OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202211-0920-010 · OMB 0920-1391 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Att5 STARS Determination.pdf Supplementary Document Uploaded 2022-11-23 Missing upstream
Att4b ED3N DSA Approved Template.pdf Supplementary Document Uploaded 2022-11-23 Repair queued
Att4a PrivacyImpact Assessment.pdf Supplementary Document Uploaded 2022-11-23 Repair queued
Att2b Public Comment from FDMS-1.pdf Supplementary Document Uploaded 2022-11-23 Repair queued
Att2a 60D FRN ED3N.pdf Supplementary Document Uploaded 2022-11-23 Repair queued
Att1 AuthLegislation.docx Supplementary Document Uploaded 2022-11-23 Missing upstream
1 - SSB ED3N.docx Supporting Statement B Uploaded 2022-11-23 Repair queued
1 - SSA ED3N_11-22-2022.docx Supporting Statement A Uploaded 2022-11-23 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
257072 Ongoing Transfer of ED3N Data Elements Other-Specification of Data Elements for Electronic Transfer New
257071 Set-up of ED3N Data Elements Instruction New
ICR Details
0920-1391 202211-0920-010
Active
HHS/CDC 0920-22BC
[NCEH] Enhancing Data-driven Disease Detection in Newborns (ED3N)
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/10/2023
Retrieve Notice of Action (NOA) 11/29/2022
  Inventory as of this Action Requested Previously Approved
04/30/2026 36 Months From Approved
19,363 0 0
1,042 0 0
0 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.
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
  86 FR 69055 12/05/2021
87 FR 73311 11/29/2022
Yes
2
IC Title Form No. Form Name
Ongoing Transfer of ED3N Data Elements
Set-up of ED3N Data Elements
  Total Approved 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 0 0 19,363 0 0
Annual Time Burden (Hours) 1,042 0 0 1,042 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request.
$1,000,000
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Renita Macaluso 770 488-6458 [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.
11/29/2022