Second Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 34740-34742 [2020-12465]
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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices
services is a key component of the
HRSA mission. HRSA’s Maternal and
Child Health Bureau (MCHB) provides
funding to address some of the most
urgent issues influencing the high rates
of maternal mortality. Recent efforts to
address persistent disparities in
maternal, infant, and child health have
employed a ‘‘life course’’ perspective
and health equity lens focused on health
promotion and disease prevention. The
life course approach can be defined as
analyzing people’s lives within
structural, social, and cultural contexts
through a defined sequence of age
categories that people are normally
expected to pass through as they
progress from birth to death. Health
equity is defined as the attainment of
the highest level of health for all people.
Achieving health equity for pregnant
and postpartum women will require
attention to barriers in access to quality
health services and promotion of equal
opportunities to seek the highest
possible level of health and well-being.
Achieving health equity also requires a
focus on social determinants of health.
With this emphasis on improving
maternal health across the life course
and promoting optimal health for all
mothers, HRSA is employing a
multipronged strategy to address
maternal mortality and severe maternal
morbidity through the following suite of
programs:
1. The State Maternal Health
Innovation Program,
2. The Alliance for Innovation on
Maternal Health Program,
3. The Alliance for Innovation on
Maternal Health—Community Care
Initiative,
4. The Rural Maternity and Obstetrics
Management Strategies Program, and
5. The Supporting Maternal Health
Innovation Program.
MCHB is conducting a portfolio-wide
evaluation of HRSA-supported Maternal
Health Programs with a primary focus
on reducing maternal mortality.
Through this evaluation, HRSA seeks to
identify individual and/or collective
strategies, interrelated activities, and
common themes within and across the
Maternal Health Programs that may be
contributing to or driving improvements
in key maternal health outcomes. HRSA
seeks to ascertain which components
should be elevated and replicated to the
national level, as well as inform future
investments to reduce rates of maternal
mortality and severe maternal
morbidity.
Need and Proposed Use of the
Information: HRSA seeks to understand
the impact of HRSA’s investments into
maternal health programs. These five
HRSA maternal health programs
represent a total of 12 state-based
grantees and three grantees with the
potential for national reach. In
understanding the strategies that are
most effective in reducing maternal
morbidity and mortality, HRSA will be
able to determine which program
elements could be replicated and/or
scaled up nationally.
Likely Respondents: Likely
respondents are recipients of the
cooperative agreements mentioned
above (State Maternal Health Innovation
Program, Alliance for Innovation on
Maternal Health Program, Alliance for
Innovation on Maternal Health—
Community Care Initiative, Rural
Maternity and Obstetrics Management
Strategies Program, and Supporting
Maternal Health Innovation Program)
which include 11 state health agencies,
2 national organizations, and 2
academic organizations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
khammond on DSKJM1Z7X2PROD with NOTICES
Instrument
Instrument
Instrument
Instrument
1:
2:
3:
4:
Number of
responses
per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Interview guide for grantee staff ....................
Interview guide for HRSA POs ......................
Partnership Survey ........................................
Web-based data collection tool .....................
75
7
290
15
1
1
1
1
75
7
290
15
1.00
1.50
0.25
0.50
75.0
10.5
72.5
7.5
Total ..............................................................................
387
........................
387
........................
165.5
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
Office of the Secretary
[FR Doc. 2020–12308 Filed 6–5–20; 8:45 am]
Second Amendment to Declaration
Under the Public Readiness and
Emergency Preparedness Act for
Medical Countermeasures Against
COVID–19
BILLING CODE 4165–15–P
ACTION:
Notice of amendment.
The Secretary issues this
amendment pursuant to section 319F–3
of the Public Health Service Act to
clarify that Covered Countermeasures
SUMMARY:
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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices
under the Declaration include qualified
pandemic and epidemic products that
limit the harm COVID–19 might
otherwise cause.
DATES: This amendment to the
Declaration as published on March 17,
2020 (85 FR 15198) was effective as of
February 4, 2020.
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.
SUPPLEMENTARY INFORMATION: The
Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes
the Secretary of Health and Human
Services (the Secretary) to issue a
Declaration to provide liability
immunity to certain individuals and
entities (Covered Persons) against any
claim of loss caused by, arising out of,
relating to, or resulting from, the
manufacture, distribution,
administration, or use of medical
countermeasures (Covered
Countermeasures), except for claims
involving ‘‘willful misconduct’’ as
defined in the PREP Act. Under the
PREP Act, a Declaration may be
amended as circumstances warrant.
