Section 95.1215, Medical Device Radiocommunication Services (MedRadio) - Disclosure Policies and Section 95.1217, Labeling Requirements

Forms and Documents

Document Name	Status
0936_ss_050912.doc Supporting Statement A	2012-05-09

IC Document Collections

IC ID	Document Title	Status
31407	Section 95.1215, Medical Device Radiocommunication Service (MedRadio) - Disclosure Policies; and Section 95.1217, Labeling Requirements	Modified

ICR Details

OMB Control No: 3060-0936	ICR Reference No: 201202-3060-004
Status: Historical Active	Previous ICR Reference No: 200904-3060-017
Agency/Subagency: FCC	Agency Tracking No: WTB/Mobility
Title: Section 95.1215, Medical Device Radiocommunication Services (MedRadio) - Disclosure Policies and Section 95.1217, Labeling Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/19/2012
	Date Received in OIRA: 05/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2015	36 Months From Approved	06/30/2012
Responses	100	0	20
Time Burden (Hours)	100	0	20
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection requires manufacturers of transmitters for the Medical Implant Communications Service (MICS) to include with each transmitting device a statement regarding harmful interference and to label the device in a conspicuous location on the device. The requirements will allow use of potential life-saving medical technology without causing interference to other users of the 402-405 MHz band.

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Authorizing Statute(s): US Code: 47 USC 303 Name of Law: Communications Act of 1934, as amended
   US Code: 47 USC 154 Name of Law: Communications Act of 1934, as amended
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3060-AJ25	Final or interim final rulemaking	77 FR 4252	01/27/2012

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 12302	02/29/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 27059	05/08/2012
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
Section 95.1215, Medical Device Radiocommunication Service (MedRadio) - Disclosure Policies; and Section 95.1217, Labeling Requirements

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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	100	20	0	0	80	0
Annual Time Burden (Hours)	100	20	0	0	80	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: The 80 hour increase in burden is due to an increase in the number of manufacturers. The Commission adopted a Report and Order, FCC 11-176, which amended Parts 2 and 95 of the Commission's rules to provide additional spectrum for the Medical Device Radiocommunication Service which requires manufacturers of MedRadio programmer/control transmitters to include a statement on the device in a conspicious location, or if it is not feasible to place the statement on the device, in the instruction manual.

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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: 05/09/2012

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