,,ii #aaith ,,congress #ast ,session ,s4 #hed ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #e1 #bjbe ,mr4 ,paul 7for himself and ,mr4 ,peters7 introduced the following bill2 which was read twice and referred to the ,committee on ,homeland ,security and ,governmental ,affairs ,a ,,bill ,to amend title #ca1 ,united ,states ,code1 to establish the ,life ,sciences ,research ,security ,board1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,risky ,research ,review ,act4 #b4 ,life ,sciences ,research ,security ,board 7a7 ,in general ,subtitle ,v of title #ca1 ,united ,states ,code1 is amended by adding at the end the following3 #gi ,life ,sciences ,research ,security ,board #gija4 ,definitions4 #gijb4 ,establishment and membership4 #gijc4 ,board personnel4 #gijd4 ,board mission and functions4 #gije4 ,agency procedures2 referral to ,board4 #gijf4 ,board review4 #gijg4 ,,gao ,audits4 #gijh4 ,funding4 #gija4 ,definitions ,in this chapter3 7#a7 ,agency ,the term agency has the meaning given the term in section #eeb7;f7 of title #e4 7#b7 ,appropriate congressional committees ,the term appropriate congressional committees means the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7#c7 ,board ,the term ,board means the ,life ,sciences ,research ,security ,board established under section #gijb7;a74 7#d7 ,dual use research of concern ,the term dual use research of concern-- 7,a7 means life sciences research that1 based on current understanding1 can be reasonably anticipated to provide knowledge1 information1 products1 or technologies that could-- 7i7 be misapplied to do harm with no modification or only a minor modification2 and 7ii7 pose a significant threat with potential consequences to public health and safety1 agricultural crops and other plants1 animals1 materiel1 or national security2 and 7,b7 includes-- 7i7 life sciences research that could-- 7,i7 increase transmissibility of a pathogen within or between host species2 7,,ii7 increase the virulence of a pathogen or convey virulence to a non-pathogen2 7,,iii7 increase the toxicity of a known toxin or produce a novel toxin2 7,,iv7 increase-- 7aa7 the stability of a pathogen or toxin in the environment2 or 7bb7 the ability to disseminate a pathogen or toxin2 7,v7 alter the host range or tropism of a pathogen or toxin2 7,,vi7 decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods2 7,,vii7 increase resistance of a pathogen or toxin to clinical or veterinary prophylactic or therapeutic interventions2 7,,viii7 alter a human or veterinary pathogen or toxin to disrupt the effectiveness of pre-existing immunity1 via immunization or natural infection1 against the pathogen or toxin2 7,,ix7 enhance the susceptibility of a host population to a pathogen or toxin2 7,x7 enhance transmissibility of a pathogen in humans2 7,,xi7 enhance the virulence of a pathogen in humans2 7,,xii7 enhance the immune evasion of a pathogen in humans1 such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection2 or 7,,xiii7 generate1 use1 reconstitute1 or transfer an eradicated or extinct high-consequence pathogen2 and 7ii7 any other category of life sciences research that the ,board1 by majority vote of the members of the ,board1 identifies and publishes in the ,federal ,register4 7#e7 ,employee ,the term employee means an individual described in section #baje7;a7 of title #e4 7#f7 ,federal funding ,the term ,federal funding means amounts awarded by an agency pursuant to an intramural or extramural grant1 cooperative agreement1 interagency agreement1 contract1 or other instrument4 7#g7 ,gain of function research ,the term gain of function research means a research experiment that may enhance the transmissibility or virulence of a high-consequence pathogen4 7#h7 ,high-consequence pathogen ,the term high-consequence pathogen-- 7,a7 means a wild-type or synthetic pathogen that-- 7i7 7,i7 is likely capable of wide and uncontrollable spread in human populations2 and 7,,ii7 would likely cause moderate to severe disease or mortality in humans2 or 7ii7 is-- 7,i7 subject to subparagraph 7,b71 influenza ,a virus2 7,,ii7 classified under subgenus ,sarbecovirus2 7,,iii7 classified under subgenus ,merbecovirus2 7,,iv7 ,variola orthopoxvirus2 7,v7 ,mpox orthopoxvirus2 7,,vi7 ,nipah henipavirus2 7,,vii7 ,hendra henipavirus2 7,,viii7 ,ebola orthoebolavirus2 7,,ix7 ,marburg marburgvirus2 7,x7 ,lassa mammarenavirus2 7,,xi7 ,junin arenavirus2 7,,xii7 ,crimean-,congo hemorrhagic fever orthonairovirus2 7,,xiii7 ,hantaan orthohantavirus2 7,,xiv7 ,sin ,nombre orthohantavirus2 7,,xv7 ,yersinia pestis2 7,,xvi7 a select agent or toxin1 work with which poses a significant risk of deliberate misuse2 7,,xvii7 any other pathogen or category of pathogen that a majority of members of the ,board-- 7aa7 identifies as a high-consequence pathogen2 and 7bb7 publishes in the ,federal ,register2 or 7,,xviii7 any synthetic construct of a pathogen or category of pathogen described in this clause2 and 7,b7 does not include a seasonal influenza virus1 unless a seasonal influenza virus has been manipulated to include genetic sequences from a pathogen described in subparagraph 7,a74 7#i7 ,high-risk life sciences research ,the term high-risk life sciences research means life sciences research that is-- 7,a7 dual use research of concern involving a high-consequence pathogen2 or 7,b7 gain of function research4 7#aj7 ,life sciences research ,the term life sciences research-- 7,a7 means the study or use of a living organism1 a virus1 or a product of a living organism or virus2 and 7,b7 includes each discipline1 methodology1 and application of biology1 including biotechnology1 genomics1 proteomics1 bioinformatics1 and pharmaceutical and biomedical research and techniques4 7#aa7 ,select agent or toxin ,the term select agent or toxin means a select agent or