52472 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Rules and Regulations 

* * * * * 

[FR Doc. 2010–21114 Filed 8–25–10; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 95 

[ET Docket No. 06–135; FCC 10–128] 

Spectrum Requirements for Advanced 

Medical Technologies 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: This document addresses a 

petition for reconsideration (petition) 

filed by Medtronic, Inc. (Medtronic) 

regarding rules for the Medical Device 

Radiocommunication (MedRadio) 

service. The Commission grants 

reconsideration to the extent of 

amending the MedRadio rules to permit 

the submission of average power 

transmitter measurements, and making 

editorial corrections or clarifications to 

several provisions concerning the 

frequency monitoring criteria and 

permissible communications for ‘‘listenbefore-talk’’ (LBT) and non-LBT devices. 

The Commission denies reconsideration 

in all other respects and otherwise 

affirms certain provisions of the 

MedRadio rules questioned by 

Medtronic. 

DATES: Effective September 27, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Mark Settle, (202) 418–1569 or Gary 

Thayer, Policy and Rules Division, 

Office of Engineering and Technology, 

(202) 418–2290, Mark.Settle@fcc.gov or 

Gary.Thayer@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s 

Memorandum Opinion and Order, ET 

Docket No. 06–135, adopted July 15, 

2010, and released July 26, 2010. The 

full text of this document is available on 

the Commission’s Internet site at 

http://www.fcc.gov. It is also available 

for inspection and copying during 

regular business hours in the FCC 

Reference Center (Room CY–A257), 445 

12th Street, SW., Washington, DC 

20554. The full text of this document 

also may be purchased from the 

Commission’s duplication contractor, 

Best Copy and Printing Inc., Portals II, 

445 12th St., SW., Room CY–B402, 

Washington, DC 20554; telephone (202) 

488–5300; fax (202) 488–5563; e-mail 

FCC@BCPIWEB.COM. 

Summary of the Memorandum Opinion 

and Order 

1. The Commission addresses a 

petition for reconsideration (petition) 

filed by Medtronic, Inc. (Medtronic) 

regarding rules for the Medical Device 

Radio-communication (MedRadio) 

service. The Commission granted 

reconsideration to the extent of 

amending the MedRadio rules to permit 

the submission of average power 

transmitter measurements, and making 

editorial corrections or clarifications to 

several provisions concerning the 

frequency monitoring criteria and 

permissible communications for ‘‘listenbefore-talk’’ (LBT) and non-LBT devices. 

The Commission denied reconsideration 

in all other respects and otherwise 

affirmed certain provisions of the 

MedRadio rules questioned by 

Medtronic. 

2. The Commission established the 

MedRadio service under part 95 of the 

rules by Report and Order (MedRadio 

Order), see 74 FR 22696, May 14, 2009. 

Altogether, the MedRadio service 

provides a total of five megahertz of 

contiguous spectrum for advanced 

wireless medical radiocommunication 

devices serving a diverse range of 

diagnostic and therapeutic purposes in 

humans. In the MedRadio Order, the 

Commission also adopted service and 

technical rules governing the operation 

of medical radiocommunication devices 

used in the MedRadio service. Building 

upon the former Medical Implant 

Communications Service (MICS)— 

which limited operation to implanted 

medical devices—the more flexible 

MedRadio rules accommodate bodyworn as well as implanted medical 

devices, including those using either 

LBT or non-LBT spectrum access 

methods. The MedRadio service 

incorporates the MICS ‘‘core’’ band at 

402–405 MHz—which continues to be 

limited to implanted devices—and also 

includes two megahertz of newly 

designated spectrum in the adjacent 

‘‘wing’’ bands at 401–402 MHz and 405– 

406 MHz—in which both body-worn 

and implanted devices are permitted. 

The MedRadio service continues to 

incorporate many of the licensing and 

technical requirements that applied to 

the legacy MICS. 

3. Medtronic requests that the new 

MedRadio rules be amended to permit 

transmitter power measurements to be 

made using average power 

instrumentation techniques that were 

formerly allowed under the MICS rules. 

The former MICS rules stated that 

compliance with the maximum 

transmitter power limits shall be based 

upon measurements using a peak 

detector function or, alternatively, the 

instrumentation techniques set forth in 

a particular American National 

Standards Institute (ANSI) standard 

referenced in the rule. That standard has 

been modified by ANSI since adoption 

of the MICS rules in 1999 and no longer 

includes the specific average power 

instrumentation techniques cited by 

Medtronic. As adopted in the MedRadio 

Order, the new rules set forth a 

compliance requirement in terms of a 

‘‘Commission-approved peak power 

technique.’’ Medtronic argues that the 

Commission did not propose to delete 

these provisions of the MICS rules in 

the Notice of Proposed Rulemaking 

(MedRadio NPRM) that preceded the 

adoption of the MedRadio rules, see 71 

FR 43682, August 2, 2006. Medtronic 

further asserts that the peak power 

requirement as set forth in the rule 

adopted in the MedRadio Order would, 

in effect, prohibit the use of average 

power instrumentation techniques that 

were acceptable within the scope of the 

former MICS rule. It contends that the 

inability to rely upon these average 

power techniques for compliance would 

require MedRadio devices to reduce 

power, and that this, in turn, would be 

detrimental to the reliable operation of 

existing equipment and adversely affect 

the development of new generation 

devices. To remedy this concern, 

Medtronic recommends that the 

Commission reinstate the former MICS 

rule provision or, in the alternative, 

restore the intent of the prior rule by 

substituting text that would permit the 

use of average power measurement 

techniques. St. Jude Medical agrees with 

Medtronic, stating that the effect of the 

peak power measurement rule will be to 

sharply reduce the range available to 

some systems. Biotronik opposes 

Medtronic’s request, stating that the 

peak power approach adopted in the 

MedRadio Order is a more appropriate 

technique for MedRadio transmitters 

because average power measurements 

would allow higher power devices in 

the band and, thus, increase the 

potential for interference in the band. 

