,,ii #aafth ,,congress #b;d ,session ,s4 #dcfh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bi1 #bjbj,mr4 ,brown introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to prepare the ,strategic ,national ,stockpile for a public health emergency and require the maintenance of a domestic supply chain for countermeasures in the stockpile1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,protecting ,american ,heroes ,act of #bjbj4 #b4 ,strategic national stockpile 7a7 ,additional provisions ,to prepare the ,strategic ,national ,stockpile for public health emergencies 7#a7 ,in general ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7,a7 by redesignating subsection 7h7 as subsection 7i72 and 7,b7 by inserting after subsection 7g7 the following3 7h7 ,additional provisions ,to prepare the ,strategic ,national ,stockpile for public health emergencies 7#a7 ,preparing for emergencies affecting all ,states 7,a7 ,in general ,the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a shall develop a model to enable the stockpile under subsection 7a77#a7 to be prepared to effectively respond to a public health emergency1 including one that simultaneously affects all ,states4 7,b7 ,model ,the model under subparagraph 7,a7 shall include-- 7i7 7,i7 requirements with respect to the number1 types1 and amounts of countermeasures that are necessary to prepare the stockpile under subsection 7a77#a7 to respond to a public health emergency described in subparagraph 7,a72 and 7,,ii7 the cost necessary to meet such requirements2 7ii7 an assessment of the domestic supply chain for all countermeasures that are needed for the stockpile to be prepared for a public health emergency described in subparagraph 7,a71 including-- 7,i7 an identification of any known domestic suppliers of such countermeasures2 7,,ii7 an identification of any gaps in the domestic supply chain for such countermeasures2 7,,iii7 steps needed to address the gaps in the domestic supply chain for such countermeasures2 7,,iv7 an identification of any countermeasure in the stockpile that only has one source1 domestic or foreign1 for procurement2 and 7,v7 steps needed to diversify sources for any countermeasure in the stockpile that has only one source1 domestic or foreign1 for procurement4 7,c7 ,submission to ,congress ,not later than #abj days after the date of enactment of the ,protecting ,american ,heroes ,act of #bjbj1 the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a shall submit the assessment required under subparagraph 7,b77ii7 to each ,committee described in subsection 7a77#b77;,a74 7#b7 ,requirement to identify and maintain domestic supply chain 7,a7 ,in general ,the ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile appointed under paragraph 7#c7 7referred to in this paragraph as the ,executive ,deputy ,assistant ,secretary7 shall1 in accordance with this paragraph1 identify and maintain a domestic source 7which may be multiple sources7 for all countermeasures in the stockpile under subsection 7a77#a74 7,b7 ,requirement for items in stockpile 7i7 ,in general ,except as provided under clause 7ii71 the ,executive ,deputy ,assistant ,secretary shall require all countermeasures in the stockpile under subsection 7a77#a71 and any component part of such countermeasures1 to be grown1 reprocessed1 reused1 or produced in the ,united ,states4 7ii7 ,waivers ,the ,executive ,deputy ,assistant ,secretary may1 on a case-by-case basis1 waive the requirement under clause 7i7 in the case of a contract for a countermeasure in the stockpile under subsection 7a77#a7-- 7,i7 for which the ,executive ,deputy ,assistant ,secretary determines that a satisfactory quality and sufficient quantity of such countermeasure that is grown1 reprocessed1 reused1 or produced in the ,united ,states cannot be procured as and when needed at ,united ,states market prices2 or 7,,ii7 that is1 or includes1 any material determined to be a nonavailable article under section #be4ajd of the ,federal ,acquisition ,regulation for purposes of subpart ,i of part #be of the ,federal ,acquisition ,regulation4 7iii7 ,notification of waivers ,in the case of any contract for the procurement of a countermeasure in the stockpile under subsection 7a77#a71 if the ,executive ,deputy ,assistant ,secretary applies a waiver under clause 7ii7 with respect to that contract1 the ,executive ,deputy ,assistant ,secretary shall1 not later than #g days after the award of the contract1 submit to each ,committee described in subsection 7a77#b77;,a7 a notification that the waiver has been applied4 7,c7 ,notice of discontinuance or interruption in domestic supply chain 7i7 ,timing ,the ,executive ,deputy ,assistant ,secretary shall require any manufacturer of a countermeasure in the stockpile under subsection 7a77#a7 7other than a countermeasure to which a waiver has been applied under subparagraph 7,b77ii77 to provide notice to the ,executive ,deputy ,assistant ,secretary of any discontinuance or interruption in the manufacture of such countermeasure4 ,such notice shall be submitted to the ,executive ,deputy ,assistant ,secretary-- 7,i7 at least #f months prior to the date of the discontinuance or interruption2 or 7,,ii7 if compliance with