Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling

Forms and Documents

Document Name	Status
Proposed Rule SS- Symbols Regulation.doc Supporting Statement A	2013-04-19

IC Document Collections

IC ID	Document Title	Status
206686	Symbols Glossary	New

ICR Details

OMB Control No: 0910-0740	ICR Reference No: 201304-0910-005
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 19293
Title: Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling
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: Comment filed on proposed rule	Conclusion Date: 05/28/2013
	Date Received in OIRA: 04/25/2013
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is proposing to revise medical device and biological product labeling regulations to explicitly allow for the use in medical device labeling of certain stand-alone symbols contained in a standard that FDA recognizes under its authority under section 514(c) of the FD&C Act. In particular, FDA will allow the inclusion of certain stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized SDO and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices, provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. As such the requirement to submit to FDA and disclose to third-parties a symbols glossary, which means "a compiled listing of (i) each symbol used in the labeling of the device, and (ii) the meaning of or explanatory text for the symbol," is subject to the PRA.

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Authorizing Statute(s): US Code: 21 USC 352 Name of Law: FD&C Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG74	Proposed rulemaking	78 FR 23508	04/19/2013

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Federal Register Notices & Comments

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
Symbols Glossary

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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 proposed rule.

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Annual Cost to Federal Government: $0

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: 04/25/2013

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