Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability, 29867-29883 [2017-13664]
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Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices
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[FR Doc. 2017–13726 Filed 6–29–17; 8:45 am]
BILLING CODE 4184–01–P
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.
mstockstill on DSK30JT082PROD with NOTICES
ACTION:
Notice.
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)
SUMMARY:
VerDate Sep<11>2014
17:32 Jun 29, 2017
Jkt 241001
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 AllHazards 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
PO 00000
Frm 00047
Fmt 4703
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29867
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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30JNN1
29868
Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices
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 lifethreatening 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 lifethreatening 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,
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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.
VerDate Sep<11>2014
17:32 Jun 29, 2017
Jkt 241001
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.
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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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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or Authorization
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Kt!SIJIOU!Se Stakeholders to Whom the Authorized Rafa
Distributed
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T.
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Healtheare Providers :ondu,etiiiJI Activities under the Direction
Authorized Rafa
Stakeholders with n~e:.,.u:\:t
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29879
y
DoD
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00.
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Condi.tiOIIIS Related to
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•
Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices
Dated: June 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–13664 Filed 6–29–17; 8:45 am]
[Docket No. FDA–2016–N–0969]
Food and Drug Administration
BILLING CODE 4164–01–P
Revocation of Authorization of
Emergency Use of an In Vitro
Diagnostic Device for Detection of Zika
Virus
AGENCY:
Food and Drug Administration
ACTION:
[Docket No. FDA–2013–N–0523]
Correction
In notice document 2017–10818
appearing on pages 24351 through
24356 in the issue of Friday, May 26,
make the following correction:
On page 24351, in the third column,
under the DATES heading, in the third
line ‘‘June 26, 2017’’ should read ‘‘July
25, 2017’’.
mstockstill on DSK30JT082PROD with NOTICES
[FR Doc. C1–2017–10818 Filed 6–29–17; 8:45 am]
VerDate Sep<11>2014
17:32 Jun 29, 2017
Jkt 241001
SUPPLEMENTARY INFORMATION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorization (EUA) (the Authorization)
issued to Roche Molecular Systems, Inc.
for the LightMix® Zika rRT–PCR Test.
FDA revoked this Authorization on
March 13, 2017, under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as requested by Roche
Molecular Systems, Inc. by letter dated
March 10, 2017. The revocation, which
includes an explanation of the reasons
for revocation, is reprinted in this
document.
SUMMARY:
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Applications for
Food and Drug Administration
Approval To Market a New Drug
BILLING CODE 1505–01–D
Food and Drug Administration,
HHS.
The Authorization is revoked as
of March 13, 2017.
ADDRESSES: Submit written requests for
single copies of the revocation 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 selfaddressed adhesive label to assist that
office in processing your request or
DATES:
PO 00000
Frm 00063
Fmt 4703
include a fax number to which the
revocation may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocation.
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 (this is not a toll free
number).
Sfmt 4703
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 AllHazards 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. On August
26, 2016, FDA issued an EUA to Roche
Molecular Systems, Inc. for the
LightMix® Zika rRT–PCR Test, subject to
the terms of the Authorization. Notice of
the issuance of the Authorization was
published in the Federal Register on
October 28, 2016 (81 FR 75092), as
required by section 564(h)(1) of the
FD&C Act. Under section 564(g)(2), the
Secretary of Health and Human Services
may revoke an EUA if, among other
things, the criteria for issuance are no
E:\FR\FM\30JNN1.SGM
30JNN1
EN30JN17.269
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
29883
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 29868]]
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