The Study to Explore Early Development (SEED)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form No number Appendix O Follow up Calls	Form and Instruction	Modified	Available
Form No number Appendix E.19 How to Collect Cheek Cell	Form and Instruction	Modified	Available
Form No number Appendix R.2 Blood Draw Form	Form and Instruction	Modified	Available
Form No number Appendix E.20 Buccal IC bio Dad	Form and Instruction	Modified	Available
Form No number Appendix R.20 Buccal IC bioMom	Form and Instruction	Modified	Available
Form No number Appendix E.21 Buccal Transmittal Form	Form and Instruction	Modified	Available
appendix P Dysmorphology Exam	Form and Instruction	Modified	Available
Appendix G.2 Mullen	Form and Instruction	Modified	Repair queued
Form No number Appendix G.1 ADOS	Form and Instruction	Modified	Available
appendix P Dysmorphology Exam	Form and Instruction	Modified	Available
Appendix G.2 Mullen	Form and Instruction	Modified	Available
Form No number Appendix E.3 Informed Consent Case	Form and Instruction	Modified	Available
Appendix F.4 Vineland	Form and Instruction	Modified	Available
Form No number Appendix E.3 Informed Consent NIC & Sub	Form and Instruction	Modified	Available
Form No number Appendix F.4 Vineland	Form and Instruction	Modified	Available
Form No number Appendic F.2 EDQ	Form and Instruction	Modified	Available
Form No number Appendix E.3 Informed Consent NIC & Sub	Form and Instruction	Modified	Available
Form No number Appendix E.3 Informed Consent	Form and Instruction	Modified	Available
Form No number Appendix F. 3 Services and Treatment Q	Form and Instruction	Modified	Available
Form No number Appendix S.1 Medical Record Request and Script	Form and Instruction	Modified	Repair queued
Form No number Appendix E.11 CBCL	Form and Instruction	Modified	Available
Form No number Appendix E.17 SRS-adult version	Form and Instruction	Modified	Available
Form No number Appendix E. 16 Child Sleep Habits	Form and Instruction	Modified	Available
Form No number Appendix E.15 PatOccup Hx	Form and Instruction	Modified	Available
Form No number Appendix E.10 Carey Temperment Scales	Form and Instruction	Modified	Available
Form No number Appendix E.18 HIPAA release form	Form and Instruction	Modified	Repair queued
Form No number Appendix H.2 7 Day Stool Diary	Form and Instruction	Modified	Available
Form No number Appendix H.1 3Day Diet Diary	Form and Instruction	Modified	Available
Form No number Appendix E.14 Paternal MedHX	Form and Instruction	Modified	Available
Form No number Appendix E.13 Maternal MedHX	Form and Instruction	Modified	Available
Form No number Appendix E.12 GI questionaire	Form and Instruction	Modified	Available
Form No number Appendix E.3 Informed Consent NIC & Sub	Form and Instruction	Modified	Available
Form No number Appendix E.17 SRS-child version	Form and Instruction	Modified	Available
Form No number SEED Brochure Appendix M.2	Form and Instruction	Modified	Available
Appendix E.3 Informed Consent NIC&Sub6-4-2007.doc	Supplementary Document	Uploaded 2007-09-14	Available
Appendix E.3 Informed Consent Case 2007 06.doc	Supplementary Document	Uploaded 2007-09-14	Available
Appendix E.8 Study Bill of Rights 2007 06.doc	Supplementary Document	Uploaded 2007-09-12	Available
Appendix E.5 Caregiver Interview Prep Guide 2007 06.doc	Supplementary Document	Uploaded 2007-09-12	Available
Appendix E.4 Clinic Visit Prep Guide 2007 06.doc	Supplementary Document	Uploaded 2007-09-12	Available
Appendix E.2 Yellow Folder Instructions 2007 06.doc	Supplementary Document	Uploaded 2007-09-12	Available
Appendix E.1 Enrollment Packet Cover letters 2007 06.doc	Supplementary Document	Uploaded 2007-09-12	Available
Appendix M.1 Invitation Letters 2007 06.doc	Supplementary Document	Uploaded 2007-09-11	Available
83-C Detailed Explanation 8-24-07.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2007-08-30	Available
CADDRE Supporting Statement to OMB 2007 06 20.doc	Supporting Statement A	Uploaded 2007-08-30	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
180497	Follow-Up Telephone Calls	Form and Instruction	Modified	Appendix O Follow up Calls
178556	SEED - Biosamples	Form and Instruction	Modified	Appendix E.19 How to Collect Cheek Cell
178556	SEED - Biosamples	Form and Instruction	Modified	Appendix R.2 Blood Draw Form
178556	SEED - Biosamples	Form and Instruction	Modified	Appendix E.20 Buccal IC bio Dad
178556	SEED - Biosamples	Form and Instruction	Modified	Appendix R.20 Buccal IC bioMom
