The Study to Explore Early Development (SEED)

Forms and Documents

Document Name	Status
Form No number SEED - Follow-Up Telephone Calls Form and Instruction	Modified
_SEED_Supp_Statement_B.doc Supporting Statement B	2010-04-12
Appendix_Y_Participant_Newsletter_example.pdf Supplementary Document	2010-04-15
Appendix_X_Confidentiality_Agreement.doc Supplementary Document	2010-04-15
Appendix_W7_Certificate_Confidentiality_PA_Univ_PA.pdf Supplementary Document	2010-04-15
Appendix_W6_Certificate_Confidentiality_MD_JHU.pdf Supplementary Document	2010-04-15
Appendix_W5_Certificate_Confidentiality_NC.pdf Supplementary Document	2010-04-15
Appendix_W4_Certificate_Confidentiality_CO.pdf Supplementary Document	2010-04-15
Appendix_W3_Certificate_Confidentiality_CA.pdf Supplementary Document	2010-04-15
Appendix_W2_Certificate_Confidentiality_GA_RTI.pdf Supplementary Document	2010-04-15
Appendix_W1_Certificate_Confidentiality_GA_Batelle.pdf Supplementary Document	2010-04-15
Appendix_V_ListofRequestedChangestoICR_3_31_Clean.doc Supplementary Document	2010-04-15
Appendix_U _DataSharingApprovalProcess_DC_3_30_2010.doc Supplementary Document	2010-04-15
Appendix_T Hypotheses.doc Supplementary Document	2010-04-15
Appendix_Q Study Start Vineland Phone script 2007.doc Supplementary Document	2010-04-15
Appendix_L. ICD DSM Code List.doc Supplementary Document	2010-04-15
Appendix_K. SEED Acsertainment methodology.doc Supplementary Document	2010-04-15
Appendix_I CDC IRB Approval.pdf Supplementary Document	2010-04-15
Appendix_D.4 Research Domains by DC Activity.doc Supplementary Document	2010-04-15
Appendix_D.3 DC Instrument Summary Table.doc Supplementary Document	2010-04-15
Appendix_D.1 Study Data Collection Flow.pdf Supplementary Document	2010-04-15
Appendix_B.1 60dy FRN.pdf Supplementary Document	2010-04-15
Appendix_A_Authorizing Legislation.pdf Supplementary Document	2010-04-15
Appendix_Z_Detailed_Breakdown_BurdenHOURSand COSTS_margins_ok.docx Supplementary Document	2010-05-03
Appendix_R.1 Biosample Shipping, Processing & Storage.doc Supplementary Document	2010-04-27
Appendix_M.2_SEED ThankYouLetter 2007.doc Supplementary Document	2010-04-14
Appendix_M.3_SEED Parent feedback letter 17Aug09.doc Supplementary Document	2010-04-14
Appendix_M.1_SEEDPassive refusal letter 2007.doc Supplementary Document	2010-04-14
Appendix_E.7 Study Start Frequently Asked Questions on Biosampling 2007 .doc Supplementary Document	2010-04-26
Appendix_R.1 Biosample Shipping, Processing & Storage.doc Supplementary Document	2010-04-15
Appendix_E.19 Study Start How to collect Cheek Swab 2007.doc Supplementary Document	2010-04-15
Appendix P.1_ Dysmorphology Protocol.doc Supplementary Document	2010-04-27
Appendix_P.1 Study Start Child Control Clinic Visit Coversheet 2007.doc Supplementary Document	2010-04-26
Appendix_E.3 Study Start Informed Consent NIC- Sub 2007.doc Supplementary Document	2010-04-26
Appendix_S.5 PEDIATRIC FORM 3.6.09 FINAL.DOC Supplementary Document	2010-04-27
Appendix_S.4 NEONATAL FORM FINAL.DOC Supplementary Document	2010-04-27
Appendix_S.3 Labor and Delivery MR Form Final.doc Supplementary Document	2010-04-27
Appendix_S.2 Prenatal MR Form FINAL STUDY START VERSION.doc Supplementary Document	2010-04-27
Appendix_E.19 Study Start How to collect Cheek Swab 2007.doc Supplementary Document	2010-04-15
Appendix_E.16.1 Study Start Child Sleep Habits Questionnaires Coversheet 2007.doc Supplementary Document	2010-04-15
Appendix_E.8 Study Start Rights of Research Subjects.doc Supplementary Document	2010-04-15
Appendix_E.7 Study Start Frequently Asked Questions on Biosampling 2007 .doc Supplementary Document	2010-04-15
Appendix_E.6 Study Start Medical Glossary 2007.doc Supplementary Document	2010-04-15
Appendix_E.18.2 Study start medical records release cover sheets.doc Supplementary Document	2010-04-13
Appendix_E.18.1 Study Start HIPAA letter providerwksht 2007.doc Supplementary Document	2010-04-13
Appendix_E.17.3 Study Start Social Responsiveness Scale-preschool coversheet 2007.doc Supplementary Document	2010-04-13
Appendix_E.17.2 Study Start Social Responsiveness Scale adult coversheet 2007.doc Supplementary Document	2010-04-13
Appendix_E.17.1 Study Start Social Responsiveness Scale-child coversheet 2007.doc Supplementary Document	2010-04-13
Appendix_E.10.1 Study Start Carey Questionnaires Coversheet 2007.doc Supplementary Document	2010-04-13
Appendix_J Social Communication Questionnaire Coversheet.pdf Supplementary Document	2010-04-15
Appendix_M.2_SEED ThankYouLetter 2007.doc Supplementary Document	2010-04-14
Appendix_M.3_SEED Parent feedback letter 17Aug09.doc Supplementary Document	2010-04-14
Appendix_M.1_SEEDPassive refusal letter 2007.doc Supplementary Document	2010-04-14
_SEED_Sup St_A_042110.doc Supporting Statement A	2010-05-03

