[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]
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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.
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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\
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\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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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\
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\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).
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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).
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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\
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\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).
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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\
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\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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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/index.html (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).
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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/index.html (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
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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\
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\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).
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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\
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\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\
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\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\
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\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\
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\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\
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\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.
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\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).
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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\
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\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.
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\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