Crosetto Foundation suggests two changes to subsection (a). The first change would replace the words "the area of cancer prevention and cures for cancer" in (a)(1) with the phrase, "providing the maximum reduction of premature cancer death at the lowest cost per life saved compared to current cost and to costs from other proposals." The Institute declines to make this change. Subsection (a) provides the statutory direction regarding prioritization for funding cancer research and prevention applications submitted to the Institute. The suggested change is not found in the statute and will not be made in the rule. The second change is to delete subsection (a)(2) - (7). The Institute declines to make this change. The provisions in subsection (a) proposed for deletion provide the statutory direction regarding prioritization for funding cancer research and prevention applications submitted to the Institute. The rule will not be amended.

Crosetto Foundation suggests three changes to subsection (b). The first suggested change is further define the projects the Institute will endeavor to fund as those with "the maximum impact in the reduction of premature cancer death at a lower cost per life saved compared to current cost and to costs of other proposals." The Institute declines to make this change because the statute does not require this calculation. Furthermore, the proposed change may serve to unduly restrict the types of projects eligible for funding by requiring a specific quantification of the reduction of premature cancer deaths. It may be impossible to calculate this figure for most, if not all, cancer research projects at the time applications are submitted. The Institute notes that the potential for scientific discoveries that will make a meaningful difference to cancer patients can occur at any stage in the research process. If the Institute limits funding at the outset to only those proposals that claim to demonstrate an immediate reduction in premature cancer death, early stage and developing research would suffer and potential treatment-altering innovations may be missed. The second change suggested to subsection (b) is to describe the peer review process as proposed by Crosetto Foundation, where each reviewer should provide scientific arguments supporting his acceptance or rejection of the proposal that comply with Crosetto Foundation's proposed standard evaluation criteria. The Institute declines to make this change because it describes a process that is inconsistent with the peer review process set forth elsewhere in Chapter 703, particularly with regard to Crosetto Foundation's recommended standard evaluation criteria. The third change suggested to subsection (b) requires the Chief Scientific Officer and Chief Prevention Officer to guarantee that the reviewer's acceptance or rejection of the proposal complies with Crosetto Foundation's recommended standard evaluation criteria. "In case of doubts or disagreements that cannot be resolved with logical reasoning, calculations, etc., because the reviewer who is rejecting applicant's claims cannot support his rejection with solid scientific arguments," Crosetto Foundation proposes resolving the issue, "by having the two parties in disagreement propose a small experiment at the expense of CPRIT. The result of the experiment will establish who was correct and in the event applicant's claims were proven to be correct, the reviewer who could not be convinced by logical reasoning should resign from his position. In the event the results will show applicant's claims were wrong, the proposal will be withdrawn from further consideration." CPRIT disagrees with this change because it is inconsistent with the peer review process set forth in Chapter 703. The decision to recommend funding for an application is entirely within the purview of the scientific research and prevention program committee and will be based on the sufficiency, scientific merit and, if applicable, the commercial prospects of the application. Debates and dueling experiments as proposed by the Crosetto Foundation will increase the time, expense, and resources necessary for the evaluation of grant applications.

Crosetto Foundation suggests a change to subsections (c), (d), and (f) to require that the results for the peer review process and the funding recommendations by the Scientific and Prevention Review Councils and the Executive Director should be mainly based on the supporting arguments for the scores assigned pursuant to Crosetto Foundation's recommended standard evaluation criteria. The Institute disagrees with these changes because the Crosetto Foundation's recommended evaluation criteria will not used in the Institute's application evaluation and funding recommendation process. It is left to the Institute's discretion to establish the evaluation criteria used to score grant applications, as guided by the statute. Crosetto Foundation also recommends deleting the requirement in subsection (f) that the grant funding recommendations include a statement of how the grant applications recommended for funding meet one or more standards of subsection (a). The Institute disagrees with this change and the rule will not be amended. The statement required by subsection (f) demonstrates the Institute's obligation to prioritize funding recommendation based on the several statutory criteria included in subsection (a). Crosetto Foundation suggests a change to subsection (g) to state that the decision to recommend a grant application for funding is based on "objective criteria calculated with a score, supported by solid scientific argument" by the scientific research and prevention programs committee. The Institute declines to make this change because it may serve to unreasonably limit the reasons for recommending a grant for funding. The Institute notes that scientific research and prevention program committee's decision regarding funding recommendations will encompass consideration of objective criteria, scores, and scientific support, as set forth elsewhere in this section.

