Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 52136-52141 [2020-18542]
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Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices
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• Drawing the program link between
outreach and education, promoting
consumer understanding of health care
coverage choices, and facilitating
consumer selection/enrollment, which
in turn support the overarching goal of
improved access to quality care,
including prevention services,
envisioned under the Affordable Care
Act.
The current members of the Panel as
of February 28, 2020 are: E. Lorraine
Bell, Chief Officer, Population Health,
Catholic Charities USA; Nazleen
Bharmal, Medical Director of
Community Partnerships, Cleveland
Clinic; Angie Boddie, Director of Health
Programs, National Caucus and Center
on Black Aging, Inc.; Julie Carter, Senior
Federal Policy Associate, Medicare
Rights Center; Scott Ferguson, Director
of Care Transitions and Population
Health, Mount Sinai St. Luke’s Hospital;
Leslie Fried, Senior Director, Center for
Benefits Access, National Council on
Aging; David Goldberg, President and
CEO of Mon Health System; JeanVenable Robertson Goode, Professor,
Department of Pharmacotherapy and
Outcomes Science, School of Pharmacy,
Virginia Commonwealth University;
Ted Henson, Director of Health Center
Performance and Innovation, National
Association of Community Health
Centers; Joan Ilardo, Director of
Research Initiatives, Michigan State
University, College of Human Medicine;
Cheri Lattimer, Executive Director,
National Transitions of Care Coalition;
Cori McMahon, Vice President,
Tridiuum; Alan Meade, Director of
Rehab Services, Holston Medical group;
Michael Minor, National Director,
H.O.P.E. HHS Partnership, National
Baptist Convention USA, Incorporated;
Jina Ragland, Associate State Director of
Advocacy and Outreach, AARP
Nebraska; Morgan Reed, Executive
Director, Association for Competitive
Technology; Margot Savoy, Chair,
Department of Family and Community
Medicine, Temple University
Physicians; Congresswoman Allyson
Schwartz, President and CEO, Better
Medicare Alliance; and; Tia Whitaker,
Statewide Director, Outreach and
Enrollment, Pennsylvania Association
of Community Health Centers.
II. Provisions of This Notice
In accordance with section 10(a) of
the FACA, this notice announces a
meeting of the APOE. The agenda for
the September 23, 2020 meeting will
include the following:
• Welcome and listening session with
CMS leadership
• Recap of the previous (June 25, 2020)
meeting
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• CMS programs, initiatives, and
priorities
• An opportunity for public comment
• Meeting summary, review of
recommendations, and next steps
Individuals or organizations that wish
to make a 5-minute oral presentation on
an agenda topic should submit a written
copy of the oral presentation to the DFO
at the address listed in the ADDRESSES
section of this notice by the date listed
in the DATES section of this notice. The
number of oral presentations may be
limited by the time available.
Individuals not wishing to make an oral
presentation may submit written
comments to the DFO at the address
listed in the ADDRESSES section of this
notice by the date listed in the DATES
section of this notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Meeting Participation
DATES:
The meeting is open to the public, but
attendance is limited to registered
participants. Persons wishing to attend
this meeting must register at the website
https://www.eventbrite.com/e/apoeseptember-23-2020-virtual-meetingtickets-114295017474 or contact the
DFO at the address or number listed in
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date
specified in the DATES section of this
notice. This meeting will be held
virtually. Individuals who are not
registered in advance will be unable to
attend the meeting.
IV. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Seema Verma, having reviewed and
approved this document, authorizes
Lynette Wilson, who is the Federal
Register Liaison, to electronically sign
this document for purposes of
publication in the Federal Register.
Authority: Sec. 1114(f) of the Social
Security Act (42 U.S.C. 1314(f)), sec. 222 of
the Public Health Service Act (42 U.S.C.
217a), and sec. 10(a) of Pub. L. 92–463 (5
U.S.C. App. 2, sec. 10(a) and 41 CFR part
102–3).
Dated: August 17, 2020.
Lynette Wilson,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–18535 Filed 8–21–20; 8:45 am]
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Office of the Secretary
Third Amendment to Declaration Under
the Public Readiness and Emergency
Preparedness Act for Medical
Countermeasures Against COVID–19
ACTION:
Notice of amendment.
The Secretary issues this
amendment pursuant to section 319F–3
of the Public Health Service Act to add
additional categories of Qualified
Persons and amend the category of
disease, health condition, or threat for
which he recommends the
administration or use of the Covered
Countermeasures.
SUMMARY:
This amendment to the
Declaration published on March 17,
2020 (85 FR 15198) is effective as of
August 24, 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,
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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, and July
25, 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) (the Declaration). On April 10,
the Secretary amended the Declaration
under the PREP Act to extend liability
immunity to covered countermeasures
authorized under the CARES Act (85 FR
21012, Apr. 15, 2020). On June 4, the
Secretary amended the Declaration to
clarify that covered countermeasures
under the Declaration include qualified
countermeasures that limit the harm
COVID–19 might otherwise cause.
The Secretary now amends section V
of the Declaration to identify as
qualified persons covered under the
PREP Act, and thus authorizes, certain
State-licensed pharmacists to order and
administer, and pharmacy interns (who
are licensed or registered by their State
board of pharmacy and acting under the
supervision of a State-licensed
pharmacist) to administer, any vaccine
that the Advisory Committee on
Immunization Practices (ACIP)
recommends to persons ages three
through 18 according to ACIP’s standard
immunization schedule (ACIPrecommended vaccines).1
The Secretary also amends section
VIII of the Declaration to clarify that the
category of disease, health condition, or
threat for which he recommends the
administration or use of the Covered
Countermeasures includes not only
COVID–19 caused by SARS–CoV–2 or a
virus mutating therefrom, but also other
diseases, health conditions, or threats
that may have been caused by COVID–
19, SARS–CoV–2, or a virus mutating
therefrom, including the decrease in the
rate of childhood immunizations, which
will lead to an increase in the rate of
infectious diseases.
1 The only vaccines that ACIP has recommended
are authorized or approved by the Food and Drug
Administration (FDA). PREP Act coverage here is
limited to covered persons ordering and
administering FDA-authorized or FDA-approved
vaccines.
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Description of This Amendment by
Section
Section V. Covered Persons
Under the PREP Act and the
Declaration, a ‘‘qualified person’’ is a
‘‘covered person.’’ Subject to certain
limitations, a covered person is immune
from suit and liability under Federal
and State law with respect to all claims
for loss caused by, arising out of,
relating to, or resulting from the
administration or use of a covered
countermeasure if a declaration under
subsection (b) has been issued with
respect to such countermeasure.
‘‘Qualified person’’ includes
(A) a licensed health professional or other
individual who is authorized to prescribe,
administer, or dispense such
countermeasures under the law of the State
in which the countermeasure was prescribed,
administered, or dispensed; or
(B) ‘‘a person within a category of persons
so identified in a declaration by the
Secretary’’ under subsection (b) of the PREP
Act.
42 U.S.C. 247d–6d(i)(8).2
By this amendment to the Declaration,
the Secretary identifies an additional
category of persons who are qualified
persons under section 247d–6d(i)(8)(B).3
On May 8, 2020, CDC reported, ‘‘The
identified declines in routine pediatric
vaccine ordering and doses
administered might indicate that U.S.
children and their communities face
increased risks for outbreaks of vaccinepreventable diseases,’’ and suggested
that a decrease in rates of routine
childhood vaccinations were due to
changes in healthcare access, social
distancing, and other COVID–19
mitigation strategies.4 The report also
stated that ‘‘[p]arental concerns about
potentially exposing their children to
COVID–19 during well child visits
2 See Advisory Opinion on the Public Readiness
and Emergency Preparedness Act and the March 10,
2020 Declaration under the Act, 5–6 (May 19, 2020),
https://www.hhs.gov/sites/default/files/prep-actadvisory-opinion-hhs-ogc.pdf (last visited Aug. 5,
2020).
3 See Advisory Opinion 20–02 on the Public
Readiness and Emergency Preparedness Act and the
Secretary’s Declaration under the Act, 3–5 (May 19,
2020), https://www.hhs.gov/sites/default/files/
advisory-opinion-20-02-hhs-ogc-prep-act.pdf
(setting forth PREP Act’s legal framework for
identifying a ‘‘qualified person’’ and preemption of
state law that is different from, or is in conflict with,
that designation).
4 Jeanne M. Santoli et al., Effects of the COVID–
19 Pandemic on Routine Pediatric Vaccine
Ordering and Administration—United States, 2020,
69 MMWR 591, 592 (2020), https://www.cdc.gov/
mmwr/volumes/69/wr/pdfs/mm6919e2-H.pdf. (last
visited July 15, 2020); see also Melissa Jenco, AAP
urges vaccination as rates drop due to COVID–19,
AAP News (May 8, 2020), https://
www.aappublications.org/news/2020/05/08/
covid19vaccinations050820 (last visited July 15,
2020).
