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

ICR 202106-0910-002

OMB: 0910-0892

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0892 202106-0910-002
Received in OIRA 202012-0910-004
HHS/FDA CDER
Health Care Providers Understanding of Opioid Analgesic Abuse-Deterrent Formulations: Phase 2 and 3 Surveys
No material or nonsubstantive change to a currently approved collection   No
Regular 06/09/2021
  Requested Previously Approved
08/31/2023 08/31/2023
10,886 10,135
2,261 2,131
0 0

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.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  85 FR 6562 02/05/2020
85 FR 40663 07/07/2020
Yes

  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 10,886 10,135 0 751 0 0
Annual Time Burden (Hours) 2,261 2,131 0 130 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The estimated annual reporting burden for Phase 3, formerly estimated at 955.42 hours has been increased by 129.01 hours to a new total estimate annual hourly burden of 1,084.43 hours.

$1,040,002
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/09/2021


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