178556	SEED - Biosamples	Form and Instruction	Modified	Appendix E.21 Buccal Transmittal Form
178555	SEED - Clinic Visit- Case Child	Form and Instruction	Modified	appendix P Dysmorphology Exam
178555	SEED - Clinic Visit- Case Child	Form and Instruction	Modified	Appendix G.2 Mullen
178555	SEED - Clinic Visit- Case Child	Form and Instruction	Modified	Appendix G.1 ADOS
178554	SEED - Clinic Visit -Control Children	Form and Instruction	Modified	appendix P Dysmorphology Exam
178554	SEED - Clinic Visit -Control Children	Form and Instruction	Modified	Appendix G.2 Mullen
178553	SEED- Clinic Visit - Control Parent	Form and Instruction	Modified	Appendix E.3 Informed Consent Case
178553	SEED- Clinic Visit - Control Parent	Instruction	Modified
178553	SEED- Clinic Visit - Control Parent	Form and Instruction	Modified	Appendix F.4 Vineland
178553	SEED- Clinic Visit - Control Parent	Form and Instruction	Modified	Appendix E.3 Informed Consent NIC & Sub
178552	SEED - Clinic Visit- Case Parent	Form and Instruction	Modified	Appendix F.4 Vineland
178552	SEED - Clinic Visit- Case Parent	Form and Instruction	Modified	Appendic F.2 EDQ
178552	SEED - Clinic Visit- Case Parent	Form and Instruction	Modified	Appendix E.3 Informed Consent NIC & Sub
178552	SEED - Clinic Visit- Case Parent	Form and Instruction	Modified	Appendix E.3 Informed Consent
178552	SEED - Clinic Visit- Case Parent	Form and Instruction	Modified	Appendix F. 3 Services and Treatment Q
178551	SEED- Care Giver Appendix B.2 , Appendix B.1	Instruction	Modified
178550	SEED - Medical Record Abstraction	Form and Instruction	Modified	Appendix S.1 Medical Record Request and Script
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.11 CBCL
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.17 SRS-adult version
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E. 16 Child Sleep Habits
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.15 PatOccup Hx
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.10 Carey Temperment Scales
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.18 HIPAA release form
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix H.2 7 Day Stool Diary
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix H.1 3Day Diet Diary
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.14 Paternal MedHX
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.13 Maternal MedHX
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.12 GI questionaire
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.3 Informed Consent NIC & Sub
178540	SEED - Questionaire Packets	Other-Autoimmune Questionnaire	Modified
178540	SEED - Questionaire Packets	Form and Instruction	Modified	Appendix E.17 SRS-child version
178539	SEED - Invitation Telephone Call	Other-Other	Modified
178538	SEED - Mailed Invitation Packet	Form and Instruction	Modified	SEED Brochure Appendix M.2
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
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/28/2007
Terms of Clearance:

table that charts list comparision

	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
   US Code: 42 USC 257b-4
  

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

table that charts list of burden

IC Title	Form No.	Form Name
Follow-Up Telephone Calls	No number	Appendix O Follow up Calls
SEED - Biosamples	No number, No number, No number, No number, No number	Appendix R.20 Buccal IC bioMom ,   Appendix E.20 Buccal IC bio Dad ,   Appendix E.21 Buccal Transmittal Form ,   Appendix R.2 Blood Draw Form ,   Appendix E.19 How to Collect Cheek Cell
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 - 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 - Invitation Telephone Call
SEED - Mailed Invitation Packet	No number	SEED Brochure Appendix M.2
SEED - Medical Record Abstraction	No number	Appendix S.1 Medical Record Request and Script
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.3 Informed Consent NIC & Sub ,   Appendix E.12 GI questionaire ,   Appendix E.13 Maternal MedHX ,   Appendix E.14 Paternal MedHX ,   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
SEED- Care Giver Appendix B.2 , Appendix B.1
SEED- Clinic Visit - Control Parent	None, No number, No number	Appendix F.4 Vineland ,   Appendix E.3 Informed Consent Case ,   Appendix E.3 Informed Consent NIC & Sub

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ICR Summary of Burden

table that charts list 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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