Sec. 403. STRATEGIC NATIONAL STOCKPILE
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## SEC. 403 STRATEGIC NATIONAL STOCKPILE ###
(a)In General Section 319F-2(a) (42 U.S.C. 247d-6b(a)) is amended— ####
(1)by redesignating paragraphs
(2)and
(3)as paragraphs
(3)and (4), respectively; and ####
(2)in paragraph (1)— #####
(A)by inserting “the Assistant Secretary for Preparedness and Response and” after “collaboration with”; #####
(B)by inserting “and optimize” after “provide for”; #####
(C)by inserting “and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under section 2811-1, make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph (2)” before the period of the first sentence; and #####
(D)by striking the second sentence; ####
(3)by inserting after paragraph
(1)the following: > > #### “(2) Threat-based review > > > ##### “(A) In general > > The Secretary shall conduct an annual threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811-1, review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section 2811-1(c)(1)(A). Such review shall be submitted on June 15, 2019, and on March 15 of each year thereafter, 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, in a manner that does not compromise national security. > > > ##### “(B) Additions, modifications, and replenishments > > Each annual threat-based review under subparagraph
(A)shall, for each new or modified countermeasure procurement or replenishment, provide— > > > ###### “(i) > > information regarding— > > > ###### “(I) > > the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile; > > > ###### “(II) > > planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system; > > > ###### “(III) > > the presence or lack of a commercial market for the countermeasure at the time of procurement; > > > ###### “(IV) > > the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats; > > > ###### “(V) > > an assessment of whether the emergency health security threat or threats described in subclause
(IV)could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats; > > > ###### “(VI) > > whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile; > > > ###### “(VII) > > a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under section 2811(b)(7), including expected life-cycle costs, expenditures related to countermeasure procurement to address the threat or threats described in subclause (IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and > > > ###### “(VIII) > > appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and > > > ###### “(ii) > > an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.” > ; ####
(4)in paragraph (3), as so redesignated— #####
(A)in subparagraph (A), by inserting “and the Public Health Emergency Medical Countermeasures Enterprise established under section 2811-1” before the semicolon; #####
(B)in subparagraph (C), by inserting “, and the availability, deployment, dispensing, and administration of countermeasures” before the semicolon; #####
(C)by amending subparagraph
(E)to read as follows: > > ##### “(E) > > devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, Tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;” > ; #####
(D)in subparagraph (G), by striking “; and” and inserting a semicolon; #####
(E)in subparagraph (H), by striking the period and inserting a semicolon; and #####
(F)by adding at the end the following: > > ##### “(I) > > ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under section 319L, including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States; and > > > ##### “(J) > > provide assistance, including technical assistance, to maintain and improve State and local public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as appropriate.” > ; and ####
(5)by adding at the end the following: > > #### “(5) GAO report > > > ##### “(A) In general > > Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015. Such review shall include— > > > ###### “(i) > > an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment; > > > ###### “(ii) > > an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment; > > > ###### “(iii) > > an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment; > > > ###### “(iv) > > an accounting of countermeasures procured, modified, or replenished under paragraph
(1)that received advanced research and development funding from the Biomedical Advanced Research and Development Authority; > > > ###### “(v) > > an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1); > > > ###### “(vi) > > a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of the stockpile to meet emergency health security needs; > > > ###### “(vii) > > an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph
(2)align with previous relevant reports or reviews by the Secretary or the Comptroller General; > > > ###### “(viii) > > with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities; and > > > ###### “(ix) > > an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection
(a)receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section 319L, including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the United States. > > > ##### “(B) Submission > > Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.” > . ###
(b)Additional Reporting In the first threat-based review submitted after the date of enactment of this Act pursuant to paragraph
(2)of section 319F-2(a) of the Public Health Service Act (42 U.S.C. 247d-6b(a)), as amended by subsection (a), the Secretary shall include a description of the processes and procedures through which the Director of the Strategic National Stockpile and the Director of the Biomedical Advanced Research and Development Authority coordinate with respect to countermeasures and products procured under such section 319F-2(a), including such processes and procedures in place to ensure countermeasures and products under consideration for procurement pursuant to such section 319F-2(a) receive the same consideration regardless of whether such countermeasures or products receive or had received funding under section 319L of the Public Health Service Act (42 U.S.C. 247d-7e), and whether such countermeasures and products are the most appropriate to meet the emergency health security needs of the United States. ###
(c)Authorization of Appropriations, Strategic National Stockpile Section 319F-2(f)(1) (42 U.S.C. 247d-6b(f)(1)) is amended by striking “$533,800,000 for each of fiscal years 2014 through 2018” and inserting “$610,000,000 for each of fiscal years 2019 through 2023, to remain available until expended”.
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