Public health emergencies
Emergencies
If the Secretary determines, after consultation with such public health officials as may be necessary, that—
a disease or disorder presents a public health emergency; or
a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.
Public Health Emergency Fund
In general
Uses
The Secretary may use amounts in the Fund established under paragraph (1), to—
facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);
make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 247d–3a, 247d–3b, or 247d–3c of this title;
facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 247d–6b of this title), qualified countermeasures (as defined in section 247d–6a of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title), that are applicable to the public health emergency or potential public health emergency under paragraph (1);
strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under section 247d–4 of this title;
support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 300hh–11 of this title and the Medical Reserve Corps under section 300hh–15 of this title;
support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and
carry out other activities, as the Secretary determines applicable and appropriate.
Report
Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—
the expenditures made from the Public Health Emergency Fund in such fiscal year, including—
the amount obligated;
the recipient or recipients of such obligated funds;
the specific response activities such obligated funds will support; and
the declared or potential public health emergency for which such funds were obligated; and
each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund.
Review
GAO report
Not later than 4 years after
conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and
submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.
Supplement not supplant
Data submittal and reporting deadlines
Temporary reassignment of State and local personnel during a public health emergency
Emergency reassignment of federally funded personnel
Activation of emergency reassignment
Public health emergency
Contents of request
To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:
An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available.
An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1).
An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 247d–3a of this title.
An identification of—
each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and
the number of personnel who would be so reassigned from each such program.
Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree.
Consideration
Termination and extension
Termination
A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:
The Secretary’s determination that the public health emergency no longer exists.
Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility.
Extension of reassignment flexibility
The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if—
the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and
the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B).
Voluntary nature of temporary reassignment of State and local personnel
In general
Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—
shall have the opportunity to volunteer for temporary reassignment; and
shall not be required to agree to a temporary reassignment.
Prohibition on conditioning Federal awards
Notice to Congress
The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of—
any initial request for temporary reassignment of personnel; and
any request for an extension of such temporary reassignment.
Guidance
The Secretary shall—
not later than 6 months after
after providing notice and a 60-day period for public comment, finalize such guidance.
Report to Congress
Not later than 4 years after
a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes;
an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies;
an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;
an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and
recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.
Definitions
In this subsection—
the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25; and
the term “State” includes, in addition to the entities listed in the definition of such term in section 201 of this title, the Freely Associated States.
Sunset
Determination with respect to Paperwork Reduction Act waiver during a public health emergency
Determination
If the Secretary determines, after consultation with such public health officials as may be necessary, that—
the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or
a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and
the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of chapter 35 of title 44 (commonly referred to as the Paperwork Reduction Act),
then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time.
Transparency
Effectiveness of waiver
Termination of waiver
Limitations
Period of waiver
Subsequent compliance
Certain appointments to support public health emergency responses
In general
In order to support the initial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to sections 3309 through 3318 of title 5, appoint individuals directly to positions in the Department of Health and Human Services for which the Secretary has provided public notice in order to—
address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or
address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section.
Number of appointments
Each fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than—
400 individuals under paragraph (1)(A); and
100 individuals under paragraph (1)(B).
Compensation
Reporting
The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including—
the number of positions filled through such authority;
the types of appointments of such positions;
the titles, occupational series, and grades of such positions;
the number of positions publicly noticed to be filled under such authority;
the number of qualified applicants who apply for such positions;
the qualification criteria for such positions; and
the demographic information of individuals appointed to such positions.
Notification to Congress
In the event the Secretary, within a single fiscal year, directly appoints more than 50 percent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include—
information on each such appointment within such fiscal year;
a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and
the additional number of personnel, if any, the Secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year.
Reports to Congress
Sunset
Stockpile depletion reporting
The Secretary shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under section 247d–6b(a) of this title to respond to a public health emergency declared by the Secretary under this section or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act [42 U.S.C. 5121 et seq.], and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, or major disaster, submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on—
the deployment of the contents of the stockpile in response to State, local, and Tribal requests;
the amount of such products that remain within the stockpile following such deployment; and
plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.
Source
(July 1, 1944, ch. 373, title III, § 319, as added Pub. L. 106–505, title I, § 102,Notes
Editorial Notes
References in Text
Prior Provisions
Amendments
Statutory Notes and Related Subsidiaries
Change of Name
Effective Date of 2002 Amendment
Consideration of Unique Challenges in Noncontiguous States and Territories
Funding for COVID–19 Vaccine Activities at the Centers for Disease Control and Prevention
In General.—
In addition to amounts otherwise available, there is appropriated to the Secretary of Health and Human Services (in this subtitle [subtitle D (§§ 2301–2305) of title II of Pub. L. 117–2, see Tables for classification] referred to as the ‘Secretary’) for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $7,500,000,000, to remain available until expended, to carry out activities to plan, prepare for, promote, distribute, administer, monitor, and track COVID–19 vaccines.
