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

ICR 202101-0920-008

OMB: 0920-0010

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
 Modified
Form and Instruction
 Modified
Form and Instruction
 Unchanged
Form and Instruction
 Unchanged
Form and Instruction
 Unchanged
Supplementary Document
2021-01-21
Justification for No Material/Nonsubstantive Change
2021-01-21
Justification for No Material/Nonsubstantive Change
2020-03-26
Supplementary Document
2021-01-21
Supplementary Document
2021-01-21
Supplementary Document
2021-01-21
Supplementary Document
2021-01-21
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supplementary Document
2019-08-26
Supporting Statement B
2019-08-26
Supporting Statement A
2019-08-26
IC Document Collections
IC ID
Document
Title
Status
6608 Modified
222820 Modified
216974 Unchanged
216968 Unchanged
187391 Unchanged
ICR Details
0920-0010 202101-0920-008
Received in OIRA 202003-0920-021
HHS/CDC 0920-0010-21CJ
Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
No material or nonsubstantive change to a currently approved collection   No
Regular 01/21/2021
  Requested Previously Approved
02/28/2023 02/28/2023
8,940 8,940
4,433 4,433
44,307 44,307
The purpose of 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. We propose to make two non-substantive changes to the currently-approved protocol for the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). 1. To streamline the process by which women who are eligible are notified of and administered the stillbirth portion of BD-STEPS. 2. To add questions to the BD-STEPS interview to ask women about receipt of a COVID-19 vaccine.
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
  84 FR 7374 03/04/2019
84 FR 44314 08/23/2019
No
5
IC Title Form No. Form Name
Consent for Bloodspot Retrieval n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a Bloodspot Consent for Multiples (English) ,   Bloodspot Consent (English) ,   Bloodspot Consent (Spanish) ,   Bloodspot Verbal Consent (Spanish) ,   Bloodspot Consent for Multiples (Spanish) ,   Bloodspot Verbal Consent for Multiples (English) ,   Bloodspot Verbal Consent (English) ,   Bloodspot Verbal Consent for Multiples (Spanish)
Mother's Consent Script and Computer Assisted Telephone Interview n/a, n/a, n/a, n/a Introductory Phone Script (English) ,   Introductory Phone Script (Spansih) ,   BDSTEPS_CATI_V8.0_SPAN ,   BDSTEPS_CATI_V8.0
Consent for Linkage to Reportable Infectious Diseases Results n/a, n/a, n/a, n/a Verbal Consent for Release of Reportable Infectious Diseases (English) ,   Written Consent for Release of Reportable Infectious Diseases (English) ,   Written Consent for Release of Reportable Infectious Diseases (Spanish) ,   Verbal Consent for Release of Reportable Infectious Diseases (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 Janitorial_Screenshots_English ,   Electronic Equipment Operators_Screenshots_English ,   Teaching_Screenshots_Spanish ,   Cosmetology_Screenshots_Spanish ,   Healthcare_Screenshots_English ,   Healthcare_Screenshots_Spansih ,   Janitorial_Screenshots_Spanish ,   Office Worker_Screenshots_English ,   Office Worker_Screenshots_Spanish ,   Restaurant Worker_Screenshots_English ,   Electronic Equipment Operators_Screenshots_Spanish ,   Restaurant Worker_Screenshots_Spanish ,   Teaching_Screenshots_English ,   Agriculture_Screenshots_English ,   Agriculture_Screenshots_Spanish ,   Cosmetology_Screenshots_English
Supplemental CATI about Stillbirth n/a, n/a, n/a, n/a Introductory Phone Script for the Interview about Stillborth (Spanish) ,   Computer Assisted Phone Interview about Stillbirth (Spanish) ,   Introductory Phone Script for the Interview about Stillborth (English) ,   Computer Assisted Phone Interview about Stillbirth (English)
  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 8,940 8,940 0 0 0 0
Annual Time Burden (Hours) 4,433 4,433 0 0 0 0
Annual Cost Burden (Dollars) 44,307 44,307 0 0 0 0
No
No
$2,783,726
Yes Part B of Supporting Statement
    Yes
    Yes
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.
01/21/2021
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