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AN ACT
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relating to enrollment and participation in certain research |
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programs of certain children in foster care. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 266.001, Family Code, as added by |
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Chapter 268, Acts of the 79th Legislature, Regular Session, 2005, |
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is amended by adding Subdivisions (2-a) and (4-a) to read as |
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follows: |
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(2-a) "Drug research program" means any clinical |
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trial, clinical investigation, drug study, or active medical or |
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clinical research that has been approved by an institutional review |
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board in accordance with the standards provided in the Code of |
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Federal Regulations, 45 C.F.R. Sections 46.404 through 46.407, |
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regarding: |
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(A) an investigational new drug; or |
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(B) the efficacy of an approved drug. |
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(4-a) "Investigational new drug" has the meaning |
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assigned by 21 C.F.R. Section 312.3(b). |
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SECTION 2. Subchapter A, Chapter 266, Family Code, as added |
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by Chapter 268, Acts of the 79th Legislature, Regular Session, |
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2005, is amended by adding Section 266.0041 to read as follows: |
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Sec. 266.0041. ENROLLMENT AND PARTICIPATION IN CERTAIN |
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RESEARCH PROGRAMS. (a) Notwithstanding Section 266.004, a person |
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may not authorize the enrollment of a foster child or consent to the |
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participation of a foster child in a drug research program without a |
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court order as provided by this section, unless the person is the |
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foster child's parent and the person has been authorized by the |
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court to make medical decisions for the foster child in accordance |
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with Section 266.004. |
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(b) Before issuing an order authorizing the enrollment or |
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participation of a foster child in a drug research program, the |
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court must: |
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(1) appoint an independent medical advocate; |
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(2) review the report filed by the independent medical |
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advocate regarding the advocate's opinion and recommendations |
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concerning the foster child's enrollment and participation in the |
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drug research program; |
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(3) consider whether the person conducting the drug |
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research program: |
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(A) informed the foster child in a |
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developmentally appropriate manner of the expected benefits of the |
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drug research program, any potential side effects, and any |
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available alternative treatments and received the foster child's |
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assent to enroll the child to participate in the drug research |
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program as required by the Code of Federal Regulations, 45 C.F.R. |
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Section 46.408; or |
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(B) received informed consent in accordance with |
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Subsection (h); and |
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(4) determine whether enrollment and participation in |
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the drug research program is in the foster child's best interest and |
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determine that the enrollment and participation in the drug |
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research program will not interfere with the appropriate medical |
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care of the foster child. |
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(c) An independent medical advocate appointed under |
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Subsection (b) is not a party to the suit but may: |
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(1) conduct an investigation regarding the foster |
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child's participation in a drug research program to the extent that |
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the advocate considers necessary to determine: |
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(A) whether the foster child assented to or |
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provided informed consent to the child's enrollment and |
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participation in the drug research program; and |
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(B) the best interest of the child for whom the |
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advocate is appointed; and |
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(2) obtain and review copies of the foster child's |
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relevant medical and psychological records and information |
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describing the risks and benefits of the child's enrollment and |
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participation in the drug research program. |
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(d) An independent medical advocate shall, within a |
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reasonable time after the appointment, interview: |
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(1) the foster child in a developmentally appropriate |
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manner, if the child is four years of age or older; |
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(2) the foster child's parent, if the parent is |
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entitled to notification under Section 266.005; |
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(3) an advocate appointed by an institutional review |
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board in accordance with the Code of Federal Regulations, 45 C.F.R. |
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Section 46.409(b), if an advocate has been appointed; |
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(4) the medical team treating the foster child as well |
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as the medical team conducting the drug research program; and |
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(5) each individual who has significant knowledge of |
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the foster child's medical history and condition, including any |
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foster parent of the child. |
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(e) After reviewing the information collected under |
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Subsections (c) and (d), the independent medical advocate shall: |
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(1) submit a report to the court presenting the |
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advocate's opinion and recommendation regarding whether: |
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(A) the foster child assented to or provided |
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informed consent to the child's enrollment and participation in the |
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drug research program; and |
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(B) the foster child's best interest is served by |
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enrollment and participation in the drug research program; and |
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(2) at the request of the court, testify regarding the |
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basis for the advocate's opinion and recommendation concerning the |
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foster child's enrollment and participation in a drug research |
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program. |
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(f) The court may appoint any person eligible to serve as |
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the foster child's guardian ad litem, as defined by Section |
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107.001, as the independent medical advocate, including a physician |
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or nurse or an attorney who has experience in medical and health |
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care, except that a foster parent, employee of a substitute care |
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provider or child placing agency providing care for the foster |
