View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-1171
ICR Reference No:
202012-0920-003
Status:
Historical Active
Previous ICR Reference No:
202011-0920-002
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1171-21BF
Title:
The Study to Explore Early Development (SEED) - Phase 3 (Modified for COVID-19 Impact Assessment)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
12/10/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/08/2020
Terms of Clearance:
Previous terms continue: Approved consistent with the understanding that tokens of appreciation offered to participants in the study will not be offered prior to agreement to participate in the full study (i.e., no incentives offered for eligibility screening).
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2021
12/31/2021
12/31/2021
Responses
16,767
0
16,767
Time Burden (Hours)
8,670
0
8,670
Cost Burden (Dollars)
39,902
0
39,902
Abstract:
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.
Authorizing Statute(s):
US Code:
42 USC 247b-4
Name of Law: The Combating Autism Act of 2006
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 24144
05/24/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 51588
09/30/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
31
IC Title
Form No.
Form Name
ASD - ENROLLMENT-Invitation Call Script and SCQ (Mother)
ASD - POST ENROLLMENT _F/U Phone Call / Pregnancy Ref Form- (Mother)
ASD - PRE-ENROLLMENT_Invitation Packet/Response Card (Mother)
Child Behavior Checklist (for Covid-19 Impact Assessment)
n/a, n/a
Child Behavior Checklist for Ages 1 1/2 - 5 Years
,
Child Behavior Checklist for Ages 6-18
Clicnic/Home Visit - Developmental Assessment (Mother)
Clinc/Home Visit - Saliva Collection (optional) Father
Clinic / Home Visit - Saliva Collection (Mother)
Clinic / Home Visit -Development Assessment (Child)
Clinic / Home Vist -- Saliva Collection (Father)
Clinic/Home Visit - Developmental Assessment (Child)
Covid-19 Impact Survey
0920-21BF, 0920-21BF
COVID-19 Impact Study, 2020
,
Survey Cover Sheet
DD - POST-ENROLLMENT F/U Phone Call Script
DD- PRE-ENROLLMENT Invitation Packet/Response Card (Mother)
ENROLLMENT Packet (Mother)
Enrollment Packet (DD)
Enrollment Packet - ASD (Mother)
Follow-up Call 2
Follow-up Call 2 (Mother) POP
Followup Call 2
Invitation Call Script
Invitation Call Script and SCQ (Mother)
Invitation to Participate in the Covid-19 Impact Assessment
Maternal Interview (Mother)
Maternal Interview Call
Maternal Interview Call
POP - POST ENROLLMENT_F/U Phone Call Script and Pregnancy Ref Form (Mother)
POP - PRE-ENROLLMENT Invitation Packet/Response Card (Mother)
Self Administered Forms
Self Administered Forms (Mother)
Self-Administered Forms (Mother)
Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment)
n/a
Vineland Adaptive Behavior Scales, second edition, Survey Interview Form
ICR Summary of Burden
Total Approved
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$6,702,262
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Odion Clunis 770 488-0045 lta2@cdc.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/08/2020
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