22696 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

environmental standard intended to 

mitigate health or safety risks. 

H. Executive Order 13211—Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This final action is not subject to 

Executive Order 13211 (66 FR 28355, 

May 22, 2001) because it is not a 

significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law 104– 

113, 12(d) (15 U.S.C. 272 note), directs 

EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (for 

example, materials specifications, test 

methods, sampling procedures, and 

business practices) that are developed or 

adopted by voluntary consensus 

standards bodies. The NTTAA directs 

EPA to provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

This final action does not involve 

technical standards; therefore, EPA did 

not consider the use of any voluntary 

consensus standards. 

J. Executive Order 12898—Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 (59 FR 7629, 

February 16, 1994) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this final 

action will not have disproportionately 

high and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. Therefore, Executive 

Order 12898 does not apply to this final 

action. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA submitted a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This final action is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). Therefore, 

this final action will be effective on May 

14, 2009. 

L. Judicial Review 

Under CAA section 307(b), judicial 

review of this final action is available 

only by filing a petition for review in 

the U.S. Court of Appeals for the District 

of Columbia Circuit on or before July 13, 

2009. Under CAA section 307(d)(7)(B), 

only those objections to the final rule 

that were raised with specificity during 

the period of public comment may be 

raised during judicial review. Moreover, 

under CAA section 307(b)(2), the 

requirements established by this final 

rule may not be challenged separately in 

any civil or criminal proceedings 

brought by EPA to enforce these 

requirements. 

VI. Statutory Authority 

The statutory authority for this action 

is provided by sections 307(d)(7)(B), 

101, 111, 114, 116, and 301 of the CAA 

as amended (42 U.S.C. 7401, 7411, 7414, 

7416, and 7601). This notice is also 

subject to section 307(d) of the CAA (42 

U.S.C. 7407(d)). 

List of Subjects 

40 CFR Part 51 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Baseline 

emissions, Intergovernmental relations, 

Aggregation, Major modifications, 

Reporting and recordkeeping 

requirements. 

40 CFR Part 52 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Baseline 

emissions, Incorporation by reference, 

Intergovernmental relations, 

Aggregation, Major modifications, 

Reporting and recordkeeping 

requirements. 

Dated: May 8, 2009. 

Lisa P. Jackson, 

Administrator. 

[FR Doc. E9–11271 Filed 5–13–09; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1, 2 and 95 

[ET Docket Nos. 06–135, 05–213 and 03– 

92, RM–11271; FCC 09–23] 

Spectrum Requirements for Advanced 

Medical Technologies 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: This document establishes a 

new Medical Device 

Radiocommunication Service 

(MedRadio Service) of the Commission’s 

rules. This new service incorporates the 

existing Medical Implant 

Communications Service (MICS) ‘‘core’’ 

band at 402–405 MHz, and also includes 

two megahertz of newly designated 

spectrum in the adjacent ‘‘wing’’ bands 

at 401–402 MHz and 405–406 MHz. The 

MedRadio Service will accommodate 

the operation of body-worn as well as 

implanted medical devices, including 

those using either listen-before-talk 

(‘‘LBT’’) frequency monitoring or nonLBT spectrum access methods, in 

designated portions of the 401–406 MHz 

band. 

DATES: Effective August 12, 2009. 

FOR FURTHER INFORMATION CONTACT: Gary 

Thayer, (202) 418–2290, e-mail 

Gary.Thayer@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Report 

and Order, ET Docket Nos. 06–135, 05– 

213, and 03–92, RM–11271, FCC 09–23, 

adopted March 19, 2009, and released 

March 20, 2009. 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 St., 

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. 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 22697 

Summary of the Report and Order 

1. Overview. In July 2006, the 

Commission adopted a Notice of 

Proposed Rulemaking (NPRM), Notice 

of Inquiry (NOI) and Order— 

collectively, the MedRadio NPRM. In 

the MedRadio NPRM, the Commission 

proposed to establish a new service for 

medical radiocommunication devices to 

better accommodate the varieties of new 

implantable and body-worn medical 

devices. 

2. In this Report and Order, the 

Commission decided to establish a new 

Medical Device Radio-communication 

Service (MedRadio Service) under part 

95 of the Commission’s rules. Under the 

rules adopted by the Commission in this 

Report and Order, this new service 

incorporates the existing Medical 

Implant Communications Service 

(MICS) ‘‘core’’ band at 402–405 MHz, 

and also includes two megahertz of 

newly designated spectrum in the 

adjacent ‘‘wing’’ bands at 401–402 MHz 

and 405–406 MHz. Thus, the MedRadio 

Service will provide a total of five 

megahertz of contiguous spectrum on a 

secondary basis and non-interference 

basis for advanced wireless medical 

radiocommunication devices used for 

diagnostic and therapeutic purposes in 

humans. In addition, the MedRadio 

Service will accommodate the operation 

of body-worn as well as implanted 

medical devices, including those using 

either listen-before-talk (‘‘LBT’’) 

frequency monitoring or non-LBT 

spectrum access methods, in designated 

portions of the 401–406 MHz band. 

3. The Commission found that the 

new MedRadio spectrum in the 401–402 

MHz and 405–406 MHz wing bands is 

well suited for use on a secondary basis 

by the medical implant and body-worn 

devices covered by this Order for 

several reasons. First, these frequencies 

offer the same propagation, availability, 

and compatibility characteristics that 

were found to be favorable for the MICS 

in the 402–405 MHz core band. In 

addition, this new designation will 

result in a continuous span of spectrum 

(from 401–406 MHz) that matches the 

five-megahertz of spectrum that is also 

designated internationally for similar 

use by medical implant and body-worn 

devices. 

4. The Commission noted that the 

service and technical rules adopted in 

this Report and Order for the MedRadio 

Service are based upon the existing 

MICS rules, and include modified 

spectrum sharing requirements in the 

new wing bands. The new rules will 

permit the use of both medical implant 

devices and medical body-worn devices 

in specified segments of the 401–406 

MHz band. 

5. The Commission found that these 

new MedRadio sharing rules will 

provide a greater degree of flexibility 

than is permitted by the existing 

medical implant rules, while also 

assuring spectrum use compatibility 

among different device types. The 

Commission further found that the new 

designation in the wing bands will 

provide the additional shared spectrum 

that is urgently needed for operation of 

both implant and body-worn devices. 

The Commission stated its further belief 

that the MedRadio rules adopted in this 

Order should encourage the continuing 

use of the legacy MICS core band 

predominantly for life-critical 

applications, such as those served by 

the existing population of medical 

implant devices presently used. 

6. With respect to the potential for 

interference to incumbent users of the 

401–402 MHz and 405–406 MHz wing 

bands arising from the operation of 

MedRadio devices, the Commission 

concluded that the potential for such 

interference is negligibly small. The 

Commission noted that, in the United 

States, the 401–406 MHz band is 

allocated for various Federal and nonFederal uses on a primary basis, and the 

402–405 MHz band is allocated for 

mobile, except mobile aeronautical, 

service on a secondary basis, with use 

limited to MICS. The Commission 

determined that, given the ultra low 

power limits and intermittent operating 

modes that will be used by these 

medical devices, and the expectation of 

large separation distances, there is little 

likelihood that these medical devices 

could cause harmful interference to 

incumbent operations. 

7. With respect to the potential for 

harmful effects to MedRadio devices 

due to received interference from 

incumbent users, the Commission 

observed that it would be beneficial if 

MedRadio devices employed robust 

designs. For example, the Commission 

noted that MedRadio medical devices— 

particularly those devices used for life 

critical and time-sensitive 

applications—might need to employ a 

variety of error detection and correction 

techniques, frequency monitoring 

capabilities, and re-transmission 

protocols. 

8. In broader terms, the Commission 

determined that the additional spectrum 

and enhanced flexibility afforded in the 

new rules will promote the accelerated 

development of newer generations of 

advanced medical device technologies. 

These advances, the Commission found, 

will herald dramatic improvements in 

therapeutic/diagnostic patient care and 

quality of life for countless individuals. 

The Commission also noted that the 

MedRadio designation and rules 

adopted in this Order are harmonized 

for the most part in their general 

approach with similar European 

Telecommunication Standards Institute 

(ETSI) standards relating to use of the 

401–406 MHz band by medical implant 

and body-worn devices in other regions 

of the world. The Commission stated its 

belief that such harmonization will 

serve the public interest by offering 

Americans greater confidence of reliable 

device operation while traveling abroad, 

and conversely, by offering similar 

confidence for foreign visitors to the 

United States. The Commission also 

determined that economies of scale 

resulting from harmonized rules for 

domestic manufacturers seeking to 

compete in the world market should 

foster a reduction of device prices, thus 

making the benefits of such technologies 

more widely available and affordable for 

the American public. 

9. Licensing. Consistent with the 

existing MICS licensing scheme, the 

Commission decided that the new 

MedRadio service at 401–406 MHz will 

be governed under Part 95 of the 

Commission’s rules, thus providing for 

license-by-rule operation throughout the 

5 megahertz band. The Commission 

concluded that this approach minimizes 

regulatory procedures and will facilitate 

the more expeditious deployment of 

new generations of beneficial wireless 

medical devices in these bands that can 

improve the quality of life for countless 

Americans, thus serving the public 

interest, convenience and necessity. The 

Commission also decided that the 

operation of medical devices in the 

MedRadio band will be on a secondary, 

non-interference basis with respect to 

other authorized services and as such 

they must accept harmful interference 

from the systems operating in those 

services. MedRadio devices will operate 

on a shared, non-exclusive basis with 

respect to each other. 

10. Definitions—Implant and Bodyworn Devices. In order to be deemed a 

medical body-worn device or medical 

body-worn transmitter, the Commission 

required that the antenna of the 

associated patient-worn device be 

placed upon or in very close proximity 

(e.g., within a few centimeters) to the 

body. In order to be classified as a 

medical implant transmitter or medical 

implant device, the Commission 

required that the transmitting antenna of 

the patient device must itself be 

implanted wholly within the body— 

which would include any point below 

the skin, or more deeply within the 

body. The Commission retained the 


jlentini on PROD1PC65 with RULES
22698 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

existing definitions for medical implant 

devices. 

