,i #aafth ,,congress #b;d ,session ,h4 ,r4 #ficj ,,in ,,the ,,house ,,of ,,representatives ,may #ai1 #bjbj ,mr4 ,carter of ,georgia 7for himself1 ,mr4 ,griffith1 ,mr4 ,mc,kinley1 ,mr4 ,crawford1 and ,mr4 ,soto7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to mitigate drug shortages and provide incentives for maintaining1 expanding1 and relocating the manufacturing of active pharmaceutical ingredients1 excipients1 medical diagnostic devices1 pharmaceuticals1 and personal protective equipment in the ,united ,states1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,manufacturing ,,api1 ,drugs1 and ,excipients in ,america ,act of #bjbj or the ,,made in ,america ,act of #bjbj4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,title ,i--,health provisions ,sec4 #aja4 ,report to ,congress on barriers to domestic manufacturing of medical products and supplies4 ,sec4 #ajb4 ,enhance intraagency coordination and public health assessment with regard to compliance activities4 ,sec4 #ajc4 ,encouraging international harmonization4 ,sec4 #ajd4 ,mutual recognition agreements for inspections and review activities4 ,sec4 #aje4 ,enhancing transparency of drug facility inspection timelines4 ,sec4 #ajf4 ,advanced manufacturing technologies program4 ,title ,,ii--,tax incentives to increase domestic pharmaceutical and medical device production ,sec4 #bja4 ,credit for pharmaceutical and medical device production activities in distressed zones4 ,i ,health provisions #aja4 ,report to ,congress on barriers to domestic manufacturing of medical products and supplies 7a7 ,report ,not later than ,january #a1 #bjba1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 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 barriers to domestic manufacturing of active pharmaceutical ingredients1 drugs1 and devices that are sourced or manufactured outside of the ,united ,states4 7b7 ,contents ,such report shall-- 7#a7 identify factors that limit or otherwise discourage the domestic manufacturing of active pharmaceutical ingredients1 drugs1 and devices that are currently sourced or manufactured outside of the ,united ,states1 including any ,federal1 ,state1 local1 or ,tribal laws and regulations that hinder domestic manufacturing opportunities2 and 7#b7 recommend specific strategies to overcome the challenges identified under paragraph 7#a71 including strategies-- 7,a7 to develop effective incentives for domestic manufacturing2 and 7,b7 to make changes to laws or regulations that hinder domestic manufacturing opportunities4 7c7 ,consultation ,in carrying out the report under subsection 7a71 the ,secretary shall consult with-- 7#a7 the ,food and ,drug ,administration1 the ,centers for ,medicare ,medicaid ,services1 the ,department of ,defense1 the ,department of ,commerce1 the ,department of ,state1 the ,department of ,veterans ,affairs1 the ,department of ,justice1 and any other ,federal agencies as appropriate2 and 7#b7 relevant stakeholders1 including drug1 device1 and active pharmaceutical ingredient manufacturers1 and other entities1 as appropriate4 7d7 ,definition ,in this section1 the term active pharmaceutical ingredient has the meaning given to such term in section #bjg4a of title #ba1 ,code of ,federal ,regulations 7and any successor regulations74 7e7 ,publication ,the ,secretary shall make the report under subsection 7a7 available on the public website of the ,department of ,health and ,human ,services4 #ajb4 ,enhance intraagency coordination and public health assessment with regard to compliance activities 7a7 ,benefit_/,risk framework 7#a7 ,in general ,paragraph 7#b7 of section #gjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b77 is amended by adding at the end the following3 ,the ,secretary shall ensure timely and effective coordination among such offices regarding the reviews of such report and the alignment of any feedback regarding such report1 and any corrective or preventive actions in response to such report1 after consideration of the benefits and risks to the public health1 patient safety1 the drug supply and drug supply chain1 and timely patient access to drugs44 7#b7 ,annual reporting ,subsection 7b7 of section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is amended by adding at the end the following new paragraph3 7#c7 ,on an annual basis1 the ,secretary shall prepare a report on the utilization of the framework described in paragraph 7#b7 and post such report on the public website of the ,food and ,drug ,administration4 4 7#c7 ,applicability ,the amendments made by paragraphs 7#a7 and 7#b7 shall take effect on the effective date described in section #caab of the ,,cares ,act 7,public ,law #aaf-acf71 after executing the amendments made by such section #caab1 and shall apply beginning on the date that is #a year after the date of enactment of this ,act4 7b7 ,public meeting ,the ,secretary of ,health and ,human ,services shall publish in the ,federal ,register a notice of a public meeting to be held no later than six months after the date of enactment of this ,act to discuss and obtain input and recommendations from public stakeholders1 including patient advocates1 consumers1 regulated industry1 and health care providers1 regarding the contents of a benefit_/risk framework described in section #gjd7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a71 that supports a safe1 stable1 redundant drug supply chain4 7c7 ,guidance ,the ,secretary of ,health and ,human ,services shall-- 7#a7 not later than one year after the date of enactment of this ,act1 issue draft guidance regarding the goals and implementation of a benefit_/risk framework described in subsection 7b72 and 7#b7 not later than two years after such date of enactment1 issue final guidance with respect to the implementation of such a framework4 #ajc4 ,encouraging international harmonization 7a7 ,,gao study ,not later than one year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall issue a report evaluating-- 7#a7 the consistency with which the ,international ,conference on ,harmonisation 7in this section referred to as ,,ich7 guidelines on good manufacturing practices1 including ,,ich ,guidelines ,q#h-aa1 are being implemented by drug regulatory authorities across countries and international regions2 7#b7 whether domestic active pharmaceutical ingredient manufacturers 7including any such contract manufacturers7 are provided sufficient opportunity to participate with regulatory authorities in the development of guidelines prior to implementation2 7#c7 whether divergence from ,,ich guidelines or differing regulatory standards or requirements by drug regulatory authorities across countries and international regions creates-- 7,a7 inefficiencies in drug manufacturing2 7,b7 incompatible requirements that can contribute to or exacerbate drug shortages2 and 7,c7 the most common areas of divergence between ,,ich guidelines and regulatory standards and requirements by drug regulatory authorities across countries and international regions that1 if rectified1 may reduce the inefficiencies and incompatibilities identified pursuant to subparagraphs 7,a7 and 7,b74 7b7 ,international training program ,not later than two years after the date of enactment of this ,act1 informed by the needs identified in the report issued pursuant to subsection 7a71 the ,secretary of ,health and ,human ,services1 in conjunction with drug regulatory authorities across countries and international regions and the ,,ich1 shall develop and implement a training program for drug regulatory authorities across countries and international regions to promote consistent application of and reduce divergence from ,,ich guidelines on good manufacturing practices4 #ajd4 ,mutual recognition agreements for inspections and review activities 7a7 ,mutual ,recognition of ,inspections ,pursuant to section #hji of the ,federal ,food1 ,drug and ,cosmetics ,act 7#ba ,u4,s4,c4 #chd;e71 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall establish or expand initiatives for mutual sharing of review and inspection criteria between drug regulatory authorities across countries and international regions1 such as through the ,pharmaceutical ,cooperation ,inspection ,scheme1 the ,mutual ,recognition ,agreement with the ,european ,union1 and the ,australia-,canada-,singapore-,switzerla nd ,consortium1 to-- 7#a7 reduce the potential for duplicative regulatory evaluation of medical products regulated by the ,food and ,drug ,administration2 and 7#b7 more constructively allocate appropriations to the ,food and ,drug ,administration1 including those attributable to user fees1 to harmonized regulatory processes4 7b7 ,additional countries1 regions1 and evaluation ,in carrying out subsection 7a71 the ,secretary may expand the initiatives to include-- 7#a7 additional countries and geographic regions with established and competent regulatory frameworks2 and 7#b7 additional types of regulatory evaluation1 including with respect to-- 7,a7 good manufacturing practice inspections2 and 7,b7 approval of changes to the manufacturing of drugs for which an approval or licensure is in effect under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7c7 ,implementation framework 7#a7 ,publication ,not later than one year after the date of enactment of this ,act1 the ,secretary shall publish an implementation framework for the agreements to share review and inspection criteria under subsection 7a7 on the public website of the ,food and ,drug ,administration4 7#b7 ,contents ,the implementation framework under this subsection shall-- 7,a7 include the timeline for establishing or expanding initiatives described in subsection 7a72 7,b7 describe additional types of regulatory processes that will become subject to such initiatives2 7,c7 specify the countries and geographic regions where such initiatives will be established or expanded2 and 7,d7 identify additional opportunities and challenges for expanding mutual recognition agreements in drug and biologic regulation4 7d7 ,annual reporting 7#a7 ,in general ,not later than the end of calendar year #bjbj and annually thereafter1 the ,secretary shall publish a report on the public website of the ,food and ,drug ,administration on the utilization of agreements described in subsection 7c77#a7 in the previous fiscal year4 7#b7 ,contents ,the report under paragraph 7#a7 shall include each of the following3 7,a7 ,the total number of establishments that are registered under section #eaj7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 and located outside of the ,united ,states1 and of these establishments1 