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

Forms and Documents

Document Name	Status
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
6812New Approval - IRB.docx Supplementary Document	2016-10-27
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 2 _60dy FRN published.pdf Supplementary Document	2016-10-19
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
SupSta B_SEED Phase 3.docx Supporting Statement B	2016-10-19
SEED-3_SupSta A_revised 3-8-17.docx Supporting Statement A	2017-03-16

IC Document Collections

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

ICR Details

OMB Control No: 0920-1171	ICR Reference No: 201610-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16PA
Title: The Study to Explore Early Development (SEED) - Phase 3
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/16/2017
	Date Received in OIRA: 10/31/2016
Terms of Clearance: 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	03/31/2020	36 Months From Approved
Responses	11,447	0	0
Time Burden (Hours)	7,118	0	0
Cost Burden (Dollars)	0	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.

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Authorizing Statute(s): 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
  

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:
	81 FR 9600	02/24/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 71505	10/17/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 27

IC Title	Form No.	Form Name
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
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)

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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	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

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: This is a new data collection.

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Annual Cost to Federal Government: $6,130,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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? Uncollected

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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: 10/31/2016

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