,,ib ,union ,calendar ,no4 #dah #aafth ,,congress #b;d ,session ,h4 ,r4 #gegd ,report ,no4 #aaf-eah ,,in ,,the ,,house ,,of ,,representatives ,july #ac1 #bjbj,ms4 ,slotkin 7for herself1 ,mrs4 ,brooks of ,indiana1 ,ms4 ,eshoo1 ,mr4 ,carter of ,georgia1 ,mrs4 ,dingell1 ,mrs4 ,walorski1 ,ms4 ,de,gette1 ,mr4 ,mc,kinley1 ,mr4 ,butterfield1 ,mr4 ,van ,drew1 ,mr4 ,soto1 ,mr4 ,upton1 ,mr4 ,malinowski1 ,mr4 ,hudson1 ,ms4 ,schrier1 ,mr4 ,gianforte1 ,mr4 ,cisneros1 ,mr4 ,neguse1 and ,mr4 ,burgess7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,september #ah1 #bjbj;,additional sponsors3 ,mr4 ,lujn and ,mr4 ,fitzpatrick ,september #ah1 #bjbj,reported with an amendment2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed,strike out all after the enacting clause and insert the part printed in italic,for text of introduced bill1 see copy of bill as introduced on ,july #ac1 #bjbj ,a ,,bill ,to amend the ,public ,health ,service ,act with respect to the ,strategic ,national ,stockpile1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,strengthening ,america's ,strategic ,national ,stockpile ,act of #bjbj4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,reimbursable transfers4,sec4 #c4 ,equipment maintenance4,sec4 #d4 ,supply chain flexibility manufacturing pilot4,sec4 #e4 ,,gao study on the feasibility and benefits of a user fee agreement4,sec4 #f4 ,grants for ,state strategic stockpiles4,sec4 #g4 ,action reporting4,sec4 #h4 ,improved1 transparent processes4,sec4 #i4 ,authorization of appropriations4 #b4 ,reimbursable transfers ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is amended by adding at the end the following3 7#f7 ,transfers and reimbursements 7,a7 ,in general ,without regard to chapter #e of title #dj1 ,united ,states ,code1 the ,secretary may transfer to any ,federal department or agency1 on a reimbursable basis1 any drugs1 vaccines and other biological products1 medical devices1 and other supplies in the stockpile if-- 7i7 the transferred supplies are less than one year from expiry2 7ii7 the stockpile is able to replenish the supplies1 as appropriate2 and 7iii7 the ,secretary decides the transfer is in the best interest of the ,united ,states ,government4 7,b7 ,use of reimbursement ,reimbursement derived from the transfer of supplies pursuant to subparagraph 7,a7 may be used by the ,secretary1 without further appropriation and without fiscal year limitation1 to carry out this section4 7,c7 ,rule of construction ,this paragraph shall not be construed to preclude transfers of products in the stockpile under other authorities4 7,d7 ,report ,not later than ,september #cj1 #bjbb1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on each transfer made under this paragraph and the amount received by the ,secretary in exchange for that transfer4 7,e7 ,sunset ,the authority to make transfers under this paragraph shall cease to be effective on ,september #cj1 #bjbc4 4 #c4 ,equipment maintenance ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 in subparagraph 7,i71 by striking 2 and and inserting a semicolon2 7,b7 in subparagraph 7,j71 by striking the period at the end and inserting a semicolon2 and 7,c7 by inserting the following new subparagraph at the end3 7,k7 ensure contents of the stockpile remain in good working order and1 as appropriate1 conduct maintenance services on contents of the stockpile2 and 2 and 7#b7 in subsection 7c77#g77;,b71 by adding at the end the following new clause3 7ix7 ,equipment maintenance service ,in carrying out this section1 the ,secretary may enter into contracts for the procurement of equipment maintenance services4 4 #d4 ,supply chain flexibility manufacturing pilot 7a7 ,in general ,section #cai;,f-#b7;a77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c771 as amended by section #c1 is further amended by adding at the end the following new subparagraph3 7,l7 enhance medical supply chain elasticity and establish and maintain domestic reserves of critical medical supplies 7including personal protective equipment1 ancillary medical supplies1 and other applicable supplies required for the administration of drugs1 vaccines and other biological products1 and other medical devices 7including diagnostic tests77 by-- 7i7 increasing emergency stock of critical medical supplies2 7ii7 geographically diversifying domestic production of such medical supplies1 as appropriate2 7iii7 entering into cooperative agreements or partnerships with respect to manufacturing lines1 facilities1 and equipment for the domestic production of such medical supplies2 and 7iv7 managing1 either directly or through cooperative agreements with manufacturers and distributors1 domestic reserves established under this subparagraph by refreshing and replenishing stock of such medical supplies4 4 7b7 ,reporting2 sunset ,section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 as amended by section #b1 is further amended by adding at the end the following3 7#g7 ,reporting ,not later than ,september #cj1 #bjbb1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate a report on the details of each cooperative agreement or partnership entered into under paragraph 7#c77,l71 including the amount expended by the ,secretary on each such cooperative agreement or partnership4 7#h7 ,sunset ,the authority to enter into cooperative agreements or partnerships pursuant to paragraph 7#c77,l7 shall cease to be effective on ,september #cj1 #bjbc4 4 7c7 ,funding ,section #cai;,f-#b7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77 is amended by adding at the end the following3 7#c7 ,supply chain elasticity 7,a7 ,in general ,for the purpose of carrying out subsection 7a77#c77,l71 there is authorized to be appropriated #ejj1jjj1jjj for each of fiscal years #bjbj through #bjbc1 to remain available until expended4 7,b7 ,relation to other amounts ,the amount authorized to be appropriated by subparagraph 7,a7 for the purpose of carrying out subsection 7a77#c77,l7 is in addition to any other amounts available for such purpose4 4 #e4 ,,gao study on the feasibility and benefits of a user fee agreement 7a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study to investigate the feasibility of establishing user fees to offset certain ,federal costs attributable to the procurement of single-source materials for the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 and distributions of such materials from the ,stockpile4 ,in conducting this study1 the ,comptroller ,general shall consider1 to the extent information is available-- 7#a7 whether entities receiving such distributions generate profits from those distributions2 7#b7 any ,federal costs attributable to such distributions2 7#c7 whether such user fees would provide the ,secretary with funding to potentially offset procurement costs of such materials for the ,strategic ,national ,stockpile2 and 7#d7 any other issues the ,comptroller ,general identifies as relevant4 7b7 ,report ,not later than ,february #a1 #bjbc1 the ,comptroller ,general of the ,united ,states shall submit to the ,congress a report on the findings and conclusions of the study under subsection 7a74 #f4 ,grants for ,state strategic stockpiles ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cai;,f-#d of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 the following new section3 #cai;,f-#e4 ,grants for ,state strategic stockpiles 7a7 ,in general ,the ,secretary may establish a pilot program consisting of awarding grants to ,states to expand or maintain a strategic stockpile of commercially available drugs1 medical equipment1 personal protective equipment1 and other products deemed by the ,state to be essential in the event of a public health emergency4 7b7 ,allowable use of funds 7#a7 ,uses ,a ,state receiving a grant under this section may use the grant funds to-- 7,a7 acquire commercially available products listed pursuant to paragraph 7#b7 for inclusion in the ,state's strategic stockpile2 7,b7 store1 maintain1 and distribute products in such stockpile2 and 7,c7 conduct planning in connection with such activities4 7#b7 ,list ,the ,secretary shall develop and publish a list of the products that are eligible1 as described in subsection 7a71 for inclusion in a ,state's strategic stockpile using funds received under this section4 7#c7 ,consultation ,in developing the list under paragraph 7#b7 and otherwise determining the allowable uses of grant funds under this section1 the ,secretary shall consult with ,states and relevant stakeholders1 including public health organizations4 7c7 ,funding requirement ,the ,secretary may not obligate or expend any funds to award grants or fund any previously awarded grants under this section for a fiscal year unless the total amount made available to carry out section #cai;,f-#b for such fiscal year is equal to or greater than the total amount of funds made available to carry out section #cai;,f-#b for fiscal year #bjbj4 7d7 ,matching funds 7#a7 ,in general ,with respect to the costs of expanding and maintaining a strategic stockpile through a grant under this section1 as a condition on receipt of the grant1 a ,state shall make available 7directly7 non-,federal contributions in cash toward such costs in an amount that is equal to not less than the amount of ,federal funds provided through the grant4 7#b7 ,waiver ,the ,secretary may waive the requirement of paragraph 7#a7 with respect to a ,state for the first two years of the ,state receiving a grant under this section if the ,secretary determines that such waiver is needed for the ,state to establish a strategic stockpile described in subsection 7a74 7e7 ,technical assistance ,the ,secretary shall provide technical assistance to ,states in establishing1 expanding1 and maintaining a stockpile described in subsection 7a74 7f7 ,definition ,in this section1 the term drug has the meaning given to that term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #c1ejj1jjj1jjj for each of fiscal years #bjbj through #bjbc1 to remain available until expended4 7h7 ,sunset ,the authority vested by this section terminates at the end of fiscal year #bjbc4 4 #g4 ,action reporting 7a7 ,in general ,the ,assistant ,secretary for ,preparedness and ,response 7in this section referred to as the ,assistant ,secretary71 in coordination with the ,administrator of the ,federal ,emergency ,management ,agency1 shall-- 7#a7 not later than #cj days after the date of enactment of this ,act1 issue a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate regarding all ,state1 local1 ,tribal1 and territorial requests for supplies from the ,strategic ,national ,stockpile related to ,,covid-#ai2 and 7#b7 not less than every #cj days thereafter through the end of the emergency period 7as such term is defined in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b7771 submit to such committees an updated version of such report4 7b7 ,reporting period 7#a7 ,initial report ,the initial report under subsection 7a7 shall address all requests described in such subsection made during the period-- 7,a7 beginning on ,january #ca1 #bjbj2 and 7,b7 ending on the date that is #cj days before the date of submission of the report4 7#b7 ,updates ,each update to the report under subsection 7a7 shall address all requests described in such subsection made during the period-- 7,a7 beginning at the end of the previous reporting period under this section2 and 7,b7 ending on the date that is #cj days before the date of submission of the updated report4 7c7 ,contents of report ,the report under subsection 7a7 7and updates thereto7 shall include-- 7#a7 the details of each request described in such subsection1 including-- 7,a7 the specific medical countermeasures1 devices1 personal protective equipment1 and other materials requested2 and 7,b7 the amount of such materials requested2 and 7#b7 the outcomes of each request described in subsection 7a71 including-- 7,a7 whether the request was wholly fulfilled1 partially fulfilled1 or denied2 7,b7 if the request was wholly or partially fulfilled1 the fulfillment amount2 and 7,c7 if the request was partially fulfilled or denied1 a rationale for such outcome4 #h4 ,improved1 transparent processes 7a7 ,in general ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services1 in collaboration with the ,assistant ,secretary for ,preparedness and ,response and the ,director of the ,centers for ,disease ,control and ,prevention1 shall develop and implement improved1 transparent processes for the use and distribution of drugs1 vaccines and other biological products1 medical devices1 and 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 tests7 in the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 7in this section referred to as the ,stockpile74 7b7 ,processes ,the processes developed under subsection 7a7 shall include-- 7#a7 the form and manner in which ,states1 localities1 ,tribes1 and territories are required to submit requests for supplies from the ,stockpile2 7#b7 the criteria used by the ,secretary of ,health and ,human ,services in responding to such requests1 including the reasons for fulfilling or denying such requests2 7#c7 what circumstances result in prioritization of distribution of supplies from the ,stockpile to ,states1 localities1 ,tribes1 or territories2 7#d7 clear plans for future1 urgent communication between the ,secretary and ,states1 localities1 ,tribes1 and territories regarding the outcome of such requests2 and 7#e7 any differences in the processes developed under subsection 7a7 for geographically related emergencies1 such as weather events1 and national emergencies1 such as pandemics4 7c7 ,classification ,the processes developed under subsection 7a7 shall be unclassified to the greatest extent possible consistent with national security4 ,the ,secretary of ,health and ,human ,services may classify portions of such processes as necessary to protect national security4 7d7 ,report to ,congress ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services shall-- 7#a7 submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate regarding the improved1 transparent processes developed under this section2 7#b7 include in such report recommendations for opportunities for communication 7by telebriefing1 phone calls1 or in-person meetings7 between the ,secretary and ,states1 localities1 ,tribes1 and territories regarding such improved1 transparent processes2 and 7#c7 submit such report in unclassified form to the greatest extent possible1 except that the ,secretary may include a classified appendix if necessary to protect national security4 #i4 ,authorization of appropriations ,section #cai;,f-#b7;f77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is amended by striking #faj1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #gje1jjj1jjj for each of fiscal years #bjbj through #bjbc4 ,september #ah1 #bjbj,reported with an amendment2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed