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

Forms and Documents

Document	Type	Status	Availability
Mother's Consent Script and Computer Assisted Telephone Interview	Form and Instruction	Modified	Repair queued
Supplemental CATI about Stillbirth	Form and Instruction	Modified	Repair queued
Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Unchanged	Repair queued
Occupational Questionnaires	Form and Instruction	Unchanged	Repair queued
Consent for Bloodspot Retrieval	Form and Instruction	Unchanged	Repair queued
Att35_BDSTEPS_Stillbirth_SOP_Protocol_two_part_intvw_CLEAN_v2.docx	Supplementary Document	Uploaded 2021-01-21	Repair queued
ICR Non-substantive Change Request_BD-STEPS_20201221 final.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-01-21	Repair queued
OMB0920-0010_BD-STEPS_NonSubstantive Change request .docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-03-26	Repair queued
Att44A_BD2_SBSupp_Combined_ThankYou_Letter_Combo_InfectiousBSIntroLtr_SPAN_083120_Clean.docx	Supplementary Document	Uploaded 2021-01-21	Repair queued
Att44A_BD2_SBSupp_Combined_ThankYou_Letter_InterviewsCompletedTogether_InfectiousBloodIntroLtr_English_08_31_2020_Clean.docx	Supplementary Document	Uploaded 2021-01-21	Missing upstream
Att44B_44C_BD2_SBSupp_IntvThankYou_Reminder_BS4Cont_SING_MULTI_SPAN_083020_v2_Clean1.7.2021.docx	Supplementary Document	Uploaded 2021-01-21	Repair queued
Att44B_44C_BD2_SBSupp_IntvThankYou_Reminder_BloodIntroLtr_SINGLE_MULTIPLE_08_30_2020_Clean_v3.docx	Supplementary Document	Uploaded 2021-01-21	Missing upstream
AttK_Collaborators List.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttI_Stillbirth_Case_Definition.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttZ_JustificationNewQuestions.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttH_ Birth_Defects_Case_Definition.docx	Supplementary Document	Uploaded 2019-08-26	Missing upstream
AttW_CBDRP_ConfidentialityOaths.docx	Supplementary Document	Uploaded 2019-08-26	Missing upstream
AttX_PrivacyImpactAssessment.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttDD1_PrivacyActStatement.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttE_ListofBDSTEPSCenters.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttCC_NBDPS-Publications.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttD_CDC-IRB_ApprovalLetter.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttC2_CDC-IRB_AmendmentApproval_92.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttC1_CDC-IRB_AmendmentApproval_89.docx	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttB_60dayFRN.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
AttA_BDPreventionActof1998.pdf	Supplementary Document	Uploaded 2019-08-26	Repair queued
BD-STEPS_OMBStatementB_20190813-Final.docx	Supporting Statement B	Uploaded 2019-08-26	Repair queued
BD-STEPS_OMBStatementA_20190813-Final.docx	Supporting Statement A	Uploaded 2019-08-26	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6608	Mother's Consent Script and Computer Assisted Telephone Interview	Form and Instruction	Modified
222820	Supplemental CATI about Stillbirth	Form and Instruction	Modified
216974	Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Unchanged
216968	Occupational Questionnaires	Form and Instruction	Unchanged
187391	Consent for Bloodspot Retrieval	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 202101-0920-008
Status: Received in OIRA	Previous ICR Reference No: 202003-0920-021
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0010-21CJ
Title: Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/21/2021

	Requested	Previously Approved
Expiration Date	02/28/2023	02/28/2023
Responses	8,940	8,940
Time Burden (Hours)	4,433	4,433
Cost Burden (Dollars)	44,307	44,307

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 7374	03/04/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 44314	08/23/2019
Did the Agency receive public comments on this ICR? No

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

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ICR Summary 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	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

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:

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Annual Cost to Federal Government: $2,783,726

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.     Yes

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

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Common Form ICR:  No

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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: 01/21/2021

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