toxin identified under-- 7,a7 section #gc4c7;b7 of title #db1 ,code of ,federal ,regulations1 as in effect on the date of enactment of the ,risky ,research ,review ,act2 7,b7 section #cca4c7;b7 of title #g1 ,code of ,federal ,regulations1 as in effect on the date of enactment of the ,risky ,research ,review ,act2 or 7,c7 section #aba4c7;b7 of title #i1 ,code of ,federal ,regulations1 as in effect on the date of enactment of the ,risky ,research ,review ,act4 #gijb4 ,establishment and membership 7a7 ,establishment ,there is established as an independent agency within the ,executive ,branch a board to be known as the ,life ,sciences ,research ,security ,board to review proposed ,federal funding for life sciences research in accordance with section #gijf4 7b7 ,appointment of members 7#a7 ,in general ,the ,president shall appoint1 without regard to political affiliation1 #i individuals who are citizens of the ,united ,states to serve as members of the ,board for not more than #b terms of #d years each1 including-- 7,a7 the ,executive ,director appointed under section #gijc7;a72 7,b7 #e nongovernmental scientists in a life sciences field2 7,c7 #b nongovernmental national security experts2 and 7,d7 #a nongovernmental biosafety expert4 7#b7 ,period for nominations ,the ,president shall make appointments1 other than the ,executive ,director1 to the ,board not later than #cj days after the date of enactment of this chapter4 7#c7 ,considerations of recommendations ,the ,president shall make appointments to the ,board after considering individuals recommended by the chair and ranking member of the appropriate congressional committees4 7#d7 ,qualifications ,individuals appointed to the ,board-- 7,a7 shall-- 7i7 be impartial individuals2 and 7ii7 be distinguished individuals of high national professional reputation in their respective fields who are capable of exercising the independent and objective judgment necessary to conduct an impartial assessment of the potential risks and benefits associated with ,federal funding of high-risk life sciences research to public health and national security2 and 7,b7 may not be an employee on the date of the appointment or during the #c-year period preceding the date of the appointment4 7#e7 ,limitations ,not more than #d concurrent members of the ,board may be an employee1 a subcontractor1 a previous employee1 or a previous subcontractor of-- 7,a7 the ,department of ,defense2 7,b7 the ,department of ,homeland ,security2 7,c7 the ,national ,institute of ,allergy and ,infectious ,diseases of the ,department of ,health and ,human ,services2 7,d7 the ,office of the ,director of ,national ,intelligence2 or 7,e7 the ,department of ,energy4 7#f7 ,consideration by the ,senate 7,a7 ,in general ,nominations for appointment to the ,executive ,director of the ,board shall be referred to the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate for consideration4 7,b7 ,renomination ,a member of the ,board who is recommended to serve a second term shall be nominated for appointment to the ,board1 and such nomination shall be referred pursuant to subparagraph 7,a74 7#g7 ,vacancy ,not later than #cj days after the date on which a vacancy on the ,board occurs1 the vacancy shall be filled in the same manner as specified for the original appointment4 7#h7 ,removal 7,a7 ,in general ,no member of the ,board shall be removed from office1 other than by-- 7i7 impeachment and conviction2 7ii7 the action of the ,president for inefficiency1 neglect of duty1 malfeasance in office1 physical disability1 mental incapacity1 or any other condition that substantially impairs the performance of the member's duties2 or 7iii7 the ,board in accordance with subparagraph 7,b74 7,b7 ,action by ,board ,if the ,director of the ,office of ,government ,ethics determines that participation by a member of the ,board in high-risk life sciences research constitutes a conflict of interest1 the ,board shall take steps to mitigate or manage the conflict1 which may include removal4 7,c7 ,notice of removal by ,president 7i7 ,in general ,in the case of the removal of a member of the ,board by the ,president as described in subparagraph 7,a77ii71 not later than #aj days after the removal1 the ,president shall submit to the chair and ranking member of the appropriate congressional committees a report specifying the facts found and the grounds for removal4 7ii7 ,publication of report ,the ,president shall publish in the ,federal ,register each report submitted under clause 7i71 except that the ,president may1 if necessary to protect the rights of a person named in the report or to prevent undue interference with any pending prosecution1 postpone or refrain from publicly publishing any or all of the report until the completion of such pending cases or pursuant to privacy protection requirements in law4 7c7 ,mandatory conflicts of interest review 7#a7 ,in general ,the ,board1 in consultation with the ,director of the ,office of ,government ,ethics1 shall-- 7,a7 not later than #ahj days after the date of the enactment of this chapter-- 7i7 establish criteria to determine whether there is a conflict of interest with respect to any individual appointed to the ,board1 taking into consideration requirements under ,federal law relating to ethics requirements for employees2 and 7ii7 upon an appointment of a member to the ,board under subsection 7a77#a7 thereafter1 conduct a review of each individual nominated and appointed to the ,board to ensure the individual does not have any conflict of interest under the criteria established pursuant to clause 7i72 and 7,b7 periodically thereafter1 conduct a review of each individual nominated and appointed to the ,board to ensure the individual does not have any conflict of interest under the criteria established pursuant to subparagraph 