The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(4)(H), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (b)(5), is Pub. L. 93–288,
The National Emergencies Act, referred to in subsec. (b)(5), is Pub. L. 94–412,
The Consolidated Appropriations Act, 2018, referred to in subsec. (f)(2)(C), is Pub. L. 115–141,
A prior section 2811 of act
2022—Subsec. (b)(1). Pub. L. 117–328, § 2103(b)(2)(A), inserted “and, consistent with the National Response Framework and other applicable provisions of law, assist the Secretary in carrying out the functions under section 300hh of this title” after “emergencies”.
Subsec. (b)(4)(D). Pub. L. 117–263 substituted “section 660(b) of title 6” for “section 228(c) of the Homeland Security Act of 2002 (6 U.S.C. 149(c))”.
Subsec. (b)(4)(E). Pub. L. 117–328, § 2103(b)(2)(B)(i), substituted “recommend actions necessary to overcome these obstacles, such as—” and cls. (i) to (iii) for “the actions necessary to overcome these obstacles.”
Subsec. (b)(4)(G). Pub. L. 117–328, § 2103(b)(2)(B)(ii), inserted “each year, including national-level and State-level full-scale exercises not less than once every 4 years” after “operational exercises”, substituted “exercises—” and “(i) based on” for “exercises based on—”, added cls. (ii) and (iii), and redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i).
Subsec. (b)(4)(J). Pub. L. 117–328, § 2103(b)(2)(B)(iii), added subpar. (J).
Subsec. (g). Pub. L. 117–328, § 2103(c), added subsec. (g).
2019—Subsec. (b). Pub. L. 116–22, § 401(1), inserted “utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to” after “shall” in introductory provisions.
Subsec. (b)(4)(D). Pub. L. 116–22, § 703(b), amended subpar. (D) generally. Prior to amendment, text read as follows: “Provide integrated policy coordination and strategic direction with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan developed pursuant to section 314(a)(6) of title 6, or any successor plan, before, during, and following public health emergencies.”
Subsec. (b)(4)(I). Pub. L. 116–22, § 401(2), added subpar. (I).
Subsec. (b)(5). Pub. L. 116–22, § 302(a), inserted at end “Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise.”
Subsec. (b)(7). Pub. L. 116–22, § 501(1), substituted “March 15” for “March 1” in introductory provisions.
Subsec. (b)(7)(A)(iii) to (v). Pub. L. 116–22, § 501(2), added cls. (iii) to (v) and struck out former cl. (iii) which read as follows: “procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile;”.
Subsec. (b)(7)(D) to (F). Pub. L. 116–22, § 501(3), (4), added subpar. (D) and redesignated former subpars. (D) and (E) as (E) and (F), respectively.
Subsec. (d)(1). Pub. L. 116–22, § 402(b)(1), substituted “Not later than
Subsec. (d)(2)(C). Pub. L. 116–22, § 302(b), inserted “, and ancillary medical supplies to assist with the utilization of such countermeasures or products,” after “products”.
Subsec. (d)(2)(J)(v). Pub. L. 116–22, § 402(b)(2), substituted “2-year period” for “one-year period”.
Subsec. (f). Pub. L. 116–22, § 404(b), added subsec. (f).
2016—Subsec. (b)(7). Pub. L. 114–255, § 3083(1), in introductory provisions, substituted “Develop, and update not later than March 1 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) for each such threat.” for “Develop, and update on an annual basis, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d).”
Subsec. (b)(7)(D). Pub. L. 114–255, § 3083(3), substituted “, not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and” for “to the appropriate committees of Congress upon request.”
Subsec. (b)(7)(E). Pub. L. 114–255, § 3083(2), (4), added subpar. (E).
2013—Subsec. (b)(3). Pub. L. 113–5, § 102(a)(1)(A), inserted “, security countermeasures (as defined in section 247d–6b of this title),” after “qualified countermeasures (as defined in section 247d–6a of this title)”.
Subsec. (b)(4)(D) to (H). Pub. L. 113–5, § 102(a)(1)(B), added subpars. (D) to (H).
Subsec. (b)(7). Pub. L. 113–5, § 102(a)(1)(C), added par. (7).
Subsec. (c). Pub. L. 113–5, § 102(a)(2), added subsec. (c) and struck out former subsec. (c) which directed that the Assistant Secretary would have authority over and responsibility for the National Disaster Medical System and the Hospital Preparedness Cooperative Agreement Program, would exercise the responsibilities and authorities of the Secretary with respect to the coordination of the Medical Reserve Corps, the Emergency System for Advance Registration of Volunteer Health Professionals, the Strategic National Stockpile, and the Cities Readiness Initiative, and would assume other duties as determined appropriate by the Secretary.
Subsecs. (d), (e). Pub. L. 113–5, § 102(a)(3), added subsecs. (d) and (e).
Pub. L. 109–417, title I, § 102(b), “(1) There shall be transferred to the Office of the Assistant Secretary for Preparedness and Response the functions, personnel, assets, and liabilities of the Assistant Secretary for Public Health Emergency Preparedness as in effect on the day before the date of enactment of this Act [“(2) Any reference in any Federal law, Executive order, rule, regulation, or delegation of authority, or any document of or pertaining to the Assistant Secretary for Public Health Emergency Preparedness as in effect the day before the date of enactment of this Act, shall be deemed to be a reference to the Assistant Secretary for Preparedness and Response.”
Pub. L. 113–5, title I, § 102(b), “(1) the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet identified needs; and“(2) the coordination of efforts between the Department of Health and Human Services and the Department of Defense to address countermeasure needs for various segments of the population.”