The Cancer Prevention and Research Institute of Texas (Institute) proposes amendments to §§703.1 - 703.20; and new §703.21, concerning Grants for Cancer Prevention and Research.

The purpose of these proposed amendments and new rule is to clarify several existing rules, to reflect changes to the statute, for consistency with other chapters, and to provide additional guidance regarding the grant application review and award process and procedures, including the monitoring of grant award contracts. In addition, these amendments are proposed pursuant to and in satisfaction of the provisions Texas Health and Safety Code, Chapter 102, and other relevant statutes.

Section 703.1 is amended to further identify and clarify the types of grant awards funded by the Institute. It also adds the process for the Oversight Committee to set annual priorities for each of the Institute's grant programs.

Section 703.2 is amended to delete the definitions in the chapter. The Institute proposes the deletion of the definitions from this chapter because the definitions of the words and terms used in this chapter have the meanings provided in 25 TAC Chapter 701, §701.3 (relating to Definitions), thus maintaining consistency of terms used throughout Chapters 701 - 703.

Section 703.3 is amended to include additional guidance regarding the requests for applications as well as to clarify the areas of research and prevention that the Institute's requests for applications may address. The proposed changes also specify mandatory eligibility requirements for applicants, including certification that no donations to CPRIT or to any foundation established to benefit CPRIT have been or will be made. It adds the required disclosure of all sources of a grant applicant's funding for purposes of identifying conflicts of interest.

Section 703.4 is amended to establish the Institute's electronic grant management system as the repository to maintain complete grant records for the submission, review, award, contracting, and monitoring processes implemented by the Institute.

Section 703.5 is amended to provide additional guidance for Scientific Research and Prevention Programs Committee members related to refraining from business activities with grant applicants and recipients, including a prohibition on providing professional services to a grant recipient or serving on the grant recipient's board of directors. The section is amended to require the Institute to provide a list of all current reviewers by panel and notify grant applicants of the panel assignment, as well as the recruitment, training and appointment of patient advocates to the Scientific Research and Prevention Committee.

Section 703.6 is amended to further clarify and describe the grants review process and procedures, including processes that are unique to particular grant mechanisms or grant programs. The proposed changes include score assignment and record retention requirements for each application. Other changes include the incorporation of an independent third party observer of the scientific research and prevention programs committee meetings.

Section 703.7 is amended to implement §102.251(a)(2) of the Texas Health and Safety Code and clarify the Program Integration Committee that role to recommend meritorious projects for funding to the Oversight Committee. The amendment sets forth the process for the Program Integration Committee to approve a list of grant applications to the Oversight Committee. This section also defines the contents of the affidavits submitted by the Chief Executive Officer for every grant recommendation.

Section 703.8 is amended to provide for the Oversight Committee's process to approve grant award recommendations from the Program Integration Committee, including consideration of the Compliance Officer's reports.

Section 703.9 is amended to clarify the limitation on reconsidering grant application decisions unless an undisclosed conflict of interest is identified.

Section 703.10 is amended to delineate the required contract provisions for grant awards, including reporting requirements and penalty provisions if the grant recipient does not comply with the terms and conditions of grant contract.

Section 703.11 is amended to clarify the guidelines for the matching funds obligation for Research grant recipients, including appropriate sources of matching funds, reporting requirements, and penalty provisions, including contract termination.

Section 703.12 is amended to provide further guidance on limitations on the use of grant award funds, including a list of expenses that are not authorized to be paid from grant award funds.

Section 703.13 is amended to clarify audit requirements for grant recipients. The proposed changes include penalties for delinquent submission of required audits to the Institute.

Section 703.14 is amended to set forth the termination, extension and close out processes for grant contracts, including termination of the contract by the Institute for the grant recipient's failure to fulfill contractual obligations.

Section 703.15 is amended to clarify obligations specific to multi-year contracts, including limitations on carry forward of unexpended fund balances.

Section 703.16 is amended with non-substantive changes such as capitalization of defined terms.

Section 703.17 is amended to provide further guidance on the types of financial benefits associated with grant project results that may be shared with the Institute.

Section 703.18 and §703.19 are amended with non-substantive changes such as capitalization of defined terms.

Section 703.20 is amended to clarify the certification of the tobacco-free policy for grant recipients and its documentation.

New §703.21 is proposed to set forth the methods used by the Institute to monitor grant award performances and expenditures, including annual verification and certification by the grant recipient of compliance with grant contract provisions, and provides explicit penalty provisions for failure to comply. This section also specifies the documentation and reporting of such monitoring.

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 also has 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. 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 on micro businesses.

Written comments on the rules may be submitted to Ms. Kristen Pauling Doyle, General Counsel, Cancer Prevention and Research Institute of Texas, P.O. Box 12097, Austin, Texas 78711 no later than December 16, 2013. Parties filing comments are asked to indicate whether or not they support the rule revisions proposed by the Institute and, if changes are requested, to provide specific text proposed to be included in the rule. Comments may be submitted electronically to kdoyle@cprit.state.tx.us. Comments may be submitted by facsimile transmission to (512) 475-2563.

The amendments and new rule are proposed under the authority of the Texas Health and Safety Code Annotated, §102.101(e) and §102.106, which provide the Institute with the authority to govern members of the Oversight Committee and its own activities, and which direct the Oversight Committee to adopt rules relating to conflict of interest.

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