OMB control number

The Study to Explore Early Development (SEED) - Phase 3 (Modified for COVID-19 Impact Assessment)

OMB 0920-1171 · HHS/CDC.

OMB 0920-1171

SEED is a multi-state case-control study designed to investigate risk factors for Autism Spectrum Disorders (ASDs) and the health and behavioral characteristics of children with ADS. SEED is specifically designed focused on preconception, prenatal, perinatal and early postnatal risk factors with primary emphasis on genetic, infectious, immunological, hormonal, and obstetric risk factors. Due to COVID-19, remote administration and feedback is being proposed in this change request.

The latest form for The Study to Explore Early Development (SEED) - Phase 3 (Modified for COVID-19 Impact Assessment) expires 2021-12-31 and is listed under ICR 202012-0920-003.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Form 0920-21CS Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment)	Form
Form 0920-21CS Covid-19 Impact Survey	Form and Instruction
Form 0920-21CS Child Behavior Checklist (for Covid-19 Impact Assessment)	Form and Instruction
Appendix C.1s_COV-IMP_Spanish CBCL_1-5yrs_pages 2-4.pdf	Supplementary Document
Appendix C.1_COV-IMP_CBCL_1-5yrs.pdf	Supplementary Document
OMB0920_1171 NonSubstantive Change_Spanish_1-20-21_final.docx	Supplementary Document
OMB0920_1171 NonSubstantive Change Request Memo_11022020.docx	Justification for No Material/Nonsubstantive Change
ITEM #2 Appendix B_COV-IMP_Power Calculations.docx	Supplementary Document
ITEM #1 Appendix A_COV-IMP_Surveys with prior COVID content.docx	Supplementary Document
ITEM #7 Appendix A.1_COV-IMP_ Invitation letter.docx	Supplementary Document
OMB0920_1171 NonSubstantive Change Request August 24 2020.docx	Justification for No Material/Nonsubstantive Change
Att 1 SEED 3 PROTOCOL_amendment #6_7-21-20.docx	Supplementary Document
Att 21.d. Follow-up Call Items Checklist SEED 3_3-7-17.docx	Supplementary Document
Att 19.h. Invitation E-mail Notice SEED 3_3-7-17.docx	Supplementary Document
Attachment 19.h. Invitation E-mail Notice SEED 3.docx	Supplementary Document
Attachment 25. References.docx	Supplementary Document
Attachment 23.f. Age Out Letter_SEED 3.doc	Supplementary Document
Attachment 23.e. Thank you or general Greeting Card_SEED 3.docx	Supplementary Document
Attachment 23.d. ThankYouLetter_DD Completion Letter _SEED 3.doc	Supplementary Document
Attachment 23.c. ThankYouLetter ASD POP_SEED 3.doc	Supplementary Document
Attachment 23.b. ThankYou_Open-Ended Refusal Letter_SEED 3.doc	Supplementary Document
Attachment 23.a. Parental Feedback Letter SEED3.docx	Supplementary Document
Attachment 22. Passive Refusal Letter SEED 3.doc	Supplementary Document
Attachment 15.d. Clinic Visit Prep Guide POP SEED 3_revised.docx	Supplementary Document
Attachment 15.c. Clinic Visit Prep Guide ASD SEED 3_revised.doc	Supplementary Document
Attachment 15.b. Picture Story Book SEED 3.docx	Supplementary Document
Attachment 15.a. Frequently Asked Questions about Biologic Sampling SEED 3.doc	Supplementary Document
Attachment 14. Review Panel for SEED 2015.docx	Supplementary Document
Attachment 13. List of SEED 2 PIs.docx	Supplementary Document
Att 19 - IRB Approval.doc	Supplementary Document
Attachment 4.b. ICD DSM Code Spec ED Lists SEED 3.xls	Supplementary Document
Attachment 4.a. SEED_3 Eligibility Criteria_12sept2016.docx	Supplementary Document
Attachment 3 Site Specific Ascertainment SEED 3_9-16-16.docx	Supplementary Document
Att 9a 60-Day FRN.pdf	Supplementary Document
Attachment 1.c. - Children's Health ACT SEED 3.doc	Supplementary Document
Attachment 1.b. - Combating Autism Act of 2006.pdf	Supplementary Document
Attachment 1.a. - Public Health Service Act.pdf	Supplementary Document
SS B_SEED Phase 3 revised 8-1-2019.docx	Supporting Statement B
SS A_SEED Phase 3 revised 8-8-2019.docx	Supporting Statement A
Invitation to Participate in the Covid-19 Impact Assessment	Other-Invitation Letter
Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment)	Form
Covid-19 Impact Survey	Form and Instruction
Child Behavior Checklist (for Covid-19 Impact Assessment)	Form and Instruction
Follow-up Call 2	Other-WORD
Self Administered Forms	Other-WORD
Maternal Interview Call	Other-WORD
DD - POST-ENROLLMENT F/U Phone Call Script	Other-WORD
Enrollment Packet (DD)	Other-WORD
Invitation Call Script	Other-WORD
DD- PRE-ENROLLMENT Invitation Packet/Response Card (Mother)	Other-WORD
Clinic/Home Visit - Developmental Assessment (Child)	Other-WORD
Clinc/Home Visit - Saliva Collection (optional) Father	Instruction
Clicnic/Home Visit - Developmental Assessment (Mother)	Other-WORD
Followup Call 2	Other-WORD
Self-Administered Forms (Mother)	Other-WORD
Maternal Interview Call	Other-WORD
POP - POST ENROLLMENT_F/U Phone Call Script and Pregnancy Ref Form (Mother)	Other-WORD
ENROLLMENT Packet (Mother)	Instruction
Invitation Call Script and SCQ (Mother)	Other-WORD
POP - PRE-ENROLLMENT Invitation Packet/Response Card (Mother)	Other-WORD
Clinic / Home Visit -Development Assessment (Child)	Other-WORD
Clinic / Home Vist -- Saliva Collection (Father)	Other-WORD
Clinic / Home Visit - Saliva Collection (Mother)	Instruction
Follow-up Call 2 (Mother) POP	Other-WORD
Self Administered Forms (Mother)	Other-WORD
Maternal Interview (Mother)	Other-WORD
ASD - POST ENROLLMENT _F/U Phone Call / Pregnancy Ref Form- (Mother)	Other-WORD
Enrollment Packet - ASD (Mother)	Other-WORD
ASD - ENROLLMENT-Invitation Call Script and SCQ (Mother)	Other-WORD
ASD - PRE-ENROLLMENT_Invitation Packet/Response Card (Mother)	Other-WORD

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202102-0920-008	No material or nonsubstantive change to a currently approved collection	2021-02-18	Approved without change
202012-0920-003	No material or nonsubstantive change to a currently approved collection	2020-12-08	Approved with change
202011-0920-014	Revision of a currently approved collection	2020-11-25	Withdrawn and continue
202011-0920-002	No material or nonsubstantive change to a currently approved collection	2020-11-04	Approved without change
202008-0920-014	No material or nonsubstantive change to a currently approved collection	2020-08-27	Approved without change
201910-0920-002	Extension without change of a currently approved collection	2019-10-16	Approved without change
201610-0920-010	New collection (Request for a new OMB Control Number)	2016-10-31	Approved with change

OMB Details

ASD - PRE-ENROLLMENT_Invitation Packet/Response Card (Mother)

Federal Enterprise Architecture: Health - Public Health Monitoring