OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202602-0920-011 · OMB 0920-1391 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Att2c 60d FRN Comment Responses_v2.docx Public Comments Uploaded 2025-07-28 Repair queued
Att2b Public Comment from FDMS_2026.pdf Public Comments Uploaded 2025-07-28 Repair queued
Att2a Public Comment from FDMS_2026.csv Public Comments Uploaded 2025-07-28 Repair queued
Att5 STARS Determination 2025.pdf Supplementary Document Uploaded 2026-02-24 Available
Att4b ED3N DSA Approved Template 2026.pdf Supplementary Document Uploaded 2026-02-24 Available
Att4a Privacy Impact Assessment.pdf Supplementary Document Uploaded 2026-02-24 Available
Att2a 60D FRN 2026.pdf Supplementary Document Uploaded 2026-02-24 Available
Att1 AuthLegislation.docx Supplementary Document Uploaded 2026-02-24 Available
1 - SSB ED3N_2026_v2_final.docx Supporting Statement B Uploaded 2026-02-24 Available
1 - SSA ED3N_2026_v2_final.docx Supporting Statement A Uploaded 2026-02-24 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
257072 Ongoing Transfer of ED3N Data Elements Other-Specification of Data Elements for Electronic Transfer Modified
257071 Set-up of ED3N Data Elements Instruction Modified
ICR Details
0920-1391 202602-0920-011
Received in OIRA 202211-0920-010
HHS/CDC 0920-26-0106
[NCEH] Enhancing Data-driven Disease Detection in Newborns (ED3N)
Extension without change of a currently approved collection   No
Regular 03/09/2026
  Requested Previously Approved
36 Months From Approved 04/30/2026
19,363 19,363
1,042 1,042
0 0
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. This is an Extension of the previous submission.
US Code: 42 USC Chapter 6A 300b-8 to 300b-15 Name of Law: Newborn Screening Saves Lives Reauthorization Act
  
None
Not associated with rulemaking
  90 FR 33961 07/18/2025
91 FR 11313 03/09/2026
Yes
2
IC Title Form No. Form Name
Ongoing Transfer of ED3N Data Elements
Set-up of ED3N Data Elements
  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 19,363 19,363 0 0 0 0
Annual Time Burden (Hours) 1,042 1,042 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$1,000,000
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Kevin Joyce 404 639-1944 [email protected]
  No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
03/09/2026