TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 97. COMMUNICABLE DISEASES

SUBCHAPTER G. VACCINATION STAMPS

25 TAC §§97.151 - 97.156

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (DSHS), proposes amendments to §97.151, concerning Purpose and Scope; §97.152, concerning Definitions; §97.153, concerning Criteria for Issuing Uniform Stamps to Physicians; §97.154, concerning Criteria for Operating as a Vaccination Center; §97.155, concerning Format of the Uniform Stamp; and §97.156, concerning Denial, Suspension, or Revocation of a Uniform Stamp.

BACKGROUND AND PURPOSE

The purpose of the amendments is to update the protocols for providers who administer yellow fever vaccine and issue vaccination certificates for persons who travel to countries outside the United States, and to clarify the rules. Sections 97.151 - 97.156 have been reviewed and DSHS has determined that reasons for adopting the sections continue to exist because rules on this subject are required by federal law and provide guidance for the ongoing vaccination stamp program (program).

SECTION-BY-SECTION SUMMARY

The proposed amendment to §97.151 changes the conjunction "which" to "that" to comply with rules of grammar.

Proposed amendments in §§97.152, 97.153, 97.154, and 97.156, replace the word "branch" with "unit" to reflect changes to the organizational structure under the Infectious Disease Prevention Section. Proposed amendments to §97.153 and §97.154 capitalize the words "Vaccination Center." Proposed amendments to §§97.153, 97.154, and 97.156 clarify which form is needed for application by naming the "Uniform Stamp Application Form" in lieu of "application," "application form," or "Application forms." Additionally, throughout §§97.151 - 97.156, "Uniform Stamp" was capitalized the first time the stamp was referenced, and thereafter "stamp" was used if the term reoccurred in the same sentence.

The proposed amendments to §97.152 clarify and enhance the meanings of terms relevant to the program. The proposed amendment to §97.152(3) clarifies access to the program by amending the definition of physician to include both medical doctors and doctors of osteopathic medicine licensed to practice medicine in the State of Texas.

The proposed amendments to §97.153 clarify criteria for issuing Uniform Stamps to physicians. The proposed amendments to §97.153(1) clarify the administrative process by adding language specifying the exact title of the form needed to apply for the program and provide the recently updated website address needed to obtain the form. The proposed amendment to §97.153(2) was added to clarify procedures for physicians who move locations within the same county or to another county. Physicians who move their practice to another county must submit a Uniform Stamp Replacement Form and a stamp replacement fee because of the additional administrative requirements for establishing a provider in a new county. As a result of adding §97.153(2), all subsequent subsections are renumbered progressively. The proposed amendment to §97.153(3) clarifies that approval of the application is only for the specific Vaccination Center listed on the form. The proposed amendment to §97.153(6) clarifies that vaccine adverse event reporting is not limited to cases of febrile illness in order to align with federal reporting guidelines for the CDC/FDA Vaccine Adverse Events Reporting System (VAERS). The proposed amendments to §97.153(7)(B) replace the word "or" with "of" to clarify the federal Division's name. The proposed amendments to §97.153(7)(C) substitute the Immunization Unit's P.O. Box in place of the physical address to ensure that correspondence through the postal system is delivered to the correct mailing address. The proposed amendment also adds the Immunization Unit's main phone number to provide greater access to information for providers. The proposed amendment to §97.153(8) replaces "charges" with "fees" to be consistent with the terminology in the subsequent subparagraphs (A), (B), (C), and (D). The proposed amendment to §97.153(8)(B) clarifies which form is needed for renewal by naming the "Uniform Stamp Renewal Form" in lieu of "agency's Annual Renewal Form" or "renewal." The proposed amendment to §97.153(8)(C) provides the name of the form to be submitted ("Uniform Stamp Replacement Form") for the stamp replacement process, and specifies that the stamp replacement requirements-including the fee-also apply to physicians who move their practices to another county. The proposed amendment to §97.153(D) adds the heading "Waived Fees" for consistency in the rule. Also, the amendment replaces "public health regions" with "health service regions" to reflect current DSHS terminology.

The proposed amendments to §97.154(3) remove the heading "Annual report" for consistency in the rule. Also, the amendments insert specific titles for the application and renewal forms to reduce confusion regarding form requirements, and the updated website address is provided in this paragraph in order to improve accessibility. The amendments to §97.154(3)(A) also clarify that the renewal form must be received by the Immunization Unit by a specific deadline stated on the Uniform Stamp Renewal Form in order to improve administration of the program.

The proposed amendment to §97.155 clarifies the source of the federal guidelines for the format of the Uniform Stamp as listed in the Division of Quarantine Circular No. 106.