4. As a threshold matter, the 

Commission addresses Medtronic’s 

suggestion that it failed to provide 

sufficient notice for modifying the 

power measurement provisions. While 

the Commission acknowledges that the 

MedRadio NPRM did not explicitly 

request comment on whether the power 

measurement provisions should be 

modified, changes to these measurement 

provisions are a logical outgrowth of 

issues in the MedRadio NPRM that we 

did present for comment. More 

specifically, the Commission 

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specifically invited comment on power 

and duty cycle thresholds for MedRadio 

devices and emphasized that its 

proposed rules were intended to allow 

flexibility in spectrum usage for 

MedRadio devices. Thus, it would be 

reasonable for interested parties to 

anticipate that the Commission would 

also adopt rules for determining 

whether such devices comply with 

those rules, including power 

measurement methods. In addition, in 

the MedRadio NPRM, the Commission 

sought comment on ‘‘whether the 

various current MICS rules would 

continue to be appropriate for 

operations under the new allocation.’’ 

Parties should have anticipated that the 

Commission could conclude that a 

reference to an outdated ANSI standard 

would not ‘‘continue to be appropriate 

for operations under the new 

allocation.’’ Accordingly, the 

Commission concluded that the power 

measurement rule revisions adopted in 

the MedRadio Order are logical 

outgrowths of the MedRadio NPRM, and 

therefore, that the Commission provided 

sufficient APA notice for these 

revisions. 

5. The Commission notes that it was 

not its intent to change the underlying 

frame of reference for measuring 

allowable transmit power, which is a 

maximum EIRP over a specified 

bandwidth, but recognizes that 

removing the reference to the obsolete 

ANSI standard (in combination with the 

reference to the alternative power 

measurement technique using a peak 

detector function) contributed to the 

uncertainty over whether a previously 

acceptable average power measurement 

technique would continue to be 

allowed. Accordingly, the Commission 

is amending § 95.628(g)(3) of the 

MedRadio rules to restore the approach 

in the former MICS rule which specified 

a peak detector function as one 

measurement technique for 

demonstrating compliance with 

transmitter power limits. In substitution 

for the obsolete ANSI standard of the 

former MICS rule, the Commission is 

also adding a provision that expands the 

available options for demonstrating 

compliance by stating that measurement 

procedures found acceptable to the 

Commission in accordance with 47 CFR 

2.947 may also be used. In addition, the 

Office of Engineering and Technology 

(OET) Laboratory Division has 

published information in its Knowledge 

Data Base (KDB) concerning acceptable 

average power measurement procedures 

under this provision. The Commission 

believes that this approach satisfies the 

substance of Medtronic’s request that 

the MedRadio rules be modified to 

permit the average power 

instrumentation techniques formerly 

acceptable under the MICS rules. 

6. This approach also provides greater 

flexibility than the former MICS rule, 

which, in part, relied upon the ANSI 

standards, because it avoids inadvertent 

rule obsolescence as industry standards 

are modified or new measurement 

techniques are developed. Under its Part 

2 rules, the Commission can provide 

specific guidance as to the measurement 

approaches that are acceptable through 

the issuance of bulletins or reports— 

such as recently has been provided in 

the OET KDB noted in the 

Memorandum Opinion and Order—and 

without the need to correct outdated 

references in the underlying rules 

through time-consuming, formal 

proceedings. Moreover, in the event the 

Commission has not provided guidance 

on a particular matter through bulletins 

or reports, the rules also allow parties to 

provide a detailed description of the 

measurement procedures actually used 

for the Commission’s consideration in 

determining compliance with its 

technical rules. 

7. Non-LBT devices. Regarding the 

frequency monitoring criteria for nonLBT devices, Medtronic correctly points 

out in its petition that the text of the 

MedRadio Order limits the number of 

transmissions per hour for non-LBT 

devices, but that these restrictions were 

omitted from the appropriate paragraph 

of § 95.628 (‘‘MedRadio Transmitters’’) 

as adopted. Medtronic requests that 

these limitations be added to paragraphs 

(b)(2) through (b)(4)—the paragraphs 

which also specify the duty cycle limits 

for non-LBT devices. The Commission 

concurs. The text of the MedRadio 

Order explicitly states that maximum 

number of communication sessions per 

hour for non-LBT devices shall be ten 

(10) per hour for devices operating with 

0.01% duty cycle within the 402–405 

MHz core band, and one hundred (100) 

per hour for devices operating with 

0.1% duty cycle in the wing bands. The 

omission of these provisions from the 

adopted rule was an editorial oversight. 

Therefore, the Commission amends 

§ 95.628, paragraphs (b)(2) through 

(b)(4) to add these limits to conform to 

the literal intent of the MedRadio Order. 

8. Medtronic also states that 

§ 95.1209(d) (‘‘Permissible 

Communications’’) as adopted appears 

to contain unnecessary language that 

could be interpreted as allowing nonLBT devices to operate without the 

communication of data. Medtronic 

argues that such non-data transmissions 

are inappropriate for non-LBT devices 

which do not employ frequency 

monitoring pursuant to § 95.628(b). 

Biotronik also supports this request for 

the same reasons. In the same 

subsection, Medtronic points out a 

clerical error in the text which 

mismatches the cross-references to 

limits set forth in § 95.628, subsections 

(b)(3) through (b)(4), with respect to 

non-LBT devices operating with 0.1% or 

0.01% duty cycles. 

9. The Commission agrees that the 

rules should be changed as Medtronic 

requests. The reference to non-LBT 

devices operating ‘‘without the 

communication of data’’ in § 95.1209(d) 

as adopted in the MedRadio Order was 

inadvertently carried over from the 

legacy MICS rule provisions. 

Historically, MICS devices were limited 

to LBT operation. Further, as Medtronic 

correctly points out, some small amount 

of non-data transmission is necessary to 

perform the LBT frequency monitoring 

protocol prescribed in the rules. By 

comparison, the new MedRadio rules 

encompass the operation of non-LBT as 

well as LBT devices. Since non-LBT 

devices, by definition, do not employ 

frequency monitoring prior to 

transmitting data, it would be spectrally 

inefficient and contrary to the intent of 

the MedRadio Order for such devices to 

operate without the transmission of 

data. 