11. Authorized Frequencies for 

Implant and Body-Worn Devices. The 

Commission concluded that implanted 

devices will be permitted in both the 

existing MICS core band at 402–405 

MHz, as well as in the wing bands at 

401–402 MHz and 405–406 MHz. This 

will allow medical implant devices to 

operate anywhere in the 401–406 MHz 

band—but subject to different technical 

requirements in the core and wing 

bands. 

12. The Commission decided, with 

one exception, to permit body-worn 

devices to operate only in the wing 

bands at 401–402 MHz and 405–406 

MHz. Thus, in the new MedRadio wing 

bands, both implant and body-worn 

devices will be allowed to operate— 

under common technical requirements 

for each—throughout both the 401–402 

MHz and 405–406 MHz frequency 

range. The Commission stated its belief 

this approach will serve to 

accommodate a greater variety of 

implant and body-worn devices. The 

Commission also observed that, by 

preserving the core band at 402–405 

MHz primarily for communications 

involving deeply implanted devices, 

these frequencies would likely continue 

to be used largely for life-critical 

medical devices such as cardiac 

defibrillators. 

13. As an exception to the general rule 

for body-worn devices, the Commission 

decided to permit the operation in the 

core band of temporary body-worn 

devices that are used to evaluate the 

efficacy of an implanted medical device. 

14. The Commission determined that 

allowing the operation of such 

temporary body-worn devices will 

enhance the therapeutic and diagnostic 

options available to patients. In 

particular, the Commission noted that 

this will allow physicians to better 

evaluate the efficacy of proposed 

treatments involving implanted devices 

prior to actual device implantation. The 

Commission decided to permit the 

operation of such temporary body-worn 

devices on any frequency in the 402– 

405 MHz core band provided that: (1) 

Such external operation is limited solely 

to evaluating with a patient the efficacy 

of a fully implanted permanent medical 

device that is intended to replace the 

temporary body-worn device; (2) RF 

transmissions from the external device 

must cease following the patient 

evaluation period, which may not 

exceed 30 days, except where a health 

care practitioner determines that 

additional time is necessary due to 

unforeseen circumstances; (3) the 

maximum output power of the external, 

temporary body-worn device shall not 

exceed 200 nW EIRP; and (4) the 

external device must comply fully with 

all other MedRadio rules described 

throughout the core 402–405 MHz band. 

15. The Commission declined to 

explicitly limit the core band to lifecritical and time-sensitive applications, 

or to designate the wing bands for nonlife-critical, non-time sensitive 

applications. The Commission said that 

its decision to limit the core band 

primarily to communications involving 

implanted devices, coupled with the 

technical rules adopted for use of the 

core and wing bands will achieve much 

the same result, while providing greater 

flexibility for device manufacturers and 

practitioners. The Commission 

determined that leaving the ultimate 

decision on these matters to health care 

professionals and medical device 

manufactures, in concert with FDArequired risk management processes, 

would result in better and more flexible 

use of this scarce spectrum resource. 

16. Permissible Communications and 

Operator Eligibility. The Commission 

concluded that the new MedRadio 

service will be governed by the same 

operator eligibility and permissible 

communications requirements that 

pertain to the legacy MICS. According to 

the Commission, this will result in a 

more beneficial use of the spectrum 

than alternative approaches. 

17. More specifically, the Commission 

decided that MedRadio devices may be 

used only by persons for diagnostic and 

therapeutic purposes, and only when 

provided for such purposes to a human 

patient under the direction of a duly 

authorized health care professional. 

Furthermore, the Commission limited 

the MedRadio service to the 

transmission of non-voice data. 

MedRadio programmer/control 

transmitters may not relay information 

on MedRadio frequencies to a receiver 

that is not included with a MedRadio 

device. The Commission concluded that 

these requirements are central to 

maintaining the originally intended 

character and utility of this spectrum, 

which the Commission found has 

proven to be of significant benefit to 

many patients over the years. 

18. The Commission declined to 

adopt rules in this Order that would 

permit the operation of wireless hearing 

aids in the upper portion of the lower 

MedRadio wing band. However, in 

recognition of the important public 

interest benefits associated with this 

proposal, the Commission welcomed 

additional technical submissions or 

revisions to address whether this or 

some other band(s) could accommodate 

various types of hearing aid devices, 

and stated that it would consider 

developing a record through a notice of 

proposed rulemaking to more fully 

analyze these matters. 

19. The Commission also declined to 

allow the use of MedRadio devices in 

connection with animal test subjects in 

the course of human drug research. The 

Commission found that such testing 

would not, in and of itself, directly 

perform any diagnostic or therapeutic 

function for a human patient. In 

contrast, the Commission observed that, 

since its creation, the legacy MICS had 

been explicitly reserved for use by 

devices performing diagnostic and 

therapeutic functions with human 

patients and only when such use has 

been duly authorized by a health care 

professional. It further found that 

changing the eligibility requirements to 

permit animal test subject use would 

constitute a major departure from these 

underlying requirements and that such 

a departure did not appear to be 

warranted based upon the record in this 

proceeding. From a procedural 

perspective, the Commission further 

stated that the MedRadio NPRM neither 

proposed, nor sought comment on, 

modifying these basic service and 

eligibility provisions; and that it 

particularly did not address the specific 

question at issue here of whether use of 

the MICS/MedRadio frequencies should 

be extended to animal testing. Thus, the 

Commission concluded that it had an 

insufficient substantive record or 

procedural notice upon which to pursue 

the matter of animal test subjects. 

20. MedRadio channels. The 

Commission decided to generally carry 

forward the MICS rules into the new 

MedRadio Service. Under the existing 

rules, no particular channeling scheme 

is specified for the operation of MICS 

devices. Instead, a ‘‘channel’’ is simply 

defined as any continuous segment of 

spectrum used by a medical device. 

Thus, a MedRadio device may transmit 

on any center frequency so long as the 

maximum authorized emission 

bandwidth is not exceeded. The 

Commission stated its belief that this 

approach is beneficial because it would 

continue to provide the greater 

flexibility that device manufacturers 

now use as compared with a rigid 

channeling scheme. 

21. Emission Bandwidth. With respect 

to the new MedRadio wing bands at 

401–402 MHz and 405–406 MHz, the 

Commission concluded that a 100 

kilohertz maximum authorized emission 

bandwidth in the limited space of the 

one-megahertz wide wing bands will 

foster more intensive spectrum 

utilization by a greater number of 

devices as compared with a 300 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 22699 

kilohertz maximum bandwidth. The 

Commission determined that this 

smaller bandwidth would allow more 

devices to use the wing bands on nonoverlapping spectrum. In addition, the 

Commission found that this bandwidth 

will also serve to minimize interference 

potential from other MedRadio devices, 

particularly in light of the fact that both 

LBT and non-LBT devices will share the 

entire wing bands. 

22. As one exception to the general 

bandwidth requirement for the wing 

bands, the Commission decided to allow 

up to a 150 kilohertz maximum 

authorized emission bandwidth at 

401.85–402 MHz. In reaching this 

decision, the Commission recognized 

that some body worn devices, such as 

the glucose monitoring devices that are 

now operating in the core band under a 

waiver, need a slightly wider emission 

bandwidth. Thus, the Commission 

found that its decision here to allow a 

slightly wider emission bandwidth at 

the upper edge of the 401–402 MHz 

wing band will facilitate transitioning 

such devices now operating under rule 

waivers out of the core band. In 

addition, the Commission observed that 

the narrower bandwidth for the wing 

bands, is expected to be better suited for 

non-life-critical devices—namely, those 

with less severe battery life constraints 

that are tailored for operation with 

lower bandwidth data streams utilizing 

a relatively greater number of longer 

data transmission sessions as compared 

with devices used in the core band. 

23. For the core band at 402–405 

MHz, the Commission decided to 

maintain the existing maximum 

authorized emission bandwidth of 300 

kilohertz. The Commission found that, 

relative to the 100 kilohertz bandwidth 

it adopted for the wing bands, this 300 

kilohertz bandwidth will better facilitate 

more data-intensive transmissions of 

shorter duration which tend to be more 

energy efficient, and thus prolong 

battery life for implants. This will also 

support higher data transmission rates 

than could be accommodated by the 

maximum authorized emission 

bandwidth of 100 kilohertz channels of 

the wing bands, and thus may be more 

desirable for certain applications. The 

Commission found that such 

characteristics are especially beneficial 

in extending the battery life of deep 

implant devices. 

24. The Commission decided that it 

would continue to permit MedRadio 

transmitters to utilize full duplex or half 

duplex communications if the total 

amount of bandwidth used by all of the 

MedRadio channels employed by a 

MedRadio device during a MedRadio 

communications session does not 

exceed the maximum authorized 

emission bandwidth (i.e., 100 kilohertz 

in the wing bands and 300 kilohertz in 

the core band). Moreover, smaller 

bandwidths may be employed by a 

single MedRadio device so long as the 

device adheres to all other EIRP and 

unwanted emission limits. For example, 

a single MedRadio device operating in 

the wing bands could be designed to 

operate nominally on two channels, 

each having a maximum emission 

bandwidth of 50 kilohertz, because the 

communications session would, in 

aggregate, be 100 kilohertz. The 

Commission noted that, in essence, 

these provisions carry forward the 

existing channel use provisions of the 

MICS rules into the new MedRadio 

rules. 

25. Frequency monitoring 

requirement. In the Report and Order, 

the Commission observed the current 

MICS rules require that the 

programmer/control transmitter 

associated with a medical implant 

device in the 402–405 MHz band must 

incorporate a frequency monitoring 

mechanism to monitor the channel or 

channels that the medical device 

transmitters intend to occupy. The 

Commission further stated its belief that 

an LBT frequency monitoring 

requirement is beneficial because it 

facilitates spectrum sharing among 

many uncoordinated devices and can 

reduce the likelihood of harmful 

interference from federal systems that 

are allocated on a primary basis. Thus, 

the Commission decided to maintain the 

current frequency monitoring protocol 

specified in the form MICS rules as a 

general requirement for implant devices 

permitted throughout the entire 401– 

406 MHz MedRadio core band, as well 

as for body-worn devices permitted in 

the new wing bands. In addition, the 

Commission also extended the ‘‘medical 

implant event’’ exception of the current 

rules to LBT-enabled implant devices 

operating throughout the 401–406 MHz 

MedRadio band. 

