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

Forms and Documents

Document Name	Status
Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment) Form and Instruction	New
Child Behavior Checklist (for Covid-19 Impact Assessment) Form and Instruction	New
OMB0920_1171 NonSubstantive Change Request Memo_11022020.docx Justification for No Material/Nonsubstantive Change	2020-11-03
ITEM #2 Appendix B_COV-IMP_Power Calculations.docx Supplementary Document	2020-11-03
ITEM #1 Appendix A_COV-IMP_Surveys with prior COVID content.docx Supplementary Document	2020-11-03
ITEM #7 Appendix A.1_COV-IMP_ Invitation letter.docx Supplementary Document	2020-11-03
OMB0920_1171 NonSubstantive Change Request August 24 2020.docx Justification for No Material/Nonsubstantive Change	2020-08-27
Att 1 SEED 3 PROTOCOL_amendment #6_7-21-20.docx Supplementary Document	2020-08-27
Att 21.d. Follow-up Call Items Checklist SEED 3_3-7-17.docx Supplementary Document	2017-03-16
Att 19.h. Invitation E-mail Notice SEED 3_3-7-17.docx Supplementary Document	2017-03-16
Attachment 19.h. Invitation E-mail Notice SEED 3.docx Supplementary Document	2016-10-27
Attachment 25. References.docx Supplementary Document	2016-10-27
Attachment 23.f. Age Out Letter_SEED 3.doc Supplementary Document	2016-10-27
Attachment 23.e. Thank you or general Greeting Card_SEED 3.docx Supplementary Document	2016-10-27
Attachment 23.d. ThankYouLetter_DD Completion Letter _SEED 3.doc Supplementary Document	2016-10-27
Attachment 23.c. ThankYouLetter ASD POP_SEED 3.doc Supplementary Document	2016-10-27
Attachment 23.b. ThankYou_Open-Ended Refusal Letter_SEED 3.doc Supplementary Document	2016-10-27
Attachment 23.a. Parental Feedback Letter SEED3.docx Supplementary Document	2016-10-27
Attachment 22. Passive Refusal Letter SEED 3.doc Supplementary Document	2016-10-27
Attachment 15.d. Clinic Visit Prep Guide POP SEED 3_revised.docx Supplementary Document	2016-10-27
Attachment 15.c. Clinic Visit Prep Guide ASD SEED 3_revised.doc Supplementary Document	2016-10-27
Attachment 15.b. Picture Story Book SEED 3.docx Supplementary Document	2016-10-27
Attachment 15.a. Frequently Asked Questions about Biologic Sampling SEED 3.doc Supplementary Document	2016-10-27
Attachment 14. Review Panel for SEED 2015.docx Supplementary Document	2016-10-27
Attachment 13. List of SEED 2 PIs.docx Supplementary Document	2016-10-27
Att 19 - IRB Approval.doc Supplementary Document	2019-10-11
Attachment 4.b. ICD DSM Code Spec ED Lists SEED 3.xls Supplementary Document	2016-10-27
Attachment 4.a. SEED_3 Eligibility Criteria_12sept2016.docx Supplementary Document	2016-10-27
Attachment 3 Site Specific Ascertainment SEED 3_9-16-16.docx Supplementary Document	2016-10-27
Att 9a 60-Day FRN.pdf Supplementary Document	2019-10-11
Attachment 1.c. - Children's Health ACT SEED 3.doc Supplementary Document	2016-10-19
Attachment 1.b. - Combating Autism Act of 2006.pdf Supplementary Document	2016-10-19
Attachment 1.a. - Public Health Service Act.pdf Supplementary Document	2016-10-19
SS B_SEED Phase 3 revised 8-1-2019.docx Supporting Statement B	2019-10-11
SS A_SEED Phase 3 revised 8-8-2019.docx Supporting Statement A	2019-10-11

IC Document Collections

IC ID	Document Title	Status
244371	Invitation to Participate in the Covid-19 Impact Assessment Other-Invitation Letter	New
244369	Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment) Form and Instruction	New
244367	Covid-19 Impact Survey	New
244362	Child Behavior Checklist (for Covid-19 Impact Assessment) Form and Instruction	New
224190	Follow-up Call 2 Other-WORD	Unchanged
224189	Self Administered Forms Other-WORD	Unchanged
224188	Maternal Interview Call Other-WORD	Unchanged
224186	DD - POST-ENROLLMENT F/U Phone Call Script Other-WORD	Unchanged
224184	Enrollment Packet (DD) Other-WORD	Unchanged
224183	Invitation Call Script Other-WORD	Unchanged
224182	DD- PRE-ENROLLMENT Invitation Packet/Response Card (Mother) Other-WORD	Unchanged
224167	Clinic/Home Visit - Developmental Assessment (Child) Other-WORD	Unchanged
224166	Clinc/Home Visit - Saliva Collection (optional) Father Instruction	Unchanged
224165	Clicnic/Home Visit - Developmental Assessment (Mother) Other-WORD	Unchanged
224164	Followup Call 2 Other-WORD	Unchanged
224163	Self-Administered Forms (Mother) Other-WORD	Unchanged
224156	Maternal Interview Call Other-WORD	Unchanged
224023	POP - POST ENROLLMENT_F/U Phone Call Script and Pregnancy Ref Form (Mother) Other-WORD	Unchanged
224022	ENROLLMENT Packet (Mother) Other-WORD	Unchanged
224021	Invitation Call Script and SCQ (Mother) Other-WORD	Unchanged
224020	POP - PRE-ENROLLMENT Invitation Packet/Response Card (Mother) Other-WORD	Unchanged
224019	Clinic / Home Visit -Development Assessment (Child) Other-WORD	Unchanged
224018	Clinic / Home Vist -- Saliva Collection (Father) Instruction	Unchanged
224017	Clinic / Home Visit - Saliva Collection (Mother) Other-WORD	Unchanged
224016	Follow-up Call 2 (Mother) POP Other-WORD	Unchanged
224015	Self Administered Forms (Mother) Other-WORD	Unchanged
224014	Maternal Interview (Mother) Other-WORD	Unchanged
224013	ASD - POST ENROLLMENT _F/U Phone Call / Pregnancy Ref Form- (Mother) Other-WORD	Unchanged
224012	Enrollment Packet - ASD (Mother) Other-WORD	Unchanged
224011	ASD - ENROLLMENT-Invitation Call Script and SCQ (Mother) Other-WORD	Unchanged
224009	ASD - PRE-ENROLLMENT_Invitation Packet/Response Card (Mother) Other-WORD	Unchanged

ICR Details

OMB Control No: 0920-1171	ICR Reference No: 202011-0920-002
Status: Historical Active	Previous ICR Reference No: 202008-0920-014
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1171-21AW
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 without change	Conclusion Date: 11/11/2020
	Date Received in OIRA: 11/04/2020
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	11,447
Time Burden (Hours)	8,670	0	7,118
Cost Burden (Dollars)	39,902	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 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
Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment)	n/a	Vineland Adaptive Behavior Scales, second edition, Survey Interview Form
Invitation to Participate in the Covid-19 Impact Assessment
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
Covid-19 Impact Survey	n/a

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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	11,447	0	5,320	0	0
Annual Time Burden (Hours)	8,670	7,118	0	1,552	0	0
Annual Cost Burden (Dollars)	39,902	0	0	39,902	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Additional information collection will support assessment of Covid-19 impacts.

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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

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Common Form ICR:  No

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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: 11/04/2020

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