Health Care Providers Understanding of Opioid Analgesic Abuse-Deterrent Formulations: Phase 2 and 3 Surveys

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
242693	Main Survey - Phase 3	Unchanged
242692	Main Study Screener - Phase 3	Unchanged
242691	Pretest - Phase 3	Unchanged
242690	Pretest Screener - Phase 3	Unchanged
242689	Main Survey - Phase 2	Modified
242688	Main Survey Screener - Phase 2	Modified
242687	Pretest - Phase 2	Modified
242686	Pretest Screener - Phase 2	Modified

ICR Details

OMB Control No: 0910-0892	ICR Reference No: 202012-0910-004
Status: Active	Previous ICR Reference No: 202007-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Health Care Providers Understanding of Opioid Analgesic Abuse-Deterrent Formulations: Phase 2 and 3 Surveys
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: 01/04/2021
	Date Received in OIRA: 12/14/2020
Terms of Clearance: Terms continue: The ICR will need to be updated if changes are made between phases or between pretests and the main studies.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	08/31/2023	08/31/2023
Responses	10,135	0	8,163
Time Burden (Hours)	2,131	0	1,823
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from healthcare professionals (physicians, PAs, NPs and pharmacists) through two surveys of aimed at obtaining information about their knowledge, attitudes, experiences about abuse-deterrent formulation opioids (ADFs), including related to the ADF terminology. One of the surveys will collect representative data in these areas; the second survey, which will follow the first, will experimentally test the ADF term (the control) against three alternative terms derived, in part, from the general survey to objectively and subjectively determine which term elicits the greatest accuracy in understanding about these products and minimizes knowledge gaps and misperceptions that surfaced in the first qualitative phase of this research as well as in other research. The two surveys described in this ICR make up the second and third phases of a three-phase research project and were informed by the findings obtained from focus groups with healthcare professionals in Phase 1.

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Authorizing Statute(s): None

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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 6562	02/05/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 40663	07/07/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Pretest - Phase 2
Main Survey Screener - Phase 2
Main Survey - Phase 2
Pretest Screener - Phase 3
Main Study Screener - Phase 3
Pretest - Phase 3
Main Survey - Phase 3
Pretest Screener - Phase 2

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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	10,135	8,163	0	1,972	0	0
Annual Time Burden (Hours)	2,131	1,823	0	308	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The estimated annual reporting burden for Phase 2, formerly estimated as 868 hours, has increased by 308 hours to a new total estimate annual hourly burden of 1,176 hours.

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Annual Cost to Federal Government: $1,040,002

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.     No

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: 12/14/2020

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