Use of Funds.—
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in consultation with other agencies, as applicable, shall, in conducting activities referred to in subsection (a)—
conduct activities to enhance, expand, and improve nationwide COVID–19 vaccine distribution and administration, including activities related to distribution of ancillary medical products and supplies related to vaccines; and
provide technical assistance, guidance, and support to, and award grants or cooperative agreements to, State, local, Tribal, and territorial public health departments for enhancement of COVID–19 vaccine distribution and administration capabilities, including—
the distribution and administration of vaccines licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) or authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) and ancillary medical products and supplies related to vaccines;
the establishment and expansion, including staffing support, of community vaccination centers, particularly in underserved areas;
the deployment of mobile vaccination units, particularly in underserved areas;
information technology, standards-based data, and reporting enhancements, including improvements necessary to support standards-based sharing of data related to vaccine distribution and vaccinations and systems that enhance vaccine safety, effectiveness, and uptake, particularly among underserved populations;
facilities enhancements;
communication with the public regarding when, where, and how to receive COVID–19 vaccines; and
transportation of individuals to facilitate vaccinations, including at community vaccination centers and mobile vaccination units, particularly for underserved populations.
Supplemental Funding for State Vaccination Grants.—
Definitions.—
In this subsection:
Base formula.—
The term ‘base formula’ means the allocation formula that applied to the Public Health Emergency Preparedness cooperative agreement in fiscal year 2020.
Alternative allocation.—
The term ‘alternative allocation’ means an allocation to each State, territory, or locality calculated using the percentage derived from the allocation received by such State, territory, or locality of the aggregate amount of fiscal year 2020 Public Health Emergency Preparedness cooperative agreement awards under section 319C–1 of the Public Health Service Act (42 U.S.C. 247d–3a).
Supplemental funding.—
In general.—
Not later than 21 days after the date of enactment of this Act [
Amount.—
The amount of supplemental funding provided under this subsection shall be equal to the difference between—
the amount the State, locality, or territory received, or would receive, under the base formula; and
the amount the State, locality, or territory would receive under the alternative allocation.”
Funding for COVID–19 Testing, Contact Tracing, and Mitigation Activities
In General.—
In addition to amounts otherwise available, there is appropriated to the Secretary of Health and Human Services (in this subtitle [subtitle E (§§ 2401–2404) of title II of Pub. L. 117–2, see Tables for classification] referred to as the ‘Secretary’) for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $47,800,000,000, to remain available until expended, to carry out activities to detect, diagnose, trace, and monitor SARS–CoV–2 and COVID–19 infections and related strategies to mitigate the spread of COVID–19.
Use of Funds.—
From amounts appropriated by subsection (a), the Secretary shall—
implement a national, evidence-based strategy for testing, contact tracing, surveillance, and mitigation with respect to SARS–CoV–2 and COVID–19, including through activities authorized under section 319(a) of the Public Health Service Act [42 U.S.C. 247d(a)];
provide technical assistance, guidance, and support, and award grants or cooperative agreements to State, local, and territorial public health departments for activities to detect, diagnose, trace, and monitor SARS–CoV–2 and COVID–19 infections and related strategies and activities to mitigate the spread of COVID–19;
support the development, manufacturing, procurement, distribution, and administration of tests to detect or diagnose SARS–CoV–2 and COVID–19, including through—
support for the development, manufacture, procurement, and distribution of supplies necessary for administering tests, such as personal protective equipment; and
support for the acquisition, construction, alteration, or renovation of non-federally owned facilities for the production of diagnostics and ancillary medical products and supplies where the Secretary determines that such an investment is necessary to ensure the production of sufficient amounts of such supplies;
establish and expand Federal, State, local, and territorial testing and contact tracing capabilities, including—
through investments in laboratory capacity, such as—
academic and research laboratories, or other laboratories that could be used for processing of COVID–19 testing;
community-based testing sites and community-based organizations; or
mobile health units, particularly in medically underserved areas; and
with respect to quarantine and isolation of contacts;
enhance information technology, data modernization, and reporting, including improvements necessary to support sharing of data related to public health capabilities;
award grants to, or enter into cooperative agreements or contracts with, State, local, and territorial public health departments to establish, expand, and sustain a public health workforce; and
to cover administrative and program support costs necessary to conduct activities related to subparagraph (a).”
Importance of the Blood Supply
In General.—
The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall carry out a national campaign to improve awareness of, and support outreach to the public and health care providers about the importance and safety of blood donation and the need for donations for the blood supply during the public health emergency declared by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19.
Awareness Campaign.—
In carrying out subsection (a), the Secretary may enter into contracts with one or more public or private nonprofit entities, to establish a national blood donation awareness campaign that may include television, radio, internet, and newspaper public service announcements, and other activities to provide for public and professional awareness and education.
Consultation.—
In carrying out subsection (a), the Secretary shall consult with the Commissioner of Food and Drugs, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, and the heads of other relevant Federal agencies, and relevant accrediting bodies and representative organizations.
Report to Congress.—
Not later than 2 years after the date of enactment of this Act [
a description of the activities carried out under subsection (a);
a description of trends in blood supply donations; and
an evaluation of the impact of the public awareness campaign, including any geographic or population variations.”
Reporting by Laboratories of Results of Tests To Detect SARS–CoV–2 or To Diagnose COVID–19
In General.—
Every laboratory that performs or analyzes a test that is intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19 shall report the results from each such test, to the Secretary of Health and Human Services in such form and manner, and at such timing and frequency, as the Secretary may prescribe until the end of the Secretary’s Public Health Emergency declaration with respect to COVID–19 or any extension of such declaration.
Laboratories Covered.—
The Secretary may prescribe which laboratories must submit reports pursuant to this section.
Implementation.—
The Secretary may make prescriptions under this section by regulation, including by interim final rule, or by guidance, and may issue such regulations or guidance without regard to the procedures otherwise required by section 553 of title 5, United States Code.”