10. Thus, the Commission amends 

§ 95.1209(d) to remove the reference to 

non-LBT devices operating without the 

communication of data. In addition, the 

Commission rectifies the cross 

references to the appropriate duty cycle 

and maximum transmission limits set 

forth in § 95.628—namely, that non-LBT 

devices operating pursuant to § 95.628, 

subsections (b)(2) and (b)(3), with 0.1% 

duty cycle may transmit for no more 

than 3.6 seconds per hour; and that nonLBT devices operating pursuant to 

§ 95.628, subsection (b)(4), with 0.01% 

duty cycle may transmit for no more 

than 360 milliseconds per hour. 

11. LBT Devices. The frequency 

monitoring rules for LBT devices 

require that the devices monitor 

channel(s) that they intend to occupy 

but not initiate a communications 

session unless certain access criteria are 

met. These criteria include a threshold 

power level; the LBT device may use a 

channel if no signal above the threshold 

power level is detected on that channel 

or, if no monitored channel meets this 

requirement, the channel with the 

lowest ambient power level (the ‘‘leastinterfered-channel’’ or ‘‘LIC’’). Medtronic 

urges the Commission to amend the 

MedRadio rules to clarify that singlechannel LBT devices operating under 

the LIC provisions of § 95.628(a)(4) must 

wait to transmit until the monitoring 

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52474 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Rules and Regulations 

threshold power level specified in 

§ 95.628(a)(1) is not exceeded on the 

device’s single channel of operation. 

Medtronic states its belief that this 

interpretation was intended by the 

MedRadio Order, but nevertheless seeks 

clarification to resolve any ambiguity. 

More specifically, Medtronic observes 

that the rule’s language tacitly envisions 

MedRadio transmitters capable of 

operating on multiple channels—such 

that the availability of an alternate 

channel is a meaningful option. In this 

light, Medtronic argues that a strained 

reading as applied to single channel 

LBT devices—which, by definition, 

cannot operate on an alternate 

channel—could lead to the 

interpretation that such devices may 

transmit at will regardless of whether 

the LBT monitoring threshold had been 

met. Such an interpretation, Medtronic 

argues, would essentially write the LBT 

requirement out of the rule for single 

channel devices. Biotronik supports this 

request. 

12. The Commission agrees that the 

rules should be amended to state this 

clarification. The intended 

interpretation is that the LBT threshold 

requirement applies to both multi- and 

single-channel devices. It also concurs 

with Medtronic’s assertion that a 

contrary interpretation would obviate 

the LBT requirement for single channel 

devices, thereby undermining our goal 

of fostering equitable band sharing by 

all LBT devices. Further, while the 

Commission believes that the contrary 

characterization that Medtronic cautions 

against would be a strained reading of 

the rule, it nevertheless wishes to 

prevent any misunderstanding. 

Accordingly, as applied to single 

channel LBT devices, the Commission 

clarifies that § 95.628(a)(4) shall be 

interpreted to require that such devices 

must wait to transmit until the 

monitoring threshold on the single 

channel of operation is not exceeded. 

The Commission is adding text to 

§ 95.628(a)(4) reflecting this 

clarification. 

13. Medtronic also requested that the 

Commission clarify that a MedRadio 

device operating under the LIC 

provisions of § 95.628(a)(4) must 

monitor—and be capable of operating 

on—a specified minimum number of 

channels (e.g., 9 for the core band, and 

18 for the wing bands). With support 

from Biotronik, Medtronic argues that 

such a requirement would ensure that 

devices using the least interfered 

channel provisions of § 95.628(a)(4) 

operate on the remaining alternate 

channels that have the lowest ambient 

power levels, thereby fostering more 

efficient band sharing while minimizing 

mutual interference. 

14. The Commission declines to 

modify the rule and affirms the rule as 

adopted. As an initial matter, the 

Commission notes that no such 

requirement was contained in the 

former MICS rules, and that no mention 

of adopting such a requirement was 

made in the MedRadio NPRM. 

Furthermore, and on the merits, the 

Commission also finds that establishing 

such a requirement on reconsideration 

would be inconsistent with our general 

desire, as articulated in the MedRadio 

Order, to adopt rules generally in 

conformance with the MICS while 

providing greater flexibility. The 

Commission believes that it is desirable 

to give manufacturers and the 

marketplace ample opportunity to 

determine the device channeling 

capabilities that are most useful for a 

particular application. Thus far, no 

problems have been reported to us 

resulting from this flexibility, and 

Medtronic presents no facts that would 

cause us to reconsider this decision. 

15. Finally, Medtronic asks that the 

Commission reconsider the decision in 

the MedRadio Order to reject 

Medtronic’s request—which it first 

raised in a January 10, 2008 ex parte 

submission—to modify the LBT 

monitoring threshold set forth in 

§ 95.628(a)(3) for devices that transmit 

with less than the maximum allowed 

power. The Commission declined to 

modify the LBT monitoring threshold 

because the issue was not raised in the 

MedRadio NPRM and thus there was 

little substantive basis on the record for 

modifying the rule. At the time of its 

submission, Medtronic asked that LBT 

threshold specified in the MICS rules be 

modified to increase the LBT threshold 

by 1 db for every 1 dB that the EIRP of 

the monitoring systems transmitter is 

below the maximum permitted level of 

25 microwatts EIRP for both body-worn 

and implanted MedRadio devices across 

the entire 401–406 MHz MedRadio 

band. Medtronic further stated that this 

modification would harmonize with 

recently adopted ETSI standards for 

low-power medical device data 

communications in other countries. 

Medtronic merely reiterates these claims 

in its petition, and suggests that the 

requested modification would only 

affect devices with lower interference 

potential. More recently, in subsequent 

ex parte submissions, Medtronic 

characterizes its request as being limited 

to body-worn devices when acting as 

programmer/control transmitters, and 

that it is not seeking a change to the LBT 

threshold for standalone programmer/ 

control transmitters. 