26. In further recognition of the 

potential advantages of non-LBT 

spectrum access methods for certain low 

power, low duty cycle (LP–LDC) 

devices—particularly, in terms of 

extended battery life, reduced 

complexity, and lower device cost to 

patients—the Commission decided to 

permit the use of non-LBT spectrum 

access methods in the wing bands, with 

certain transmitter power and duty 

cycle limits, by both implant and bodyworn devices. In addition, the 

Commission permitted the use of nonLBT spectrum access methods for 

implant devices that operate with an 

emission bandwidth not exceeding 300 

kilohertz centered at 403.65 MHz in the 

existing core band with certain 

transmitter power and duty cycle limits. 

Finally, the Commission also decided to 

permit the operation on any of the 

frequencies in the 402–405 MHz band of 

temporary body-worn transmitting 

devices that are used solely during a 

limited patient evaluation period in 

order to determine the suitability of a 

fully implanted device, provided that 

they fully comply with all other 

MedRadio rules applicable to the band. 

27. Transmitter power and duty cycle. 

The Commission limited the maximum 

EIRP of LBT-enabled implant devices 

throughout the 401–406 MHz band and 

LBT-enabled body-worn medical 

devices in the wing bands to 25 

microwatts EIRP. The Commission 

determined that, as with the original 

MICS rules, this limit is intended to 

ensure efficient spectrum sharing and 

compatibility among multiple 

uncoordinated devices. Furthermore, 

the 25 microwatt limit will maintain 

continuity with the present EIRP limit 

and LBT frequency monitoring 

requirement for the core band (which 

we also maintain under the new 

MedRadio rules) that has served well for 

spectrum access. 

28. With respect to access to the 402– 

405 MHz band by non-LBT devices, the 

Commission found that the convergence 

of comments in the record, particularly 

subsequent to the adoption by ETSI of 

similar standards, supported permitting 

operation by such devices with a total 

emission bandwidth not exceeding 300 

kilohertz, centered at 403.65 MHz, with 

a maximum EIRP of 100 nanowatts and 

with maximum duty-cycle and 

transmission session limits of 0.01% 

and ten per hour, respectively. The 

Commission stated that its decision was 

informed by the increasingly 

widespread adoption of standards 

internationally that provide for non-LBT 

spectrum access methods in the 402– 

405 MHz band. Furthermore, based 

upon the Commission’s prior experience 

with single-channel non-LBT devices 

operating under rule waivers in the core 

MICS band the Commission concluded 

that these EIRP and duty cycle limits 

would be sufficiently conservative to 

permit efficient spectrum sharing 

between LBT enabled and non-LBT 

devices that choose to operate at 403.65 

MHz. 

29. For devices using non-LBT 

spectrum access methods in the new 

MedRadio wing bands at 401–402 and 

405–406 MHz, the Commission adopted 

power and duty cycle limits that match 

the proposals in the MedRadio NPRM, 

namely a maximum EIRP of 250 

nanowatts, together with a maximum 


jlentini on PROD1PC65 with RULES
22700 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

duty cycle limit of 0.1% and a 

maximum limit of 100 communication 

sessions per hour. The Commission 

stated its belief that permitting the 

higher EIRP of 250 nanowatts for nonLBT operation in the wing bands, as 

compared with the 100 nanowatts 

adopted for non-LBT operation in the 

core band, will serve to encourage use 

of the wing bands for the majority of 

non-LBT applications. 

30. The Commission also recognized 

that some body worn devices may 

require higher power and greater 

bandwidth, such as the glucose 

monitoring devices manufactured by 

one manufacturer that are now 

operating in the core band under a 

waiver. Thus, the Commission decided 

to also allow non-LBT MedRadio 

devices using a maximum of 25 

microwatts EIRP to operate at 401.85– 

402 MHz at the upper end of the lower 

wing band. The Commission 

determined that its decision would 

facilitate the transition of such devices 

now operating under waivers out of the 

core band, and into the new MedRadio 

wing bands. The Commission also noted 

that permitting the higher power and 

bandwidth would also provide 

flexibility for other manufacturers 

designing medical devices in these 

bands. 

31. Unwanted emissions. The 

Commission retained without 

modification the existing in-band and 

out-of-band emission limits for the 

MedRadio core band frequencies at 402– 

405 MHz. For the new MedRadio wing 

bands at 401–402 MHz and 405–406 

MHz, the Commission adopted an 

emission mask having the same form as 

the emission mask that already exists for 

the core band, but modified to apply 

over the narrower 100 kilohertz 

maximum authorized emission 

bandwidth of the wing band. Thus, the 

Commission required that emissions 

from devices operating within the 

MedRadio wing bands more than 50 

kilohertz away from the center 

frequency of a transmission be 

attenuated below the actual transmitter 

output power by at least 20 dB. In 

addition, it required emissions 100 

kilohertz or less below 401 MHz, or 

above 406 MHz, to be attenuated below 

the maximum permitted output power 

by at least 20 dB. Finally, for out-ofband emissions at more than 100 

kilohertz outside the 401 MHz and 406 

MHz MedRadio band edges, the 

Commission adopted generally the same 

field strength limits on emissions that 

presently apply to the core band. 

32. The Commission declined to 

impose more restrictive limits on 

emissions from MedRadio wing band 

devices into the existing core band. The 

Commission said that under such an 

approach, which was recommended by 

one commenter, wing band devices 

would be burdened with more stringent 

limits on radiation into the core band as 

compared to core band devices. The 

Commission found no compelling 

reason to place wing band devices on 

such an unequal footing with core band 

devices, particularly if such a limit were 

to be set below the existing general 

emission limits contained in § 15.209 as 

suggested by one commenter. The 

Commission stated that it was confident 

that manufacturers of wing band devices 

are capable of designing their products 

to be compatible with and to protect 

core band devices, especially when both 

types of devices are used by the same 

patient. In addition, the Commission 

found that the emission limits it 

adopted would afford sufficient 

protection to satellite operations on 

frequencies below 401 MHz adjacent to 

the lower MedRadio wing band. 

33. RF safety and EIRP compliance. 

The Commission retained the basic 

requirements in the current rules as they 

apply RF safety and EIRP compliance 

requirements for implanted devices. In 

addition, the Commission decided that, 

to the extent feasible, body-worn 

MedRadio devices shall be governed by 

the same requirements as other handheld transmitting devices for the 

purposes of demonstrating compliance 

with RF safety and EIRP limits. 

34. The Commission observed that it 

has another ongoing proceeding 

concerning RF exposure that would be 

better suited to address several other 

concerns expressed by some 

commenters. One issue involves 

whether and when open-area test sites 

or body-torso simulator measurements 

should be performed, and whether a 4 

dB EIRP correction factor should be 

applied between implant and bodyworn devices to account for the 

absorption of radio energy by body 

tissue that can be associated with 

implanted devices. A second issue 

involves whether unspecified ‘‘other 

techniques’’ (beyond the finite 

difference time domain (FDTD) 

technique cited in the existing rules) 

could be used for equipment 

authorization and RF exposure 

evaluation purposes. In view of the 

ongoing RF safety proceeding, the 

Commission declined to make any 

further modifications in this Report and 

Order. 

35. Disposition of Biotronik and 

DexCom Waivers. The Commission 

noted that it had previously granted 

waivers to two device manufacturers 

(Biotronik and DexCom) that permit the 

manufacture and marketing in the 

United States of certain models of 

cardiac and diabetic therapy devices 

that do not possess the LBT frequency 

monitoring capability required by the 

present MICS rules for the core band at 

402–405 MHz. Both waivers were stated 

to be valid for one year from the 

effective date of the final MedRadio 

rules adopted in this proceeding. 

36. With respect to the Biotronik 

Waiver, the Commission found that the 

technical parameters of the authorized 

cardiac devices would now be 

encompassed within the provisions of 

the new MedRadio rules adopted 

herein—which provide for non-LBT 

operation by low power, low duty cycle 

implants operating between 403.5–403.8 

MHz in the 402–405 MHz core band. 

Consequently, the Commission found 

that Biotronik Waiver would be 

rendered moot upon the effective date of 

the MedRadio rules adopted in this 

Report and Order. 

37. With respect to the DexCom 

Waiver, the Commission found that the 

covered devices did not comply with 

the new MedRadio rules. It thus decided 

to extend the waiver term for four years 

from the effective date of the MedRadio 

rules adopted herein. The Commission 

stated that this extended term should 

provide DexCom with sufficient time to 

come into compliance with the new 

MedRadio rules and to obtain the 

required FDA approval. The 

Commission also found that continued 

operation of the DexCom non-LBT 

devices in the core band, particularly at 

the higher power levels they use, could 

in the long term prove problematic for 

other rules-compliant devices— 

especially those used for life-critical 

applications—as the numbers of these 

types of devices grow. Further, the 

Commission also observed that the wing 

bands provide adequate spectrum for 

both LBT and non-LBT body-worn 

devices and that DexCom’s devices may 

reasonably be accommodated under the 

new MedRadio rules for these bands. In 

declining to extend the waiver for 5 

years as requested by DexCom, the 

Commission stated that it was not 

persuaded that the relatively small 

move in operating frequency, while 

maintaining emission bandwidth, power 

and duty cycle specifications, would 

require 5 additional years. Thus, the 

Commission encouraged DexCom to 

transition to the newly designated 

spectrum as soon as practicable. 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 22701 

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 1966 

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

857 (1996). 

2 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 Rulemaking 

and Notice of Inquiry and Order, 21 FCC Rcd 8164 

(2006). 

3 Id. 

4 5 U.S.C. 603(b)(3). 

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

6 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). 

7Small Business Act, 15 U.S.C. 632 (1996). 

8See SBA, Programs and Services, SBA Pamphlet 

No. CO–0028, at page 40 (July 2002). 

9 5 U.S.C. 601(4). 

10 Independent Sector, The New Nonprofit 

Almanac & Desk Reference (2002). 

11 5 U.S.C. 601(5). 

12U.S. Census Bureau, Statistical Abstract of the 

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

13We 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. 

14 47 CFR part 90. 

Final Regulatory Flexibility Analysis 

38. As required by the Regulatory 

Flexibility Act (RFA),1 an Initial 

Regulatory Flexibility Analysis (IFRA) 

was incorporated in the Notice of 

Proposed Rulemaking and Notice of 

Inquiry and Order (MedRadio NPRM) in 

ET Docket No. 06–135.2 The 

Commission sought written public 

comment on the proposals in the 

MedRadio NPRM, including comment 

on the IRFA. This present Final 

Regulatory Flexibility Analysis (FRFA) 

conforms to the RFA. 