subclause 7,i7 is not possible1 as soon as practicable4 7ii7 ,contents ,the notice required under clause 7i7 shall include disclosure of-- 7,i7 reasons for the discontinuation or interruption of the countermeasure2 7,,ii7 if applicable1 and without disclosing proprietary information1 if an active pharmaceutical ingredient is a reason for1 or risk factor in1 such discontinuation or interruption1 the source of the active pharmaceutical ingredient1 and any alternative sources for the active pharmaceutical ingredient known by the manufacturer2 7,,iii7 if applicable1 whether any associated device used for preparation or administration included in the countermeasure is a reason for1 or a risk factor in1 such discontinuation or interruption2 7,,iv7 if applicable1 the expected duration of the interruption2 and 7,v7 any such other information as the ,executive ,deputy ,assistant ,secretary may require4 7#c7 ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile 7,a7 ,in general ,the ,assistant ,secretary for ,preparedness and ,response shall appoint an ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile 7referred to in this paragraph as the ,executive ,deputy ,assistant ,secretary71 who shall report directly to the ,assistant ,secretary for ,preparedness and ,response and serve in a career reserved position1 as defined in section #cacb7;a7 of title #e1 ,united ,states ,code4 7,b7 ,qualifications ,any individual appointed as the ,executive ,deputy ,assistant ,secretary under subparagraph 7,a7 shall be selected from individuals who1 on the day before the date of enactment of the ,protecting ,american ,heroes ,act of #bjbj-- 7i7 are career appointees1 as defined in section #cacb7;a7 of title #e1 ,united ,states ,code2 or 7ii7 are former such career appointees and are eligible for reinstatement as such career appointees4 7,c7 ,functions ,the ,executive ,deputy ,assistant ,secretary appointed under subparagraph 7,a7 shall-- 7i7 notwithstanding the functions of the ,assistant ,secretary for ,preparedness and ,response under section #bhaa-a1 have authority to make decisions with respect to the stockpile under subsection 7a77#a72 7ii7 establish and maintain a domestic supply chain for countermeasures in such stockpile to the greatest extent possible2 7iii7 consult with ,states and relevant stakeholders1 including public health organizations1 about the procurement and distribution of countermeasures in the stockpile2 and 7iv7 carry out all other duties of any individual serving as the ,director of the ,strategic ,national ,stockpile prior to the date of enactment of the ,protecting ,american ,heroes ,act of #bjbj4 7,d7 ,quarterly report ,not later than #ahj days after the date of enactment of the ,protecting ,american ,heroes ,act of #bjbj1 and each calendar quarter thereafter1 the ,executive ,deputy ,assistant ,secretary shall submit to the ,assistant ,secretary for ,preparedness and ,response and each ,committee described in subsection 7a77#b77;,a7 a report that includes-- 7i7 the number1 types1 and amounts of countermeasures in the stockpile under subsection 7a77#a72 7ii7 whether such number1 types1 and amounts are sufficient to meet a public health emergency that simultaneously affects all ,states2 7iii7 whether any countermeasures in the stockpile have expired or failed to receive necessary maintenance in a timely fashion2 7iv7 the status of the domestic supply chain with respect to countermeasures in such stockpile1 including-- 7,i7 whether there are gaps in the supply chain1 including the domestic supply chain1 for such countermeasures2 and 7,,ii7 any instance in which the ,executive ,deputy ,assistant ,secretary applies a waiver under paragraph 7#b77;,b77ii7 to a countermeasure2 7v7 recommended steps necessary to address any gap described in clause 7iv77,i72 and 7vi7 7,i7 whether any countermeasures in such stockpile are obtained from a sole source2 and 7,,ii7 whether any steps should be taken to diversify sourcing of such countermeasures4 7,e7 ,first appointment ,with respect to the first individual to serve as the ,executive ,deputy ,assistant ,secretary after the date of enactment of the ,protecting ,american ,heroes ,act of #bjbj1 the ,assistant ,secretary for ,preparedness and ,response shall appoint such individual under subparagraph 7,a7 not later than #ij days after such date of enactment4 7#d7 ,definition of countermeasure ,in this subsection1 the term countermeasure includes a drug1 vaccine or other biological product1 medical device1 or other supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 medical devices1 and diagnostic tests in the stockpile7 described in subsection 7a77#a74 4 7#b7 ,appropriations ,section #cai;,f-#b7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77 is amended-- 7,a7 in the subsection heading1 by striking ,authorization of ,appropriations and inserting ,appropriations2 authorization of appropriations2 and 7,b7 by amending paragraph 7#a7 to read as follows3 7#a7 ,strategic ,national ,stockpile ,there are appropriated1 out of any money in the ,treasury not otherwise appropriated1 such sums as necessary1 to remain available until expended1 to carry out subsections 7a7 and 7h74 ,such amounts are in addition to