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52137
might contribute to the declines
observed.’’ 5
On July 10, 2020, CDC reported its
findings of a May survey it conducted
to assess the capacity of pediatric health
care practices to provide immunization
services to children during the COVID–
19 pandemic. The survey, which was
limited to practices participating in the
Vaccines for Children program, found
that, as of mid-May, 15 percent of
Northeast pediatric practices were
closed, 12.5 percent of Midwest
practices were closed, 6.2 percent of
practices in the South were closed, and
10 percent of practices in the West were
closed. Most practices had reduced
office hours for in-person visits. When
asked whether their practices would
likely be able to accommodate new
patients for immunization services
through August, 418 practices (21.3
percent) either responded that this was
not likely or the practice was
permanently closed or not resuming
immunization services for all patients,
and 380 (19.6 percent) responded that
they were unsure. Urban practices and
those in the Northeast were less likely
to be able to accommodate new patients
compared with rural practices and those
in the South, Midwest, or West.6
In response to these troubling
developments, CDC and the American
Academy of Pediatrics have stressed,
‘‘Well-child visits and vaccinations are
essential services and help make sure
children are protected.’’ 7
The Secretary re-emphasizes that
important recommendation to parents
and legal guardians here: If your child
is due for a well-child visit, contact your
pediatrician’s or other primary-care
provider’s office and ask about ways
that the office safely offers well-child
visits and vaccinations.
Many medical offices are taking extra
steps to make sure that well-child visits
can occur safely during the COVID–19
pandemic, including:
• Scheduling sick visits and wellchild visits during different times of the
5 Jeanne M. Santoli et al., Effects of the COVID–
19 Pandemic on Routine Pediatric Vaccine
Ordering and Administration—United States, 2020,
69 MMWR 591, 592 (2020), https://www.cdc.gov/
mmwr/volumes/69/wr/pdfs/mm6919e2-H.pdf (last
visited July 15, 2020).
6 Tara M. Vogt, Provision of Pediatric
Immunization Services During the COVID–19
Pandemic: an Assessment of Capacity Among
Pediatric Immunization Providers Participating in
the Vaccines for Children Program—United States,
May 2020, 69 MMWR 859, 859–61, https://
www.cdc.gov/mmwr/volumes/69/wr/pdfs/
mm6927a2-H.pdf (last visited July 15, 2020).
7 Routine Vaccination During the COVID–19
Outbreak, CDC, https://www.cdc.gov/vaccines/
parents/visit/vaccination-during-COVID-19.html
(last visited July 14, 2020).
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day or days of the week, or at different
locations.
• Asking patients to remain outside
until it is time for their appointments to
reduce the number of people in waiting
rooms.
• Adhering to recommended social
(physical) distancing and other
infection-control practices, such as the
use of masks.
The decrease in childhoodvaccination rates is a public health
threat and a collateral harm caused by
COVID–19. Together, the United States
must turn to available medical
professionals to limit the harm and
public health threats that may result
from decreased immunization rates. We
must quickly do so to avoid preventable
infections in children, additional strains
on our healthcare system, and any
further increase in avoidable adverse
health consequences—particularly if
such complications coincide with
additional resurgence of COVID–19.
Together with pediatricians and other
healthcare professionals, pharmacists
are positioned to expand access to
childhood vaccinations. Many States
already allow pharmacists to administer
vaccines to children of any age.8 9 Other
8 For purposes of this amendment, ‘‘State’’ shall
have the same meaning ascribed to it in 42 U.S.C.
201(f). Under section 201(f), ‘‘State’’ includes the
several States, the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Northern
Mariana Islands, the Virgin Islands, American
Samoa, and the Trust Territory of the Pacific
Islands.
9 See, e.g., Ala. Code § 34–23–1(5), (21) (2020);
Ala. Admin. Code r. 680–X–2–.14(1) (2000); Alaska
Stat. Ann. § 08.80.168(a) (West 2020); Cal. Bus. &
Prof. Code § 4052(a)(11) (West 2020); Colo. Code
Regs. § 719–1:19.00.00 (West 2020); Ga. Code Ann.
§ 43–34–26.1 (West 2020); Idaho Code Ann. § 54–
1704 (West 2020); Idaho Code Ann. § 37–201 (West
2020); Ind. Code Ann. § 25–26–13–31.2(a) (West
2020); Iowa Admin. Code § 657–39.10(6) (2020); La.
Admin. Code tit. 46, Pt. LIII, § 521 (2020); Mich.
Comp. Laws Ann. § 333.9204 (2020); Miss. Code
Ann. § 73–21–73(a), (dd) (West 2000); MO 20 CSR
2220–6.040; MO 20 CSR 2220–6.050; Neb. Rev. Stat.
Ann. §§ 38–2806, 38–2837 (West 2000); 175 Neb.
Admin. Code. § 8.003.01A(3)(m)(4)(a) (2020); N.H.
Rev. Stat. § 318:16–b (2020); Nev. Admin. Code
§ 639.2971 (2020); N.M. Stat. Ann. § 61–11–2(A),
(G), (CC) (West 2020); Okla. Stat. Ann. tit. 59,
§ 353.30 (West 2020); Or. Rev. Stat. § 689.645 (West
2020); https://www.oregon.gov/oha/PH/
PREVENTIONWELLNESS/VACCINES
IMMUNIZATION/IMMUNIZATIONPROVIDER
RESOURCES/Pages/pharmacy.aspx#:∼:text=
Immunization%20Resources%20for%20Oregon
%20Pharmacists,a%20patient%20of%20any
%20age (last visited Aug. 13, 2020); S.C. Code Ann.
§ 40–43–190 (2020); S.D. Codified Laws § 36–11–2,
S.D. Codified Laws § 36–11–19.1; Tenn. Code Ann.
§ 63–10–204(1), 39(A) (West 2020); Tex. Occ. Code
Ann. § 551.003(33) (2020); 22 Tex. Admin. Code
§ 295.15(e) (2020); Utah Code Ann. § 58–17b–
102(1), (57) (West 2020); Utah Admin. Code R156–
17b–621(5) (2020); Va. Code Ann. § 54.1–3408(I)
(2020); Wash. Rev. Code Ann. § 18.64.011(1), (28)
(West 2020); Wis. Stat. Ann. § 450.035 (West 2020).
While these states allow pharmacists to administer
vaccines to children of any age, some impose
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States permit pharmacists to administer
vaccines to children depending on the
age—for example, 2, 3, 5, 6, 7, 9, 10, 11,
or 12 years of age and older.10 Few
States restrict pharmacist-administered
vaccinations to only adults.11 Many
States also allow properly trained
individuals under the supervision of a
trained pharmacist to administer those
vaccines.12
Pharmacists are well positioned to
increase access to vaccinations,
particularly in certain areas or for
certain populations that have too few
pediatricians and other primary-care
providers, or that are otherwise
medically underserved.13 As of 2018,
nearly 90 percent of Americans lived
within five miles of a community
additional requirements. See, e.g., Cal. Bus. & Prof.
Code §§ 4052(a)(11), 4052.8 (permitting pharmacists
to administer any vaccine listed on the routine
immunization schedules recommended by the
Advisory Committee on Immunization Practices to
persons three years of age and older, but requiring
the pharmacist to administer immunizations to
persons under three years of age only pursuant to
a protocol with a prescriber); Colo. Code Regs.
§ 719–1:19.00.00 (West 2020) (requiring that
pharmacists administer vaccines and
immunizations ‘‘per authorization of a physician’’).
10 See, e.g., Ariz. Rev. Stat. Ann. § 32–1974(B)
(2020); Ark. Code Ann. § 17–92–101 (2020); D.C.
Mun. Reg Tit. 17 sec. 6512.10 (2012); Haw. Rev.
Stat. § 461–11.4 (West 2019); 225 Ill. Comp. Stat.
Ann. 85/3(d) (West 2020); Kan. Stat. Ann. § 65–
1635a (2020); Ky. Rev. Stat. Ann. § 315.010(22)
(West 2020); Me. Rev. Stat. Ann. tit. 32, § 13831
(West 2020); Md. Code Ann., Health Occ. § 12–508
(2020); 247 Mass. Code Regs. 16.03 (2020); Minn.
Stat. Ann. § 151.01 (West 2020); Mont. Code Ann.
§ 37–7–105 (West 2019); N.J. Stat. Ann. § 45:14–63
(West 2020); N.Y. Comp. Codes R. & Regs. tit. 8,
§ 63.9 (2020); N.C. Gen. Stat. Ann. § 90–85.15B
(West 2020); N.D. Cent. Code Ann. § 43–15–01
(West 2020); Ohio Rev. Code Ann. § 4729.41 (West
2020); 63 Pa. Cons. Stat. § 390–9.2 (West 2020); P.R.
Laws tit. 20, § 410c (2018); 5 R.I. Gen. Laws Ann.
§ 5–19.1–31 (West 2020); W.Va. Code Ann. § 30–5–
7 (West 2020); Wyo Stat. Ann. § 33–24–157 (2020).
11 See, e.g., Conn. Gen. Stat. § 20–633(a) (West
2012); 24 Del. Code Ann. § 2502(23)(h) (West 2020);
Fla. Stat. Ann. § 465.189(1) (West 2020); Vt. Admin.
R. of Board of Pharm. § 10.35 (West 2020).
12 See, e.g., Or. Admin. R. 855–019–0270 (2020)
(‘‘[A]n intern who is appropriately trained and
qualified in accordance with Section (3) of this rule
may perform the same duties as a pharmacist,
provided that the intern is supervised by an
appropriately trained and qualified pharmacist.’’).