16. Upon reconsideration, the 

Commission affirms the finding in the 

MedRadio Order that insufficient notice 

was provided in the MedRadio NPRM to 

support modifying the LBT threshold as 

requested. The mere fact that Medtronic 

raised the subject of a modified LBT 

threshold for the first time in an ex 

parte submission does not cure this 

basic lack of sufficient notice in the 

MedRadio NPRM itself. 

17. The Commission also affirms the 

finding in the MedRadio Order that 

there was insufficient substantive 

discussion in the comment record to 

support such a modification. The 

Commission believes that modifying the 

monitoring threshold as suggested by 

Medtronic raises several issues that 

require further analysis. For example, 

Medtronic states that this modification 

would harmonize with recently adopted 

ETSI standards for low-power medical 

device data communications in other 

countries, but seeks to limit its 

application to only body-worn devices 

when acting as programmer/control 

transmitters across the entire 401–406 

MHz MedRadio band. Although the 

ETSI standard cited by Medtronic does 

include the substance of the modified 

LBT threshold, this standard only 

covers the 401–402 MHz and 405–406 

MHz wing bands, and also applies to 

both implanted and body-worn devices 

when used to select the frequency of 

operation. In addition, the Commission 

has to consider the impact of a higher 

monitoring threshold on primary 

METAIDS users in these frequency 

bands which might increase the 

likelihood of a medical device seeking 

to operate on a channel being used by 

a METAIDS device. Medtronic seeks to 

minimize these concerns by asserting 

that LBT medical devices would suffer 

no more interference from METAIDS 

devices than non-LBT devices, but it 

offers no analysis to support this 

assertion. These concerns lead us to 

conclude that insufficient substantive 

record has been developed to act on 

Medtronic’s request at this time. The 

first step to develop such a record, to 

the extent it wishes to further proceed 

on this question, is for Medtronic to file 

a petition for rulemaking with the 

Commission. 

18. Human Torso Simulator and 

Testing Technique. The transmitters 

used for medical implant and bodyworn devices authorized under the 

MedRadio rules are required to be tested 

to determine compliance with radiated 

emissions and EIRP limits. Medtronic 

requests that the rules be modified to 

reinstate a provision requiring use of a 

particular human torso simulator test 

technique for implanted medical 

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Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Rules and Regulations 52475 

1See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601– 

612, has been amended by the Small Business 

Regulatory Enforcement Fairness Act of 1996 

(SBREFA), Public Law 104–121, Title II, 110 Stat. 

857 (1996). 

2See Investigation of the Spectrum Requirements 

for Advanced Medical Technologies, Amendment 

of Parts 2 and 95 of the Commission’s Rules to 

Establish the Medical Device Radio 

Communications Service at 401–402 and 405–406 

MHz, Dexcom, Inc., Request for Waiver of the 

Frequency Monitoring Requirements of the Medical 

Implant Communications Service Rules, Biotronik, 

Inc. Request for Waiver of the Frequency 

Monitoring Requirements for the Medical Implant 

Communications Service Rules, ET Docket No. 06– 

135, RM–11271, Notice of Proposed Rule Making 

and Notice of Inquiry and Order, (MedRadio NPRM) 

21 FCC Rcd 8164 (2006). 

3See Investigation of the Spectrum Requirements 

for Advanced Medical Technologies, Amendment 

of Parts 2 and 95 of the Commission’s Rules to 

Establish the Medical Device Radio 

Communications Service at 401–402 and 405–406 

MHz, Dexcom, Inc., Request for Waiver of the 

Frequency Monitoring Requirements of the Medical 

Implant Communications Service Rules, Biotronik, 

Inc. Request for Waiver of the Frequency 

Monitoring Requirements for the Medical Implant 

Communications Service Rules, ET Docket No. 06– 

135, RM–11271, Report and Order, (MedRadio 

Report and Order) 24 FCC Rcd 22696 (2009). 

4See 5 U.S.C. 604. 

5See Petition for Reconsideration, ET Docket No. 

06–135, filed by Medtronic on June 15, 2009. 

6Part 95 governs the Personal Radio Services, 

including General Mobile Radio Service, Radio 

Control Service and Citizens Band (CB) Radio 

Service. The CB Radio Service, in turn, covers a 

number of specialized services, including the 

MedRadio Service. As with the legacy MICS, the 

MedRadio service devices operate on a secondary, 

non-interference basis with respect to primary 

authorized services and, as such, they must accept 

harmful interference from devices operated under 

such services. Further, MedRadio devices operate 

on a shared, non-exclusive basis with respect to 

each other and other secondary devices. 

devices that was set forth in former 

§ 95.639(f)(2)(i) of the MICS rules. 

Medtronic states that the corresponding 

new MedRadio provision, 

§ 95.628(g)(3)(i), which more broadly 

requires a ‘‘Commission-approved 

human body simulator and test 

technique,’’ fails to provide sufficient 

guidance about what type of 

measurement data is required. 

Medtronic also claims that no changes 

to the test technique were proposed in 

the MedRadio NPRM. Medtronic further 

argues that the former MICS provision 

reduces possible confusion by 

providing, in effect, a safe harbor for 

compliance purposes. Biotronik 

supports this request for the same 

reasons. 

19. The Commission denies this 

request and affirms § 95.628(g)(3)(i) of 

the new MedRadio rules as adopted. 

