Information Collection Request

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

ICR 201608-0920-002 · OMB 0920-0010 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Mother's Questionnaire Form Modified Repair queued
Medical Record Request Form Modified Available
Occupational Questionnaires Form Modified Available
Consent for Bloodspot Retrieval Form and Instruction Modified Available
AttAA_SBsupp_IntroLetter.docx Supplementary Document Uploaded 2016-08-03 Repair queued
AttY2_IntvThankYou_BloodspotIntroLtr_Spanish.pdf Supplementary Document Uploaded 2016-08-03 Repair queued
AttY1_IntvThankYou_BloodspotIntroLtr_English.pdf Supplementary Document Uploaded 2016-08-03 Repair queued
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 Repair queued
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 Repair queued
AttM_CertificateofConfidentialityExpFeb2019.pdf Supplementary Document Uploaded 2016-08-03 Repair queued
AttL_CollaboratorsList_CBDRP.docx Supplementary Document Uploaded 2016-08-03 Repair queued
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 Repair queued
AttE_2087Continuation_ApprovalMemo.docx Supplementary Document Uploaded 2016-08-03 Repair queued
AttC_LetterofAuthorizationDHR2013-18.pdf Supplementary Document Uploaded 2016-08-02 Repair queued
AttB_60-day_Fed_Registry_Notice_Mar17_2016.pdf Supplementary Document Uploaded 2016-08-02 Repair queued
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 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
6608 Mother's Questionnaire Form Modified
222820 Intro Phone Script including Consent to Supplemental Stillbirth Other-WORD New
216978 Medical Record Review Instruction Modified
216974 Medical Record Request Form Modified
216968 Occupational Questionnaires Form Modified
187391 Consent for Bloodspot Retrieval Form and Instruction Modified
ICR Details
0920-0010 201608-0920-002
Historical Active 201505-0920-009
HHS/CDC 0920-0010
Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
Revision of a currently approved collection   No
Regular
Approved without change 02/06/2017
Retrieve Notice of Action (NOA) 08/08/2016
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.
  Inventory as of this Action Requested Previously Approved
02/29/2020 36 Months From Approved 12/31/2018
6,190 0 4,712
3,034 0 2,291
0 0 0

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.

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
  
None

Not associated with rulemaking

  81 FR 14446 03/17/2016
81 FR 52436 08/08/2016
No

  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
Yes
Miscellaneous Actions
No
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.

$1,880,110
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Thelma Sims 4046394771

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/08/2016