13 See, e.g., Guidance for Pharmacists and
Pharmacy Technicians in Community Pharmacies
during the COVID–19 Response, CDC, https://
www.cdc.gov/coronavirus/2019-ncov/hcp/
pharmacies.html (last updated June 28, 2020) (‘‘As
a vital part of the healthcare system, pharmacies
play an important role in providing medicines,
therapeutics, vaccines, and critical health services
to the public.’’); Kimberly McKeirnan & Gregory
Sarchet, Implementing Immunizing Pharmacy
Technicians in a Federal Healthcare Facility, 7
Pharmacy 1, 7 (2019), https://www.mdpi.com/22264787/7/4/152/htm (last visited Aug. 5, 2020) (HHS
Indian Health Service study demonstrating ‘‘the
effective implementation of immunization-trained
pharmacy technicians and the positive impact
utilization of pharmacy support personnel can
create’’ on childhood vaccination rates in medically
underserved populations).
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pharmacy.14 Pharmacies often offer
extended hours and added convenience.
What is more, pharmacists are trusted
healthcare professionals with
established relationships with their
patients. Pharmacists also have strong
relationships with local medical
providers and hospitals to refer patients
as appropriate.
For example, pharmacists already
play a significant role in annual
influenza vaccination. In the early
2018–19 season, they administered the
influenza vaccine to nearly a third of all
adults who received the vaccine.15
Given the potential danger of serious
influenza and continuing COVID–19
outbreaks this autumn and the impact
that such concurrent outbreaks may
have on our population, our healthcare
system, and our whole-of-nation
response to the COVID–19 pandemic,
we must quickly expand access to
influenza vaccinations. Allowing more
qualified pharmacists to administer the
influenza vaccine to children will make
vaccinations more accessible.
Therefore, the Secretary amends the
Declaration to identify State-licensed
pharmacists (and pharmacy interns
acting under their supervision if the
pharmacy intern is licensed or
registered by his or her State board of
pharmacy) as qualified persons under
section 247d–6d(i)(8)(B) when the
pharmacist orders and either the
pharmacist or the supervised pharmacy
intern administers vaccines to
individuals ages three through 18
pursuant to the following requirements:
• The vaccine must be FDAauthorized or FDA-approved.
• The vaccination must be ordered
and administered according to ACIP’s
standard immunization schedule.16
• The licensed pharmacist must
complete a practical training program of
at least 20 hours that is approved by the
Accreditation Council for Pharmacy
Education (ACPE). This training
14 Get to Know Your Pharmacist, CDC, https://
www.cdc.gov/features/pharmacist-month/
index.html (last visited July 14, 2020).
15 Early-Season Flu Vaccination Coverage—
United States, November 2018, CDC, https://
www.cdc.gov/flu/fluvaxview/nifs-estimatesnov2018.htm (last visited July 14, 2020).
16 See Immunization Schedules: For Health Care
Providers, CDC, https://www.cdc.gov/vaccines/
schedules/hcp/ (last visited July 14,
2020). The immunization schedule recommends
that certain vaccines be administered only to
children of a certain age. For example, the second
dose of both the measles, mumps, and rubella
vaccine, as well as the varicella vaccine, should not
be administered until a child is between four and
six years old. See Recommended Child and
Adolescent Immunization Schedule for ages 18
years or younger, United States, 2020, CDC (Jan. 29,
2020), https://www.cdc.gov/vaccines/schedules/
downloads/child/0-18yrs-child-combinedschedule.pdf (last visited Aug. 5, 2020).
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program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines.17
• The licensed or registered
pharmacy intern must complete a
practical training program that is
approved by the ACPE. This training
program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines.18
• The licensed pharmacist and
licensed or registered pharmacy intern
must have a current certificate in basic
cardiopulmonary resuscitation.19
• The licensed pharmacist must
complete a minimum of two hours of
ACPE-approved, immunization-related
continuing pharmacy education during
each State licensing period.20
• The licensed pharmacist must
comply with recordkeeping and
reporting requirements of the
jurisdiction in which he or she
administers vaccines, including
informing the patient’s primary-care
provider when available, submitting the
required immunization information to
the State or local immunization
information system (vaccine registry),
complying with requirements with
respect to reporting adverse events, and
complying with requirements whereby
the person administering a vaccine must
review the vaccine registry or other
17 Cf., e.g., Cal. Bus. & Prof. Code § 4052.8; 3 Colo.
Code Regs. § 719–1:19.00.00; 856 Ind. Admin. Code
4–1–1; 46 La. Admin. Code tit. 46Part LIII, § 521;
Nev. Admin. Code § 639.2973; 22 Tex. Admin. Code
§ 295.15(c).
18 Cf., e.g., Ark. Admin. Code § 070.00.9–09–00–
0002; 3 Colo. Code Regs. § 719–1:19.00.00; Nev.
Admin. Code § 639.2973; N.H. Rev. Stat. § 318:16–
d; Ohio Rev. Code Ann. § 4729.41(B); Or. Admin.
R. 855–019–0270 (2020); S.C. Code Ann. §§ 40–43–
190(B)(1), (4); Utah Admin. Code r. 156R–17b–
621(5); Vt. Admin. Code 20–4–1400:10.35.
19 Cf., e.g., Ariz. Admin. Code § R4–23–411(D(3);
Conn. Gen. Stat. § 20–633(b); D.C. Mun. Regs. tit.
17, § 6512.3; 856 Ind. Admin. Code 4–1–1(c); Iowa
Admin. Code r. 657–39.10(2)(A); Kan. Stat. Ann.
§ 65–1635a(a); La. Admin. Code tit. 46 Part LIII,
§ 521(D); Me. Rev. Stat. Ann. tit. 32, § 13832; Md.
Code Ann., Health Occ. § 12–508(b)(2)(ii); Mont.
Code Ann. § 37–7–101(24)(b); N.J. Admin. Code
§ 13:39–4.21(b)(2); N.D. Cent. Code Ann. § 43–15–
31.5; Or. Admin. R. 855–019–0270 (2020); 63 Pa.
Stat. Ann. § 390–9.2;(a)(2) 216 R.I. Code R. § 40–15–
1.11; S.C. Code Ann. §§ 40–43–190(B)(4); S.D.
Admin. R. 20:51:28:02; W. Va. Code St. R. § 15–12–
4; Wyo. Admin. Code 059.0001.16 § 7.
20 Cf., e.g., AR ADC § 070.00.9–09–00–0002; 3
Colo. Code Regs. § 719–1:19.00.00; N.J. Stat. Ann.
§ 13:39–4.21; S.C. Code Ann. §§ 40–43–190(B)(1),
(5); 22 Tex. Admin. Code § 295.15(c); Utah Admin.
Code r. 156–17b–621(5); 59–0001–16 Wyo. Code R.
§ 7.
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vaccination records prior to
administering a vaccine.21
• The licensed pharmacist must
inform his or her childhood-vaccination
patients and the adult caregivers
accompanying the children of the
importance of a well-child visit with a
pediatrician or other licensed primarycare provider and refer patients as
appropriate.22
These requirements are consistent
with those in many States that permit
licensed pharmacists to order and
administer vaccines to children and
permit licensed or registered pharmacy
interns acting under their supervision to
administer vaccines to children.23
Administering vaccinations to
children age three and older is less
complicated and requires less training
and resources than administering
vaccinations to younger children. That
is because ACIP generally recommends
administering intramuscular injections
in the deltoid muscle for individuals age
three and older.24 For individuals less
than three years of age, ACIP generally
recommends administering
intramuscular injections in the
anterolateral aspect of the thigh
muscle.25 Administering injections in
the thigh muscle often presents
additional complexities and requires
additional training and resources
including additional personnel to safely
position the child while another
healthcare professional injects the
vaccine.26
21 Cf., e.g., Ala. Admin. Code. r. 680–X–2.14;
Ariz. Admin. Code § R4–23–411(E); AR ADC
§ 070.00.9–09–00–0002; Cal. Code Regs. tit. 16,
§ 1746.4; Conn. Gen. Stat. § 20–633(b); 225 Ill.
Comp. Stat. Ann. 85/3(d)(4); Kan. Stat. Ann. § 65–
1635a(a); Mont. Admin. R. 24.174.503; Nev. Rev.
Stat. Ann. § 454.213(s); N.H. Rev. Stat. § 318:16–d;
N.J. Stat. Ann. § 45:14–63; N.Y. Comp. Codes R. &
Regs. tit. 8, § 63.9; N.D. Cent. Code Ann. § 43–15–
31.5; Or. Admin. r. 855–019–0280; 216–40; R.I.
Code R. § 15–1.11; S.C. Code Ann. §§ 40–43–
190(B)(1), (5); S.D. Admin. R. 20:51:28:04; Tenn.
Code Ann. § 53–10–211; 22 Tex. Admin. Code
§ 295.15(c); 04–230 Vt. Code R. § 10.35; Va. Code
Ann. § 54.1–3408; Wis. Stat. Ann. § 450.035.
22 See, e.g., Letter from Kathleen E. Toomey, M.D.,
M.P.H., Comm’r and State Health Officer, Ga. Dep’t
of Pub. Health, available at https://www.gpha.org/
immunization/ (last visited July 15, 2020).
23 See, e.g., AL ST § 34–23–53; 12 AAC 52.992;
Cal. Bus. & Prof. Code § 4052; Cal. Bus. & Prof. Code
§ 4052.8(b); 3 Colo. Code Regs. § 719–1:19.00.00;
Ga. Code Ann., § 43–34–26.1; 856 IAC 4–1–1; Iowa
Code § 39.10(2)(a); N.M. Admin. Code 16.19.26;
Okla. Admin. Code 535:10–11–5; Code 1976 § 40–
43–190 (South Carolina).