The new rule is more permissive than 

the former MICS rule and provides 

greater flexibility in testing devices by 

expanding, rather than limiting, 

available measurement compliance 

options. As the Commission observed 

regarding procedures for measuring 

average power, § 2.947 of the rules 

allows the Commission to provide 

specific guidance as to the measurement 

approaches that would be acceptable in 

a more responsive and timely manner 

through the issuance of bulletins or 

reports and without the need to correct 

outdated references in the underlying 

rules through time-consuming, formal 

proceedings. Moreover, in the event the 

Commission has not provided guidance 

through bulletins or reports, the rules 

also allow parties to provide a detailed 

description of the measurement 

procedures actually used for the 

Commission’s consideration in 

determining compliance with its 

technical rules. This approach also 

forestalls inadvertent rule obsolescence 

as new measurement techniques are 

developed. More to the point with 

respect to Medtronic’s concerns herein, 

the Commission affirms that the new 

rules do not preclude use of the ‘‘human 

torso’’ simulator described in the former 

MICS rules. Finally, as with the 

transmitter power measurement issue, 

the Commission notes that the OET 

Laboratory Division has published 

information in its KDB concerning 

acceptable measurement procedures 

under this provision, including a 

statement that use of the human torso 

technique formerly codified in the MICS 

rules continues to be acceptable. 

Paperwork Reduction Analysis 

20. This document does not contain 

new or modified information collection 

requirements subject to the Paperwork 

Reduction Act of 1995 (PRA), Public 

Law 104–13. In addition, therefore, it 

does not contain any new or modified 

information collection burden for small 

business concerns with fewer than 25 

employees, pursuant to the Small 

Business Paperwork Relief Act of 2002, 

Public Law 107–198, see 44 U.S.C. 

3506(c)(4). 

Congressional Review Act 

21. The Commission will send a copy 

of this Memorandum Opinion and 

Order, in a report to be sent to Congress 

and the Government Accountability 

Office pursuant to the Congressional 

Review Act, see 5 U.S.C. 801(a)(1)(A). 

Final Regulatory Flexibility Analysis 

22. As required by the Regulatory 

Flexibility Act of 1980, as amended 

(RFA),1 an Initial Regulatory Flexibility 

Analysis (IRFA) was incorporated in the 

Notice of Proposed Rulemaking 

(MedRadio NPRM) in this proceeding.2

The Commission sought written public 

comment on the proposals in the 

MedRadio NPRM, including comment 

on the IRFA. In addition, a Final 

Regulatory Flexibility Analysis (FRFA) 

was incorporated in the subsequent 

Report and Order (MedRadio Order) in 

this same proceeding.3 This Final 

Regulatory Flexibility Analysis (FRFA) 

for the subject Memorandum Opinion 

and Order conforms to the RFA.4

A. Need for and Objective of Adopted 

Rules 

23. The subject Memorandum 

Opinion and Order responds to the 

Petition for Reconsideration submitted 

by Medtronic, Inc. on June 15, 2009.5 It 

grants reconsideration to the extent of 

including a provision in the MedRadio 

rules that permits the submission of 

transmitter output power measurements 

made using average power 

instrumentation techniques. It also 

makes several minor corrections or 

clarifications of an editorial nature with 

respect to other provisions. It denies 

reconsideration in all other respects. 

24. The need for and objectives of the 

amended rules adopted in this 

Memorandum Opinion and Order are 

the same as those discussed in the FRFA 

for the Report and MedRadio Order. In 

the MedRadio Order, the Commission 

found that additional spectrum was 

required for the operation of advanced 

medical devices using wireless 

telecommunication technologies. Thus, 

building upon the legacy Medical 

Implant Communications Service 

(MICS), the Commission adopted 

service and technical rules for a new 

MedRadio Service that replicated, and 

expanded upon, many of the former 

MICS requirements. For example, the 

legacy MICS rules limited operation to 

implanted medical devices. However, 

the rules for the new MedRadio Service 

adopted in the MedRadio Order 

accommodate body-worn as well as 

implanted medical devices. Under this 

framework, the rules for MedRadio 

service incorporates the MICS ‘‘core’’ 

band at 402–405 MHz—which 

continues to be limited to implanted 

devices; and also includes two 

megahertz of newly designated 

spectrum in the adjacent ‘‘wing’’ bands 

at 401–402 MHz and 405–406 MHz— in 

which both body-worn and implanted 

devices are permitted. As with the 

MICS, the MedRadio service is housed 

within Part 95 of the Commission’s 

rules.6 As a result, the legacy MICS and 

new MedRadio rules share many of the 

same licensing and technical 

requirements. Altogether, the MedRadio 

service provides a total of five 

megahertz of contiguous spectrum for 

advanced wireless medical 

radiocommunication devices serving a 

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52476 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Rules and Regulations 

7 5 U.S.C. 603(b)(3). 

8 5 U.S.C. 601(6). 

9 5 U.S.C. 601(3) (incorporating by reference the 

definition of ‘‘small business concern’’ in 15 U.S.C. 

632). Pursuant to the RFA, the statutory definition 

of a small business applies ‘‘unless an agency, after 

consultation with the Office of Advocacy of the 

Small Business Administration and after 

opportunity for public comment, establishes one or 

more definitions of such term which are 

appropriate to the activities of the agency and 

publishes such definition(s) in the Federal 

Register.’’ 5 U.S.C. 601(3). 

10Small Business Act, 15 U.S.C. 632 (1996). 

11See SBA, Programs and Services, SBA 

Pamphlet No. CO–0028, at page 40 (July 2002). 

12 5 U.S.C. 601(4). 

13 Independent Sector, The New Nonprofit 

Almanac & Desk Reference (2002). 

14 5 U.S.C. 601(5). 

15U.S. Census Bureau, Statistical Abstract of the 

United States: 2006, Section 8, page 272, Table 415. 

16We assume that the villages, school districts, 

and special districts are small, and total 48,558. See 

U.S. Census Bureau, Statistical Abstract of the 

United States: 2006, section 8, page 273, Table 417. 

For 2002, Census Bureau data indicate that the total 

number of county, municipal, and township 

governments nationwide was 38,967, of which 

35,819 were small. Id. 

17U.S. Census Bureau, 2007 NAICS Definitions, 

‘‘334220 Radio and Television Broadcasting and 

Wireless Communications Equipment 

Manufacturing’’; http://www.census.gov/naics/ 

2007/def/ND334220.HTM#N334220. 

