,,ii ,calendar ,no4 #aeb #aaith ,,congress #ast ,session ,s4 #bbib ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ae1 #bjbe,mr4 ,banks 7for himself1 ,mr4 ,kaine1 ,mr4 ,kim1 and ,mr4 ,husted7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,september #h1 #bjbe,reported by ,mr4 ,cassidy1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to revise and extend the user fee program for over-the-counter monograph drugs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,over-the-,counter ,monograph ,drug ,user ,fee ,amendments4 #b4 ,finding ,congress finds that the fees authorized by the amendments made in this ,act will be dedicated to ,,otc monograph drug activities1 as set forth in the goals identified for purposes of part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 as set forth in the ,congressional ,record4 #c4 ,definitions ,section #gdd,l7#i77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga7i77;,a77 is amended-- 7#a7 in clause 7v71 by striking 2 or and inserting a semicolon2 7#b7 in clause 7vi7-- 7,a7 by striking addition and inserting the addition2 and 7,b7 by striking the period and inserting 2 or2 and 7#c7 by adding at the end the following3 7vii7 the addition or modification of a testing procedure applicable to one or more ,,otc monograph drugs1 provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is-- 7,i7 established by a national or international standards development organization2 and 7,,ii7 recognized by the ,secretary through a process described in guidance for industry1 initially published in ,july #bjbc1 or any successor guidance1 publicly available on the website of the ,food and ,drug ,administration1 which addresses voluntary consensus standards for pharmaceutical quality4 4 #d4 ,authority to assess and use ,,otc monograph fees 7a7 ,types of fees ,section #gdd,m7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7;a77#a77 is amended-- 7#a7 in subparagraph 7,a7-- 7,a7 by striking on ,december #ca of the fiscal year or at any time during the preceding #ab-month period and inserting at any time during the applicable period specified in clause 7ii7 for a fiscal year2 7,b7 by striking ,each person and inserting the following3 7i7 ,assessment of fees ,each person 2 and 7,c7 by adding at the end the following3 7ii7 ,applicable period ,for purposes of clause 7i71 the applicable period is-- 7,i7 for fiscal year #bjbf1 the #ab-month period ending on ,december #ca1 #bjbe2 7,,ii7 for fiscal year #bjbg1 the #i-month period ending on ,september #cj1 #bjbf2 and 7,,iii7 for fiscal year #bjbh and each subsequent fiscal year1 the #ab-month period ending on ,september #cj of the preceding fiscal year4 2 7#b7 in subparagraph 7,b77i71 by amending subclause 7,i7 to read as follows3 7,i7 has ceased all activities related to ,,otc monograph drugs prior to-- 7aa7 for purposes of fiscal year #bjbf1 ,january #a1 #bjbe2 7bb7 for purposes of fiscal year #bjbg1 ,january #a1 #bjbf2 and 7cc7 for purposes of fiscal year #bjbh and each subsequent fiscal year1 ,october #a of the preceding fiscal year2 and 2 and 7#c7 by amending subparagraph 7,d7 to read as follows3 7,d7 ,due date 7i7 ,fiscal year #bjbf ,for fiscal year #bjbf1 the facility fees required under subparagraph 7,a7 shall be due on the later of-- 7,i7 the first business day of ,june of such year2 or 7,,ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees under this section for such year4 7ii7 ,fiscal year #bjbg ,for fiscal year #bjbg1 the facility fees required under subparagraph 7,a7 shall be due-- 7,i7 in a first installment representing #ej percent of such fee1 on the later of-- 7aa7 ,october #a1 #bjbf2 or 7bb7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees under this section for such year2 and 7,,ii7 in a second installment representing the remaining #ej percent of such fee1 on-- 7aa7 ,february #a1 #bjbg2 or 7bb7 if an appropriations ,act described in subclause 7,i77bb7 is not in effect on ,february #a1 #bjbg1 the first business day after enactment of such an appropriations ,act4 7iii7 ,subsequent fiscal years ,for fiscal year #bjbh and each subsequent fiscal year1 the facility fees required under subparagraph 7,a7 shall be due on the later of-- 7,i7 the first business day on or after ,october #a of the fiscal year2 or 7,,ii7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees under this section for the fiscal year4 4 7b7 ,fee revenue amounts ,section #gdd,m7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7;b77 is amended to read as follows3 7b7 ,fee revenue amounts 7#a7 ,in general ,for each of the fiscal years #bjbf through #bjcj1 fees under subsection 7a77#a7 shall be established to generate a total facility fee revenue amount equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#b772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#b772 