the number in each region of interest4 7,b7 ,the total number of inspections conducted at establishments described in subparagraph 7,a74 7,c7 ,of the inspections described in subparagraph 7,b71 the total number of inspections in each of region of interest4 7,d7 ,of the inspections in each region of interest reported pursuant to subparagraph 7,c71 the number of inspections in each ,,fda inspection category4 7,e7 ,of the number of inspections reported under each of subparagraphs 7,b71 7,c71 and 7,d7-- 7i7 the number of inspections which have been conducted pursuant to an agreement described in subsection 7c77#a72 and 7ii7 the number of inspections which have been conducted by employees or other agents of the ,food and ,drug ,administration4 7#c7 ,definitions ,in this subsection3 7,a7 ,the term region of interest refers to ,china1 ,india1 the ,european ,union1 and any other geographic region as determined appropriate by the ,secretary4 7,b7 ,the term ,,fda inspection category means refers to the following inspection categories3 7i7 ,inspections to support an approval of a drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7ii7 ,good manufacturing practice inspections4 7iii7 ,for-cause inspections4 #aje4 ,enhancing transparency of drug facility inspection timelines ,section #ijb of the ,,fda ,reauthorization ,act of #bjag 7#ba ,u4,s4,c4 #cee note7 is amended to read as follows3 #ijb4 ,annual report on inspections ,not later than ,march #a of each year1 the ,secretary of ,health and ,human ,services shall post on the public website of the ,food and ,drug ,administration information related to inspections of facilities necessary for approval of a drug under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 approval of a device under section #eae of such ,act 7#ba ,u4,s4,c4 #cfj;e71 or clearance of a device under section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfj7k77 that were conducted during the previous calendar year4 ,such information shall include the following3 7#a7 ,the median time following a request from staff of the ,food and ,drug ,administration reviewing an application or report to the beginning of the inspection1 and the median time from the beginning of an inspection to the issuance of a report pursuant to section #gjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b771 including-- 7,a7 the median time for drugs described in #eje7;j77#aa77;,a77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aa77;,a77i772 7,b7 the median time for drugs described in section #ejf;,c7a7 of such ,act 7#ba ,u4,s4,c4 #cef;c7a77 only2 and 7,c7 the median time for drugs on the drug shortage list in effect under section #ejf;,e of such ,act 7#ba ,u4,s4,c4 #cef;f74 7#b7 ,the median time from the issuance of a report pursuant to such section #gjd7;b7 to the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting for inspections for which the ,secretary concluded that regulatory or enforcement action was indicated1 including the median time for each category of drugs listed in subparagraphs 7,a7 through 7,c7 of paragraph 7#a74 7#c7 ,the median time from the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting to resolution of the regulatory or enforcement action indicated for inspections for which the ,secretary concluded that such action was indicated4 7#d7 ,the number of times that a facility was issued a report pursuant to such section #gjd7;b7 and approval of an application was delayed due to the issuance of a withhold recommendation1 including the number of such times for each category of drugs listed in subparagraphs 7,a7 through 7,c7 of paragraph 7#a74 4 #ajf4 ,advanced manufacturing technologies program ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 #ebd;,b4 ,advanced manufacturing technologies program 7a7 ,in general ,not later than #a year after the date of enactment of the ,manufacturing ,,api1 ,drugs1 and ,excipients in ,america ,act of #bjbj1 the ,secretary shall continue in effect the program to evaluate new drug manufacturing technologies that are included in an application1 or supplement to an application1 for a drug under subsection 7b7 or 7j7 of section #eje of this ,act or for a biological product submitted under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act4 7b7 ,designation ,the ,secretary shall designate a method of manufacturing a drug as an advanced manufacturing technology under this section if the drug manufacturer demonstrates that such technology is likely to-- 7#a7 prevent or resolve a drug shortage2 7#b7 maintain an adequate supply of critical medications for national emergencies2 or 7#c7 promote the adoption of innovative approaches to drug product design and manufacturing4 7c7 ,consultation ,if the ,secretary designates a method of manufacturing as an advanced manufacturing technology under this section1 the ,secretary shall take actions to expedite the development and implementation of such method of manufacture for purposes of approval of the application under subsection 7c7 or 7j7 of section #eje of this ,act or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 which may include1 as appropriate-- 7#a7 holding meetings between the sponsor of the application and appropriate ,food and ,drug ,administration staff throughout the development of the