The Cancer Prevention and Research Institute of Texas (Institute or CPRIT) adopts new Chapter 703, §§703.1 - 703.15, concerning grants for cancer prevention and research, with changes to the proposed text as published in the August 28, 2009, issue of the Texas Register (34 TexReg 5861). Simultaneous with the adoption of the new Chapter 703, the Institute adopts the repeal of current Chapter 703 in its entirety.

The 2007 Legislature enacted legislation amending Chapter 102 of the Health and Safety Code to create the Institute and provide rulemaking authority to the Institute's Oversight Committee. The 2009 Legislature adopted legislation that expressly directs the Institute's Oversight Committee to adopt rules regarding the procedure for making grant awards for cancer prevention and research by the Institute. The adopted rules provide guidance regarding the Institute's grant applications and awards for cancer prevention and research. In addition, these rules are adopted pursuant to and in satisfaction of the provisions of Health and Safety Code, Chapter 102, and other relevant statutes.

The Institute received comments from the following parties: the American Cancer Society, Cancer Care Services, the Crosetto Foundation to End Premature Cancer Deaths (Crosetto Foundation), Global Contour Group, the Gulf Coast Consortia (GCC), the Methodist Hospital Research Institute (MHRI), the Office of the Vice President of Research at Texas A&M University (TAMU), Texas Tech University Health Sciences Center (TTUHSC), and the University of Texas System (UT System). No party indicated that they did not support the new Chapter 703 rules with revisions. Specific observations and suggested changes are provided in the following section-by-section summary of the comments received and the Institute's response.

The Institute notes that in addition to comments filed regarding the proposed rules, the Crosetto Foundation also filed extensive revisions to a request for a research grant application previously issued by the Institute as well as ten pages of commentary titled "Introduction" that details "background information about issues that, had they been resolved, would have opened the door to my innovation that could have saved many lives from premature cancer death through early detection." The historical information provided by Crosetto Foundation is specific to the founder's invention and an account of his efforts to receive funding from various international, federal and non-profit organizations spanning 17 years, as well as his discussions with various elected officials. Because the historical information provided by Crosetto Foundation pertaining to the founder's invention and the revisions to the Institute's request for research grant applications are beyond the scope of the rulemaking, the Institute will not respond specifically to these items. Crosetto Foundation provided several changes to the text of the Institute's proposed rules. Crosetto Foundation's recommended changes to the proposed rules are addressed herein.

§703.1. Purpose and Application.

Crosetto Foundation suggests a change to subsection (a) to insert, "Identify and fund innovations and projects that demonstrate having higher potential with respect to others to substantially reduce premature cancer death and save lives at a lower cost per life saved compared to current costs." The Institute declines to make this change because subsection (a) reflects the Institute's mandate as set forth in the Texas Constitution and the statute. The text of the suggested insertion is not included in the statute and will not be made to the rule. Crosetto Foundation suggests a change to subsection (a)(2) to add the words, "in saving lives from premature death from cancer at a lower cost per life saved through" following "...substantial increase" and before "in cancer research..." The Institute declines to make this change because subsection (a) reflects the Institute's mandate as set forth in the Texas Constitution and the statute. The text of the suggested insertion is not included in the statute and will not be made to the rule. Crosetto Foundation states that the suggested changes are "aimed to solve the calamity of premature cancer death...Everywhere taxpayer money needs to be justified and spent in that effort and not used to create a market that does not solve the problem as has occurred over the past half century...If everyone will focus on making efforts toward solutions that substantially reduce cancer death, the goal will be reached; if money is just spent to gain knowledge by doing research, the cancer calamity will never be solved and more money will be justified to be spent without solving the problem." The Institute's mission, as set forth by the statute and approved by Texas voters, is to create and expedite innovation in the area of cancer research leading to the medical or scientific breakthroughs in the prevention or cancer and cures for cancer. The Institute notes that Crosetto Foundation's position is not inconsistent with the Institute's more expansive statutory mandate.

MHRI suggests a change to subsection (a)(1) to add cancer treatments to areas of potential medical or scientific breakthroughs. The Institute declines to make this change because subsection (a)(1) reflects the Institute's mandate as set forth in the Texas Constitution and the statute. The text of the suggested insertion is not included in the statute and will not be made to the rule.

§703.2. Definitions.

American Cancer Society suggests a change to reflect that cancer prevention programs should include early detection of cancer and be designed to mitigate the mortality of all types of cancer in humans. The Institute agrees with the proposed change and the definition of "cancer prevention" includes early detection.

Cancer Care Services suggests a change to address post-diagnosis effects in cancer prevention programs. The Institute agrees with the proposed change and amends the definition of "cancer prevention" to include post-diagnosis effects.