24 Vaccine Recommendations and Guidelines of
the ACIP, https://www.cdc.gov/vaccines/hcp/aciprecs/general-recs/administration.html (last visited
July 29, 2020).
25 Id.
26 Id.; Nicole E. Omecene, et al., Implementation
of pharmacist-administered pediatric vaccines in
the United States: major barriers and potential
solutions for the outpatient setting, https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC6594428/
(last visited July 29, 2020).
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Moreover, as of 2018, 40% of threeyear-olds were enrolled in preprimary
programs (i.e. preschool or kindergarten
programs).27 Preprimary programs are
beginning in the coming weeks or
months, so the Secretary has concluded
that it is particularly important for
individuals ages three through 18 to
receive ACIP-recommended vaccines
according to ACIP’s standard
immunization schedule. All States
require children to be vaccinated against
certain communicable diseases as a
condition of school attendance. These
laws often apply to both public and
private schools with identical
immunization and exemption
provisions.28 As nurseries, preschools,
kindergartens, and schools reopen,
increased access to childhood
vaccinations is essential to ensuring
children can return.
Notwithstanding any State or local
scope-of-practice legal requirements, (1)
qualified licensed pharmacists are
identified as qualified persons to order
and administer ACIP-recommended
vaccines and (2) qualified State-licensed
or registered pharmacy interns are
identified as qualified persons to
administer the ACIP-recommended
vaccines ordered by their supervising
qualified licensed pharmacist.29
Both the PREP Act and the June 4,
2020 Second Amendment to the
Declaration define ‘‘covered
countermeasures’’ to include qualified
pandemic and epidemic products that
‘‘limit the harm such pandemic or
epidemic might otherwise cause.’’ 30
The troubling decrease in ACIPrecommended childhood vaccinations
and the resulting increased risk of
associated diseases, adverse health
conditions, and other threats are
categories of harms otherwise caused by
27 Preschool and Kindergarten Enrollment,
https://nces.ed.gov/programs/coe/indicator_cfa.asp
(last visited July 29, 2020).
28 State School Immunization Requirements and
Vaccine Exemption Laws, https://www.cdc.gov/
phlp/docs/school-vaccinations.pdf, (last visited July
29, 2020).
29 Nothing herein shall affect federal law
requirements in 42 CFR part 455, subpart E
regarding screening and enrollment of Medicare
and Medicaid providers. Moreover, nothing herein
shall preempt State laws that permit additional
individuals to administer vaccines that ACIP
recommends to persons age 18 or younger
according to ACIP’s standard immunization
schedule. For example, Idaho permits pharmacy
technicians who meet certain requirements to
administer vaccines under the supervision of an
immunizing pharmacist. Such technicians can still
administer vaccines to the extent they would have
been able to absent publication of this amendment.
Moreover, pharmacists and pharmacy interns may
still order or administer vaccines to individuals
ages two or younger to the extent authorized under
State law.
30 42 U.S.C. 247d–d6(i)(7)(A); 85 FR 35–100, 35–
102.
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COVID–19 as set forth in Sections VI
and VIII of this Declaration.31 Hence,
such vaccinations are ‘‘covered
countermeasures’’ under the PREP Act
and the June 4, 2020 Second
Amendment to the Declaration.
Nothing in this Declaration shall be
construed to affect the National Vaccine
Injury Compensation Program,
including an injured party’s ability to
obtain compensation under that
program. Covered countermeasures that
are subject to the National Vaccine
Injury Compensation Program
authorized under 42 U.S.C. 300aa-10 et
seq. are covered under this Declaration
for the purposes of liability immunity
and injury compensation only to the
extent that injury compensation is not
provided under that Program. All other
terms and conditions of the Declaration
apply to such covered countermeasures.
Section VIII. Category of Disease, Health
Condition, or Threat
As discussed, the troubling decrease
in ACIP-recommended childhood
vaccinations and the resulting increased
risk of associated diseases, adverse
health conditions, and other threats are
categories of harms otherwise caused by
COVID–19. The Secretary therefore
amends section VIII, which describes
the category of disease, health
condition, or threat for which he
recommends the administration or use
of the Covered Countermeasures, to
clarify that the category of disease,
health condition, or threat for which he
recommends the administration or use
of the Covered Countermeasures is not
only COVID–19 caused by SARS–CoV–
2 or a virus mutating therefrom, but also
other diseases, health conditions, or
threats that may have been caused by
COVID–19, SARS–CoV–2, or a virus
mutating therefrom, including the
decrease in the rate of childhood
immunizations, which will lead to an
increase in the rate of infectious
diseases.
jbell on DSKJLSW7X2PROD with NOTICES
Amendments to Declaration
Amended Declaration for Public
Readiness and Emergency Preparedness
Act Coverage for medical
countermeasures against COVID–19.
Sections V and VIII of the March 10,
2020 Declaration under the PREP Act
31 Jeanne M. Santoli et al., Effects of the COVID–
19 Pandemic on Routine Pediatric Vaccine
Ordering and Administration—United States, 2020,
69 MMWR No. 19, at 591–93 (May 15, 2020),
https://www.cdc.gov/mmwr/volumes/69/wr/
mm6919e2.htm; Cristi A. Bramer et al., Decline in
Child Vaccination Coverage During the COVID–19
Pandemic—Michigan Care Improvement Registry,
May 2016–May 2020, 69 MMWR No. 20, at 630–31
(May 22, 2020), https://www.cdc.gov/mmwr/
volumes/69/wr/mm6920e1.htm.
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for medical countermeasures against
COVID–19, as amended April 10, 2020
and June 4, 2020, are 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) and 85 FR 35100 (June
8, 2020).
1. Covered Persons, section V, delete
in full and replace with:
V. Covered Persons
42 U.S.C. 247d–6d(i)(2), (3), (4), (6),
(8)(A) and (B)
Covered Persons who are afforded
liability immunity under this
Declaration are ‘‘manufacturers,’’
‘‘distributors,’’ ‘‘program planners,’’
‘‘qualified persons,’’ and their officials,
agents, and employees, as those terms
are defined in the PREP Act, and the
United States.
In addition, I have determined that
the following additional persons are
qualified persons: (a) Any person
authorized in accordance with the
public health and medical emergency
response of the Authority Having
Jurisdiction, as described in Section VII
below, to prescribe, administer, deliver,
distribute or dispense the Covered
Countermeasures, and their officials,
agents, employees, contractors and
volunteers, following a Declaration of an
emergency; (b) any person authorized to
prescribe, administer, or dispense the
Covered Countermeasures or who is
otherwise authorized to perform an
activity under an Emergency Use
Authorization in accordance with
Section 564 of the FD&C Act; (c) any
person authorized to prescribe,
administer, or dispense Covered
Countermeasures in accordance with
Section 564A of the FD&C Act; and (d)
a State-licensed pharmacist who orders
and administers, and pharmacy interns
who administer (if the pharmacy intern
acts under the supervision of such
pharmacist and the pharmacy intern is
licensed or registered by his or her State
board of pharmacy), vaccines that the
Advisory Committee on Immunization
Practices (ACIP) recommends to persons
ages three through 18 according to
ACIP’s standard immunization
schedule.
Such State-licensed pharmacists and
the State-licensed or registered interns
under their supervision are qualified
persons only if the following
requirements are met:
• The vaccine must be FDAauthorized or FDA-approved.
• The vaccination must be ordered
and administered according to ACIP’s
standard immunization schedule.
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• The licensed pharmacist must
complete a practical training program of
at least 20 hours that is approved by the
Accreditation Council for Pharmacy
Education (ACPE). This training
program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines.
• The licensed or registered
pharmacy intern must complete a
practical training program that is
approved by the ACPE. This training
program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines.
• The licensed pharmacist and
licensed or registered pharmacy intern
must have a current certificate in basic
cardiopulmonary resuscitation.
• The licensed pharmacist must
complete a minimum of two hours of
ACPE-approved, immunization-related
continuing pharmacy education during
each State licensing period.
• The licensed pharmacist must
comply with recordkeeping and
reporting requirements of the
jurisdiction in which he or she
administers vaccines, including
informing the patient’s primary-care
provider when available, submitting the
required immunization information to
the State or local immunization
information system (vaccine registry),
complying with requirements with
respect to reporting adverse events, and
complying with requirements whereby
the person administering a vaccine must
review the vaccine registry or other
vaccination records prior to
administering a vaccine.
• The licensed pharmacist must
inform his or her childhood-vaccination
patients and the adult caregiver
accompanying the child of the
importance of a well-child visit with a
pediatrician or other licensed primarycare provider and refer patients as
appropriate.
Nothing in this Declaration shall be
construed to affect the National Vaccine
Injury Compensation Program,
including an injured party’s ability to
obtain compensation under that
program. Covered countermeasures that
are subject to the National Vaccine
Injury Compensation Program
authorized under 42 U.S.C. 300aa–10 et
seq. are covered under this Declaration
for the purposes of liability immunity
and injury compensation only to the
extent that injury compensation is not
provided under that Program. All other
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Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Notices
terms and conditions of the Declaration
apply to such covered countermeasures.