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child, representative of the department, medical professional |
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affiliated with the drug research program, independent medical |
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advocate appointed by an institutional review board, or any person |
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the court determines has a conflict of interest may not serve as the |
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foster child's independent medical advocate. |
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(g) A person otherwise authorized to consent to medical care |
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for a foster child may petition the court for an order permitting |
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the enrollment and participation of a foster child in a drug |
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research program under this section. |
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(h) Before a foster child, who is at least 16 years of age |
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and has been determined to have the capacity to consent to medical |
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care in accordance with Section 266.010, may be enrolled to |
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participate in a drug research program, the person conducting the |
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drug research program must: |
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(1) inform the foster child in a developmentally |
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appropriate manner of the expected benefits of participation in the |
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drug research program, any potential side effects, and any |
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available alternative treatments; and |
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(2) receive written informed consent to enroll the |
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foster child for participation in the drug research program. |
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(i) A court may render an order approving the enrollment or |
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participation of a foster child in a drug research program |
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involving an investigational new drug before appointing an |
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independent medical advocate if: |
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(1) a physician recommends the foster child's |
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enrollment or participation in the drug research program to provide |
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the foster child with treatment that will prevent the death or |
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serious injury of the child; and |
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(2) the court determines that the foster child needs |
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the treatment before an independent medical advocate could complete |
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an investigation in accordance with this section. |
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(j) As soon as practicable after issuing an order under |
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Subsection (i), the court shall appoint an independent medical |
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advocate to complete a full investigation of the foster child's |
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enrollment and participation in the drug research program in |
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accordance with this section. |
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(k) This section does not apply to: |
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(1) a drug research study regarding the efficacy of an |
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approved drug that is based only on medical records, claims data, or |
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outcome data, including outcome data gathered through interviews |
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with a child, caregiver of a child, or a child's treating |
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professional; |
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(2) a retrospective drug research study based only on |
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medical records, claims data, or outcome data; or |
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(3) the treatment of a foster child with an |
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investigational new drug that does not require the child's |
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enrollment or participation in a drug research program. |
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(l) The department shall annually submit to the governor, |
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lieutenant governor, speaker of the house of representatives, and |
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the relevant committees in both houses of the legislature, a report |
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regarding: |
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(1) the number of foster children who enrolled or |
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participated in a drug research program during the previous year; |
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(2) the purpose of each drug research program in which |
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a foster child was enrolled or participated; and |
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(3) the number of foster children for whom an order was |
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issued under Subsection (i). |
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(m) A foster parent or any other person may not receive a |
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financial incentive or any other benefit for recommending or |
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consenting to the enrollment and participation of a foster child in |
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a drug research program. |
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SECTION 3. Subsection (b), Section 266.005, Family Code, as |
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added by Chapter 268, Acts of the 79th Legislature, Regular |
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Session, 2005, is amended to read as follows: |
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(b) Except as provided by Subsection (c), the department |
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shall make reasonable efforts to notify the child's parents within |
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24 hours of: |
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(1) a significant medical condition involving a foster |
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child; and |
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(2) the enrollment or participation of a foster child |
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in a drug research program under Section 266.0041. |
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SECTION 4. The change in law made by this Act by the |
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enactment of Section 266.0041, Family Code, applies only to the |
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enrollment and participation of a foster child in a drug research |
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program on or after the effective date of this Act. A foster child |
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enrolled or participating in a drug research program before the |
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effective date of this Act is governed by the law in effect when the |
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foster child was enrolled or began participating in the drug |
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research program, and the former law is continued in effect for that |
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purpose. |
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SECTION 5. This Act takes effect September 1, 2007. |
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______________________________ |
______________________________ |
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President of the Senate |
Speaker of the House |
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I hereby certify that S.B. No. 450 passed the Senate on |
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April 17, 2007, by the following vote: Yeas 30, Nays 0; and that |
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the Senate concurred in House amendment on May 21, 2007, by the |
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following vote: Yeas 31, Nays 0. |
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______________________________ |
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Secretary of the Senate |
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I hereby certify that S.B. No. 450 passed the House, with |
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amendment, on May 16, 2007, by the following vote: Yeas 142, |
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Nays 0, one present not voting. |
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______________________________ |
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Chief Clerk of the House |
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Approved: |
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______________________________ |
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Date |
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______________________________ |
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Governor |