18 13 CFR 121.201, NAICS code 334220. 

19U.S. Census Bureau, American FactFinder, 

2002 Economic Census, Industry Series, Industry 

Statistics by Employment Size, NAICS code 334220 

(released May 26, 2005); http:// 

factfinder.census.gov. The number of 

‘‘establishments’’ is a less helpful indicator of small 

business prevalence in this context than would be 

the number of ‘‘firms’’ or ‘‘companies,’’ because the 

latter take into account the concept of common 

ownership or control. Any single physical location 

for an entity is an establishment, even though that 

location may be owned by a different establishment. 

Thus, the numbers given may reflect inflated 

numbers of businesses in this category, including 

the numbers of small businesses. In this category, 

the Census breaks out data for firms or companies 

only to give the total number of such entities for 

2002, which was 929. 

20 Id. An additional 18 establishments had 

employment of 1,000 or more. 

21We note that 47 U.S.C. 307(e)(3) provides that 

the term ‘‘citizens band radio service’’ shall have the 

meaning given it by the Commission by rule. 47 

U.S.C. 307(e)(1) provides that upon determination 

by the Commission that an authorization serves the 

public interest, convenience, and necessity, the 

Commission may by rule authorize the operation of 

radio stations without individual licenses in the 

citizens band radio service. 

22See 5 U.S.C. 603(c). 

diverse range of diagnostic and 

therapeutic purposes in humans. 

B. Summary of Significant Issues Raised 

by Public Comments in Response to the 

FRFA 

25. No comments were filed in 

response to the FRFA in this 

proceeding. In addition, no comments 

were submitted concerning small 

business issues. 

C. Description and Estimate of the 

Number of Small Entities to Which the 

Adopted Rules Will Apply 

26. The RFA directs agencies to 

provide a description of and, where 

feasible, an estimate of the number of 

small entities that may be affected by 

the proposed rules, if adopted.7 The 

RFA generally defines the term ‘‘small 

entity’’ as having the same meaning as 

the terms ‘‘small business,’’ ‘‘small 

organization,’’ and ‘‘small governmental 

jurisdiction.’’ 8 In addition, the term 

‘‘small business’’ has the same meaning 

as the term ‘‘small business concern’’ 

under the Small Business Act.9 A small 

business concern is one which: (1) Is 

independently owned and operated; (2) 

is not dominant in its field of operation; 

and (3) satisfies any additional criteria 

established by the SBA.10

27. In the FRFA the Commission 

stated that nationwide, there are a total 

of approximately 22.4 million small 

businesses, according to SBA data.11 A 

‘‘small organization’’ is generally ‘‘any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field.’’ 12

Nationwide, as of 2002, there were 

approximately 1.6 million small 

organizations.13 The term ‘‘small 

governmental jurisdiction’’ is defined 

generally as ‘‘governments of cities, 

towns, townships, villages, school 

districts, or special districts, with a 

population of less than fifty 

thousand.’’ 14 Census Bureau data for 

2002 indicate that there were 87,525 

local governmental jurisdictions in the 

United States.15 The Commission 

estimates that, of this total, 84,377 

entities were ‘‘small governmental 

jurisdictions.’’ 16 Thus, we estimate that 

most governmental jurisdictions are 

small. 

28. Radio and Television 

Broadcasting and Wireless 

Communications Equipment 

Manufacturing. The Census Bureau 

defines this category as follows: ‘‘This 

industry comprises establishments 

primarily engaged in manufacturing 

radio and television broadcast and 

wireless communications equipment. 

Examples of products made by these 

establishments are: transmitting and 

receiving antennas, cable television 

equipment, GPS equipment, pagers, 

cellular phones, mobile 

communications equipment, and radio 

and television studio and broadcasting 

equipment.’’ 17 The SBA has developed 

a small business size standard for firms 

in this category, which is: all such firms 

having 750 or fewer employees.18

According to Census Bureau data for 

2002, there were a total of 1,041 

establishments in this category that 

operated for the entire year.19 Of this 

total, 1,010 had employment of under 

500, and an additional 13 had 

employment of 500 to 999.20 Thus, 

under this size standard, the majority of 

firms can be considered small. 

D. Description of Reporting, 

Recordkeeping, and Other Compliance 

Requirements for Small Entities 

29. The Memorandum Opinion and 

Order does not change any of the 

reporting, recordkeeping, or other 

compliance requirements resulting from 

the rules adopted in the MedRadio 

Order. As stated above, the only 

substantive rule change in the 

Memorandum Opinion and Order 

merely reinstates a provision from the 

former MICS rules that permits the 

submission of average power transmitter 

measurements. 

30. Furthermore, as stated in the 

FRFA, the rules adopted by the 

Commission in the MedRadio Order use 

the same licensing approach for the 

entire 401–406 MHz MedRadio band 

that was previously used for the legacy 

MICS band at 402–405 MHz. Rather 

than require individual transmitter 

licensing, the Commission authorizes 

operation by rule within the Citizens 

Band (CB) Radio Service under Part 95 

of our Rules and pursuant to Section 

307(e) of the Communications Act.21

Thus, licensing will be accomplished 

through adherence to applicable 

technical standards and other operating 

rules. The Commission concluded in the 

MedRadio Order that this approach is 

beneficial because it would minimize 

the administrative burden on 

prospective licensees as compared with 

an individual licensing scheme. 

E. Steps Taken To Minimize Significant 

Economic Impact on Small Entities, and 

Significant Alternatives Considered 

31. The RFA requires an agency to 

describe any significant alternatives that 

it has considered in reaching its 

proposed approach, which may include 

the following four alternatives (among 

others): (1) The establishment of 

differing compliance or reporting 

requirements or timetables that take into 

account the resources available to small 

entities; (2) the clarification, 

consolidation, or simplification of 

compliance or reporting requirements 

under the rule for small entities; (3) the 

use of performance, rather than design, 

standards; and (4) an exemption from 

coverage of the rule, or any part thereof, 

for small entities.22

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Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Rules and Regulations 52477 

23See 5 U.S.C. 801(a)(1)(A). 

