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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
BD-STEPS Questionnaire - Spanish	Form	Modified	Repair queued
BD-STEPS Questionnaire	Form	Modified	Available
Supplemental Stillbirth Computer Assisted Telphone Interview	Form	New	Available
Supplemental Stillbirth Computer Assisted Telephone Interview	Form	New	Available
Medical Record Release Authorization	Form	Modified	Available
Medical Record Release Authorization	Form	Modified	Available
Teacher Questionnaire	Form	Modified	Available
Restaurant Work Questionnaire	Form	Modified	Available
Office Work Questionnaire	Form	Modified	Repair queued
Housekeeping Questionnaire	Form	Modified	Available
Healthcare Questionnaire	Form	Modified	Available
Cosmetology Questionnaire	Form	Modified	Available
Electronic Equipment Operator Questionnaire	Form	Modified	Available
Agriculture Questionnaire	Form	Modified	Available
Consent for Bloodspot Retrieval - Multiples - Spanish	Form and Instruction	Modified	Available
Consent for Bloodspot Retrieval - Multiples	Form and Instruction	Modified	Available
Consent for Bloodspot Retrieval - Spanish	Form and Instruction	Modified	Repair queued
Consent for Bloodspot Release	Form and Instruction	Modified	Available
AttAA_SBsupp_IntroLetter.docx	Supplementary Document	Uploaded 2016-08-03	Available
AttY2_IntvThankYou_BloodspotIntroLtr_Spanish.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttY1_IntvThankYou_BloodspotIntroLtr_English.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttX2_IntroEmailScripts_CellphoneTexts_Spanish.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttX1_IntroEmailScripts_CellphoneTexts_English.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttW_NBDPS Publications 3_21_16.docx	Supplementary Document	Uploaded 2016-08-03	Available
AttV2_Rights_Spanish-English.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttV1_Rights_AllStates_Graphics_April10_2015.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttU2_IntroLetter_Spanish.pdf	Supplementary Document	Uploaded 2016-08-03	Repair queued
AttU1_IntroLetter_English.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttT2_IntroQandA_Spanish.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttT1_IntroQandA_Graphics_English.pdf	Supplementary Document	Uploaded 2016-08-03	Repair queued
AttS_BD_STEPS_Blank_ConfidentialityOathPledges_Jul15_2013.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttM_CertificateofConfidentialityExpFeb2019.pdf	Supplementary Document	Uploaded 2016-08-03	Repair queued
AttL_CollaboratorsList_CBDRP.docx	Supplementary Document	Uploaded 2016-08-03	Available
AttK_Stillbirth with No Mjor Defect Definition.docx	Supplementary Document	Uploaded 2016-08-03	Available
AttJ_BD-STEPSBirthDefects_Oct15_2014.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttF_ListofBDSTEPSCenters.pdf	Supplementary Document	Uploaded 2016-08-03	Available
AttE_2087Continuation_ApprovalMemo.docx	Supplementary Document	Uploaded 2016-08-03	Available
AttC_LetterofAuthorizationDHR2013-18.pdf	Supplementary Document	Uploaded 2016-08-02	Available
AttB_60-day_Fed_Registry_Notice_Mar17_2016.pdf	Supplementary Document	Uploaded 2016-08-02	Available
BDSTEPS_SupSta B_052016.docx	Supporting Statement B	Uploaded 2016-08-02	Available
BDSTEPS_SupSta A.docx	Supporting Statement A	Uploaded 2016-08-02	Available
AttA_BDPreventionActof1998.pdf	Supplementary Document	Uploaded 2015-05-28	Available
42 USC 247b_4.pdf	Supplementary Document	Uploaded 2013-12-02	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6608	Mother's Questionnaire	Form	Modified	BD-STEPS Questionnaire - Spanish
6608	Mother's Questionnaire	Form	Modified	BD-STEPS Questionnaire
222820	Intro Phone Script including Consent to Supplemental Stillbirth	Form	New	Supplemental Stillbirth Computer Assisted Telphone Interview
222820	Intro Phone Script including Consent to Supplemental Stillbirth	Form	New	Supplemental Stillbirth Computer Assisted Telephone Interview
222820	Intro Phone Script including Consent to Supplemental Stillbirth	Other-WORD	New
216978	Medical Record Review	Instruction	Modified
216974	Medical Record Request	Form	Modified	Medical Record Release Authorization
216974	Medical Record Request	Form	Modified	Medical Record Release Authorization
216968	Occupational Questionnaires	Form	Modified	Teacher Questionnaire
216968	Occupational Questionnaires	Form	Modified	Restaurant Work Questionnaire
216968	Occupational Questionnaires	Form	Modified	Office Work Questionnaire
216968	Occupational Questionnaires	Form	Modified	Housekeeping Questionnaire
216968	Occupational Questionnaires	Form	Modified	Healthcare Questionnaire
216968	Occupational Questionnaires	Form	Modified	Cosmetology Questionnaire
216968	Occupational Questionnaires	Form	Modified	Electronic Equipment Operator Questionnaire
216968	Occupational Questionnaires	Form	Modified	Agriculture Questionnaire
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Consent for Bloodspot Retrieval - Multiples - Spanish
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Consent for Bloodspot Retrieval - Multiples
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Consent for Bloodspot Retrieval - Spanish
187391	Consent for Bloodspot Retrieval	Form and Instruction	Modified	Consent for Bloodspot Release

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 201608-0920-002
Status: Historical Active	Previous ICR Reference No: 201505-0920-009
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 without change	Conclusion Date: 02/06/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/08/2016
Terms of Clearance: Previous terms continue: 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.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	12/31/2018
Responses	6,190	0	4,712
Time Burden (Hours)	3,034	0	2,291
Cost Burden (Dollars)	0	0	0

---

Abstract: The NCBDDD Division of Birth Defects and Developmental Disabilities (DBDDD) seeks to fund a collaborative project for 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.

---

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

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 14446	03/17/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 52436	08/08/2016
Did the Agency receive public comments on this ICR? No

---

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	none, none, none, none	Consent for Bloodspot Release ,   Consent for Bloodspot Retrieval - Spanish ,   Consent for Bloodspot Retrieval - Multiples ,   Consent for Bloodspot Retrieval - Multiples - Spanish
Intro Phone Script including Consent to Supplemental Stillbirth	N/A, N/A	Supplemental Stillbirth Computer Assisted Telephone Interview ,   Supplemental Stillbirth Computer Assisted Telphone Interview
Medical Record Request	none, none	Medical Record Release Authorization ,   Medical Record Release Authorization
Medical Record Review
Mother's Questionnaire	none, none	BD-STEPS Questionnaire ,   BD-STEPS Questionnaire - Spanish
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

---

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	6,190	4,712	0	1,478	0	0
Annual Time Burden (Hours)	3,034	2,291	0	743	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: No

Burden Reduction Due to:

Short Statement: This REVISION includes an additional computer assisted telephone interview for 2 center's stillbirths without birth defects groups and a supplemental telephone interview for all of the 2 centers' stillbirths and control group.

---

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

---

Common Form ICR:  No

---

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: 08/08/2016

---