The Study to Explore Early Development (SEED) - Phase 3

ICR 201610-0920-010

OMB: 0920-1171

Federal Form Document

Forms and Documents
Document
Name
Status
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
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-27
Supplementary Document
2016-10-19
Supplementary Document
2016-10-19
Supplementary Document
2016-10-19
Supplementary Document
2016-10-19
Supporting Statement B
2016-10-19
Supporting Statement A
2017-03-16
IC Document Collections
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ICR Details
0920-1171 201610-0920-010
Historical Active
HHS/CDC 16PA
The Study to Explore Early Development (SEED) - Phase 3
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 03/16/2017
Retrieve Notice of Action (NOA) 10/31/2016
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
03/31/2020 36 Months From Approved
11,447 0 0
7,118 0 0
0 0 0

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.

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

Not associated with rulemaking

  81 FR 9600 02/24/2016
81 FR 71505 10/17/2016
Yes

  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 11,447 0 0 11,447 0 0
Annual Time Burden (Hours) 7,118 0 0 7,118 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$6,130,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Thelma Sims 4046394771

  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.
10/31/2016


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