,,ii #aagth ,,congress #b;d ,session ,s4 #cehh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #g 7legislative day1 ,february #c71 #bjbb,mr4 ,romney 7for himself and ,ms4 ,hassan7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act to improve domestic manufacturing surge capacity and capabilities for biodefense and pandemic preparedness4 #a4 ,short title ,this ,act may be cited as the ,medical ,countermeasures ,surge ,capacity ,act of #bjbb4 #b4 ,warm base manufacturing capacity for medical countermeasures 7a7 ,in general ,section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended-- 7#a7 in subsection 7a77#f77;,b7-- 7,a7 by redesignating clauses 7iv7 and 7v7 as clauses 7v7 and 7vi71 respectively2 7,b7 by inserting after clause 7iii71 the following3 7iv7 activities to support1 maintain1 and improve domestic manufacturing surge capacity and capabilities1 as appropriate1 including through the utilization of advanced manufacturing and platform technologies1 to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products2 2 and 7,c7 in clause 7vi7 7as so redesignated71 by inserting manufacturing1 after improvement12 7#b7 in subsection 7b7-- 7,a7 in the first sentence of paragraph 7#a71 by inserting support for domestic manufacturing surge capacity and capabilities1 after initiatives for innovation12 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 and 7iii7 by inserting after subparagraph 7,b71 the following3 7,c7 activities to support1 maintain1 and improve domestic manufacturing surge capacity and capabilities1 as appropriate1 including through the utilization of advanced manufacturing and platform technologies1 to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products2 and 2 7#c7 in subsection 7c7-- 7,a7 in paragraph 7#b77;,b71 by inserting before the semicolon 1 including through the establishment and maintenance of domestic manufacturing surge capacity and capabilities1 consistent with subsection 7a77#f77;,b77iv72 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,a7-- 7,i7 in clause 7i7-- 7aa7 in subclause 7,i71 by striking and at the end2 and 7bb7 by adding at the end the following3 7,,iii7 facilitating such communication1 as appropriate1 regarding manufacturing surge capacity and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic products to prepare for1 or respond to1 a public health emergency or potential public health emergency2 and 7,,iv7 facilitating such communication1 as appropriate and in a manner that does not compromise national security1 with respect to potential eligibility for the material threat medical countermeasure priority review voucher program under section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 2 7,,ii7 in clause 7ii77,,iii71 by striking and at the end2 7,,iii7 by redesignating clause 7iii7 as clause 7iv72 and 7,,iv7 by inserting after clause 7ii71 the following3 7iii7 communicate regularly with entities in receipt of an award pursuant to subparagraph 7,b77v71 and facilitate communication between such entities and other entities in receipt of an award pursuant to subparagraph 7,b77iv71 as appropriate1 for purposes of planning regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities1 including any planned uses of such capacity and capabilities in the near- and mid-term1 and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities2 and 2 7ii7 in subparagraph 7,b7-- 7,i7 in clause 7iii71 by striking and at the end2 7,,ii7 in clause 7iv71 by striking the period and inserting 2 and2 and 7,,iii7 by adding at the end the following3 7v7 award contracts1 grants1 and cooperative agreements and enter into other transactions to support1 maintain1 and improve domestic manufacturing surge capacity and capabilities1 including through supporting flexible or advanced manufacturing1 to ensure that additional capacity is available to rapidly manufacture products that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency4 2 7iii7 in subparagraph 7,c7-- 7,i7 in clause 7i71 by striking and at the end2 7,,ii7 in clause 7ii71 by striking the period at the end and inserting 2 and2 and 7,,iii7 by adding at the end the following3 7iii7 consult with the ,commissioner of ,food and ,drugs1 pursuant to section #efe7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 to ensure that facilities performing manufacturing1 pursuant to an award under subparagraph 7,b77v71 are in compliance with applicable requirements under such ,act and this ,act1 as appropriate1 including current good manufacturing practice pursuant to section #eja7;a77#b77;,b7 of the ,food1 ,drug1 and ,cosmetic ,act2 and 2 7iv7 in subparagraph 7,d77i71 by inserting 1 including to improve manufacturing capacities and capabilities for medical countermeasures before the semicolon2 7v7 in subparagraph 7,e77ix71 by striking #bjbc and inserting #bjbh2 and 7vi7 by adding at the end the following3 7,g7 ,annual reports by award recipients ,as a condition of receiving an award under subparagraph 7,b77v71 a recipient shall develop and submit to the ,secretary annual reports related to the maintenance of such capacity and capabilities1 including ensuring that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the ,secretary4 2 and 7,c7 in paragraph 7#e71 by adding at the end the following3 7,h7 ,supporting warm-base and surge capacity and capabilities ,pursuant to an award under subparagraph 7,b77v71 the ,secretary may make payments for activities necessary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the ,secretary to prepare for1 or respond to1 an existing or potential public health emergency or otherwise address threats that pose a significant level of risk to national security4 ,the ,secretary may support the utilization of such capacity and capabilities under awards for countermeasure and product advanced research and development1 as appropriate1 to provide for the maintenance of such capacity and capabilities4 2 and 7#d7 in subsection 7f7-- 7,a7 in paragraph 7#a71 by striking ,not later than #ahj days after the date of enactment of this subsection and inserting ,not later than #ahj days after the date of enactment of the ,medical ,countermeasures ,surge ,capacity ,act of #bjbb2 7,b7 in paragraph 7#b7-- 7i7 in the matter preceding subparagraph 7,a71 by striking this subsection and inserting the ,medical ,countermeasures ,surge ,capacity ,act of #bjbb2 7ii7 in subparagraph 7,b71 by striking and at the end2 and 7iii7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7,d7 plans for the near-1 mid-1 and long-term sustainment of manufacturing activities carried out under this section1 including such activities pursuant to subsection 7c77#e77;,h71 specific actions to regularly assess the ability of recipients of an award under subsection 7c77#d77;,b77v7 to rapidly manufacture countermeasures as required by the ,secretary1 and recommendations to address challenges1 if any1 related to such activities4 4