Testing Communications On Medical Devices and Radiation-Emitting Products

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0678 OMB Memo Template 3-30-2023.docx	Supplementary Document	Uploaded 2023-03-30	Repair queued
0678 83-C June 2022.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-06-30	Repair queued
0678 SS Part A FINAL.docx	Supporting Statement A	Uploaded 2023-03-30	Repair queued
0678 SS Part B FINAL.docx	Supporting Statement B	Uploaded 2023-03-30	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
274292	CDRH Rapid Message Testing with Consumers and Caregivers- Products and Medical Procedures Page	Other-Current Products Landing Page	New
266023	CDRH Rapid Message Testing with Consumers and Caregivers- February 2024 Smartwatch and Smart Ring Safety Communication	Other-Stimuli - safety communication	New
263781	CDRH Rapid Message Testing with Consumers and Caregivers- Infusion Therapy - Getting the Most Out of Your Pump	Other-Web content	New
262295	CDRH Rapid Message Testing with Consumers and Caregivers- November 2022 Pulse Oximeter Safety Communication	Other-Attachment A - FDA Safety Communication	New
261580	CDRH Rapid Message Testing with Consumers and Caregivers-May 2023 Renuvion/J-Plasma Device Safety Communication	Other-FDA Safety Communication	New
261063	CDRH Rapid Message Testing with Consumers and Caregivers -- March 2023 Breast Implant Safety Communication	Other-Attachment A - FDA Safety Communication, "Update: Reports	New

ICR Details

OMB Control No: 0910-0678	ICR Reference No: 202303-0910-022
Status: Historical Active	Previous ICR Reference No: 202206-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Testing Communications On Medical Devices and Radiation-Emitting Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/01/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/30/2023
Terms of Clearance: Prior terms remain in effect: OMB approves this generic ICR, with the understanding that FDA will submit each individual IC into ROCIS for approval. Justification must be provided for the collection of any personally identifiable information.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2026	36 Months From Approved	04/30/2023
Responses	9,124	0	8,848
Time Burden (Hours)	2,391	0	2,076
Cost Burden (Dollars)	0	0	0

---

Abstract: This generic ICR collects information through a variety of research methods for developing and testing communications involving medical devices and radiation-emitting products that are regulated by FDA. The information will be used to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations.

---

Authorizing Statute(s): US Code: 21 USC 393 Name of Law: FFDCA
  

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:
	87 FR 66192	11/02/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 18556	03/29/2023
Did the Agency receive public comments on this ICR? No

---

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

table that charts list of burden

IC Title	Form No.	Form Name
CDRH Rapid Message Testing with Consumers and Caregivers -- March 2023 Breast Implant Safety Communication
CDRH Rapid Message Testing with Consumers and Caregivers- February 2024 Smartwatch and Smart Ring Safety Communication
CDRH Rapid Message Testing with Consumers and Caregivers- Infusion Therapy - Getting the Most Out of Your Pump
CDRH Rapid Message Testing with Consumers and Caregivers- November 2022 Pulse Oximeter Safety Communication
CDRH Rapid Message Testing with Consumers and Caregivers- Products and Medical Procedures Page
CDRH Rapid Message Testing with Consumers and Caregivers-May 2023 Renuvion/J-Plasma Device Safety Communication

---

ICR Summary of Burden

table that charts list 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	9,124	8,848	0	0	276	0
Annual Time Burden (Hours)	2,391	2,076	0	0	315	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: Over the next 3-year approval period, we anticipate increasing our capability to conduct more communication surveys, which aligns with CDRH’s strategic priority of advancing health equity. We have adjusted our burden estimates accordingly. Additionally, we have added an estimated hour burden for “Healthcare professional individual in-depth interviews.” These changes reflect an increase of 315 burden hours and a corresponding increase of 276 responses annually.

---

Annual Cost to Federal Government: $1,719,390

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.     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: 03/30/2023

---