The PREP Act was enacted on
December 30, 2005, as Public Law 109–
148, Division C, § 2. It amended the
Public Health Service (PHS) Act, adding
section 319F–3, which addresses
liability immunity, and section 319F–4,
which creates a compensation program.
These sections are codified at 42 U.S.C.
247d–6d and 42 U.S.C. 247d–6e,
respectively. Section 319F–3 of the PHS
Act has been amended by the Pandemic
and All-Hazards Preparedness
Reauthorization Act (PAHPRA), Public
Law 113–5, enacted on March 13, 2013,
and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public
Law 116–136, enacted on March 27,
2020, to expand Covered
Countermeasures under the PREP Act.
On January 31, 2020, the Secretary
declared a public health emergency
pursuant to section 319 of the PHS Act,
42 U.S.C. 247d, effective January 27,
2020, for the entire United States to aid
in the response of the nation’s health
care community to the COVID–19
outbreak. Pursuant to section 319 of the
PHS Act, the Secretary renewed that
Declaration on April 26, 2020. On
March 10, 2020, the Secretary issued a
Declaration under the PREP Act for
medical countermeasures against
COVID–19 (85 FR 15198, Mar. 17, 2020).
On April 10, the Secretary amended the
VerDate Sep<11>2014
17:09 Jun 05, 2020
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March 10, 2020 Declaration under the
PREP Act to extend liability immunity
to covered countermeasures authorized
under the CARES Act (85 FR 21012,
Apr. 15, 2020).
The Secretary now amends the March
10, 2020, Declaration to clarify that
covered countermeasures under the
Declaration include qualified products
that limit the harm COVID–19 might
otherwise cause. 42 U.S.C. 247d–
6d(i)(7)(A)(i)(II). This amendment is
made in accordance with section 319F–
3(b)(4) of the PHS Act, which authorizes
the Secretary to amend a PREP Act
Declaration at any time.
Description of This Amendment by
Section
Section VI. Covered Countermeasures
Section VI of the Declaration
identifies the Covered Countermeasures
for which the Secretary has
recommended activities under section
III of the Declaration. The PREP Act, as
amended, states that a ‘‘Covered
Countermeasure’’ must be a ‘‘qualified
pandemic or epidemic product,’’ a
‘‘security countermeasure,’’ a drug,
biological product, or device authorized
for emergency use in accordance with
sections 564, 564A, or 564B of the
Federal Food, Drug, and Cosmetic
(FD&C) Act, or a respiratory protective
device approved by NIOSH under 42
CFR part 84, or any successor
regulations, that the Secretary
determines to be a priority for use
during a public health emergency
declared under section 319 of the PHS
Act.
As described in section VI of the
preamble to the March 10, 2020
Declaration, the PREP Act further
defines a ‘‘qualified pandemic or
epidemic product’’ to mean a drug or
device, as defined in the FD&C Act or
a biological product, as defined in the
PHS Act that is (i) manufactured, used,
designed, developed, modified, licensed
or procured to diagnose, mitigate,
prevent, treat, or cure a pandemic or
epidemic or limit the harm such a
pandemic or epidemic might otherwise
cause; (ii) manufactured, used,
designed, developed, modified,
licensed, or procured to diagnose,
mitigate, prevent, treat, or cure a serious
or life-threatening disease or condition
caused by such a drug, biological
product, or device; or (iii) a product or
technology intended to enhance the use
or effect of such a drug, biological
product, or device. A qualified
pandemic or epidemic product must
also be approved, cleared, licensed, or
authorized for investigational or
emergency use under the FD&C Act or
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34741
PHS Act. The Coronavirus Aid, Relief,
and Economic Security (CARES) Act
section 3103, Public Law 116–136 (Mar.
27, 2020), amended the PREP Act to add
respiratory protective devices to the list
of covered countermeasures so long as
they are NIOSH approved and
determined by the Secretary to be a
priority for use during a public health
emergency declared by the Secretary
under section 319 of the Public Health
Service Act. 85 FR 21012 (Apr. 15,
2020) (amending the Declaration
effective March 27, 2020 to address this
statutory change).
