List of OMB appendices (2)

Appendices

Appendix A: Authorizing legislation & other relevant laws

Appendix B: Primary Caregiver Interview

B.1 –Telephone Script

B.2 – Primary Caregiver Interview

Appendix C.1: 60 day Federal Registry Notice

Appendix C.2: Public Comment Received

Appendix D: Study Flow

D.1 Data Collection Flow Diagram

D.2 Data Collection Flow Outline

D.3 Data Collection Instruments Summary Table

D.4 Research Domains by Data Collection Activity

Appendix E: Enrollment Packet

E.1 Cover Letter

E.2 Cover Sheet

E.3 Written Informed Consent Document

E.4 Clinic Visit Prep Guide

E.5 Caregiver Interview Prep Guide

E.6 Glossary of Medical Terms

E.7 Frequently Asked Questions on Biosampling

E.8 Rights of Research Subjects Fact Sheet

E.9 Autoimmune Disease Survey

E.10 Carey Temperament Scales

E.11 Child Behavior Checklist

E.12 Survey of Gastrointestinal Function

E.13 Maternal Medical History

E.14 Paternal Medical History

E.15 Paternal Occupational Questionnaire

E.16 Child’s Sleep Habits Questionnaire

E.17 Social Responsiveness Scale (Adult & Child versions)

E.18 HIPAA Provider Checklist and Medical Records Release Form

E.19 How to Collect Cheek Cell Samples

E.20 Informed Consent Document – Cheek Swab (Mother & Father)

E.21 Cheek Swab Sample Record Sheet

E.22 Social Story Example: Trip to the JFK Center

Appendix F: Clinic Visit – Parent Portion

F.1 ADI-R

F.2 Early Development Questionnaire

F.3 Services and Treatments Interview

F.4 Vineland Adaptive Behavior Scales

Appendix G: Clinic Visit – Child Development Evaluation

G.1 ADOS

G.2 Mullen Scales of Early Learning

Appendix H: Self-Administered Packet II

H.1 Three-day diet diary

H.2 Seven-day stool diary

Appendix I: CDC IRB Approval Letter

Appendix J: Social Communication Questionnaire

Appendix K: CADDRE Case, Comparison Group, and Subcohort Ascertainment Methodology

Appendix L: ICD-9 Codes/Part B School Eligibility Criteria

Appendix M: Introductory Packet (Letter of Introduction, Study Brochure, Response Card, Study Posters)

Appendix N: Invitation Phone Call

Appendix O: Follow-Up Phone Calls

O.1 Follow-Up Phone Call

O.2 Reminder Phone Call Script for Clinic Visits and Caregiver Interview

Appendix P: Dysmorphology Exam: Protocol and Data Collection Form

Appendix Q: Administration of the Vineland in the Sub-cohort Telephone Script

Appendix R: Biosamples

R.1 Summary of Biosample Shipping, Processing and Storage

R.2 Blood Draw Information Form

Appendix S: Medical Record Abstraction Forms

S.1 Medical Record Request Script and Fax Letter

S.2 Prenatal Chart Abstraction Form

S.3 Labor & Delivery Chart Abstraction Form

S.4 Neonatal Medical Record Abstraction Form

S.5 Pediatric Chart Abstraction Form

Appendix T: Study Hypotheses and Data Collection Tools

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