technology2 7#b7 providing timely advice to1 and interactive communication with1 the sponsor regarding the development of the technology2 and 7#c7 involving senior managers and experienced staff of the ,food and ,drug ,administration1 as appropriate1 in a collaborative1 cross-disciplinary review of the method of manufacturing4 7d7 ,evaluation of an ,advanced ,manufacturing ,technology 7#a7 ,package ,a sponsor who receives designation of an advanced manufacturing technology under this section shall provide the ,secretary with a package of scientific evidence supporting the implementation of the advanced manufacturing technology in a particular context-of-use4 7#b7 ,evaluation ,within #ij days of receiving the package1 the ,secretary shall determine whether a designated advanced manufacturing technology is validated for the proposed context of use based on the scientific merit the supporting evidence provided by the sponsor4 7#c7 ,effect of ,approval ,upon approval1 the same sponsor may rely upon the advanced manufacturing technology for use across multiple manufacturing product lines within the same context-of-use without having to re-submit data to the ,secretary validating the underlying technology4 7e7 ,implementation and ,reporting 7#a7 ,public meeting ,the ,secretary shall publish in the ,federal ,register a notice of a public meeting to be held no later than #a year after the date of enactment of the ,manufacturing ,,api1 ,drugs1 and ,excipients in ,america ,act of #bjbj to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of1 and a suitable framework and procedures and requirements for1 the program under this section4 7#b7 ,program guidance ,the ,secretary shall-- 7,a7 not later than #a year after the date of enactment of the ,manufacturing ,,api1 ,drugs1 and ,excipients in ,america ,act of #bjbj1 issue draft guidance regarding the goals and implementation of the program under this section2 and 7,b7 not later than #b years after the date of enactment of the ,manufacturing ,,api1 ,drugs1 and ,excipients in ,america ,act of #bjbj1 issue final guidance with respect to the implementation of such program4 7#c7 ,report ,the ,secretary shall make available on the public website of the ,food and ,drug ,administration an annual report on the progress of the program under this section4 4 ,,ii ,tax incentives to increase domestic pharmaceutical and medical device production #bja4 ,credit for pharmaceutical and medical device production activities in distressed zones 7a7 ,in general ,subpart ,d of part ,,iv of subchapter ,a of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #de,u4 ,distressed zone pharmaceutical and medical device production credit 7a7 ,in general ,for purposes of section #ch1 the distressed zone pharmaceutical and medical device production credit for the taxable year shall be an amount equal to #cj percent of the qualified production activity expenditures of the taxpayer for the taxable year4 7b7 ,qualified production activity expenditures ,for purposes of this section-- 7#a7 ,in general ,the term qualified production activity expenditures means-- 7,a7 wages paid or incurred to an employee of the taxpayer for services performed by such employee in the conduct of a qualified pharmaceutical or diagnostic medical device production business in a distressed zone 7but only if the employee's principal place of employment is in a distressed zone71 or 7,b7 amounts paid or incurred for any tangible personal property 7whether or not otherwise properly chargeable to capital account7 used in the conduct of a qualified pharmaceutical or medical device production business in a distressed zone 7but only if the primary use of such property is in a distressed zone74 7#b7 ,qualified pharmaceutical or medical device production business 7,a7 ,in general ,the term qualified pharmaceutical or medical device production business means the trade or business of producing pharmaceuticals1 excipients1 active pharmaceutical ingredients1 medical diagnostic devices1 or personal protective equipment4 7,b7 ,active pharmaceutical ingredient ,the term active pharmaceutical ingredients has the meaning given to such term in section #bjg4a of title #ba1 ,code of ,federal ,regulations 7and any successor regulations74 7,c7 ,excipient ,the term excipient-- 7i7 means any inactive ingredient that is intentionally added to a pharmaceutical that is not intended to exert therapeutic effects at the intended dosage1 other than by acting to improve product delivery2 and 7ii7 includes any such filler1 extenders1 diluent1 wetting agent1 solvent1 emulsifier1 preservative1 flavor1 absorption enhancer1 sustained release matrix1 and coloring agent4 7,d7 ,medical diagnostic device ,the term medical diagnostic device means any device 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 intended for use in the diagnosis of disease or other conditions4 7,e7 ,personal protective equipment ,the term personal protective equipment means-- 7i7 any device 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 that is a face mask1 filtering facepiece respirator1 face shield1 surgical mask1 gown1 other apparel1 or glove that is intended for a medical purpose2 and 7ii7 any particulate filtering air purifying respiratory protective device that is approved by the ,national ,institute for ,occupational ,safety and ,health under part #hd of title #db1 ,code of ,federal ,regulations 7or successor regulations74 7,f7 ,pharmaceutical ,the term pharmaceutical-- 7i7 means any drug 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act72 and 7ii7 includes a biological product 7as defined in section #cea of the ,public ,health ,service ,act74 7#c7 ,certain health plan expenses treated as wages 7,a7 ,in general ,for purposes of paragraph 7#a71 the term wages shall include so much of the eligible employer's qualified health plan expenses as are properly allocable to such wages4 7,b7 ,qualified health plan expenses ,for purposes of this paragraph1 the term qualified health plan expenses means amounts paid or incurred by the eligible employer to provide and maintain a group health plan 7as defined in section #ejjj7;b77#a771 but only to the extent that such amounts are excluded from the gross income of employees by reason of section #ajf7;a7 of such ,code4 7,c7 ,allocation rules ,for purposes of this paragraph1 qualified health plan expenses shall be allocated to qualified wages in such manner as the ,secretary may prescribe4 ,except as otherwise provided by the ,secretary1 such allocation shall be treated as properly made if made on the basis of being pro rata among employees and pro rata on the basis of periods of coverage 7relative to the periods to which such wages relate74 7#d7 ,distressed zone ,the term distressed zone means a population census tract-- 7,a7 which has been designated as a qualified opportunity zone under section #adjj,z-#a1 and 7,b7 which has a poverty rate in excess of #cj percent for the calendar year prior to the calendar year that includes the date of enactment of this section4 7c7 ,special rules 7#a7 ,reduction in basis ,if a credit is determined under this section with respect to any property by reason of any qualified production activity expenditures described in subsection 7b77#a77;,b71 the basis of such property shall be reduced by the amount of the credit so determined4 7#b7 ,coordination with other credits ,any qualified production activity expenditures taken into account in determining the amount of the credit under subsection 7a7 shall not be taken into account in determining a credit under any other provision of this chapter4 7#c7 ,limitation on wages taken into account ,the amount of wages taken into account under subsection 7a7 with respect to any employee shall not exceed an amount equal to the contribution and benefit base in effect under section #bcj of the ,social ,security ,act for the calendar year in which the taxable year begins4 4 7b7 ,credit allowed against alternative minimum tax ,section #ch7;c77#d77;,b7 of such ,code is amended by redesignating clauses 7x71 7xi71 and 7xii7 as clauses 7xi71 7xii71 and 7xiii71 respectively and by inserting after clause 7ix7 the following new clause3 7x7 the credit determined under section #de,u1 4 7c7 ,special rule for controlled foreign corporations ,section #ifj7;d7 of such ,code is amended by adding at the end the following new paragraph3 7#d7 ,special for controlled foreign corporations with distressed zone pharmaceutical and medical device expenditures ,the amount of foreign taxes deemed paid by a domestic corporation under paragraph 7#a7 7determined without regard to this paragraph7 shall be increased by an amount equal to the lesser of-- 7,a7 the excess of-- 7i7 the amount calculated with respect to such corporation under paragraph 7#a7 7determined without regard to this paragraph and by substituting #ajj percent for #hj percent71 over 7ii7 the amount calculated with respect to such corporation under paragraph 7#a7 7determined without regard to this paragraph71 or 7,b7 an amount equal to #ae percent of the qualified production activity expenditures 7as defined in section #de,u7b77#a77 of the controlled foreign corporation for the taxable year of the foreign corporation ending in or with the taxable year of the domestic corporation4 4 7d7 ,denial of deduction ,section #bhj;,c of such ,code is amended by adding at the end the following new subsection3 7i7 ,distressed zone pharmaceutical and medical device production credit ,no deduction shall be allowed for that portion of the qualified production activity expenditures 7as defined in section #de,u7b77 otherwise allowable as a deduction for the taxable year which is equal to the amount of the distressed zone pharmaceutical and medical device production credit determined for such taxable year under section #de,u7a74 4 7e7 ,part of general business credit ,section #ch7;b7 of such ,code is amended by striking plus at the end of paragraph 7#cb71 by striking the period at the end of paragraph 7#cc7 and inserting 1 plus1 and by adding at the end the following new paragraph3 7#cd7 the distressed zone pharmaceutical and medical device production credit determined under section #de,u7a74 4 7f7 ,clerical amendment ,the table of sections for subpart ,d of part ,,iv of subchapter ,a of chapter #a is amended by adding at the end the following new item3 ,sec4 #de,u4 ,distressed zone pharmaceutical and medical device production credit4 4 7g7 ,effective date ,the amendments made by this section shall apply to amounts paid or incurred after the date of the enactment of this ,act4