Survey of Health Care Practitioners for Device Labeling Format and Content

Forms and Documents

Document Name	Status
NEW--Survey of HCPs for Device Labeling Format and Content--SS--Part A--04-06-15.doc Supporting Statement A	2015-04-06
NEW--Survey of HCPs for Device Labeling Format and Content--SS--Part B--03-03-15.docx Supporting Statement B	2015-04-06

IC Document Collections

IC ID	Document Title	Status
215653	Health Care Professionals Participating at FDA Other-Labeling Current mfr TOC Only Acuvue	New
215652	Health Care Professionals Participating at a Hospital Other-Scenarios - Acuvue	New
215651	Screener Other-Contact Letter with Screener	New

ICR Details

OMB Control No: 0910-0790	ICR Reference No: 201503-0910-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Survey of Health Care Practitioners for Device Labeling Format and Content
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/27/2015
	Date Received in OIRA: 04/14/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved
Responses	96	0	0
Time Burden (Hours)	83	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from health care providers (HCPs). The study will compare existing device labeling with a standard content and format of the same labeling that FDA researchers will develop. The study will quantify the usability and usefulness of standardized labeling for the HCP community. The anticipated final outcome will be standardized medical device labeling that will lead to an increase in the safe and effective use of medical devices and a reduction in adverse events and recalls.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	79 FR 54727	09/12/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 18410	04/06/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Screener
Health Care Professionals Participating at a Hospital
Health Care Professionals Participating at FDA

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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	96	0	0	96	0	0
Annual Time Burden (Hours)	83	0	0	83	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: No

Burden Reduction Due to:

Short Statement: This is a new collection

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Annual Cost to Federal Government: $408,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 04/14/2015

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