Information Collection Request

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

ICR 202012-0920-014 · OMB 0920-1218 · Received in OIRA

Forms and Documents

Document	Type	Status	Availability
Client questionnaire - 18 month follow-up	Form	Modified	Missing upstream
Client questionnaire - 12 month follow-up	Form	Removed	Repair queued
Client Questionnaire - baseline	Form	Removed	Repair queued
Client Check-in Questionnaire	Form	Removed	Repair queued
Client Screener	Form	Removed	Repair queued
Attachment 9 Power Calculations.docx	Supplementary Document	Uploaded 2020-12-22	Repair queued
Non substantial change request Memo OMB 0920-1218 MAT 05-03-19.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-05-15	Available
MAT Study PRA Change Request 11-30-18.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2018-12-07	Available
Attachment 8_CoC for MAT Study.pdf	Supplementary Document	Uploaded 2020-12-22	Repair queued
SSA_MAT_1218 (003) new_final.docx	Supporting Statement A	Uploaded 2020-12-22	Missing upstream
SSB_MAT_1218.docx	Supporting Statement B	Uploaded 2020-12-22	Repair queued
Attachment 7 Informed Consent.docx	Supplementary Document	Uploaded 2020-12-22	Repair queued
Attachment 6 IRB Doc.pdf	Supplementary Document	Uploaded 2020-12-22	Repair queued
Attachment 5_ Privacy Impact Assessment MAT.pdf	Supplementary Document	Uploaded 2020-12-22	Repair queued
Attachment 2 FRN 60 day_ 1218_MAT.pdf	Supplementary Document	Uploaded 2020-12-22	Repair queued
Attachment 1 Authorizing Legislation.docx	Supplementary Document	Uploaded 2020-12-22	Repair queued

IC Document Collections

IC ID	Collection	Type	Status
228981	Treatment Facility Staff Focus Groups	Other-Focus group guide	Removed
228980	Client Focus Groups	Other-Focus group guide	Removed
228979	Client questionnaire - 18 month follow-up	Form	Modified
228978	Client questionnaire - 12 month follow-up	Form	Removed
228977	Client Questionnaire - baseline	Form	Removed
228976	Client Check-in Questionnaire	Form	Removed
228975	Client Screener	Form	Removed

ICR Details

OMB Control No: 0920-1218	ICR Reference No: 202012-0920-014
Status: Received in OIRA	Previous ICR Reference No: 201905-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1218
Title: Evaluation of Medication- Assisted Treatment (MAT) for Opioid Use Disorders Study
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 01/26/2021

	Requested	Previously Approved
Expiration Date	12 Months From Approved	02/28/2021
Responses	400	6,871
Time Burden (Hours)	300	3,093
Cost Burden (Dollars)	0	0

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. This revision is to request an additional year of approval because of later collection of the last respondents.

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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 168	08/26/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 7094	01/26/2021
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Client questionnaire - 18 month follow-up	none	Client questionnaire - 18 month follow-up
Client Screener	none	Client Screener
Client Check-in Questionnaire	none, none	Check-in Questionnaire - English , Client Check-in Questionnaire - Spanish
Client Questionnaire - baseline	none, none	Client questionnaire - baseline - Spanish , Client questionnaire - baseline English
Client questionnaire - 12 month follow-up	none, none	Client questionnaire - 12 month follow-up - English , Client questionnaire - 12 month follow up - Spanish
Client Focus Groups
Treatment Facility Staff Focus Groups

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	400	6,871	-344	-6,127
Annual Time Burden (Hours)	300	3,093	-258	-2,535
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: All information has been collected except for some of the 18 month follow-up. Thus we are only requesting for a portion of the previously approved burden hours.

Annual Cost to Federal Government: $1,976,128

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? No

Agency Contact: Kevin Joyce 404 639-1944 [email protected]

Common Form ICR: No