The Study to Explore Early Development - Teen Follow-up Study (SEED-TEEN)

Forms and Documents

Document Name	Status
Social Responsiveness Scale Form	New
Health and Development Survey Form	New
Invitation Call Script Form and Instruction	New
Attachment 12.a - Full Response to SEED Teen PIA Question 37.pdf Supplementary Document	2018-02-28
Attachment 12 - SEED Teen Privacy Impact Assessment.pdf Supplementary Document	2018-02-28
SEED Teen_SSB_Clean_2-28-18.docx Supporting Statement B	2018-02-28
SEED Teen_SSA_Clean_2-28-18.docx Supporting Statement A	2018-02-28
Attachment 11 - References.docx Supplementary Document	2017-08-09
Attachment 10 - CDC IRB Approval Letter for SEED Teen.doc Supplementary Document	2017-08-09
Attachment 9 - SEED Teen Passive Refusal Letter.doc Supplementary Document	2017-08-09
Attachment 8 - SEED Teen Thank You Letter.doc Supplementary Document	2017-08-09
Published 60-Day FRN for SEED Teen_2017-08706.pdf Supplementary Document	2017-08-09
Attachment 1.c - Children's Health ACT SEED 3.doc Supplementary Document	2017-08-09
Attachment 1.b - Combating Autism Act of 2006.pdf Supplementary Document	2017-08-09
Attachment 1.a - Publich Health Service Act.docx Supplementary Document	2017-08-09

IC Document Collections

IC ID	Document Title	Status
227870	Supplemental Consent Forms Instruction	New
227867	Social Responsiveness Scale Form	New
227866	Health and Development Survey Form	New
227865	Data Collection Packet Instruction	New
227864	Follow-up Call Packet Instruction	New
227863	Invitation Call Script Form and Instruction	New
227862	Invitation Packet Instruction	New

ICR Details

OMB Control No: 0920-1219	ICR Reference No: 201708-0920-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17ADR
Title: The Study to Explore Early Development - Teen Follow-up Study (SEED-TEEN)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/01/2018
	Date Received in OIRA: 09/22/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved
Responses	1,494	0	0
Time Burden (Hours)	303	0	0
Cost Burden (Dollars)	5,273	0	0

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Abstract: The purpose of the Study to Explore Early Development, Teen Follow-up Study (SEED Teen) is to assess the long term health and functioning of children with autism spectrum disorder (ASD) and other developmental disabilities (DDs), family impacts associated with ASD and other DDs, and service needs and use associated with having and ASD and other DDs, particularly during the teen years.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
   PL: Pub.L. 109 - 416 843 Name of Law: Combatting Autism Act of 2006
   PL: Pub.L. 106 - 310 101 Name of Law: Children's Health Care Act of 2000
  

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:
	82 FR 20343	05/01/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 44184	09/21/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Health and Development Survey	none, none	Health and Development Survey
Social Responsiveness Scale	none	Social Responsiveness Scale
Supplemental Consent Forms	none, none, none	Teen consent for future contact ,   Teen consent for genetic sharing - mother ,   Teen consent for generic data sharing - legal guardian
Invitation Call Script	none	Invitation Call Script
Invitation Packet	none	Response Card
Follow-up Call Packet
Data Collection 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	1,494	0	0	1,494	0	0
Annual Time Burden (Hours)	303	0	0	303	0	0
Annual Cost Burden (Dollars)	5,273	0	0	5,273	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: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

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Annual Cost to Federal Government: $697,632

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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]? No

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: 09/22/2017

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