7,d7 additional direct cost adjustments 7as determined under subsection 7c77#c772 7,e7 an additional dollar amount equal to-- 7i7 #b1cgc1jjj for fiscal year #bjbf2 7ii7 #a1bcc1jjj for fiscal year #bjbg2 and 7iii7 #hed1jjj for fiscal year #bjbh2 and 7,f7 in the case of a fiscal year for which the ,secretary applies the one-time facility fee workload adjustment under subsection 7c77#d71 the dollar amount equal to such adjustment4 7#b7 ,annual base revenue ,for purposes of paragraph 7#a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjbf1 the dollar amount of the total revenue amount established for fiscal year #bjbe under this subsection as in effect on the day before the date of enactment of the ,over-the-,counter ,monograph ,drug ,user ,fee ,amendments1 not including any adjustments made for such fiscal year #bjbe under subsection 7c77#b71 as so in effect2 and 7,b7 for fiscal years #bjbg through #bjcj1 the dollar amount of the total revenue amount established under this subsection for the previous fiscal year1 not including any adjustments made for such previous fiscal year under subsection 7c77#b7 or 7c77#c74 4 7c7 ,adjustments2 annual fee setting ,section #gdd,m7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 in the matter preceding clause 7i7-- 7i7 by striking subsection 7b77#b77;,b7 and inserting subsection 7b77#a77;,b72 and 7ii7 by striking fiscal year #bjbb and each subsequent fiscal year and inserting each fiscal year2 7,b7 in subparagraph 7,b71 by striking fiscal year #bjbb and all that follows through the period at the end and inserting the following3 a fiscal year shall be equal to the product of-- 7i7 for fiscal year #bjbf-- 7,i7 the fee for fiscal year #bjbe under subsection 7a77#b72 and 7,,ii7 the inflation adjustment percentage under subparagraph 7,c72 and 7ii7 for each of fiscal years #bjbg through #bjcj-- 7,i7 the applicable fee under subsection 7a77#b7 for the preceding fiscal year2 and 7,,ii7 the inflation adjustment percentage under subparagraph 7,c74 2 and 7,c7 in subparagraph 7,c7-- 7i7 in the matter preceding clause 7i71 by inserting the sum of after is equal to2 7ii7 by striking clause 7i72 7iii7 by redesignating subclauses 7,i7 and 7,,ii7 of clause 7ii7 as clauses 7i7 and 7ii71 respectively1 and adjusting the margins accordingly2 7iv7 by striking 7ii7 for each of fiscal years #bjbd and #bjbe1 the sum of--2 and 7v7 in clause 7ii71 as so redesignated1 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria-,,dc- ,,va-,,md-,,wv2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking fiscal year #bjba and subsequent fiscal years and inserting each fiscal year2 7ii7 by striking subsections 7b77#a77;,b7 and 7b77#b77;,c7 and inserting subsection 7b77#a77;,c72 and 7iii7 by striking the number of weeks specified in subparagraph 7,b7 and inserting #aj weeks2 7,b7 by striking subparagraph 7,b72 7,c7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,b7 and 7,c71 respectively2 and 7,d7 in subparagraph 7,c71 as so redesignated1 by striking paragraph 7#d7 establishing and inserting paragraph 7#e7 publishing2 7#c7 in paragraph 7#c7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking subsection 7b77#b77;,d7 and inserting subsection 7b77#a77;,d72 and 7,b7 by striking subparagraphs 7,a7 through 7,e7 and inserting the following3 7,a7 #ace1jjj for fiscal year #bjbf2 7,b7 #cjj1jjj for fiscal year #bjbg2 7,c7 #ee1jjj for fiscal year #bjbh2 7,d7 #cj1jjj for fiscal year #bjbi2 and 7,e7 #j for fiscal year #bjcj4 2 and 7#d7 by striking paragraph 7#d7 and inserting the following3 7#d7 ,one-time facility fee workload adjustment 7,a7 ,in general ,in addition to the adjustments under paragraphs 7#a71 7#b71 and 7#c71 the ,secretary may further increase the fee revenues and fees through a one-time adjustment made for fiscal year #bjbh1 #bjbi1 or #bjcj1 in accordance with this paragraph4 7,b7 ,adjustment described 7i7 ,conditions for adjustment ,an adjustment under this paragraph may be made for a fiscal year only if-- 7,i7 an adjustment under this paragraph had not been made for any prior fiscal year2 7,,ii7 the average number of ,,otc monograph drug facilities subject to a facility fee under subsection 7a77#a7 over the period of the preceding #c fiscal years exceeds #a1fbe2 and 7,,iii7 with respect to facilities described in subclause 7,,ii71 the average number of such facilities 7expressed as a percentage7 that appeared on the arrears lists pursuant to subsection 7e77#a77;,a77i7 over the period of the preceding #c fiscal years is less than #cj percent4 7ii7 ,amount of adjustment ,an adjustment under this paragraph for a fiscal year shall equal the product of-- 7,i7 the total facility revenue amount determined under subsection 7b7 for the fiscal year1 exclusive of the adjustment