Healthcare Provider Perception of Boxed Warning Information Survey

Forms and Documents

Document Name	Status
0890 Nonsub change request memo 2020.docx Justification for No Material/Nonsubstantive Change	2020-10-26
Supporting Statement Part B - HCP Boxed Warning Survey 2020.docx Supporting Statement B	2020-07-02
Supporting Statement Part A - HCP Boxed Warning Survey 2020.docx Supporting Statement A	2020-07-02

IC Document Collections

IC ID	Document Title	Status
242553	HCP Survey - Main Study Other-Survey Instrument	Modified
242551	Informed Consent - Main Study Other-Consent Form	Unchanged
242550	HCP Screener - Main Study Other-Invitation	Unchanged
242549	HCP Survey - Pretest Other-Survey Instrument	Modified
242548	Informed Consent - Pretest Other-Consent Form - GPs	Unchanged
242546	Healthcare Providers - Pretest Other-Invitation	Unchanged

ICR Details

OMB Control No: 0910-0890	ICR Reference No: 202010-0910-009
Status: Active	Previous ICR Reference No: 202007-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Healthcare Provider Perception of Boxed Warning Information Survey
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: 10/30/2020
	Date Received in OIRA: 10/26/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	08/31/2023	08/31/2023
Responses	4,423	0	4,423
Time Burden (Hours)	499	0	499
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR is a web-based survey to investigate healthcare providers’ (HCPs’) awareness, perceptions, and beliefs about the benefits and risks of an FDA-approved product that includes a boxed warning as part of its approved prescribing information. This study will strengthen FDA’s understanding of how HCPs may receive, process, and use boxed warning information and identify HCPs’ potential information needs with respect to the topics addressed by a product’s boxed warning. This research will evaluate two treatment scenarios involving an FDA-approved medication or class of medications that include boxed warning information.

---

Authorizing Statute(s): None

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:
	84 FR 38996	08/08/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 40292	07/06/2020
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
HCP Screener - Main Study
Informed Consent - Pretest
Healthcare Providers - Pretest
HCP Survey - Pretest
Informed Consent - Main Study
HCP Survey - Main Study

---

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	4,423	4,423	0	0	0	0
Annual Time Burden (Hours)	499	499	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:

---

Annual Cost to Federal Government: $297,546

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

---

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: 10/26/2020

---