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

Forms and Documents

Document Name	Status
Mother's Questionnaire Form	Modified
Medical Record Request Form	New
Occupational Questionnaires Form	New
Consent for Bloodspot Retrieval Form and Instruction	Modified
AttV2_IntvThankYou_BloodspotIntroLtr_Spanish.pdf Supplementary Document	2015-06-10
AttV1_IntvThankYou_BloodspotIntroLtr_English.pdf Supplementary Document	2015-06-10
AttU2_IntroEmailScripts_CellphoneTexts_Spanish.pdf Supplementary Document	2015-06-10
AttU1_IntroEmailScripts_CellphoneTexts_English.pdf Supplementary Document	2015-06-10
AttT_NBDPS Publications 3_31_15.pdf Supplementary Document	2015-06-10
AttS2_Rights_Spanish-English.pdf Supplementary Document	2015-06-10
AttS1_Rights_AllStates_Graphics_April10_2015.pdf Supplementary Document	2015-06-10
AttR2_IntroLetter_Spanish.pdf Supplementary Document	2015-06-10
AttR1_IntroLetter_English.pdf Supplementary Document	2015-06-10
AttQ2_IntroQandA_Spanish.pdf Supplementary Document	2015-06-10
AttQ1_IntroQandA_Graphics_English.pdf Supplementary Document	2015-06-10
AttP_BD_STEPS_Blank_ConfidentialityOathPledges_Jul15_2013.pdf Supplementary Document	2015-06-10
AttK_CertificateofConfidentialityExpFeb2019.pdf Supplementary Document	2015-06-10
AttJ_CollaboratorsList_July2014.pdf Supplementary Document	2015-06-10
AttI_BD-STEPSBirthDefects_Oct15_2014.pdf Supplementary Document	2015-06-10
AttF_ListofBDSTEPSCenters.pdf Supplementary Document	2015-06-10
AttE_IRB_Continuation_BD-STEPSAmend_Approvals.pdf Supplementary Document	2015-06-10
AttD_LetterofAuthorizationDHR2013-18.pdf Supplementary Document	2015-06-10
AttB_60-day_Fed_Registry_Notice_Feb18_2015.pdf Supplementary Document	2015-06-10
OMBStatementB_CLEAN_June6_2015_FINAL.docx Supporting Statement B	2015-06-10
OMBStatementA_CLEAN_June6_2015FINAL.docx Supporting Statement A	2015-06-10
AttA_BDPreventionActof1998.pdf Supplementary Document	2015-05-28
42 USC 247b_4.pdf Supplementary Document	2013-12-02

IC Document Collections

IC ID	Document Title	Status
6608	Mother's Questionnaire Form	Modified
216978	Medical Record Review Instruction	New
216974	Medical Record Request Form	New
216968	Occupational Questionnaires Form	New
187391	Consent for Bloodspot Retrieval Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 201505-0920-009
Status: Historical Active	Previous ICR Reference No: 201312-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No:
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: 12/03/2015
	Date Received in OIRA: 06/16/2015
Terms of Clearance: 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	12/31/2018	36 Months From Approved	01/31/2017
Responses	4,712	0	7,700
Time Burden (Hours)	2,291	0	2,888
Cost Burden (Dollars)	0	0	0

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Abstract: BD-STEPS is a multi-site case control study of a select number of major birth defects. The purpose of the Birth Defects Case Control Collaborative is to identify causes of birth defects using epidemiologic and genetic research methods and provide information that will be translated into public health prevention messages and to promote health and quality of life by preventing and controlling disease, injury and disability.

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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:
	80 FR 8655	02/18/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 31380	06/02/2015
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
Mother's Questionnaire	none, none	BD-STEPS Questionnaire ,   BD-STEPS Questionnaire - Spanish
Consent for Bloodspot Retrieval	none, none, none, none	Consent for Bloodspot Release ,   Consent for Bloodspot Retrieval - Spanish ,   Consent for Bloodspot Retrieval - Multiples ,   Consent for Bloodspot Retrieval - Multiples - Spanish
Medical Record Request	none, none	Medical Record Release Authorization ,   Medical Record Release Authorization
Medical Record Review
Occupational Questionnaires	none, none, none, none, none, none, none, none	Agriculture Questionnaire ,   Electronic Equipment Operator Questionnaire ,   Cosmetology Questionnaire ,   Healthcare Questionnaire ,   Housekeeping Questionnaire ,   Office Work Questionnaire ,   Restaurant Work Questionnaire ,   Teacher Questionnaire

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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	4,712	7,700	0	-2,988	0	0
Annual Time Burden (Hours)	2,291	2,888	0	-597	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: This revision removes saliva collection from the protocol, adds bloodspot collection, and implements new on-line questionnaires. There is a total reduction in burden.

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Annual Cost to Federal Government: $1,880,110

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? No

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: 06/16/2015

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