,,ii #aafth ,,congress #ast ,session ,s4 #bgdj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,october #cj1 #bjai,mr4 ,isakson 7for himself and ,mr4 ,casey7 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 clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,act of #bjai4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,,otc ,drug ,review,sec4 #aja4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application4,sec4 #ajb4 ,misbranding4,sec4 #ajc4 ,drugs excluded from the over-the-counter drug review4,sec4 #ajd4 ,treatment of ,sunscreen ,innovation ,act4,sec4 #aje4 ,annual update to ,congress on appropriate pediatric indication for certain ,,otc cough and cold drugs4,sec4 #ajf4 ,technical corrections4,,title ,,ii--,user ,fees,sec4 #bja4 ,short title2 finding4,sec4 #bjb4 ,fees relating to over-the-counter drugs4 ,i ,,otc ,drug ,review #aja4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje;,f of such ,act 7#ba ,u4,s4,c4 #cee;g7 the following3 #eje;,g4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application 7a7 ,nonprescription drugs marketed without an approved application ,nonprescription drugs marketed without an approved drug application under section #eje1 as of the date of the enactment of this section1 shall be treated in accordance with this subsection4 7#a7 ,drugs subject to a final monograph2 category ,i drugs subject to a tentative final monograph ,a drug is deemed to be generally recognized as safe and effective under section #bja7p77#a71 not a new drug under section #bja7p71 and not subject to section #ejc7;b77#a71 if-- 7,a7 the drug is-- 7i7 in conformity with the requirements for nonprescription use of a final monograph issued under part #ccj of title #ba1 ,code of ,federal ,regulations 7except as provided in paragraph 7#b771 the general requirements for nonprescription drugs1 and conditions or requirements under subsections 7b71 7c71 and 7k72 and 7ii7 except as permitted by an order issued under subsection 7b7 or1 in the case of a minor change in the drug1 in conformity with an order issued under subsection 7c71 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b72 or 7,b7 the drug is-- 7i7 classified in category ,i for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with the proposed requirements for nonprescription use of such tentative final monograph1 any applicable subsequent determination by the ,secretary1 the general requirements for nonprescription drugs1 and conditions or requirements under subsections 7b71 7c71 and 7k72 and 7iii7 except as permitted by an order issued under subsection 7b7 or1 in the case of a minor change in the drug1 in conformity with an order issued under subsection 7c71 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b74 7#b7 ,treatment of sunscreen drugs ,with respect to sunscreen drugs subject to this section1 the applicable requirements in terms of conformity with a final monograph1 for purposes of paragraph 7#a77;,a77i71 shall be the requirements specified in part #ceb of title #ba1 ,code of ,federal ,regulations1 as published on ,may #ba1 #aiii1 beginning on page #bgfhg of volume #fd of the ,federal ,register1 except that the applicable requirements governing effectiveness and labeling shall be those specified in section #bja4cbg of title #ba1 ,code of ,federal ,regulations4 7#c7 ,category ,,iii drugs subject to a tentative final monograph2 category ,i drugs subject to proposed monograph or advance notice of proposed rulemaking ,a drug that is not described in paragraph 7#a71 7#b71 or 7#d7 is not required to be the subject of an application approved under section #eje1 and is not subject to section #ejc7;b77#a71 if-- 7,a7 the drug is-- 7i7 classified in category ,,iii for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with-- 7,i7 the conditions of use1 including indication and dosage strength1 if any1 described for such category ,,iii drug in such preamble or in an applicable subsequent proposed rule2 7,,ii7 the proposed requirements for drugs classified in such tentative final monograph in category ,i in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug2 and 7,,iii7 the general requirements for nonprescription drugs and conditions or requirements under subsection 7b7 or 7k72 and 7iii7 in a dosage form that1 immediately prior to the date of the enactment of this section1 had been used to a material extent and for a material time under section #bja7p77#b72 or 7,b7 the drug is-- 7i7 classified in category ,i for safety and effectiveness under a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination for such drug issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with the requirements for nonprescription use of such proposed monograph or advance notice of proposed rulemaking1 any applicable subsequent determination by the ,secretary1 the general requirements for nonprescription drugs1 and conditions or requirements under subsection 7b7 or 7k72 and 7iii7 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b74 7#d7 ,category ,,ii drugs deemed new drugs ,a drug that is classified in category ,,ii for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part #ccj of title #ba1 ,code of ,federal ,regulations1 shall be deemed to be a new drug under section #bja7p71 misbranded under section #ejb7;ee71 and subject to the requirement for an approved new drug application under section #eje beginning on the day that is #ahj calendar days after the date of the enactment of this section1 unless1 before such day1 the ,secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application4 7#e7 ,drugs not ,,grase deemed new drugs ,a drug that the ,secretary has determined not to be generally recognized as safe and effective under section #bja7p77#a7 under a final determination issued under part #ccj of title #ba1 ,code of ,federal ,regulations1 shall be deemed to be a new drug under section #bja7p71 misbranded under section #ejb7;ee71 and subject to the requirement for an approved new drug application under section #eje4 7#f7 ,other drugs deemed new drugs ,except as provided in subsection 7m71 a drug is deemed to be a new drug under section #bja7p7 and misbranded under section #ejb7;ee7 if the drug-- 7,a7 is not subject to section #ejc7;b77#a72 and 7,b7 is not described in paragraph 7#a71 7#b71 7#c71 7#d71 or 7#e71 or subsection 7b77#a77;,b74 7b7 ,administrative orders 7#a7 ,in general 7,a7 ,determination ,the ,secretary may1 on the initiative of the ,secretary or at the request of one or more requestors1 issue an administrative order determining whether there are conditions under which a specific drug1 a class of drugs1 or a combination of drugs1 is determined to be-- 7i7 not subject to section #ejc7;b77#a72 and 7ii7 generally recognized as safe and effective under section #bja7p77#a74 7,b7 ,effect ,a drug or combination of drugs shall be deemed to not require approval under section #eje if such drug or combination of drugs-- 7i7 is determined by the ,secretary to meet the conditions specified in clauses 7i7 and 7ii7 of subparagraph 7,a72 7ii7 is marketed in conformity with an administrative order under this subsection2 7iii7 meets the general requirements for nonprescription drugs2 and 7iv7 meets the requirements under subsections 7c7 and 7k74 7,c7 ,standard ,the ,secretary shall find that a drug is not generally recognized as safe and effective under section #bja7p77#a7 if-- 7i7 the evidence shows that the drug is not generally recognized as safe and effective under section #bja7p77#a72 or 7ii7 the evidence is inadequate to show that the drug is generally recognized as safe and effective under section #bja7p77#a74 7#b7 ,administrative orders initiated by the secretary 7,a7 ,in general ,in issuing an administrative order under paragraph 7#a7 upon the ,secretary's initiative1 the ,secretary shall-- 7i7 make reasonable efforts to notify informally1 not later than #b business days before the issuance of the proposed order1 the sponsors of drugs who have a listing in effect under section #eaj7;j7 for the drugs or combination of drugs that will be subject to the administrative order2 7ii7 after any such reasonable efforts of notification-- 7,i7 issue a proposed administrative order by publishing it on the website of the ,food and ,drug ,administration and include in such order the reasons for the issuance of such order2 and 7,,ii7 publish a notice of availability of such proposed order in the ,federal ,register2 7iii7 except as provided in subparagraph 7,b71 provide for a public comment period with respect to such proposed order of not less than #de calendar days2 and 7iv7 if1 after completion of the proceedings specified in clauses 7i7 through 7iii71 the ,secretary determines that it is appropriate to issue a final administrative order-- 7,i7 issue the final administrative order1 together with a detailed statement of reasons1 which order shall not take effect until the time for requesting judicial review under paragraph 7#c77;,d77ii7 has expired2 7,,ii7 publish a notice of such final administrative order in the ,federal ,register2 7,,iii7 afford requestors of drugs that will be subject to such order the opportunity for formal dispute resolution up to the level of the ,director of the ,center for ,drug ,evaluation and ,research1 which initially must be requested within #de calendar days of the issuance of the order1 and1 for subsequent levels of appeal1 within #cj calendar days of the prior decision2 and 7,,iv7 except with respect to drugs described in paragraph 7#c77;,b71 upon completion of the formal dispute resolution procedure1 inform the persons which sought such dispute resolution of their right to request a hearing4 7,b7 ,exceptions ,when issuing an administrative order under paragraph 7#a7 on the ,secretary's initiative proposing to determine that a drug described in subsection 7a77#c7 is not generally recognized as safe and effective under section #bja7p77#a71 the ,secretary shall follow the procedures in subparagraph 7,a71 except that-- 7i7 the proposed order shall include notice of-- 7,i7 