Formative Research on Community-Level Factors that Promote the Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid Misuse Among Children, Youth, and Families in Tribal American India

Forms and Documents

Document Name	Status
Form 0920-20PJ Community Leaders or Service Providers Form and Instruction	New
Form 0920-20PJ Parents, Caregivers, and Young Adults Form and Instruction	New
Form 0920-20PJ Tribal Elders/Tribal Leaders/Traditional Healers Form and Instruction	New
Form 0920-20PJ Demographic Survey Form and Instruction	New
Form 0920-20PJ Informed Consent Form and Instruction	New
Form 0920-20PJ Telephone Screening Form and Instruction	New
Attachment O_Study Flyer.docx Supplementary Document	2021-05-11
Attachment N_IRB Letter.pdf Supplementary Document	2021-05-11
Attachment M_ PIA.pdf Supplementary Document	2021-05-11
Attachment H List of local and national resources for participants.docx Supplementary Document	2021-05-11
Attachment B_ Federal Register Notice.pdf Supplementary Document	2021-05-11
Attachment A_ Authorizing Legislation.docx Supplementary Document	2021-05-11
SSB Formative Research Tribal Communities_final.docx Supporting Statement B	2021-05-11
SSA Formative Research Tribal Communities_final.docx Supporting Statement A	2021-05-11

IC Document Collections

IC ID	Document Title	Status
247307	Community Leaders or Service Providers Form and Instruction	New
247306	Parents, Caregivers, and Young Adults Form and Instruction	New
247305	Tribal Elders/Tribal Leaders/Traditional Healers Form and Instruction	New
247304	Demographic Survey Form and Instruction	New
247303	Informed Consent Form and Instruction	New
247302	Reminder Email/Letter Other-Letter	New
247301	Confirmatin Email/Letter Other-Letter	New
247300	Telephone Screening Form and Instruction	New
247298	Informational Letter Other-Letter	New

ICR Details

OMB Control No:	ICR Reference No: 202105-0920-002
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20PJ
Title: Formative Research on Community-Level Factors that Promote the Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid Misuse Among Children, Youth, and Families in Tribal American India
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/14/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	920	0
Time Burden (Hours)	441	0
Cost Burden (Dollars)	0	0

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Abstract: The goal of this Information Collection Request (ICR) is to conduct formative qualitative studies to identify community-level protective factors (e.g., intergenerational connection to Tribal Elders) and primary prevention strategies across a range of Tribal communities (i.e., urban and rural/reservation) to prevent adverse childhood experiences (ACEs) and opioid misuse.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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:
	85 FR 128	07/02/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 26519	05/14/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Community Leaders or Service Providers	0920-20PJ	Interview Discussion Guide
Confirmatin Email/Letter
Demographic Survey	0920-20PJ	Demographic Survey
Informational Letter
Informed Consent	0920-20PJ	Informed Consent
Parents, Caregivers, and Young Adults	0920-20PJ	Focus Group Discussion Guide
Reminder Email/Letter
Telephone Screening	0920-20PJ	Telephone Screening
Tribal Elders/Tribal Leaders/Traditional Healers	0920-20PJ	Interview - Focus Group Discussion Guide TE/TL/TH

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ICR Summary of Burden

	Total Request	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	920	0	0	920	0	0
Annual Time Burden (Hours)	441	0	0	441	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: No

Burden Reduction Due to:

Short Statement: This is a New Collection.

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Annual Cost to Federal Government: $651,396

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? No

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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: 05/14/2021

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