under this paragraph for such fiscal year2 and 7,,ii7 the excess facility percentage described in clause 7iii74 7iii7 ,excess facility percentage ,the excess facility percentage described in this clause is-- 7,i7 the amount by which the average number of ,,otc monograph drug facilities subject to a facility fee under subsection 7a77#a7 over the preceding #c fiscal years exceeds #a1fbe2 divided by 7,,ii7 #a1fbe4 7#e7 ,annual fee setting ,the ,secretary shall1 not later than #fj days before the first day of each fiscal year-- 7,a7 establish for such fiscal year1 based on the revenue amounts under subsection 7b7 and the adjustments provided under this subsection-- 7i7 ,,otc monograph drug facility fees under subsection 7a77#a72 and 7ii7 ,,otc monograph order request fees under subsection 7a77#b72 and 7,b7 publish such fee revenue amounts1 facility fees1 and ,,otc monograph order request fees in the ,federal ,register4 4 7d7 ,crediting and availability of fees ,section #gdd,m7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7;f77 is amended-- 7#a7 in paragraph 7#b77;,d7-- 7,a7 in the subparagraph heading1 by striking in subsequent years2 and 7,b7 by striking 7after fiscal year #bjba72 and 7#b7 in paragraph 7#c71 by striking #bjba through #bjbe and inserting #bjbf through #bjcj4 #e4 ,reauthorization2 reporting requirements ,section #gdd,n of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gc7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking ,beginning with fiscal year #bjba1 and not later than #abj calendar days after the end of each fiscal year thereafter and inserting ,not later than #abj calendar days after the end of each fiscal year2 and 7,b7 by striking section #chfa7;b7 of the ,,cares ,act and inserting section #b of the ,over-the-,counter ,monograph ,drug ,user ,fee ,amendments2 7#b7 in subsection 7b71 by striking fiscal year #bjba and each subsequent fiscal year and inserting each fiscal year2 and 7#c7 in subsection 7d71 by striking #bjbe each place it appears and inserting #bjcj4 #f4 ,sunset dates 7a7 ,authorization ,sections #gdd,l and #gdd,m of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga2 #cgi;j-#gb7 shall cease to be effective ,october #a1 #bjcj4 7b7 ,reporting requirements ,section #gdd,n of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gc7 shall cease to be effective ,january #ca1 #bjca4 #g4 ,effective date ,the amendments made by this ,act shall take effect on ,october #a1 #bjbe1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga et seq47 shall be assessed beginning ,october #a1 #bjbe1 regardless of the date of the enactment of this ,act4 #h4 ,savings clause ,notwithstanding the amendments made by this ,act1 part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga et seq471 as in effect on the day before the date of enactment of this ,act1 shall continue to be in effect with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbf4 #a4 ,short title ,this ,act may be cited as the ,over-the-,counter ,monograph ,drug ,user ,fee ,amendments4 #b4 ,finding ,congress finds that the fees authorized by the amendments made in this ,act will be dedicated to ,,otc monograph drug activities1 as set forth in the goals identified for purposes of part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga et seq47 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 as set forth in the ,congressional ,record4 #c4 ,definitions ,section #gdd,l7#i77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga7i77;,a77 is amended-- 7#a7 in clause 7v71 by striking 2 or and inserting a semicolon2 7#b7 in clause 7vi7-- 7,a7 by striking addition and inserting the addition2 and 7,b7 by striking the period and inserting 2 or2 and 7#c7 by adding at the end the following3 7vii7 the addition or modification of a testing procedure applicable to one or more ,,otc monograph drugs1 provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is-- 7,i7 established by a national or international standards development organization2 and 7,,ii7 recognized by the ,secretary through a process described in guidance for industry1 initially published in ,july #bjbc1 or any successor guidance1 publicly available on the website of the ,food and ,drug ,administration1 which addresses voluntary consensus standards for pharmaceutical quality4 4 #d4 ,authority to assess and use ,,otc monograph fees 7a7 ,types of fees ,section #gdd,m7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7;a77#a77 is amended-- 7#a7 in subparagraph 7,a7-- 7,a7 by striking on ,december #ca of the fiscal year or at any time during the preceding #ab-month period and inserting at any time during the applicable period specified in clause 7ii7 for a fiscal year2 7,b7 by striking ,each person and inserting the following3 7i7 ,assessment of fees ,each