32. In the preceding MedRadio NPRM, 

the Commission sought comment on 

which regulatory approaches would be 

appropriate to govern the MedRadio 

Service. Subsequently, in the MedRadio 

Order the Commission considered the 

responsive comments filed by interested 

parties, and determined that record as a 

whole supported extending the licenseby-rule approach under Part 95—used 

by the former MICS—to the new 

MedRadio service because of the 

reduced regulatory impact on all 

licensees. 

F. Report to Congress 

33. The Commission will send a copy 

of the Memorandum Opinion and 

Order, including this FRFA, in a report 

to be sent to Congress pursuant to the 

Congressional Review Act.23 In 

addition, the Commission’s Consumer 

and Governmental Affairs Bureau will 

send a copy of the Memorandum 

Opinion and Order, including the 

FRFA, to the Chief Counsel for 

Advocacy of the SBA. 

Ordering Clauses 

34. Pursuant to the authority 

contained in §§ 4(i), 302, 303(e), 303(f), 

and 307 of the Communications Act of 

1934, as amended, 47 U.S.C. 154(i), 302, 

303(c), 303(f), and 307 this 

Memorandum Opinion and Order is 

hereby adopted. 

35. Part 95 of the Commission’s rules 

is amended and such rule amendments 

shall be effective September 27, 2010 

36. Pursuant to §§ 4(i), 302, 303(e) 

303(f), 303(g), 303(r) and 405 of the 

Communications Act of 1934, as 

amended, 47 U.S.C. 154(i), 302, 303(e), 

303(f), 303(g) and 405, that the petition 

for reconsideration filed by Medtronic, 

Inc. Is granted in part and denied in 

part as set forth. 

37. The Commission’s Consumer and 

Governmental Affairs Bureau, Reference 

Information Center, shall send a copy of 

this Memorandum Opinion and Order, 

including the Final Regulatory 

Flexibility Analysis, to the Chief 

Counsel for Advocacy of the Small 

Business Administration. 

38. It is further ordered that ET Docket 

No. 06–135 is terminated. 

List of Subjects in 47 CFR Part 95 

Communications equipment, Medical 

devices. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

Final Rules 

■ For the reasons discussed in the 

preamble, the Federal Communications 

Commission amends 47 CFR part 95 to 

read as follows: 

PART 95—PERSONAL RADIO 

SERVICES 

■ 1. The authority citation for part 95 

continues to read as follows: 

Authority: Sections 4, 303, 48 Stat. 1066, 

1082, as amended; 47 U.S.C. 154, 303. 

■ 2. Section 95.628 is amended by 

revising paragraphs (a)(4), (b)(2) through 

(b)(4), and (g)(3) introductory text to 

read as follows: 

§ 95.628 MedRadio transmitters. 

(a) * * * 

(4) If no signal in a MedRadio channel 

above the monitoring threshold power 

level is detected, the MedRadio 

programmer/control transmitter may 

initiate a MedRadio-communications 

session involving transmissions to and 

from a medical implant or medical 

body-worn device on that channel. The 

MedRadio communications session may 

continue as long as any silent period 

between consecutive data transmission 

bursts does not exceed 5 seconds. If a 

channel meeting the criteria in 

paragraph (a)(3) of this section is 

unavailable, MedRadio transmitters that 

are capable of operating on multiple 

channels may transmit on the alternate 

channel accessible by the device with 

the lowest monitored ambient power 

level. Except as provided in paragraph 

(b) of this section, MedRadio 

transmitters that operate on a single 

channel and thus do not have the 

capability of operating on alternate 

channels may not transmit unless no 

signal on the single channel of operation 

exceeds the monitoring threshold power 

level. 

* * * * * 

(b) * * * 

(2) MedRadio devices operating in 

either the 401–401.85 MHz or 405–406 

MHz bands, provided that the transmit 

power is not greater than 250 nanowatts 

EIRP and the duty cycle for such 

transmissions does not exceed 0.1%, 

based on the total transmission time 

during a one-hour interval, and a 

maximum of 100 transmissions per 

hour. 

(3) MedRadio devices operating in the 

401.85–402 MHz band, provided that 

the transmit power is not greater than 25 

microwatts EIRP and the duty cycle for 

such transmissions does not exceed 

0.1%, based on the total transmission 

time during a one hour interval, and a 

maximum of 100 transmissions per 

hour. 

(4) MedRadio devices operating with 

a total emission bandwidth not 

exceeding 300 kHz centered at 403.65 

MHz, provided that the transmit power 

is not greater than 100 nanowatts EIRP 

and the duty cycle for such 

transmissions does not exceed 0.01%, 

based on the total transmission time 

during a one-hour interval, and a 

maximum of 10 transmissions per hour. 

* * * * * 

(g) * * * 

(3) Radiated emissions and EIRP 

measurements may be determined by 

measuring the radiated field from the 

equipment under test at 3 meters and 

calculating the EIRP. The equivalent 

radiated field strength at 3 meters for 25 

microwatts, 250 nanowatts, and 100 

nanowatts EIRP is 18.2, 1.8, or 1.2 mV/ 

meter, respectively, when measured on 

an open area test site; or 9.1, 0.9, or 0.6 

mV/meter, respectively, when measured 

on a test site equivalent to free space 

such as a fully anechoic test chamber. 

Compliance with the maximum 

transmitter power requirements set forth 

in § 95.639(f) shall be based on 

measurements using a peak detector 

function and measured over an interval 

of time when transmission is 

continuous and at its maximum power 

level. In lieu of using a peak detector 

function, measurement procedures that 

have been found to be acceptable to the 

Commission in accordance with § 2.947 

of this chapter may be used to 

demonstrate compliance. 

* * * * * 

■ 3. Section 95.1209 is amended by 

revising paragraph (d) to read as 

follows: 

§ 95.1209 Permissible communications. 