2. Category of Disease, Health
Condition, or Threat, section VIII, delete
in full and replace with:
VIII. Category of Disease, Health
Condition, or Threat
42 U.S.C. 247d–6d(b)(2)(A)
The category of disease, health
condition, or threat for which I
recommend the administration or use of
the Covered Countermeasures is not
only COVID–19 caused by SARS-CoV–
2 or a virus mutating therefrom, but also
other diseases, health conditions, or
threats that may have been caused by
COVID–19, SARS-CoV–2, or a virus
mutating therefrom, including the
decrease in the rate of childhood
immunizations, which will lead to an
increase in the rate of infectious
diseases.
Authority: 42 U.S.C. 247d–6d.
Dated: August 19, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020–18542 Filed 8–20–20; 4:15 pm]
BILLING CODE 4150–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As required by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working
Group (TBDWG) will hold a virtual
meeting. The meeting will be open to
the public. For this meeting, the
TBDWG will review the draft 2020
report to the HHS Secretary and
Congress and review and approve
graphics and images for the report. The
2020 report will address ongoing tickborne disease research, including
research related to causes, prevention,
treatment, surveillance, diagnosis,
diagnostics, and interventions for
individuals with tick-borne diseases;
advances made pursuant to such
research; federal activities related to
tick-borne diseases; and gaps in tickborne disease research.
DATES: The meeting will be held online
via webcast on September 15, 2020 and
September 22, 2020 from 9:00 a.m. to
2:30 p.m. ET both days (times are
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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Jkt 250001
tentative and subject to change). The
confirmed times and agenda items for
the meeting will be posted on the
TBDWG web page at https://
www.hhs.gov/ash/advisory-committees/
tickbornedisease/meetings/2020-9-15/
index.html when this information
becomes available.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the TBDWG; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Mary E. Switzer Building, 330
C Street SW, Suite L600, Washington,
DC, 20024. Email: tickbornedisease@
hhs.gov; Phone: 202–795–7608.
The
registration link will be posted on the
website at https://www.hhs.gov/ash/
advisory-committees/tickbornedisease/
meetings/2020-9-15/ when it
becomes available. After registering, you
will receive an email confirmation with
a personalized link to access the
webcast on September 15, 2020 and
September 22, 2020
The public will have an opportunity
to present their views to the TBDWG
orally during the meeting’s public
comment session or by submitting a
written public comment. Comments
should be pertinent to the meeting
discussion. Persons who wish to
provide verbal or written public
comment should review instructions at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2020-9-15/ and respond by
midnight September 4, 2020 ET. Verbal
comments will be limited to three
minutes each to accommodate as many
speakers as possible during the 30
minute session. Written public
comments will be accessible to the
public on the TBDWG web page prior to
the meeting.
Background and Authority: The TickBorne Disease Working Group was
established on August 10, 2017, in
accordance with Section 2062 of the
21st Century Cures Act, and the Federal
Advisory Committee Act, 5 U.S.C. App.,
as amended, to provide expertise and
review federal efforts related to all tickborne diseases, to help ensure
interagency coordination and minimize
overlap, and to examine research
priorities. The TBDWG is required to
submit a report to the HHS Secretary
and Congress on their findings and any
recommendations for the federal
response to tick-borne disease every two
years.
SUPPLEMENTARY INFORMATION:
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52141
Dated: August 12, 2020.
James J. Berger,
Designated Federal Officer, Tick-Borne
Disease Working Group, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2020–18519 Filed 8–21–20; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; 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 of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel RFA–DK–20–503
Limited Competition: TEDDY Data
Coordinating Center.
Date: October 7, 2020.
Time: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Dianne Camp, Ph.D.,
Scientific Review Officer, Review Branch,
Division of Extramural Activities, NIDDK,
National Institutes of Health, Room 7013,
6707 Democracy Boulevard, Bethesda, MD
20892–2542, (301) 5947682, campd@
extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: August 18, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–18438 Filed 8–21–20; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Notices]
[Pages 52136-52141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Third 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 add additional categories of
Qualified Persons and amend the category of disease, health condition,
or threat for which he recommends the administration or use of the
Covered Countermeasures.
DATES: This amendment to the Declaration published on March 17, 2020
(85 FR 15198) is effective as of August 24, 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,
[[Page 52137]]
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, and July 25, 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) (the
Declaration). On April 10, the Secretary amended the Declaration under
the PREP Act to extend liability immunity to covered countermeasures
authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4,
the Secretary amended the Declaration to clarify that covered
countermeasures under the Declaration include qualified countermeasures
that limit the harm COVID-19 might otherwise cause.
The Secretary now amends section V of the Declaration to identify
as qualified persons covered under the PREP Act, and thus authorizes,
certain State-licensed pharmacists to order and administer, and
pharmacy interns (who are licensed or registered by their State board
of pharmacy and acting under the supervision of a State-licensed
pharmacist) to administer, any vaccine that the Advisory Committee on
Immunization Practices (ACIP) recommends to persons ages three through
18 according to ACIP's standard immunization schedule (ACIP-recommended
vaccines).\1\
---------------------------------------------------------------------------
\1\ The only vaccines that ACIP has recommended are authorized
or approved by the Food and Drug Administration (FDA). PREP Act
coverage here is limited to covered persons ordering and
administering FDA-authorized or FDA-approved vaccines.
---------------------------------------------------------------------------
The Secretary also amends section VIII of the Declaration to
clarify that the category of disease, health condition, or threat for
which he recommends the administration or use of the Covered
Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a
virus mutating therefrom, but also other diseases, health conditions,
or threats that may have been caused by COVID-19, SARS-CoV-2, or a
virus mutating therefrom, including the decrease in the rate of
childhood immunizations, which will lead to an increase in the rate of
infectious diseases.
Description of This Amendment by Section
Section V. Covered Persons
Under the PREP Act and the Declaration, a ``qualified person'' is a
``covered person.'' Subject to certain limitations, a covered person is
immune from suit and liability under Federal and State law with respect
to all claims for loss caused by, arising out of, relating to, or
resulting from the administration or use of a covered countermeasure if
a declaration under subsection (b) has been issued with respect to such
countermeasure. ``Qualified person'' includes
(A) a licensed health professional or other individual who is
authorized to prescribe, administer, or dispense such
countermeasures under the law of the State in which the
countermeasure was prescribed, administered, or dispensed; or
(B) ``a person within a category of persons so identified in a
declaration by the Secretary'' under subsection (b) of the PREP Act.
42 U.S.C. 247d-6d(i)(8).\2\
---------------------------------------------------------------------------
\2\ See Advisory Opinion on the Public Readiness and Emergency
Preparedness Act and the March 10, 2020 Declaration under the Act,
5-6 (May 19, 2020), https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-hhs-ogc.pdf (last visited Aug. 5, 2020).
---------------------------------------------------------------------------
By this amendment to the Declaration, the Secretary identifies an
additional category of persons who are qualified persons under section
247d-6d(i)(8)(B).\3\
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\3\ See Advisory Opinion 20-02 on the Public Readiness and
Emergency Preparedness Act and the Secretary's Declaration under the
Act, 3-5 (May 19, 2020), https://www.hhs.gov/sites/default/files/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (setting forth PREP
Act's legal framework for identifying a ``qualified person'' and
preemption of state law that is different from, or is in conflict
with, that designation).
---------------------------------------------------------------------------
On May 8, 2020, CDC reported, ``The identified declines in routine
pediatric vaccine ordering and doses administered might indicate that
U.S. children and their communities face increased risks for outbreaks
of vaccine-preventable diseases,'' and suggested that a decrease in
rates of routine childhood vaccinations were due to changes in
healthcare access, social distancing, and other COVID-19 mitigation
strategies.\4\ The report also stated that ``[p]arental concerns about
potentially exposing their children to COVID-19 during well child
visits might contribute to the declines observed.'' \5\
---------------------------------------------------------------------------
\4\ Jeanne M. Santoli et al., Effects of the COVID-19 Pandemic
on Routine Pediatric Vaccine Ordering and Administration--United
States, 2020, 69 MMWR 591, 592 (2020), https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6919e2-H.pdf. (last visited July 15, 2020); see
also Melissa Jenco, AAP urges vaccination as rates drop due to
COVID-19, AAP News (May 8, 2020), https://www.aappublications.org/news/2020/05/08/covid19vaccinations050820 (last visited July 15,
2020).
\5\ Jeanne M. Santoli et al., Effects of the COVID-19 Pandemic
on Routine Pediatric Vaccine Ordering and Administration--United
States, 2020, 69 MMWR 591, 592 (2020), https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6919e2-H.pdf (last visited July 15, 2020).
---------------------------------------------------------------------------
On July 10, 2020, CDC reported its findings of a May survey it
conducted to assess the capacity of pediatric health care practices to
provide immunization services to children during the COVID-19 pandemic.