A. Need for and Objectives, of the 

Report and Order 

39. The Report and Order establishes 

the Medical Device 

Radiocommunication Service 

(MedRadio) under part 95 of the 

Commission’s rules. This new service 

will incorporate the existing Medical 

Implant Communications Service 

(MICS) ‘‘core’’ band at 402–405 MHz, 

and include two megahertz of newly 

designated spectrum in the adjacent 

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

406 MHz. Altogether, the MedRadio 

Service will provide a total of five 

megahertz of contiguous spectrum for 

advanced wireless medical 

radiocommunication devices to be used 

for diagnostic and therapeutic purposes 

in humans. Among other benefits, the 

MedRadio Service will accommodate 

the operation of body-worn as well as 

implanted medical devices, including 

those using either LBT or non-LBT 

spectrum access methods, in designated 

portions of the 401–406 MHz band. 

40. Significant advances in wireless 

implanted and body-worn medical 

technologies are revolutionizing 

treatment for a wide variety of medical 

conditions and, even more 

fundamentally, creating new health care 

models serving to improve quality of life 

for all Americans. As demonstrated by 

the comment record in this proceeding, 

implanted and body-worn medical 

devices that rely upon wireless 

technologies are being used even today 

to treat a variety of cardiac and diabetic 

conditions. For example, wireless 

implanted cardiac devices serve as 

defibrillators and pacemakers without 

the need for external wired connections; 

while other radio-equipped devices, 

such as blood glucose monitors and 

insulin pumps, support more timely 

treatment for diabetic patients and allow 

physicians to wirelessly retrieve data 

and then make operating parameter 

adjustments with greater ease and 

accuracy than with the more traditional 

wired connection technologies. Some 

examples of newer generations of 

devices that could benefit from the use 

of wireless technologies include 

implanted vagus nerve stimulators that 

send electric pulses to the brain to treat 

severe chronic depression, and deep 

brain stimulators used to treat tremors 

related to Parkinson’s disease.3 Such 

advances have the potential to 

significantly improve the quality of life 

and sophistication of therapy for 

countless Americans living with a 

variety of medical conditions; and, in 

turn, could result in lower medical costs 

and extend the time between hospital 

visits and surgical procedures. 

B. Summary of Significant Issues Raised 

by Public Comments in Response to the 

IRFA 

41. There were no comments filed 

that specifically addressed the rules and 

policies proposed in the IFRA. 

C. Description and Estimate of the 

Number of Small Entities to Which the 

Rules Will Apply 

42. 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.4 The 

RFA generally defines the term ‘‘small 

entity’’ as having the same meaning as 

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

organization,’’ and ‘‘small governmental 

jurisdiction.’’ 5 In addition, the term 

‘‘small business’’ has the same meaning 

as the term ‘‘small business concern’’ 

under the Small Business Act.6 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.7

43. Nationwide, there are a total of 

approximately 22.4 million small 

businesses, according to SBA data.8 A 

‘‘small organization’’ is generally ‘‘any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field.’’ 9

Nationwide, as of 2002, there were 

approximately 1.6 million small 

organizations.10 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.’’ 11 Census Bureau data for 

2002 indicate that there were 87,525 

local governmental jurisdictions in the 

United States.12 We estimate that, of this 

total, 84,377 entities were ‘‘small 

governmental jurisdictions.’’ 13 Thus, 

we estimate that most governmental 

jurisdictions are small. 

44. Personal Radio Services. The 

Medical Device Radio Communications 

Service are being placed within part 95 

of our rules (‘‘Personal Radio Services’’). 

Personal radio services provide shortrange, low power radio for personal 

communications, radio signaling, and 

business communications not provided 

for in other services. The Personal Radio 

Services include spectrum licensed 

under part 95 of our rules and covers a 

broad range of uses.14 Many of the 

licensees in these services are 

individuals, and thus are not small 

entities. In addition, due to the fact that 

licensing of operation under part 95 is 

accomplished by rule (rather than by 

issuance of individual license), and due 

to the shared nature of the spectrum 

utilized by some of these services, the 

Commission lacks direct information 

other than the census data above, upon 

which to base an estimation of the 

number of small entities under an SBA 


jlentini on PROD1PC65 with RULES
22702 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

15NAICS code 334220. 

16NAICS code 11210. 

17 13 CFR 121.201, NAICS code 517211. 

18 13 CFR 121.201, NAICS code 517212. 

19U.S. Census Bureau, 2002 Economic Census, 

Subject Series: ‘‘Information,’’ Table 5, Employment 

Size of Firms for the United States: 2002, NAICS 

code 517211 (issued Nov. 2005). 

20 Id. The census data do not provide a more 

precise estimate of the number of firms that have 

employment of 1,500 or fewer employees; the 

largest category provided is for firms with ‘‘1000 

employees or more.’’ 

21U.S. Census Bureau, 2002 Economic Census, 

Subject Series: ‘‘Information,’’ Table 5, Employment 

Size of Firms for the United States: 2002, NAICS 

code 517212 (issued Nov. 2005). 

22 Id. The census data do not provide a more 

precise estimate of the number of firms that have 

employment of 1,500 or fewer employees; the 

largest category provided is for firms with ‘‘1000 

employees or more.’’ 

23With the exception of the special emergency 

service, these services are governed by Subpart B 

of part 90 of the Commission’s Rules, 47 CFR 

90.15–90.27. The police service includes 

approximately 27,000 licensees that serve state, 

county, and municipal enforcement through 

telephony (voice), telegraphy (code) and teletype 

and facsimile (printed material). The fire radio 

service includes approximately 23,000 licensees 

comprised of private volunteer or professional fire 

companies as well as units under governmental 

control. The local government service that is 

presently comprised of approximately 41,000 

licensees that are state, county, or municipal 

entities that use the radio for official purposes not 

covered by other public safety services. There are 

approximately 7,000 licensees within the forestry 

service which is comprised of licensees from state 

departments of conservation and private forest 

organizations who set up communications networks 

among fire lookout towers and ground crews. The 

approximately 9,000 state and local governments 

are licensed to highway maintenance service 

provide emergency and routine communications to 

aid other public safety services to keep main roads 

safe for vehicular traffic. The approximately 1,000 

licensees in the Emergency Medical Radio Service 

(EMRS) use the 39 channels allocated to this service 

for emergency medical service communications 

related to the delivery of emergency medical 

treatment. 47 CFR 90.15–90.27. The approximately 

20,000 licensees in the special emergency service 

include medical services, rescue organizations, 

veterinarians, handicapped persons, disaster relief 

organizations, school buses, beach patrols, 

establishments in isolated areas, communications 

standby facilities, and emergency repair of public 

communications facilities. 47 CFR 90.33–90.55. 

24 47 CFR 1.1162. 

25 5 U.S.C. 601(5). 

26See Medtronic Petition at i, 16, and Appendix 

A, at proposed § 95.1601. We 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. 

definition that might be directly affected 

by the proposed rules. 

45. The Commission notes, however, 

that the designation for the two 

megahertz of spectrum for the Medical 

Device Radio Communications Service 

would be limited to use by medical 

implant and body-worn medical devices 

and, thus, would not be shared with 

other non-Federal Governmental uses. 

To date, there are only a small number 

of manufacturers (i.e., less than ten—as 

few as five) that produce these devices, 

and FDA approval must be secured 

before such devices are brought to 

market. Due to the stringent FDA 

approval requirements, the small 

number of existing medical device 

manufacturers tends to focus very 

narrowly on this highly specialized 

market niche. 

46. Wireless Communications 

Equipment Manufacturers. The Census 

Bureau does not have a category specific 

to medical device radiocommunication 

manufacturing. The appropriate 

category is that for wireless 

communications equipment 

manufacturers. 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.’’ The SBA has developed a 

small business size standard for Radio 

and Television Broadcasting and 

Wireless Communications Equipment 

Manufacturing, which is: all such firms 

having 750 or fewer employees.15

According to Census Bureau data for 

2002, there were a total of 1,041 

establishments in this category that 

operated for the entire year. Of this 

total, 1,010 had employment of under 

500, and an additional 13 had 

employment of 500 to 999. Thus, under 

this size standard, the majority of firms 

can be considered small.16

47. Wireless Service Providers. The 

SBA has developed a small business 

size standard for wireless firms within 

the two broad economic census 

categories of ‘‘Paging’’ 17 and ‘‘Cellular 

and Other Wireless 

Telecommunications.’’ 18 Under both 

categories, the SBA deems a wireless 

business to be small if it has 1,500 or 

fewer employees. For the census 

category of Paging, Census Bureau data 

for 2002 show that there were 807 firms 

in this category that operated for the 

entire year. 19 Of this total, 804 firms 

had employment of 999 or fewer 

employees, and three firms had 

employment of 1,000 employees or 

more.20 Thus, under this category and 

associated small business size standard, 

the majority of firms can be considered 

small. For the census category of 

Cellular and Other Wireless 

Telecommunications, Census Bureau 

data for 2002 show that there were 1,397 

firms in this category that operated for 

the entire year.21 Of this total, 1,378 

firms had employment of 999 or fewer 

employees, and 19 firms had 

employment of 1,000 employees or 

more.22 Thus, under this second 

category and size standard, the majority 

of firms can, again, be considered small. 

48. Public Safety Radio Services. 

Public Safety radio services include 

police, fire, local government, forestry 

conservation, highway maintenance, 

and emergency medical services.23 For 

small businesses in this category, the 

above small business size standard 

applies to 1500 or fewer employees. 

There are a total of approximately 

127,540 licensees in these services. 

Governmental entities 24 as well as 

private businesses comprise the 

licensees for these services. All 

governmental entities with populations 

of less than 50,000 fall within the 

definition of a small entity.25

D. Description of Projected Reporting, 

Recordkeeping, and Other Compliance 

Requirements for Small Entities 

49. The Commission is using the 

licensing approach for the entire 401– 

406 MHz MedRadio band that is 

identical to that used for the existing 

MICS band at 402–405 MHz. Thus, 

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.26 Licensing will be accomplished 

through adherence to applicable 

technical standards and other operating 

rules (unlicensed operations). The 

Commission concludes 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 the 

Significant Economic Impact on Small 

Entities, and Significant Alternatives 

Considered 

50. 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 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 22703 

27See 5 U.S.C. 603(c). 

