Testing Communications On Medical Devices and Radiation-Emitting Products

Forms and Documents

Document Name	Status
0678 83-C June 2022.docx Justification for No Material/Nonsubstantive Change	2022-06-30
0678 Supporting Statement Part A - Testing Communications on Medical Devices REV June 2022.docx Supporting Statement A	2022-06-30
0678 Supporting Statement Part B -Testing Communications 2020.docx Supporting Statement B	2020-03-09

IC Document Collections

IC ID	Document Title	Status
258459	CDRH Rapid Message Testing with Consumers and Caregivers-Web Content About Recently-Approved Medical Devices Other-Web content of recently approved devices	New
258448	CDRH Rapid Message Testing with Consumers and Caregivers- Information About At-Home COVID-19 Diagnostic Tests Other-FDA Webpages-list of authorized tests	New

ICR Details

OMB Control No: 0910-0678	ICR Reference No: 202206-0910-013
Status: Received in OIRA	Previous ICR Reference No: 202003-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Testing Communications On Medical Devices and Radiation-Emitting Products
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/30/2022

	Requested	Previously Approved
Expiration Date	04/30/2023	04/30/2023
Responses	8,848	8,848
Time Burden (Hours)	2,076	2,076
Cost Burden (Dollars)	0	0

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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. FDA creates and uses a variety of media, including print, broadcast, and electronic formats to communicate with the public and health professionals about the risks and benefits of regulated products. To ensure that such health communication messages have the highest potential to be received, understood, and accepted by those for whom they are intended, FDA will conduct research and studies relating to the control and prevention of disease. This type of research involves (1) assessing audience knowledge, attitudes, behaviors and other characteristics for the planning/development of health messages, communication strategies, and public information programs; (2) testing these health messages, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions; and (3) evaluating the final communication products to determine the effectiveness of the messages and distribution methods.

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

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 62541	11/15/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 7566	02/10/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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	8,848	8,848	0	0	0	0
Annual Time Burden (Hours)	2,076	2,076	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:

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Annual Cost to Federal Government: $1,712,514

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

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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: 06/30/2022

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