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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Core CATI (Spanish)	Form and Instruction	Modified	Available
Core CATI	Form and Instruction	Modified	Available
Mother's Consent Script and Computer Assisted Telephone Interview	Form and Instruction	Modified	Repair queued
Stillbirth COVID-19 Sub-Study Form (Non-Interviewed) Spanish	Form and Instruction	New	Available
Stillbirth COVID-19 Sub-Study Form (Interviewed) Spanish	Form and Instruction	New	Available
Stillbirth COVID-19 Sub-Study Form (Non-Interviewed)	Form and Instruction	New	Available
Stillbirth COVID-19 Sub-Study Form (Interviewed)	Form and Instruction	New	Available
Stillbirth COVID-19 Sub-Study	Form and Instruction	New	Repair queued
Computer Assisted Phone Interview about Stillbirth (Spanish)	Form and Instruction	Modified	Available
Computer Assisted Phone Interview about Stillbirth (English)	Form and Instruction	Modified	Available
Supplemental CATI about Stillbirth	Form and Instruction	Modified	Repair queued
Verbal Consent for Release of Reportable Infectious Diseases (Spanish)	Form and Instruction	Modified	Available
Verbal Consent for Release of Reportable Infectious Diseases (English)	Form and Instruction	Modified	Available
Written Consent for Release of Reportable Infectious Diseases (Spanish)	Form and Instruction	Modified	Available
Written Consent for Release of Reportable Infectious Diseases (English)	Form and Instruction	Modified	Available
Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Modified	Repair queued
Teaching_Screenshots_Spanish	Form and Instruction	Modified	Available
Teaching_Screenshots_English	Form and Instruction	Modified	Available
Restaurant Worker_Screenshots_Spanish	Form and Instruction	Modified	Available
Restaurant Worker_Screenshots_English	Form and Instruction	Modified	Available
Office Worker_Screenshots_Spanish	Form and Instruction	Modified	Available
Office Worker_Screenshots_English	Form and Instruction	Modified	Available
Janitorial_Screenshots_Spanish	Form and Instruction	Modified	Available
Janitorial_Screenshots_English	Form and Instruction	Modified	Available
Healthcare_Screenshots_Spansih	Form and Instruction	Modified	Available
Healthcare_Screenshots_English	Form and Instruction	Modified	Available
Electronic Equipment Operators_Screenshots_Spanish	Form and Instruction	Modified	Available
Electronic Equipment Operators_Screenshots_English	Form and Instruction	Modified	Available
Cosmetology_Screenshots_Spanish	Form and Instruction	Modified	Available
Cosmetology_Screenshots_English	Form and Instruction	Modified	Available
Agriculture_Screenshots_Spanish	Form and Instruction	Modified	Available
Agriculture_Screenshots_English	Form and Instruction	Modified	Available
Occupational Questionnaires	Form and Instruction	Modified	Repair queued
Bloodspot Verbal Consent for Multiples (Spanish)	Form and Instruction	Modified	Available
Bloodspot Consent for Multiples (Spanish)	Form and Instruction	Modified	Available
Bloodspot Verbal Consent (Spanish)	Form and Instruction	Modified	Available
Bloodspot Consent (Spanish)	Form and Instruction	Modified	Available
Bloodspot Verbal Consent for Multiples (English)	Form and Instruction	Modified	Available
Bloodspot Consent for Multiples (English)	Form and Instruction	Modified	Repair queued
Bloodspot Verbal Consent (English)	Form and Instruction	Modified	Available
Bloodspot Consent (English)	Form and Instruction	Modified	Available
Consent for Bloodspot Retrieval	Form and Instruction	Modified	Repair queued
AttG5.2b_Stillbirth_COVID_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG5.1b_Stillbirth_COVID_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG4.13b_Stillbirth_Thank_You_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG4.2b_Stillbirth_Thank_You_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG4.1b_Stillbirth_Thank_You_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Available
AttG3b_Stillbirth_Phone_Script.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG2.2b_Stillbirth_Intro_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG2.1b_Stillbirth_Intro_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttF2b_OOQ_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttE6b_Bloodspot_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttD4b_Infection_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC8.2b_Core_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC8.1b_Core_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC7b_Core_Phone_Scripts.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC6b_Address_Correction.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC5b_Privacy_Act.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC4b_Q_and_A.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC2b_Study_Intro_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
List of Attachments_BD-STEPS.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttO_NSCR_Core_CATI_09Nov2022.docx	Supplementary Document	Uploaded 2022-12-23	Available
AttN_Publications.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttM2_PIA_Explanation.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttM1_PIA.pdf	Supplementary Document	Uploaded 2022-12-23	Available
AttL_Confidentiality.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttK_Stillbirth_Case_Definition.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttJ_ Birth_Defects_Case_Definition.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttI_IRB_Amendment.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttH_IRB_2022Continuation.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG5.2a_Stillbirth_COVID_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG5.1a_Stillbirth_COVID_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG4.3a_Stillbirth_Thank_You_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG4.2a_Stillbirth_Thank_You_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG4.1a_Stillbirth_Thank_You_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG3a_Stillbirth_Phone_Script.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG2.2a_Stillbirth_Intro_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttG2.1a_Stillbirth_Intro_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttF2a_OOQ_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttE6a_Bloodspot_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttE1_Bloodspot_FAQ.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttD4a_Infection_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttD1_Infection_FAQ.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC8.2a_Core_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC8.1a_Core_Thank_You.docx	Supplementary Document	Uploaded 2022-12-23	Available
AttC7a_Core_Phone_Scripts.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC6a_Address_Correction.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC5a_Privacy_Act.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC4a_Q_and_A.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC3_Human_Subjects_Fact_Sheet.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttC2a_Study_Intro_Letter.docx	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttB_60_day_FRN.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
