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

Forms and Documents

Document Name	Status
Mother's Consent Script and Computer Assisted Telephone Interview Form and Instruction	Modified
Supplemental CATI about Stillbirth Form and Instruction	Modified
Consent for Linkage to Reportable Infectious Diseases Results Form and Instruction	Modified
Occupational Questionnaires Form and Instruction	Modified
Consent for Bloodspot Retrieval Form and Instruction	Modified
AttBB2_IntvThankYou_Infection_BloodspotIntroLtr_MULTI_SPAN.docx Supplementary Document	2019-08-26
AttBB1_IntvThankYou_Infection_BloodspotIntroLtr_MULTI.docx Supplementary Document	2019-08-26
AttAA2_IntvThankYou_Infection_Bloodspot_IntroLtr_SPAN.docx Supplementary Document	2019-08-26
AttAA1_IntvThankYou_Infection_Bloodspot_IntroLtr.docx Supplementary Document	2019-08-26
AttK_Collaborators List.docx Supplementary Document	2019-08-26
AttI_Stillbirth_Case_Definition.docx Supplementary Document	2019-08-26
AttZ_JustificationNewQuestions.docx Supplementary Document	2019-08-26
AttH_ Birth_Defects_Case_Definition.docx Supplementary Document	2019-08-26
AttW_CBDRP_ConfidentialityOaths.docx Supplementary Document	2019-08-26
AttX_PrivacyImpactAssessment.pdf Supplementary Document	2019-08-26
AttDD1_PrivacyActStatement.docx Supplementary Document	2019-08-26
AttE_ListofBDSTEPSCenters.pdf Supplementary Document	2019-08-26
AttCC_NBDPS-Publications.docx Supplementary Document	2019-08-26
AttD_CDC-IRB_ApprovalLetter.pdf Supplementary Document	2019-08-26
AttC2_CDC-IRB_AmendmentApproval_92.docx Supplementary Document	2019-08-26
AttC1_CDC-IRB_AmendmentApproval_89.docx Supplementary Document	2019-08-26
AttB_60dayFRN.pdf Supplementary Document	2019-08-26
AttA_BDPreventionActof1998.pdf Supplementary Document	2019-08-26
BD-STEPS_OMBStatementB_20190813-Final.docx Supporting Statement B	2019-08-26
BD-STEPS_OMBStatementA_20190813-Final.docx Supporting Statement A	2019-08-26

IC Document Collections

IC ID	Document Title	Status
6608	Mother's Consent Script and Computer Assisted Telephone Interview Form and Instruction	Modified
222820	Supplemental CATI about Stillbirth Form and Instruction	Modified
216978	Medical Record Review Instruction	Removed
216974	Consent for Linkage to Reportable Infectious Diseases Results Form and Instruction	Modified
216968	Occupational Questionnaires Form and Instruction	Modified
187391	Consent for Bloodspot Retrieval Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 201908-0920-005
Status: Historical Active	Previous ICR Reference No: 201608-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0010
Title: 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 with change	Conclusion Date: 02/07/2020
	Date Received in OIRA: 08/27/2019
Terms of Clearance: 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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	02/29/2020
Responses	8,940	0	6,190
Time Burden (Hours)	4,433	0	3,034
Cost Burden (Dollars)	44,307	0	0

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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.

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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 (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)
Mother's Consent Script and Computer Assisted Telephone Interview	n/a, n/a, n/a, n/a	Computer Assisted Telephone Interview for Mothers (Spanish) ,   Computer Assisted Telephone Interview for Mothers (English) ,   Introductory Phone Script (English) ,   Introductory Phone Script (Spansih)
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)
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 ,   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 ,   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
Supplemental CATI about Stillbirth	n/a, n/a, n/a, n/a	Introductory Phone Script for the Interview about Stillborth (English) ,   Introductory Phone Script for the Interview about Stillborth (Spanish) ,   Computer Assisted Phone Interview about Stillbirth (English) ,   Computer Assisted Phone Interview about Stillbirth (Spanish)
Medical Record Review

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ICR Summary 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	8,940	6,190	0	2,750	0	0
Annual Time Burden (Hours)	4,433	3,034	0	1,399	0	0
Annual Cost Burden (Dollars)	44,307	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The length of the CATI for Mothers will increase due to an increase in the number of qualifying birth defects. The number of respondents will increase. The number of respondents will increase for the Online Occupational Questionnaires but there is no change to the estimated burden per response. The previously approved Medical Record Review was not implemented and is being removed in this Revision request.

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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? Uncollected

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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: 08/27/2019

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