Crosetto Foundation suggests a change to the definition of "cancer prevention and control program" to refer to primary and secondary prevention, including "early detection through screening of asymptomatic people." The Institute agrees that cancer prevention includes early detection, and reflects the change in the definition of "cancer prevention." Crosetto Foundation proposes adding "the study of the signals that can be extracted from the mutation of normal cells into cancerous cells in order to identify the ones that provide the best and most reliable information for early cancer detection," to the definition of "cancer research." The Institute declines to make the proposed change because it is too specific to provide general guidance. The Institute notes that research into the causes and cures for all types of cancer encompasses Crosetto Foundation's proposed change without the requested revision to the rule. Crosetto Foundation proposes changes to the definition of "scientific research and prevention program committee" to include several questions Crosetto Foundation desires all applicants to address as well as the "responsibility of the reviewer not to reject innovations that can benefit mankind" if certain conditions are met, including "the reviewer or the decision maker cannot provide scientific arguments to invalidate applicant's claims," "the reviewer or decision maker declares himself/herself incompetent in the specific field" or "the applicant demonstrates that the reviewer's judgment was not scientifically correct or that he/she was incompetent in the field." The Institute declines to make the proposed revisions because the changes are too specific to provide general guidance. In addition, the proposed revisions are contrary to other Chapter 703 rule provisions.

MHRI suggests changes to the definitions of "applicant," and "cancer research." The Institute agrees with expanding the definition of "applicant" to include research institutions and non-profit organizations and amends the definition. To maintain consistency, the Institute also amends the definition of "recipient" to reflect the changes made to the definition of "applicant." The Institute agrees with expanding the definition of "cancer research" to include cancer detection and treatment and amends the definition. MHRI also suggests that the definition for "Institute" be added. The Institute agrees with the proposed change and amends the rule.

TAMU suggests expanding the definition of "cancer research" to include cancer related medical devices as well as preclinical studies and animal studies. The Institute agrees with the changes and amends the definition.

TTUHSC comments generally to seek clarification regarding the use of money from the Cancer Prevention and Research Fund to pay for travel for research collaborators and/or training. The Institute notes that the definition of "authorized expenses" includes travel as an authorized expense.

UT System suggests changes to the definitions of "applicant," "authorized expenses," "Cancer Prevention and Research Fund," and "recipient." The Institute agrees with the change proposed for the definitions of "applicant" and "recipient" to collectively refer university and academic health institutions by the statutory definition for institutions of higher education and to include consortia. These definitions have been amended. The Institute declines to make the change to add tuition expenses for training programs to the definition of "authorized expenses" because the items are not included in the statutory definition of this term. The Institute declines to replace the term "contract" with the term "grant agreement" in the definition of "Cancer Prevention and Research Fund." Health and Safety Code Chapter 102 is clear that the grants awarded by the Institute must be awarded by a contract. The rules in Chapter 703 reflect this statutory mandate. UT System also suggests that the term "cancer prevention" should be defined. The Institute agrees and adds the definition.

The Institute includes the definitions for "Chief Commercialization Officer," "Commercialization Review Council," and "Commercial prospects" to provide additional guidance. The definition of "Scientific research and prevention program committee" is changed to clarify that experts in the field of commercialization may also be appointed to scientific research and prevention program committees and to reflect proposed revisions to Chapter 702.

§703.3. Grant Applications.

Crosetto Foundation suggests a change to subsection (b) to reflect that modifications to the format and content requirements for requests for application may be made in order to improve the return to taxpayers and maximize the number of lives saved from premature cancer death at a lower cost per life saved compared to current costs. The Institute declines to amend the rule because the proposed change unreasonably limits the reasons that the Institute may modify format and content requirements. The Institute notes that it is possible to modify format and content requirements for the reasons proposed by Crosetto Foundation without the requested change to the rule. Crosetto Foundation suggests changes to subsection (c) to include specific requirements for four different grant programs proposed by Crosetto Foundation with particular budgets, timeframes, funding priorities and evaluation criteria. The Institute disagrees with the proposed changes and the rule is not amended. It is the Institute's discretion to design grant programs to achieve statutory objectives. The Institute notes that the potential areas for research and prevention requests for applications as included in the rule are broad in scope and may encompass several areas addressed by Crosetto Foundation without the requested change to the rule. Crosetto Foundation suggests a change to subsection (f) to state that the failure to send a written copy to CPRIT Scientific Review Office or provide a recording of the exchanged messages between the applicant and a reviewer for the purpose of making sure the reviewer fully understands the innovation's benefits to the patient will serve as grounds for disqualification. The Institute disagrees with this change and the rule will not be amended. The proposed change is inconsistent with other provisions of Chapter 703 that prohibits an applicant from contacting a reviewer about the status or substance of a pending application. The proposed change also unreasonably eliminates all potential grounds for disqualification. Crosetto Foundation suggests a change to subsection (g). Subsection (g) is moved to §703.6(h). The Institute will address Crosetto Foundation's suggested change in the response to comments for §703.6.

