,i #aacth ,,congress #b;d ,session ,h4 ,r4 #dhgi ,,in ,,the ,,house ,,of ,,representatives ,june #ag1 #bjad ,mr4 ,cooper 7for himself and ,mrs4 ,lummis7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for expedited review of drugs and biological products to provide safer or more effective treatment for males or females1 to amend the ,public ,health ,service ,act to enhance the consideration of sex differences in basic and clinical research1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,research for ,all ,act of #bjad 4 #b4 ,sufficiency of design and size of clinical trials during expedited review ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall review and develop policies1 as appropriate1 to ensure that the design and size of clinical trials for products granted expedited approval pursuant to section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 are sufficient to determine the safety and effectiveness of such products for men and women using subgroup analysis4 #c4 ,expedited review of drugs and biological products to provide safer or more effective treatment for males or females 7a7 ,in general ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended by adding at the end the following3 7g7 ,expedited review of drugs and biological products ,to provide safer or more effective treatment for males or females 7#a7 ,eligible product ,the ,secretary shall1 at the request of the sponsor of a new drug1 facilitate the development and expedite the review of such drug if the drug-- 7,a7 is intended-- 7i7 to avoid serious adverse events2 or 7ii7 to treat a serious or life-threatening disease or condition2 7,b7 whether alone or in combination with one or more other drugs or biological products1 is intended for safer or more effective treatment for men or women than a currently available product approved to treat the general population or the other sex2 and 7,c7 is supported by results of clinical trials that include and separately examine outcomes for both men and women4 7#b7 ,designation ,at the request of the sponsor of an eligible product described in paragraph 7#a71 the ,secretary shall designate the drug as an expedited product to provide safer or more effective treatment for males or females4 7#c7 ,early and frequent communication ,the ,secretary shall1 with respect to each expedited product designated under this subsection1 provide early and frequent communication and review of incomplete applications to the same extent and in the same manner as is provided under subsections 7b7 and 7d74 7#d7 ,rule of construction ,nothing in this subsection shall be construed-- 7,a7 to lessen or otherwise alter the standard of safety and effectiveness required for the approval or licensing of drugs or biological products under section #eje of this ,act or section #cea of the ,public ,health ,service ,act2 or 7,b7 to authorize application of the provisions of subsection 7c7 7relating to the use of surrogate endpoints7 to expedited products designated under this subsection4 4 7b7 ,technical corrections ,subsection 7f7 of section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 7relating to awareness efforts71 as designated by section #ijb7;a7 of ,public ,law #aab-add1 is amended-- 7#a7 in paragraph 7#a71 by striking and and and inserting and2 and 7#b7 by moving such subsection 7f7 so that it follows subsection 7e7 of such section #ejf4 #d4 ,research on sex differences 7a7 ,inclusion in ,,nih research 7#a7 ,in general ,section #dib;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7 is amended-- 7,a7 by redesignating subsections 7b7 through 7g7 as subsections 7c7 through 7h71 respectively2 and 7,b7 by inserting after subsection 7a7 the following3 7b7 ,inclusion of sex differences in basic research 7#a7 ,applicability to basic research 7,a7 ,in general ,the ,director of ,,nih shall determine when it is appropriate for projects of basic research involving cells1 tissues or animals to include both male and female cells1 tissues1 or animals4 7,b7 ,deadline for initial determination2 updates ,the ,director of ,,nih-- 7i7 shall make the initial determinations required by subparagraph 7,a7 not later than one year after the date of enactment of the ,research for ,all ,act of #bjad2 and 7ii7 may subsequently update or revise such determinations as the ,director determines appropriate4 7,c7 ,consultation ,in making the initial determinations required by subparagraph 7,a71 the ,director of ,,nih-- 7i7 shall consult with the ,office of ,research on ,women's ,health1 the ,institute of ,medicine1 the ,office of ,laboratory ,animal ,welfare1 and appropriate members of the scientific and academic communities2 and 7ii7 may conduct outreach and educational initiatives within the scientific and academic communities on the influence of sex as a variable in basic research in order to develop a consensus within such communities on when it is appropriate for projects of basic research involving cells1 tissues or animals to include both male and female cells1 tissues1 or animals4 7#b7 ,inclusion ,beginning on the date that is #a year after the date of enactment of the ,research for ,all ,act of #bjad1 in conducting or supporting basic research in accordance with paragraph 7#a71 the ,director of ,,nih shall1 subject to paragraph 7#c71 ensure that-- 7,a7 in the case of research on cells or tissues-- 7i7 cells or tissues1 as applicable1 are derived from both male and female organisms in each project of such research2 and 7ii7 the results are disaggregated according to whether the cells or tissues are derived from male or female organisms2 and 7,b7 in the case of animal research-- 7i7 both male and female animals are included as subjects in each project of such research2 and 7ii7 the results are disaggregated according to whether the subjects are