Additional Spectrum for the Medical Device Radiocommunication Service, 22491-22498 [E9-11066]

Agencies

• FEDERAL COMMUNICATIONS COMMISSION

[Federal Register Volume 74, Number 91 (Wednesday, May 13, 2009)]
[Proposed Rules]
[Pages 22491-22498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11066]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Parts 2 and 95

[ET Docket No. 09-36, RM-11404; FCC 09-20]


Additional Spectrum for the Medical Device Radiocommunication 
Service

AGENCY: Federal Communications Commission.

ACTION: Proposed rule.

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SUMMARY: In this document the Commission seeks comment on the 
feasibility of allowing up to 24 megahertz of spectrum in the 413-457 
MHz band to be used on a secondary basis under the umbrella of the 
existing Medical Device Radiocommunication Service. This action 
reflects the Commission's ongoing effort to foster the development and 
deployment of advanced medical devices using wireless technologies that 
benefit the health and well-being of the American public.

DATES: Comments must be filed on or before August 11, 2009 and reply 
comments must be filed on or before September 10, 2009.

FOR FURTHER INFORMATION CONTACT: Gary Thayer, Office of Engineering and 
Technology, (202) 418-2290, e-mail: Gary.Thayer@fcc.gov, TTY (202) 418-
2989.

ADDRESSES: You may submit comments, identified by ET Docket No. 09-36, 
by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Federal Communications Commission's Web Site: https://www.fcc.gov/cgb/ecfs/. Follow the instructions for submitting comments.
     E-mail: [Optional: Include the E-mail address only if you 
plan to accept comments from the public]. Include the docket number(s) 
in the subject line of the message.
     Mail: [Optional: Include the mailing address for paper, 
disk, or CD-ROM submissions needed/requested by your Bureau or Office. 
Do not include the Office of the Secretary's mailing address here.]
     People With Disabilities: Contact the FCC to request 
reasonable accommodations (accessible format documents, sign language 
interpreters, CART, etc.) by e-mail: FCC504@fcc.gov or phone: 202-418-
0530 or TTY: 202-418-0432.
    For detailed instructions for submitting comments and additional 
information on the rulemaking process, see the SUPPLEMENTARY 
INFORMATION section of this document.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Notice 
of Proposed Rule Making, ET Docket No. 09-36, FCC 09-20, adopted March 
17, 2009, and released March 20, 2009. The full text of this document 
is available for public inspection and copying during regular business 
hours in the Commission's Reference Information Center, Portals II, 445 
12th Street, SW., (Room CY-A257), Washington, DC 20554. The complete 
text of this document also may be purchased from the Commission's copy 
contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, 
SW., Room, CY-B402, Washington, DC 20554, telephone (202) 488-5300, 
facsimile (202) 488-5563 or via e-mail FCC@BCPIWEB.com. The full text 
may also be downloaded at: https://www.fcc.gov.
    Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 
CFR 1.415, 1.419, interested parties may file comments and reply 
comments on or before the dates indicated on the first page of this 
document. Comments may be filed using: (1) The Commission's Electronic 
Comment Filing System (ECFS), (2) the Federal Government's eRulemaking 
Portal, or (3) by filing paper copies. See Electronic Filing of 
Documents in Rulemaking Proceedings, 63 FR 24121 (1998).
     Electronic Filers: Comments may be filed electronically 
using the Internet by accessing the ECFS: https://www.fcc.gov/cgb/ecfs/ 
or the Federal eRulemaking Portal: https://www.regulations.gov. Filers 
should follow the instructions provided on the website for submitting 
comments.
     For ECFS filers, if multiple docket or rulemaking numbers 
appear in the caption of this proceeding, filers must transmit one 
electronic copy of the comments for each docket or rulemaking number 
referenced in the caption. In completing the transmittal screen, filers 
should include their full name, U.S. Postal Service mailing address, 
and the applicable docket or rulemaking number. Parties may also submit 
an electronic comment by Internet e-mail. To get filing instructions, 
filers should send an e-mail to ecfs@fcc.gov, and include the following 
words in the body of the message, ``get form.'' A sample form and 
directions will be sent in response.
     Paper Filers: Parties who choose to file by paper must 
file an original and four copies of each filing. If more than one 
docket or rulemaking number appears in the caption of this proceeding, 
filers must submit two additional copies for each additional docket or 
rulemaking number.
    Filings can be sent by hand or messenger delivery, by commercial 
overnight courier, or by first-class or overnight U.S. Postal Service 
mail (although we continue to experience delays in receiving U.S. 
Postal Service mail). All filings must be addressed to the Commission's 
Secretary, Office of the Secretary, Federal Communications Commission.
     The Commission's contractor will receive hand-delivered or 
messenger-delivered paper filings for the Commission's Secretary at 236 
Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing 
hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be 
held together with rubber bands or fasteners. Any envelopes must be 
disposed of before entering the building.
     Commercial overnight mail (other than U.S. Postal Service 
Express Mail and Priority Mail) must be sent to 9300 East Hampton 
Drive, Capitol Heights, MD 20743.
     U.S. Postal Service first-class, Express, and Priority 
mail should be addressed to 445 12th Street, SW., Washington DC 20554.
    People With Disabilities: To request materials in accessible 
formats for people with disabilities (braille, large print, electronic 
files, audio format), send an e-mail to fcc504@fcc.gov or call the 
Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-
418-0432 (tty).

