OMB control number

[NCEH] Enhancing Data-driven Disease Detection in Newborns (ED3N)

OMB 0920-1391 ยท HHS/CDC.

OMB 0920-1391

CDC's Newborn Screening and Molecular Biology Branch (NSMBB) is developing a National Newborn Screening Data Platform (known as ED3N) that will address analytic and post-analytic challenges and promote sharing of molecular, biochemical, and clinical information amongst state-based newborn screening (NBS) partners. The information shared will help NSMBB and newborn screening partners be better equipped to assess disease risk and will help harmonize approaches for disease detection in newborns. Given the rarity of newborn screening diseases, it is imperative that data be collected and analyzed at a national level in order to glean useful insights and trend analyses. The NSMBB is best-suited to oversee this work given its role in providing technical assistance to NBS programs nationally.

The latest form for [NCEH] Enhancing Data-driven Disease Detection in Newborns (ED3N) expires 2026-07-31 and is listed under ICR 202211-0920-010.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Att2c 60d FRN Comment Responses_v2.docxPublic Comments
Att2b Public Comment from FDMS_2026.pdfPublic Comments
Att2a Public Comment from FDMS_2026.csvPublic Comments
Att5 STARS Determination 2025.pdf (document unavailable)Supplementary Document
Att4b ED3N DSA Approved Template 2026.pdfSupplementary Document
Att4a Privacy Impact Assessment.pdfSupplementary Document
Att2a 60D FRN 2026.pdfSupplementary Document
Att1 AuthLegislation.docxSupplementary Document
1 - SSB ED3N_2026_v2_final.docxSupporting Statement B
1 - SSA ED3N_2026_v2_final.docxSupporting Statement A
Ongoing Transfer of ED3N Data Elements Other-Specification of Data Elements for Electronic Transfer
Set-up of ED3N Data Elements Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202602-0920-011 Extension without change of a currently approved collection 2026-03-09
202211-0920-010 New collection (Request for a new OMB Control Number) 2022-11-29 Approved without change

OMB Details

Set-up of ED3N Data Elements

Federal Enterprise Architecture: Health - Public Health Monitoring