the general categories of data the ,secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section #bja7p77#a72 and 7,,ii7 the format for submissions by interested persons2 7ii7 the ,secretary shall provide for a public comment period of no less than #ahj calendar days with respect to such proposed order1 except when the ,secretary determines1 for good cause1 that a shorter period is in the interest of public health2 and 7iii7 any person who submits data in such comment period shall include a certification that the person has submitted all evidence created1 obtained1 or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section #bja7p77#a74 7#c7 ,hearings2 judicial review 7,a7 ,in general ,only a person who participated in each stage of formal dispute resolution under subclause 7,,iii7 of paragraph 7#b77;,a77iv7 of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug4 ,if a hearing is sought1 such person must submit a request for a hearing1 which shall be based solely on information in the administrative record1 to the ,secretary not later than #cj calendar days after receiving notice of the final decision of the formal dispute resolution procedure4 7,b7 ,no hearing required with respect to orders relating to certain drugs 7i7 ,in general ,the ,secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph 7#b77;,a77iv7 if the final administrative order involved relates to a drug-- 7,i7 that is described in subsection 7a77#c77;,a72 and 7,,ii7 with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug4 7ii7 ,human data studies and non-human data defined ,in this subparagraph3 7,i7 ,the term human data studies means clinical trials of safety or effectiveness 7including actual use studies71 pharmacokinetics studies1 or bioavailability studies4 7,,ii7 ,the term non-human data means data from testing other than with human subjects which provides information concerning safety or effectiveness4 7,c7 ,hearing procedures 7i7 ,denial of request for hearing ,if the ,secretary determines that information submitted in a request for a hearing under subparagraph 7,a7 with respect to a final administrative order issued under paragraph 7#b77;,a77iv7 does not identify the existence of a genuine and substantial question of material fact1 the ,secretary may deny such request4 ,in making such a determination1 the ,secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies4 7ii7 ,single hearing for multiple related requests ,if more than one request for a hearing is submitted with respect to the same administrative order under subparagraph 7,a71 the ,secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate4 7iii7 ,presiding officer ,the presiding officer of a hearing requested under subparagraph 7,a7 shall-- 7,i7 be designated by the ,secretary2 7,,ii7 not be an employee of the ,center for ,drug ,evaluation and ,research2 and 7,,iii7 not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order4 7iv7 ,rights of parties to hearing ,the parties to a hearing requested under subparagraph 7,a7 shall have the right to present testimony1 including testimony of expert witnesses1 and to cross-examine witnesses presented by other parties4 ,where appropriate1 the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication4 7v7 ,final decision 7,i7 ,at the conclusion of a hearing requested under subparagraph 7,a71 the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law4 ,the decision of the presiding officer shall be final4 7,,ii7 ,the final decision may not take effect until the period under subparagraph 7,d77ii7 for submitting a request for judicial review of such decision expires4 7,d7 ,judicial review of final administrative order 7i7 ,in general ,the procedures described in section #eje7;h7 shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the ,united ,states in lieu of the appellate courts specified in such section4 7ii7 ,period to submit a request for judicial review ,a person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than #fj calendar days after the latest of-- 7,i7 the date on which notice of such order is published2 7,,ii7 the date on which a hearing with respect to such order is denied under subparagraph 7,b7 or 7,c77i72 7,,iii7 the date on which a final decision is made following a hearing under subparagraph 7,c77v72 or 7,,iv7 if no hearing is requested1 the date on which the time for requesting a hearing expires4 7#d7 ,expedited procedure with respect to administrative orders initiated by the ,secretary 7,a7 ,imminent hazard to the public health 7i7 ,in general ,in the case of a determination by the ,secretary that a drug1 class of drugs1 or combination of drugs subject to this section poses an imminent hazard to the public health1 the ,secretary1 after first making reasonable efforts to notify1 not later than #dh hours before issuance of such order under this subparagraph1 sponsors who have a listing in effect under section #eaj7;j7 for such drug or combination of drugs-- 7,i7 may issue an interim final administrative order for such drug1 class of drugs1 or combination of drugs under paragraph 7#a71 together with a detailed statement of the reasons for such order2 7,,ii7 shall publish in the ,federal ,register a notice of availability of any such order2 and 7,,iii7 shall provide for a public comment period of at least #de calendar days with respect to such interim final order4 7ii7 ,nondelegation ,the ,secretary may not delegate the authority to issue an interim final administrative order under this subparagraph4 7,b7 ,safety labeling changes 7i7 ,in general ,in the case of a determination by the ,secretary that a change in the labeling of a drug1 class of drugs1 or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug1 the ,secretary may-- 7,i7 make reasonable efforts to notify informally1 not later than #dh hours before the issuance of the interim final order1 the sponsors of drugs who have a listing in effect under section #eaj7;j7 for such drug or combination of drugs2 7,,ii7 after reasonable efforts of notification1 issue an interim final administrative order in accordance with paragraph 7#a7 to require such change1 together with a detailed statement of the reasons for such order2 7,,iii7 publish in the ,federal ,register a notice of availability of such order2 and 7,,iv7 provide for a public comment period of at least #de calendar days with respect to such interim final order4 7ii7 ,content of order ,an interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug4 7,c7 ,effective date ,an order under subparagraph 7,a7 or 7,b7 shall take effect on a date specified by the ,secretary4 7,d7 ,final order ,after the completion of the proceedings in subparagraph 7,a7 or 7,b71 the ,secretary shall-- 7i7 issue a final order in accordance with paragraph 7#a72 7ii7 publish a notice of availability of such final administrative order in the ,federal ,register2 and 7iii7 afford sponsors of such drugs that will be subject to such an order the opportunity for formal dispute resolution up to the level of the ,director of the ,center for ,drug ,evaluation and ,research1 which must initially be within #de calendar days of the issuance of the order1 and for subsequent levels of appeal1 within #cj calendar days of the prior decision4 7,e7 ,hearings ,a sponsor of a drug subject to a final order issued under subparagraph 7,d7 and that participated in each stage of formal dispute resolution under clause 7iii7 of such subparagraph may request a hearing on such order4 ,the provisions of subparagraphs 7,a71 7,b71 and 7,c7 of paragraph 7#c71 other than paragraph 7#c77;,c77v77,,ii71 shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under paragraph 7#b77;,a77iv74 7,f7 ,timing 7i7 ,final order and hearing ,the ,secretary shall-- 7,i7 not later than #f months after the date on which the comment period closes under subparagraph 7,a7 or 7,b71 issue a final order in accordance with paragraph 7#a72 and 7,,ii7 not later than #ab months after the date on which such final order is issued1 complete any hearing under subparagraph 7,e74 7ii7 ,dispute resolution request ,the ,secretary shall specify in an interim final order issued under subparagraph 7,a7 or 7,b7 such shorter periods for requesting dispute resolution under subparagraph 7,d77iii7 as are necessary to meet the requirements of this subparagraph4 7,g7 ,judicial review ,a final order issued pursuant to subparagraph 7,f7 shall be subject to judicial review in accordance with paragraph 7#c77;,d74 7#e7 ,administrative order initiated at the request of a requestor 7,a7 ,in general ,in issuing an administrative order under paragraph 7#a7 at the request of a requestor with respect to certain drugs1 classes of drugs1 or combinations of drugs-- 7i7 the ,secretary shall1 after receiving a request under this subparagraph1 determine whether the request is sufficiently complete and formatted to permit a substantive review2 7ii7 if the ,secretary determines that the request is sufficiently complete and formatted to permit a substantive review1 the ,secretary shall-- 7,i7 file the request2 and 7,,ii7 initiate proceedings with respect to issuing an administrative order in accordance with paragraphs 7#b7 and 7#c72 and 7iii7 except as provided in paragraph 7#f71 if the ,secretary determines that a request does not meet the requirements for filing or is not sufficiently complete and formatted to permit a substantive review1 the requestor may demand that the request be filed over protest1 and the ,secretary shall initiate proceedings to review the request in accordance with paragraph 7#b77;,a74 7,b7 ,request to initiate proceedings 7i7 ,in general ,a requestor seeking an administrative order under paragraph 7#a7 with respect to certain drugs1 classes of drugs1 or combinations of drugs1 shall submit to the ,secretary a request to initiate proceedings for such order in the form and manner as specified by the ,secretary4 ,such requestor may submit a request under this subparagraph for the issuance of an administrative order-- 7,i7 determining whether a drug is generally recognized