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

ICR 202102-0920-008

OMB: 0920-1171

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Supplementary Document
2021-02-11
Supplementary Document
2021-02-11
Supplementary Document
2021-02-11
Justification for No Material/Nonsubstantive Change
2020-11-03
Supplementary Document
2020-11-03
Supplementary Document
2020-11-03
Supplementary Document
2020-11-03
Justification for No Material/Nonsubstantive Change
2020-08-27
Supplementary Document
2020-08-27
Supplementary Document
2017-03-16
Supplementary Document
2017-03-16
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2019-10-11
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2019-10-11
Supplementary Document
2016-10-19
Supplementary Document
2016-10-19
Supplementary Document
2016-10-19
Supporting Statement B
2019-10-11
Supporting Statement A
2019-10-11
IC Document Collections
IC ID
Document
Title
Status
244371 Unchanged
244369 Modified
244367 Modified
244362 Modified
224190 Unchanged
224189 Unchanged
224188 Unchanged
224186 Unchanged
224184 Unchanged
224183 Unchanged
224182 Unchanged
224167 Unchanged
224166 Unchanged
224165 Unchanged
224164 Unchanged
224163 Unchanged
224156 Unchanged
224023 Unchanged
224022 Unchanged
224021 Unchanged
224020 Unchanged
224019 Unchanged
224018 Unchanged
224017 Unchanged
224016 Unchanged
224015 Unchanged
224014 Unchanged
224013 Unchanged
224012 Unchanged
224011 Unchanged
224009 Unchanged
ICR Details
0920-1171 202102-0920-008
Received in OIRA 202012-0920-003
HHS/CDC 0920-1171-21CS
The Study to Explore Early Development (SEED) - Phase 3 (Modified for COVID-19 Impact Assessment)
No material or nonsubstantive change to a currently approved collection   No
Regular 02/18/2021
  Requested Previously Approved
12/31/2021 12/31/2021
16,767 16,767
8,670 8,670
39,902 39,902

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.

US Code: 42 USC 301(a) Name of Law: PHSA
   PL: Pub.L. 109 - 416 409c Name of Law: The Children's Heath Care Act of 2000
   US Code: 42 USC 247b-4 Name of Law: The Combating Autism Act of 2006
  
None

Not associated with rulemaking

  84 FR 24144 05/24/2019
84 FR 51588 09/30/2019
No

31
IC Title Form No. Form Name
Maternal Interview Call
Self Administered Forms (Mother)
ASD - POST ENROLLMENT _F/U Phone Call / Pregnancy Ref Form- (Mother)
Clinic / Home Visit -Development Assessment (Child)
Self-Administered Forms (Mother)
POP - PRE-ENROLLMENT Invitation Packet/Response Card (Mother)
Follow-up Call 2 (Mother) POP
ASD - PRE-ENROLLMENT_Invitation Packet/Response Card (Mother)
Clinic / Home Vist -- Saliva Collection (Father)
Invitation Call Script and SCQ (Mother)
ENROLLMENT Packet (Mother)
DD- PRE-ENROLLMENT Invitation Packet/Response Card (Mother)
Invitation Call Script
Enrollment Packet (DD)
POP - POST ENROLLMENT_F/U Phone Call Script and Pregnancy Ref Form (Mother)
ASD - ENROLLMENT-Invitation Call Script and SCQ (Mother)
Enrollment Packet - ASD (Mother)
Maternal Interview (Mother)
Clinic / Home Visit - Saliva Collection (Mother)
Followup Call 2
Clicnic/Home Visit - Developmental Assessment (Mother)
Clinc/Home Visit - Saliva Collection (optional) Father
Clinic/Home Visit - Developmental Assessment (Child)
DD - POST-ENROLLMENT F/U Phone Call Script
Maternal Interview Call
Self Administered Forms
Follow-up Call 2
Child Behavior Checklist (for Covid-19 Impact Assessment) 0920-21CS, 0920-21CS CBCL Spanish 1-5 ,   CBCL School Age
Covid-19 Impact Survey 0920-21CS COVID-19 Impact Study, 2020
Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment) 0920-21CS, 0920-21CS Vinland Scoresheet ,   Vineland Adaptive Behavior Scales, second edition, Survey Interview Form
Invitation to Participate in the Covid-19 Impact Assessment

  Total Request 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 16,767 16,767 0 0 0 0
Annual Time Burden (Hours) 8,670 8,670 0 0 0 0
Annual Cost Burden (Dollars) 39,902 39,902 0 0 0 0
No
No

$6,702,262
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
No
Odion Clunis 770 488-0045 [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.
02/18/2021


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