[NCBDDD] Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)

ICR 202504-0920-004

OMB: 0920-0010

Federal Form Document

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Justification for No Material/Nonsubstantive Change
2025-04-03
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IC Document Collections
IC ID
Document
Title
Status
6608 Modified
6608 Modified
257626 Unchanged
257626 Unchanged
222820 Unchanged
222820 Unchanged
216968 Unchanged
216968 Unchanged
187391 Unchanged
187391 Unchanged
ICR Details
0920-0010 202504-0920-004
Active 202405-0920-002
HHS/CDC 0920-0010-25-0089
[NCBDDD] Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/09/2025
Retrieve Notice of Action (NOA) 05/01/2025
  Inventory as of this Action Requested Previously Approved
04/30/2026 04/30/2026 04/30/2026
6,507 0 6,507
3,825 0 3,825
0 0 0
The purpose of the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS) is to evaluate factors associated with the occurrence of birth defects and stillbirths and ultimately to work to prevent major birth defects and stillbirths associated with maternal risk factors. Data from BD-STEPS and the National Birth Defects Prevention Study (NBDPS) will play an important part in the decision-making process that determines federal research agendas, birth defect prevention activities, and the direction of funding programs such as cooperative agreements. This Non-Substantive Change Request is submitted to modify (BD-STEPS) Computer-Assisted Telephone Interview to align with issued EO [14168]. There is no change to the approved burden.
PL: Pub.L. 105 - 168 1 Name of Law: Birth Defects Prevention Act
   US Code: 42 USC 247b-4 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  87 FR 11442 03/01/2022
87 FR 70830 11/21/2022
Yes
5
IC Title Form No. Form Name
BD-STEPS_ Core CATI Questionnaire.v11 0920-0010, 0920-0010, 0920-0010, 0920-0010 Birth Defects Study to Pregnancy exposureS (BD-STEPS) _ Core CATI Questionnaire (English) ,   Birth Defects Study to Evaluate Pregnancy exposuresS (BD-STEPS) _ Core CATI Questionnaire (Spanish) ,   BD-STEPS Computer-Assisted Telephone Interview - English_REVISED 03APR2025 ,   BD-STEPS Computer-Assisted Telephone Interview - Spanish_REVISED 03APR2025
Consent for Bloodspot Retrieval n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a Bloodspot Consent (English) ,   Bloodspot Verbal Consent (English) ,   Bloodspot Consent for Multiples (English) ,   Bloodspot Verbal Consent for Multiples (English) ,   Bloodspot Consent (Spanish) ,   Bloodspot Verbal Consent (Spanish) ,   Bloodspot Consent for Multiples (Spanish) ,   Bloodspot Verbal Consent for Multiples (Spanish)
Occupational Questionnaires n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a Agriculture_Screenshots_English ,   Agriculture_Screenshots_Spanish ,   Cosmetology_Screenshots_English ,   Cosmetology_Screenshots_Spanish ,   Electronic Equipment Operators_Screenshots_English ,   Electronic Equipment Operators_Screenshots_Spanish ,   Healthcare_Screenshots_English ,   Healthcare_Screenshots_Spansih ,   Janitorial_Screenshots_English ,   Janitorial_Screenshots_Spanish ,   Office Worker_Screenshots_English ,   Office Worker_Screenshots_Spanish ,   Restaurant Worker_Screenshots_English ,   Restaurant Worker_Screenshots_Spanish ,   Teaching_Screenshots_English ,   Teaching_Screenshots_Spanish
Stillbirth COVID-19 Sub-Study n/a, n/a, n/a, n/a Stillbirth COVID-19 Sub-Study Form (Interviewed) ,   Stillbirth COVID-19 Sub-Study Form (Non-Interviewed) ,   Stillbirth COVID-19 Sub-Study Form (Interviewed) Spanish ,   Stillbirth COVID-19 Sub-Study Form (Non-Interviewed) Spanish
Supplemental CATI about Stillbirth n/a, n/a Computer Assisted Phone Interview about Stillbirth (English) ,   Computer Assisted Phone Interview about Stillbirth (Spanish)
  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 6,507 6,507 0 0 0 0
Annual Time Burden (Hours) 3,825 3,825 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$3,825,876
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
No
Jeffrey Zirger 404 639-7118 [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.
05/01/2025
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