List of Attachments

List of Attachments_BD-STEPS.docx

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

List of Attachments

OMB: 0920-0010

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List of Attachments

Attachment A Birth Defects Prevention Act of 1998

Attachment B 60 Day Federal Register Notice


Core Interview

Attachment C1 Core Computer Assisted Telephone Interview (CATI)1

Attachment C2 Study Introductory Letter1

Attachment C3 Human Subjects Fact Sheet

Attachment C4 Question and Answer Sheet1

Attachment C5 Privacy Act Statement1

Attachment C6 Address Correction Form1

Attachment C7 Core Phone Scripts1

Attachment C8 Core Thank You Letter1,2


Infectious Disease Information

Attachment D1 Infectious Disease FAQ

Attachment D2 Linkage to Reportable Infectious Disease Written Consent1

Attachment D3 Linkage to Reportable Infectious Disease Verbal Consent1

Attachment D4 Linkage to Reportable Infectious Disease Thank You Letter1


Residual Newborn Bloodspot Information

Attachment E1 Residual Newborn Bloodspot FAQ

Attachment E2 Residual Newborn Bloodspot Written Consent1

Attachment E3 Residual Newborn Bloodspot Written Consent (multiple births)1

Attachment E4 Residual Newborn Bloodspot Verbal Consent1

Attachment E5 Residual Newborn Bloodspot Verbal Consent (multiple births)1

Attachment E6 Residual Newborn Bloodspot Thank You Letter1


Online Occupational Questionnaire

Attachment F1 Online Occupational Questionnaire1,3

Attachment F2 Online Occupational Questionnaire Thank You Letter1


Supplemental Stillbirth-Specific Materials

Attachment G1 Supplemental Computer Assisted Telephone Interview (CATI)1

Attachment G2 Stillbirth Introductory Letter1,4

Attachment G3 Stillbirth Introductory Script1

Attachment G4 Stillbirth Thank You Letter1,5

Attachment G5 Introductory Letter for Stillbirth COVID-19 Sub-Study1,6

Attachment G6 Authorization Form for Stillbirth COVID-19 Sub-Study1,6


Other

Attachment H IRB Continuation Approval

Attachment I Most Recent IRB Amendment Approval

Attachment J Birth Defects Case Definition

Attachment K Stillbirth Case Definitions

Attachment L CBDRP Confidentiality Acknowledgement

Attachment M1 Privacy Impact Assessment (PIA)

Attachment M2 PIA Email (Explanation of Why PIA is Not Signed)

Attachment N List of Publications

Attachment O Pending Non-Substantive Change Request (NSCR) ____________________________________________________

1 English version is provided as Att^a (e.g., AttC1a_Core_CATI) and Spanish translation is available as Att^b (e.g., AttC1b_Core_CATI)

2 Multiple gestation live birth pregnancies receive Att^2; all others receive Att^1

3 Online occupational questionnaire (OOQ) varies slightly depending upon the participant’s reported area of occupation (agriculture [AttF1.1], cosmetology [AttF1.2], electronic equipment operator [AttF1.3], healthcare [AttF1.4], janitorial [AttF1.5], office worker [AttF1.6], restaurant [AttF.7], or teaching [AttF1.8])

4 Att^1 is for stillbirth without a birth defect and Att^2 for live born controls and stillbirths with a birth defect

5 Att^1 is for women who completed both the core and stillbirth CATI, Att^2 is for women who completed the core CATI but not the stillbirth CATI, and Att^3 for women completed the stillbirth CATI at a later date.

6 Att^1 is for former BD-STEPS participants and Att^2 for women who did not participate in BD-STEPS

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorAiles, Elizabeth (CDC/DDNID/NCBDDD/DBDID)
File Modified0000-00-00
File Created2024-07-20

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