,,ii #aaith ,,congress #ast ,session ,s4 #bbib ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ae1 #bjbe,mr4 ,banks 7for himself and ,mr4 ,kaine7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,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