[Federal Register Volume 89, Number 142 (Wednesday, July 24, 2024)]
[Notices]
[Pages 59919-59921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

[[Page 59921]]

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