Evaluation of Medication- Assisted Treatment (MAT) for Opioid Use Disorders Study

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Client questionnaire - 24 month follow-up - English	Form	Unchanged	Available
Client questionnaire - 24 month follow-up - Spanish	Form	Unchanged	Available
Client questionnaire - 12 month follow-up - English	Form	Unchanged	Available
Client questionnaire - 12 month follow up - Spanish	Form	Unchanged	Available
Client questionnaire - baseline English	Form	Unchanged	Available
Client questionnaire - baseline - Spanish	Form	Unchanged	Available
Client Check-in Questionnaire - Spanish	Form	Unchanged	Available
Check-in Questionnaire - English	Form	Unchanged	Available
Client Screener	Form	Unchanged	Available
MAT Study PRA Change Request 11-30-18.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-12-07	Available
Attachment 10 IRB Documents 17ACE_MAT.PDF	Supplementary Document	Uploaded 2018-02-12	Available
Att. 14_CoC for MAT Study.pdf	Supplementary Document	Uploaded 2018-02-12	Available
Att 6a. SSN collection.pdf	Supplementary Document	Uploaded 2018-02-12	Available
SSA_MAT_Clean_2.08.18.docx	Supporting Statement A	Uploaded 2018-02-12	Available
Signed CoC for study titled MAT Study.pdf	Supplementary Document	Uploaded 2017-11-08	Available
SSB_MAT_Clean_2.08.18.docx	Supporting Statement B	Uploaded 2018-02-12	Available
Attachment 13 Staff (Provider) Focus Group Consent 17ACE_MAT.docx	Supplementary Document	Uploaded 2017-11-08	Available
Attachment 12 Client Informed Consent_17ACE_MAT.docx	Supplementary Document	Uploaded 2017-11-08	Available
Attachment 11 Client Supporting Documents 17ACE_MAT.docx	Supplementary Document	Uploaded 2017-11-08	Available
Attachment 10 IRB Documents 17ACE_MAT.pdf	Supplementary Document	Uploaded 2017-11-08	Available
Attachment 9 Privacy Impact Assessment 17ACE_MAT.pdf	Supplementary Document	Uploaded 2017-11-08	Available
Attachment 2 60 Day FRN 17ACE_MAT.pdf	Supplementary Document	Uploaded 2017-11-08	Available
Attachment 1 Authorizing Legislation.docx	Supplementary Document	Uploaded 2017-11-08	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
228981	Treatment Facility Staff Focus Groups	Other-Focus group guide	Unchanged
228980	Client Focus Groups	Other-Focus group guide	Unchanged
228979	Client questionnaire - 24 month follow-up	Form	Unchanged	Client questionnaire - 24 month follow-up - English
228979	Client questionnaire - 24 month follow-up	Form	Unchanged	Client questionnaire - 24 month follow-up - Spanish
228978	Client questionnaire - 12 month follow-up	Form	Unchanged	Client questionnaire - 12 month follow-up - English
228978	Client questionnaire - 12 month follow-up	Form	Unchanged	Client questionnaire - 12 month follow up - Spanish
228977	Client Questionnaire - baseline	Form	Unchanged	Client questionnaire - baseline English
228977	Client Questionnaire - baseline	Form	Unchanged	Client questionnaire - baseline - Spanish
228976	Client Check-in Questionnaire	Form	Unchanged	Client Check-in Questionnaire - Spanish
228976	Client Check-in Questionnaire	Form	Unchanged	Check-in Questionnaire - English
228975	Client Screener	Form	Unchanged	Client Screener

ICR Details

OMB Control No: 0920-1218	ICR Reference No: 201812-0920-002
Status: Historical Active	Previous ICR Reference No: 201711-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19GX
Title: Evaluation of Medication- Assisted Treatment (MAT) for Opioid Use Disorders Study
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/19/2018
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/10/2018
Terms of Clearance: Approved consistent with the understanding that CDC will continue to coordinate opioid research efforts and outcomes with partners both within HHS and external (SAMHSA, NIH/NIDA, FDA)

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	02/28/2021	02/28/2021
Responses	6,871	0	6,871
Time Burden (Hours)	3,093	0	3,093
Cost Burden (Dollars)	0	0	0

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Abstract: Conduct an epidemiologic study to assess the real-world client outcomes of three types of Medication Assisted Treatment (MAT) and counseling without medication for individuals with Opioid Use Disorder (OUD). This study will also examine the contextual, provider, and individual factors that influence treatment implementation and client outcomes.

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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:
	82 FR 27832	06/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 57757	12/07/2017
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Client Check-in Questionnaire	none, none	Check-in Questionnaire - English ,   Client Check-in Questionnaire - Spanish
Client Focus Groups
Client Questionnaire - baseline	none, none	Client questionnaire - baseline - Spanish ,   Client questionnaire - baseline English
Client Screener	none	Client Screener
Client questionnaire - 12 month follow-up	none, none	Client questionnaire - 12 month follow up - Spanish ,   Client questionnaire - 12 month follow-up - English
Client questionnaire - 24 month follow-up	none, none	Client questionnaire - 24 month follow-up - Spanish ,   Client questionnaire - 24 month follow-up - English
Treatment Facility Staff Focus Groups

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ICR Summary of Burden

table that charts list 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	6,871	6,871	0	0	0	0
Annual Time Burden (Hours)	3,093	3,093	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

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: $1,940,535

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.     Yes

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: 12/10/2018

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