7,a77i7 during the term of service of the individual4 7#b7 ,notification 7,a7 ,in general ,not later than #c days after the date on which the ,director of the ,office of ,government ,ethics becomes aware that a member of the ,board possesses a potential conflict of interest under the criteria established pursuant to paragraph 7#a77;,a77i71 the ,director of the ,office of ,government ,ethics shall notify the chair and ranking member of the appropriate congressional committees of the potential conflict of interest4 7,b7 ,notification by member ,not later than #cj days after the date on which a member of the ,board becomes aware that another member of the ,board possesses a potential conflict of interest under the criteria established pursuant to paragraph 7#a77;,a77i71 the member of the ,board or the ,executive ,director of the ,board shall notify the chair and ranking member of the appropriate congressional committees of the potential conflict of interest4 7d7 ,security clearances ,all members of the ,board shall be granted all the necessary security clearances and accesses1 including to relevant ,presidential and department or agency special access and compartmented access programs1 in an accelerated manner1 subject to the standard procedures for granting such clearances4 ,all nominees for appointment to the ,board shall qualify for the necessary security clearances and accesses prior to being considered for confirmation by the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate4 7e7 ,participation in high-,risk life sciences research 7#a7 ,disclosure required ,a member of the ,board shall disclose whether the member has participated in or is currently participating in high-risk life sciences research4 7#b7 ,conflicts of interest 7,a7 ,in general ,the participation in high-risk life sciences research by a member of the ,board-- 7i7 shall be considered a potential conflict of interest2 and 7ii7 shall be subject to scrutiny by the ,director of the ,office of ,government ,ethics4 7,b7 ,determination ,if the ,director of the ,office of ,government ,ethics determines that participation by a member of the ,board in high-risk life sciences research constitutes a conflict of interest1 the ,board shall take steps to mitigate or manage the conflict1 which may include-- 7i7 the recusal of the affected member from relevant discussions and determinations2 and 7ii7 removal of the affected member from the ,board4 7f7 ,compensation of members 7#a7 ,in general ,subject to such rules as may be adopted by the ,board1 without regard to the provisions of chapter #ea and subchapter ,,iii of chapter #ec of title #e relating to classification and ,general ,schedule pay rates1 a member of the ,board1 other than the ,executive ,director1 shall be compensated at a rate-- 7,a7 proposed by the ,executive ,director and approved by the ,board2 7,b7 not to exceed the rate of basic pay for level ,,ii of the ,executive ,schedule2 and 7,c7 that is commensurate with-- 7i7 the time a member of the ,board spends engaged in the performance of duties on the ,board2 and 7ii7 necessary traveling expenses4 7#b7 ,outside employment ,subject to terms and approval determined by the ,director of the ,office of ,government ,ethics1 a member of the ,board may maintain outside employment and affiliations while serving on the ,board4 7g7 ,oversight 7#a7 ,senate ,the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate shall-- 7,a7 have continuing legislative oversight jurisdiction in the ,senate with respect to the official conduct of the ,board and agency compliance with requirements issued by the ,board2 and 7,b7 have access to any records provided to or created by the ,board4 7#b7 ,house of ,representatives ,the ,committee on ,energy and ,commerce of the ,house of ,representatives shall-- 7,a7 have continuing legislative oversight jurisdiction in the ,house of ,representatives with respect to the official conduct of the ,board and agency compliance with requirements issued by the ,board2 and 7,b7 have access to any records provided to or created by the ,board4 7#c7 ,duty to cooperate ,the ,board shall have the duty to cooperate with the exercise of oversight jurisdiction described in this subsection4 7#d7 ,security clearances ,the chair and ranking member of the appropriate congressional committees1 and designated committee staff1 shall be granted all security clearances and accesses held by the ,board1 including to relevant ,presidential and department or agency special access and compartmented access programs4 7h7 ,office space 7#a7 ,in general ,in selecting office space for the ,board1 the ,board shall exhaust options for unused office spaces owned by the ,federal ,government as of the date of enactment of this chapter4 7#b7 ,secure office space 7,a7 ,requests ,in order to review or discuss classified information1 the ,board shall request an accommodation from relevant agencies to access sensitive compartmented information facilities on an as-needed basis4 7,b7 ,fulfilment ,the head of an agency from which the ,board requests an accommodation under subparagraph 7,a7 shall accommodate the request in a timely manner4 #gijc4 ,board personnel 7a7 ,executive director 7#a7 ,appointment ,not later than #de days after the date of enactment of this chapter1 the ,president shall appoint1 by and with the advice and consent of the ,senate1 #a individual who is a citizen of the ,united ,states1 without regard to political affiliation1 to the position of ,executive ,director of the ,board for a term of #d years4 7#b7 ,qualifications ,the individual appointed as ,executive ,director under paragraph 7#a7 shall be a private individual of integrity and impartiality who-- 7,a7 is a distinguished scientist in a life sciences field2 and 7,b7 is not1 and has not been for the #c-year period preceding