The survey, which was limited to practices participating in the
Vaccines for Children program, found that, as of mid-May, 15 percent of
Northeast pediatric practices were closed, 12.5 percent of Midwest
practices were closed, 6.2 percent of practices in the South were
closed, and 10 percent of practices in the West were closed. Most
practices had reduced office hours for in-person visits. When asked
whether their practices would likely be able to accommodate new
patients for immunization services through August, 418 practices (21.3
percent) either responded that this was not likely or the practice was
permanently closed or not resuming immunization services for all
patients, and 380 (19.6 percent) responded that they were unsure. Urban
practices and those in the Northeast were less likely to be able to
accommodate new patients compared with rural practices and those in the
South, Midwest, or West.\6\
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\6\ Tara M. Vogt, Provision of Pediatric Immunization Services
During the COVID-19 Pandemic: an Assessment of Capacity Among
Pediatric Immunization Providers Participating in the Vaccines for
Children Program--United States, May 2020, 69 MMWR 859, 859-61,
https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6927a2-H.pdf (last
visited July 15, 2020).
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In response to these troubling developments, CDC and the American
Academy of Pediatrics have stressed, ``Well-child visits and
vaccinations are essential services and help make sure children are
protected.'' \7\
---------------------------------------------------------------------------
\7\ Routine Vaccination During the COVID-19 Outbreak, CDC,
https://www.cdc.gov/vaccines/parents/visit/vaccination-during-COVID-19.html (last visited July 14, 2020).
---------------------------------------------------------------------------
The Secretary re-emphasizes that important recommendation to
parents and legal guardians here: If your child is due for a well-child
visit, contact your pediatrician's or other primary-care provider's
office and ask about ways that the office safely offers well-child
visits and vaccinations.
Many medical offices are taking extra steps to make sure that well-
child visits can occur safely during the COVID-19 pandemic, including:
Scheduling sick visits and well-child visits during
different times of the
[[Page 52138]]
day or days of the week, or at different locations.
Asking patients to remain outside until it is time for
their appointments to reduce the number of people in waiting rooms.
Adhering to recommended social (physical) distancing and
other infection-control practices, such as the use of masks.
The decrease in childhood-vaccination rates is a public health
threat and a collateral harm caused by COVID-19. Together, the United
States must turn to available medical professionals to limit the harm
and public health threats that may result from decreased immunization
rates. We must quickly do so to avoid preventable infections in
children, additional strains on our healthcare system, and any further
increase in avoidable adverse health consequences--particularly if such
complications coincide with additional resurgence of COVID-19.
Together with pediatricians and other healthcare professionals,
pharmacists are positioned to expand access to childhood vaccinations.
Many States already allow pharmacists to administer vaccines to
children of any age.8 9 Other States permit pharmacists to
administer vaccines to children depending on the age--for example, 2,
3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.\10\ Few States
restrict pharmacist-administered vaccinations to only adults.\11\ Many
States also allow properly trained individuals under the supervision of
a trained pharmacist to administer those vaccines.\12\
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\8\ For purposes of this amendment, ``State'' shall have the
same meaning ascribed to it in 42 U.S.C. 201(f). Under section
201(f), ``State'' includes the several States, the District of
Columbia, Guam, the Commonwealth of Puerto Rico, the Northern
Mariana Islands, the Virgin Islands, American Samoa, and the Trust
Territory of the Pacific Islands.
\9\ See, e.g., Ala. Code Sec. 34-23-1(5), (21) (2020); Ala.
Admin. Code r. 680-X-2-.14(1) (2000); Alaska Stat. Ann. Sec.
08.80.168(a) (West 2020); Cal. Bus. & Prof. Code Sec. 4052(a)(11)
(West 2020); Colo. Code Regs. Sec. 719-1:19.00.00 (West 2020); Ga.
Code Ann. Sec. 43-34-26.1 (West 2020); Idaho Code Ann. Sec. 54-
1704 (West 2020); Idaho Code Ann. Sec. 37-201 (West 2020); Ind.
Code Ann. Sec. 25-26-13-31.2(a) (West 2020); Iowa Admin. Code Sec.
657-39.10(6) (2020); La. Admin. Code tit. 46, Pt. LIII, Sec. 521
(2020); Mich. Comp. Laws Ann. Sec. 333.9204 (2020); Miss. Code Ann.
Sec. 73-21-73(a), (dd) (West 2000); MO 20 CSR 2220-6.040; MO 20 CSR
2220-6.050; Neb. Rev. Stat. Ann. Sec. Sec. 38-2806, 38-2837 (West
2000); 175 Neb. Admin. Code. Sec. 8.003.01A(3)(m)(4)(a) (2020);
N.H. Rev. Stat. Sec. 318:16-b (2020); Nev. Admin. Code Sec.
639.2971 (2020); N.M. Stat. Ann. Sec. 61-11-2(A), (G), (CC) (West
2020); Okla. Stat. Ann. tit. 59, Sec. 353.30 (West 2020); Or. Rev.
Stat. Sec. 689.645 (West 2020); https://www.oregon.gov/oha/PH/
PREVENTIONWELLNESS/VACCINESIMMUNIZATION/
IMMUNIZATIONPROVIDERRESOURCES/Pages/
pharmacy.aspx#:~:text=Immunization%20Resources%20for%20Oregon%20Pharm
acists,a%20patient%20of%20any%20age (last visited Aug. 13, 2020);
S.C. Code Ann. Sec. 40-43-190 (2020); S.D. Codified Laws Sec. 36-
11-2, S.D. Codified Laws Sec. 36-11-19.1; Tenn. Code Ann. Sec. 63-
10-204(1), 39(A) (West 2020); Tex. Occ. Code Ann. Sec. 551.003(33)
(2020); 22 Tex. Admin. Code Sec. 295.15(e) (2020); Utah Code Ann.
Sec. 58-17b-102(1), (57) (West 2020); Utah Admin. Code R156-17b-
621(5) (2020); Va. Code Ann. Sec. 54.1-3408(I) (2020); Wash. Rev.
Code Ann. Sec. 18.64.011(1), (28) (West 2020); Wis. Stat. Ann.
Sec. 450.035 (West 2020). While these states allow pharmacists to
administer vaccines to children of any age, some impose additional
requirements. See, e.g., Cal. Bus. & Prof. Code Sec. Sec.
4052(a)(11), 4052.8 (permitting pharmacists to administer any
vaccine listed on the routine immunization schedules recommended by
the Advisory Committee on Immunization Practices to persons three
years of age and older, but requiring the pharmacist to administer
immunizations to persons under three years of age only pursuant to a
protocol with a prescriber); Colo. Code Regs. Sec. 719-1:19.00.00
(West 2020) (requiring that pharmacists administer vaccines and
immunizations ``per authorization of a physician'').
\10\ See, e.g., Ariz. Rev. Stat. Ann. Sec. 32-1974(B) (2020);
Ark. Code Ann. Sec. 17-92-101 (2020); D.C. Mun. Reg Tit. 17 sec.
6512.10 (2012); Haw. Rev. Stat. Sec. 461-11.4 (West 2019); 225 Ill.
Comp. Stat. Ann. 85/3(d) (West 2020); Kan. Stat. Ann. Sec. 65-1635a
(2020); Ky. Rev. Stat. Ann. Sec. 315.010(22) (West 2020); Me. Rev.
Stat. Ann. tit. 32, Sec. 13831 (West 2020); Md. Code Ann., Health
Occ. Sec. 12-508 (2020); 247 Mass. Code Regs. 16.03 (2020); Minn.
Stat. Ann. Sec. 151.01 (West 2020); Mont. Code Ann. Sec. 37-7-105
(West 2019); N.J. Stat. Ann. Sec. 45:14-63 (West 2020); N.Y. Comp.
Codes R. & Regs. tit. 8, Sec. 63.9 (2020); N.C. Gen. Stat. Ann.
Sec. 90-85.15B (West 2020); N.D. Cent. Code Ann. Sec. 43-15-01
(West 2020); Ohio Rev. Code Ann. Sec. 4729.41 (West 2020); 63 Pa.
Cons. Stat. Sec. 390-9.2 (West 2020); P.R. Laws tit. 20, Sec. 410c
(2018); 5 R.I. Gen. Laws Ann. Sec. 5-19.1-31 (West 2020); W.Va.
Code Ann. Sec. 30-5-7 (West 2020); Wyo Stat. Ann. Sec. 33-24-157
(2020).
\11\ See, e.g., Conn. Gen. Stat. Sec. 20-633(a) (West 2012); 24
Del. Code Ann. Sec. 2502(23)(h) (West 2020); Fla. Stat. Ann. Sec.
465.189(1) (West 2020); Vt. Admin. R. of Board of Pharm. Sec. 10.35
(West 2020).
\12\ See, e.g., Or. Admin. R. 855-019-0270 (2020) (``[A]n intern
who is appropriately trained and qualified in accordance with
Section (3) of this rule may perform the same duties as a
pharmacist, provided that the intern is supervised by an
appropriately trained and qualified pharmacist.'').
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Pharmacists are well positioned to increase access to vaccinations,
particularly in certain areas or for certain populations that have too
few pediatricians and other primary-care providers, or that are
otherwise medically underserved.\13\ As of 2018, nearly 90 percent of
Americans lived within five miles of a community pharmacy.\14\
Pharmacies often offer extended hours and added convenience. What is
more, pharmacists are trusted healthcare professionals with established
relationships with their patients. Pharmacists also have strong
relationships with local medical providers and hospitals to refer
patients as appropriate.