* * * * * 

(d) For the purpose of facilitating 

MedRadio system operation during a 

MedRadio communications session, as 

defined in § 95.628, MedRadio 

transmitters may transmit in accordance 

with the provisions of § 95.628(a) for no 

more than 5 seconds without the 

communications of data; MedRadio 

transmitters may transmit in accordance 

with the provisions of § 95.628(b)(2) and 

(b)(3) for no more than 3.6 seconds in 

total within a one hour time period; and 

MedRadio transmitters may transmit in 

accordance with the provisions of 

§ 95.628(b)(4) for no more than 360 

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52478 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Rules and Regulations 

milliseconds in total within a one hour 

time period. 

* * * * * 

[FR Doc. 2010–21011 Filed 8–25–10; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 0910131363–0087–02] 

RIN 0648–XY45 

Fisheries of the Economic Exclusive 

Zone Off Alaska; Pacific Cod in the 

Bering Sea and Aleutian Islands 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; modification 

of a closure. 

SUMMARY: NMFS is opening directed 

fishing for Pacific cod by catcher vessels 

less than 60 feet (18.3 meters) length 

overall (LOA) using hook-and-line or 

pot gear in the Bering Sea and Aleutian 

Islands management area (BSAI). This 

action is necessary to fully use the 2010 

total allowable catch (TAC) of Pacific 

cod specified for catcher vessels less 

than 60 feet (18.3 meters) LOA using 

hook-and-line or pot gear specified for 

the BSAI. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), August 27, 2010, through 

2400 hrs, A.l.t., December 31, 2010. 

Comments must be received at the 

following address no later than 4:30 

p.m., A.l.t., September 10, 2010. 

ADDRESSES: Send comments to Sue 

Salveson, Assistant Regional 

Administrator, Sustainable Fisheries 

Division, Alaska Region, NMFS, Attn: 

Ellen Sebastian. You may submit 

comments, identified by RIN 0648– 

XY45, by any one of the following 

methods: 

• Electronic Submissions: Submit all 

electronic public comments via the 

Federal eRulemaking Portal http:// 

www.regulations.gov. 

• Mail: P.O. Box 21668, Juneau, AK 

99802. 

• Fax: (907) 586–7557. 

• Hand delivery to the Federal 

Building: 709 West 9th Street, Room 

420A, Juneau, AK. 

All comments received are a part of 

the public record. No comments will be 

posted to http://www.regulations.gov for 

public viewing until after the comment 

period has closed. Comment will 

generally be posted without change. All 

Personal Identifying Information (for 

example, name, address, etc.) 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit Confidential Business 

Information or otherwise sensitive or 

protected information. 

NMFS will accept anonymous 

comments (enter N/A in the required 

fields, if you wish to remain 

anonymous). You may submit 

attachments to electronic comments in 

Microsoft Word, Excel, WordPerfect, or 

Adobe PDF file formats only. 

FOR FURTHER INFORMATION CONTACT: 

Obren Davis, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Bering Sea 

and Aleutian Islands Management Area 

(FMP) prepared by the North Pacific 

Fishery Management Council under 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 

Act. Regulations governing fishing by 

U.S. vessels in accordance with the FMP 

appear at subpart H of 50 CFR part 600 

and 50 CFR part 679. 

NMFS closed directed fishing for 

Pacific cod by catcher vessels less than 

60 feet (18.3 meters) length overall using 

hook-and-line or pot gear in the BSAI 

under § 679.20(d)(1)(iii) on May 19, 

2010 (75 FR 28502, May 21, 2010). 

NMFS has determined that as of 

August 20, 2010, approximately 500 

metric tons of Pacific cod remain in the 

2010 Pacific cod apportionment for 

catcher vessels less than 60 feet (18.3 

meters) length overall using hook-andline or pot gear in the BSAI. Therefore, 

in accordance with § 679.25(a)(1)(i), 

(a)(2)(i)(C), and (a)(2)(iii)(D), and to fully 

use the 2010 TAC of Pacific cod in the 

BSAI, NMFS is terminating the previous 

closure and is opening directed fishing 

for Pacific cod by catcher vessels less 

than 60 feet (18.3 meters) length overall 

using hook-and-line or pot gear in the 

BSAI. 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Assistant 

Administrator for Fisheries, NOAA 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 5 

U.S.C. 553(b)(B) as such requirement is 

impracticable and contrary to the public 

interest. This requirement is 

impracticable and contrary to the public 

interest as it would prevent NMFS from 

responding to the most recent fisheries 

data in a timely fashion and would 

delay the opening of the Pacific cod 

fishery by Pacific cod by catcher vessels 

less than 60 feet (18.3 meters) length 

overall using hook-and-line or pot gear 

in the BSAI. Immediate notification is 

necessary to allow for the orderly 

conduct and efficient operation of this 

fishery, to allow the industry to plan for 

the fishing season, and to avoid 

potential disruption to the fishing fleet 

and processors. NMFS was unable to 

publish a notice providing time for 

public comment because the most 

recent, relevant data only became 

available as of August 20, 2010. 

The AA also finds good cause to 

waive the 30–day delay in the effective 

date of this action under 5 U.S.C. 

553(d)(3). This finding is based upon 

the reasons provided above for waiver of 

prior notice and opportunity for public 

comment. 

Without this inseason adjustment, 

NMFS could not allow the fishery for 

Pacific cod by catcher vessels less than 

60 feet (18.3 meters) length overall using 

hook-and-line or pot gear in the BSAI to 

be harvested in an expedient manner 

and in accordance with the regulatory 

schedule. Under § 679.25(c)(2), 

interested persons are invited to submit 

written comments on this action to the 

above address until September 10, 2010. 

This action is required by § 679.25 

and is exempt from review under 

Executive Order 12866. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: August 23, 2010. 

Carrie Selberg, 

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. 2010–21260 Filed 8–23–10; 4:15 pm] 

BILLING CODES S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 0910131363–0087–02] 

RIN 0648–XY44 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Reallocation of 

Pacific Cod in the Bering Sea and 

Aleutian Islands Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; reallocation. 

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