Information Collection Request

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

ICR 201505-0920-009 · OMB 0920-0010 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Mother's Questionnaire Form Modified Repair queued
Medical Record Request Form New Available
Occupational Questionnaires Form New Available
Consent for Bloodspot Retrieval Form and Instruction Modified Repair queued
AttV2_IntvThankYou_BloodspotIntroLtr_Spanish.pdf Supplementary Document Uploaded 2015-06-10 Available
AttV1_IntvThankYou_BloodspotIntroLtr_English.pdf Supplementary Document Uploaded 2015-06-10 Available
AttU2_IntroEmailScripts_CellphoneTexts_Spanish.pdf Supplementary Document Uploaded 2015-06-10 Repair queued
AttU1_IntroEmailScripts_CellphoneTexts_English.pdf Supplementary Document Uploaded 2015-06-10 Repair queued
AttT_NBDPS Publications 3_31_15.pdf Supplementary Document Uploaded 2015-06-10 Repair queued
AttS2_Rights_Spanish-English.pdf Supplementary Document Uploaded 2015-06-10 Available
AttS1_Rights_AllStates_Graphics_April10_2015.pdf Supplementary Document Uploaded 2015-06-10 Repair queued
AttR2_IntroLetter_Spanish.pdf Supplementary Document Uploaded 2015-06-10 Available
AttR1_IntroLetter_English.pdf Supplementary Document Uploaded 2015-06-10 Available
AttQ2_IntroQandA_Spanish.pdf Supplementary Document Uploaded 2015-06-10 Available
AttQ1_IntroQandA_Graphics_English.pdf Supplementary Document Uploaded 2015-06-10 Available
AttP_BD_STEPS_Blank_ConfidentialityOathPledges_Jul15_2013.pdf Supplementary Document Uploaded 2015-06-10 Available
AttK_CertificateofConfidentialityExpFeb2019.pdf Supplementary Document Uploaded 2015-06-10 Available
AttJ_CollaboratorsList_July2014.pdf Supplementary Document Uploaded 2015-06-10 Available
AttI_BD-STEPSBirthDefects_Oct15_2014.pdf Supplementary Document Uploaded 2015-06-10 Available
AttF_ListofBDSTEPSCenters.pdf Supplementary Document Uploaded 2015-06-10 Repair queued
AttE_IRB_Continuation_BD-STEPSAmend_Approvals.pdf Supplementary Document Uploaded 2015-06-10 Available
AttD_LetterofAuthorizationDHR2013-18.pdf Supplementary Document Uploaded 2015-06-10 Repair queued
AttB_60-day_Fed_Registry_Notice_Feb18_2015.pdf Supplementary Document Uploaded 2015-06-10 Available
OMBStatementB_CLEAN_June6_2015_FINAL.docx Supporting Statement B Uploaded 2015-06-10 Available
OMBStatementA_CLEAN_June6_2015FINAL.docx Supporting Statement A Uploaded 2015-06-10 Repair queued
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
IC IDCollectionTypeStatusForm
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
0920-0010 201505-0920-009
Historical Active 201312-0920-002
HHS/CDC
Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
Revision of a currently approved collection   No
Regular
Approved with change 12/03/2015
Retrieve Notice of Action (NOA) 06/16/2015
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
12/31/2018 36 Months From Approved 01/31/2017
4,712 0 7,700
2,291 0 2,888
0 0 0

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.

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

  80 FR 8655 02/18/2015
80 FR 31380 06/02/2015
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 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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This revision removes saliva collection from the protocol, adds bloodspot collection, and implements new on-line questionnaires. There is a total reduction in burden.

$1,880,110
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Shari Steinberg 404 639-4942 [email protected]

  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.
06/16/2015