The Secretary intended section VI of
the March 10, 2020 Declaration to
include all qualified pandemic and
epidemic products defined under the
PREP Act and described in the preamble
to the Declaration. But section VI of the
March 10, 2020 Declaration identified
Covered Countermeasures under the
Declaration as ‘‘any antiviral, any other
drug, any biologic, any diagnostic, any
other device, or any vaccine, used to
treat, diagnose, cure, prevent, or
mitigate COVID–19, or the transmission
of SARS–CoV–2 or a virus mutating
therefrom, or any device used in the
administration of any such product, and
all components and constituent
materials of any such product.’’ 85 FR
15202. That description omitted the
phrase from the statutory definition that
qualified pandemic and epidemic
products may also include products that
‘‘limit the harm such a pandemic or
epidemic might otherwise cause.’’ The
Secretary intended to identify the full
range of qualified countermeasures in
the March 10, 2020 Declaration. The
Secretary accordingly amends section VI
of the Declaration to clarify that intent.
Qualified pandemic and epidemic
products that limit the harm that
COVID–19 might otherwise cause are
those that would not have been
manufactured, administered, used,
designed, developed, modified,
licensed, or procured but for the
COVID–19 pandemic, even when the
products are manufactured,
administered, used, designed,
developed, modified, licensed, or
procured to diagnose, mitigate, prevent,
treat, or cure health threats or
conditions other than COVID–19. For
example, the COVID–19 pandemic has
resulted in shortages of certain drugs
and devices that the FDA has
authorized. These drugs and devices
may be used for COVID–19 and other
health conditions. Those shortages are
‘‘harm[s] [COVID–19] might otherwise
cause.’’ Filling those shortages caused
by COVID–19 reduces the strain on the
American healthcare system by
mitigating the escalation of adverse
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34742
Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices
health conditions from COVID–19 and
non-COVID–19 causes. And mitigating
that escalation conserves limited
healthcare resources—from personal
protective equipment to healthcare
providers—which are essential in the
whole-of-Nation response to the
COVID–19 pandemic.
Amendments to Declaration
Amended Declaration for Public
Readiness and Emergency Preparedness
Act Coverage for medical
countermeasures against COVID–19.
Section VI of the March 10, 2020,
Declaration under the PREP Act for
medical countermeasures against
COVID–19, as amended April 10, 2020,
is further amended pursuant to section
319F–3(b)(4) of the PHS Act, as
described below. All other sections of
the Declaration remain in effect as
published at 85 FR 15198 (Mar. 17,
2020) and amended at 85 FR 21012
(Apr. 15, 2020).
Covered Countermeasures, section VI,
delete in full and replace with:
VI. Covered Countermeasures
khammond on DSKJM1Z7X2PROD with NOTICES
42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C.
247d–6d(i)(1) and (7)
Covered Countermeasures are
(1) any antiviral, any other drug, any
biologic, any diagnostic, any other
device, any respiratory protective
device, or any vaccine, used
a. to treat, diagnose, cure, prevent,
mitigate or limit the harm from COVID–
19, or the transmission of SARS–CoV–
2 or a virus mutating therefrom, or
b. to limit the harm that COVID–19,
or the transmission of SARS–CoV–2 or
a virus mutating therefrom, might
otherwise cause; or
(2) any device used in the
administration of any such product, and
all components and constituent
materials of any such product.
Covered Countermeasures must be
‘‘qualified pandemic or epidemic
products,’’ or ‘‘security
countermeasures,’’ or drugs, biological
products, or devices authorized for
investigational or emergency use, as
those terms are defined in the PREP Act,
the FD&C Act, and the Public Health
Service Act, or a respiratory protective
device approved by NIOSH under 42
CFR part 84, or any successor
regulations, that the Secretary
determines to be a priority for use
during a public health emergency
declared under section 319 of the PHS
Act.
Authority: 42 U.S.C. 247d–6d.
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Dated: June 4, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020–12465 Filed 6–4–20; 4:15 pm]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Minority Health
and Health Disparities; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Minority Health and Health Disparities
Special Emphasis Panel; Addressing Racial
Disparities in Maternal Mortality and
Morbidity (R01 Clinical Trial Optional).
