Declaration of Emergency Pursuant to the Federal Food, Drug and Cosmetic Act, 59919-59921 [2024-16247]
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59919
Federal Register / Vol. 89, No. 142 / Wednesday, July 24, 2024 / Notices
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Prevention
Communication Formative Research.
Type of Collection: Revision.
OMB No.: 0990–0281.
Abstract: The Office of Disease
Prevention and Health Promotion
(ODPHP) is focused on developing and
disseminating health information to the
public. ODPHP faces an increasingly
urgent interest in finding effective ways
to communicate health information to
America’s diverse population. ODPHP
strives to be responsive to the needs of
America’s diverse audiences while
simultaneously serving all Americans
across a range of channels, from print to
new communication technologies. To
carry out prevention information efforts,
ODPHP is committed to conducting
formative and usability research to
provide guidance on the development
and implementation of their
communication and education efforts.
The information collected will be used
to improve communication, products,
and services that support key office
initiatives including: Dietary Guidelines
for Americans, Food is Medicine,
Healthy People, Health Literacy,
Healthy Aging, Physical Activity
Guidelines for Americans, the Move
Your Way Campaign and the President’s
Council on Sports, Fitness & Nutrition.
ODPHP communicates through its
website (www.health.gov) and through
other channels including social media,
print materials, interactive training
modules, and reports. Data collection
will be qualitative and quantitative and
may include in-depth interviews, focus
groups, web-based surveys, omnibus
surveys, card sorting, and several forms
of usability testing of materials and
interactive tools to assess the public’s
understanding of disease prevention
and health promotion content,
responses to prototype materials, and
barriers to effective use.
The program is requesting a 3-year
extension of the clearance.
ANNUALIZED BURDEN HOUR TABLE
Forms
(if necessary)
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
In-depth interviews—Screener ........................................................................
In-depth interviews—Instrument ......................................................................
Focus groups—Screener .................................................................................
Focus groups—Instrument ..............................................................................
Intercept interviews ..........................................................................................
Cognitive testing of instruments—Screener ....................................................
Cognitive testing of instruments—Cognitive test .............................................
Web-based surveys—Screener .......................................................................
Web-based surveys—Survey ..........................................................................
Omnibus surveys .............................................................................................
Gatekeeper reviews .........................................................................................
Card sorting—Screener ...................................................................................
Card sorting—Card sort ...................................................................................
Usability and prototype testing of materials (print and web)—Screener .........
Usability and prototype testing of materials (print and web)—usability tests
500
167
975
325
1,750
50
17
10,000
3,333
700
109
200
67
600
208
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
10/60
1.00
10/60
1.50
5/60
10/60
2.00
5/60
15/60
10/60
30/60
10/60
1.00
10/60
1.00
83
167
162.5
487.5
146
8
34
833
833
117
54
33
67
100
208
Total ..........................................................................................................
........................
........................
........................
3,333
OMB No.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–16210 Filed 7–23–24; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Declaration of Emergency Pursuant to
the Federal Food, Drug and Cosmetic
Act
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
respondents
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice of amendment.
AGENCY:
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Jkt 262001
The section 564(b)(1)(C)
determination that was originally issued
on April 19, 2013, is amended as of July
18, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
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
SUMMARY:
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.
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
E:\FR\FM\24JYN1.SGM
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ddrumheller on DSK120RN23PROD with NOTICES1
59920
Federal Register / Vol. 89, No. 142 / Wednesday, July 24, 2024 / Notices
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,
VerDate Sep<11>2014
17:57 Jul 23, 2024
Jkt 262001
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-
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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-tomammal 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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Federal Register / Vol. 89, No. 142 / Wednesday, July 24, 2024 / Notices
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
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[OMB Control Number 1651–0037]
Agency Information Collection
Activities; Extension; Entry of Articles
for Exhibition
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day notice and request for
comments.
AGENCY:
The Department of Homeland
Security, U.S. Customs and Border
Protection (CBP) will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
DATES: Comments are encouraged and
must be submitted (no later than
September 23, 2024) to be assured of
consideration.
SUMMARY:
Written comments and/or
suggestions regarding the item(s)
contained in this notice must include
the OMB Control Number 1651–0037 in
the subject line and the agency name.
Please submit written comments and/or
suggestions in English. Please use the
following method to submit comments:
Email. Submit comments to: CBP_
PRA@cbp.dhs.gov.
FOR FURTHER INFORMATION CONTACT:
Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
ddrumheller on DSK120RN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
17:57 Jul 23, 2024
Jkt 262001
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177,
Telephone number 202–325–0056 or via
email CBP_PRA@cbp.dhs.gov. Please
note that the contact information
provided here is solely for questions
regarding this notice. Individuals
seeking information about other CBP
programs should contact the CBP
National Customer Service Center at
877–227–5511, (TTY) 1–800–877–8339,
or CBP website at https://www.cbp.gov/.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on the
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This process is conducted in
accordance with 5 CFR 1320.8. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points: (1) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
suggestions to enhance the quality,
utility, and clarity of the information to
be collected; and (4) suggestions to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses. The
comments that are submitted will be
summarized and included in the request
for approval. All comments will become
a matter of public record.
Overview of This Information
Collection
Title: Entry of Articles for Exhibition.
OMB Number: 1651–0037.
Current Actions: CBP proposes to
extend the expiration date of this
information collection with no change
to the burden hours or to the
information collected.
Type of Review: Extension (without
change).
Affected Public: Businesses.
Abstract: Goods entered for the
purpose of exhibit at fairs, or for use in
constructing, installing, or maintaining
foreign exhibits at a fair may be free of
duty under 19 U.S.C. 1752. In order to
substantiate that goods qualify for dutyfree treatment, the consignee of the
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
59921
merchandise must provide information
to CBP about the imported goods, which
is specified in 19 CFR 147.11(c).
Without the required information CBP
will not be able to determine if the
goods qualify for duty free treatment. A
trade fair entry allows for duty-free
entry of imported articles intended for
exhibitions or for articles that will be
used in the construction, installation or
maintenance of foreign exhibits at trade
fairs. These importations do not require
the payment of any taxes or fees except
for the Harbor Maintenance Fee (HMF).
Trade Fair entries are not exempt from
Harbor Maintenance Fee (HMF)
pursuant to 19 CFR 24.24(c). ‘‘The
collection of information is made upon
arrival at the port of the fair on a special
form of entry, 19 CFR 147.11(c).’’
Type of Information Collection:
Articles for Exhibition.
Estimated Number of Respondents:
50.
Estimated Number of Annual
Responses per Respondent: 50.
Estimated Number of Total Annual
Responses: 2,500.
Estimated Time per Response: 20
minutes.
Estimated Total Annual Burden
Hours: 833.
Dated: July 19, 2024.
Seth D Renkema,
Branch Chief, Economic Impact Analysis
Branch, U.S. Customs and Border Protection.
[FR Doc. 2024–16242 Filed 7–23–24; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[OMB Control Number 1651–0058]
Agency Information Collection
Activities; Extension; Documents
Required Aboard Private Aircraft
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day notice and request for
comments.
AGENCY:
The Department of Homeland
Security, U.S. Customs and Border
Protection (CBP) will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
DATES: Comments are encouraged and
must be submitted (no later than
SUMMARY:
E:\FR\FM\24JYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