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\13\ See, e.g., Guidance for Pharmacists and Pharmacy
Technicians in Community Pharmacies during the COVID-19 Response,
CDC, https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html
(last updated June 28, 2020) (``As a vital part of the healthcare
system, pharmacies play an important role in providing medicines,
therapeutics, vaccines, and critical health services to the
public.''); Kimberly McKeirnan & Gregory Sarchet, Implementing
Immunizing Pharmacy Technicians in a Federal Healthcare Facility, 7
Pharmacy 1, 7 (2019), https://www.mdpi.com/2226-4787/7/4/152/htm
(last visited Aug. 5, 2020) (HHS Indian Health Service study
demonstrating ``the effective implementation of immunization-trained
pharmacy technicians and the positive impact utilization of pharmacy
support personnel can create'' on childhood vaccination rates in
medically underserved populations).
\14\ Get to Know Your Pharmacist, CDC, https://www.cdc.gov/features/pharmacist-month/ (last visited July 14, 2020).
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For example, pharmacists already play a significant role in annual
influenza vaccination. In the early 2018-19 season, they administered
the influenza vaccine to nearly a third of all adults who received the
vaccine.\15\ Given the potential danger of serious influenza and
continuing COVID-19 outbreaks this autumn and the impact that such
concurrent outbreaks may have on our population, our healthcare system,
and our whole-of-nation response to the COVID-19 pandemic, we must
quickly expand access to influenza vaccinations. Allowing more
qualified pharmacists to administer the influenza vaccine to children
will make vaccinations more accessible.
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\15\ Early-Season Flu Vaccination Coverage--United States,
November 2018, CDC, https://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2018.htm (last visited July 14, 2020).
---------------------------------------------------------------------------
Therefore, the Secretary amends the Declaration to identify State-
licensed pharmacists (and pharmacy interns acting under their
supervision if the pharmacy intern is licensed or registered by his or
her State board of pharmacy) as qualified persons under section 247d-
6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the
supervised pharmacy intern administers vaccines to individuals ages
three through 18 pursuant to the following requirements:
The vaccine must be FDA-authorized or FDA-approved.
The vaccination must be ordered and administered according
to ACIP's standard immunization schedule.\16\
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\16\ See Immunization Schedules: For Health Care Providers, CDC,
https://www.cdc.gov/vaccines/schedules/hcp/ (last visited
July 14, 2020). The immunization schedule recommends that certain
vaccines be administered only to children of a certain age. For
example, the second dose of both the measles, mumps, and rubella
vaccine, as well as the varicella vaccine, should not be
administered until a child is between four and six years old. See
Recommended Child and Adolescent Immunization Schedule for ages 18
years or younger, United States, 2020, CDC (Jan. 29, 2020), https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf (last visited Aug. 5, 2020).
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The licensed pharmacist must complete a practical training
program of at least 20 hours that is approved by the Accreditation
Council for Pharmacy Education (ACPE). This training
[[Page 52139]]
program must include hands-on injection technique, clinical evaluation
of indications and contraindications of vaccines, and the recognition
and treatment of emergency reactions to vaccines.\17\
---------------------------------------------------------------------------
\17\ Cf., e.g., Cal. Bus. & Prof. Code Sec. 4052.8; 3 Colo.
Code Regs. Sec. 719-1:19.00.00; 856 Ind. Admin. Code 4-1-1; 46 La.
Admin. Code tit. 46Part LIII, Sec. 521; Nev. Admin. Code Sec.
639.2973; 22 Tex. Admin. Code Sec. 295.15(c).
---------------------------------------------------------------------------
The licensed or registered pharmacy intern must complete a
practical training program that is approved by the ACPE. This training
program must include hands-on injection technique, clinical evaluation
of indications and contraindications of vaccines, and the recognition
and treatment of emergency reactions to vaccines.\18\
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\18\ Cf., e.g., Ark. Admin. Code Sec. 070.00.9-09-00-0002; 3
Colo. Code Regs. Sec. 719-1:19.00.00; Nev. Admin. Code Sec.
639.2973; N.H. Rev. Stat. Sec. 318:16-d; Ohio Rev. Code Ann. Sec.
4729.41(B); Or. Admin. R. 855-019-0270 (2020); S.C. Code Ann.
Sec. Sec. 40-43-190(B)(1), (4); Utah Admin. Code r. 156R-17b-
621(5); Vt. Admin. Code 20-4-1400:10.35.
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The licensed pharmacist and licensed or registered
pharmacy intern must have a current certificate in basic
cardiopulmonary resuscitation.\19\
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\19\ Cf., e.g., Ariz. Admin. Code Sec. R4-23-411(D(3); Conn.
Gen. Stat. Sec. 20-633(b); D.C. Mun. Regs. tit. 17, Sec. 6512.3;
856 Ind. Admin. Code 4-1-1(c); Iowa Admin. Code r. 657-39.10(2)(A);
Kan. Stat. Ann. Sec. 65-1635a(a); La. Admin. Code tit. 46 Part
LIII, Sec. 521(D); Me. Rev. Stat. Ann. tit. 32, Sec. 13832; Md.
Code Ann., Health Occ. Sec. 12-508(b)(2)(ii); Mont. Code Ann. Sec.
37-7-101(24)(b); N.J. Admin. Code Sec. 13:39-4.21(b)(2); N.D. Cent.
Code Ann. Sec. 43-15-31.5; Or. Admin. R. 855-019-0270 (2020); 63
Pa. Stat. Ann. Sec. 390-9.2;(a)(2) 216 R.I. Code R. Sec. 40-15-
1.11; S.C. Code Ann. Sec. Sec. 40-43-190(B)(4); S.D. Admin. R.
20:51:28:02; W. Va. Code St. R. Sec. 15-12-4; Wyo. Admin. Code
059.0001.16 Sec. 7.
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The licensed pharmacist must complete a minimum of two
hours of ACPE-approved, immunization-related continuing pharmacy
education during each State licensing period.\20\
---------------------------------------------------------------------------
\20\ Cf., e.g., AR ADC Sec. 070.00.9-09-00-0002; 3 Colo. Code
Regs. Sec. 719-1:19.00.00; N.J. Stat. Ann. Sec. 13:39-4.21; S.C.
Code Ann. Sec. Sec. 40-43-190(B)(1), (5); 22 Tex. Admin. Code Sec.
295.15(c); Utah Admin. Code r. 156-17b-621(5); 59-0001-16 Wyo. Code
R. Sec. 7.
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The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers vaccines, including informing the patient's primary-care
provider when available, submitting the required immunization
information to the State or local immunization information system
(vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby the
person administering a vaccine must review the vaccine registry or
other vaccination records prior to administering a vaccine.\21\
---------------------------------------------------------------------------
\21\ Cf., e.g., Ala. Admin. Code. r. 680-X-2.14; Ariz. Admin.
Code Sec. R4-23-411(E); AR ADC Sec. 070.00.9-09-00-0002; Cal. Code
Regs. tit. 16, Sec. 1746.4; Conn. Gen. Stat. Sec. 20-633(b); 225
Ill. Comp. Stat. Ann. 85/3(d)(4); Kan. Stat. Ann. Sec. 65-1635a(a);
Mont. Admin. R. 24.174.503; Nev. Rev. Stat. Ann. Sec. 454.213(s);
N.H. Rev. Stat. Sec. 318:16-d; N.J. Stat. Ann. Sec. 45:14-63; N.Y.
Comp. Codes R. & Regs. tit. 8, Sec. 63.9; N.D. Cent. Code Ann.
Sec. 43-15-31.5; Or. Admin. r. 855-019-0280; 216-40; R.I. Code R.
Sec. 15-1.11; S.C. Code Ann. Sec. Sec. 40-43-190(B)(1), (5); S.D.
Admin. R. 20:51:28:04; Tenn. Code Ann. Sec. 53-10-211; 22 Tex.
Admin. Code Sec. 295.15(c); 04-230 Vt. Code R. Sec. 10.35; Va.
Code Ann. Sec. 54.1-3408; Wis. Stat. Ann. Sec. 450.035.
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The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregivers accompanying the children
of the importance of a well-child visit with a pediatrician or other
licensed primary-care provider and refer patients as appropriate.\22\
---------------------------------------------------------------------------
\22\ See, e.g., Letter from Kathleen E. Toomey, M.D., M.P.H.,
Comm'r and State Health Officer, Ga. Dep't of Pub. Health, available
at https://www.gpha.org/immunization/ (last visited July 15, 2020).
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These requirements are consistent with those in many States that
permit licensed pharmacists to order and administer vaccines to
children and permit licensed or registered pharmacy interns acting
under their supervision to administer vaccines to children.\23\
---------------------------------------------------------------------------
\23\ See, e.g., AL ST Sec. 34-23-53; 12 AAC 52.992; Cal. Bus. &
Prof. Code Sec. 4052; Cal. Bus. & Prof. Code Sec. 4052.8(b); 3
Colo. Code Regs. Sec. 719-1:19.00.00; Ga. Code Ann., Sec. 43-34-
26.1; 856 IAC 4-1-1; Iowa Code Sec. 39.10(2)(a); N.M. Admin. Code
16.19.26; Okla. Admin. Code 535:10-11-5; Code 1976 Sec. 40-43-190
(South Carolina).
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Administering vaccinations to children age three and older is less
complicated and requires less training and resources than administering
vaccinations to younger children. That is because ACIP generally
recommends administering intramuscular injections in the deltoid muscle
for individuals age three and older.\24\ For individuals less than
three years of age, ACIP generally recommends administering
intramuscular injections in the anterolateral aspect of the thigh
muscle.\25\ Administering injections in the thigh muscle often presents
additional complexities and requires additional training and resources
including additional personnel to safely position the child while
another healthcare professional injects the vaccine.\26\
---------------------------------------------------------------------------
\24\ Vaccine Recommendations and Guidelines of the ACIP, https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/administration.html
(last visited July 29, 2020).
