Vol. 35 Iss. 20 - May 27, 2019

Chapter 71
Notice of Intended Regulatory Action

Notice is hereby given in accordance with § 2.2-4007.01 of the Code of Virginia that the State Board of Health intends to consider amending 12VAC5-71, Regulations Governing Virginia Newborn Screening Services. The purpose of the proposed action is to amend the existing newborn screening regulation to add spinal muscular atrophy (SMA) and X-linked adrenoleukodystrophy (X-ALD) to the newborn screening panel. SMA is a genetic disorder that is estimated to occur in approximately 9.1 out of every 100,000 live births. X-ALD is a genetic disorder that is estimated to occur in approximately six out of every 100,000 live births. Treatment for both X-ALD and SMA is available if detected early. Screening is necessary as these disorders cannot be detected at birth through physical examinations. The addition of SMA and X-ALD to the newborn screening panel has been recommended by the Virginia Genetics Advisory Committee. On the national level, these disorders have been added to the core panel of 35 genetic disorders included in the Recommended Uniform Screening Panel of the U.S. Secretary of Health and Human Services Advisory Committee on Heritable Disorders in Newborns and Children.

The agency does not intend to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: §§ 32.1-12 and 32.1-67 of the Code of Virginia.

Public Comment Deadline: June 27, 2019.

Agency Contact: Joseph Hilbert, Deputy Commissioner, Governmental and Regulatory Affairs, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7001, FAX (804) 864-7022, or email

VA.R. Doc. No. R19-5996; Filed May 2, 2019, 4:49 p.m.