28See 5 U.S.C. 801(a)(1)(A). 

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.27

51. In the Report and Order the 

Commission established a new Medical 

Device Radiocommunication Service 

(MedRadio Service) under part 95, 

which will encompass all medical 

devices permitted to operate in the 401– 

406 MHz band. It sought comment on 

the options concerning whether and 

how the five megahertz of spectrum that 

would comprise this MedRadio band 

could be divided among the evolving 

varieties of both implanted and bodyworn medical transmitters, including 

low-power, low-duty-cycle (LPLDC) 

devices that do not employ ‘‘listenbefore-talk’’ (LBT) frequency monitoring 

spectrum access techniques. 

52. Report to Congress: The 

Commission will send a copy of the 

Report and Order, including this FRFA, 

in a report to be sent to Congress 

pursuant to the Congressional Review 

Act.28 In addition, the Commission will 

send a copy of the Report and Order, 

including this FRFA, to the Chief 

Counsel for Advocacy of the SBA. 

Ordering Clauses 

53. Pursuant to the authority 

contained in Sections 4(i), 301, 302, 

303(e), 303(f) and 303(r) of the 

Communications Act of 1934, as 

amended, 47 USC Sections 154(i), 301, 

302, 303(e), 303(f) and 303(r), this 

Report and Order is adopted and parts 

1, 2 and 95 of the Commission’s Rules 

are amended as set forth in Final Rules 

effective 90 days after publication in the 

Federal Register. 

54. The Commission grants in part, 

consistent with the terms of this order, 

DexCom, Inc.’s request for extension of 

waiver, and otherwise deny the request 

in all other respects. 

55. ET Docket No. 03–92 is 

terminated. 

56. The Commission’s Consumer and 

Governmental Affairs Bureau, Reference 

Information Center, shall send a copy of 

this Report and Order, including the 

Final Regulatory Flexibility Analysis in 

Appendix C, to the Chief Counsel for 

Advocacy of the Small Business 

Administration. 

List of Subjects 

47 CFR Part 1 

Administrative practice and 

procedure. 

47 CFR Parts 2 and 95 

Communications equipment, Radio, 

Reporting and recordkeeping 

requirements. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

Final Rules 

■ For the reasons discussed in the 

preamble, the Federal Communications 

Commission amends 47 CFR parts 1, 2, 

and 95 to read as follows: 

PART 1—PRACTICE AND 

PROCEDURE 

■ 1. The authority citation for part 1 

continues to read as follows: 

Authority: 15 U.S.C. 79 et seq.; 47 U.S.C. 

151, 154(i), 154(j), 155, 157, 225, 303(r), and 

309. 

■ 2. Section 1.1307 is amended by 

revising the fourth sentence in 

paragraph (b)(2) to read as follows: 

§ 1.1307 Actions that may have a 

significant environmental effect, for which 

Environmental Assessments (EAs) must be 

prepared. 

* * * * * 

(b) * * * 

(2) * * * Equipment authorized for 

use in the Medical Device 

Radiocommunication Service 

(MedRadio) as a medical implant or 

body-worn transmitter (as defined in 

Appendix 1 to Subpart E of part 95 of 

this chapter) is subject to routine 

environmental evaluation for RF 

exposure prior to equipment 

authorization, as specified in § 2.1093 of 

this chapter by finite difference time 

domain computational modeling or 

laboratory measurement techniques. 

* * * 

* * * * * 

PART 2—FREQUENCY ALLOCATIONS 

AND RADIO TREATY MATTERS; 

GENERAL RULES AND REGULATIONS 

■ 3. The authority citation for part 2 

continues to read as follows: 

Authority: 47 U.S.C. 154, 302a, 303, and 

336, unless otherwise noted. 

■ 4. Section 2.106, the Table of 

Frequency Allocations, is amended as 

follows: 

■ a. Revise page 24. 

■ b. In the list of United States (US) 

footnotes, revise footnote US345. 

The revisions read as follows: 

§ 2.106 Table of Frequency Allocations. 

* * * * * 

BILLING CODE 6712–01–P 


jlentini on PROD1PC65 with RULES
22704 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

BILLING CODE 6712–01–C 

* * * * * 

United States (US) Footnotes 

* * * * * 

US345 In the band 401–406 MHz, the 

mobile, except aeronautical mobile, 

service is allocated on a secondary basis 

and is limited to, with the exception of 

military tactical mobile stations, 

Medical Device Radiocommunication 

Service (MedRadio) operations. 

MedRadio stations are authorized by 

rule on the condition that harmful 

interference is not caused to stations in 

the meteorological aids, meteorologicalsatellite, and Earth exploration-satellite 

services, and that MedRadio stations 

accept interference from stations in the 

meteorological aids, meteorologicalsatellite, and Earth exploration-satellite 

services. 

* * * * * 

■ 5. Section 2.1093 is amended by 

revising paragraph (c) to read as follows: 

§ 2.1093 Radiofrequency radiation 

exposure evaluation: portable devices. 

* * * * * 

(c) Portable devices that operate in the 

Cellular Radiotelephone Service, the 

Personal Communications Service 

(PCS), the Satellite Communications 

Services, the General Wireless 

Communications Service, the Wireless 

Communications Service, the Maritime 

Services, the Specialized Mobile Radio 

Service, the 4.9 GHz Band Service, the 

Wireless Medical Telemetry Service 

(WMTS) and the Medical Device 

Radiocommunication Service 

(MedRadio), authorized under subpart H 

of part 22 of this chapter, parts 24, 25, 

26, 27, 80 and 90 of this chapter, 

subparts H and I of part 95 of this 

chapter, and unlicensed personal 

communication service, unlicensed NII 

devices and millimeter wave devices 

authorized under subparts D and E, 

15.253, 15.255 and 15.257 of this 

chapter are subject to routine 

environmental evaluation for RF 

exposure prior to equipment 

authorization or use. All other portable 

transmitting devices are categorically 

excluded from routine environmental 

evaluation for RF exposure prior to 

equipment authorization or use, except 

as specified in 1.1307(c) and 1.1307(d) 

of this chapter. Applications for 

equipment authorization of portable 

transmitting devices subject to routine 

environmental evaluation must contain 

a statement confirming compliance with 

the limits specified in paragraph (d) of 

this section as part of their application. 

Technical information showing the 

basis for this statement must be 

submitted to the Commission upon 

request. 

* * * * * 

■ 6. Section 2.1204 is amended by 

revising paragraph (a)(9) to read as 

follows: 

§ 2.1204 Import conditions. 

(a) * * * 

* * * * * 

(9) The radio frequency device is a 

medical implant transmitter inserted in 

a person or a medical body-worn 

transmitter as defined in part 95, 

granted entry into the United States or 

is a control transmitter associated with 

such an implanted or body-worn 

transmitter, provided, however that the 

transmitters covered by this provision 

otherwise comply with the technical 

requirements applicable to transmitters 


jlentini on PROD1PC65 with RULESER14MY09.000</GPH>
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 22705 

authorized to operate in the Medical 

Device Radiocommunication Service 

(MedRadio) under part 95 of this 

chapter. Such transmitters are permitted 

to be imported without the issuance of 

a grant of equipment authorization only 

for the personal use of the person in 

whom the medical implant transmitter 

has been inserted or on whom the 

medical body-worn transmitter is 

applied. 

* * * * * 

PART 95—PERSONAL RADIO 

SERVICES 

■ 7. 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. 

■ 8. Section 95.401 is amended by 

revising paragraph (d) to read as 

follows: 

§ 95.401 (CB Rule 1) What are the Citizens 

Band Radio Services? 

* * * * * 

(d) The Medical Device 

Radiocommunication Service 

(MedRadio)—an ultra-low power radio 

service, for the transmission of nonvoice data for the purpose of facilitating 

diagnostic and/or therapeutic functions 

involving implanted and body-worn 

medical devices. The rules for this 

service are contained in subpart I of this 

part. 

* * * * * 

■ 9. Section 95.601 is amended by 

revising the last sentence to read as 

follows: 

§ 95.601 Basis and purpose. 

* * * The Personal Radio Services 

are the GMRS (General Mobile Radio 

Service)—subpart A, the Family Radio 

Service (FRS)—subpart B, the R/C 

(Radio Control Radio Service)—subpart 

C, the CB (Citizens Band Radio 

Service)—subpart D, the Low Power 

Radio Service (LPRS)—subpart G, the 

Wireless Medical Telemetry Service 

(WMTS)—subpart H, the Medical 

Device Radiocommunication Service 

(MedRadio)—subpart I, the Multi-Use 

Radio Service (MURS)—subpart J, and 

Dedicated Short-Range Communications 

Service On-Board Units (DSRCS– 

OBUs)—subpart L. 

■ 10. Section 95.603 is amended by 

revising paragraph (f) to read as follows: 

§ 95.603 Certification required. 

* * * * * 

(f) Each Medical Device 

Radiocommunication Service 

(MedRadio) transmitter (a transmitter 

that operates or is intended to operate 

in the MedRadio service) must be 

certificated except for such transmitters 

that are not marketed for use in the 

United States, but which otherwise 

comply with the MedRadio Service 

technical requirements and are operated 

in the United States by individuals who 

have traveled to the United States from 

abroad. 

* * * * * 

■ 11. Section 95.605 is revised to read 

as follows: 

§ 95.605 Certification procedures. 

Any entity may request certification 

for its transmitter when the transmitter 

is used in the GMRS, FRS, R/C, CB, 

218–219 MHz Service, LPRS, MURS, or 

MedRadio Service following the 

procedures in part 2 of this chapter. 

Dedicated Short-Range Communications 

Service On-Board Units (DSRCS–OBUs) 

must be certified in accordance with 

subpart L of this part and subpart J of 

part 2 of this chapter. 

■ 12. Section 95.628 is revised to read 

as follows: 

§ 95.628 MedRadio transmitters. 

(a) Frequency monitoring. Except as 

provided in (b) of this section, all 

MedRadio programmer/control 

transmitters operating in the 401–406 

MHz band must operate under the 

control of a monitoring system that 

incorporates a mechanism for 

monitoring the channel or channels that 

the MedRadio system devices intend to 

occupy. The monitoring system antenna 

shall be the antenna normally used by 

the programmer/control transmitter for a 

communications session. Before the 

monitoring system of a MedRadio 

programmer/control transmitter initiates 

a MedRadio communications session, 

the following access criteria must be 

met: 

(1) The monitoring system bandwidth 

measured at its 20 dB down points must 

be equal to or greater than the emission 

bandwidth of the intended 

transmission. 