\25\ Id.
\26\ Id.; Nicole E. Omecene, et al., Implementation of
pharmacist-administered pediatric vaccines in the United States:
major barriers and potential solutions for the outpatient setting,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6594428/ (last visited
July 29, 2020).
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Moreover, as of 2018, 40% of three-year-olds were enrolled in
preprimary programs (i.e. preschool or kindergarten programs).\27\
Preprimary programs are beginning in the coming weeks or months, so the
Secretary has concluded that it is particularly important for
individuals ages three through 18 to receive ACIP-recommended vaccines
according to ACIP's standard immunization schedule. All States require
children to be vaccinated against certain communicable diseases as a
condition of school attendance. These laws often apply to both public
and private schools with identical immunization and exemption
provisions.\28\ As nurseries, preschools, kindergartens, and schools
reopen, increased access to childhood vaccinations is essential to
ensuring children can return.
---------------------------------------------------------------------------
\27\ Preschool and Kindergarten Enrollment, https://nces.ed.gov/programs/coe/indicator_cfa.asp (last visited July 29, 2020).
\28\ State School Immunization Requirements and Vaccine
Exemption Laws, https://www.cdc.gov/phlp/docs/school-vaccinations.pdf, (last visited July 29, 2020).
---------------------------------------------------------------------------
Notwithstanding any State or local scope-of-practice legal
requirements, (1) qualified licensed pharmacists are identified as
qualified persons to order and administer ACIP-recommended vaccines and
(2) qualified State-licensed or registered pharmacy interns are
identified as qualified persons to administer the ACIP-recommended
vaccines ordered by their supervising qualified licensed
pharmacist.\29\
---------------------------------------------------------------------------
\29\ Nothing herein shall affect federal law requirements in 42
CFR part 455, subpart E regarding screening and enrollment of
Medicare and Medicaid providers. Moreover, nothing herein shall
preempt State laws that permit additional individuals to administer
vaccines that ACIP recommends to persons age 18 or younger according
to ACIP's standard immunization schedule. For example, Idaho permits
pharmacy technicians who meet certain requirements to administer
vaccines under the supervision of an immunizing pharmacist. Such
technicians can still administer vaccines to the extent they would
have been able to absent publication of this amendment. Moreover,
pharmacists and pharmacy interns may still order or administer
vaccines to individuals ages two or younger to the extent authorized
under State law.
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Both the PREP Act and the June 4, 2020 Second Amendment to the
Declaration define ``covered countermeasures'' to include qualified
pandemic and epidemic products that ``limit the harm such pandemic or
epidemic might otherwise cause.'' \30\ The troubling decrease in ACIP-
recommended childhood vaccinations and the resulting increased risk of
associated diseases, adverse health conditions, and other threats are
categories of harms otherwise caused by
[[Page 52140]]
COVID-19 as set forth in Sections VI and VIII of this Declaration.\31\
Hence, such vaccinations are ``covered countermeasures'' under the PREP
Act and the June 4, 2020 Second Amendment to the Declaration.
---------------------------------------------------------------------------
\30\ 42 U.S.C. 247d-d6(i)(7)(A); 85 FR 35-100, 35-102.
\31\ Jeanne M. Santoli et al., Effects of the COVID-19 Pandemic
on Routine Pediatric Vaccine Ordering and Administration--United
States, 2020, 69 MMWR No. 19, at 591-93 (May 15, 2020), https://www.cdc.gov/mmwr/volumes/69/wr/mm6919e2.htm; Cristi A. Bramer et
al., Decline in Child Vaccination Coverage During the COVID-19
Pandemic--Michigan Care Improvement Registry, May 2016-May 2020, 69
MMWR No. 20, at 630-31 (May 22, 2020), https://www.cdc.gov/mmwr/volumes/69/wr/mm6920e1.htm.
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Nothing in this Declaration shall be construed to affect the
National Vaccine Injury Compensation Program, including an injured
party's ability to obtain compensation under that program. Covered
countermeasures that are subject to the National Vaccine Injury
Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are
covered under this Declaration for the purposes of liability immunity
and injury compensation only to the extent that injury compensation is
not provided under that Program. All other terms and conditions of the
Declaration apply to such covered countermeasures.
Section VIII. Category of Disease, Health Condition, or Threat
As discussed, the troubling decrease in ACIP-recommended childhood
vaccinations and the resulting increased risk of associated diseases,
adverse health conditions, and other threats are categories of harms
otherwise caused by COVID-19. The Secretary therefore amends section
VIII, which describes the category of disease, health condition, or
threat for which he recommends the administration or use of the Covered
Countermeasures, to clarify that the category of disease, health
condition, or threat for which he recommends the administration or use
of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-
2 or a virus mutating therefrom, but also other diseases, health
conditions, or threats that may have been caused by COVID-19, SARS-CoV-
2, or a virus mutating therefrom, including the decrease in the rate of
childhood immunizations, which will lead to an increase in the rate of
infectious diseases.
Amendments to Declaration
Amended Declaration for Public Readiness and Emergency Preparedness
Act Coverage for medical countermeasures against COVID-19.
Sections V and VIII of the March 10, 2020 Declaration under the
PREP Act for medical countermeasures against COVID-19, as amended April
10, 2020 and June 4, 2020, are 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) and 85 FR 35100 (June
8, 2020).
1. Covered Persons, section V, delete in full and replace with:
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
Covered Persons who are afforded liability immunity under this
Declaration are ``manufacturers,'' ``distributors,'' ``program
planners,'' ``qualified persons,'' and their officials, agents, and
employees, as those terms are defined in the PREP Act, and the United
States.
In addition, I have determined that the following additional
persons are qualified persons: (a) Any person authorized in accordance
with the public health and medical emergency response of the Authority
Having Jurisdiction, as described in Section VII below, to prescribe,
administer, deliver, distribute or dispense the Covered
Countermeasures, and their officials, agents, employees, contractors
and volunteers, following a Declaration of an emergency; (b) any person
authorized to prescribe, administer, or dispense the Covered
Countermeasures or who is otherwise authorized to perform an activity
under an Emergency Use Authorization in accordance with Section 564 of
the FD&C Act; (c) any person authorized to prescribe, administer, or
dispense Covered Countermeasures in accordance with Section 564A of the
FD&C Act; and (d) a State-licensed pharmacist who orders and
administers, and pharmacy interns who administer (if the pharmacy
intern acts under the supervision of such pharmacist and the pharmacy
intern is licensed or registered by his or her State board of
pharmacy), vaccines that the Advisory Committee on Immunization
Practices (ACIP) recommends to persons ages three through 18 according
to ACIP's standard immunization schedule.
Such State-licensed pharmacists and the State-licensed or
registered interns under their supervision are qualified persons only
if the following requirements are met:
The vaccine must be FDA-authorized or FDA-approved.
The vaccination must be ordered and administered according
to ACIP's standard immunization schedule.
The licensed pharmacist must complete a practical training
program of at least 20 hours that is approved by the Accreditation
Council for Pharmacy Education (ACPE). This training program must
include hands-on injection technique, clinical evaluation of
indications and contraindications of vaccines, and the recognition and
treatment of emergency reactions to vaccines.
The licensed or registered pharmacy intern must complete a
practical training program that is approved by the ACPE. This training
program must include hands-on injection technique, clinical evaluation
of indications and contraindications of vaccines, and the recognition
and treatment of emergency reactions to vaccines.
The licensed pharmacist and licensed or registered
pharmacy intern must have a current certificate in basic
cardiopulmonary resuscitation.
The licensed pharmacist must complete a minimum of two
hours of ACPE-approved, immunization-related continuing pharmacy
education during each State licensing period.
The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers vaccines, including informing the patient's primary-care
provider when available, submitting the required immunization
information to the State or local immunization information system
(vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby the
person administering a vaccine must review the vaccine registry or
other vaccination records prior to administering a vaccine.
The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregiver accompanying the child of
the importance of a well-child visit with a pediatrician or other
licensed primary-care provider and refer patients as appropriate.
Nothing in this Declaration shall be construed to affect the
National Vaccine Injury Compensation Program, including an injured
party's ability to obtain compensation under that program. Covered
countermeasures that are subject to the National Vaccine Injury
Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are
covered under this Declaration for the purposes of liability immunity
and injury compensation only to the extent that injury compensation is
not provided under that Program. All other
[[Page 52141]]
terms and conditions of the Declaration apply to such covered
countermeasures.
2. Category of Disease, Health Condition, or Threat, section VIII,
delete in full and replace with:
VIII. Category of Disease, Health Condition, or Threat
42 U.S.C. 247d-6d(b)(2)(A)
The category of disease, health condition, or threat for which I
recommend the administration or use of the Covered Countermeasures is
not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom,
but also other diseases, health conditions, or threats that may have
been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom,
including the decrease in the rate of childhood immunizations, which
will lead to an increase in the rate of infectious diseases.
Authority: 42 U.S.C. 247d-6d.
Dated: August 19, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020-18542 Filed 8-20-20; 4:15 pm]
BILLING CODE 4150-03-P
