TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 1. MISCELLANEOUS PROVISIONS

SUBCHAPTER D. LOW-THC CANNABIS FOR COMPASSIONATE USE [DESIGNATING INCURABLE NEURODEGENERATIVE DISEASES]

25 TAC §1.65

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new §1.65, relating to Compassionate-use Research and Reporting.

BACKGROUND AND PURPOSE

This proposal is necessary to comply with House Bill (H.B.) 1535, 87th Legislature, Regular Session, 2021, which amended Texas Health and Safety Code, Chapter 487 by adding Subchapter F, Compassionate-use Research and Reporting. H.B. 1535 requires the Executive Commissioner of HHSC to adopt rules to implement Subchapter F. H.B. 1535 also states that a compassionate-use institutional review board (CIRB) may be established to evaluate, approve, and oversee research programs to study the medical use of low-THC cannabis and to submit written reports that describe and assess the research findings to HHSC and the Legislature. The Executive Commissioner charged the implementation of H.B. 1535 to DSHS.

SECTION-BY-SECTION SUMMARY

Proposed new §1.65(a) - (f) provides guidance for compassionate-use IRBs when reviewing and approving low-THC cannabis research program studies.

Proposed new §1.65(g) designates that each CIRB submit a written report to DSHS by October 1 of each year, and to the Texas Legislature by October 1 of even-numbered years.

FISCAL NOTE

Donna Sheppard, DSHS Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rule will be in effect:

(1) the proposed rule will not create or eliminate a government program;

(2) implementation of the proposed rule will not affect the number of DSHS employee positions;

(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;

(4) the proposed rule will not affect fees paid to DSHS;

(5) the proposed rule will create a new rule;

(6) the proposed rule will not expand, limit, or repeal existing rule;

(7) the proposed rule will not change the number of individuals subject to the rule; and

(8) the proposed rule will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The new rule does not impose any requirements or costs to small businesses, microbusinesses, or rural communities.

LOCAL EMPLOYMENT IMPACT

The proposed rule will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to this rule because the rule is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.

PUBLIC BENEFIT AND COSTS

Dr. Manda Hall, Associate Commissioner of DSHS Community Health Improvement Division, has determined that for each year of the first five years the rule is in effect, the public may benefit from research programs approved by compassionate-use IRBs to investigate low-THC cannabis in treating certain medical conditions.

Donna Sheppard has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule. The new rule is intended to provide guidelines for compassionate-use IRBs, which may be established to evaluate and approve proposed research studies for the investigation of low-THC cannabis in treating certain medical conditions.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4900 North Lamar Boulevard, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 21R129" in the subject line.

STATUTORY AUTHORITY

The new section is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; and Texas Health and Safety Code Chapter 487, Subchapter F, which requires the Executive Commissioner of HHSC to adopt a rule to implement H.B. 1535.

The new section affects Texas Health and Safety Code, Chapter 487.

§1.65.Compassionate-use Research and Reporting.

(a) A compassionate-use institutional review board (CIRB) will be established to evaluate and approve proposed research to study the medical use of low-THC cannabis, in accordance with Texas Health and Safety Code §487.253.

(b) When seeking approval from a CIRB, the principal investigator of a proposed research program must clearly identify the medical condition for which a patient will be treated with low-THC cannabis.

(c) A principal investigator shall only study the use of low-THC cannabis in treating the medical condition identified in the proposed research program application approved by a CIRB.

(d) The CIRB shall specify an end date to any study it approves. A study may terminate earlier than the date specified by the CIRB if the principal investigator chooses to end the study early. However, a CIRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the CIRB's requirements or that has been associated with unexpected serious harm to subjects.

(e) Approval of a research program by a CIRB is not transferable to another research program.

(f) A medical condition may be treated with low-THC cannabis as part of an approved research program if:

(1) treatment is overseen by a CIRB;

(2) it is administered by a physician in accordance with Texas Occupations Code §169.002 and certified by a CIRB to participate in the program;

(3) the patient is a resident of Texas; and

(4) the patient or, if the patient is a minor or lacks capacity to consent, a parent, guardian, or conservator signs a written informed consent form provided by the approved research program.

(g) Reports.

(1) Not later than October 1 of each year, each CIRB must submit a written report that describes and assesses the research findings of each approved research program to the Texas Department of State Health Services.

(2) Not later than October 1 of each even-numbered year, each CIRB must submit a written report that describes and assesses the research findings of each approved research program to the Legislature.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on August 9, 2021.

TRD-202103085

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 19, 2021

For further information, please call: (512) 776-3829