DAR File No. 38537

Health, Center for Health Data, Vital Records and Statistics

Rule R436-55

Hemp Extract Registration

Notice of Proposed Rule

(New Rule)

DAR File No.: 38537
Filed: 05/15/2014 04:38:32 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule establishes the general procedures and requirements that an individual must follow to obtain and maintain a hemp extract registration card.

Summary of the rule or change:

This is a new rule to meet the legislative mandates specified in H.B. 105 from the 2014 General Legislative Session.

State statutory or constitutional authorization for this rule:

• Title 26, Chapter 55

Anticipated cost or savings to:

the state budget:

Net impact of zero--Statute requires that Office of Vital Records and Statistics charge a fee sufficient to cover all costs of administration. Fee revenue cannot exceed costs of implementation and operation.

local governments:

Local government has no role in registration or issuance of registry certificates. Local law enforcement will have access to a verification process UCJIS.

small businesses:

Private sector has no role in implementation under statute.

persons other than small businesses, businesses, or local governmental entities:

Individuals applying for the registry will be required to pay a $400 annual fee to cover the costs to the Department of implementing and operating the registry. Total costs to the Department for FY2015 are $40,000.

Compliance costs for affected persons:

Each applicant to the Hemp Extract Registry will pay a registration fee ($400) per application. There are about 100 individuals/families who may apply for the registration card.

Comments by the department head on the fiscal impact the rule may have on businesses:

May create a small increase in business for certifying labs.

David Patton, PhD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Center for Health Data, Vital Records and Statistics
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Janice Houston at the above address, by phone at 801-538-6262, by FAX at 801-538-7012, or by Internet E-mail at jlhouston@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

07/01/2014

This rule may become effective on:

07/08/2014

Authorized by:

Janice Houston, Director

R436. Health, Center for Health Data, Vital Records and Statistics.

R436-55. Hemp Extract Registration.

R436-55-1. Legal Authority.

This rule is promulgated under authority granted in Utah Code Title 26, Chapter 55.

 

R436-55-2. Purpose.

This rule establishes the general procedures and requirements that an individual must follow to obtain and maintain a hemp extract registration card.

 

R436-55-3. Definitions.

For purposes of this rule, the definitions in Section 26-55-102 apply, in addition:

(1) "Applicant" means any individual applying for a hemp extract registration card.

(2) "Evaluation record" means the neurologist's clinical evaluation and observation records as described in Subsection 26-55-103(7).

(3) "Higher education institute" as defined in 20 U.S.C. Sec. 1001.

(4) "Institutional Review Board" or "IRB" means a multi-disciplinary committee which reviews proposed research involving human subjects.

(5) "Qualifying patient" means an individual who has been diagnosed by a neurologist as having intractable epilepsy.

(6) "Written certification" means a non-prescription statement signed by a neurologist that indicates the qualifying patient suffers from intractable epilepsy and may benefit from the use of hemp extract. The statement may be on a form prescribed by the department or in another format.

 

R436-55-4. Application for a Hemp Extract Registration Card.

(1) For an applicant who is a qualifying patient and is at least 18 years of age, the applicant shall submit the following to the department:

(a) an application on a form prescribed by the department that includes:

(i) the applicant's name, date of birth, and address; and

(ii) the name, address, and telephone number of the neurologist providing the written certification;

(b) a copy of the applicant's photographic identification;

(c) proof of Utah residency;

(d) a written certification; and

(e) the applicable fee.

(2) To apply for a hemp extract registration card for a qualifying patient who is under 18 years of age, the qualifying patient's parent shall submit the following to the department:

(a) an application on a form prescribed by the department that includes:

(i) the qualifying patient's name, date of birth, and address;

(ii) the parent's name and address;

(iii) the name, address, and telephone number of the neurologist providing the written certification;

(b) a copy of the parent's photographic identification;

(c) proof of the parent's Utah residency;

(d) an attestation that the parent is responsible for health care decisions for the qualifying patient;

(e) a written certification; and

(f) the applicable fee.

 

R436-55-5. Submission of an Evaluation Record.

(1) The neurologist shall transmit the evaluation record to the department by first class mail or through secure electronic transmission within five business days after signing a written certification or upon request by the department.

(2) The evaluation record must include at least the following:

(a) the qualifying patient's name and date of birth;

(b) date of clinic office visit;

(c) the neurologist's name, Department of Professional Licensing number and expiration date;

(d) diagnosis of epilepsy; and

(e) if evaluation record is submitted for the initial registration, an indication that qualifying patient currently suffers from intractable epilepsy; or

(f) if evaluation record is submitted after registration of a hemp extract registration card:

(i) the hemp extract's effect on seizure control; and

(ii) any adverse effects or other effects that may be attributed to use of the hemp extract.

