Part 1. DEPARTMENT OF STATE HEALTH SERVICES

Chapter 97. COMMUNICABLE DISEASES

Subchapter E. PROVISION OF ANTI-RABIES BIOLOGICALS

25 TAC §§97.121, 97.123 - 97.125

The Executive Commissioner of the Health and Human Services Commission (commission) on behalf of the Department of State Health Services (department) adopts amendments to §97.121 and §§97.123 - 97.125, concerning the provision of anti-rabies biologicals (vaccines and hyper-immune sera) by the department in accordance with recommendations of the Advisory Committee on Immunization Practices (ACIP). The amendments to §97.121 and §§97.123 - 97.125 are adopted without changes to the proposed text as published in the June 1, 2007, issue of the Texas Register (32 TexReg 2977) and, therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

Government Code, §2001.039, requires that each state agency review and consider for readoption every 4 years each rule adopted by that agency pursuant to the Government Code, Chapter 2001. Sections 97.121 and 97.123 - 97.125 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

The adopted amendments to §97.121 and §§97.123 - 97.125 update the agency, division, section, and branch names, plus, reorder text to simplify processes. In addition, the adopted amendments clarify the department's policies for storage, distribution, loss due to negligence, and reporting requirements of anti-rabies biologicals, plus, provide the ACIP as a reference for assessing rabies exposure and treatment recommendations.

The department consulted with the Health Service Regions, the Zoonosis Control Program, and the regional doctors of veterinarian medicine during the rule development process.

SECTION-BY-SECTION SUMMARY

Amendments to §97.121 and §§97.123-97.125 update the agency, division, section, and branch names and update language for consistent terminology. Amendments to §97.121 establish that the provision of anti-rabies biologicals be in accordance with recent recommendations of the ACIP. Amendments to §97.123 reorder the text, and clarify procedures for stocking, issuing, and returning anti-rabies biologicals. Amendments to §97.124 provide clarification of payment responsibilities, including the clarification that issuance of anti-rabies biologicals will not be withheld due to a patient's inability to pay. Amendments to §97.125 clarify that department-owned anti-rabies biologicals may be dispensed from depots at the price the department procures the vaccine under the current state contract, plus, explains the depot's responsibilities when vaccine is lost due to negligence.

COMMENTS

The department, on behalf of the commission, did not receive any comments regarding the proposed rules during the comment period.

LEGAL CERTIFICATION

The department's General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

STATUTORY AUTHORITY

The amendments are authorized by Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; and §81.004 which allows the department to adopt rules for the effective administration of the Communicable Disease Act; §826.025 which allows the department to adopt rules to provide, and obtain payment for anti-rabies biologicals; §826.011 which allows the department to adopt rules necessary to administer the Rabies Control Act; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 17, 2007.

TRD-200703667

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: September 6, 2007

Proposal publication date: June 1, 2007

For further information, please call: (512) 458-7111 x6972