person 2 and 7,c7 by adding at the end the following3 7ii7 ,applicable period ,for purposes of clause 7i71 the applicable period is-- 7,i7 for fiscal year #bjbf1 the #ab-month period ending on ,december #ca1 #bjbe2 7,,ii7 for fiscal year #bjbg1 the #i-month period ending on ,september #cj1 #bjbf2 and 7,,iii7 for fiscal year #bjbh and each subsequent fiscal year1 the #ab-month period ending on ,september #cj of the preceding fiscal year4 2 7#b7 in subparagraph 7,b77i71 by amending subclause 7,i7 to read as follows3 7,i7 has ceased all activities related to ,,otc monograph drugs prior to-- 7aa7 for purposes of fiscal year #bjbf1 ,january #a1 #bjbe2 7bb7 for purposes of fiscal year #bjbg1 ,january #a1 #bjbf2 and 7cc7 for purposes of fiscal year #bjbh and each subsequent fiscal year1 ,october #a of the preceding fiscal year2 and 2 and 7#c7 by amending subparagraph 7,d7 to read as follows3 7,d7 ,due date 7i7 ,fiscal year #bjbf ,for fiscal year #bjbf1 the facility fees required under subparagraph 7,a7 shall be due on the later of-- 7,i7 the first business day of ,june of such year2 or 7,,ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees under this section for such year4 7ii7 ,fiscal year #bjbg ,for fiscal year #bjbg1 the facility fees required under subparagraph 7,a7 shall be due-- 7,i7 in a first installment representing #ej percent of such fee1 on the later of-- 7aa7 ,october #a1 #bjbf2 or 7bb7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees under this section for such year2 and 7,,ii7 in a second installment representing the remaining #ej percent of such fee1 on-- 7aa7 ,february #a1 #bjbg2 or 7bb7 if an appropriations ,act described in subclause 7,i77bb7 is not in effect on ,february #a1 #bjbg1 the first business day after enactment of such an appropriations ,act4 7iii7 ,subsequent fiscal years ,for fiscal year #bjbh and each subsequent fiscal year1 the facility fees required under subparagraph 7,a7 shall be due on the later of-- 7,i7 the first business day on or after ,october #a of the fiscal year2 or 7,,ii7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees under this section for the fiscal year4 4 7b7 ,fee revenue amounts ,section #gdd,m7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7;b77 is amended to read as follows3 7b7 ,fee revenue amounts 7#a7 ,in general ,for each of the fiscal years #bjbf through #bjcj1 fees under subsection 7a77#a7 shall be established to generate a total facility fee revenue amount equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#b772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#b772 7,d7 additional direct cost adjustments 7as determined under subsection 7c77#c772 7,e7 an additional dollar amount equal to-- 7i7 #b1cgc1jjj for fiscal year #bjbf2 7ii7 #a1bcc1jjj for fiscal year #bjbg2 and 7iii7 #hed1jjj for fiscal year #bjbh2 and 7,f7 in the case of a fiscal year for which the ,secretary applies the one-time facility fee workload adjustment under subsection 7c77#d71 the dollar amount equal to such adjustment4 7#b7 ,annual base revenue ,for purposes of paragraph 7#a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjbf1 the dollar amount of the total revenue amount established for fiscal year #bjbe under this subsection as in effect on the day before the date of enactment of the ,over-the-,counter ,monograph ,drug ,user ,fee ,amendments1 not including any adjustments made for such fiscal year #bjbe under subsection 7c77#b71 as so in effect2 and 7,b7 for fiscal years #bjbg through #bjcj1 the dollar amount of the total revenue amount established under this subsection for the previous fiscal year1 not including any adjustments made for such previous fiscal year under subsection 7c77#b7 or 7c77#c74 4 7c7 ,adjustments2 annual fee setting ,section #gdd,m7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 in the matter preceding clause 7i7-- 7i7 by striking subsection 7b77#b77;,b7 and inserting subsection 7b77#a77;,b72 and 7ii7 by striking fiscal year #bjbb and each subsequent fiscal year and inserting each fiscal year2 7,b7 in subparagraph 7,b71 by striking fiscal year #bjbb and all that follows through the period at the end and inserting the following3 a fiscal year shall be equal to the product of-- 7i7 for fiscal year #bjbf-- 7,i7 the fee for fiscal year #bjbe under subsection 7a77#b72 and 7,,ii7 the inflation adjustment percentage under subparagraph 7,c72 and 7ii7 for each of fiscal years #bjbg through #bjcj-- 7,i7 the applicable fee under subsection 7a77#b7 for the preceding fiscal year2 and 7,,ii7 the inflation adjustment percentage under subparagraph 7,c74 2 and 7,c7 in subparagraph 7,c7-- 7i7 in the matter preceding clause 7i71 by inserting the sum of after is equal to2 7ii7 by striking clause 7i72 7iii7 by redesignating subclauses 7,i7 and 7,,ii7 