Declaration Regarding Emergency Use of Treatment for Uncontrolled Hemorrhage Due to Agents of Military Combat, 32884-32885 [2018-15152]
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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
Guidance for Industry and FDA Staff—
Class II Special Controls Guidance
Document: Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Separation
Principle
OMB Control Number 0910–0594—
Extension
Under the Safe Medical Devices Act
of 1990 (Pub. L. 101–629), FDA may
establish special controls, including
performance standards, postmarket
surveillance, patient registries,
guidelines, and other appropriate
actions it believes necessary to provide
reasonable assurance of the safety and
effectiveness of the device. The special
control guidance serves as the special
control for the automated blood cell
separator device operating by
centrifugal or filtration separation
principle intended for the routine
collection of blood and blood
components (§ 864.9245 (21 CFR
864.9245)).
For currently marketed products not
approved under the premarket approval
process, the manufacturer should file
with FDA for 3 consecutive years an
annual report on the anniversary date of
the device reclassification from class III
to class II or on the anniversary date of
the 510(k) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360(k)) clearance. Any subsequent
change to the device requiring the
submission of a premarket notification
in accordance with section 510(k) of the
FD&C Act should be included in the
annual report. Also, a manufacturer of a
device determined to be substantially
equivalent to the centrifugal or
filtration-based automated cell separator
device intended for the routine
collection of blood and blood
components should comply with the
same general and special controls.
The annual report should include, at
a minimum, a summary of anticipated
and unanticipated adverse events that
have occurred and that are not required
to be reported by manufacturers under
Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation. The report should
also include any subsequent change to
the preamendments class III device
requiring a 30-day notice in accordance
with 21 CFR 814.39(f).
Reclassification of this device from
class III to class II relieves
manufacturers of the burden of
complying with the premarket approval
requirements of section 515 of the FD&C
Act (21 U.S.C. 360e) and may permit
small potential competitors to enter the
marketplace by reducing the burden.
Although the special control guidance
recommends that manufacturers of these
devices file with FDA an annual report
for 3 consecutive years, this would be
less burdensome than the current
postapproval requirements under 21
CFR part 814, subpart E, including the
submission of periodic reports under 21
CFR 814.84.
Collecting or transfusing facilities, the
intended users of the device, and the
device manufacturers have certain
responsibilities under the Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the device manufacturer
is responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b) (21 CFR 803.50(b))). In
addition, manufacturers of medical
devices are required to submit to FDA
individual adverse event reports of
death, serious injury, and malfunctions
(§ 803.50).
In the special control guidance
document, FDA recommends that
manufacturers include in their three
annual reports a summary of adverse
reactions maintained by the collecting
or transfusing facility or similar reports
of adverse events collected.
In the Federal Register of February
22, 2018, (83 FR 7745), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was received
but did not respond to any of the four
information collection topics solicited
and is therefore not discussed here.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Reporting activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
Annual Report ......................................................................
3
1
3
5
15
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are
approximately three manufacturers of
automated blood cell separator devices.
We estimate that the manufacturers will
spend approximately 5 hours preparing
and submitting the annual report. The
total burden hours are reduced from
previous collections due to a decrease in
the number of manufacturers.
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
510(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR,
part 803).
VerDate Sep<11>2014
17:31 Jul 13, 2018
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Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15089 Filed 7–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Declaration Regarding Emergency Use
of Treatment for Uncontrolled
Hemorrhage Due to Agents of Military
Combat
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to the Federal Food,
Drug, and Cosmetic (FD&C) Act. On
June 7, 2018, Patrick M. Shanahan,
Deputy Secretary of Defense,
determined in accordance with the
Federal Food, Drug and Cosmetic Act,
as delegated by the Secretary of Defense,
that there is a military emergency or
significant potential for a military
emergency, involving a heightened risk
to U.S. military forces of an attack with
an agent or agents that may cause, or are
otherwise associated with an
imminently life-threatening and specific
risk to those forces. More specifically,
U.S. Forces are now deployed in
multiple locations where they serve at
SUMMARY:
E:\FR\FM\16JYN1.SGM
16JYN1
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
heightened risk of an enemy attack with
agents of military combat, including
firearms, projectiles, and explosive
devices, that may cause major and
imminently life-threatening combat
casualties involving uncontrolled
hemorrhage.
