HR1495 - Suspending limitations on conference committee jurisdiction, S.B. No. 2308.

      H.R. No. 1495       R E S O L U T I O N          BE IT RESOLVED by the House of Representatives of the State of   Texas, 89th Legislature, Regular Session, 2025, That House Rule 13,   Section 9(a), be suspended in part as provided by House Rule 13,   Section 9(f), to enable the conference committee appointed to   resolve the differences on Senate Bill 2308 (the establishment of a   consortium to conduct United States Food and Drug Administration's   drug development clinical trials with ibogaine to secure the   administration's approval of the medication's use for treatment of   opioid use disorder, co-occurring substance use disorder, and any   other neurological or mental health conditions for which ibogaine   demonstrates efficacy and to the administration of that treatment)   to consider and take action on the following matters:          (1)  House Rule 13, Section 9(a)(2), is suspended to permit   the committee to omit text not in disagreement by omitting in   proposed SECTION 1 of the bill added Section 491.001(2), Health and   Safety Code.  The omitted text reads:                 (2)     "Executive commissioner" means the executive   commissioner of the Health and Human Services Commission.          Explanation: The change is necessary to remove a definition   that no longer appears in added Chapter 491, Health and Safety Code.          (2)  House Rule 13, Section 9(a)(4), is suspended to permit   the committee to add text on a matter not included in either the   house or senate version of the bill in proposed SECTION 1 of the   bill, by adding Sections 491.001(2), (3), (4), and (6), Health and   Safety Code, to read as follows:                 (2)     "Comptroller" means the comptroller of public   accounts.                 (3)     "Drug developer" means a pharmaceutical company,   biotechnology company, or contract development and manufacturing   organization engaged in drug development and manufacturing.                 (4)     "Hospital" has the meaning assigned by Section   241.003.                 (6)     "Institution of higher education" has the meaning   assigned by Section 61.003, Education Code.          Explanation: The change is necessary to define   "comptroller," "drug developer," "hospital," and "institution of   higher education" for purposes of added Chapter 491, Health and   Safety Code.          (3)  House Rule 13, Section 9(a)(2), is suspended to permit   the committee to omit text not in disagreement in proposed SECTION 1   of the bill by omitting added Sections 491.002 and 491.003, Health   and Safety Code.  The omitted text reads:           Sec.   491.002.     RULES. The executive commissioner shall   adopt rules necessary to administer this chapter.           Sec.   491.003.     ESTABLISHMENT OF GRANT PROGRAM. The   commission shall establish and administer a grant program to fund a   public-private partnership program that will pay for the costs of   the United States Food and Drug Administration's drug development   trials with ibogaine to secure the administration's approval as a   medication for treatment of opioid use disorder, co-occurring   substance use disorder, and any other neurological or mental health   conditions for which ibogaine demonstrates efficacy.          Explanation: The change is necessary to eliminate rulemaking   authority and remove a grant program.          (4)  House Rule 13, Section 9(a)(4), is suspended to permit   the committee to add text on a matter not included in either the   house or senate version of the bill in proposed SECTION 1 of the   bill, by adding a heading for added Subchapter B, Chapter 491,   Health and Safety Code, to read as follows:   SUBCHAPTER B. DRUG DEVELOPMENT OF IBOGAINE TREATMENT          Explanation: The change is necessary for better organization   of added Chapter 491, Health and Safety Code.          (5)  House Rule 13, Section 9(a)(4), is suspended to permit   the committee to add text on a matter not included in either the   house or senate version of the bill in proposed SECTION 1 of the   bill, by adding Sections 491.051 and 491.052, Health and Safety   Code, to read as follows:           Sec.   491.051.     ESTABLISHMENT OF CONSORTIUM. (a) A   consortium may be established under this section and apply for   commission selection under this subchapter to conduct drug   development clinical trials with ibogaine and secure the United   States Food and Drug Administration's approval of ibogaine as a   medication for the treatment of:                 (1)  opioid use disorder;                 (2)  co-occurring substance use disorder; and                 (3)     any other neurological or mental health condition   for which ibogaine demonstrates efficacy.           (b)     A consortium established under this section must   include one or more of each of the following entities:                 (1)  a drug developer;                 (2)  an institution of higher education; and                 (3)  a hospital.           Sec.   491.052.     LEAD INSTITUTION; ADMINISTRATION; PERSONNEL.   (a) A consortium established under this subchapter shall select a   lead institution of higher education from among the consortium's   members to represent the consortium and perform administrative   functions under this subchapter, including contracting with and   reporting to the commission as required by this subchapter.           (b)     A consortium selected by the commission under this   subchapter may employ personnel, including clinical,   administrative, and data management personnel, necessary to   support any consortium member's activities related to drug   development clinical trials conducted under this subchapter.          Explanation: The change is necessary to allow formation of a   consortium for the conduct of certain drug development clinical   trials, to secure United States Food and Drug Administration's   approval for certain medical treatments, and to allow the   consortium to select a lead institution and employ necessary   personnel.          (6)  House Rule 13, Section 9(a)(2), is suspended to permit   the committee to omit text not in disagreement in proposed SECTION 1   of the bill by omitting the heading and Subsections (a) and (c) of   added Section 491.004, Health and Safety Code.  The omitted text   reads:           Sec.   491.004.     APPLICATION. (a) The commission shall   prepare and issue a notice of funding opportunity to solicit   applications for the grant program established under this   subchapter.           (c)  The commission shall:                 (1)     make available the application required under this   section; and                 (2)     announce a period of not less than 90 days during   which applicants may submit an application under this subchapter.          Explanation: The change is necessary to remove an application   process for a removed grant program.          (7)  House Rule 13, Section 9(a)(4), is suspended to permit   the committee to add text on a matter not included in either the   house or senate version of the bill in proposed SECTION 1 of the   bill, by adding a heading and Subsection (a) for Section 491.053,   Health and Safety Code, to read as follows:           Sec.   491.053.     CONSORTIUM PROPOSAL. (a) The lead   institution of higher education of a consortium shall submit to the   commission a proposal and request for funding on behalf of the   consortium for purposes of conducting ibogaine drug development   clinical trials in accordance with this subchapter.          Explanation: The change is necessary to require a consortium   formed under added Chapter 491, Health and Safety Code, to submit to   the Health and Human Services Commission a proposal for selection   to conduct a drug development clinical trial under that chapter.          (8)  House Rule 13, Sections 9(a)(1), (2), and (3), are   suspended to permit the committee to change, alter, or amend text   not in disagreement, omit text not in disagreement, and add text on   a matter not in disagreement in proposed SECTION 1 of the bill, by   adding Section 491.053(b), Health and Safety Code, to read as   follows:           (b)  A proposal submitted under Subsection (a) must provide:                 (1)  the identity of all consortium members;                 (2)     a detailed description of the planned strategy for   obtaining approval for the drug development clinical trials from   the United States Food and Drug Administration;                 (3)     a detailed drug development clinical trial design   that includes:                       (A)     a description of the composition of the   consortium's drug development clinical trial team and the expertise   of the team members;                       (B)     a drug development clinical trial   participant recruitment plan;                       (C)     patient screening criteria and cardiac   safety protocols;                       (D)  administration protocols;                       (E)     an aftercare and post-acute treatment   support plan; and                       (F)  a data integrity plan;                 (4)     a detailed plan to seek a breakthrough therapy   designation for ibogaine from the United States Food and Drug   Administration under 21 U.S.C. Section 356;                 (5)     a proposal to recognize this state's commercial   interest in all intellectual property that may be generated over   the course of the drug development clinical trials, including:                       (A)     the treatment that is the subject of the   trials;                       (B)  administration protocols;                       (C)  treatment models or techniques; and                       (D)  technology used in the trials;                 (6)     a plan to establish a corporate presence in this   state and to promote and maintain ibogaine-related biomedical   research, development, treatment, manufacturing, and distribution   in this state;                 (7)     a plan to secure third-party payor approval for   ibogaine treatment following approval by the United States Food and   Drug Administration through:                       (A)  private insurers;                  & [Text truncated for display. Full text available on Congress.gov.]