of clause 7ii7 as clauses 7i7 and 7ii71 respectively1 and adjusting the margins accordingly2 7iv7 by striking 7ii7 for each of fiscal years #bjbd and #bjbe1 the sum of--2 and 7v7 in clause 7ii71 as so redesignated1 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria-,,dc- ,,va-,,md-,,wv2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking fiscal year #bjba and subsequent fiscal years and inserting each fiscal year2 7ii7 by striking subsections 7b77#a77;,b7 and 7b77#b77;,c7 and inserting subsection 7b77#a77;,c72 and 7iii7 by striking the number of weeks specified in subparagraph 7,b7 and inserting #aj weeks2 7,b7 by striking subparagraph 7,b72 7,c7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,b7 and 7,c71 respectively2 and 7,d7 in subparagraph 7,c71 as so redesignated1 by striking paragraph 7#d7 establishing and inserting paragraph 7#e7 publishing2 7#c7 in paragraph 7#c7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking subsection 7b77#b77;,d7 and inserting subsection 7b77#a77;,d72 and 7,b7 by striking subparagraphs 7,a7 through 7,e7 and inserting the following3 7,a7 #ace1jjj for fiscal year #bjbf2 7,b7 #cjj1jjj for fiscal year #bjbg2 7,c7 #ee1jjj for fiscal year #bjbh2 7,d7 #cj1jjj for fiscal year #bjbi2 and 7,e7 #j for fiscal year #bjcj4 2 and 7#d7 by striking paragraph 7#d7 and inserting the following3 7#d7 ,one-time facility fee workload adjustment 7,a7 ,in general ,in addition to the adjustments under paragraphs 7#a71 7#b71 and 7#c71 the ,secretary may further increase the fee revenues and fees through a one-time adjustment made for fiscal year #bjbh1 #bjbi1 or #bjcj1 in accordance with this paragraph4 7,b7 ,adjustment described 7i7 ,conditions for adjustment ,an adjustment under this paragraph may be made for a fiscal year only if-- 7,i7 an adjustment under this paragraph had not been made for any prior fiscal year2 7,,ii7 the average number of ,,otc monograph drug facilities subject to a facility fee under subsection 7a77#a7 over the period of the preceding #c fiscal years exceeds #a1fbe2 and 7,,iii7 with respect to facilities described in subclause 7,,ii71 the average number of such facilities 7expressed as a percentage7 that appeared on the arrears lists pursuant to subsection 7e77#a77;,a77i7 over the period of the preceding #c fiscal years is less than #cj percent4 7ii7 ,amount of adjustment ,an adjustment under this paragraph for a fiscal year shall equal the product of-- 7,i7 the total facility revenue amount determined under subsection 7b7 for the fiscal year1 exclusive of the adjustment under this paragraph for such fiscal year2 and 7,,ii7 the excess facility percentage described in clause 7iii74 7iii7 ,excess facility percentage ,the excess facility percentage described in this clause is-- 7,i7 the amount by which the average number of ,,otc monograph drug facilities subject to a facility fee under subsection 7a77#a7 over the preceding #c fiscal years exceeds #a1fbe2 divided by 7,,ii7 #a1fbe4 7#e7 ,annual fee setting ,the ,secretary shall1 not later than #fj days before the first day of each fiscal year-- 7,a7 establish for such fiscal year1 based on the revenue amounts under subsection 7b7 and the adjustments provided under this subsection-- 7i7 ,,otc monograph drug facility fees under subsection 7a77#a72 and 7ii7 ,,otc monograph order request fees under subsection 7a77#b72 and 7,b7 publish such fee revenue amounts1 facility fees1 and ,,otc monograph order request fees in the ,federal ,register4 4 7d7 ,crediting and availability of fees ,section #gdd,m7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gb7;f77 is amended-- 7#a7 in paragraph 7#b77;,d7-- 7,a7 in the subparagraph heading1 by striking in subsequent years2 and 7,b7 by striking 7after fiscal year #bjba72 and 7#b7 in paragraph 7#c71 by striking #bjba through #bjbe and inserting #bjbf through #bjcj4 #e4 ,reauthorization2 reporting requirements 7a7 ,performance report ,section #gdd,n of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gc7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking ,beginning with fiscal year #bjba1 and not later than #abj calendar days after the end of each fiscal year thereafter and inserting the following3 7#a7 ,in general ,not later than #abj calendar days after the end of each fiscal year 2 7,b7 by striking section #chfa7;b7 of the ,,cares ,act and inserting section #b of the ,over-the-,counter ,monograph ,drug ,user ,fee ,amendments2 and 7,c7 by adding at the end the following3 7#b7 ,additional information ,beginning with fiscal year #bjbf1 the annual report under this subsection shall include-- 7,a7 the progress of the ,food and ,drug ,administration in achieving the goals1 and future plans for meeting the goals1 including-- 7i7 the number of ,tier #a ,,otc monograph order