The Study to Explore Early Development (SEED)

Forms and Documents

Document Name	Status
Form No number Follow-Up Telephone Calls Form and Instruction	Modified
Form No number SEED - Biosamples Form and Instruction	Modified
Form No number SEED - Clinic Visit- Case Child Form and Instruction	Modified
SEED - Clinic Visit -Control Children Form and Instruction	Modified
Form No number SEED- Clinic Visit - Control Parent Form and Instruction	Modified
Form No number SEED - Clinic Visit- Case Parent Form and Instruction	Modified
Form No number SEED - Medical Record Abstraction Form and Instruction	Modified
Form No number SEED - Questionaire Packets Form and Instruction	Modified
Appendix E.3 Informed Consent NIC&Sub6-4-2007.doc Supplementary Document	2007-09-14
Appendix E.3 Informed Consent Case 2007 06.doc Supplementary Document	2007-09-14
Appendix E.8 Study Bill of Rights 2007 06.doc Supplementary Document	2007-09-12
Appendix E.5 Caregiver Interview Prep Guide 2007 06.doc Supplementary Document	2007-09-12
Appendix E.4 Clinic Visit Prep Guide 2007 06.doc Supplementary Document	2007-09-12
Appendix E.2 Yellow Folder Instructions 2007 06.doc Supplementary Document	2007-09-12
Appendix E.1 Enrollment Packet Cover letters 2007 06.doc Supplementary Document	2007-09-12
Appendix M.1 Invitation Letters 2007 06.doc Supplementary Document	2007-09-11
83-C Detailed Explanation 8-24-07.doc Justification for No Material/Nonsubstantive Change	2007-08-30
CADDRE Supporting Statement to OMB 2007 06 20.doc Supporting Statement A	2007-08-30

IC Document Collections

IC ID	Document Title	Status
180497	Follow-Up Telephone Calls Form and Instruction	Modified
178556	SEED - Biosamples Form and Instruction	Modified
178555	SEED - Clinic Visit- Case Child Form and Instruction	Modified
178554	SEED - Clinic Visit -Control Children Form and Instruction	Modified
178553	SEED- Clinic Visit - Control Parent Form and Instruction	Modified
178552	SEED - Clinic Visit- Case Parent Form and Instruction	Modified
178551	SEED- Care Giver Appendix B.2 , Appendix B.1 Instruction	Modified
178550	SEED - Medical Record Abstraction Form and Instruction	Modified
178540	SEED - Questionaire Packets Form and Instruction	Modified
178539	SEED - Invitation Telephone Call Other-Other	Modified
178538	SEED - Mailed Invitation Packet Instruction	Modified

ICR Details

OMB Control No: 0920-0741	ICR Reference No: 200709-0920-004
Status: Historical Active	Previous ICR Reference No: 200702-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: The Study to Explore Early Development (SEED)
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: 10/21/2007
	Date Received in OIRA: 09/28/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2010	06/30/2010	06/30/2010
Responses	146,278	0	146,278
Time Burden (Hours)	50,448	0	50,448
Cost Burden (Dollars)	0	0	0

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Abstract: The Children's Health Act of 2000 mandated the National Center on Birth Defects and Developmental Disabilities (NCBDDD) to collect data on the causes, diagnosis, early detection, prevention, control, and treatment of autism. In response to this mandate, this collaborative research study was developed to identify risk factors and possible causes for autism spectrum disorders. The study will be conducted at six sites throughout the U.S., including NCBDDD. Data collection will include participant interviews and questionnaires, medical record review, genetic sampling, and child developmental evaluations. Six hundred forty-four participants identified as cases will be enrolled across sites. One thousand two hundred eight-eight participants identified as controls will be enrolled across sites. Information gathered from each site will be pooled into a common dataset.

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Authorizing Statute(s): PL: Pub.L. 108 - 154 2 Name of Law: Birth Defects and Developmental Disabilities Prevention Act of 2003
   US Code: 42 USC 241 Name of Law: null
   US Code: 42 USC 257b-4 Name of Law: null
  

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:
	71 FR 58865	10/05/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 566	01/05/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
SEED - Mailed Invitation Packet	No number	SEED Brochure Appendix M.2
SEED - Invitation Telephone Call
SEED - Questionaire Packets	No number, No number, No number, No number, No number, No number, No number, No number, No number, No number, No number, No number, No number	Appendix E.17 SRS-child version ,   Appendix H.1 3Day Diet Diary ,   Appendix H.2 7 Day Stool Diary ,   Appendix E.18 HIPAA release form ,   Appendix E.10 Carey Temperment Scales ,   Appendix E.15 PatOccup Hx ,   Appendix E. 16 Child Sleep Habits ,   Appendix E.17 SRS-adult version ,   Appendix E.11 CBCL ,   Appendix E.3 Informed Consent NIC & Sub ,   Appendix E.12 GI questionaire ,   Appendix E.13 Maternal MedHX ,   Appendix E.14 Paternal MedHX
SEED - Medical Record Abstraction	No number	Appendix S.1 Medical Record Request and Script
SEED- Care Giver Appendix B.2 , Appendix B.1
SEED - Clinic Visit- Case Parent	No number, No number, No number, No number, No number	Appendix F. 3 Services and Treatment Q ,   Appendix E.3 Informed Consent ,   Appendix E.3 Informed Consent NIC & Sub ,   Appendic F.2 EDQ ,   Appendix F.4 Vineland
SEED- Clinic Visit - Control Parent	None, No number, No number	Appendix E.3 Informed Consent NIC & Sub ,   Appendix F.4 Vineland ,   Appendix E.3 Informed Consent Case
SEED - Clinic Visit -Control Children	None, None	Appendix G.2 Mullen ,   appendix P Dysmorphology Exam
SEED - Clinic Visit- Case Child	No number, None, None	Appendix G.1 ADOS ,   Appendix G.2 Mullen ,   appendix P Dysmorphology Exam
SEED - Biosamples	No number, No number, No number, No number, No number	Appendix E.21 Buccal Transmittal Form ,   Appendix R.2 Blood Draw Form ,   Appendix R.20 Buccal IC bioMom ,   Appendix E.20 Buccal IC bio Dad ,   Appendix E.19 How to Collect Cheek Cell
Follow-Up Telephone Calls	No number	Appendix O Follow up Calls

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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	146,278	146,278	0	0	0	0
Annual Time Burden (Hours)	50,448	50,448	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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:

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Annual Cost to Federal Government: $3,380,292

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/28/2007

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