(2) Within 5 seconds prior to 

initiating a communications session, 

circuitry associated with a MedRadio 

programmer/control transmitter must 

monitor the channel or channels the 

system devices intend to occupy for a 

minimum of 10 milliseconds per 

channel. 

(3) Based on use of an isotropic 

monitoring system antenna, the 

monitoring threshold power level must 

not be more than 10logB(Hz) ¥150 

(dBm/Hz) + G(dBi), where B is the 

emission bandwidth of the MedRadio 

communications session transmitter 

having the widest emission and G is the 

MedRadio programmer/control 

transmitter monitoring system antenna 

gain relative to an isotropic antenna. For 

purposes of showing compliance with 

the above provision, the above 

calculated threshold power level must 

be increased or decreased by an amount 

equal to the monitoring system antenna 

gain above or below the gain of an 

isotropic antenna, respectively. 

(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, the channel with the lowest 

ambient power level may be accessed. 

(5) When a channel is selected prior 

to a MedRadio communications session, 

it is permissible to select an alternate 

channel for use if communications are 

interrupted, provided that the alternate 

channel selected is the next best choice 

using the above criteria. The alternate 

channel may be accessed in the event a 

communications session is interrupted 

by interference. The following criteria 

must be met: 

(i) Before transmitting on the alternate 

channel, the channel must be monitored 

for a period of at least 10 milliseconds. 

(ii) The detected power level during 

this 10 millisecond or greater 

monitoring period must be no higher 

than 6dB above the power level detected 

when the channel was chosen as the 

alternate channel. 

(iii) In the event that this alternate 

channel provision is not used by the 

MedRadio system or if the criteria in 

paragraphs (a)(5)(i) and (ii) are not met, 

a channel must be selected using the 

access criteria specified in paragraphs 

(a)(1) through (a)(4) of this section. 

(6) As used in this section, the 

following definitions apply: 

(i) Emission bandwidth— Measured 

as the width of the signal between the 

points on either side of carrier center 

frequency that are 20 dB down relative 

to the maximum level of the modulated 

carrier. Compliance will be determined 

using instrumentation employing a peak 

detector function and a resolution 

bandwidth approximately equal to 1% 

of the emission bandwidth of the device 

under test. 

(ii) MedRadio channel—Any 

continuous segment of spectrum in the 

MedRadio band that is equal to the 


jlentini on PROD1PC65 with RULES
22706 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

emission bandwidth of the device with 

the largest bandwidth that is to 

participate in a MedRadio 

communications session. 

Note to paragraph (a)(6)(ii): The rules 

do not specify a channeling scheme for 

use by MedRadio systems. 

(iii) MedRadio communications 

session—A collection of transmissions, 

that may or may not be continuous, 

between MedRadio system devices. 

(b) Exceptions to frequency 

monitoring criteria. MedRadio devices 

or communications sessions that meet 

any one of the following criteria are not 

required to use the access criteria set 

forth in paragraph (a) of this section: 

(1) MedRadio communications 

sessions initiated by a medical implant 

event. 

(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. 

(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. 

(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. 

(c) Operating frequency. MedRadio 

stations authorized under this part may 

operate on frequencies in the 401–406 

MHz band as follows provided that the 

out-of-band emissions are attenuated in 

accordance with § 95.635: 

(1) MedRadio stations associated with 

medical implant devices, which 

incorporate a frequency monitoring 

system as set forth in paragraph (a) of 

this section, may operate on any of the 

frequencies in the 401–406 MHz band. 

(2) MedRadio stations associated with 

medical implant devices, which do not 

incorporate a frequency monitoring 

system as set forth in paragraph (a) of 

this section, may operate on any 

frequency in 401–402 MHz or 405–406 

MHz bands, or at 403.65 MHz in the 

402–405 MHz band. 

(3) MedRadio stations associated with 

medical body-worn devices, regardless 

of whether a frequency monitoring 

system as set forth in paragraph (a) of 

this section is employed, may operate 

on any of the frequencies in the 401–402 

MHz or 405–406 MHz bands. 

(4) MedRadio stations that are used 

externally to evaluate the efficacy of a 

more permanent medical implant 

device, regardless of whether a 

frequency monitoring system as set forth 

in paragraph (a) of this section is 

employed, may operate on any of the 

frequencies in the 402–405 MHz band, 

provided that: 

(i) Such external body-worn operation 

is limited solely to evaluating with a 

patient the efficacy of a fully implanted 

permanent medical device that is 

intended to replace the temporary bodyworn device; 

(ii) RF transmissions from the external 

device must cease following the patient 

evaluation period, which may not 

exceed 30 days, except where a health 

care practitioner determines that 

additional time is necessary due to 

unforeseen circumstances; 

(iii) The maximum output power of 

the temporary body-worn device shall 

not exceed 200 nW EIRP; and 

(iv) The temporary body-worn device 

must comply fully with all other 

MedRadio rules applicable to medical 

implant device operation in the 402–405 

MHz band. 

(d) Authorized bandwidth. The 

authorized bandwidth of the emission 

from a MedRadio station operating 

between 402–405 MHz shall not exceed 

300 kHz, and no communications 

session involving MedRadio stations 

shall use more than a total of 300 kHz 

of bandwidth during such a session. The 

authorized bandwidth of the emission 

from a MedRadio station operating 

between 401–401.85 MHz or 405–406 

MHz shall not exceed 100 kHz, and no 

communications session involving 

MedRadio stations shall use more than 

a total of 100 kHz of bandwidth during 

such a session. The authorized 

bandwidth of the emission from a 

MedRadio station operating between 

401.85–402 MHz shall not exceed 150 

kHz, and no communications session 

involving MedRadio stations shall use 

more than a total of 150 kHz of 

bandwidth during such a session. 

Note to paragraph (d): This provision 

does not preclude full duplex or half 

duplex communications provided that 

the total amount of bandwidth utilized 

by all of the MedRadio channels 

employed in such a MedRadio 

communications session does not 

exceed 300 kHz in the 402–405 MHz 

band, or 100 kHz in the 401–402 MHz 

and 405–406 MHz bands. 

(e) Frequency stability. Each 

transmitter in the MedRadio service 

must maintain a frequency stability of 

±100 ppm of the operating frequency 

over the range: 

(1) 25° C to 45° C in the case of 

medical implant transmitters; and 

(2) 0° C to 55° C in the case of 

MedRadio programmer/control 

transmitters and MedRadio body-worn 

transmitters. 

(f) Shared access. The provisions of 

this section shall not be used to extend 

the range of spectrum occupied over 

space or time for the purpose of denying 

fair access to spectrum for other 

MedRadio systems. 

(g) Measurement procedures. (1) 

MedRadio transmitters shall be tested 

for frequency stability, radiated 

emissions and EIRP limit compliance in 

accordance with paragraphs (g)(2) and 

(g)(3) of this section. 

(2) Frequency stability testing shall be 

performed over the temperature range 

set forth in (e) of this section. 

(3) Radiated emissions and EIRP limit 

measurements limit 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. 

Power measurements for transmissions 

by stations authorized under this 

section may be made either in 

accordance with a Commissionapproved peak power technique, or the 

following. Peak transmit power must be 

measured over any interval of 

continuous transmission using 

instrumentation calibrated in terms of 

an rms-equivalent voltage. The 

measurement results shall be properly 

adjusted for any instrument limitations, 

such as detector response times, limited 

resolution bandwidth capability when 

compared to the emission bandwidth, 

sensitivity, etc., so as to obtain a true 

peak measurement for the emission in 

question over the full bandwidth of the 

channel. 

(i) For a transmitter intended to be 

implanted in a human body, radiated 

emissions and EIRP measurements for 

transmissions by stations authorized 

under this section may be made in 

accordance with a Commissionapproved human body simulator and 

test technique. A formula for a suitable 

tissue substitute material is defined in 

OET Bulletin 65 Supplement C (01–01). 

■ 13. Section 95.631 is amended by 

revising paragraph (h) to read as 

follows: 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 22707 

§ 95.631 Emission types. 

* * * * * 

(h) A MedRadio station may transmit 

any emission type appropriate for 

communications in this service. Voice 

communications, however, are 

prohibited. 

* * * * * 

■ 14. Section 95.633 is amended by 

revising paragraph (e) to read as follows: 

§ 95.633 Emission bandwidth. 

* * * * * 

(e) For transmitters in the MedRadio 

Service: 

(1) For stations operating in 402–405 

MHz, the maximum authorized 

emission bandwidth is 300 kHz. For 

stations operating in 401–401.85 MHz or 

405–406 MHz, the maximum authorized 

emission bandwidth is 100 kHz, and 

stations operating in 401.85–402 MHz, 

the maximum authorized emission 

bandwidth is 150 kHz. 

(2) Lesser emission bandwidths may 

be employed, provided that the 

unwanted emissions are attenuated as 

provided in § 95.635. See §§ 95.628(g) 

and 95.639(f) regarding maximum 

transmitter power and measurement 

procedures. 

(3) Emission bandwidth will be 

determined by measuring the width of 

the signal between points, one below 

the carrier center frequency and one 

above the carrier center frequency, that 

are 20 dB down relative to the 

maximum level of the modulated 

carrier. Compliance with the emission 

bandwidth limit is based on the use of 

measurement instrumentation 

employing a peak detector function with 

an instrument resolution bandwidth 

approximately equal to 1.0 percent of 

the emission bandwidth of the device 

under measurement. 

* * * * * 

■ 15. Section 95.635 is amended by 

revising the table to paragraph (b), and 

by revising paragraph (d) to read as 

follows: 

§ 95.635 Unwanted radiation. 

* * * * * 

(b) * * * 

Transmitter Emission type Applicable paragraphs (b) 

GMRS .............................................. A1D, A3E, F1D, G1D, F3E, G3E with filtering ...................................... (1), (3), (7). 

A1D, A3E, F1D, G1D, F3E, G3E without filtering ................................. (5), (6), (7). 

H1D, J1D, R1D, H3E, J3E, R3E ........................................................... (2), (4), (7). 

FRS ................................................. F3E with filtering .................................................................................... (1), (3), (7). 

