APHL collaborates with state newborn screening programs and legal counsels to monitor legal and legislative issues affecting state newborn screening programs. It conducts these activities through the Legal and Legislative Issues in Newborn Screening Workgroup. APHL also disseminates related policy resources.
Common Rule: Final Rule Issued
On January 18, the Department of Health and Human Services (HHS) and 15 other agencies issued the final rule on the body of regulations that protect human subjects involved in research, commonly known as the "Common Rule". The changes to the Newborn Screening Saves Lives Reauthorization Act with respect to informed consent and the use of dried blood spots will no longer apply after the effective date of January 19, 2018.
Newborn Screening Saves Lives Reauthorization Act, 2014
The informed consent provisions included in the
Newborn Screening Saves Lives Reauthorization Act (NBSSLRA) went into effect on March 16, 2015. The law includes two significant changes to the human subjects regulations as they apply to research with newborn dried blood spots. First, the law requires that all research funded pursuant to the Public Health Service Act using newborn dried spots be considered human subjects research regardless of whether the specimens are identifiable. Second, the law eliminates the ability of the Institutional Review Board to approve alterations or waivers of informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots. The informed consent provisions of the NBSSLRA will remain in effect until January 19, 2018.
Legal and Legislative News
- Missouri NBS panel expanded to include SMA and MPS II testing by January 2019.
- FL SB1124 was signed into law, which requires the Department of Health to expand newborn screening for conditions added to the RUSP upon recommendation by the Genetics and Newborn Screening Advisory Council within a specified period of time.
- MA HB1167 would require newborn screening for Krabbe.
- MA HB3714 introduced, which would establish a rare disease advisory council.
- GA HB 241, also known as Cove's Law, was signed into law, and allows the Georgia Department of Health to offer optional Krabbe newborn screening.
- SCID added to the Arizona NBS panel. View the press release for more information
State NBS Legislation
This section contains compiled state NBS legislation. If you would like to add information from your state, please contact Laura Russell.
State NBS Advisory Committee Statutes and Regulations (Click to Expand)
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exist establishing a
state Advisory Committee?
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making authority by the
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The state established an advisory board without a mandate, which consists of three committees: 1) The NBS Workgroup, 2) The NBS QI Workgroup, 3) The AR Genetic Health Committee
Missouri Code §191.305.1 establishes and outlines the “Missouri Genetic Advisory Committee” that advises the Department of Health, and its required members.
Iowa Code § 641-4.1 outlines the role of the Advisory Committee that advises the Director of the Department of Public Health
Florida Code §383.14(2) outlines the role of the Florida Advisory Committee that advises the Department of Health and required members.
Michigan Code §191.305.1 establishes and outlines the Quality Assurance Advisory Committee, whose recommendations are approved or rejected by legislature.
Kansas code §65-180 appoints an advisory council to advise the Department of Health and Environment
Ohio Code §3701.501 B establishes the newborn screening advisory council to the Director of Health and required members.
Minnesota Code §144.1255
establishes the advisory committee to the Commissioner of Health, required members and function and objectives.
Minnesota code 144.125 states that conditions are added to the state NBS panel if recommendations by the advisory committee are approved by the commissioner.
M.G.L. c. 111, §110A states that the commissioner may convene an advisory committee in determining which newborn screening tests are necessary.
Tennesee Code § 68-5-503 establishes an advisory committee to consult with the Department of Health and outlines required members appointed by the commissioner.
An ad hoc committee is formed as needed.
The New Jersery Advisory Committee was establised by an executive order issued by the New Jersey Department of Health Commissioner.
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