,i #aaith ,,congress #b;d ,session ,h4 ,r4 #ajebb ,,in ,,the ,,house ,,of ,,representatives ,september #ba1 #bjbf,mr4 ,langworthy 7for himself1 ,mr4 ,pocan1 ,ms4 ,norton1 ,mr4 ,fine1 ,mr4 ,quigley1 ,ms4 ,wasserman ,schultz1 ,ms4 ,escobar1 and ,ms4 ,titus7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to prohibit the obligation or expenditure of ,department of ,health and ,human ,services funds for the use of live dogs and live cats in biomedical research1 to strengthen accountability for ,federal research expenditures1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,companion ,animal ,protection ,against ,cruel ,testing ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,definitions4,sec4 #c4 ,prohibition on the use of ,,hhs funding for biomedical research involving live dogs or live cats4,sec4 #d4 ,disposition of live dogs and live cats4,sec4 #e4 ,limited waiver authority4,sec4 #f4 ,certification requirements4,sec4 #g4 ,recordkeeping1 audits1 and access to records4,sec4 #h4 ,enforcement4,sec4 #i4 ,debarment and suspension4,sec4 #aj4 ,whistleblower protections4,sec4 #aa4 ,transparency and annual reporting4,sec4 #ab4 ,government ,accountability ,office review4,sec4 #ac4 ,rules of construction4,sec4 #ad4 ,effective date4,sec4 #ae4 ,severability4 #b4 ,definitions ,in this ,act3 7#a7 ,biomedical research ,the term biomedical research-- 7,a7 means any systematic scientific investigation1 including basic research1 applied research1 translational research1 preclinical research1 product development1 toxicological evaluation1 or testing1 that is designed to develop or contribute to generalizable knowledge concerning the prevention1 diagnosis1 treatment1 or understanding of human disease1 injury1 health1 or human physiology2 7,b7 includes any research conducted to evaluate the safety1 efficacy1 pharmacology1 toxicology1 mechanism of action1 or biological effects of a drug1 biologic1 medical device1 vaccine1 chemical substance1 gene therapy1 cell therapy1 medical intervention1 or other investigational product2 and 7,c7 does not include-- 7i7 the provision of routine veterinary diagnosis1 treatment1 or clinical care performed solely for the health or welfare of an individual animal2 7ii7 the ordinary husbandry1 feeding1 housing1 or care of animals that is not conducted for purposes of a covered activity2 7iii7 noninterventional observation of animals in which the investigator does not manipulate the animal's environment1 physiology1 behavior1 or medical care2 7iv7 research conducted solely for the prevention1 diagnosis1 treatment1 or understanding of disease1 injury1 health1 or physiology of dogs or cats2 and 7v7 comparative clinical research involving client-owned dogs or cats with naturally occurring disease that is conducted to evaluate or develop interventions with potential relevance to human disease1 including research conducted through the ,canine ,cancer ,immunotherapy ,network of the ,national ,cancer ,institute4 7#b7 ,cat ,the term cat means any live individual of the species ,felis catus1 regardless of age1 purpose1 ownership status1 or breeding history4 7#c7 ,covered activity ,the term covered activity has the meaning given such term in section #c7;b74 7#d7 ,covered ,federal agency ,the term covered ,federal agency means-- 7,a7 the ,national ,institutes of ,health2 7,b7 the ,centers for ,disease ,control and ,prevention2 7,c7 the ,food and ,drug ,administration2 7,d7 the ,advanced ,research ,projects ,agency for ,health2 7,e7 the ,biomedical ,advanced ,research and ,development ,authority2 7,f7 the ,agency for ,healthcare ,research and ,quality2 and 7,g7 any other agency or office within the ,department of ,health and ,human ,services that awards1 administers1 or expends ,federal funds for biomedical research4 7#e7 ,dog ,the term dog means any live individual of the species ,canis lupus familiaris1 regardless of age1 purpose1 ownership status1 or breeding history4 7#f7 ,recipient ,the term recipient means1 with respect to the receipt of ,federal funds1 an individual or entity that receives such funds 7or seeks to receive such funds7 directly or indirectly1 including institutions of higher education1 nonprofit organizations1 hospitals1 research institutes1 contractors1 subcontractors1 consortium participants1 foreign entities1 ,state governments1 local