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

Forms and Documents

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

IC Document Collections

IC ID	Document Title	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 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	400	6,871	0	-344	-6,127	0
Annual Time Burden (Hours)	300	3,093	0	-258	-2,535	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: 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

---

Common Form ICR:  No

---

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: 01/26/2021

---