On the basis of this determination, on
July 9, 2018 the Secretary declared that
circumstances exist justifying the
authorization of emergency use of
Freeze Dried Plasma (FDP) to treat
uncontrolled hemorrhage due to agents
of military combat (e.g., firearms,
projectiles, and explosive devices) in
emergency situations when plasma is
not available for use or its use is not
practical, pursuant to section 564 of the
FD&C Act, subject to the terms of any
authorization issued under that section.
DATES: The declaration is effective July
9, 2018.
FOR FURTHER INFORMATION CONTACT:
Robert P. Kadlec, MD, MTM&H, MS,
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:
sradovich on DSK3GMQ082PROD with NOTICES
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 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 biological, chemical, 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
1 42 U.S.C. 247d–6b, which states: ‘‘[t]he
Homeland Security Secretary, in consultation with
the Secretary and the heads of other agencies as
appropriate, shall on an ongoing basis—(i) assess
current and emerging threats of chemical,
biological, radiological, and nuclear agents; and (ii)
determine which of such agents present a material
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
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, including
personnel operating under the authority
of title 10 or title 50, of attack with (i)
a biological, chemical, radiological, or
nuclear agent or agents; or (ii) an agent
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to United States military forces; or
(4) a determination by the Secretary 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.
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 determination of
a military emergency or significant
potential for a military emergency by
the Deputy Secretary of Defense, and the
declaration that circumstances exist
justifying emergency use of French FDP
by the Secretary of HHS, as described
below, enable the FDA Commissioner to
issue an EUA for FDP in emergency
situations when plasma is not available
for use or its use is not practical for
emergency use under section 564 of the
FD&C Act.
II. Determination of a Military
Emergency or Significant Potential for a
Military Emergency by the Deputy
Secretary of Defense
On June 7, 2018, Patrick M.
Shanahan, Deputy Secretary of Defense,
determined in accordance with section
564(b)(1)(B) of the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. 360bbb–
3(b)(1)(B), as delegated by the Secretary
of Defense, that there is a military
emergency or significant potential for a
military emergency, involving a
heightened risk to U.S. military forces of
an attack with an agent or agents that
may cause, or are otherwise associated
with an imminently life-threatening and
specific risk to those forces. The Deputy
Secretary further stated that, more
threat against the United States population
sufficient to affect national security.’’
PO 00000
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Fmt 4703
Sfmt 4703
32885
specifically, U.S. Forces are now
deployed in multiple locations where
they serve at heightened risk of an
enemy attack with agents of military
combat, including firearms, projectiles,
and explosive devices, that may cause
major and imminently life-threatening
combat casualties involving
uncontrolled hemorrhage.
III. Declaration of the Secretary of
Health and Human Services
On July 9, 2018, on the basis of the
Deputy Secretary of Defense’s
determination that there is a military
emergency or significant potential for a
military emergency involving a
heightened risk to U.S. military forces of
an attack with an agent or agents that
may cause, or are otherwise associated
with an imminently life-threatening and
specific risk to those forces, I declared
that circumstances exist justifying the
authorization of emergency use of FDP
to treat uncontrolled hemorrhage due to
agents of military combat (e.g., firearms,
projectiles, and explosive devices) in
emergency situations when plasma is
not available for use or its use is not
practical, 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.
Alex M. Azar II,
Secretary.
[FR Doc. 2018–15152 Filed 7–13–18; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[Docket No. USCBP–2018–0026]
Commercial Customs Operations
Advisory Committee (COAC)
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security (DHS).
ACTION: Committee management; notice
of Federal Advisory Committee meeting.
AGENCY:
The Commercial Customs
Operations Advisory Committee (COAC)
will hold its public meeting on
Wednesday, August 1, 2018 via
webinar. The meeting will be open to
the public.