as safe and effective under section #bja7p77#a71 exempt from section #ejc7;b77#a71 and not required to be the subject of an approved application under section #eje2 or 7,,ii7 determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section #bja7p77#a71 exempt from section #ejc7;b77#a71 and not required to be the subject of an approved application under section #eje1 if1 absent such a changed condition of use1 such drug is-- 7aa7 generally recognized as safe and effective under section #bja7p77#a7 in accordance with subsection 7a77#a71 7a77#b71 or an order under this subsection2 or 7bb7 subject to subsection 7a77#c71 but only if such requestor initiates such request in conjunction with a request for the ,secretary to determine whether such drug is generally recognized as safe and effective under section #bja7p77#a71 which is filed by the ,secretary under subparagraph 7,a77ii74 7ii7 ,exception ,the ,secretary is not required to complete review of a request for a change described in clause 7i77,,ii7 if the ,secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section #bja7p77#a7 under paragraph 7#a7 and issues a final order announcing that determination4 7iii7 ,withdrawal ,the requestor may withdraw a request under this paragraph1 according to the procedures set forth pursuant to subsection 7d77#b77;,b74 ,notwithstanding any other provision of this section1 if such request is withdrawn1 the ,secretary may cease proceedings under this subparagraph4 7,c7 ,exclusivity 7i7 ,in general ,a final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor 7or the licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such order71 for a period of #ah months following the effective date of such final order and beginning on the date the requestor may lawfully market such drugs pursuant to the order1 to market drugs-- 7,i7 incorporating changes described in clause 7ii72 and 7,,ii7 subject to the limitations under clause 7iv74 7ii7 ,changes described ,a change described in this clause is a change subject to an order specified in clause 7i71 which-- 7,i7 provides for a drug to contain an active ingredient 7including any ester or salt of the active ingredient7 not previously incorporated in a drug described in clause 7iii72 or 7,,ii7 provides for a change in the conditions of use of a drug1 for which new human data studies conducted or sponsored by the requestor 7or for which the requestor has an exclusive right of reference7 were essential to the issuance of such order4 7iii7 ,drugs described ,the drugs described in this clause are drugs-- 7,i7 specified in subsection 7a77#a71 7a77#b71 or 7a77#c72 7,,ii7 subject to a final order issued under this section2 7,,iii7 subject to a final sunscreen order 7as defined in section #ehf7b77;,a772 or 7,,iv7 described in subsection 7m77#a71 other than drugs subject to an active enforcement action under chapter ,,iii of this ,act4 7iv7 ,limitations on exclusivity 7,i7 ,in general ,only one #ah-month period under this subparagraph shall be granted1 under each order described in clause 7i71 with respect to changes 7to the drug subject to such order7 which are either-- 7aa7 changes described in clause 7ii77,i71 relating to active ingredients2 or 7bb7 changes described in clause 7ii77,,ii71 relating to conditions of use4 7,,ii7 ,no exclusivity allowed ,no exclusivity shall apply to changes to a drug which are-- 7aa7 the subject of a ,tier #b ,,otc monograph order request 7as defined in section #gdd,l72 7bb7 safety-related changes1 as defined by the ,secretary1 or any other changes the ,secretary considers necessary to assure safe use2 or 7cc7 changes related to methods of testing safety or efficacy4 7v7 ,new human data studies defined ,in this subparagraph1 the term new human data studies means clinical trials of safety or effectiveness 7including actual use studies71 pharmacokinetics studies1 or bioavailability studies1 the results of which-- 7,i7 have not been relied on by the ,secretary to support-- 7aa7 a proposed or final determination that a drug described in subclause 7,i71 7,,ii71 or 7,,iii7 of clause 7iii7 is generally recognized as safe and effective under section #bja7p77#a72 or 7bb7 approval of a drug that was approved under section #eje2 and 7,,ii7 do not duplicate the results of another study that was relied on by the ,secretary to support-- 7aa7 a proposed or final determination that a drug described in subclause 7,i71 7,,ii71 or 7,,iii7 of clause 7iii7 is generally recognized as safe and effective under section #bja7p77#a72 or 7bb7 approval of a drug that was approved under section #eje4 7vi7 ,notification of drug not available for sale ,a requestor that is granted exclusivity with respect to a drug under this subparagraph shall notify the ,secretary in writing within #a year of the issuance of the final administrative order if the drug that is the subject of such order will not be available for sale within #a year of the date of issuance of such order4 ,the requestor shall include with such notice the-- 7,i7 identity of the drug by established name and by proprietary name1 if any2 7,,ii7 strength of the drug2 7,,iii7 date on which the drug will be available for sale1 if known2 and 7,,iv7 reason for not marketing the drug after issuance of the order4 7#f7 ,information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request 7,a7 ,in general ,in response to a request under this section that a drug described in subparagraph 7,b7 be generally recognized as safe and effective1 the ,secretary-- 7i7 may file such request1 if the request includes information specified under subparagraph 7,c7 with respect to safe nonprescription marketing and use of such drug2 or 7ii7 if the request fails to include information specified under subparagraph 7,c71 shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph 7,d74 7,b7 ,drug described ,a drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug-- 7i7 specified in subsection 7a77#a71 7a77#b71 or 7a77#c72 7ii7 subject to a final order under this section2 or 7iii7 subject to a final sunscreen order 7as defined in section #ehf7b77;,a774 7,c7 ,information demonstrating prima facie safe nonprescription marketing and use ,information specified in this subparagraph1 with respect to a request described in subparagraph 7,a77i71 is-- 7i7 information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the ,united ,states as a nonprescription drug under comparable conditions of use2 7ii7 if the drug has not been previously marketed in the ,united ,states as a nonprescription drug1 information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section #hjb7;b77#a77;,a7 or designated by the ,secretary in accordance with section #hjb7;b77#a77;,b7-- 7,i7 for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug2 and 7,,ii7 during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the ,secretary for such monitoring purposes1 including for adverse events associated with nonprescription use of the drug2 or 7iii7 if the ,secretary determines that information described in clause 7i7 or 7ii7 is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug1 such other information the ,secretary determines is sufficient for such purposes4 7,d7 ,marketing pursuant to new drug application ,in the case of a request described in subparagraph 7,a77ii71 the drug subject to such request may be resubmitted for filing only if-- 7i7 the drug is marketed as a nonprescription drug1 under conditions of use comparable to the conditions specified in the request1 for such period as the ,secretary determines appropriate 7not to exceed #e consecutive years7 pursuant to an application approved under section #eje2 and 7ii7 during such period1 #a1jjj1jjj retail packages of the drug1 or an equivalent quantity as determined by the ,secretary1 were distributed for retail sale1 as determined in such manner as the ,secretary finds appropriate4 7,e7 ,rule of application ,except in the case of a request involving a drug described in section #ehf7i71 as in effect on ,january #a1 #bjag1 if the ,secretary refuses to file a request under this paragraph1 the requestor may not file such request over protest under paragraph 7#e77;,a77iii74 7#g7 ,packaging ,an administrative order issued under paragraph 7#b71 7#d77;,a71 or 7#e7 may include requirements for the packaging of a drug to encourage use in accordance with labeling4 ,such requirements may include unit dose packaging1 requirements for products intended for use by pediatric populations1 requirements to reduce risk of harm from unsupervised ingestion1 and other appropriate requirements4 ,this paragraph does not authorize the ,food and ,drug ,administration to require standards or testing procedures as described in part #agjj of title #af1 ,code of ,federal ,regulations4 7#h7 ,final and tentative final monographs for category ,i drugs deemed final administrative orders 7,a7 ,in general ,a final monograph or tentative final monograph described in subparagraph 7,b7 shall be deemed to be a final administrative order under this subsection and may be amended1 revoked1 or otherwise modified in accordance with the procedures of this subsection4 7,b7 ,monographs described ,for purposes of subparagraph 7,a71 a final monograph or tentative final monograph is described in this subparagraph if it-- 7i7 establishes conditions of use for a drug described in paragraph 7#a7 or 7#b7 of subsection 7a72 and 7ii7 represents the most recently promulgated version of such conditions1 including as modified1 in whole or in part1 by any proposed or final rule4 7,c7 ,deemed orders include harmonizing technical amendments ,the deemed establishment of a final administrative order under subparagraph 7,a7 shall be construed to include any technical amendments to such order as the ,secretary determines necessary to ensure that such order is appropriately harmonized1 in terms of terminology or cross-references1 with the applicable provisions of this ,act 7and regulations thereunder7 and any other orders issued under this section4 7c7 ,procedure for minor