governments1 and any subrecipient thereof4 7#g7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services1 unless otherwise specified4 #c4 ,prohibition on the use of ,,hhs funding for biomedical research involving live dogs or live cats 7a7 ,general prohibition ,notwithstanding any other provision of ,federal law1 no funds appropriated to1 or otherwise made available for1 a covered ,federal agency may be obligated or expended1 directly or indirectly1 for any covered activity4 7b7 ,covered activity defined ,in this section1 the term covered activity-- 7#a7 means any biomedical research activity involving a live dog or live cat1 including-- 7,a7 to procure1 purchase1 lease1 rent1 receive by donation1 or otherwise acquire a live dog or live cat2 7,b7 to breed1 reproduce1 maintain breeding colonies1 or support breeding programs involving live dogs or live cats2 7,c7 to import into1 export from1 or transport within the ,united ,states any dog or cat for purposes of biomedical research2 7,d7 to house1 kennel1 shelter1 maintain1 feed1 exercise1 provide veterinary care for1 or otherwise maintain live dogs or live cats used in biomedical research2 7,e7 to perform1 assist with1 supervise1 design1 sponsor1 conduct1 or support biomedical research involving a live dog or cat2 7,f7 to administer any drug1 biologic1 medical device1 investigational product1 infectious agent1 toxin1 radiation1 chemical substance1 or other experimental intervention to a live dog or live cat for purposes of a covered activity2 7,g7 to perform1 direct1 supervise1 sponsor1 or support any surgical procedure1 behavioral experiment1 genetic modification1 reproductive manipulation1 tissue collection1 imaging study conducted primarily for research purposes1 biological sample collection1 restraint1 environmental manipulation1 euthanasia performed as part of a covered activity1 or any other experimental intervention involving a live dog or live cat2 7,h7 to establish or maintain colonies of live dogs or live cats intended for present or future biomedical research2 7,i7 to reimburse allocable indirect costs1 facilities and administrative costs1 overhead1 or other institutional expenses attributable to a covered activity2 7,j7 to support any substantially similar activity determined by the ,secretary to involve the use of a live dog or live cat for biomedical research2 and 7,k7 any activity that materially facilitates biomedical research activity involving a live dog or live cat1 including-- 7i7 construction1 renovation1 maintenance1 or operation of facilities principally dedicated to covered activities2 7ii7 acquisition or maintenance of equipment primarily used in covered activities2 7iii7 providing salaries1 wages1 benefits1 stipends1 or consulting fees attributable to covered activities2 7iv7 data collection or management services performed principally for covered activities2 and 7v7 administrative support directly for covered activities2 and 7#b7 does not include-- 7,a7 veterinary care provided solely for the health or welfare of a dog or cat2 7,b7 observational activities that do not involve intervention1 manipulation1 restraint1 administration of substances1 collection of biological samples1 or alteration of the animal's normal environment or medical care2 7,c7 transportation and rehousing of animals that were previously used in biomedical research2 7,d7 analysis of existing data1 records1 or specimens where no live dog or live cat is used in a covered activity2 7,e7 activities unrelated to biomedical research involving a live dog or live cat2 and 7,f7 the housing1 sheltering1 transportation1 veterinary care1 rehabilitation1 retirement1 adoption1 transfer1 or other disposition of dogs or cats previously used in biomedical research1 provided that such activities are undertaken solely to provide for the health1 welfare1 or placement of such animals and not to facilitate any covered activity4 7c7 ,no circumvention ,no recipient of funding from a covered ,federal agency may circumvent the requirements of this section by-- 7#a7 acquiring dogs or cats using non-,federal funds while charging personnel1 equipment1 supplies1 facilities1 or other research costs to ,federal funds2 7#b7 transferring covered activities to affiliated institutions or related entities2 7#c7 conducting covered activities through subcontractors1 