the date of the appointment-- 7i7 an employee2 or 7ii7 a participant in high-risk life sciences research supported by ,federal funding4 7#c7 ,security clearances 7,a7 ,in general ,a candidate for ,executive ,director of the ,board shall be granted all security clearances and accesses held by the ,board1 including to relevant ,presidential and department or agency special access and compartmented access programs in an accelerated manner1 subject to the standard procedures for granting such clearances4 7,b7 ,qualification prior to appointment ,the ,president shall ensure that a candidate for ,executive ,director of the ,board qualifies for the security clearances and accesses described in subparagraph 7,a7 prior to appointment4 7#d7 ,functions ,the ,executive ,director of the ,board shall-- 7,a7 serve as principal liaison to ,congress and agencies2 7,b7 serve as chair of the ,board2 7,c7 be responsible for the administration and coordination of the responsibilities of the ,board2 and 7,d7 be responsible for the administration of all official activities conducted by the ,board4 7#e7 ,removal ,notwithstanding section #gijb7;b77#h71 the ,executive ,director shall not be removed for reasons other than for cause on the grounds of inefficiency1 neglect of duty1 malfeasance in office1 physical disability1 mental incapacity1 or any other condition that substantially impairs the performance of the responsibilities of the ,executive ,director or the staff of the ,board4 7#f7 ,terms ,an ,executive ,director of the ,board shall not serve more than #b terms4 7b7 ,staff 7#a7 ,in general ,without regard to the provisions of subchapter ,i of chapter #cc of title #e governing appointments in the competitive service1 the ,board may appoint not more than #be additional personnel to enable the ,board and the ,executive ,director to perform the duties of the ,board4 7#b7 ,qualifications ,each individual appointed to the staff of the ,board-- 7,a7 shall be a citizen of the ,united ,states of integrity and impartiality2 7,b7 shall have expertise in the life sciences field or the national security field2 and 7,c7 may not be a participant in any federally funded research activity on the date of the appointment or during the course of service of the individual on the ,board4 7#c7 ,security clearances 7,a7 ,in general ,a candidate for appointment to the staff of the ,board shall be granted all security clearances and accesses held by the ,board1 including to relevant ,presidential and department or agency special access and compartmented access programs1 in an accelerated manner1 subject to the standard procedures for granting such clearances4 7,b7 ,conditional employment 7i7 ,in general ,the ,board may offer conditional employment to a candidate for a staff position of the ,board pending the completion of security clearance background investigations4 ,during the pendency of such investigations1 the ,board shall ensure that any such employee does not have access to1 or responsibility involving1 classified or otherwise restricted materials4 7ii7 ,unqualified staff ,if the ,board determines that an individual hired on a conditional basis under clause 7i7 is not eligible or otherwise does not qualify for all security clearances necessary to carry out the responsibilities of the position for which conditional employment has been offered1 the ,board shall immediately terminate the individual's employment4 7#d7 ,support from agencies 7,a7 ,in general ,the head of each agency shall designate not less than #a full-time employee of the agency as the representative of the agency to-- 7i7 provide technical assistance to the ,board2 and 7ii7 support the review process of the ,board with respect to the agency under section #gijf in a non-voting staff capacity4 7,b7 ,prohibition ,a representative of an agency designated under subparagraph 7,a7 and any employee of an agency may not directly or indirectly influence in any capacity a determination by the ,board under section #gijf with respect to life sciences research funded by the agency4 7c7 ,compensation ,subject to such rules as may be adopted by the ,board1 without regard to the provisions of title #e governing appointments in the competitive service and without regard to the provisions of chapter #ea and subchapter ,,iii of chapter #ec of that title relating to classification and ,general ,schedule pay rates1 the ,executive ,director of the ,board shall-- 7#a7 be compensated at a rate not to exceed the rate of basic pay for level ,,ii of the ,executive ,schedule2 7#b7 serve the entire tenure as ,executive ,director as #a full-time employee2 and 7#c7 appoint and fix the compensation of such other personnel as may be necessary to carry out this chapter4 #gijd4 ,board mission and functions 7a7 ,mission ,the mission of the ,board shall be to issue an independent determination as to whether an agency may award ,federal funding for proposed high-risk life sciences research1 which shall be binding upon the agency4 7b7 ,powers ,the ,board shall have the authority to act in a manner to carry out the mission described in subsection 7a71 including authority to-- 7#a7 prescribe regulations to carry out the responsibilities of the ,board2 7#b7 establish a process for the review of ,federal funding for high-risk life sciences research prior to the award of the ,federal funding1 which shall be binding upon an agency1 including information designated as classified or otherwise protected from disclosure2 7#c7 direct an agency to make available to the ,board additional information and records1 including information designated as classified or otherwise protected from disclosure1 that the ,board determines are required to fulfill the functions and responsibilities ,board under this chapter2 7#d7 review any classified research conducted or