changes 7#a7 ,in general ,minor changes in the dosage form of a drug that is described in paragraph 7#a7 or 7#b7 of subsection 7a7 or the subject of an order issued under subsection 7b7 may be made by a requestor without the issuance of an order under subsection 7b7 if-- 7,a7 the requestor maintains such information as is necessary to demonstrate that the change-- 7i7 will not affect the safety or effectiveness of the drug2 and 7ii7 will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product2 and 7,b7 the change is in conformity with the requirements of an applicable administrative order issued by the ,secretary under paragraph 7#c74 7#b7 ,additional information 7,a7 ,access to records ,a sponsor shall submit records requested by the ,secretary relating to such a minor change under section #gjd7;a77#d71 within #ae business days of receiving such a request1 or such longer period as the ,secretary may provide4 7,b7 ,insufficient information ,if the ,secretary determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient1 the ,secretary-- 7i7 may so inform the sponsor of the drug in writing2 and 7ii7 if the ,secretary so informs the sponsor1 shall provide the sponsor of the drug with a reasonable opportunity to provide additional information4 7,c7 ,failure to submit sufficient information ,if the sponsor fails to provide such additional information within a time prescribed by the ,secretary1 or if the ,secretary determines that such additional information does not demonstrate that the change does not-- 7i7 affect the safety or effectiveness of the drug2 or 7ii7 materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product1 the drug as modified is a new drug under section #bja7p7 and shall be deemed to be misbranded under section #ejb7;ee74 7#c7 ,determining whether a change will affect safety or effectiveness 7,a7 ,in general ,the ,secretary shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a sponsor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product1 together with guidance for applying those orders to specific dosage forms4 7,b7 ,standard practices ,the orders and guidance issued by the ,secretary under subparagraph 7,a7 shall take into account relevant public standards and standard practices for evaluating the quality of drugs1 and may take into account the special needs of populations1 including children4 7d7 ,confidentiality of information submitted to the ,secretary 7#a7 ,in general ,subject to paragraph 7#b71 any information1 including reports of testing conducted on the drug or drugs involved1 that is submitted by a requestor in connection with proceedings on an order under this section 7including any minor change under subsection 7c77 and is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code1 shall not be disclosed to the public unless the requestor consents to that disclosure4 7#b7 ,public availability 7,a7 ,in general ,except as provided in subparagraph 7,b71 the ,secretary shall-- 7i7 make any information submitted by a requestor in support of a request under subsection 7b77#e77;,a7 available to the public not later than the date on which the proposed order is issued2 and 7ii7 make any information submitted by any other person with respect to an order requested 7or initiated by the ,secretary7 under subsection 7b71 available to the public upon such submission4 7,b7 ,limitations on public availability ,information described in subparagraph 7,a7 shall not be made public if-- 7i7 the information pertains to pharmaceutical quality information1 unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section #bja7p77#a72 7ii7 the information is submitted in a requestor-initiated request1 but the requestor withdraws such request1 in accordance with withdrawal procedures established by the ,secretary1 before the ,secretary issues the proposed order2 7iii7 the ,secretary requests and obtains the information under subsection 7c7 and such information is not submitted in relation to an order under subsection 7b72 or 7iv7 the information is of the type contained in raw datasets4 7e7 ,updates to drug listing information ,a sponsor who makes a change to a drug subject to this section shall submit updated drug listing information for the drug in accordance with section #eaj7;j7 within #cj calendar days of the date when the drug is first commercially marketed1 except that a sponsor who was the order requestor with respect to an order subject to subsection 7b77#e77;,c7 7or a licensee1 assignee1 or successor in interest of such requestor7 shall submit updated drug listing information on or before the date when the drug is first commercially marketed4 7f7 ,approvals under section #eje ,the provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections #eje7;b77#a71 #eje7;b77#b71 and #eje7;j74 ,a determination under this section that a drug is not subject to section #ejc7;b77#a71 is generally recognized as safe and effective under section #bja7p77#a71 and is not a new drug under section #bja7p7 shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section #eje7;b77#b71 so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section4 7g7 ,public availability of administrative orders ,the ,secretary shall establish1 maintain1 update 7as determined necessary by the ,secretary but no less frequently than annually71 and make publicly available1 with respect to orders issued under this section-- 7#a7 a repository of each final order and interim final order in effect1 including the complete text of the order2 and 7#b7 a listing of all orders proposed and under development under subsection 7b77#b71 including-- 7,a7 a brief description of each such order2 and 7,b7 the ,secretary's expectations1 if resources permit1 for issuance of proposed orders over a #c-year period4 7h7 ,development advice to sponsors or requestors ,the ,secretary shall establish procedures under which sponsors or requestors may meet with appropriate officials of the ,food and ,drug ,administration to obtain advice on the studies and other information necessary to support submissions under this section and other matters relevant to the regulation of nonprescription drugs and the development of new nonprescription drugs under this section4 7i7 ,participation of multiple sponsors or requestors ,the ,secretary shall establish procedures to facilitate efficient participation by multiple sponsors or requestors in proceedings under this section1 including provision for joint meetings with multiple sponsors or requestors or with organizations nominated by sponsors or requestors to represent their interests in a proceeding4 7j7 ,electronic format ,all submissions under this section shall be in electronic format4 7k7 ,effect on existing regulations governing nonprescription drugs 7#a7 ,regulations of general applicability to nonprescription drugs ,except as provided in this subsection1 nothing in this section supersedes regulations establishing general requirements for nonprescription drugs1 including regulations of general applicability contained in parts #bja1 #bej1 and #ccj of title #ba1 ,code of ,federal ,regulations1 or any successor regulations4 ,the ,secretary shall establish or modify such regulations by means of rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7#b7 ,regulations establishing requirements for specific nonprescription drugs 7,a7 ,the provisions of section #caj4ede of title #ba1 ,code of ,federal ,regulations1 as in effect on the day before the date of the enactment of this section1 shall be deemed to be a final order under subsection 7b74 7,b7 ,regulations in effect on the day before the date of the enactment of this section1 establishing requirements for specific nonprescription drugs marketed pursuant to this section 7including such requirements in parts #bja and #bej of title #ba1 ,code of ,federal ,regulations71 shall be deemed to be final orders under subsection 7b71 only as they apply to drugs-- 7i7 subject to paragraph 7#a71 7#b71 7#c71 or 7#d7 of subsection 7a72 or 7ii7 otherwise subject to an order under this section4 7#c7 ,withdrawal of regulations ,the ,secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part #ccj and other relevant parts of title #ba1 ,code of ,federal ,regulations 7as in effect on the day before the date of the enactment of this section71 or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references4 ,notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the ,federal ,register 7or upon such date as specified in such notice74 7l7 ,guidance ,the ,secretary shall issue guidance that specifies-- 7#a7 the procedures and principles for formal meetings between the ,secretary and sponsors or requestors for drugs subject to this section2 7#b7 the format and content of data submissions to the ,secretary under this section2 7#c7 the format of electronic submissions to the ,secretary under this section2 7#d7 consolidated proceedings for appeal and the procedures for such proceedings where appropriate2 and 7#e7 for minor changes in drugs1 recommendations on how to comply with the requirements in orders issued under subsection 7c77#c74 7m7 ,rule of construction 7#a7 ,in general ,this section shall not affect the treatment or status of a nonprescription drug-- 7,a7 that is marketed without an application approved under section #eje as of the date of the enactment of this section2 7,b7 that is not subject to an order issued under this section2 and 7,c7 to which paragraph 7#a71 7#b71 7#c71 7#d71 or 7#e7 of subsection 7a7 do not apply4 7#b7 ,treatment of products previously found to be subject to time and extent requirements 7,a7 ,notwithstanding subsection 7a71 a drug described in subparagraph 7,b7 may only be lawfully marketed1 without an application approved under section #eje1 pursuant to an order issued under this section4 7,b7 ,a drug described in this subparagraph is a drug which1 prior to the date of the enactment of this section1 the ,secretary determined in a proposed or final rule to be ineligible for review under the ,,otc drug review 7as such phrase ,,otc