DATES: The COAC will meet on
Wednesday, August 1, 2018 from 1:00
p.m. to 4:00 p.m. EST. Please note that
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32884-32885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Declaration Regarding Emergency Use of Treatment for Uncontrolled
Hemorrhage Due to Agents of Military Combat
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 the Federal Food, Drug, and Cosmetic (FD&C)
Act. On June 7, 2018, Patrick M. Shanahan, Deputy Secretary of Defense,
determined in accordance with the Federal Food, Drug and Cosmetic Act,
as delegated by the Secretary of Defense, that there is a military
emergency or significant potential for a military emergency, involving
a heightened risk to U.S. military forces of an attack with an agent or
agents that may cause, or are otherwise associated with an imminently
life-threatening and specific risk to those forces. More specifically,
U.S. Forces are now deployed in multiple locations where they serve at
[[Page 32885]]
heightened risk of an enemy attack with agents of military combat,
including firearms, projectiles, and explosive devices, that may cause
major and imminently life-threatening combat casualties involving
uncontrolled hemorrhage.
On the basis of this determination, on July 9, 2018 the Secretary
declared that circumstances exist justifying the authorization of
emergency use of Freeze Dried Plasma (FDP) to treat uncontrolled
hemorrhage due to agents of military combat (e.g., firearms,
projectiles, and explosive devices) in emergency situations when plasma
is not available for use or its use is not practical, pursuant to
section 564 of the FD&C Act, subject to the terms of any authorization
issued under that section.
DATES: The declaration is effective July 9, 2018.
FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS,
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 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 biological, chemical,
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, including personnel operating
under the authority of title 10 or title 50, of attack with (i) a
biological, chemical, radiological, or nuclear agent or agents; or (ii)
an agent or agents that may cause, or are otherwise associated with, an
imminently life-threatening and specific risk to United States military
forces; or (4) a determination by the Secretary 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.
---------------------------------------------------------------------------
\1\ 42 U.S.C. 247d-6b, which states: ``[t]he Homeland Security
Secretary, in consultation with the Secretary and the heads of other
agencies as appropriate, shall on an ongoing basis--(i) assess
current and emerging threats of chemical, biological, radiological,
and nuclear agents; and (ii) determine which of such agents present
a material threat against the United States population sufficient to
affect national security.''
---------------------------------------------------------------------------
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 determination of a military emergency or significant potential for
a military emergency by the Deputy Secretary of Defense, and the
declaration that circumstances exist justifying emergency use of French
FDP by the Secretary of HHS, as described below, enable the FDA
Commissioner to issue an EUA for FDP in emergency situations when
plasma is not available for use or its use is not practical for
emergency use under section 564 of the FD&C Act.
II. Determination of a Military Emergency or Significant Potential for
a Military Emergency by the Deputy Secretary of Defense
On June 7, 2018, Patrick M. Shanahan, Deputy Secretary of Defense,
determined in accordance with section 564(b)(1)(B) of the Federal Food,
Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1)(B), as delegated by the
Secretary of Defense, that there is a military emergency or significant
potential for a military emergency, involving a heightened risk to U.S.
military forces of an attack with an agent or agents that may cause, or
are otherwise associated with an imminently life-threatening and
specific risk to those forces. The Deputy Secretary further stated
that, more specifically, U.S. Forces are now deployed in multiple
locations where they serve at heightened risk of an enemy attack with
agents of military combat, including firearms, projectiles, and
explosive devices, that may cause major and imminently life-threatening
combat casualties involving uncontrolled hemorrhage.
III. Declaration of the Secretary of Health and Human Services
On July 9, 2018, on the basis of the Deputy Secretary of Defense's
determination that there is a military emergency or significant
potential for a military emergency involving a heightened risk to U.S.
military forces of an attack with an agent or agents that may cause, or
are otherwise associated with an imminently life-threatening and
specific risk to those forces, I declared that circumstances exist
justifying the authorization of emergency use of FDP to treat
uncontrolled hemorrhage due to agents of military combat (e.g.,
firearms, projectiles, and explosive devices) in emergency situations
when plasma is not available for use or its use is not practical,
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.
Alex M. Azar II,
Secretary.
[FR Doc. 2018-15152 Filed 7-13-18; 8:45 am]
BILLING CODE 4150-37-P
