ADMINISTRATIVE CODE

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TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER j: MATERNAL AND CHILD HEALTH
PART 661 NEWBORN AND INFANT SCREENING AND TREATMENT CODE
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SUBPART A: GENERAL PROVISIONS

Section 661.10 Definitions
Section 661.20 Incorporated and Referenced Materials
Section 661.30 General Procedures for the Newborn Screening
Section 661.40 Genetic and Metabolic Diseases Advisory Board
Section 661.50 Exemption
Section 661.60 Fee Assessment and Payment

SUBPART B: NEWBORN AND INFANT SCREENING REGISTRIES

Section 661.100 Newborn Screening Registries
Section 661.110 Early Hearing Detection and Intervention (EHDI) Registry
Section 661.120 Confidentiality and Access to Data in Newborn Screening Registries
Section 661.130 Data Submission
Section 661.140 Provider Sites
Section 661.150 Individual User Agreement

SUBPART C: NEWBORN BLOOD SPOT SCREENINGS

Section 661.200 Collection and Submission of Specimens
Section 661.210 Blood Spot Reporting
Section 661.220 Retention of Specimens
Section 661.230 Designation of Medical Specialists

SUBPART D: DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS

Section 661.300 Adrenoleukodystrophy (ALD)
Section 661.310 Biotinidase Deficiency
Section 661.320 Congenital Adrenal Hyperplasia (CAH) (Secondary to 21-hydroxylase deficiency)
Section 661.330 Congenital Hypothyroidism (CH)
Section 661.340 Cystic Fibrosis (CF)
Section 661.350 Galactosemia
Section 661.360 Lysosomal Storage Disorders (LSDs)
Section 661.370 Amino Acid, Organic Acid and Fatty Acid Oxidation Disorders
Section 661.380 Severe Combined Immunodeficiency (SCID) and T-Cell Lymphopenia
Section 661.390 Sickle Cell Disease/Trait and Other Hemoglobinopathies
Section 661.400 Spinal Muscular Atrophy (SMA)

SUBPART E: DETAILED PROCEDURES FOR NEWBORN NON-METABOLIC CONDITIONS

Section 661.500 Critical Congenital Heart Disease (CCHD)

SUBPART F: EARLY HEARING DETECTION AND INTERVENTION (EHDI)

Section 661.599 Newborn Hearing Screening Program Goals
Section 661.600 Newborn Hearing Screening
Section 661.610 Responsibilities of Medical Care Facilities
Section 661.620 Responsibilities of Service Providers
Section 661.630 Access to Diagnostic Testing
AUTHORITY: Implementing and authorized by the Newborn Metabolic Screening Act [410 ILCS 240], the Genetic and Metabolic Diseases Advisory Committee Act [410 ILCS 265], the Early Hearing Detection and Intervention Act [410 ILCS 213], and the Illinois Health Statistics Act [410 ILCS 520].
SOURCE: Adopted December 14, 1973; emergency rules at 3 Ill. Reg. 28, p. 224, effective June 28, 1979, for a maximum of 150 days; rules repealed and new rules adopted at 3 Ill. Reg. 48, p. 42, effective November 20, 1979; amended at 5 Ill. Reg. 4593, effective April 15, 1981; amended and codified at 8 Ill. Reg. 19041, effective September 26, 1984; amended at 11 Ill. Reg. 12921, effective August 1, 1987; amended at 13 Ill. Reg. 15079, effective October 1, 1989; amended at 14 Ill. Reg. 13292, effective August 15, 1990; amended at 17 Ill. Reg. 13609, effective August 1, 1993; amended at 19 Ill. Reg. 15720, effective November 1, 1995; expedited correction at 20 Ill. Reg. 3590, effective November 1, 1995; amended at 22 Ill. Reg. 20639, effective November 10, 1998; amended at 26 Ill. Reg. 10676, effective July 1, 2002; amended at 26 Ill. Reg. 18412, effective January 1, 2003; amended at 31 Ill. Reg. 13203, effective August 28, 2007; amended at 34 Ill. Reg. 940, effective December 31, 2009; amended at 36 Ill. Reg. 1753, effective January 19, 2012; amended at 37 Ill. Reg. 13452, effective July 31, 2013; amended at 38 Ill. Reg. 12509, effective June 2, 2014; former Part repealed at 47 Ill. Reg. 3774 and new Part adopted at 47 Ill. Reg. 3776, effective March 2, 2023; Sections 661.599 and 661.630 recodified from Sections 662.10 and 662.50 of 77 Ill. Adm. Code 662 at 47 Ill. Reg. 12808; amended at 48 Ill. Reg. 5175, effective March 12, 2024; amended at 49 Ill. Reg. 4706, effective March 25, 2025; Subchapter i recodified at 49 Ill. Reg. 8275; amended at 49 Ill. Reg. 13014, effective October 6, 2025.