The proposed amendment to §97.156 inserts the specific title "Uniform Stamp" instead of "stamp" to be consistent with the other sections of Subchapter G, Vaccination Stamps. Also, language was changed in §97.156 from "these sections" to "this subchapter (relating to Vaccination Stamps)" to clarify the reference.

FISCAL NOTE

Imelda Garcia, Director, Infectious Disease Prevention Section, has determined that for each year of the first five-year period that the sections will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Ms. Garcia has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. Small businesses and micro-businesses will not be required to alter their business practices in order to comply with the sections. The sections do not apply to rural communities.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

Ms. Garcia has determined that there is an anticipated economic cost to persons who are required to comply with the sections as proposed. For physicians who hold Uniform Stamps and who move their practice outside of the county where the physician initially applied for the Uniform Stamp, the physician would be required to submit a Uniform Stamp Replacement Form with a $50 fee.

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Ms. Garcia has determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. Healthcare providers who administer yellow fever vaccine and issue vaccination certificates would benefit from clearer and more efficient processes to apply for, maintain, and renew yellow fever vaccination stamps. The public benefit anticipated as a result of enforcing or administering the sections is that persons traveling to certain countries with a risk of yellow fever transmission will obtain a valid yellow fever vaccination certificate for international travel when they are vaccinated at a designated Vaccination Center. It is expected that vaccine adverse event reporting for yellow fever vaccine would be more comprehensive by clarifying federal reporting guidelines, and vaccine adverse event monitoring would help ensure the safety of vaccines.

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 Government Code, §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Lesley Brannan, Department of State Health Services, Infectious Disease Prevention Section, Immunization Unit, Mail Code 1946, P.O. Box 149347, Austin, Texas 78714-9347; by fax to (512) 776-7176; or by email to ImmRulesFeedback@dshs.texas.gov within 30 days of publication of this proposal in the Texas Register.

STATUTORY AUTHORITY

The amendments are informed by U.S. Public Health Services (PHS) requirements: Code of Federal Regulations, Title 42-Public Health, Part 71-Foreign Quarantine, §71.3, Designation of Yellow Fever Vaccination Centers; Validation Stamps; and PHS publications entitled, Division of Quarantine Circular No. 106; Advisory Memorandum No. 66; and Advisory Memorandum No. 72. The amendments are authorized by Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Health and Safety Code, Chapter 1001.

The amendments affect Government Code, Chapter 531, and Health and Safety Code, Chapter 1001.

§97.151.Purpose and Scope.

The U.S. Public Health Service has designated the Department of State Health Services as the governmental entity in the State of Texas that [which] is responsible for determining which physicians in the state are authorized to administer yellow fever vaccine for persons who travel outside the United States. The department provides this authorization by issuing Uniform Stamps to designated physicians. These sections cover the criteria by which the department issues the Uniform Stamp and the criteria for designating and operating a Vaccination Center.

§97.152.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:

(1) (No change.)

(2) Unit [Branch]--The Immunization Unit, Infectious Disease Prevention [Branch, Disease Prevention and Intervention] Section, Department of State Health Services.

(3) Physician--A physician (medical doctor or doctor of osteopathic medicine) licensed to practice medicine in the State of Texas.

(4) (No change.)

(5) Uniform Stamp--A stamp issued by the unit [branch] to a physician for use in validating certificates of yellow fever vaccination for persons who travel outside the United States.

§97.153.Criteria for Issuing Uniform Stamps to Physicians.

Uniform Stamps may be issued to physicians holding a current Texas medical license, for use only at the specific Vaccination Center [vaccination center] designated on the Uniform Stamp Application Form [application]. If a physician practices at more than one Vaccination Center [vaccination center], a separate Uniform Stamp Application Form and Uniform Stamp are required for each Vaccination Center [application for each is required].

(1) Physicians may apply for the Uniform Stamp by sending the Uniform Stamp Application Form [an application form] to the unit. The Uniform Stamp Application Form [branch. Application forms] may be obtained from the unit [branch ] or online at http://www.dshs.texas.gov/immunize/ [www.immunizetexas.org].

(2) Physicians who move the location of their practice within the same county must report a change of address in writing to the unit. Physicians who move their practice to another county must submit a Uniform Stamp Replacement Form and a Uniform Stamp replacement fee.

(3) [(2)] Physicians are authorized to use the Uniform Stamp solely for the purpose of validating administration of yellow fever vaccine on vaccination certificates issued only at the approved Vaccination Center [vaccination center] indicated on the Uniform Stamp Application Form [their application].

(4) [(3)] Physicians are authorized to use only the Uniform Stamp assigned to them. Uniform Stamps may not be assigned, loaned, or given to another person or physician except those working under supervision of the physician holding the stamp. The physician will at all times be responsible for the Uniform Stamp.