requests for which a proposed order was issued1 and the number of such requests for which a final order was issued1 in the previous fiscal year2 7ii7 the number of ,tier #b ,,otc monograph order requests for which a proposed order was issued1 and the number of such requests for which a final order was issued1 in the previous fiscal year2 7iii7 the number of specified safety ,,otc monograph order requests for which a proposed order was issued1 and the number of such requests for which a final order was issued1 in the previous fiscal year2 7iv7 the number of generally recognized as safe and effective finalization ,,otc monograph order requests for which a proposed order was issued1 and the number of such requests for which a final order was issued1 in the previous fiscal year2 7v7 the average timeline for processing ,,otc monograph order requests1 in the aggregate and by submission type1 in the previous fiscal year2 and 7vi7 postmarket safety activities with respect to ,,otc monograph drugs1 including-- 7,i7 collecting1 developing1 and reviewing safety information on ,,otc monograph drugs1 including adverse event reports2 7,,ii7 developing and using improved analytical tools1 adverse event data-collection systems1 including information technology systems1 to assess potential safety problems1 including access to external databases2 and 7,,iii7 activities under section #gfj2 7,b7 information regarding registration of ,,otc monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities1 including-- 7i7 the ,,otc monograph drug facilities and contract manufacturing organization facilities that were first registered under section #eaj7;c7 or #eaj7;i7 in the fiscal year2 and 7ii7 for each ,,otc monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section #gdd,m7a7 in the fiscal year1 whether the facility paid such fee2 7,c7 the status of implementation of evidence and testing standards for nonprescription drugs intended for topical administration1 including-- 7i7 the application of evidence or testing standards2 and 7ii7 the number of active ingredient requests for nonprescription drugs intended for topical administration reviewed using the standards under section #eje;,g7b72 and 7,d7 the progress of the ,food and ,drug ,administration in allowing nonclinical testing alternatives to animal testing for the consideration of sunscreen active ingredients4 7#c7 ,confidentiality ,nothing in paragraph 7#b7 shall be construed to authorize the disclosure of information that is prohibited from disclosure under section #cja7;j7 of this ,act or section #aije of title #ah1 ,united ,states ,code1 or that is subject to withholding under section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 2 7#b7 in subsection 7b71 by striking fiscal year #bjba and each subsequent fiscal year and inserting each fiscal year2 and 7#c7 in subsection 7d7-- 7,a7 by striking #bjbe each place it appears and inserting #bjcj2 and 7,b7 by adding at the end the following3 7#d7 ,minutes of negotiation meetings 7,a7 ,public availability ,the ,secretary shall make publicly available1 on the public website of the ,food and ,drug ,administration1 robust written minutes of all negotiation meetings conducted under this subsection between the ,food and ,drug ,administration and the regulated industry1 not later than #cj days after each such negotiation meeting4 7,b7 ,content ,the robust written minutes described under subparagraph 7,a7 shall contain1 in detail1 any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution4 4 7b7 ,,gao report 7#a7 ,in general ,not later than ,september #cj1 #bjbg1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report assessing the supply chain of over-the-counter monograph drugs4 7#b7 ,contents ,the report required under paragraph 7#a7 shall include an assessment of-- 7,a7 the overall stability of the supply chain of over-the-counter monograph drugs2 7,b7 what information is collected by the ,food and ,drug ,administration with respect to the supply chain of over-the-counter monograph drugs2 7,c7 how the ,food and ,drug ,administration uses information collected on the supply chain of over-the-counter monograph drugs to inform regulatory decisions2 7,d7 how the ,food and ,drug ,administration coordinates with other ,federal agencies to monitor and mitigate disruptions to the supply chain of over-the-counter monograph drugs2 and 7,e7 the unique characteristics of the over-the-counter monograph drug marketplace and what additional authorities or information the ,food and ,drug ,administration may need to ensure the stability of the supply chain of over-the-counter monograph drugs4 #f4 ,treatment of active ingredients for topical administration 7a7 ,in general ,section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 is amended by