Survey of "Health Care Providers' Responses to Medical Device Labeling"

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Revised_Follow Up Letter.doc	Supplementary Document	Uploaded 2012-07-02	Available
Initial Contacting Letter.doc	Supplementary Document	Uploaded 2012-07-02	Available
FINAL FDA letter.doc	Supplementary Document	Uploaded 2012-07-02	Available
Consent Form In Person.doc	Supplementary Document	Uploaded 2012-07-02	Available
Health_Care_response_to_Medical_Device_Labelin_SS_Part_B.docx	Supporting Statement B	Uploaded 2012-07-02	Available
Advamed Comment.pdf	Supplementary Document	Uploaded 2012-03-01	Available
Device Label Survey screenshots.doc	Supplementary Document	Uploaded 2012-03-01	Available
Attachment F - Label Version 2.pdf	Supplementary Document	Uploaded 2012-03-01	Available
Attachment E - Label Version 1.pdf	Supplementary Document	Uploaded 2012-03-01	Available
Attachment G - Label Version 3.pdf	Supplementary Document	Uploaded 2012-03-01	Available
Health_Care_response_to_Medical_Device_Labeling_SS_Part_A.docx	Supporting Statement A	Uploaded 2012-07-03	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
201489	Survey of "Health Care Providers' Responses to Medical Device Labeling Content	Other-Telephone Script	New

ICR Details

OMB Control No: 0910-0715	ICR Reference No: 201203-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Survey of "Health Care Providers' Responses to Medical Device 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: Approved with change	Conclusion Date: 07/05/2012
	Date Received in OIRA: 03/08/2012
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2015	36 Months From Approved
Responses	1,248	0	0
Time Burden (Hours)	324	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a survey to inform FDA's development of evidence-based guidelines and federal regulations for the content and format (headings, layout, word choices, tables and diagrams) of medical device labeling. 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 associated with the use of medical devices. This data collection from the private sector is an important element for the Agency to use in evaluating the existing problems associated with current medical device labeling.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: the 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:
	76 FR 67459	11/01/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 12597	03/01/2012
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Survey of "Health Care Providers' Responses to Medical Device Labeling Content

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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	1,248	0	0	1,248	0	0
Annual Time Burden (Hours)	324	0	0	324	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 information collection.

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Annual Cost to Federal Government: $36,540

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: 03/08/2012

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