funded by any agency to determine whether the research would be considered high-risk life sciences research2 and 7#e7 through the promulgation of regulations1 establish processes1 policies1 and procedures of the ,board for rendering decisions under this chapter4 7c7 ,initial requirements ,the ,board shall-- 7#a7 not later than #ahj days after the date of appointment of the initial members of the ,board under section #gijb1 publish procedures in the ,federal ,register establishing the process for the review by the ,board under section #gijf2 7#b7 prior to the establishment of the procedures under paragraph 7#a71 consult with the appropriate congressional committees and heads of agencies for purposes of developing such procedures2 and 7#c7 not later than #bgj days after the date of the enactment of this chapter1 begin carrying out the duties described in section #gijf4 7d7 ,responsiveness to ,congress ,notwithstanding any other provision of law1 not later than #cj days after the date on which the ,board receives a request for information from a ,member of ,congress1 the ,board shall respond to the request4 7e7 ,congressional briefings ,not less frequently than quarterly1 the ,board shall brief the appropriate congressional committees on the work of the ,board4 7f7 ,select agent or toxin updates 7#a7 ,in general ,not later than #ae days after the date on which the ,board receives a notification that a select agent or toxin has been added to a list of agent or toxins under a regulation described in paragraph 7#b71 the ,board shall-- 7,a7 review the select agent or toxin2 7,b7 by majority vote of members of the ,board1 determine whether the select agent or toxin should be added into the definition of select agent or toxin under section #gija2 and 7,c7 publish any addition determined under subparagraph 7,b7 in the ,federal ,register4 7#b7 ,regulations described ,a regulation described in this paragraph is-- 7,a7 section #gc4c7;b7 of title #db1 ,code of ,federal ,regulations1 or any successor regulation2 7,b7 section #cca4c7;b7 of title #g1 ,code of ,federal ,regulations1 or any successor regulation2 and 7,c7 section #aba4c7;b7 of title #i1 ,code of ,federal ,regulations1 or any successor regulation4 7g7 ,final determination authority ,in any dispute with an agency or entity relating to the classification of life sciences research under this chapter1 the ,board shall retain final and ultimate authority in-- 7#a7 determining whether the life sciences research is high-risk life sciences research1 dual use research of concern involving a high-consequence pathogen or gain of function research2 7#b7 interpreting definitions in section #gija2 and 7#c7 determining whether a proposed ,federal award for life sciences research is subject to the review process of the ,board under section #gijf7;a77#a74 #gije4 ,agency procedures2 referral to ,board 7a7 ,in general 7#a7 ,prohibition ,the head of an agency may not award ,federal funding for-- 7,a7 high-risk life sciences research without approval by the ,board under section #gijf7;a77#a77;,b72 or 7,b7 life sciences research if the ,board1 in accordance with section #gijf7;a77#b77;,a77ii71 submits notification to the agency under section #gijf7;a77#b77;,b77i7 that ,board is reviewing the ,federal funding for life sciences research under section #gijf7;a7 until the date on which the ,board makes a final determination with respect to the proposed ,federal funding4 7#b7 ,effective date ,paragraph 7#a7 shall take effect on the date that is #ahj days after the date of enactment of this chapter4 7b7 ,high-,risk attestation2 select agent or toxin disclosure2 certification 7#a7 ,in general ,an entity seeking ,federal funding from an agency for life sciences research shall1 under the penalty of perjury-- 7,a7 attest whether-- 7i7 the life sciences research will constitute high-risk life sciences research2 and 7ii7 the entity is performing active research with a select agent or toxin2 and 7,b7 if the entity makes a positive attestation under subparagraph 7,a71 disclose the source of funding for all active research4 7#b7 ,active research with select agents or toxins 7,a7 ,in general ,the head of an agency that receives a disclosure from an entity under paragraph 7#a77;,b7 shall submit to the ,board the disclosure4 7,b7 ,board inquiries ,the ,board may contact an entity that submits a disclosure under paragraph 7#a77;,b7 to request additional information relating to the disclosure4 7#c7 ,agency certification 7,a7 ,positive attestations ,the head of an agency making an award of ,federal funding to an entity that makes a positive attestation under paragraph 7#a77;,a77i7 shall-- 7i7 submit to the ,board the high-risk life sciences proposal2 and 7ii7 using the process established by the head of the agency under paragraph 7#d71 certify the validity of the attestation4 7,b7 ,negative attestations ,the head of an agency making an award of ,federal funding to an entity that makes a negative attestation under paragraph 7#a77;,a77i7 shall-- 7i7 review the attestation2 and 7ii7 using the process established by the head of the agency under paragraph 7#d71 certify the validity of the attestation4 7#d7 ,process for review ,the head of each agency that awards ,federal funding for life sciences research1 in consultation with the ,board1 shall establish and implement a process for identifying proposals from entities seeking ,federal funding for life sciences research from the agency that will constitute high-risk life sciences research4 7#e7 ,maintenance of records ,the head of each agency shall-- 7,a7 maintain records of the certification process described in paragraph 7#c7 for each application for ,federal funding in accordance with chapter #ca of title #dd2 and 7,b7 make the records maintained under subparagraph 7,a7 available for