(5) [(4)] A physician shall report immediately to the unit [branch] any loss or theft of the Uniform Stamp.

(6) [(5)] Physicians are encouraged to report adverse events [cases of febrile illness] potentially caused by yellow fever vaccination to the CDC/FDA Vaccine Adverse Events Reporting System (VAERS http://www.vaers.hhs.gov/).

(7) [(6)] U.S. Public Health Services (PHS) requirements. The PHS requirements are found, as follows:

(A) Code of Federal Regulations, Title 42-Public Health, Part 71-Foreign Quarantine, §71.3, Designation of Yellow Fever Vaccination Centers; Validation Stamps; and

(B) PHS publications entitled, Division of [or] Quarantine Circular No. 106; Advisory Memorandum No. 66; and Advisory Memorandum No. 72.

(C) The department adopts the PHS requirements listed in subparagraphs (A) and (B) of this paragraph by reference. Copies of the requirements are available upon request from the Immunization Unit [Branch], Department of State Health Services, P.O. Box 149347 [1100 West 49th Street], Austin, Texas 78714-9347 or (800) 252-9152.

(8) [(7)] Fees [Charges ] for the Uniform Stamp.

(A) New Applicant Fee. Each new applicant is required to submit a fee of $68 by personal check, cashier's check, or money order along with the completed Uniform Stamp Application Form [application]. If the unit [branch] denies the Uniform Stamp Application Form [application], the unit [branch] will return the $68 to the physician.

(B) Annual Renewal Fee. In January of each year, each physician holding a Uniform Stamp is required to pay an annual fee of $38. The physician shall submit the $38 by personal check, cashier's check, or money order to the unit [branch] with the Uniform Stamp [agency's Annual] Renewal Form. If the unit [branch] denies the Uniform Stamp Renewal Form [renewal], the unit [branch] will return the $38 to the physician.

(C) Stamp Replacement Fee. A fee of $50 and submission of the Uniform Stamp Replacement Form will be required for issuing replacement Uniform Stamps in the event the original is lost or stolen, or if the physician moves their practice to another county.

(D) Waived Fees. All fees will be waived for public health departments, public health districts, and health service [public health] regions.

§97.154.Criteria for Operating as a Vaccination Center.

Designation as a Vaccination Center [vaccination center] is made upon completion and approval of a Uniform Stamp Application Form [an application].

(1) A physician shall use the Uniform Stamp only at the Vaccination Center [vaccination center] where the yellow fever vaccine is delivered and the vaccine may not be redistributed. The physician to whom the Uniform Stamp has been issued is not authorized to administer yellow fever vaccine on board ship or aircraft.

(2) (No change.)

(3) [Annual report.] Each physician holding a Uniform Stamp shall establish the need for continuing possession of the stamp [Uniform Stamp] by completing and returning the Uniform Stamp Renewal Form [an annual renewal form] along with the annual renewal fee. The Uniform Stamp Renewal Form [annual renewal form] is available from the unit [Branch] or online [on line] at http://www.dshs.texas.gov/immunize/ [www.immunizetexas.org].

(A) If the Uniform Stamp Renewal Form [annual renewal form] is not received by the unit by [Branch within] the deadline [timeframe] stated on the Uniform Stamp Renewal Form [form], designation as an authorized Vaccination Center [vaccination center] may be removed and the physician will be required to return the [their] Uniform Stamp.

(B) If the physician no longer wishes to retain the [their] Uniform Stamp, the stamp must be returned to the unit [Branch].

(4) (No change.)

§97.155.Format of the Uniform Stamp.

The format of the Uniform Stamps will be according to federal guidelines in the Division of Quarantine Circular No. 106, which is adopted by reference in §97.153 of this title (relating to Criteria for Issuing Uniform Stamps to Physicians).

§97.156.Denial, Suspension, or Revocation of a Uniform Stamp.

(a) The unit [branch] may deny a Uniform Stamp Application Form [an application] for a Uniform Stamp [stamp] or suspend or revoke an existing stamp or not renew a stamp if the applicant or holder fails to comply with the requirements of this subchapter (relating to Vaccination Stamps) [these sections]. The applicant or holder has the opportunity to request a hearing on any of these actions in accordance with department fair hearing rules, §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).

(b) The unit [branch] will not suspend or revoke a Uniform Stamp [stamp] without a prior hearing, except if the unit [branch] determines that immediate suspension or revocation is necessary because of imminent threat to public health.

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 September 18, 2017.

TRD-201703672

Barbara Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: November 5, 2017

For further information, please call: (512) 776-6972