Citation of law — screening for lysosomal storage diseases — rulemaking authority — fee increase authorized.

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Effective - 28 Aug 2009

191.333. Citation of law — screening for lysosomal storage diseases — rulemaking authority — fee increase authorized. — 1. This section shall be known and may be cited as the "Brady Alan Cunningham Newborn Screening Act".

2. By July 1, 2012, the department of health and senior services shall expand the newborn screening requirements in section 191.331 to include the following lysosomal storage diseases: Krabbe disease, Pompe disease, Gaucher disease, Niemann-Pick disease, and Fabry disease. The department may by rule screen for additional lysosomal storage disorders when the following occurs:

(1) The registration of the necessary reagents with the federal Food and Drug Administration;

(2) The availability of the necessary reagents from the Centers for Disease Control and Prevention;

(3) The availability of quality assurance testing methodology for such processes; and

(4) The acquisition and installment by the department of equipment necessary to implement the expanded screening tests.

3. The department may promulgate rules to implement the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2009, shall be invalid and void.

4. The department may increase the fee authorized in subsection 6 of section 191.331 to cover the additional cost of the expanded newborn screening test required in this section.

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(L. 2009 H.B. 716)


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