Information Collection Request

The National Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Study

ICR 200702-0920-001 · OMB 0920-0741 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Appendix U CADDRE Analysis and Pub Guidelines.doc Supplementary Document Uploaded 2007-06-05 Available
CADDRE Supporting Statement to OMB 6-4-2007.doc Supporting Statement B Uploaded 2007-06-05 Repair queued
Appendix Q Vineland Follow Up call.doc Supplementary Document Uploaded 2007-01-10 Available
Appendix J SCQ.pdf Supplementary Document Uploaded 2007-01-10 Available
Appendix E.21 Buccal Transmittal Form.doc Supplementary Document Uploaded 2007-01-10 Repair queued
Appendix E.5 Caregiver Interview Prep Guide.doc Supplementary Document Uploaded 2007-01-10 Available
Appendix E.4 Clinic Visit Prep Guide.doc Supplementary Document Uploaded 2007-01-10 Available
Appendix E.2 Cover Sheet Yellow Folder Instructions.doc Supplementary Document Uploaded 2007-01-10 Repair queued
Appendix E.1 Enrollment Packet Cover letters .doc Supplementary Document Uploaded 2007-01-10 Available
OMBappendices (2).doc Supplementary Document Uploaded 2007-01-10 Repair queued
Appendix T Hypotheses 6-4-2007.doc Supplementary Document Uploaded 2007-06-05 Available
Appendix S.5 Pediatric MR Form.DOC Supplementary Document Uploaded 2007-01-05 Available
Appendix S.4 Neonatal MR Form.DOC Supplementary Document Uploaded 2007-01-05 Available
Appendix S.3 L&D MR Form.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix S.2 PRENATAL MR Form.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix S.1 Medical Record Request Script & Fax.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix R.1 Shipping and Handling of Biosamples.doc Supplementary Document Uploaded 2007-01-05 Available
Appendix O.2 Reminder call script.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix O.1 follow-up telephone script.doc Supplementary Document Uploaded 2007-01-05 Available
Appendix L ICD DSM Code Lists .xls Supplementary Document Uploaded 2007-06-05 Available
Appendix K site specific ascert.doc Supplementary Document Uploaded 2007-06-05 Available
Appendix I CDC IRB Approval Letter.doc Supplementary Document Uploaded 2007-06-05 Repair queued
Appendix E.22 case cohort picture story.pdf Supplementary Document Uploaded 2007-01-05 Available
Appendix E.20 Buccal IC bioDad.doc Supplementary Document Uploaded 2007-01-05 Available
Appendix E.18 HIPAA release form.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix E.8 Study Bill of Rights.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix E.7 Biosample FAQs.doc Supplementary Document Uploaded 2007-01-05 Available
Appendix E.6 Medical Glossary.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix E.3 Informed Consent Docs.doc Supplementary Document Uploaded 2007-01-05 Available
Appendix D.4 Research Domains by DC Activity 2007 05.doc Supplementary Document Uploaded 2007-06-05 Available
Appendix D.3 DC Instrument Summary Table.doc Supplementary Document Uploaded 2007-06-05 Available
Appendix D.2 Data Collect Process Outline .doc Supplementary Document Uploaded 2007-01-05 Available
Appendix D.1 study Flow 2007 05.pdf Supplementary Document Uploaded 2007-06-05 Available
Appendix C.2 Public Comment.doc Supplementary Document Uploaded 2007-06-05 Repair queued
Appendix C.1 60-Day Federal Registry Notice.pdf Supplementary Document Uploaded 2007-06-05 Available
Appendix B 1 Caregiver Interview Tel Script.doc Supplementary Document Uploaded 2007-01-05 Repair queued
Appendix A Authorizing Legislation.pdf Supplementary Document Uploaded 2007-06-05 Available
CADDRE Supporting Statement to OMB 6-4-2007.doc Supporting Statement A Uploaded 2007-06-05 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
180497 Follow-Up Telephone Calls Other-First Follow-Up Phone Call New
178556 Biosamples Other-Cheek Swab Sample Record Sheet New
178555 Clinic Visit - Case Child Other-Mullen Scales of Early Learning New
178554 Clinic Visit- Control Children Other-Mullen Scales of Early Learning New
178553 Clinic Visit- Control Parent Other-Written Informed Consent New
178552 Clinic Visit - Case Parent Other-Written Informed Consent Form New
178551 Caregiver Interview Other-Primary Caregiver Interview New
178550 Medical Record Abstraction Other-Medical Record Request Script and Fax Letter New
178540 Questionaire Packets Other-Self Administered Consent New
178539 Invitation Telephone Call Other-Other New
178538 Mailed Invitation Packet Other-Response Card New
ICR Details
0920-0741 200702-0920-001
Historical Active
HHS/CDC
The National Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Study
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 06/11/2007
Retrieve Notice of Action (NOA) 02/01/2007
Approved consistent with CDC revisions to the ICR justification and associated forms.
  Inventory as of this Action Requested Previously Approved
06/30/2010 36 Months From Approved
146,278 0 0
50,448 0 0
0 0 0

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.

US Code: 42 USC 241 Name of Law: null
   US Code: 42 USC 257b-4 Name of Law: null
   PL: Pub.L. 108 - 154 2 Name of Law: Birth Defects and Developmental Disabilities Prevention Act of 2003
  
None

Not associated with rulemaking

  71 FR 58865 10/05/2006
72 FR 566 01/05/2007
Yes

  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 0 0 146,278 0 0
Annual Time Burden (Hours) 50,448 0 0 50,448 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
The Children's Health Care Act of 2000 mandated CDC to establish autism surveillance and research programs to address the number, incidence, correlates, and causes of autism and related developmental disabilities. Under the previsions of this act, the National Center on Birth Defects and Developmental Disabilities (NCBDDD) at CDC funded five centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE), including Kaiser Research Foundation in California, Colorado Department of Public Health and Environment, Johns Hopkins University, University of Pennsylvania, and University of North Carolina at Chapel Hill. CDC participates as the sixth CADDRE site.

$3,380,292
Yes Part B of Supporting Statement
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/31/2007