GCC comments that the Chapter 703 rules do not provide for submissions from research consortia such as the GCC. The Institute disagrees with this comment. Subsection (c)(3) specifies that cancer research grant applications may address multiple investigator awards, including collaborative projects. The Institute notes that changes made to the definition of "applicant" and "recipient" to include consortia provide additional clarification that a research consortia is eligible to receive a grant from the Institute.

MHRI suggests a change to subsections (a) and (d) 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 recommends inserting a requirement in subsection (a) that rules for data and intellectual property sharing be included in the request for applications. The Institute declines to make this change because data and intellectual property sharing provisions will be addressed by the contract between the Institute and the grant recipient. The contract terms may be specific to the recipient and subject to negotiation. MHRI suggests including retention of investigators as one of the possible cancer research grant application areas. The Institute declines to make this change because retention of talented investigators can be accomplished through the support provided by other grant applications. Recruitment grants will focus on bringing talented investigators from outside of the state to relocate to Texas.

MHRI and UT Systems comment that general rules are required to address the confidential treatment, if any, of grant applications and suggest changes to various sections of Chapter 703 rules requiring parties with access to confidential and proprietary information during the grant application and review process to certify in writing that they will maintain the confidentiality of the process and proceedings, including all associated materials, and will not disclose the information to third parties. The Institute agrees and adds subsections (g), (h), and (i) to address confidential and proprietary information submitted by applicants to the Institute. Subsection (h) reflects the statutory guidance on information that is considered public information with regard to grant applications.

TTUHSC comments that CPRIT funding should be used to ensure retention of key translational researchers like clinical investigators and clinical pharmacologists in academic medicine. TTUHSC comments that these investigators "take many years to get to the point of being ready to receive their first independent grant support and when they face frustrations in getting funded they are easily lured away by industry." Retaining highly trained translational investigators in the state's medical schools and research institutes will clearly benefit the CPRIT mission, according to TTUHSC. The Institute declines to amend the rule at this time and notes that several research and prevention grants are designed to support new and emerging talent, including recruitment grants, training, and short-term, high impact programs.

UT System suggests that modifications to the Institute's requests for applications that change format and content requirements be published in the Texas Register. The Institute agrees and amends the rule. The Institute notes that modifications to format and content requirements may be time-sensitive. Publication through the Institute's website will disseminate the modifications to potential applicants more quickly. UT System suggests a change to subsection (e) to clarify that grounds failure to comply with the material and substantive requirements of a request for applications may serve as grounds for disqualification. The Institute agrees with this change and amends the rule.

The Institute deletes subsection (e) regarding designation of contractors and moves subsection (f) to §703.10(c)(13) and subsection (g) to §703.6(h). The Institute includes a new subsection (e) to clarify that requests for applications will seek information regarding whether the proposed project includes commercial aspects.

§703.4. Grants Management.

MHRI suggests adding a requirement that any third-party grants management service must operate under the terms of a confidentiality agreement. The Institute agrees with the change and reflects the requirement suggested by MHRI in §703.6(i).

§703.5. Scientific Research and Prevention Programs Committee Members.

MHRI and UT System suggest a change to subsection (b) to require that an individual appointed to serve as a member of a scientific research and prevention programs committee must reside in another state. The Institute declines to make this change. The Institute will endeavor to recruit individuals that are not residents of Texas to serve on scientific research and prevention program committees in order to minimize potential conflicts of interest. However, the Institute wishes to retain some flexibility in the event that particular specialties or other reasons justify recruiting individuals that reside in the state to serve on the review committees. MHRI suggests a change to subsection (c) to require that scientific research and prevention program committee members execute an agreement to maintain the confidentiality of the proceedings and grant applications submitted to the Institute. UT System offers a similar suggestion to change 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 changes and reflects the requirements suggested by MHRI and UT System in §703.6(i).

UT System suggests a change to subsection (f) to include the statutory reference to recusal requirements for scientific research and prevention program committee members. The Institute agrees with the change and the rule is amended.

The Institute makes a change to subsection (a) to recognize that an expert in the field of commercialization may be a member of a scientific research and prevention program committee. The Institute deletes subsections (g) and (h) because these provisions are now addressed in the proposed amendments to Chapter 702.

§703.6. Grants Review Process.