drug review was used in section #ccj4ad of title #ba1 ,code of ,federal ,regulations1 as in effect on the day before the date of the enactment of this section74 7#c7 ,preservation of authority 7,a7 ,nothing in paragraph 7#a7 shall be construed to preclude or limit the applicability of any provision of this ,act other than this section4 7,b7 ,nothing in subsection 7a7 shall be construed to prohibit the ,secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section #bja7p77#a71 as the ,secretary determines appropriate4 7n7 ,investigational new drugs ,a drug is not subject to this section if an exemption for investigational use under section #eje7;i7 is in effect for such drug4 7o7 ,inapplicability of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to collections of information made under this section4 7p7 ,inapplicability of notice and comment rulemaking and other requirements ,the requirements of subsection 7b7 shall apply with respect to orders issued under this section instead of the requirements of subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7q7 ,definitions ,in this section3 7#a7 ,the term nonprescription drug refers to a drug not subject to the requirements of section #ejc7;b77#a74 7#b7 ,the term sponsor refers to any person marketing1 manufacturing1 or processing a drug that-- 7,a7 is listed pursuant to section #eaj7;j72 and 7,b7 is or will be subject to an administrative order under this section of the ,food and ,drug ,administration4 7#c7 ,the term requestor refers to any person or group of persons marketing1 manufacturing1 processing1 or developing a drug4 4 7b7 ,,gao study ,not later than #d years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a study to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate addressing the effectiveness and overall impact of exclusivity under section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 and section #ehf;,c of such ,act 7#ba ,u4,s4,c4 #cfj;fff-#c71 including the impact of such exclusivity on consumer access4 ,such study shall include-- 7#a7 an analysis of the impact of exclusivity under such section #eje;,g for nonprescription drug products1 including-- 7,a7 the number of nonprescription drug products that were granted exclusivity and the indication for which the nonprescription drug products were determined to be generally recognized as safe and effective2 7,b7 whether the exclusivity for such drug products was granted for-- 7i7 a new active ingredient 7including any ester or salt of the active ingredient72 or 7ii7 changes in the conditions of use of a drug1 for which new human data studies conducted or sponsored by the requestor were essential2 7,c7 whether1 and to what extent1 the exclusivity impacted the requestor's or sponsor's decision to develop the drug product2 7,d7 an analysis of the implementation of the exclusivity provision in such section #eje;,g1 including-- 7i7 the resources used by the ,food and ,drug ,administration2 7ii7 the impact of such provision on innovation1 as well as research and development in the nonprescription drug market2 7iii7 the impact of such provision on competition in the nonprescription drug market2 7iv7 the impact of such provision on consumer access to nonprescription drug products2 7v7 the impact of such provision on the prices of nonprescription drug products2 and 7vi7 whether the administrative orders initiated by requestors under such section #eje;,g have been sufficient to encourage the development of nonprescription drug products that would likely not be otherwise developed1 or developed in as timely a manner2 and 7,e7 whether the administrative orders initiated by requestors under such section #eje;,g have been sufficient incentive to encourage innovation in the nonprescription drug market2 and 7#b7 an analysis of the impact of exclusivity under such section #ehf;,c for sunscreen ingredients1 including-- 7,a7 the number of sunscreen ingredients that were granted exclusivity and the specific ingredient that was determined to be generally recognized as safe and effective2 7,b7 whether1 and to what extent1 the exclusivity impacted the requestor's or sponsor's decision to develop the sunscreen ingredient2 7,c7 whether1 and to what extent1 the sunscreen ingredient granted exclusivity had previously been available outside of the ,united ,states2 7,d7 an analysis of the implementation of the exclusivity provision in such section #ehf;,c1 including-- 7i7 the resources used by the ,food and ,drug ,administration2 7ii7 the impact of such provision on innovation1 as well as research and development in the sunscreen market2 7iii7 the impact of such provision on competition in the sunscreen market2 7iv7 the impact of such provision on consumer access to sunscreen products2 7v7 the impact of such provision on the prices of sunscreen products2 and 7vi7 whether the administrative orders initiated by requestors under such section #eje;,g have been utilized by sunscreen ingredient sponsors and whether such process has been sufficient to encourage the development of sunscreen ingredients that would likely not be otherwise developed1 or developed in as timely a manner2 and 7,e7 whether the administrative orders initiated by requestors under such section #ehf;,c have been sufficient incentive to encourage innovation in the sunscreen market4 7c7 ,conforming amendment ,section #gea7;d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgir7d77#a77 is amended-- 7#a7 in the matter preceding subparagraph 7,a7-- 7,a7 by striking final regulation promulgated and inserting final order under section #eje;,g2 and 7,b7 by striking and not misbranded2 and 7#b7 in subparagraph 7,a71 by striking regulation in effect and inserting regulation or order in effect4 #ajb4 ,misbranding ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7ee7 ,if it is a nonprescription drug that is subject to section #eje;,g1 is not the subject of an application approved under section #eje1 and does not comply with the requirements under section #eje;,g4 7ff7 ,if it is a drug and it was manufactured1 prepared1 propagated1 compounded1 or processed in a facility for which fees have not been paid as required by section #gdd,m4 4 #ajc4 ,drugs excluded from the over-the-counter drug review 7a7 ,in general ,nothing in this ,act 7or the amendments made by this ,act7 shall apply to any nonprescription drug 7as defined in section #eje;,g7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #aja of this ,act7 which was excluded by the ,food and ,drug ,administration from the ,over-the-,counter ,drug ,review in accordance with the paragraph numbered #be on page #idff of volume #cg of the ,federal ,register1 published on ,may #aa1 #aigb4 7b7 ,rule of construction ,nothing in this section shall be construed to preclude or limit the applicability of any other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #ajd4 ,treatment of ,sunscreen ,innovation ,act 7a7 ,review of nonprescription sunscreen active ingredients 7#a7 ,applicability of section #eje;,g for pending submissions 7,a7 ,in general ,a sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that1 as of the date of enactment of this ,act1 is subject to a proposed sunscreen order under section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 may elect1 by means of giving written notification to the ,secretary of ,health and ,human ,services within #ahj calendar days of the enactment of this ,act1 to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #aja of this ,act4 7,b7 ,election exercised ,upon receipt by the ,secretary of ,health and ,human ,services of a timely notification under subparagraph 7,a7-- 7i7 the proposed sunscreen order involved is deemed to be a request for an order under subsection 7b7 of section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #aja of this ,act2 and 7ii7 such order is deemed to have been accepted for filing under subsection 7b77#f77;,a77i7 of such section #eje;,g4 7,c7 ,election not exercised ,if a notification under subparagraph 7,a7 is not received by the ,secretary of ,health and ,human ,services within #ahj calendar days of the date of enactment of this ,act1 the review of the proposed sunscreen order described in subparagraph 7,a7-- 7i7 shall continue under section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c72 and 7ii7 shall not be eligible for review under section #eje;,g1 added by section #aja of this ,act4 7#b7 ,definitions ,in this subsection1 the terms sponsor1 nonprescription1 sunscreen active ingredient1 and proposed sunscreen order have the meanings given to those terms in section #ehf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff74 7b7 ,amendments to sunscreen provisions 7#a7 ,final sunscreen orders ,paragraph 7#c7 of section #ehf;,c7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;e77 is amended to read as follows3 7#c7 ,relationship to orders under section #eje;,g ,a final sunscreen order shall be deemed to be a final order under section #eje;,g4 4 7#b7 ,meetings ,paragraph 7#g7 of section #ehf;,c7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is amended-- 7,a7 by striking ,a sponsor may request and inserting the following3 7,a7 ,in general ,a sponsor may request 2 and 7,b7 by adding at the end the following3 7,b7 ,confidential meetings ,a sponsor may request one or more confidential meetings with respect to a proposed sunscreen order1 including a letter deemed to be a proposed sunscreen order under paragraph 7#c71 to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order1 as appropriate4 ,the ,secretary shall convene a confidential meeting with such sponsor in a reasonable time period4 ,if a sponsor requests more than one confidential meeting for the same proposed sunscreen order1 the ,secretary may refuse to grant an additional confidential meeting request if the ,secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order1 or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion4 ,the ,secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets4 ,this subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 7#c7 ,exclusivity ,section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 is amended by adding at the end the following3 7f7 ,exclusivity 7#a7 ,in general ,a final sunscreen order shall have the effect of authorizing solely the order requestor 7or the licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such request and listed under paragraph 7#e77 for a period of #ah months1 to market a sunscreen ingredient under this section incorporating changes described in paragraph 7#b7 subject to the limitations under paragraph 7#d71 beginning on the date the requestor 7or any licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such request and listed under paragraph 7#e77 may lawfully market such sunscreen ingredient pursuant to the order4 7#b7 ,changes described ,a change described in this paragraph is a change subject to an order specified in paragraph 7#a7 that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph 7#c74 7#c7 ,marketed sunscreen ,the marketed sunscreen ingredients described in this paragraph are sunscreen ingredients-- 7,a7 marketed in accordance with a final monograph for sunscreen drug products set forth at part #ceb of title #ba1 ,code of ,federal ,regulations 7as published at #fd ,fed4 ,reg4 #bgfhg72 or 7,b7 marketed in accordance with a final order issued under this section4 7#d7 ,limitations on exclusivity ,only one #ah-month period may be granted per ingredient under paragraph 7#a74 7#e7 ,listing of licensees1 assignees1 or successors in interest ,requestors shall submit to the ,secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce1 a list of licensees1 assignees1 or successors in interest under paragraph 7#a74 4 7#d7 ,sunset provision ,subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq47 is amended by adding at the end the following3 #ehf;,h4 ,sunset ,this subchapter shall cease to be effective at the end of fiscal year #bjbb4 4 7#e7 ,treatment of final sunscreen order ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by striking section #ehf;,e of such ,act 7#ba ,u4,s4,c4 #cfj;fff-#e74 7c7 ,treatment of ,authority ,regarding ,finalization of ,sunscreen ,monograph 7#a7 ,in general 7,a7 ,revision of final sunscreen order ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall amend and revise the final administrative order concerning nonprescription sunscreen 7referred to in this subsection as the sunscreen order7 for which the content1 prior to the date of enactment of this ,act1 was represented by the final monograph for sunscreen drug products set forth in part #ceb of title #ba1 ,code of ,federal ,regulations 7as in effect on ,may #ba1 #aiii74 7,b7 ,issuance of revised sunscreen order2 effective date ,a revised sunscreen order described in subparagraph 7,a7 shall be-- 7i7 issued in accordance with the procedures described in section #eje;,g7b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7ii7 issued in proposed form not later than #ah months after the date of enactment of this ,act2 and 7iii7 issued by the ,secretary at least #a year prior to the effective date of the revised order4 7#b7 ,reports ,if a revised sunscreen order issued under paragraph 7#a7 does not include provisions related to the effectiveness of various sun protection factor levels1 and does not address all dosage forms known to the ,secretary to be used in sunscreens marketed in the ,united ,states without a new drug application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 the ,secretary shall submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate on the rationale for omission of such provisions from such order1 and a plan and timeline to compile any information necessary to address such provisions through such order4 7d7 ,treatment of non-,sunscreen time and extent applications 7#a7 ,in general ,any application described in section #ehf;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 that was submitted to the ,secretary pursuant to section #ccj4ad of title #ba1 ,code of ,federal ,regulations1 as such provisions were in effect immediately prior to the date of enactment date of this ,act1 shall be extinguished as of such date of enactment1 subject to paragraph 7#b74 7#b7 ,order request ,nothing in paragraph 7#a7 precludes the submission of an order request under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #aja of this ,act1 with respect to a drug that was the subject of an application extinguished under paragraph 7#a74 #aje4 ,annual update to ,congress on appropriate pediatric indication for certain ,,otc cough and cold drugs 7a7 ,in general ,subject to subsection 7c71 the ,secretary of ,health and ,human ,services shall1 beginning not later than #a year after the date of enactment of this ,act1 annually 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 letter describing the progress of the ,food and ,drug ,administration-- 7#a7 in evaluating the cough and cold monograph described in subsection 7b7 with respect to children under age #f2 and 7#b7 as appropriate1 revising such cough and cold monograph to address such children through the order process under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #aja of this ,act4 7b7 ,cough and cold monograph described ,the cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive1 expectorant1 nasal decongestant1 or antihistamine active ingredients 7or combinations thereof7 are generally recognized as safe and effective1 as specified in part #cda of title #ba1 ,code of ,federal ,regulations 7as in effect immediately prior to the date of enactment of this ,act71 and included in an order deemed to be established under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #aja of this ,act4 7c7 ,duration of authority ,the requirement under subsection 7a7 shall terminate as of the date of a letter submitted by the ,secretary of ,health and ,human ,services pursuant to such subsection in which the ,secretary indicates that the ,food and ,drug ,administration has completed its evaluation and revised1 in a final order1 as applicable1 the cough and cold monograph as described in subsection 7a77#b74 #ajf4 ,technical corrections 7a7 ,imports and exports ,section #hja7;e77#d77;,e77iii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77;,e77iii77 is amended by striking subparagraph each place such term appears and inserting paragraph4 7b7 ,,fda ,reauthorization ,act of #bjag 7#a7 ,in general ,section #ije7;b77#d7 of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 is amended by striking ,section #gdd;,h7e77#b77;,b7 and inserting ,section #gdd;,h7f77#b77;,b74 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall take effect as of the enactment of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb74 ,,ii ,user ,fees #bja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,over-the-,counter ,monograph ,user ,fee ,act of #bjai4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title 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 ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #bjb4 ,fees relating to over-the-counter drugs ,subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is amended by inserting after part #i the following3 #aj ,fees ,relating to ,over-the-,counter ,drugs #gdd,l4 ,definitions ,in this part3 7#a7 ,the term affiliate means a business entity that has a relationship with a second business entity if1 directly or indirectly-- 7,a7 one business entity controls1 or has the power to control1 the other business entity2 or 7,b7 a third party controls1 or has power to control1 both of the business entities4 7#b7 ,the term contract manufacturing organization facility means an ,,otc monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the ,,otc monograph drug produced at such facility directly to wholesalers1 retailers1 or consumers in the ,united ,states4 7#c7 ,the term costs of resources allocated for ,,otc monograph drug activities means the expenses in connection with ,,otc monograph drug activities for-- 7,a7 officers and employees of the ,food and ,drug ,administration1 contractors of the ,food and ,drug ,administration1 advisory committees1 and costs related to such officers1 employees1 and committees and costs related to contracts with such contractors2 7,b7 management of information1 and the acquisition1 maintenance1 and repair of computer resources2 7,c7 leasing1 maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies2 and 7,d7 collecting fees under section #gdd,m and accounting for resources allocated for ,,otc monograph drug activities4 7#d7 ,the term ,,fda establishment identifier is the unique number automatically generated by ,food and ,drug ,administration's ,field ,accomplishments and ,compliance ,tracking ,system 7,,facts7 7or any successor system74 7#e7 ,the term ,,otc monograph drug means a nonprescription drug without an approved new drug application which is governed by the provisions of section #eje;,g4 7#f7 ,the term ,,otc monograph drug activities means activities of the ,secretary associated with ,,otc monograph drugs and inspection of facilities associated with such products1 including the following activities3 7,a7 ,the activities necessary for review and evaluation of ,,otc monographs and ,,otc monograph order requests1 including-- 7i7 orders proposing or finalizing applicable conditions of use for ,,otc monograph drugs2 7ii7 orders affecting status regarding general recognition of safety and effectiveness of an ,,otc monograph ingredient or combination of ingredients under specified conditions of use2 7iii7 all ,,otc monograph drug development and review activities1 including intra-agency collaboration2 7iv7 regulation and policy development activities related to ,,otc monograph drugs2 7v7 development of product standards for products subject to review and evaluation2 7vi7 meetings referred to in section #eje;,g7i72 7vii7 review of labeling prior to issuance of orders related to ,,otc monograph drugs or conditions of use2 and 7viii7 regulatory science activities related to ,,otc monograph drugs4 7,b7 ,inspections related to ,,otc monograph drugs4 7,c7 ,monitoring of clinical and other research conducted in connection with ,,otc monograph drugs4 7,d7 ,safety activities with respect to ,,otc monograph drugs1 including-- 7i7 collecting1 developing1 and reviewing safety information on ,,otc monograph drugs1 including adverse event reports2 7ii7 developing and using improved adverse event data-collection systems1 including information technology systems2 and 7iii7 developing and using improved analytical tools to assess potential safety risks1 including access to external databases4 7,e7 ,other activities necessary for implementation of section #eje;,g4 7#g7 ,the term ,,otc monograph order request means a request for an order submitted under section #eje;,g7b77#e74 7#h7 ,the term ,tier #a ,,otc monograph order request means any ,,otc monograph order request not determined to be a ,tier #b ,,otc monograph order request4 7#i7 7,a7 ,the term ,tier #b ,,otc monograph order request means1 subject to subparagraph 7,b71 an ,,otc monograph order request for-- 7i7 the reordering of existing information in the drug facts label of an ,,otc monograph drug2 7ii7 the addition of information to the other information section of the drug facts label of an ,,otc monograph drug1 as limited by section #bja4ff7;c77#g7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7iii7 modification to the directions for use section of the drug facts label of an ,,otc monograph drug1 if such changes conform to changes made pursuant to section #eje;,g7c77#c77;,a72 7iv7 the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph2 7v7 a change to ingredient nomenclature to align with nomenclature of a standards-setting organization2 or 7vi7 addition of an interchangeable term in accordance with section #ccj4a of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,b7 ,the ,secretary may1 based on program implementation experience or other factors found appropriate by the ,secretary1 characterize any ,,otc monograph order request as a ,tier #b ,,otc monograph order request 7including recharacterizing a request from ,tier #a to ,tier #b7 and publish such determination in a proposed order issued pursuant to section #eje;,g4 7#aj7 7,a7 ,the term ,,otc monograph drug facility means a foreign or domestic business or other entity that-- 7i7 is-- 7,i7 under one management1 either direct or indirect2 and 7,,ii7 at one geographic location or address engaged in manufacturing or processing the finished dosage form of an ,,otc monograph drug2 7ii7 includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more ,,otc monograph drugs to manufacture or process such drugs2 and 7iii7 does not include a business or other entity whose only manufacturing or processing activities are one or more of the following3 production of clinical research supplies1 testing1 or placement of outer packaging on packages containing multiple products1 for such purposes as creating multipacks1 when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging4 7,b7 ,for purposes of subparagraph 7,a77i77,,ii71 separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are-- 7i7 closely related to the same business enterprise2 7ii7 under the supervision of the same local management2 and 7iii7 under a single ,,fda establishment identifier and capable of being inspected by the ,food and ,drug ,administration during a single inspection4 7,c7 ,if a business or other entity would meet criteria specified in subparagraph 7,a71 but for being under multiple management1 the business or other entity is deemed to constitute multiple facilities1 one per management entity1 for purposes of this paragraph4 7#aa7 ,the term ,,otc monograph drug meeting means any meeting regarding the content of a proposed ,,otc monograph order request4 7#ab7 ,the term person includes an affiliate of a person4 7#ac7 ,the terms requestor and sponsor have the meanings given such terms in section #eje;,g4 #gdd,m4 ,authority to assess and use ,,otc monograph fees 7a7 ,types of fees ,beginning with fiscal year #bjba1 the ,secretary shall assess and collect fees in accordance with this section as follows3 7#a7 ,facility fee 7,a7 ,in general ,each person that owns a facility identified as an ,,otc monograph drug facility on ,december #ca of the fiscal year or at any time during the preceding #ab-month period shall be assessed an annual fee for each such facility as determined under subsection 7c74 7,b7 ,exceptions 7i7 ,facilities that cease activities ,a fee shall not be assessed under subparagraph 7,a7 if the identified ,,otc monograph drug facility-- 7,i7 has ceased all activities related to ,,otc monograph drugs prior to ,december #ca of the year immediately preceding the applicable fiscal year2 and 7,,ii7 has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section #eaj4 7ii7 ,contract manufacturing organizations ,the amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an ,,otc monograph drug facility that is not a contract manufacturing organization facility4 7,c7 ,amount ,the amount of fees established under subparagraph 7,a7 shall be established under subsection 7c74 7,d7 ,due date 7i7 ,for first program year ,for fiscal year #bjba1 the facility fees required under subparagraph 7,a7 shall be due on the later of-- 7,i7 the first business day of ,june of #bjbj2 or 7,,ii7 #de calendar days after publication of the ,federal ,register notice provided for under subsection 7c77#d77;,a74 7ii7 ,subsequent fiscal years ,for each fiscal year after fiscal year #bjba1 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 7#b7 ,,otc monograph order request fee 7,a7 ,in general ,each person that submits an ,,otc monograph order request shall be subject to a fee for an ,,otc monograph order request4 ,the amount of such fee shall be-- 7i7 for a ,tier #a ,,otc monograph order request1 #ejj1jjj1 adjusted for inflation for the fiscal year 7as determined under subsection 7c77#a77;,b772 and 7ii7 for a ,tier #b ,,otc monograph order request1 #ajj1jjj1 adjusted for inflation for the fiscal year 7as determined under subsection 7c77#a77;,b774 7,b7 ,due date ,the ,,otc monograph order request fees required under subparagraph 7,a7 shall be due on the date of submission of the ,,otc monograph order request4 7,c7 ,exception for certain safety changes ,a person who is named as the requestor in an ,,otc monograph order shall not be subject to a fee under subparagraph 7,a7 if the ,secretary finds that the ,,otc monograph order request seeks to change the drug facts labeling of an ,,otc monograph drug in a way that would add to or strengthen-- 7i7 a contraindication1 warning1 or precaution2 7ii7 a statement about risk associated with misuse or abuse2 or 7iii7 an instruction about dosage and administration that is intended to increase the safe use of the ,,otc monograph drug4 7,d7 ,refund of fee if order request is recategorized as a ,tier #b ,,otc monograph order request ,if the ,secretary determines that an ,,otc monograph request initially characterized as ,tier #a shall be re-characterized as a ,tier #b ,,otc monograph order request1 and the requestor has paid a ,tier #a fee in accordance with subparagraph 7,a77i71 the ,secretary shall refund the requestor the difference between the ,tier #a and ,tier #b fees determined under subparagraphs 7,a77i7 and 7,a77ii71 respectively4 7,e7 ,refund of fee if order request refused for filing or withdrawn before filing ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,b7 for any order request which is refused for filing or was withdrawn before being accepted or refused for filing4 7,f7 ,fees for order requests previously refused for filing or withdrawn before filing ,an ,,otc monograph order request that was submitted but was refused for filing1 or was withdrawn before being accepted or refused for filing1 shall be subject to the full fee under subparagraph 7,a7 upon being resubmitted or filed over protest4 7,g7 ,refund of fee if order request withdrawn ,if an order request is withdrawn after the order request was filed1 the ,secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed4 ,the ,secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph4 ,a determination by the ,secretary concerning a refund under this subparagraph shall not be reviewable4 7#c7 ,refunds 7,a7 ,in general ,other than refunds provided pursuant to any of subparagraphs 7,d7 through 7,g7 of paragraph 7#b71 the ,secretary shall not refund any fee paid under paragraph 7#a7 except as provided in subparagraph 7,b74 7,b7 ,disputes concerning fees ,to qualify for the return of a fee claimed to have been paid in error under paragraph 7#a7 or 7#b71 a person shall submit to the ,secretary a written request justifying such return within #ahj calendar days after such fee was paid4 7#d7 ,notice ,within the timeframe specified in subsection 7c71 the ,secretary shall publish in the ,federal ,register the amount of the fees under paragraph 7#a7 for such fiscal year4 7b7 ,fee revenue amounts 7#a7 ,fiscal year #bjba ,for fiscal year #bjba1 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 fiscal year #bjba 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#b772 and 7,c7 additional direct cost adjustments 7as determined under subsection 7c77#c774 7#b7 ,subsequent fiscal years ,for each of the fiscal years #bjbb through #bjbe1 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#c772 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 and 7,e7 additional dollar amounts for each fiscal year as follows3 7i7 #g1jjj1jjj for fiscal year #bjbb4 7ii7 #f1jjj1jjj for fiscal year #bjbc4 7iii7 #g1jjj1jjj for fiscal year #bjbd4 7iv7 #c1jjj1jjj for fiscal year #bjbe4 7#c7 ,annual base revenue ,for purposes of paragraphs 7#a77;,a7 and 7#b77;,a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjba1 #h1jjj1jjj2 and 7,b7 for fiscal years #bjbb through #bjbe1 the dollar amount of the total revenue amount established under this subsection for the previous fiscal year1 not including any adjustments made under subsection 7c77#b7 or 7c77#c74 