Notice2024-16247
Declaration of Emergency Pursuant to the Federal Food, Drug and Cosmetic Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 24, 2024
Issuing agencies
Health and Human Services Department
Abstract
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act. On July 18, 2024, the Secretary amended the April 19, 2013, determination made pursuant to the FD&C Act, regarding the avian influenza A (H79N) virus, and determined pursuant to his authority under the Act 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 biological agents, namely pandemic influenza A viruses and influenza A viruses with pandemic potential.
Full Text
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<title>Federal Register, Volume 89 Issue 142 (Wednesday, July 24, 2024)</title>
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[Federal Register Volume 89, Number 142 (Wednesday, July 24, 2024)]
[Notices]
[Pages 59919-59921]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16247]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration of Emergency Pursuant to the Federal Food, Drug and
Cosmetic Act
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice of amendment.
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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 July 18, 2024, the Secretary amended the April 19, 2013,
determination made pursuant to the FD&C Act, regarding the avian
influenza A (H79N) virus, and determined pursuant to his authority
under the Act 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 biological agents, namely pandemic influenza A viruses
and influenza A viruses with pandemic potential.
DATES: The section 564(b)(1)(C) determination that was originally
issued on April 19, 2013, is amended as of July 18, 2024.
FOR FURTHER INFORMATION CONTACT: Dawn O'Connell, Administrator and
Assistant Secretary for Preparedness and Response, Administration for
Strategic Preparedness and Response, 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 and 564A of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), the U.S. Department of Health and Human Services (HHS)
has the ability to take certain steps to help facilitate the
availability of medical countermeasures after one of four
determinations under section 564(b) is made: (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 the Homeland Security pursuant to section 319F-2 of
the Public Health Service (PHS) Act sufficient to affect national
[[Page 59920]]
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 CBRN 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 [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.
After any of these four determinations is made, if other applicable
statutory criteria are met, HHS may take actions under section 564A of
the FD&C Act to help facilitate the availability of certain medical
countermeasures. For example, under section 564A(e), the Director of
the Centers for Disease Control and Prevention (CDC) may create and
issue Emergency Use Instructions to inform health care providers or
individuals about the approved, licensed, or cleared conditions of use
of ``eligible'' medical countermeasures (i.e., ``eligible products'' as
defined in section 564A(a)(1) of the FD&C Act). As another example,
under section 564A(b), the U.S. Food and Drug Administration (FDA) may
extend the expiration date of eligible medical countermeasures. Based
on any of these four determinations, the Secretary of HHS may also
declare that circumstances exist that justify an Emergency Use
Authorization (EUA), at which point the FDA may issue an 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, if the criteria for issuance of an
authorization under section 564 of the FD&C Act are met.
The Administration for Strategic Preparedness and Response (ASPR)
requested that the Secretary amend the April 19, 2013, determination
made pursuant to section 564 of the FD&C Act, regarding the avian
influenza A (H79N) virus, to apply generally to pandemic influenza A
viruses and influenza A viruses with pandemic potential. As described
below, broadening the April 19, 2013, determination to apply to
pandemic influenza A viruses and influenza A viruses with pandemic
potential--rather than just H7N9 specifically--would appropriately
cover the range of known and emerging influenza A viruses that present
a significant potential for a public health emergency.
II. Determination by the Secretary of Health and Human Services
On April 19, 2013, pursuant to section 564(b)(1)(C) of the FD&C
Act, former Secretary Sebelius 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 the avian
influenza A (H7N9) virus. I have determined that the 2013 determination
should be amended to cover a broader range of influenza A viruses,
namely pandemic influenza A viruses and influenza A viruses with
pandemic potential. For purposes of the amended determination,
``pandemic influenza A viruses and viruses with pandemic potential''
means animal viruses and/or human influenza A viruses circulating in
wild birds, domestic animals and/or humans that cause or have
significant potential to cause sporadic or ongoing human infections, or
historically have caused pandemics in humans, or have mutated to cause
pandemics in humans, and for which the majority of the population is
immunologically naive. Pandemic influenza A viruses and influenza A
viruses with pandemic potential present 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 because influenza A viruses that may initially be only
occasionally transmitted to or between humans have the potential to
become highly transmissible in humans and can cause significant
morbidity and mortality. For example, the A/H1N1 influenza pandemic in
2009 was caused by a reassortant H1N1 that emerged from a combination
of genes that had been present in various strains of swine, avian, and
human influenza.
H7N9 is another example of an influenza A virus that presents a
significant potential for a public health emergency and would be
considered an influenza A virus with pandemic potential. H7N9 has
demonstrated the ability to transmit from poultry to humans, causing
two separate human case clusters involving over 400 people and
resulting in over 100 fatalities from 2013 to 2014. While sustained
human-to-human transmission was not seen, familial clusters could not
be ruled out. Moreover, some patients treated for illness had
treatment-emergent resistance, another concern for pandemic potential.
H5N1 is a third example. From 1997 through April 2024, over 50
percent of human cases of influenza A(H5N1) have been fatal. Although
H5N1 is not easily transmissible in humans, it has demonstrated the
ability to transmit from poultry to humans, and now likely from cattle
to humans. On March 25, 2024, U.S. Department of Agriculture reported
that milk samples collected from affected cows on two dairy farms in
Kansas and one in Texas, as well as an oropharyngeal swab from another
dairy in Texas, tested positive for highly pathogenic avian influenza
(HPAI), later confirmed to be Type A H5N1. This is the first time that
these bird flu viruses were found in cattle. Since the beginning of
April 2024, CDC has reported eight HPAI A(H5N1) human cases associated
with the dairy cattle outbreak: one in Texas, two in Michigan, and five
confirmed in Colorado. All individuals had occupational exposure to
infected animals (either cattle or poultry), and none of the cases has
involved severe disease. The current risk to human health posed by HPAI
A (H5N1) virus is low. But the cases stemming from dairy cattle
represent the first instances of likely mammal-to-human transmission of
HPAI A(H5N1). Additionally, we cannot be sure that the cases known to
be associated with the dairy cattle outbreak represent the full
spectrum of disease from this currently circulating HPAI A (H5N1)
strain, nor can we be assured that the virus will not mutate to cause
more severe disease and/or to become more transmissible (e.g., acquire
a mutation conferring facile mammal-to-mammal transmission).
Broadening the April 19, 2013, determination to apply to pandemic
influenza A viruses and influenza A viruses with pandemic potential--
rather than just H7N9 specifically--would appropriately cover the range
of known and emerging influenza A viruses that present a significant
potential for a public health emergency.
Therefore, I have now amended the April 19, 2013, determination to
recognize 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 biological agents, namely pandemic influenza A viruses
and influenza A viruses with pandemic potential.
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III. Declaration of the Secretary of Health and Human Services
On April 19, 2013, pursuant to section 564(b)(1) of the FD&C Act
and subject to the terms of any authorization issued under that
section, former Secretary Sebelius declared that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics
for detection of avian influenza A (H7N9) virus. That declaration
remains in effect until that declaration is terminated in accordance
with section 564 of the FD&C Act.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-16247 Filed 7-23-24; 8:45 am]
BILLING CODE 4150-37-P
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</html>Indexed from Federal Register on July 24, 2024.
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