audit and review upon request by the ,board4 7c7 ,notification 7#a7 ,in general ,not later than #cj days before the date on which the head of an agency plans to award ,federal funding to an entity for life sciences research1 the head of the agency shall submit to the ,board a notification of the proposed ,federal funding4 7#b7 ,contents ,the notification of ,federal funding for life sciences research required under paragraph 7#a7 shall include the attestation and certification required under subsection 7b74 7#c7 ,board requests 7,a7 ,in general ,the ,board may request additional information from the head of an agency relating to a notification submitted under paragraph 7#a74 7,b7 ,provision of information ,the head of an agency from which the ,board request additional information under subparagraph 7,a7 shall provide the information in a timely manner4 7d7 ,agency procedures ,not later than #ahj days after the date on which the ,board publishes the process of the ,board in the ,federal ,register pursuant to section #gijd7;c71 the head of each agency shall publish on the website of the agency prepayment and preaward procedures of the agency with respect to ,federal funding for life sciences research to-- 7#a7 guarantee that-- 7,a7 all high-risk life science research proposals are referred to the ,board before the award of ,federal funding by the agency2 7,b7 no ,federal funding for high-risk life sciences research is awarded by the agency without approval by the ,board2 and 7,c7 not later than #cj days before the date on which the head of the agency plans to award the ,federal funding1 the agency notifies the ,board of the proposal for ,federal funding2 and 7#b7 otherwise ensure compliance with this chapter4 7e7 ,provision of additional information ,upon request by the ,board1 the head of an agency shall provide any information relating to ,federal funding awards for life sciences research determined necessary by the ,board to provide oversight of the agency4 7f7 ,change in circumstances during research ,if1 during the course of life sciences research in progress performed by an entity supported by ,federal funding from an agency1 circumstances arise such that the life sciences research in progress may constitute high-risk life sciences research in contravention to the attestation of the entity under subsection 7b77#a77;,a77i7-- 7#a7 the entity shall-- 7,a7 not later than #bd hours after the identification of the change in circumstance1 pause the life sciences research in progress2 and 7,b7 not later than #e days after the date of the identification of the change in circumstance1 submit to the head of the agency a written notification through an electronic or nonelectronic communication method that-- 7i7 notifies the head of the agency of the possibility that the life sciences research in progress may constitute high-risk life sciences research2 and 7ii7 includes a detailed description of each change in circumstance that may transform the life sciences research in progress into high-risk life sciences research2 and 7#b7 the head of the agency shall-- 7,a7 using the process of the agency established under subsection 7b77#d71 determine whether the life sciences research in progress constitutes high-risk life sciences research2 7,b7 if the head of the agency makes a negative determination under subparagraph 7,a71 inform the entity that the entity may resume the life sciences research in progress2 and 7,c7 if the head of the agency makes a positive determination under subparagraph 7,a71 immediately submit to the ,board a notification of the ,federal funding of high-risk life sciences research in progress for review under section #gijf7;a77#a74 7g7 ,enforcement 7#a7 ,applicant requirements ,if an entity seeking or receiving ,federal funding from an agency knowingly fails to make a true attestation under subsection 7b77#a7 or promptly notify the agency of a change in circumstance in accordance with subsection 7f77#a71 the head of the agency shall refer the entity to the appropriate entity for suspension and debarment proceedings relating to the receipt of ,federal funding4 7#b7 ,referral to inspector general ,the ,board shall refer any employee of an agency responsible for overseeing and reviewing research proposals relating to ,federal funding that knowingly fails to comply with subsection 7b77#c7 to the inspector general of the agency4 7#c7 ,employee discipline 7,a7 ,in general ,the head of an agency employing an employee who knowingly violates any provision of subsection 7b77#c7 7or1 in the case of the head of an agency who violates any provision of subsection 7b77#c71 the ,president7 shall impose on that employee-- 7i7 disciplinary action in accordance with chapter #ge of title #e or an equivalent procedure of the agency2 and 7ii7 permanent revocation of any applicable security clearance held by the employee4 7,b7 ,contractor penalty ,in the case of contractor working under a contract with an agency who knowingly violates subsection 7b77#a71 the head of the agency shall refer the contractor to the appropriate entity for suspension and debarment proceedings relating to the receipt of ,federal funding4 7,c7 ,employee discipline reports 7i7 ,in general ,not later than #cfj days after the date of enactment of this ,act1 and not less frequently than once every #ij days thereafter1 the head of each agency shall submit to the ,board and the appropriate congressional committees a report that discloses1 for the period covered by the report1 each violation by an employee of the agency of subsection 7b77#c74 7ii7 ,contents ,each report submitted under clause 7i7 shall include1 with respect to a violation described in that clause-- 7,i7 the name and professional title of each employee engaged in the violation2 7,,ii7 a detailed explanation of the nature