any amounts in the special reserve fund under subsection 7g74 4 7#c7 ,conforming amendments 7,a7 ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7i7 in subsection 7c71 by striking as defined in subsection 7h7 each place it appears2 and 7ii7 in subsection 7f71 by striking as referred to in subsection 7h74 7,b7 ,section #bhaa7;d77#b77;,g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#b77;,g77 is amended by striking as defined in section #cai;,f-#b7;h7 and inserting as defined in section #cai;,f-#b7;i74 7b7 ,domestic supply chain evaluations in threat assessment and ,,gao report2 functions of ,secretary ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by inserting 1 including the domestic supply chain for such contents1 after within the stockpile2 and 7,b7 in subparagraph 7,b77i77,,ii71 by inserting 1 including domestic manufacturing capacity1 after appropriate manufacturing capacity2 7#b7 in paragraph 7#c7-- 7,a7 by redesignating subparagraphs 7,e7 through 7,j7 as subparagraphs 7,f7 through 7,k71 respectively2 7,b7 by inserting after subparagraph 7,d7 the following3 7,e7 acting through the ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile appointed under subsection 7h77#c71 in accordance with subsection 7h77#b71 establish1 maintain1 and 7when necessary7 expand a supply chain based in the ,united ,states for countermeasures 7as defined in subsection 7h77#d77 in the stockpile2 2 and 7,c7 in subparagraph 7,f71 as so redesignated1 by inserting to ensure a robust supply chain for the production in the ,united ,states of countermeasures 7as defined in subsection 7h77#d771 before in consultation with2 and 7#c7 in paragraph 7#e77;,a7-- 7,a7 by redesignating clauses 7iii7 through 7ix7 as clauses 7iv7 through 7x71 respectively2 and 7,b7 by inserting after clause 7ii7 the following3 7iii7 an assessment of the plans developed by the ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile appointed under subsection 7h77#c7 to1 in accordance with subsection 7h77#b71 establish1 maintain1 and 7when necessary7 expand a supply chain based in the ,united ,states for countermeasures 7as defined in subsection 7h77#d77 procured for the stockpile2 4 7c7 ,enhancing threat-,based reviews ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is amended-- 7#a7 in paragraph 7#a71 by striking based on the review conducted under paragraph 7#b7 and inserting based on any review conducted under paragraph 7#b72 and 7#b7 in paragraph 7#b71 by adding at the end the following3 7,c7 ,in-person or virtual briefings 7i7 ,in general ,not later than #cj days after submitting each annual threat-based review under subparagraph 7,a7 to the ,committees described in such subparagraph1 the ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile1 appointed under subsection 7h77#c71 shall provide an in-person1 or virtual1 briefing on such review to the members of such ,committees4 7ii7 ,public health emergencies 7,i7 ,monthly reviews ,during the period of any public health emergency1 the ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile1 appointed under subsection 7h77#c71 shall1 on a monthly basis1 provide an in-person1 or virtual1 briefing to all members of ,congress on-- 7aa7 the countermeasures 7as defined in subsection 7h7#d77 in the stockpile under paragraph 7#a72 7bb7 the status of the supply chain1 including the domestic supply chain1 for such countermeasures2 7cc7 how such countermeasures are being distributed2 and 7dd7 communication with ,state and local governments on their needs with respect to acquiring such countermeasures in the stockpile and on the status of countermeasures that are available in the stockpile4 7,,ii7 ,baseline review ,not later than #ae days after the date of enactment of the ,protecting ,american ,heroes ,act of #bjbj1 the ,secretary shall conduct a baseline review of the stockpile under paragraph 7#a7 and provide an in-person1 or virtual1 briefing to all members of ,congress on each issue described in items 7aa7 through 7dd7 of subclause 7,i74 7,d7 ,supplemental reviews ,in the event that the ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile1 appointed under subsection 7h77#c71 determines there is a significant depletion of any countermeasure 7as defined in subsection 7h77#d77 in the stockpile under paragraph 7#a71 the ,executive ,deputy ,assistant ,secretary of the ,strategic ,national ,stockpile shall1 not later than #cj days after making such determination-- 7i7 conduct a supplemental threat-based review on each issue described in items 7aa7 through 7dd7 of subparagraph 7,c77,i72 and 7ii7 provide such review in writing to the ,committees described in subparagraph 7,a74 4 #c4 ,enhancements to the ,defense ,production ,act of #aiej ,section #ajg of the ,defense ,production ,act of #aiej 7#ej ,u4,s4,c4 #deag7 is amended by adding at the end the following3 7c7 ,health emergency authority ,with respect to a public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d71 or preparations for such a public health emergency1 the ,secretary of ,health and ,human ,services and the ,administrator of the ,federal ,emergency ,management ,agency may carry out the authorities provided under this section to the same extent as the ,president4 4