease Control and 
Prevention (CDC). The Authorization contains, among other things, 
conditions on the emergency use of the authorized injectable treatment. 
The Authorization follows the April 11, 2017, determination by the 
Department of Health and Human Services (HHS) Secretary 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 U.S. citizens living abroad and that involves nerve agents 
or certain insecticides (organophosphorus and/or carbamate). On the 
basis of such determination, the HHS Secretary declared on April 11, 
2017, that circumstances exist justifying the authorization of 
emergency use of injectable treatments for nerve agent or certain 
insecticide (organophosphorus and/or carbamate) poisoning, subject to 
the terms of any authorization issued under the FD&C Act. The 
Authorization, which includes an explanation of the reasons for 
issuance, is reprinted in this document.

DATES: The Authorization is effective as of April 11, 2017.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002, 301-796-8510.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (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 biological, 
chemical, radiological, or nuclear agent or agents; (2) 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 U.S. military forces of attack with a biological, chemical, 
radiological, or nuclear agent or agents; (3) 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 U.S. citizens living abroad, and that involves a 
biological, chemical, radiological, or nuclear agent or agents, or a 
disease or condition that may be attributable to such agent or agents; 
or (4) the identification of a material threat by the Secretary of 
Homeland Security under section 319F-2 of the Public Health Service 
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or 
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Section 564 of the FD&C Act permits FDA to authorize 
the introduction into interstate commerce of a drug, device, or 
biological product intended for use when the Secretary of HHS has 
declared that circumstances

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exist justifying the authorization of emergency use. Products 
appropriate for emergency use may include products and uses that are 
not approved, cleared, or licensed under sections 505, 510(k), or 515 
of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the 
PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after 
consultation with the HHS Assistant Secretary for Preparedness and 
Response, the Director of the National Institutes of Health, and the 
Director of the CDC (to the extent feasible and appropriate given the 
applicable circumstances), FDA \1\ concludes: (1) That an agent 
referred to in a declaration of emergency or threat can cause a serious 
or life-threatening disease or condition; (2) that, based on the 
totality of scientific evidence available to FDA, including data from 
adequate and well-controlled clinical trials, if available, it is 
reasonable to believe that: (A) The product may be effective in 
diagnosing, treating, or preventing (i) such disease or condition; or 
(ii) a serious or life-threatening disease or condition caused by a 
product authorized under section 564, approved or cleared under the 
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, 
treating, or preventing such a disease or condition caused by such an 
agent; and (B) the known and potential benefits of the product, when 
used to diagnose, prevent, or treat such disease or condition, outweigh 
the known and potential risks of the product, taking into consideration 
the material threat posed by the agent or agents identified in a 
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; 
(3) that there is no adequate, approved, and available alternative to 
the product for diagnosing, preventing, or treating such disease or 
condition; and (4) that such other criteria as may be prescribed by 
regulation are satisfied.
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    \1\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
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    No other criteria for issuance have been prescribed by regulation 
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to 
implement the EUA authority.

II. EUA Request for an Injectable Treatment for Nerve Agent or Certain 
Insecticide (Organophosphorus and/or Carbamate) Poisoning

    On April 11, 2017, under section 564(b)(1)(C) of the FD&C Act, the 
Secretary of HHS 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 U.S. citizens living 
abroad and that involves nerve agents or certain insecticides 
(organophosphorus and/or carbamate). On April 11, 2017, under section 
564(b)(1) of the FD&C Act, and on the basis of such determination, the 
Secretary of HHS declared that circumstances exist justifying the 
authorization of emergency use of injectable treatments for nerve agent 
or certain insecticide (organophosphorus and/or carbamate) poisoning, 
subject to the terms of any authorization issued under section 564 of 
the FD&C Act. Notice of the determination and declaration of the 
Secretary was published in the Federal Register on April 17, 2017 (82 
FR 18152). On March 9, 2017, CDC requested, and on April 11, 2017, FDA 
issued, an EUA for the 2 mg Rafa Atropine Auto-Injector, manufactured 
by Rafa Laboratories Ltd., subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorization are available on the Internet at https://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of an injectable treatment for nerve agent 
or certain insecticide (organophosphorus and/or carbamate) poisoning 
subject to the terms of the Authorization. The Authorization in its 
entirety (not including the authorized versions of the fact sheets and 
other written materials) follows and provides an explanation of the 
reasons for its issuance, as required by section 564(h)(1) of the FD&C 
Act.

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    Dated: June 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13664 Filed 6-29-17; 8:45 am]
 BILLING CODE 4164-01-P


