The Cancer Prevention and Research Institute of Texas (Institute) proposes amendments to §§703.2, 703.3, 703.5 - 703.8, 703.10, 703.11, and 703.13; and new §§703.21, 703.25, and 703.26, concerning grant awards for cancer prevention and research.

The purpose of the proposed amendments and new sections is to clarify several existing rules, to reflect changes to the statute, to be consistent with other chapters, and to provide additional guidance regarding the grant review and award process. The amendments and new sections are proposed pursuant to and in satisfaction of the provisions of Texas Government Code, Chapters 572 and 2255; Texas Health and Safety Code, Chapter 102; and other relevant statutes.

Section 703.2 adds the definitions for "chief product development officer", "compliance officer", "product development review council", and "product development prospects." The section proposes to delete references to the "chief commercialization officer", the "commercialization review council", and "commercial prospects". The section also clarifies the definition of "cancer research" to include research into the prevention of cancer.

Section 703.3 proposes changes to address requirements for the applicant seeking a grant award. The section clarifies the areas of cancer research and prevention program that the Institute's requests for applications will address. The section also clarifies "material requirements" that must be satisfied by the applicant to be eligible for review. It adds the high-level summary of the application to the list of information considered public information. New requirements are added regarding prohibited donations to the CPRIT Foundation or similar foundation and the identification of all sources of funding contributing to the project proposed for Institute funding.

Section 703.5 is proposed to clarify that scientific research and prevention program appointments are provisional until the Oversight Committee approves the appointments. The section is also amended to clarify the Institute's policy on residency requirements for scientific research and prevention program committee members. A limitation was added prohibiting the scientific research or prevention program committee member or immediate family member from providing professional services for more than $5,000 to any grant recipient for a period of one year from the effective date of the grant award unless waived by the Oversight Committee. The section was also amended to require the Institute to provide a list of all current reviewers by panel and notify the applicant of the panel assignment.

Section 703.6 is proposed to clarify the goals of review process and to add the Texas Cancer Plan to list of funding priorities for proposals. The section was also amended to include various requirements regarding documentation of review committee recommendations and to specify the timing and delivery of the review council recommendations. Other proposed changes are to incorporate an independent third party observer of the scientific research and prevention programs committee meetings who will issue a report and to clarify that all reviewers are required to sign the post review statements certifying compliance with the Institute's conflict of interest rules and policies.

Section 703.7 is amended to require the Executive Director to notify the Compliance Officer of award recommendations so that the Compliance Officer may review the process documentation for each recommendation and report the findings. Other changes also specify the items that must accompany the Executive Director's recommendations for funding submitted to the Oversight Committee and clarify the items that will be publicly available after the award announcement.

Section 703.8 is amended to change the section title and to require that any advance of grant funds must be approved by a majority vote of the Oversight Committee. Additional requirements proposed for this section include the Compliance Officer's public certification of the award slate and the execution of post-review statements by certain individuals involved with the review process certifying that the Institute's conflict of interest rules were followed.

Section 703.10 is amended to reflect definitional changes. In addition, the section sets forth terms to be included in the grant contract for advancing grant funds, for providing quarterly financial statements and penalties for failing to file timely reports, for certifying that the grant recipient has not made and will not make contributions to the CPRIT Foundation or similar foundation, and the Institute's right to terminate for the recipient's failure to comply with contract provisions. Proposed changes to the section also clarify that the effective date stated in the award contract controls over the signature date of the contract and provide for a process that reimburses allowable expenses expended after the award is publicly announced but prior to the effective date of the contract. The section also sets forth close-out requirements which include a list of contractual terms that extend beyond the contract termination date.

Section 703.11 clarifies the process, documentation and review required for demonstrating available funds for cancer research grants and specifies that failure to provide certification of available funds will serve as grounds for contract termination.

Section 703.13 clarifies that any grant recipient expending $500,000 or more in federal or state awards during its fiscal year will obtain either an annual single audit or a program specific audit, as appropriate, and sets forth the penalty for failing to timely submit required audit reports.

Section 703.21 is proposed to set forth how the Institute will monitor performance of grant projects, including a mandatory progress report. The rule describes the process for Institute review of the required progress reports, the public presentation of results of progress evaluations, and actions taken if it is found that sufficient progress is not being made.

Section 703.25 is proposed to set forth the Institute's compliance and ethics program, including the Compliance Officer's public report on compliance activities of the Institute.

Section 703.26 is proposed to create the procedures for investigating complaints regarding compliance violations, including the establishment of an ethics hotline, the prompt investigation by the Compliance Officer, and review by the Audit Subcommittee of the Oversight Committee. The new rule also describes documentation and reporting policies and requires ethics training for Institute staff.

Kristen Pauling Doyle, General Counsel for the Institute, has determined that for the first five-year period the rules are in effect there will be no foreseeable implications relating to costs or revenues for state or local government as a result of enforcing or administering the rules.

Ms. Doyle has also determined that for each year of the first five years the rules are in effect the public benefit anticipated as a result of enforcing the rules will be clarification of the policies and procedures the Institute will follow to implement its statutory duties to award grants from the Cancer Prevention and Research fund. There are no anticipated economic costs to persons who are required to comply with the rules as proposed.

Ms. Doyle has determined that the rules shall not have an effect on small businesses or micro businesses.

Written comments on the proposed amendments and new sections may be submitted to Kristen Pauling Doyle, General Counsel, Cancer Prevention and Research Institute of Texas, by facsimile transmission at (512) 475-2563; by electronic mail to kdoyle@cprit.state.tx.us; or by U.S. mail to P.O. Box 12097, Austin, Texas 78711. Comments are due within 30 days of the publication of proposed rules in the Texas Register.

The amendments and new sections are proposed under the authority of the Texas Health and Safety Code Annotated, §102.108 and §102.251, which provide the Institute's Oversight Committee with rulemaking authority and direct the Institute to adopt rules relating to grant award procedures.

There is no other statute, article, or code that is affected by this proposal.