R/C: 

27 MHz ..................................... As specified in § 95.631(b) .................................................................... (1), (3), (7). 

72–76 MHz ............................... As specified in § 95.631(b) .................................................................... (1), (3), (7), (10), (11), (12). 

CB ................................................... A1D, A3E ............................................................................................... (1), (3), (8), (9). 

H1D, J1D, R1D, H3E, J3E, R3E ........................................................... (2), (4), (8), (9). 

A1D, A3E type accepted before September 10, 1976 .......................... (1), (3), (7). 

H1D, J1D, R1D, H3E, J3E, R3E type accepted before September 10, 

1986.

(2), (4), (7). 

LPRS ............................................... As specified in paragraph (c). 

MedRadio ........................................ As specified in paragraph (d). 

DSRCS–OBU .................................. As specified in paragraph (f) of this section. 

* * * * * 

(d) For transmitters designed to 

operate in the MedRadio service, 

emissions shall be attenuated in 

accordance with the following: 

(paragraphs (d)(1) through (d)(5) pertain 

to MedRadio transmitters operating in 

the 402–405 MHz band; paragraphs 

(d)(6) through (d)(10) pertain to 

MedRadio transmitters operating in the 

401–402 MHz or 405–406 MHz bands). 

(1) Emissions from a MedRadio 

transmitter more than 250 kHz outside 

of the 402–405 MHz band shall be 

attenuated to a level no greater than the 

following field strength limits: 

Frequency 

(MHz) 

Field strength 

(μV/m) 

Measurement 

distance 

(m) 

30–88 ........................................................................................................................................................... 100 3 

88–216 ......................................................................................................................................................... 150 3 

216–960 ....................................................................................................................................................... 200 3 

960 and above ............................................................................................................................................. 500 3 

Note—At band edges, the tighter limit applies. 

(2) The emission limits shown in the 

table of paragraph (d)(1) are based on 

measurements employing a CISPR 

quasi-peak detector except that above 1 

GHz, the limit is based on 

measurements employing an average 

detector. Measurements above 1 GHz 

shall be performed using a minimum 

resolution bandwidth of 1 MHz. See 

also § 95.605. 

(3) The emissions from a MedRadio 

transmitter must be measured to at least 

the tenth harmonic of the highest 

fundamental frequency designed to be 

emitted by the transmitter. 

(4) Emissions within the 402–405 

MHz band more than 150 kHz away 

from the center frequency of the 

spectrum the transmission is intended 

to occupy will be attenuated below the 

transmitter output power by at least 20 

dB. Compliance with this limit is based 

on the use of measurement 

instrumentation employing a peak 

detector function with an instrument 

resolution bandwidth approximately 

equal to 1.0 percent of the emission 

bandwidth of the device under 

measurement. 

(5) Emissions 250 kHz or less that are 

above or below the 402–405 MHz band 

will be attenuated below the maximum 

permitted output power by at least 20 

dB. Compliance with this limit is based 

on the use of measurement 

instrumentation employing a peak 


jlentini on PROD1PC65 with RULES
22708 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

detector function with an instrument 

resolution bandwidth approximately 

equal to 1.0 percent of the emission 

bandwidth of the device under 

measurement. 

(6) Emissions from a MedRadio 

transmitter operating in the 401–402 

MHz or 405–406 MHz bands that are 

more than 100 kHz outside of either the 

401–402 MHz or 405–406 MHz bands, 

and all emissions from such transmitter 

in the band 406.000–406.100 MHz shall 

be attenuated to a level no greater than 

the following field strength limits: 

Frequency (MHz) Field strength 

(μV/m) 

Measurement 

distance (m) 

30–88 ........................................................................................................................................................... 100 3 

88–216 ......................................................................................................................................................... 150 3 

216–960 ....................................................................................................................................................... 200 3 

960 and above ............................................................................................................................................. 500 3 

Note—At band edges, the tighter limit applies. 

(7) The emission limits shown in 

paragraph (d)(6) are based on 

measurements employing a CISPR 

quasi-peak detector except that above 1 

GHz, the limit is based on 

measurements employing an average 

detector. Measurements above 1 GHz 

shall be performed using a minimum 

resolution bandwidth of 1 MHz. See 

also § 95.605. 

(8) The emissions from a MedRadio 

transmitter operating in the MedRadio 

bands (between 401–402 MHz or 405– 

406 MHz) must be measured to at least 

the tenth harmonic of the highest 

fundamental frequency designed to be 

emitted by the transmitter. 

(9) Emissions between 401–401.85 

MHz or 405–406 MHz within the 

MedRadio bands that are more than 50 

kHz away from the center frequency of 

the spectrum the transmission is 

intended to occupy (or more than 75 

kHz away from the center frequency of 

MedRadio transmitters operating 

between 401.85–402 MHz) shall be 

attenuated below the transmitter output 

power by at least 20 dB. Compliance 

with this limit is based on the use of 

measurement instrumentation 

employing a peak detector function with 

an instrument resolution bandwidth 

approximately equal to 1.0 percent of 

the emission bandwidth of the device 

under measurement. 

(10) Emissions 100 kHz or less below 

401 MHz or above 406 MHz shall be 

attenuated below the maximum 

permitted output power by at least 20 

dB. Compliance with this limit is based 

on the use of measurement 

instrumentation employing a peak 

detector function with an instrument 

resolution bandwidth approximately 

equal to 1.0 percent of the emission 

bandwidth of the device under 

measurement. 

* * * * * 

■ 16. Section 95.639 is amended by 

revising paragraph (f) to read as follows: 

§ 95.639 Maximum transmitter power. 

* * * * * 

(f) In the MedRadio Service for 

transmitters that are not excepted under 

§ 95.628(b) from the frequency 

monitoring requirements of § 95.628(a), 

the maximum radiated power in any 

300 kHz bandwidth by MedRadio 

transmitters operating at 402–405 MHz, 

or in any 100 kHz bandwidth by 

MedRadio transmitters operating at 

401–402 MHz or 405–406 MHz shall not 

exceed 25 microwatts EIRP. For 

transmitters that are excepted under 

§ 95.628(b) from the frequency 

monitoring requirements of § 95.628(a), 

the power radiated by any station 

operating in 402–405 MHz shall not 

exceed 100 nanowatts EIRP confined to 

a maximum total emission bandwidth of 

300 kHz centered at 403.65 MHz. For 

transmitters that are excepted under 

§ 95.628(b) from the frequency 

monitoring requirements of § 95.628(a), 

the power radiated by any station 

operating in 401–401.85 MHz or 405– 

406 MHz shall not exceed 250 

nanowatts EIRP in any 100 kHz 

bandwidth and in 401.85–402 MHz 

shall not exceed 25 microwatts in the 

150 kHz bandwidth. See §§ 95.633(e). 

The antenna associated with any 

MedRadio transmitter must be supplied 

with the transmitter and shall be 

considered part of the transmitter 

subject to equipment authorization. 

Compliance with these EIRP limits may 

be determined as set forth in § 95.628(g). 

* * * * * 

■ 17. Section 95.649 is revised to read 

as follows: 

§ 95.649 Power capability. 

No CB, R/C, LPRS, FRS, MedRadio, 

MURS, or WMTS unit shall incorporate 

provisions for increasing its transmitter 

power to any level in excess of the 

limits specified in § 95.639. 

■ 18. Section 95.651 is revised to read 

as follows: 

§ 95.651 Crystal control required. 

All transmitters used in the Personal 

Radio Services must be crystal 

controlled, except an R/C station that 

transmits in the 26–27 MHz frequency 

band, a FRS unit, a LPRS unit, a MURS 

unit, a MedRadio transmitter, or a 

WMTS unit. 

■ 19. Appendix 1 to Subpart E of Part 

95—Glossary of Terms is amended by 

removing the definition of ‘‘Medical 

Implant Communications Service 

(MICS) transmitter’’, ‘‘MICS 

programmer/control transmitter’’ and 

‘‘MICS’’; and by revising the definitions 

of ‘‘EIRP’’, ‘‘Medical implant 

transmitter’’; and by adding the 

definitions of ‘‘Medical body-worn 

device’’, ‘‘Medical body-worn 

transmitter’’, ‘‘MedRadio programmer/ 

control transmitter’’, ‘‘MedRadio 

Service’’ and ‘‘MedRadio transmitter’’ in 

alphabetical order to read as follows: 

APPENDIX 1 TO SUBPART E OF PART 

95—GLOSSARY OF TERMS 

* * * * * 

EIRP. Effective Isotropic Radiated Power. 

Antenna input power times gain for freespace or in-tissue measurement 

configurations required by MedRadio, 

expressed in watts, where the gain is 

referenced to an isotropic radiator. 

* * * * * 

Medical body-worn device. Apparatus that 

is placed on or in close proximity to the 

human body (e.g., within a few centimeters) 

for the purpose of performing diagnostic or 

therapeutic functions. 

Medical body-worn transmitter. A 

MedRadio transmitter intended to be placed 

on or in close proximity to the human body 

(e.g., within a few centimeters) used to 

facilitate communications with other medical 

communications devices for purposes of 

delivering medical therapy to a patient or 

collecting medical diagnostic information 

from a patient. 

* * * * * 

Medical implant transmitter. A MedRadio 

transmitter in which both the antenna and 

transmitter device are designed to operate 

within a human body for the purpose of 

facilitating communications from a medical 

implant device. 

MedRadio programmer/control transmitter. 

A MedRadio transmitter that operates or is 

designed to operate outside of a human body 

for the purpose of communicating with a 

receiver, or for triggering a transmitter, 


jlentini on PROD1PC65 with RULES
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 22709 

connected to a medical implant device or to 

a medical body-worn device used in the 

MedRadio Service; and which also typically 

includes a frequency monitoring system that 

initiates a MedRadio communications 

session. 

MedRadio Service. Medical Device 

Radiocommunication Service. 

MedRadio transmitter. A transmitter 

authorized to operate in the MedRadio 

service. 

* * * * * 

■ 20. Revise Subpart I to read as follows: 

Subpart I—Medical Device 

Radiocommunication Service (MedRadio) 

Sec. 

95.1201 Eligibility. 

95.1203 Authorized locations. 

95.1205 Station identification. 

95.1207 Station inspection. 

95.1209 Permissible communications. 

95.1211 Channel use policy. 

95.1213 Antennas. 

95.1215 Disclosure policies. 

95.1217 Labeling requirements. 

95.1219 Marketing limitations. 

95.1221 RF exposure. 

Subpart I—Medical Device 

Radiocommunication Service 

(MedRadio) 

§ 95.1201 Eligibility. 