Crosetto Foundation suggests a change to new subsection (h) to allow for and encourage official communication between the applicant and reviewers in order to allow reviewers to fully understand the potential impact of the subject of the application. The communication must be public or in the presence of a staff person of the CPRIT Review Office, recorded, and stored as an electronic file at the CPRIT Scientific Review Office. The Institute disagrees with this change and the rule is not amended. The application process provided for by Chapter 703 rules gives every applicant the same opportunity to explain the scientific merit, including the potential impact, of the research or prevention program that is the subject of the grant application. To allow and encourage applicants to make additional public presentations to reviewers has the potential to overwhelm the review process and the resources of the Institute. To the extent that reviewers have questions about an application, Chapter 703 rules provide for the reviewer to seek additional information from the applicant through communication initiated by CPRIT staff.

MHRI suggests a change to subsection (a) to replace the term "cancer prevention" with the term "cancer prevention and control." The Institute declines to make this change. Instead, the definition of "cancer prevention" is added to §703.2. MHRI comments to seek clarification regarding the relationship of between projects representing the most creative, most innovate science and the priorities listed in subsection (a)(1) - (11). The Institute revises subsections (a) and (b) to clarify that projects that fulfill one or more of the statutory standards listed in subsection (a)(1) - (11) are likely to also represent the types of creative, innovative scientific research and prevention program projects that the Institute seeks to identify and fund. MHRI suggests changes to subsection (a)(1) and (5) to include the terms "detection" and "treatment." The Institute declines to make these changes. Subsection (a) provides the statutory direction regarding prioritization for funding cancer research and prevention applications submitted to the Institute. The suggested changes are not found in the statute and will not be made in the rule. However, the Institute notes that cancer detection and treatment are subsumed under the general category of "research into the prevention and cure for cancer." MHRI suggests changes to subsection (a)(10) to include "other research institutions" in the statutory direction to enhance research superiority at institutions of higher education. The Institute declines to make this change. Subsection (a) provides the statutory direction regarding prioritization for funding cancer research and prevention applications submitted to the Institute. The suggested change is not found in the statute and will not be made in the rule. However, the Institute notes that the Institute's cancer research applications are designed to generally enhance research superiority in the state and are not limited to institutions of higher education. MHRI suggests a change to subsection (a)(11) to eliminate the word "substantial" when describing the desired increase in high quality jobs and to include private entities when increasing applied science or technology research capabilities at institutions of higher education. The Institute declines to make this change. Subsection (a) provides the statutory direction regarding prioritization for funding cancer research and prevention applications submitted to the Institute. The suggested change is not found in the statute and will not be made in the rule. MHRI comments seeking information regarding how the scientific research and prevention program committees will agree upon applications to be funded and what the committee will do if the members cannot agree. This rule provides several standards that the committees will use to evaluate the applications. To the extent that committee members disagree regarding applications to be funded, the resolution of the dispute is likely to be fact-specific and the Institute is unable to provide additional guidance at this time. MHRI comments to seek clarification regarding the use of the phrase "as may be appropriate" in subsection (e). The Institute amends this section to clarify that the subject matter of the application will determine which review council will evaluate the funding recommendations of the individual scientific research and prevention program committees. MHRI comments to seek clarification regarding the procedures the review councils will use to agree upon funding recommendations. This rule provides several standards that the review council will use to evaluate the applications recommended for funding. The agreement of the review council regarding its recommendation for applications to be funded is likely to be fact-specific and the Institute is unable to provide additional guidance at this time.

TAMU suggests including "substantial mitigation of cancer" in subsection (a)(1). The Institute declines to make the change. Subsection (a) provides the statutory direction regarding prioritization for funding cancer research and prevention applications submitted to the Institute. The suggested change is not found in the statute and will not be made in the rule. However, the Institute notes that the substantial mitigation of cancer is subsumed under the general category of "research into the prevention or cures for cancer."

UT System suggests a change to subsection (a)(10) to include the phrase, "retaining existing research superiority." The Institute declines to make this change. Subsection (a) provides the statutory direction regarding prioritization for funding cancer research and prevention applications submitted to the Institute. The suggested change is not found in the statute and will not be made in the rule. However, the Institute notes that the grants from Cancer Prevention and Research Funds serve to retain existing research superiority because only research and prevention programs based in Texas are eligible. UT System suggests a change to subsection (b) to include a statement that the Chief Scientific Officer or Chief Prevention Officer may determine not to forward a grant application to the applicable council for incompleteness or lack of merit. The Institute agrees with the change and revises subsections (b) and (c) to reflect that the Institute may rely upon a two-stage peer review process depending upon the number of applications received and that incomplete or non-competitive applications will not be reviewed further. UT System suggests a change to add subsection (g) to require reviewers to certify in writing to maintain the confidentiality of the process and proceedings and all associated materials. The Institute agrees with the suggested change and reflects the requirements suggested by UT System in subsection (i).

The Institute makes changes to reorder subsections (a) and (b) and include a reference to promoting commercial prospects, if applicable to the project. The Institute inserts the former §703.3(g) to create a new subsection (h). The Institute makes changes to subsections (c), (d), (e) and (f) to reflect that the Commercialization Review Council will be a part of the grant review process as may be appropriate to the subject matter of the application.