AttA_BDPreventionActof1998.pdf	Supplementary Document	Uploaded 2022-12-23	Repair queued
SSB_BD-STEPS 20221006.docx	Supporting Statement B	Uploaded 2022-12-23	Repair queued
SSA_BD-STEPS 20221109_final.docx	Supporting Statement A	Uploaded 2022-12-23	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6608	Mother's Consent Script and Computer Assisted Telephone Interview	Form and Instruction	Modified	Core CATI (Spanish)
6608	Mother's Consent Script and Computer Assisted Telephone Interview	Form and Instruction	Modified	Core CATI
6608	Mother's Consent Script and Computer Assisted Telephone Interview	Form and Instruction	Modified
257626	Stillbirth COVID-19 Sub-Study	Form and Instruction	New	Stillbirth COVID-19 Sub-Study Form (Non-Interviewed) Spanish
257626	Stillbirth COVID-19 Sub-Study	Form and Instruction	New	Stillbirth COVID-19 Sub-Study Form (Interviewed) Spanish
257626	Stillbirth COVID-19 Sub-Study	Form and Instruction	New	Stillbirth COVID-19 Sub-Study Form (Non-Interviewed)
257626	Stillbirth COVID-19 Sub-Study	Form and Instruction	New	Stillbirth COVID-19 Sub-Study Form (Interviewed)
257626	Stillbirth COVID-19 Sub-Study	Form and Instruction	New
222820	Supplemental CATI about Stillbirth	Form and Instruction	Modified	Computer Assisted Phone Interview about Stillbirth (Spanish)
222820	Supplemental CATI about Stillbirth	Form and Instruction	Modified	Computer Assisted Phone Interview about Stillbirth (English)
222820	Supplemental CATI about Stillbirth	Form and Instruction	Modified
216974	Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Modified	Verbal Consent for Release of Reportable Infectious Diseases (Spanish)
216974	Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Modified	Verbal Consent for Release of Reportable Infectious Diseases (English)
216974	Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Modified	Written Consent for Release of Reportable Infectious Diseases (Spanish)
216974	Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Modified	Written Consent for Release of Reportable Infectious Diseases (English)
216974	Consent for Linkage to Reportable Infectious Diseases Results	Form and Instruction	Modified
216968	Occupational Questionnaires	Form and Instruction	Modified	Teaching_Screenshots_Spanish
216968	Occupational Questionnaires	Form and Instruction	Modified	Teaching_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified	Restaurant Worker_Screenshots_Spanish
216968	Occupational Questionnaires	Form and Instruction	Modified	Restaurant Worker_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified	Office Worker_Screenshots_Spanish
216968	Occupational Questionnaires	Form and Instruction	Modified	Office Worker_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified	Janitorial_Screenshots_Spanish
216968	Occupational Questionnaires	Form and Instruction	Modified	Janitorial_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified	Healthcare_Screenshots_Spansih
216968	Occupational Questionnaires	Form and Instruction	Modified	Healthcare_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified	Electronic Equipment Operators_Screenshots_Spanish
216968	Occupational Questionnaires	Form and Instruction	Modified	Electronic Equipment Operators_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified	Cosmetology_Screenshots_Spanish
216968	Occupational Questionnaires	Form and Instruction	Modified	Cosmetology_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified	Agriculture_Screenshots_Spanish
216968	Occupational Questionnaires	Form and Instruction	Modified	Agriculture_Screenshots_English
216968	Occupational Questionnaires	Form and Instruction	Modified
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Verbal Consent for Multiples (Spanish)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Consent for Multiples (Spanish)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Verbal Consent (Spanish)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Consent (Spanish)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Verbal Consent for Multiples (English)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Consent for Multiples (English)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Verbal Consent (English)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Bloodspot Consent (English)
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 202212-0920-015
Status: Historical Active	Previous ICR Reference No: 202206-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0010
Title: [NCBDDD] Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/24/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/27/2022
Terms of Clearance: Previous terms continue: Approved consistent with the understanding that CDC will continue to work with SAMHSA on questions related to illicit drug use. The Agency will include the OMB control number and expiration date (as well as the burden statement) on all questionnaires and forms administered to participants in this collection. CDC will characterize the limitations given the addition of the COVID-19 vaccination question in all future publications and analyses.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2026	36 Months From Approved	04/30/2023
Responses	9,097	0	8,940
Time Burden (Hours)	4,473	0	4,433
Cost Burden (Dollars)	0	0	44,307

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Abstract: The purpose of 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. This Revision incorporates an additional COVID-19-related sub-study, additional COVID-19 questions, and other minor edits.

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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:
	87 FR 11442	03/01/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 70830	11/21/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

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 (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)
Consent for Linkage to Reportable Infectious Diseases Results	n/a, n/a, n/a, n/a	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 (English) ,   Verbal Consent for Release of Reportable Infectious Diseases (Spanish)
Mother's Consent Script and Computer Assisted Telephone Interview	n/a, n/a	Core CATI ,   Core CATI (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)

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ICR Summary of Burden

table that charts list of burden

	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	9,097	8,940	0	157	0	0
Annual Time Burden (Hours)	4,473	4,433	0	40	0	0
Annual Cost Burden (Dollars)	0	44,307	0	-44,307	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This increase is due to our revision to invite a subset of women from two Centers to participate in a COVID-19-related sub-study.

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Annual Cost to Federal Government: $3,825,876

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: 12/27/2022

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