191.333. Citation of law--screening for lysosomal storage diseases--rulemaking authority--fee increase authorized. - Missouri Statutes

Citation of law--screening for lysosomal storage diseases--rulemakingauthority--fee increase authorized.

191.333. 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 servicesshall expand the newborn screening requirements in section 191.331 toinclude the following lysosomal storage diseases: Krabbe disease, Pompedisease, Gaucher disease, Niemann-Pick disease, and Fabry disease. Thedepartment may by rule screen for additional lysosomal storage disorderswhen the following occurs:

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

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

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

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

3. The department may promulgate rules to implement the provisions ofthis section. Any rule or portion of a rule, as that term is defined insection 536.010, RSMo, that is created under the authority delegated inthis section shall become effective only if it complies with and is subjectto all of the provisions of chapter 536, RSMo, and, if applicable, section536.028, RSMo. This section and chapter 536, RSMo, are nonseverable and ifany of the powers vested with the general assembly pursuant to chapter 536,RSMo, to review, to delay the effective date, or to disapprove and annul arule are subsequently held unconstitutional, then the grant of rulemakingauthority and any rule proposed or adopted after August 28, 2009, shall beinvalid and void.

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

(L. 2009 H.B. 716)