consultants1 consortium participants1 or foreign entities2 or 7#d7 dividing a project into multiple funding sources to conceal the use of ,federal funds4 7d7 ,relationship to other law ,nothing in this section shall be construed-- 7#a7 to authorize any activity otherwise prohibited by ,federal law2 7#b7 to limit the authority of the ,secretary of ,agriculture under the ,animal ,welfare ,act 7#g ,u4,s4,c4 #baca et seq47 to administer and enforce that ,act2 or 7#c7 to diminish any requirement applicable under any other provision of ,federal law governing research misconduct1 fiscal accountability1 or animal welfare4 #d4 ,disposition of live dogs and live cats ,as a condition of receiving funding from a covered ,federal agency1 a recipient of such funding-- 7#a7 shall make reasonable efforts to retire1 adopt1 or transfer live dogs and live cats no longer needed for biomedical research to accredited animal sanctuaries1 rescue organizations1 adoption programs1 or other appropriate entities1 consistent with animal health1 veterinary judgment1 public safety1 and applicable law2 and 7#b7 may only perform euthanasia on a live dog or live cat upon the determination of a licensed veterinarian that such euthanasia is necessary due to the animal's medical condition1 behavioral condition1 or other compelling animal welfare or public safety considerations4 #e4 ,limited waiver authority 7a7 ,in general ,the ,secretary may issue 7or renew7 a waiver of any requirement of this ,act if and only if the ,secretary determines1 in writing1 that-- 7#a7 the waiver is necessary to respond to-- 7,a7 a public health emergency determined to exist by the ,secretary under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d72 7,b7 a national emergency declared by the ,president under section #bja of the ,national ,emergencies ,act 7#ej ,u4,s4,c4 #afba72 or 7,c7 a national security emergency directly affecting the ,united ,states2 7#b7 no scientifically valid alternative method is reasonably available2 7#c7 the waiver is limited to the minimum duration and scope necessary to address the emergency2 and 7#d7 failure to grant the waiver would likely result in a significant and immediate threat to public health or national security4 7b7 ,duration ,a waiver under this section shall expire not later than #ahj days after issuance unless renewed by the ,secretary in accordance with subsection 7a74 7c7 ,congressional notification ,not later than #ae days after issuing or renewing a waiver under this section1 the ,secretary shall 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 written notice describing-- 7#a7 a detailed justification for the waiver1 including the specific national security or public health need2 7#b7 a description of the relevant research to be conducted1 including the number and species of animals involved2 7#c7 the projected cost to taxpayers of such research2 7#d7 an explanation of why alternatives to such research are not feasible2 and 7#e7 the expected duration of the waiver4 #f4 ,certification requirements 7a7 ,pre-,funding certification ,as a condition of receiving funding from a covered ,federal agency1 a recipient shall certify1 in such form and manner as the ,secretary may prescribe1 that-- 7#a7 neither the applicant nor any proposed subrecipient1 contractor1 consortium participant1 or other collaborating entity will obligate or expend the funding for any covered activity2 7#b7 the recipient has implemented internal controls reasonably designed to ensure compliance with this ,act2 7#c7 all material representations made in the certification are true1 complete1 and accurate to the best knowledge of the recipient2 and 7#d7 the recipient acknowledges that the certification constitutes a material condition of the award4 7b7 ,annual certification ,each recipient shall submit an annual certification affirming continued compliance with this ,act4 7c7 ,notification of noncompliance 7#a7 ,notification ,not later than #cj days after a recipient discovers information indicating a violation of this ,act or a materially false certification by the recipient1 the recipient shall notify the ,secretary in writing of such information4 7#b7 ,withholding of funding ,if the ,secretary determines1 in writing1 that a recipient has violated paragraph 7#a71 the ,secretary may withhold funding from a covered ,federal agency from such recipient for a period not to exceed #c years4 7d7 ,false statements ,nothing in this ,act shall be construed to limit the applicability of any ,federal law concerning false statements1 false claims1 or fraud relating to certifications submitted under this section4 #g4 ,recordkeeping1 audits1 and access to records 7a7 ,record retention ,each recipient of funding from a covered ,federal agency shall maintain1 for a period of not less than #f years following the receipt of such funding1 records sufficient to demonstrate compliance with this ,act4 7b7 ,required documentation ,the records referred to in subsection 7a7 shall include1 as applicable-- 7#a7 procurement records2 7#b7 animal acquisition records2 7#c7 subaward agreements2 7#d7 contracts and purchase orders2 7#e7 invoices and financial records2 7#f7 institutional compliance policies2 7#g7 internal audit reports2 7#h7 certifications submitted under this ,act2 and 7#i7 any additional records determined by the ,secretary to be reasonably necessary for oversight4 7c7 ,access to facilities1 personnel1 and records ,as a condition of receiving funding from a covered ,federal agency1 a recipient shall provide reasonable access to the ,secretary1 the ,office of ,inspector ,general of the ,department of ,health and ,human ,services1 and the ,comptroller ,general of the ,united ,states to facilities1 personnel1 and records of the recipient necessary to demonstrate compliance with this ,act1 subject to any applicable protections in ,federal law for classified information1 confidential commercial information1 and personally identifiable information4 #h4 ,enforcement 7a7 ,administrative remedies ,if the ,secretary determines1 in writing1 that a recipient has violated this ,act1 the ,secretary may-- 7#a7 withhold further funding from a covered ,federal agency to such recipient2 7#b7 recover from the recipient such funding that the ,secretary determines has been expended in violation of this ,act2 and 7#c7 impose any other administrative remedy authorized by law4 7b7 ,opportunity ,to respond ,before taking action under subsection 7a71 the ,secretary shall provide the recipient with written notice of the proposed action and a reasonable opportunity to submit information in response1 except where the ,secretary determines1 in writing1 that immediate action is necessary to protect the interests of the ,united ,states4 7c7 ,referral ,nothing in this section shall preclude referral of a matter to the ,department of ,justice or any other appropriate authority where the facts may warrant civil1 administrative1 or criminal proceedings under other provisions of ,federal law4 #i4 ,debarment and suspension 7a7 ,authority ,in addition to any other remedy available under ,federal law1 the ,secretary may initiate suspension or debarment proceedings1 with respect to any license or privilege extended by a covered ,federal agency1 against a recipient that knowingly or repeatedly violates this ,act1 consistent with other provisions of ,federal law4 7b7 ,factors ,in determining whether suspension or debarment is appropriate under this section1 the ,secretary may consider-- 7#a7 the nature and seriousness of the violation2 7#b7 whether the violation was knowing1 reckless1 or inadvertent2 7#c7 the recipient's history of compliance with ,federal grant requirements2 7#d7 the adequacy of corrective actions undertaken by the recipient2 and 7#e7 any other factor that the ,secretary determines to be relevant to protecting the integrity of ,federal research funding4 7c7 ,effect ,a recipient that is debarred under this section shall be ineligible to receive covered ,federal funds for the period specified in the debarment determination1 consistent with applicable ,federal regulations4 #aj4 ,whistleblower protections 7a7 ,protected disclosures ,no recipient of funds from a covered ,federal agency may discharge1 demote1 suspend1 threaten1 harass1 discriminate against1 or otherwise retaliate against an employee1 contractor1 student1 trainee1 or other individual because that individual1 in good faith-- 7#a7 reports a suspected violation of this ,act2 7#b7 provides information to the ,secretary1 the ,office of ,inspector ,general1 the ,comptroller ,general1 ,congress1 or another authorized governmental entity2 7#c7 participates in an