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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Att2c 60d FRN Comment Responses_v2.docx	Public Comments	Uploaded 2025-07-28	Available
Att2b Public Comment from FDMS_2026.pdf	Public Comments	Uploaded 2025-07-28	Available
Att2a Public Comment from FDMS_2026.csv	Public Comments	Uploaded 2025-07-28	Available
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	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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

OMB Control No: 0920-1391	ICR Reference No: 202602-0920-011
Status: Received in OIRA	Previous ICR Reference No: 202211-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-26-0106
Title: [NCEH] Enhancing Data-driven Disease Detection in Newborns (ED3N)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/09/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2026
Responses	19,363	19,363
Time Burden (Hours)	1,042	1,042
Cost Burden (Dollars)	0	0

---

Abstract: 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.

---

Authorizing Statute(s): US Code: 42 USC Chapter 6A 300b-8 to 300b-15 Name of Law: Newborn Screening Saves Lives Reauthorization Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 33961	07/18/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 11313	03/09/2026
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Ongoing Transfer of ED3N Data Elements
Set-up of ED3N Data Elements

---

ICR Summary of Burden

table that charts list of burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $1,000,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/09/2026

---