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

Forms and Documents

Document Name	Status
Mother Questionnaire Form	Modified
OMBSupportingStatementB_Oct17.docx Supporting Statement B	2013-12-02
AttX_DRAFTMedRecordReleaseForm.docx Supplementary Document	2013-12-02
AttW_MedRecPatientRequestLtr_Nov5.doc Supplementary Document	2013-12-02
AttT_IntroEmailScripts_CellphoneTexts_Nov5.doc.docx Supplementary Document	2013-12-02
AttS_NBDPS Publications 6_14_2013.docx Supplementary Document	2013-12-02
AttP_RightsofResearchSubjects_Oct23.docx Supplementary Document	2013-12-02
AttO_IntroLetter_Nov5.docx Supplementary Document	2013-12-02
AttN_IntroQandA_Oct23.docx Supplementary Document	2013-12-02
AttM_BD_STEPS_Blank_ConfidentialityOathPledges_Jul15_2013.doc Supplementary Document	2013-12-02
AttJ_CertificateofConfidentialityExp1-14.pdf Supplementary Document	2013-12-02
AttI_CollaboratorsList_CBDRP.docx Supplementary Document	2013-12-02
AttH_BDSTEPSBirthDefects.docx Supplementary Document	2013-12-02
AttF_ListofBDSTEPSCenters.docx Supplementary Document	2013-12-02
AttE_2087IRBAmendmentApproval.docx Supplementary Document	2013-12-02
AttD_2087IRBContinuationApproval.docx Supplementary Document	2013-12-02
AttC_LetterofAuthorizationDCH2012-13.pdf Supplementary Document	2013-12-02
AttB_60dy_0920_0010.pdf Supplementary Document	2013-12-02
AttA_BDPreventionActof1998.pdf Supplementary Document	2013-12-02
42 USC 247b_4.pdf Supplementary Document	2013-12-02
AttU_SalIntroLtrLiving_Nov5.doc Supplementary Document	2013-12-02
AttVSalThankYouLtr_Nov5.docx Supplementary Document	2013-12-02
AttK_IntroPhoneScript_Nov5.doc Supplementary Document	2013-12-02
OMBSupportingStatementA_Nov21_OMBFeedback_CLEAN.docx Supporting Statement A	2013-12-02

IC Document Collections

IC ID	Document Title	Status
6608	Mother Questionnaire Form	Modified
187391	Biologic Specimen Collection Instruction	Modified

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 201312-0920-002
Status: Historical Active	Previous ICR Reference No: 201204-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 21038
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 without change	Conclusion Date: 01/02/2014
	Date Received in OIRA: 12/04/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	04/30/2015
Responses	7,700	0	14,400
Time Burden (Hours)	2,888	0	5,640
Cost Burden (Dollars)	0	0	0

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Abstract: BD-STEPS is a case-control study similiar to the National Birth Defects Prevention Study that stopped interviewing participants in 2013. As in NBDPS, control infants are randomly selected from birth certificates or birth hospital records; mothers of case and control infants are interviewed using CATI. Parents are asked to collect DNA samples from themselves and their infants.

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Authorizing Statute(s): US Code: 42 USC 247b-4 Name of Law: Public Health Service Act
   PL: Pub.L. 105 - 168 1 Name of Law: Birth Defects Prevention 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:
	78 FR 49758	08/15/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 72087	12/02/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Mother Questionnaire	none	BD-STEPS
Biologic Specimen Collection	none	Consent

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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	7,700	14,400	0	-6,700	0	0
Annual Time Burden (Hours)	2,888	5,640	0	-2,752	0	0
Annual Cost Burden (Dollars)	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This revision includes a reqeust for title change to Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS). Also, there will be 2 fewer respondents (Centers for Birth Defects Research and Prevention) due to funding reduction. Some questions have been removed or revised based on experience. Additional participant contact is planned for the future to request access to medical records for mothers who report certain medical procedures.

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Annual Cost to Federal Government: $2,848,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 12/04/2013

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