audit1 investigation1 hearing1 or other proceeding concerning compliance with this ,act2 or 7#d7 refuses to participate in conduct that the individual reasonably believes would violate this ,act4 7b7 ,complaint procedure ,the ,secretary shall establish procedures for receiving1 investigating1 and resolving complaints alleging retaliation prohibited under this section4 7c7 ,remedies ,where a violation of subsection 7a7 is substantiated1 the ,secretary may require appropriate corrective action as a condition of continued eligibility for funding from a covered ,federal agency1 including reinstatement1 restoration of responsibilities1 or other equitable relief consistent with applicable law4 7d7 ,construction ,nothing in this section shall be construed to limit any rights or remedies otherwise available under ,federal law relating to whistleblower protections4 #aa4 ,transparency and annual reporting 7a7 ,annual report to congress ,not later than #ahj days after the end of each fiscal year1 the ,secretary shall 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 implementation of this ,act4 7b7 ,contents ,a report under subsection 7a7 shall include-- 7#a7 the number and type of covered ,federal agency funding applications reviewed for compliance with this ,act2 7#b7 the number of certifications received pursuant to section #f2 7#c7 the number of awards withheld or denied due to noncompliance with this ,act2 7#d7 the number and status of audits1 inspections1 and investigations conducted under this ,act2 7#e7 the status of dogs and cats previously used in biomedical research and activities to ensure their welfare and encourage their rehoming and adoption2 7#f7 the total amount of ,federal funds recovered under section #h2 7#g7 a summary of corrective actions implemented by recipients2 7#h7 a description of guidance issued by the ,secretary to implement this ,act2 and 7#i7 recommendations1 if any1 for additional legislative or administrative action4 7c7 ,public availability ,not later than #cj days after submitting a report under subsection 7a71 the ,secretary shall make the report publicly available on the website of the ,department of ,health and ,human ,services1 except that information protected from public disclosure under ,federal law shall be redacted4 #ab4 ,government ,accountability ,office review 7a7 ,review required ,the ,comptroller ,general of the ,united ,states shall conduct an independent review of the implementation and administration of this ,act4 7b7 ,scope of review ,the review under subsection 7a7 shall evaluate-- 7#a7 the effectiveness of the certification process2 7#b7 the adequacy of oversight and enforcement activities2 7#c7 the veterinary services provided to dogs and cats in biomedical research facilities2 7#d7 compliance by recipients of covered ,federal agency funding2 7#e7 the administrative burden associated with implementation2 7#f7 the effectiveness of internal controls established by covered ,federal agencies2 and 7#g7 any recommendations for improving administration of this ,act4 7c7 ,submission ,not later than #c years after the effective date of this ,act1 the ,comptroller ,general of the ,united ,states shall 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 describing the results of the review under subsection 7a74 #ac4 ,rules of construction 7a7 ,relationship to ,animal ,welfare ,act ,nothing in this ,act shall be construed to amend1 repeal1 or supersede any requirement of the ,animal ,welfare ,act 7#g ,u4,s4,c4 #baca et seq474 ,compliance with that ,act shall not exempt any person or entity from the funding restrictions established by this ,act4 7b7 ,other ,federal requirements ,nothing in this ,act shall be construed to alter obligations imposed under any other applicable ,federal statute1 regulation1 or grant condition governing research integrity1 fiscal accountability1 procurement1 or animal welfare4 #ad4 ,effective date ,this ,act shall only apply to ,federal funding obligated or expended on or after the date that is #ahj days after the date of enactment of this ,act4 #ae4 ,severability ,if any provision of this ,act1 or the application of any provision to any person or circumstance1 is held to be invalid1 the remainder of this ,act1 and the application of such provisions to any other person or circumstance1 shall not be affected4