TITLE 25. HEALTH SERVICES

PART 11. CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS

CHAPTER 701. POLICIES AND PROCEDURES

25 TAC §701.3

The Cancer Prevention and Research Institute of Texas ("CPRIT" or "the Institute") adopts an amendment §701.3 to clarify the definition of relative without changes to the text as published in the March 3, 2017, issue of the Texas Register (42 TexReg 997).

Reasoned Justification

The proposed amendment removes "uncle, aunt, niece, or nephew," which the Institute listed inaccurately as examples of relatives related within the second degree by consanguinity or affinity. Texas Government Code §§573.021 - 573.025 characterizes uncles, aunts, nieces, and nephews as relatives within the third degree of consanguinity.

Summary of Public Comments and Staff Recommendation

CPRIT received one comment in response to this proposed rulemaking. Dr. Richard Luduena from University of Texas Health San Antonio requested that the definition of "relative" be "expanded to include sons-in law, daughters-in law, brothers-in-law, sisters-in-law, fathers-in-law, mothers-in-law, uncles, aunts, nephews, nieces and first cousins...A compromise might be to allow conflicts in this degree (uncles, aunts, in-laws, etc.), but to make certain that they are disclosed and perhaps the degree of the relationship described."

According to the statutory descriptions of consanguinity and affinity in Texas Government Code §§573.021 - 573.025, CPRIT's rule already includes some of the relationships identified by Dr. Luduena (sons-in law, daughters-in law, brothers-in-law, sisters-in-law, fathers-in-law, and mothers-in-law) within the first or second degree of consanguinity or affinity; therefore no change is necessary. However, CPRIT declines to make the requested change to include uncles, aunts, nephews, nieces, and cousins. The amendment as proposed is consistent with Texas Health & Safety Code Annotated §102.106, which establishes the second degree of consanguinity and affinity civil standard for determining prohibited conflicts of interest. Uncles, aunts, nieces, nephews, and cousins are related via third or fourth degrees of consanguinity and outside the statutory direction in Texas Health & Safety Code §102.106.

The Institute adopts the amendment under the authority of the Texas Health and Safety Code Annotated, §102.108 and §102.251, which provides the Institute with broad rule-making authority to administer the chapter, including rules for awarding grants.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 19, 2017.

TRD-201702007

Heidi McConnell

Chief Operating Officer

Cancer Prevention and Research Institute of Texas

Effective date: June 8, 2017

Proposal publication date: March 3, 2017

For further information, please call: (512) 305-8487


CHAPTER 703. GRANTS FOR CANCER PREVENTION AND RESEARCH

25 TAC §§703.5, 703.6, 703.11, 703.24

The Cancer Prevention and Research Institute of Texas ("CPRIT" or "the Institute") adopts the amendments §§703.5, 703.6, 703.11, and 703.24 without changes to the proposed text as published in the March 3, 2017, issue of the Texas Register (42 TexReg 1001). The proposed changes affect conflicts of interest prohibitions of Scientific Research and Prevention Program Committee Members, Product Development Review Council role in due diligence, the matching fund requirements of Academic Research and Product Development Research grantees, and disapproval of Financial Status Reports for untimely supporting documentation.

Reasoned Justification

The proposed amendment to §703.5(g) prohibits a Scientific Research and Prevention Programs Committee Member from providing professional services to a grant applicant that results in compensation of more than $5,000. The restriction would be in place for one year beginning from the due date of the Grant Application or the effective date of the Grant Award, whichever is later.

The proposed amendment to §703.6(c)(4)(B) reflects that the Product Development Review Council decides the applications moving forward in the review process for due diligence. The Review Council's bases their decision on the Grant Applications recommended by the Peer Review Panel(s).

The proposed amendment to §703.11(a) clarifies that the Institute may require a research grant recipient to demonstrate a matching funds obligation greater than one-half of the grant award amount. In the event that the Institute increases the matching funds obligation, the proposed language requires the Institute to include the obligation in the Request for Applications. Texas Health and Safety Code §102.0255 requires research grant recipients to dedicate an amount of matching funds equal to one-half of the grant award.

The proposed amendment to §703.24 allows the Institute to disapprove a Financial Status Report (FSR) if a Grant Recipient does not timely respond to a written request by the Institute for more information or backup documentation. If the Institute submits a request in writing for more information or backup documentation regarding an FSR, the Grant Recipient has 21 days to respond to the request. If there is no response by the Grant Recipient within that timeframe, the Institute will disapprove the FSR. The proposed amendment is not intended to restrict the Institute's ability to disapprove an FSR or to extend the Grant Recipient's FSR due date.

Summary of Public Comments and Staff Recommendation

CPRIT received no public comments regarding the proposed amendments.

The amendments are adopted under the authority of the Texas Health and Safety Code Annotated, §102.108 and §102.251, which provides the Institute with broad rule-making authority to administer the chapter, including rules for awarding grants.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 19, 2017.

TRD-201702008

Heidi McConnell

Chief Operating Officer

Cancer Prevention and Research Institute of Texas

Effective date: June 8, 2017

Proposal publication date: March 3, 2017

For further information, please call: (512) 305-8487