Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

Forms and Documents

Document Name	Status
0553_Supporting Statement.doc Supporting Statement A	2017-03-01

IC Document Collections

IC ID	Document Title	Status
6275	Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use	Modified

ICR Details

OMB Control No: 0910-0553	ICR Reference No: 201703-0910-005
Status: Historical Active	Previous ICR Reference No: 201401-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/18/2017
	Date Received in OIRA: 03/15/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	689	0	689
Time Burden (Hours)	2,756	0	2,756
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from medical device manufactures who wish to use selected symbols in place of text in the labeling of in vitro diagnostic devices (IVDs) intended for professional use. FDA's guidance document "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" recommends that a glossary of terms accompany each IVD to define the symbols used on that device's labels and/or labeling. Furthermore, the guidance recommends an educational outreach effort to enhance the understanding of newly introduced symbols. Both the glossary and educational outreach information will help to ensure that IVD users will have enough general familiarity with the symbols used, as well as provide a quick reference for available materials, thereby further ensuring that such labeling satisfies the applicable labeling requirements.

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Authorizing Statute(s): US Code: 21 USC 352 Name of Law: null
   US Code: 42 USC 262 Name of Law: null
  

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:
	81 FR 87570	12/05/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 13813	03/15/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

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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	689	689	0	0	0	0
Annual Time Burden (Hours)	2,756	2,756	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: $56,130,426

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 03/15/2017

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