List of Attachments

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 Letter^1,2

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 Questionnaire^1,3

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 Letter^1,4

Attachment G3 Stillbirth Introductory Script¹

Attachment G4 Stillbirth Thank You Letter^1,5

Attachment G5 Introductory Letter for Stillbirth COVID-19 Sub-Study^1,6

Attachment G6 Authorization Form for Stillbirth COVID-19 Sub-Study^1,6

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