Operation in the MedRadio service is 

permitted by rule and without an 

individual license issued by the FCC. 

Duly authorized health care 

professionals are permitted to operate 

MedRadio transmitters. Persons may 

also operate MedRadio transmitters to 

the extent the transmitters are 

incorporated into implanted or bodyworn medical devices that are used by 

the person at the direction of a duly 

authorized health care professional; this 

includes medical devices that have been 

implanted in that person or placed on 

the body of that person by or under the 

direction of a duly authorized health 

care professional. Manufacturers of 

medical devices that include MedRadio 

transmitters, and their representatives, 

are authorized to operate transmitters in 

this service for the purpose of 

demonstrating such equipment to duly 

authorized health care professionals. No 

entity that is a foreign government or 

which is acting in its capacity as a 

representative of a foreign government 

is eligible to operate a MedRadio 

transmitter. The term ‘‘duly authorized 

health care professional’’ means a 

physician or other individual 

authorized under state or federal law to 

provide health care services. Operations 

that comply with the requirements of 

this part may be conducted under 

manual or automatic control. 

§ 95.1203 Authorized locations. 

MedRadio operation is authorized 

anywhere CB station operation is 

authorized under § 95.405. 

§ 95.1205 Station identification. 

A station is not required to transmit 

a station identification announcement. 

§ 95.1207 Station inspection. 

Any non-implanted MedRadio 

transmitter must be made available for 

inspection upon request by an 

authorized FCC representative. Persons 

operating implanted or body-worn 

MedRadio transmitters shall cooperate 

reasonably with duly authorized FCC 

representatives in the resolution of 

interference. 

§ 95.1209 Permissible communications. 

(a) Except for the purposes of testing 

and for demonstrations to health care 

professionals, MedRadio programmer/ 

control transmitters may transmit only 

non-voice data containing operational, 

diagnostic and therapeutic information 

associated with a medical implant 

device or medical body-worn device 

that has been implanted or placed on 

the person by or under the direction of 

a duly authorized health care 

professional. 

(b) Except as provided in § 95.628(b) 

no MedRadio implant or body-worn 

transmitter shall transmit except in 

response to a transmission from a 

MedRadio programmer/control 

transmitter or in response to a non-radio 

frequency actuation signal generated by 

a device external to the body with 

respect to which the MedRadio implant 

or body-worn transmitter is used. 

(c) MedRadio programmer/control 

transmitters may be interconnected with 

other telecommunications systems 

including the public switched telephone 

network. 

(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)(3) for 

no more than 3.6 seconds in total within 

a one-hour time period without the 

communications of data; MedRadio 

transmitters may transmit in accordance 

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

no more than 360 milliseconds in total 

within a one-hour time period without 

the communications of data. 

(e) MedRadio programmer/control 

transmitters may not be used to relay 

information to a receiver that is not 

included with a medical implant or 

medical body-worn device. Wireless 

retransmission of information intended 

to be transmitted by a MedRadio 

programmer/control transmitter or 

information received from a medical 

implant or medical body-worn 

transmitter shall be performed using 

other radio services that operate in 

spectrum outside of the MedRadio band. 

§ 95.1211 Channel use policy. 

(a) The channels authorized for 

MedRadio operation by this part of the 

FCC Rules are available on a shared 

basis only and will not be assigned for 

the exclusive use of any entity. 

(b) To reduce interference and make 

the most effective use of the authorized 

facilities, MedRadio transmitters must 

share the spectrum in accordance with 

§ 95.628. 

(c) MedRadio operation is subject to 

the condition that no harmful 

interference is caused to stations 

operating in the 400.150–406.000 MHz 

band in the Meteorological Aids, 

Meteorological Satellite, or Earth 

Exploration Satellite Services. 

MedRadio stations must accept any 

interference from stations operating in 

the 400.150–406.000 MHz band in the 

Meteorological Aids, Meterological 

Satellite, or Earth Exploration Satellite 

Services. 

§ 95.1213 Antennas. 

No antenna for a MedRadio 

transmitter shall be configured for 

permanent outdoor use. In addition, any 

MedRadio antenna used outdoors shall 

not be affixed to any structure for which 

the height to the tip of the antenna will 

exceed three (3) meters (9.8 feet) above 

ground. 

§ 95.1215 Disclosure policies. 

Manufacturers of MedRadio 

transmitters must include with each 

transmitting device the following 

statement: 

‘‘This transmitter is authorized by 

rule under the Medical Device 

Radiocommunication Service (in part 95 

of the FCC Rules) and must not cause 

harmful interference to stations 

operating in the 400.150–406.000 MHz 

band in the Meteorological Aids (i.e., 

transmitters and receivers used to 

communicate weather data), the 

Meteorological Satellite, or the Earth 

Exploration Satellite Services and must 

accept interference that may be caused 

by such stations, including interference 

that may cause undesired operation. 

This transmitter shall be used only in 

accordance with the FCC Rules 

governing the Medical Device 

Radiocommunication Service. Analog 


jlentini on PROD1PC65 with RULES
22710 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Rules and Regulations 

and digital voice communications are 

prohibited. Although this transmitter 

has been approved by the Federal 

Communications Commission, there is 

no guarantee that it will not receive 

interference or that any particular 

transmission from this transmitter will 

be free from interference.’’ 

§ 95.1217 Labeling requirements. 

(a) MedRadio programmer/control 

transmitters shall be labeled as provided 

in part 2 of this chapter and shall bear 

the following statement in a 

conspicuous location on the device: 

‘‘This device may not interfere with 

stations operating in the 400.150– 

406.000 MHz band in the 

Meteorological Aids, Meteorological 

Satellite, and Earth Exploration Satellite 

Services and must accept any 

interference received, including 

interference that may cause undesired 

operation.’’ 

The statement may be placed in the 

instruction manual for the transmitter 

where it is not feasible to place the 

statement on the device. 

(b) Where a MedRadio programmer/ 

control transmitter is constructed in two 

or more sections connected by wire and 

marketed together, the statement 

specified in this section is required to be 

affixed only to the main control unit. 

(c) MedRadio transmitters shall be 

identified with a serial number. The 

FCC ID number associated with a 

medical implant transmitter and the 

information required by § 2.925 of this 

chapter may be placed in the instruction 

manual for the transmitter and on the 

shipping container for the transmitter, 

in lieu of being placed directly on the 

transmitter. 

§ 95.1219 Marketing limitations. 

Transmitters intended for operation in 

the MedRadio Service may be marketed 

and sold only for the permissible 

communications described in § 95.1209. 

§ 95.1221 RF exposure. 

MedRadio medical implant or 

medical body-worn transmitters (as 

defined in appendix 1 to subpart E of 

part 95 of this chapter) are subject to the 

radiofrequency radiation exposure 

requirements specified in §§ 1.1307 and 

2.1093 of this chapter, as appropriate. 

Applications for equipment 

authorization of implant devices 

operating under this section must 

contain a finite difference time domain 

(FDTD) computational modeling report 

showing compliance with these 

provisions for fundamental emissions. 

The Commission retains the discretion 

to request the submission of specific 

absorption rate measurement data. 

[FR Doc. E9–11063 Filed 5–13–09; 8:45 am] 

BILLING CODE 6712–01–C 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 09–989; MB Docket No. 09–33; RM– 

11521] 

Television Broadcasting Services; 

Derby, KS 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Commission grants a 

petition for rulemaking filed by 

Entravision Holdings, LLC, the 

permittee of station KDCU–DT, to 

substitute DTV channel 31 for posttransition DTV channel 46 at Derby, 

Kansas. 

DATES: This rule is effective May 14, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Adrienne Y. Denysyk, Media Bureau, 

(202) 418–1600. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 09–33, 

adopted April 27, 2009, and released 

April 30, 2009. The full text of this 

document is available for public 

inspection and copying during normal 

business hours in the FCC’s Reference 

Information Center at Portals II, CY– 

A257, 445 12th Street, SW., 

Washington, DC 20554. This document 

will also be available via ECFS (http:// 

www.fcc.gov/cgb/ecfs/). (Documents 

will be available electronically in ASCII, 

Word 97, and/or Adobe Acrobat.) This 

document may be purchased from the 

Commission’s duplicating contractor, 

Best Copy and Printing, Inc., 445 12th 

Street, SW., Room CY–B402, 

Washington, DC 20554, telephone 1– 

800–478–3160 or via e-mail http:// 

www.BCPIWEB.com. To request this 

document in accessible formats 

(computer diskettes, large print, audio 

recording, and Braille), send an e-mail 

to fcc504@fcc.gov or call the 

Commission’s Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). This document does not contain 

information collection requirements 

subject to the Paperwork Reduction Act 

of 1995, Public Law 104–13. In addition, 

therefore, it does not contain any 

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). Provisions of the Regulatory 

Flexibility Act of 1980 do not apply to 

this proceeding. 

The Commission will send a copy of 

this Report 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). 

List of Subjects in 47 CFR Part 73 

Television, Television broadcasting. 

■ For the reasons discussed in the 

preamble, the Federal Communications 

Commission amends 47 CFR Part 73 as 

follows: 

PART 73—RADIO BROADCAST 

SERVICES 

■ 1. The authority citation for part 73 

continues to read as follows: 

Authority: 47 U.S.C. 154, 303, 334, 336. 

§ 73.622 [Amended] 

■ 2. Section 73.622(i), the PostTransition Table of DTV Allotments 

under Kansas, is amended by adding 

DTV channel 31 and removing DTV 

channel 46 at Derby. 

Federal Communications Commission. 

Clay C. Pendarvis, 

Associate Chief, Video Division, Media 

Bureau. 

[FR Doc. E9–11207 Filed 5–13–09; 8:45 am] 

BILLING CODE 6712–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 040205043–4043–01] 

RIN 0648–XP20 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; Snappergrouper Fishery of the South Atlantic; 

Closure of the 2009 Commercial 

Fishery for Black Sea Bass in the 

South Atlantic 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS closes the commercial 

fishery for black sea bass in the 

exclusive economic zone (EEZ) of the 

South Atlantic. NMFS has determined 

that the quota for the commercial 


jlentini on PROD1PC65 with RULES