Clinic / Home Visit -Development Assessment (Child)

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Part I: PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET

Please completely fill out the applicable areas and submit with your Information Collection Request
(ICR) to CDC’s Information Collection Review Office (ICRO). This information must match the
information in your Supporting Statement.

BRIEF
Agency (Select one)
CDC
ATSDR
Office of Management and Budget (OMB) Control Number:
Agency ICR Tracking Number (CDC ID #): 0920-16PA
ICR Title:
The Study to Explore Early Development (SEED) - Phase 3
Type of Information Collection (check one)
New collection (Request for a new OMB Control Number
Extension without change of a currently approved collection
Revision of a currently approved collection
Reinstatement without change of a previously approved collection
Reinstatement with change of a previously approved collection
Existing collection in use without an OMB Control Number
Type of Review Requested (check one)
Regular
Emergency – Approval requested by: __________
Delegated
If Emergency, please attach justification.
Requested Expiration Date (check one)
Three years from approval date
Six months from approval date (Maximum for Emergency reviews)
Other – Specify: _________ (mm/yyyy) or Number of Months from Approval Date
Does this ICR contain surveys, census, or employ statistical methods?
Yes
No
(Attach Supporting Statement Part B if yes)
Note: Although statistical methods may not be used, a separate Supporting Statement Part B should
always be included to describe the data collection procedures.
Does the Supporting Statement serve as a Joint ICR and Privacy Impact Assessment per OMB
Memorandum 03-22, Section ID?
Yes
No
Is this ICR related to the Affordable Care Act (PPACA, P.L. 111-148 &111-152)?

Yes

No

Is this ICR related to the Dodd-Frank Act [Dodd-Frank Wall Street Reform and Consumer Protection Act,
P.L. 111-203]?
Yes
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Yes
No
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CDC 0.1496 (E), October 2014, CDC Adobe Acrobat 10.1, S508 Electronic Version, October 2014

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ABSTRACT (Briefly state in 3 or 4 sentences)
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.

LEGAL STATUTES
Authorizing Statute(s):

301(a)[42 U.S.C. Section 241(a)] and 317(c) of the Public Health Service Act [42 U.S.C. 247b-4]
the Combating Autism Act of 2006, Pub. Law No. 109-416
the Children's Health Care Act of 2000
Note: Authorizing Statutes include applicable Public Law, U.S. Code, Executive Orders, and Statutes.

RULEMAKING
Associated Rulemaking Information:
RIN:

Yes

No

Stage of Rulemaking (check one)
Proposed Rule
Interim Final or Final Rule
Not Associated with Rulemaking
Other Documents for OIRA Review
For Proposed Rule, OMB will not consider an ICR complete until the Notice of Proposed Rulemaking has
been published. For ICRs associated with Interim Final rules that are not significant under EO, please
include a draft of the Federal Register notice as a Supplementary Document.

FR NOTICES / COMMENTS
Federal Register Notices & Comments
60-day Notice: Federal Register Citation: Volume: ____
81 Page #: _____
9200 Publication Date: __________
02/24/2016
Did the Agency receive public comments on this ICR?
Yes
No
30-day Notice: Federal Register Citation: Volume: ____ Page #: _____ Publication Date: __________
Unless submitted as an Emergency or Associated with Rulemaking, OMB will not consider an ICR
complete until the 30-day notices has been published.
Annual Cost to Federal Government: $206,011.00

PROGRAM CHANGES OR ADJUSTMENTS REPORTING
Short Statement: Explain the reasons for any program changes or adjustments reported; that is, provide
a short statement of how the reduction in burden was achieved or why the increase in burden occurred.
This information should correspond with the ICR’s Supporting Statement (Section A.15).

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CDC 0.1496 (E), October 2014, CDC Adobe Acrobat 10.1, S508 Electronic Version, October 2014

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