adding at the end the following3 7r7 ,evidence and testing standards for active ingredients for topical administration 7#a7 ,evidence and testing standards for active ingredients for topical administration ,the ,secretary shall-- 7,a7 in evaluating the generally recognized as safe and effective status of active ingredients used in nonprescription drugs intended for topical administration for purposes of subsection 7a71 utilize standards that allow for the use of real world evidence 7as defined in section #eje;,f7b771 as appropriate1 as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients1 to supplement evidence from traditional clinical trials1 provided that such standards allow the ,secretary to evaluate whether the benefits of such active ingredients outweigh the risks2 and 7,b7 apply subsection 7b77#f77;,c7 to the regulation of active ingredients used in drugs intended for topical administration4 7#b7 ,non-animal testing methods for topical active ingredients 7,a7 ,in general ,the ,secretary shall consider the types of nonclinical tests described in paragraphs 7#a7 through 7#d7 of the first subsection 7z7 of section #eje 7as inserted by section #cbji7;a77#b7 of the ,health ,extenders1 ,improving ,access to ,medicare1 ,medicaid1 and ,,chip1 and ,strengthening ,public ,health ,act of #bjbb 7division ,,ff of ,public ,law #aag-cbh771 or any other alternative to animal testing that the ,secretary determines appropriate1 in the consideration of drugs intended for topical administration under this section4 7,b7 ,guidance ,not later than #a year after the date of enactment of this subsection1 the ,secretary shall issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing1 as appropriate1 to meet safety and efficacy standards under this section for drugs intended for topical administration4 7#c7 ,clarification ,nothing in this subsection shall be construed to alter1 supersede1 or limit the standards for making determinations of whether a drug is generally recognized as safe and effective under section #bja7p7 or the standards set forth under section #eje for determining the safety and effectiveness of drugs4 4 7b7 ,sunscreen final administrative order ,a final administrative order on nonprescription sunscreen active ingredients issued under section #ched of the ,coronavirus ,aid1 ,relief1 and ,economic ,security ,act 7,public ,law #aaf-acf2 #ba ,u4,s4,c4 #cfj;fff-#c note7 shall-- 7#a7 account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the ,united ,states2 7#b7 account for the role of broad spectrum sunscreens with a ,sun ,protection ,factor of #ae or higher in effective skin cancer prevention2 and 7#c7 incorporate the evidence and testing standards for sunscreen active ingredients detailed in section #eje;,g7r7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;h7 7as added by subsection 7a774 #g4 ,increasing the clarity and predictability of the process for developing applications for ,rx-to-nonprescription switches 7a7 ,in general ,section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended by adding at the end the following3 7#g7 ,rx-to-nonprescription switches 7,a7 ,meetings ,any person planning to submit an application for an ,rx-to-nonprescription switch may submit to the ,secretary a written request for a meeting1 for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application1 including the design of any necessary studies1 and the format and content of the planned application4 ,the ,secretary may grant such a meeting1 as appropriate1 consistent with established procedures for granting meetings with1 and providing written responses to1 sponsors of applications under this section4 ,each such meeting shall be documented in meeting minutes4 7,b7 ,guidance 7i7 ,in general ,not later than #ah months after the date of enactment of this paragraph1 the ,secretary shall issue guidance to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section1 including in the case of applications for an ,rx-to-nonprescription switch1 especially with respect to prescription drugs with well-established safety profiles for which an applicant may seek approval for nonprescription use4 7ii7 ,contents ,the guidance under clause 7i7 shall-- 7,i7 describe how published reports in medical literature1 any previous finding of safety or effectiveness for the drug under this section1 the results of significant human experience with the drug1 unpublished studies and other data1 and other sources of information may be used to support an application for a nonprescription drug1 including in the context of an application for an ,rx-to-nonprescription switch2 7,,ii7 set forth procedures for sponsors to request meetings described in subparagraph 7,a7 and document the recommendations made in such meetings2 7,,iii7 describe evidentiary