§703.7. Executive Director's Funding Recommendation.

Crosetto Foundation suggests a change to include additional requirements for the Executive Director's funding recommendation such as requesting "additional supporting scientific material from the reviewers if a specific proposal is claimed by the applicant that will save more lives with respect to another proposal and the reviewer's rejection claims or claims to lower such estimates are not supported by convincing solid scientific arguments. Reviewer's rejection claims should be disclosed to the applicant so he could further explain aspects of his proposal that were not fully understood." The Institute disagrees with this change because it is inconsistent with the statute and conflicts with the Institute's grant review process. The proposed change will not improve efficiency or enhance the evaluation of the grants. Implementing a process that allows rejected applicants to seek further review threatens the finality of the review process and may serve to overwhelm the resources of the Institute.

MHRI suggests a change to replace the term "cancer prevention" with the term "cancer prevention and control." The Institute declines to make this change. Instead, the definition of "cancer prevention" is added to §703.2. MHRI comments to seek clarification regarding the Executive Director's authority to modify the list submitted by the review council. By requiring that the Executive Director's list of applications recommended for funding be substantially based on the list submitted by the review council, the rule reflects the statutory direction that the Executive Director has some discretion with regard to the list of funding recommendations. To the extent that the Executive Director exercises his/her authority to modify the list of recommendations, it is likely to be fact specific and the Institute is unable to provide additional guidance at this time. MHRI comments to seek clarification regarding whether there is any limit upon the Executive Director's discretion to modify the list. The statute states that the Oversight Committee may override the Executive Director's funding recommendations by a two-thirds vote of the committee.

The Institute amends the rule to reflect the participation of the Commercialization Review Council in developing the prioritized list of applications to be awarded cancer research and prevention grants.

§703.8. Overriding the Executive Director's Funding Recommendation.

Crosetto Foundation suggests a change to subsection (b) to expand upon the reason for the vote to disregard the slate of recommendations to include, "because [the Oversight committee] has compelling arguments that should be put forth in a document because they believe that a specific project will not reduce premature cancer death, nor will reduce health care cost." The Institute declines to make this change. Because the vote will take place in an open meeting, there will be a written record of the vote to disregard the Executive Director's funding recommendation. However, the reason suggested by Crosetto Foundation for the vote to disregard unreasonably limits the Oversight's Committee's discretion and is not supported by statute. Crosetto Foundation suggests a change to subsection (c) to insert the requirement that the Oversight Committee "must have solid arguments that CPRIT mission and mandate from the legislation is not implemented in order to disregard the slate of funding recommendations, and to permit the Oversight Committee to forward a request for further investigation to the Scientific Review Council or Prevention Review Council." The statute does not limit the Oversight Committee's authority to disregard the Executive Director's recommendation beyond requiring that at least two-thirds of the members vote to do so. For this reason, the Institute declines to make the change suggested by Crosetto Foundation requiring the Oversight Committee to find that the Executive Director's proposed slate is inconsistent with the Institute's mission or legislative mandate. The Institute agrees that the Oversight Committee should be able to request further investigation from the review council and revises subsection (c).

MHRI comments to seek information regarding whether the Oversight Committee will only review the applications in "batches" and whether this will delay the consideration of grants if the Institute waits for several applications to accumulate before forwarding the recommended slate to the committee. There is no minimum number of applications necessary to constitute a slate of recommendations under the rule. The Executive Director's slate of funding recommendations may be comprised of all applications that have received final approval from the review council(s) in time for the next scheduled Oversight Committee meeting. MHRI comments to seek information regarding how the Executive Director will put together a revised list of funding recommendations if the Oversight Committee rejects the Executive Director's list of funding recommendations. This is likely to be a fact-specific issue, however the Institute notes that subsection (c) provides that the Oversight Committee will instruct the Executive Director regarding the process and timetable for resubmission.

§703.9. Limitation on the Review of Grant Process.

MHRI comments to seek clarification regarding whether a conflict of interest held by the Executive Director or Oversight Committee member will also serve as grounds for reconsideration. Chapter 702 addresses prohibited conflict of interests and includes potential conflicts that may be held by the Executive Director, an Oversight Committee member, a scientific research and prevention programs committee member, or an Institute employee. MHRI comments to seek clarification regarding remedies for undue influence exercised by the Executive Director an Oversight Committee member. Such actions are addressed by the conflict of interest provisions of Chapter 702. The Institute amends subsections (b) and (c) to refer to the conflict of interest issues addressed fully in Chapter 702. The Institute deletes subsections (d), (e) and (f) to avoid duplication of the issues addressed fully in Chapter 702.