IC Document Collections

IC ID	Document Title	Status
192885	SEED_ Informed Consent Forms for Control Parents Other-WORD	New
192884	SEED Blood Draw Other-WORD	New
180497	SEED - Follow-Up Telephone Calls Form and Instruction	Modified
178556	SEED - Biosamples (cheek swab and blood) Other-WORD	Modified
178555	SEED - Clinic Visit- Case Child Other-WORD	Modified
178554	SEED - Clinic Visit -Control Children Other-WORD	Modified
178553	SEED- Clinic Visit - Control Parent Other-WORD	Modified
178552	SEED - Clinic Visit- Case Parent Other-WORD	Modified
178551	SEED- Care Giver Interview Other-word	Modified
178550	SEED - Medical Record Abstraction Other-WORD	Modified
178540	SEED - Questionaire Packets Other-WORD	Modified
178539	SEED - Invitation (Telephone Call) Packet Other-WORD	Modified
178538	SEED - Mailed Invitation Packet (Response Card) Other-WORD	Modified

ICR Details

OMB Control No: 0920-0741	ICR Reference No: 201005-0920-003
Status: Historical Active	Previous ICR Reference No: 200709-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: The Study to Explore Early Development (SEED)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/30/2010
	Date Received in OIRA: 05/13/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	36 Months From Approved	07/31/2010
Responses	9,720	0	146,278
Time Burden (Hours)	4,948	0	50,448
Cost Burden (Dollars)	0	0	0

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Abstract: Despite significant advances in our understanding of the clinical features of autism spectrum disorders (ASD) and substantial progress in establishing ASD prevalence studies across multiple populations, for the most part the causes of ASD remain unexplained. The most significant advance related to etiology has been recognition of the strong genetic influence on ASD occurrence, although no specific genes have been identified. In the face of these considerable gaps in our understanding of the causes of and risk factors for ASDs, large population-based epidemiologic studies of ASD etiology are lacking. The proposed data collection is designed to address this critical need. The Study to Explore Early Development (OMB 0920-0741) was initiated following OMB approval in October 2007. As planned, it is expected that SEED enrollment will continue through 2010 and data collection will continue until 2012. The overall purpose of this study is to identify risk factors and potential causes associated with ASD. This will be accomplished through the investigation of six high priority research domains concerning potential etiologic factors. Study investigators selected the domains after an extensive review of the literature. Investigators designated each of the domains as high priority based on the strength of their reported associations with ASD and recognition of the outstanding research gaps in each area, balanced by appropriateness of the SEED design and feasibility of obtaining relevant data. The specific research goals of each domain are as follows: investigation of the ASD phenotype, infection and immune function, reproductive and hormonal features, gastrointestinal features, sociodemographic features, and genetic features.

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

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:
	74 FR 46200	09/08/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 24706	05/05/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
SEED - Questionaire Packets
SEED - Medical Record Abstraction
SEED- Care Giver Interview
SEED - Clinic Visit- Case Parent
SEED- Clinic Visit - Control Parent
SEED - Clinic Visit -Control Children
SEED - Clinic Visit- Case Child
SEED - Biosamples (cheek swab and blood)
SEED - Mailed Invitation Packet (Response Card)
SEED - Follow-Up Telephone Calls	No number	Appendix O Follow up Calls
SEED Blood Draw
SEED_ Informed Consent Forms for Control Parents
SEED - Invitation (Telephone Call) Packet

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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	9,720	146,278	0	-136,558	0	0
Annual Time Burden (Hours)	4,948	50,448	0	-45,500	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The overall burden per participant remains unchanged from the initial OMB-PRA approval. Minor revisions to the forms consist of classification of some questionnaire instructions and clarifying the text for specific questions to make the instruments easier to complete and further improve data quality. While the burden hours per participant remain unchanged, the total burden hours for the next 3-year collection period are different. This is due to an expansion of the eligible study participant birth date range from September 1, 2003 - August 31, 2005 to September 1, 2003 - August 31, 2006. We have calculated the burden estimate to accommodate this change.

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Annual Cost to Federal Government: $9,449,887

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]? Uncollected

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: 05/13/2010

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