This rule will be amended to update the list of conditions included in the “Newborn Screening Disorders” to add a new condition for which each live born infant will be screened.

 

DEPARTMENT OF HEALTH

Division of Children’s Medical Services

RULE NO.:RULE TITLE:

64C-7.002Collection Procedures for Newborn Screening

PURPOSE AND EFFECT: This rule will be amended to update the list of conditions included in the “Newborn Screening Disorders” to add a new condition for which each live born infant will be screened.

SUMMARY: Infants will be screened for an additional condition.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 383.14(2) FS.

LAW IMPLEMENTED: 383.14 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dusty Edwards, Program Director, Newborn Screening Follow-up Program, [phone] or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64C-7.002Collection Procedures for Newborn Screening.

(1) Each live born infant shall be screened for those core and secondary conditions listed in the “Newborn Screening Disorders,” list (5/1/18) (12/17/2013), unless the parent or guardian objects to the screening in accordance with Section 383.14(4), F.S. The “Newborn Screening Disorders,” (5/1/18) (12/17/2013) is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          05156.

(2) through (5) No change.

Rulemaking Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 10-25-79, Formerly 10D-76.03, Amended 12-5-84, Formerly 10J-8.03, Amended 3-29-92, 9-20-94, 3-28-96, Formerly 10J-8.003, Amended 4-1-08, 3-26-15, 8-20-17,            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dusty Edwards, Program Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 20, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 25, 2018