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#b77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for fiscal year #bjbb and each subsequent fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b77#b72 and 7ii7 the inflation adjustment percentage under subparagraph 7,c74 7,b7 ,,otc monograph order request fees ,for purposes of subsection 7a77#b71 the dollar amount of the inflation adjustment to the fee for ,,otc monograph order requests for fiscal year #bjbb and each subsequent fiscal year shall be equal to the product of-- 7i7 the applicable fee under subsection 7a77#b7 for the preceding fiscal year2 and 7ii7 the inflation adjustment percentage under subparagraph 7,c74 7,c7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to-- 7i7 for each of fiscal years #bjbb and #bjbc1 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data2 and 7ii7 for each of fiscal years #bjbd and #bjbe1 the sum of-- 7,i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of ,,otc monograph drug activities for the first #c years of the preceding #d fiscal years2 and 7,,ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of ,,otc monograph drug activities for the first #c years of the preceding #d fiscal years4 7#b7 ,operating reserve adjustment 7,a7 ,in general ,for fiscal year #bjba and subsequent fiscal years1 for purposes of subsections 7b77#a77;,b7 and 7b77#b77;,c71 the ,secretary may1 in addition to adjustments under paragraph 7#a71 further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for ,,otc monograph drug activities for not more than the number of weeks specified in subparagraph 7,b74 7,b7 ,number of weeks ,the number of weeks specified in this subparagraph is-- 7i7 #c weeks for fiscal year #bjba2 7ii7 #g weeks for fiscal year #bjbb2 7iii7 #aj weeks for fiscal year #bjbc2 7iv7 #aj weeks for fiscal year #bjbd2 and 7v7 #aj weeks for fiscal year #bjbe4 7,c7 ,decrease ,if the ,secretary has carryover balances for such process in excess of #aj weeks of the operating reserves referred to in subparagraph 7,a71 the ,secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than #aj weeks of such operating reserves4 7,d7 ,rationale for adjustment ,if an adjustment under this paragraph is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#d7 establishing fee revenue and fees for the fiscal year involved4 7#c7 ,additional direct cost adjustment ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees for purposes of subsection 7b77#b77;,d7 by an amount equal to-- 7,a7 #ad1jjj1jjj for fiscal year #bjba2 7,b7 #g1jjj1jjj for fiscal year #bjbb2 7,c7 #d1jjj1jjj for fiscal year #bjbc2 7,d7 #c1jjj1jjj for fiscal year #bjbd2 and 7,e7 #c1jjj1jjj for fiscal year #bjbe4 7#d7 ,annual fee setting 7,a7 ,fiscal year #bjba ,the ,secretary shall1 not later than the second ,monday in ,march of #bjbj-- 7i7 establish ,,otc monograph drug facility fees for fiscal year #bjba under subsection 7a71 based on the revenue amount for such year under subsection 7b7 and the adjustments provided under this subsection2 and 7ii7 publish fee revenue1 facility fees1 and ,,otc monograph order requests in the ,federal ,register4 7,b7 ,subsequent fiscal years ,the ,secretary shall1 for each fiscal year that begins after ,september #cj1 #bjba1 not later than the second ,monday in ,march that precedes such fiscal year-- 7i7 establish for such fiscal year1 based on the revenue amounts under subsection 7b7 and the adjustments provided under this subsection-- 7,i7 ,,otc monograph drug facility fees under subsection 7a77#a72 and 7,,ii7 ,,otc monograph order request fees under subsection 7a77#b72 and 7ii7 publish such fee revenue amounts1 facility fees1 and ,,otc monograph order request fees in the ,federal ,register4 7d7 ,identification of facilities ,each person that owns an ,,otc monograph drug facility shall submit to the ,secretary the information required under this subsection each year4 ,such information shall1 for each fiscal year-- 7#a7 be submitted as part of the requirements for drug establishment registration set forth in section #eaj2 and 7#b7 include for each such facility1 at a minimum1 identification of the facility's business operation as that of an ,,otc monograph drug facility4 7e7 ,effect of failure ,to pay fees 7#a7 ,,otc ,monograph ,drug ,facility ,fee 7,a7 ,in general ,failure to pay the fee under subsection 7a77#a7 within #bj calendar days of the due date as specified in subparagraph 7,d7 of such subsection shall result in the following3 7i7 ,the ,secretary shall place the facility on a publicly available arrears list4 7ii7 ,all ,,otc monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section #ejb7;ff74 7,b7 ,application of penalties ,the penalties under this paragraph shall apply until the fee established by subsection 7a77#a7 is paid4 7#b7 ,order requests ,an ,,otc monograph order request submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for filing by the ,secretary until all fees owed by such person under this section have been paid4 7#c7 ,meetings ,a person subject to fees under this section shall be considered ineligible for ,,otc monograph drug meetings until all such fees owed by such person have been paid4 7f7 ,crediting and availability of fees 7#a7 ,in general ,fees authorized under subsection 7a7 shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for ,,otc monograph drug activities4 7#b7 ,collections and appropriation ,acts 7,a7 ,in general ,subject to subparagraph 7,c71 the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation ,acts1 or otherwise made available for obligation1 for such fiscal year4 7,b7 ,use of fees and limitation ,the fees authorized by this section shall be available to defray increases in the costs of the resources allocated for ,,otc monograph drug activities 7including increases in such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such activities71 only if the ,secretary allocates for such purpose an amount for such fiscal year 7excluding amounts from fees collected under this section7 no less than #ab1jjj1jjj1 multiplied by the adjustment factor applicable to the fiscal year involved under subsection 7c77#a74 7,c7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,b7 in any fiscal year if the costs funded by appropriations and allocated for ,,otc monograph drug activities are not more than #ae percent below the level specified in such subparagraph4 7,d7 ,provision for early payments in subsequent years ,payment of fees authorized under this section for a fiscal year 7after fiscal year #bjba71 prior to the due date for such fees1 may be accepted by the ,secretary in accordance with authority provided in advance in a prior year appropriations ,act4 7#c7 ,authorization of appropriations ,for each of the fiscal years #bjba through #bjbe1 there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section4 7g7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under subsection 7a7 within #cj calendar days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7h7 ,construction ,this section may not be construed to require that the number of full-time equivalent positions in the ,department of ,health and ,human ,services1 for officers1 employers1 and advisory committees not engaged in ,,otc monograph drug activities1 be reduced to offset the number of officers1 employees1 and advisory committees so engaged4 #gdd,n4 ,reauthorization2 reporting requirements 7a7 ,performance report ,beginning with fiscal year #bjba1 and not later than #abj calendar days after the end of each fiscal year thereafter for which fees are collected under this part1 the ,secretary shall prepare and 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 concerning the progress of the ,food and ,drug ,administration in achieving the goals identified in the letters described in section #bja7;b7 of the ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,act of #bjai during such fiscal year and the future plans of the ,food and ,drug ,administration for meeting such goals4 7b7 ,fiscal report ,not later than #abj calendar days after the end of fiscal year #bjba and each subsequent fiscal year for which fees are collected under this part1 the ,secretary shall prepare and 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 the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected for such fiscal year4 7c7 ,public availability ,the ,secretary shall make the reports required under subsections 7a7 and 7b7 available to the public on the internet website of the ,food and ,drug ,administration4 7d7 ,reauthorization 7#a7 ,consultation ,in developing recommendations to present to the ,congress with respect to the goals described in subsection 7a71 and plans for meeting the goals1 for ,,otc monograph drug activities for the first #e fiscal years after fiscal year #bjbe1 and for the reauthorization of this part for such fiscal years1 the ,secretary shall consult with-- 7,a7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,b7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,c7 scientific and academic experts2 7,d7 health care professionals2 7,e7 representatives of patient and consumer advocacy groups2 and 7,f7 the regulated industry4 7#b7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7,a7 present the recommendations developed under paragraph 7#a7 to the congressional committees specified in such paragraph2 7,b7 publish such recommendations in the ,federal ,register2 7,c7 provide for a period of #cj calendar days for the public to provide written comments on such recommendations2 7,d7 hold a meeting at which the public may present its views on such recommendations2 and 7,e7 after consideration of such public views and comments1 revise such recommendations as necessary4 7#c7 ,transmittal of recommendations ,not later than ,january #ae1 #bjbe1 the ,secretary shall transmit to the ,congress the revised recommendations under paragraph 7#b71 a summary of the views and comments received under such paragraph1 and any changes made to the recommendations in response to such views and comments4 4