of the violation2 and 7,,iii7 the date of the violation4 7iii7 ,publication ,not later than #e days after the date on which the ,board receives a report under clause 7i71 the ,board shall publish on a publicly accessible and searchable website the amount of violations that have been committed under clause 7i74 7h7 ,subaward and subcontractor disclosure 7#a7 ,in general ,during the course of high-risk life sciences research in progress performed by an entity supported by ,federal funding from an agency1 the entity shall-- 7,a7 continuously disclose to the head of the agency any subcontracts or subawards made or planned to be made with the ,federal funding2 and 7,b7 obtain consent from the head of the agency before awarding a subcontract or award described in subparagraph 7,a74 7#b7 ,agency submission ,not later than #cj days after the date on which the head of an agency receives a disclosure under paragraph 7#a71 the head of the agency shall submit to the ,board the disclosure4 7#c7 ,board inquiries 7,a7 ,in general ,the ,board may contact an entity that submits a disclosure under paragraph 7#a7 to request additional information relating to the disclosure4 7,b7 ,access to reports ,during the course of high-risk life sciences research in progress performed by an entity supported by ,federal funding from an agency1 upon request1 the ,board shall have access to every annual report of-- 7i7 the agency2 7ii7 the entity performing the high-risk life sciences research2 and 7iii7 any subcontractor or subawardee of an entity described in clause 7ii74 #gijf4 ,board review 7a7 ,in general 7#a7 ,high-risk life sciences research ,not later than #abj days after the date on which the ,board receives a notification from an agency under section #gije7;c7 relating to proposed ,federal funding for life sciences research that constitutes high-risk life sciences research or the ,board receives a notification from an agency under section #gije7;f77#b77;,c7 relating to ,federal funding of research in progress that constitutes high-risk life sciences research1 the ,board shall-- 7,a7 review the proposed ,federal funding or high-risk life sciences research in progress2 7,b7 by a majority vote1 determine whether the agency may award the proposed ,federal funding or continue to award the ,federal funding for the high-risk life sciences research in progress2 and 7,c7 by a majority vote1 determine with respect to the high-risk life sciences research funded by the proposed ,federal funding or ,federal funding for high-risk life sciences research in progress-- 7i7 the minimum required biosafety containment level1 engineering controls1 and operational controls2 7ii7 the minimum required biosecurity engineering controls and operational controls2 and 7iii7 the minimum required personnel assurance controls4 7#b7 ,proposed life sciences research 7,a7 ,in general ,with respect to proposed ,federal funding by an agency for life sciences research1 the ,board may-- 7i7 review the proposed ,federal funding2 and 7ii7 determine whether the ,board should review the proposed ,federal funding in accordance with paragraph 7#a74 7,b7 ,notification ,if the ,board makes a positive determination under subparagraph 7,a77ii7 with respect to proposed ,federal funding by an agency-- 7i7 the ,board shall notify the head of the agency2 and 7ii7 the head of the agency may not award the proposed ,federal funding until the date on which the ,board makes a final determination with respect to the proposed ,federal funding under paragraph 7#a74 7#c7 ,past funding ,with respect to life sciences research performed with ,federal funding awarded by an agency before the date of enactment of this chapter1 the ,board may review and audit the research in order to assess the compliance of the agency with the provisions of this chapter4 7#d7 ,ongoing funding for life sciences research ,with respect to ,federal funding for life sciences research in progress awarded by an agency before the date of enactment of this ,act that the ,board determines may constitute high-risk life sciences research1 the ,board may-- 7,a7 direct the agency to temporarily suspend the ,federal funding2 7,b7 require the agency to provide complete information on the ,federal funding in order for the ,board to complete a review of the life sciences research under paragraph 7#a72 and 7,c7 by a majority vote of members of the ,board1 determine whether the agency may continue the ,federal funding4 7b7 ,considerations 7#a7 ,in general ,in making a determination under subsection 7a77#a77;,b71 the ,board shall consider1 with respect to the high-risk life sciences research that will be conducted with the proposed ,federal funding or high-risk life sciences research in progress-- 7,a7 whether the research poses a threat to public health2 7,b7 whether the research poses a threat to public safety2 7,c7 whether the research has a high probability of producing benefits for public health2 7,d7 whether the research poses a threat to large populations of animals and plants2 7,e7 whether the research poses a threat to national security2 7,f7 whether the research is proposed to be conducted in whole or at least in part in a foreign country2 7,g7 the reasonably anticipated material risks of the research2 7,h7 the reasonably anticipated information risks of the research2 7,i7 the reasonably anticipated benefits of the research2 7,j7 whether the reasonably anticipated benefits of the research outweigh the reasonably anticipated risks2 and 7,k7 whether the benefits of the research could be obtained through procedures posing lower risks4 7#b7 ,weight of factors ,the presence or absence of any factor under paragraph 7#a7 shall not be decisive with respect to the determination of the ,board under subsection 7a77#a77;,b74 7c7 ,notice following review and determination 