expectations to support approval of an application for a nonprescription drug1 including in the context of an application for an ,rx-to-nonprescription switch1 including how sponsors can demonstrate that consumers can appropriately self-select and use the drug and comprehend the nonprescription drug label2 and 7,,iv7 provide recommendations for how mechanisms1 in addition to the required ,drug ,facts ,label1 such as mobile applications and decision aids1 can be incorporated into the information submitted in support of an application for an ,rx-to-nonprescription switch4 7,c7 ,plan to engage with stakeholders ,not later than #a year after the date of enactment of this paragraph1 the ,secretary shall develop and make publicly available on the website of the ,food and ,drug ,administration a plan to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for applications for an ,rx-to-nonprescription switch4 7,d7 ,definition ,the term ,rx-to-nonprescription switch means the approval of an application1 or supplemental application1 as applicable1 submitted under this section by the holder of an approved application for a prescription drug seeking approval to market such drug as a nonprescription drug1 including for-- 7i7 a full ,rx-to-nonprescription switch1 under which a drug previously approved for prescription use only is-- 7,i7 approved for nonprescription use under the same conditions of use as applied to the drug when approved for prescription use2 or 7,,ii7 approved for nonprescription use subject to one or more additional conditions for nonprescription use2 and 7ii7 a partial ,rx-to-nonprescription switch1 under which the drug is approved for nonprescription use only under certain conditions of use described in the approved labeling1 while the drug otherwise remains approved for prescription use only4 7,e7 ,rule of construction ,nothing in this paragraph shall be construed to-- 7i7 supersede or modify the authority of the ,secretary under section #eje;,g with respect to the regulation of ,,otc monograph drugs2 or 7ii7 authorize the disclosure by the ,secretary of confidential commercial information or trade secrets4 4 7b7 ,,gao ,report 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that evaluates-- 7,a7 the number of applications for an ,rx-to-nonprescription switch approved during the period beginning on ,october #a1 #bjbb1 and ending on the date of the report2 7,b7 the number of drugs for which an application for an ,rx-to-nonprescription switch was approved during such period subject to an additional condition for nonprescription use2 7,c7 among the drugs for which an application for a full or partial ,rx-to-nonprescription switch was approved during such period1 the average length of time from receipt by the ,food and ,drug ,administration of the application to the approval of such application2 7,d7 the number of partial ,rx-to-nonprescription switch applications approved during such period1 and the number of applications for such a partial switch was not approved2 7,e7 any barriers to timely and predictable review of applications for an ,rx-to-nonprescription switch2 7,f7 engagement by the ,food and ,drug ,administration with public stakeholders1 including public meetings or additional activities1 to support review of applications for an ,rx-to-nonprescription switch2 and 7,g7 opportunities for collaboration between the ,center for ,drug ,evaluation and ,research and the ,centers for ,medicare ,medicaid ,services for the purpose of analyzing health insurance claims data for commonly prescribed drugs that appear to be suitable for an ,rx-to-nonprescription switch4 7#b7 ,definition ,in this subsection1 the term ,rx-to-nonprescription switch has the meaning given such term in paragraph 7#g7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #bdd7;b771 as added by subsection 7a74 #h4 ,sunset dates 7a7 ,authorization ,sections #gdd,l and #gdd,m of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga2 #cgi;j-#gb7 shall cease to be effective ,october #a1 #bjcj4 7b7 ,reporting requirements ,section #gdd,n of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#gc7 shall cease to be effective ,january #ca1 #bjca4 #i4 ,effective date ,the amendments made by this ,act shall take effect on ,october #a1 #bjbe1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga et seq47 shall be assessed beginning ,october #a1 #bjbe1 regardless of the date of the enactment of this ,act4 #aj4 ,savings clause ,notwithstanding the amendments made by this ,act1 part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ga et seq471 as in effect on the day before the date of enactment of this ,act1 shall continue to be in effect with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbf4 ,september #h1 #bjbe,reported with an amendment