(3) In addition to the requirements listed in subsection (2), the department recommends the evaluation record include, which may be based on self-reporting to the neurologist by the qualified patient, the following:

(a) hemp extract information, such as the supplier, product description, dosage, frequency of use, and duration of use by the qualifying patient;

(b) frequency of seizures before and after use of hemp extract;

(c) evidence supporting the diagnosis of intractable epilepsy; and

(d) information about other treatments or medications, including dosage, frequency and dates of use, used to treat or control qualifying patient's epilepsy.

(4) For an evaluation record, a neurologist may either complete the evaluation record on a form prescribed by the department or may provide it in another format.

 

R436-55-6. Issuance, Expiration, and Renewal of Hemp Extraction Registration Card.

(1) If an application is approved, the department shall issue a hemp extract registration card to the applicant. The hemp extract registration card must include the following:

(a) the registrant's name, date of birth, and address;

(b) the qualifying patient's name, date of birth, and address, if the qualifying patient is under 18 years of age;

(c) an issuance date and expiration date;

(d) the neurologist's name, Department of Professional Licensing number and expiration date; and

(e) a department-issued registry identification number.

(2) A hemp extract registration card issued to a registrant is valid for one year after the issuance date unless revoked or surrendered.

(3) To maintain a valid hemp extract registration card, a registrant shall submit at least fifteen business days prior to the expiration date on the hemp extract registration card the following to the department:

(a) a renewal application on a form prescribed by the department;

(b) a new written certification; and

(c) the renewal fee.

 

R436-55-7. Application Denial; Revocation of Hemp Extract Registration Card.

(1) The Department shall deny an application for a hemp extract registration card that:

(a) contains false information, including a false name, address, written certification, date of birth, or photo identification; or

(b) fails to provide an evaluation record or any of the information required by Section R436-55-4.

(2) The Department shall return the denied application to the applicant, accompanied by an explanation of the reason for its return.

(3) The Department shall revoke a hemp extract registration card upon finding that a registrant or neurologist submitted false information to the department.

 

R436-55-8. Interim Changes.

(1) When there has been a change in the qualifying patient's name, address, or neurologist, the registrant must notify the department within ten business days by submitting a form as prescribed by the department.

(2) A registrant shall report to the department upon discovery that the registrant's hemp extract registration card is lost, stolen, or damaged. The registrant may request a replacement card.

(3) If the department issues a new hemp extract registration card to a registrant based on a request for a replacement card or an application to update information on the hemp extract registration card, the replacement card shall have the same expiration date as the hemp extract registration card being replaced or updated.

 

R436-55-9. Verification of Registry to Law Enforcement.

The department may verify to a law enforcement agency whether an individual is a lawful possessor of a hemp extract registration card, without disclosing more information than is reasonably necessary to verify the authenticity of the hemp extract registration card.

 

R436-55-10. Review and Approval of Research Requests.

(1) If the researcher requests statistical information, the department shall provide the higher education institution with the requested statistical information upon receipt of the written request and payment of the associated costs.

(2) If the research involves the use of identifiable health data, the request must be in writing and must be signed by the researcher of the higher education institution. In addition:

(a) The request must outline the research protocol to be used. Approval by an Institutional Review Board must be included with the request.

(b) If the research involves a follow-back or follow-up study, the request must describe who is to be contacted, how, by whom, and what questions will be asked. If a survey is planned, a copy of the survey must be submitted.

(c) If the research involves linking data files, the variables to be used to determine the match must be identified.

(d) The researcher and all persons who may have access to the identifying health data in the evaluation records shall sign a confidentiality agreement, which is available from the department.

(e) The researcher may not use or allow other persons to use the evaluation records for any purpose other than the approved research.

(f) The department shall review each research request and notify the requestor one of the following:

(i) The request is approved and the researcher is notified in writing of the approval and of the associated costs.

(ii) The request is given tentative approval and the researcher:

(A) is notified in writing of the approval and associated costs; and

(B) discusses and resolves concerns identified by the department.

(iii) The request is not approved and the researcher is:

(A) notified in writing the reasons for the disapproval;

(B) notified of the areas of concern with the request;

(C) allowed to address the areas of concern and resubmit the request; and

(D) notified that the decision to deny may be appealed to the Executive Director of the Department of Health.

 

KEY: hemp extract registration

Date of Enactment or Last Substantive Amendment:  2014

Authorizing, and Implemented or Interpreted Law:  26-55