The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes the repeal of Title 25, Part 1, Chapter 414, Subchapter P, consisting of §414.751, concerning Purpose; §414.752, concerning Application; §414.753, concerning Definitions; §414.754, concerning General Principles; §414.755, concerning Designated Institutional Review Board (IRB); §414.756, concerning IRB Functions and Operations; §414.757, concerning Review and Approval of Proposed Research; §414.758, concerning Informed Consent; §414.759, concerning Research Involving Offenders as Human Subjects; §414.760, concerning Using and Disclosing Protected Health Information (PHI) in Research; §414.761, concerning Investigation of Allegations of Misconduct in Science; §414.762, concerning Responsibilities of the Office of Research Administration (ORA); §414.763, concerning Exhibits; §414.764, concerning References; and §414.765, concerning Distribution.

BACKGROUND AND PURPOSE

The purpose of the proposal is to reflect the transition of programs from the Department of State Health Services to HHSC by repealing rules in Texas Administrative Code (TAC) Title 25, Part 1, Chapter 414, Subchapter P and simultaneously proposing new rules in 26 TAC Chapter 925. The new rules are published elsewhere in this issue of the Texas Register. The new rules reflect the transition of programs to HHSC; and update research protocols to align with applicable federal laws.

SECTION-BY-SECTION SUMMARY

The proposed repeal of 25 TAC Chapter 414, Subchapter P, deletes the rules as no longer necessary because the content of the rules are being proposed in new 26 TAC Chapter 925.

FISCAL NOTE

Trey Wood, Chief Financial Officer, has determined that for each year of the first five years that the repeals will be in effect, enforcing or administering the repeals do not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the rules are repealed:

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

(2) implementation of the repeals will not affect the number of HHSC employee positions;

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

(4) the proposed repeals will not affect fees paid to HHSC;

(5) the proposed repeals will not create a new rule;

(6) the proposed repeals will repeal existing rules;

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

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

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

Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because there is no requirement to change current business practices.

LOCAL EMPLOYMENT IMPACT

The proposed repeals will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these repeals because the repeals do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Kristy Almager, Associate Commissioner of State Hospitals, has determined that for each year of the first five years the repeals are in effect, the public will benefit from elimination of rules that refer to an agency that no longer exists.

Trey Wood has also determined that for the first five years the repeals are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed repeals because there are no requirements to alter current business practices and there are no new fees or costs imposed.

TAKINGS IMPACT ASSESSMENT

HHSC 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 HHSC, Health and Specialty Care System, Mail Code 619E, P.O. Box 13247, Austin, Texas 78711-3247, or by email to healthandspecialtycare@hhsc.state.tx.us.

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 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 20R104" in the subject line.

STATUTORY AUTHORITY

The repeals are 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 §574.154, regarding participation in research.

The repeals affect Texas Government Code §531.0055 and Texas Health and Safety Code §574.154, regarding participation in research.