7#a7 ,agency notification ,not later than #e days after the date on which the ,board makes a determination under subsection 7a77#a77;,b7 with respect to ,federal funding by an agency1 the ,executive ,director of the ,board shall notify the head of the agency of the determination4 7#b7 ,board consultation 7,a7 ,in general ,not later than #aj days after receiving a notification from the ,board under paragraph 7#a71 the head of an agency may request a meeting with the ,board to discuss the determination of the ,board4 7,b7 ,board response ,the ,board shall schedule a meeting requested by the head of an agency under subparagraph 7,a7 in a timely manner4 7#c7 ,notification to appropriate congressional committees ,if the ,board determines that the head of an agency may not proceed with an award of proposed ,federal funding under this section1 the ,executive ,director of the ,board shall notify the appropriate congressional committees when the ,board notifies the head of the agency4 7d7 ,request for expedited review 7#a7 ,definition ,in this subsection1 the term emergency research means high-risk life sciences research submitted to the ,board that relates to a public health emergency or addresses a specific national security concern4 7#b7 ,request2 notification ,the head of an agency seeking expedited review from the ,board to award ,federal funding for emergency research shall-- 7,a7 include a request for expedited review in the notification required under section #gije7;c72 and 7,b7 on the date of the notification described in subparagraph 7,a71 submit to the ,board and the appropriate congressional committees a notification that explains why the specific public health emergency or national security concern necessitates expedited review under this subsection4 7#c7 ,internal process ,the ,board shall establish an internal process under which the ,board will give proposed emergency research expedited review under this section4 7#d7 ,temporary emergency research ,if the ,board does not notify the head of an agency with a determination under subsection 7a77#a77;,b7 with respect to proposed emergency research by the #ae days after the date on which the head of the agency submits a request under paragraph 7#b77;,a71 the head of the agency may award ,federal funding for the emergency research on a temporary basis4 7e7 ,scientific expert panels 7#a7 ,in general ,the ,board may establish a scientific panel of nongovernmental experts to advise the ,board in the review by the ,board of life sciences research pursuant to this chapter4 7#b7 ,policies and procedures ,the ,board shall establish and publish in the ,federal ,register procedures and policies relating to conflicts of interest1 recusal1 expertise1 and related matters before the establishment of the panel described in paragraph 7#a74 7#c7 ,prohibition ,an individual serving on the panel established under paragraph 7#a7 may not advise the ,board on any matter with respect to which the individuals has an identified or perceived conflict of interest4 7#d7 ,report 7,a7 ,in general ,not later than #cj days after the date on which the ,board establishes a panel established under paragraph 7#a71 the ,board shall submit to the appropriate congressional committees a report that includes the names1 qualifications1 and any identified or perceived conflicts of interest of individuals who serve on the panel4 7,b7 ,panel changes ,upon a change of personnel on the panel established under paragraph 7#a71 the ,board shall immediately submit to the appropriate congressional committees an update to the report required under subparagraph 7,a74 7f7 ,report 7#a7 ,in general ,not later than #cfj days after the date on which the ,board establishes the panel described in subsection 7e77#a71 and annually thereafter1 the ,board shall submit to the appropriate congressional committees a report1 which shall include a classified annex1 summarizing1 with respect to each determination by the ,board under this section relating to high-risk life sciences research-- 7,a7 the findings of the ,board2 7,b7 the determination of the ,board2 7,c7 the name and location of the entity proposing the life sciences research2 7,d7 the name and location of any recipient of a subaward or subcontractor of an entity proposing life sciences research and the nature of the participation of such a recipient or subcontractor2 and 7,e7 an account of significant challenges or problems1 including procedural or substantive challenges or problems1 that arise during the course of the work of the ,board1 including the views of any member of the ,board who wishes to have those views included in the report4 7#b7 ,public report ,on the date on which the ,board submits a report required under paragraph 7#a71 the ,board shall make the report1 other than the classified annex included in the report1 available on a website4 7g7 ,effective date ,this section shall take effect on the date that is #bgj days after the date of enactment of this chapter4 #gijg4 ,,gao ,audits ,the ,comptroller ,general of the ,united ,states shall periodically audit the ,board4 #gijh4 ,funding ,there is authorized to be appropriated to the ,board to carry out this chapter #cj1jjj1jjj for each of fiscal years #bjbf through #bjce4 4 7b7 ,clerical amendment ,the table of chapters for subtitle ,v of title #ca1 ,united ,states ,code1 is amended by adding at the end the following3 #gi4 ,life ,sciences ,research ,security ,board#gija 4 7c7 ,financial disclosure reports of ,board members ,section #acajc7;f7 of title #e1 ,united ,states ,code1 is amended-- 7#a7 in paragraph 7#aa71 by striking and at the end2 7#b7 in paragraph 7#ab71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#ac7 a member of the ,life ,sciences ,research ,security ,board established under section #gijb of title #ca4 4