Date: July 29–30, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Gateway Plaza, 7201 Wisconsin Avenue,
Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Deborah Ismond, Ph.D.,
Scientific Review Officer, Division of
Scientific Programs, NIMHD, National
Institutes of Health, Gateway Building, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(301) 402–1366, ismonddr@mail.nih.gov.
Dated: June 2, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–12335 Filed 6–5–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Resource Related
Research Projects (R24 Clinical Trial Not
Allowed).
Date: June 30, 2020.
Time: 3:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G49,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Tara Capece, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health, 5601 Fishers
Lane, Room 3G49, Rockville, MD 20852,
240–191–4281, capecet2@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: June 2, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–12332 Filed 6–5–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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]]>Agencies
[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 34740-34742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12465]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Second Amendment to Declaration Under the Public Readiness and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19
ACTION: Notice of amendment.
-----------------------------------------------------------------------
SUMMARY: The Secretary issues this amendment pursuant to section 319F-3
of the Public Health Service Act to clarify that Covered
Countermeasures
[[Page 34741]]
under the Declaration include qualified pandemic and epidemic products
that limit the harm COVID-19 might otherwise cause.
DATES: This amendment to the Declaration as published on March 17, 2020
(85 FR 15198) was effective as of February 4, 2020.
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.
SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes the Secretary of Health and
Human Services (the Secretary) to issue a Declaration to provide
liability immunity to certain individuals and entities (Covered
Persons) against any claim of loss caused by, arising out of, relating
to, or resulting from, the manufacture, distribution, administration,
or use of medical countermeasures (Covered Countermeasures), except for
claims involving ``willful misconduct'' as defined in the PREP Act.
Under the PREP Act, a Declaration may be amended as circumstances
warrant.
The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, Sec. 2. It amended the Public Health Service (PHS)
Act, adding section 319F-3, which addresses liability immunity, and
section 319F-4, which creates a compensation program. These sections
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.
Section 319F-3 of the PHS Act has been amended by the Pandemic and All-
Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5,
enacted on March 13, 2013, and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public Law 116-136, enacted on March 27,
2020, to expand Covered Countermeasures under the PREP Act.
On January 31, 2020, the Secretary declared a public health
emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d,
effective January 27, 2020, for the entire United States to aid in the
response of the nation's health care community to the COVID-19
outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed
that Declaration on April 26, 2020. On March 10, 2020, the Secretary
issued a Declaration under the PREP Act for medical countermeasures
against COVID-19 (85 FR 15198, Mar. 17, 2020). On April 10, the
Secretary amended the March 10, 2020 Declaration under the PREP Act to
extend liability immunity to covered countermeasures authorized under
the CARES Act (85 FR 21012, Apr. 15, 2020).
The Secretary now amends the March 10, 2020, Declaration to clarify
that covered countermeasures under the Declaration include qualified
products that limit the harm COVID-19 might otherwise cause. 42 U.S.C.
247d-6d(i)(7)(A)(i)(II). This amendment is made in accordance with
section 319F-3(b)(4) of the PHS Act, which authorizes the Secretary to
amend a PREP Act Declaration at any time.
Description of This Amendment by Section
Section VI. Covered Countermeasures
Section VI of the Declaration identifies the Covered
Countermeasures for which the Secretary has recommended activities
under section III of the Declaration. The PREP Act, as amended, states
that a ``Covered Countermeasure'' must be a ``qualified pandemic or
epidemic product,'' a ``security countermeasure,'' a drug, biological
product, or device authorized for emergency use in accordance with
sections 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic
(FD&C) Act, or a respiratory protective device approved by NIOSH under
42 CFR part 84, or any successor regulations, that the Secretary
determines to be a priority for use during a public health emergency
declared under section 319 of the PHS Act.
As described in section VI of the preamble to the March 10, 2020
Declaration, the PREP Act further defines a ``qualified pandemic or
epidemic product'' to mean a drug or device, as defined in the FD&C Act
or a biological product, as defined in the PHS Act that is (i)
manufactured, used, designed, developed, modified, licensed or procured
to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic
or limit the harm such a pandemic or epidemic might otherwise cause;
(ii) manufactured, used, designed, developed, modified, licensed, or
procured to diagnose, mitigate, prevent, treat, or cure a serious or
life-threatening disease or condition caused by such a drug, biological
product, or device; or (iii) a product or technology intended to
enhance the use or effect of such a drug, biological product, or
device. A qualified pandemic or epidemic product must also be approved,
cleared, licensed, or authorized for investigational or emergency use
under the FD&C Act or PHS Act. The Coronavirus Aid, Relief, and
Economic Security (CARES) Act section 3103, Public Law 116-136 (Mar.