male or female4 7#c7 ,exception ,paragraph 7#b7 shall not apply to a project of basic research if the ,director of ,,nih determines that the inclusion of cells or tissues derived from both male and female organisms1 or the inclusion of both male and female animals as subjects1 as applicable1 is inappropriate in the case of such project4 4 7#b7 ,design of research ,subsection 7d7 of section #dib;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b71 as redesignated1 is amended-- 7,a7 by striking 7d7 and all that follows through ,in the case and inserting the following3 7d7 ,design of research 7#a7 ,clinical trials ,in the case 2 and 7,b7 by adding at the end the following3 7#b7 ,basic research ,in the case of basic research in which cells or tissues derived from both male and female organisms will be included in accordance with subsection 7b77#b77;,a7 or both male and female animals will be included as subjects in accordance with subsection 7b77#b77;,b71 the ,director of ,,nih shall ensure that sex differences are examined and analyzed1 as appropriate4 4 7#c7 ,updating guidelines for clinical and basic research ,section #dib;,b7f77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b71 as redesignated1 is amended to read as follows3 7#a7 ,date certain2 update ,the guidelines required in subsection 7e7 regarding the requirements of this section for clinical and basic research shall-- 7,a7 be updated and published in the ,federal ,register not later than #a year after the date of enactment of the ,research for ,all ,act of #bjad2 7,b7 reflect the growing understanding that sex differences matter2 7,c7 ensure better enforcement of the requirements of this section by the personnel of the agencies of the ,national ,institutes of ,health responsible for reviewing grant proposals2 and 7,d7 include guidance on when research strongly supports or strongly negates the conclusion that there is a significant difference in how the variables being studied affect women or members of minority groups1 as the case may be1 relative to how such variables affect other subjects in the research4 4 7#d7 ,applicability ,section #dib;,b7f77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b71 as redesignated1 is amended by adding at the end the following3 ,for fiscal year #bjaf and subsequent fiscal years1 the ,director of ,,nih may not approve any proposal of basic research to be conducted or supported by any agency of the ,national ,institutes of ,health unless the proposal specifies the manner in which the research will comply with this section44 7#e7 ,conforming changes ,section #dib;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7 is amended-- 7,a7 in the heading of subsection 7a71 by striking ,requirement of inclusion and inserting ,inclusion in clinical research2 7,b7 in subsection 7a77#a71 by striking subsection 7b7 and inserting subsection 7c72 7,c7 in subsection 7e77#a77;,a71 as redesignated1 by striking subsection 7b7 and inserting subsection 7c72 7,d7 in subsection 7e77#a77;,b71 as redesignated1 by striking subsection 7c7 and inserting subsection 7d72 and 7,e7 in subsection 7e77#b71 as redesignated1 by striking subsection 7b7 and inserting subsection 7c74 7b7 ,biennial reports of ,director of ,,nih ,subparagraph 7,c7 of section #djc7;a77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc7;a77#d77 is amended-- 7#a7 by redesignating clause 7vi7 as clause 7vii72 and 7#b7 by inserting after clause 7v7 the following3 7vi7 ,basic research1 including a breakdown of the sex of organisms from which cells and tissues are derived1 a breakdown of the sex of animal subjects1 and such other information as may be necessary to demonstrate compliance with section #dib;,b 7regarding sex differences in basic research74 4 7c7 ,special ,centers of ,research on ,sex ,differences ,part ,h of title ,,iv of the ,public ,health ,service ,act is amended by inserting after section #dib;,b of such ,act 7#db ,u4,s4,c4 #bhi;a-#b7 the following3 #dib;,c4 ,special ,centers of ,research on ,sex ,differences ,the ,secretary may award grants or other support to entities for the continued operation and expansion of ,special ,centers of ,research on ,sex ,differences4 4 7d7 ,rule of construction ,nothing in this ,act or the amendments made by this ,act shall be construed to lessen any standard or requirement set forth in part #a1 #b1 or #c of subchapter ,a of chapter ,i of title #i1 ,code of ,federal ,regulations4 #e4 ,,gao reports ,not later than #a year after the date of enactment of the ,research for ,all ,act of #bjad1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 submit to the ,congress updated versions of the reports of the ,government ,accountability ,office entitled ,women's ,health3 ,,nih ,has ,increased ,its ,efforts ,to ,include ,women in ,research 7published in ,may #bjjj2 ,,gao_/,,hehs-#jj-if7 and ,women's ,health3 ,women ,sufficiently ,represented in ,new ,drug ,testing1 ,but ,,fda ,oversight ,needs ,improvement 7published in ,july #bjja2 ,,gao-#ja-ged72 and 7#b7 in such updated reports-- 7,a7 examine the inclusion of women1 female animals1 and female-derived cells and tissues in federally funded research over the past decade2 7,b7 examine how ,federal agencies report and analyze subgroup information and translate any differences to the medical community and patients2 7,c7 determine whether the quality of care which women receive is being negatively impacted by inclusion rates in basic and clinical research2 and 7,d7 address current efforts within ,national ,institutes of ,health and other government agencies to encourage the sharing of research data on sex differences and evaluate mechanisms to improve such sharing1 including a publicly accessible online system that will conform with policies protecting commercial1 proprietary1 or private information4