27, 2020), amended the PREP Act to add respiratory protective devices
to the list of covered countermeasures so long as they are NIOSH
approved and determined by the Secretary to be a priority for use
during a public health emergency declared by the Secretary under
section 319 of the Public Health Service Act. 85 FR 21012 (Apr. 15,
2020) (amending the Declaration effective March 27, 2020 to address
this statutory change).
The Secretary intended section VI of the March 10, 2020 Declaration
to include all qualified pandemic and epidemic products defined under
the PREP Act and described in the preamble to the Declaration. But
section VI of the March 10, 2020 Declaration identified Covered
Countermeasures under the Declaration as ``any antiviral, any other
drug, any biologic, any diagnostic, any other device, or any vaccine,
used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the
transmission of SARS-CoV-2 or a virus mutating therefrom, or any device
used in the administration of any such product, and all components and
constituent materials of any such product.'' 85 FR 15202. That
description omitted the phrase from the statutory definition that
qualified pandemic and epidemic products may also include products that
``limit the harm such a pandemic or epidemic might otherwise cause.''
The Secretary intended to identify the full range of qualified
countermeasures in the March 10, 2020 Declaration. The Secretary
accordingly amends section VI of the Declaration to clarify that
intent.
Qualified pandemic and epidemic products that limit the harm that
COVID-19 might otherwise cause are those that would not have been
manufactured, administered, used, designed, developed, modified,
licensed, or procured but for the COVID-19 pandemic, even when the
products are manufactured, administered, used, designed, developed,
modified, licensed, or procured to diagnose, mitigate, prevent, treat,
or cure health threats or conditions other than COVID-19. For example,
the COVID-19 pandemic has resulted in shortages of certain drugs and
devices that the FDA has authorized. These drugs and devices may be
used for COVID-19 and other health conditions. Those shortages are
``harm[s] [COVID-19] might otherwise cause.'' Filling those shortages
caused by COVID-19 reduces the strain on the American healthcare system
by mitigating the escalation of adverse
[[Page 34742]]
health conditions from COVID-19 and non-COVID-19 causes. And mitigating
that escalation conserves limited healthcare resources--from personal
protective equipment to healthcare providers--which are essential in
the whole-of-Nation response to the COVID-19 pandemic.
Amendments to Declaration
Amended Declaration for Public Readiness and Emergency Preparedness
Act Coverage for medical countermeasures against COVID-19.
Section VI of the March 10, 2020, Declaration under the PREP Act
for medical countermeasures against COVID-19, as amended April 10,
2020, is further amended pursuant to section 319F-3(b)(4) of the PHS
Act, as described below. All other sections of the Declaration remain
in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85
FR 21012 (Apr. 15, 2020).
Covered Countermeasures, section VI, delete in full and replace
with:
VI. Covered Countermeasures
42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)
Covered Countermeasures are
(1) any antiviral, any other drug, any biologic, any diagnostic,
any other device, any respiratory protective device, or any vaccine,
used
a. to treat, diagnose, cure, prevent, mitigate or limit the harm
from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating
therefrom, or
b. to limit the harm that COVID-19, or the transmission of SARS-
CoV-2 or a virus mutating therefrom, might otherwise cause; or
(2) any device used in the administration of any such product, and
all components and constituent materials of any such product.
Covered Countermeasures must be ``qualified pandemic or epidemic
products,'' or ``security countermeasures,'' or drugs, biological
products, or devices authorized for investigational or emergency use,
as those terms are defined in the PREP Act, the FD&C Act, and the
Public Health Service Act, or a respiratory protective device approved
by NIOSH under 42 CFR part 84, or any successor regulations, that the
Secretary determines to be a priority for use during a public health
emergency declared under section 319 of the PHS Act.
Authority: 42 U.S.C. 247d-6d.
Dated: June 4, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020-12465 Filed 6-4-20; 4:15 pm]
BILLING CODE 4150-28-P