Summary of Notice of Proposed Rulemaking

    1. In this Notice of Proposed Rule Making, the Commission seeks 
comment on the feasibility of allowing up to 24 megahertz of spectrum 
in the

[[Page 22492]]

413-457 MHz band to be used on a secondary basis under the existing 
Medical Device Radiocommunication Service (MedRadio Service) framework 
in part 95 of the Commission's rules. This action is taken in response 
to a petition for rulemaking filed by Alfred Mann Foundation (Alfred 
Mann or AMF). Numerous commenters also support the general concept 
espoused by Alfred Mann of providing spectrum for use by advanced 
microstimulator devices that might service as artificial nervous 
systems for those suffering from a wide array of debilitating disorders 
or injuries.
    2. This Notice of Proposed Rule Making also reflects the 
Commission's ongoing effort to foster the development and deployment of 
advanced medical devices using wireless technologies that benefit the 
health and well-being of the American public. For example, large 
numbers of Americans, including U.S. service men and women returning 
each year from military service, suffer from spinal cord injuries, 
traumatic brain injuries, strokes, and various neuromusculoskeletal 
disorders. For these persons, the prospect of recovering some degree of 
sensation, mobility, and other functions for paralyzed limbs and organs 
offers new hope for improved quality of life. Furthermore, these 
individuals could be provided with safer, less-invasive, and more 
effective treatment options as compared with existing wired therapeutic 
approaches.
    3. In light of these potential health benefits, the Commission 
proposes in this Notice of Proposed Rule Making to provide access to 
spectrum for wireless micro-power networks that would be comprised of 
multiple networked implanted devices that employ wideband functional 
electrical stimulation techniques.

Frequency Allocation

    4. The Commission concludes that the record supports its 
consideration of additional spectrum in the 413-457 MHz band for the 
MedRadio Service under part 95 of our rules. Accordingly, the 
Commission seeks comment on the suitability of four segments of the 
413-457 MHz band (413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 
MHz) that Alfred Mann requested be made available for use by medical 
micro-power networks (MMN) or other similar bandwidth intensive medical 
implant networks that require a high degree of operational reliability.
    5. In its petition for rulemaking, Alfred Mann argues that WMTS 
spectrum is unsuitable for wideband MMN devices because frequencies 
above 470 MHz are outside the preferred range of spectrum for 
propagation of radiofrequency (``RF'') signals within the human body. 
To explore this assertion more fully, the Commission invites commenters 
to address the validity of Alfred Mann's arguments above in support of 
permitting MMN operations in the specified segments of the 413-457 MHz 
band rather than in the other frequency bands, which Alfred Mann 
asserts are either unavailable or undesirable.
    6. The Commission further notes that the 413-450 MHz band is 
presently used by federal agencies for land mobile radio and radar 
operations. The National Telecommunications and Information 
Administration (NTIA) has made available information that has been 
incorporated into ET Docket No. 09-36 which provides greater detail 
concerning federal operations in the band, as well as a discussion of 
technical issues related to electromagnetic compatibility between 
medical devices and federal systems in this band. The Commission 
observes that use of this band for non-Federal operations would require 
agreement with NTIA. To lay the groundwork for considering the 
ramifications of such a prospective agreement, the Commission proposes 
to allow MMNs to operate in this band on a secondary basis at 413-419 
MHz, 426-432 MHz, and 438-444 MHz, subject to the further condition 
that harmful interference should not be caused to Federal operations in 
the band. The Commission further proposes to provide for such use by 
including a U.S. footnote to the Table of Allocations in part 2 of the 
rules for the specific band segments. It seeks comment on this 
approach. The Commission also seeks comment on allowing MMNs to operate 
in the 451-457 MHz band on a secondary basis by including a U.S. 
footnote to the Table of Allocations.
    7. The Commission also seeks comment on whether permitting MMNs to 
operate in these bands would cause interference to incumbent users, as 
well as whether transmissions from incumbent stations could adversely 
affect the operation of such medical devices, possibly resulting in 
adverse effects to patients using the medical devices. Given the low 
transmitter power and duty cycle limits that would typically be used by 
either the implanted MMN device or the external MCU, the Commission 
states that it expects that the risk of interference from MMNs to 
incumbent operations in these frequency bands would be negligibly 
small. Because MMNs typically would be operating at much lower power 
than an incumbent station, the latter should be able to overcome any 
interference received from any MMN device. The risk of interference to 
incumbent operations also would likely be mitigated by other factors 
such as separation distances from a MMN to an incumbent station, and 
only a small amount of energy from a wideband MMN would be received by 
a narrowband land mobile station. The Commission seeks comment on these 
observations as well as other factors that should be considered in 
assessing potential interference from MMNs to the incumbent systems. 
For example, given the potentially large number of implanted devices 
that a MMN might use, is there a potential for interference to 
incumbent systems from the simultaneous operation of multiple implanted 
devices?
    8. Finally, the Commission seeks comment on whether allowing use of 
the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz frequency 
bands on a secondary basis for new MMN devices would be consistent with 
international spectrum allocations and operations. In this regard, the 
Commission observes that the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 
451-457 MHz bands are allocated to ``mobile, except aeronautical 
mobile,'' services on a primary basis in all or substantial portions of 
the three International Telecommunication Union regions.

Service and Technical Rules

    9. The Commission states that the central focus in this Notice of 
Proposed Rule Making is on MMNs that would be used to provide FES 
therapeutic treatment and the kinds of devices that would be part of 
these networks as described by Alfred Mann. Thus, the Commission 
invites comment on other types of functional electric stimulation (FES) 
applications that would be consistent with MMN operations and that 
would similarly require the wider emission bandwidth that might be 
accommodated in this spectrum, and which is not available in other 
spectrum currently identified for wireless medical devices. The 
Commission also notes that the AMF petition includes an appendix that 
sets forth one possible framework for the service and technical rules 
as a separate subpart of part 95 and invites comment on the suggestions 
in Alfred Mann's petition.
    10. Licensing. The Commission seeks comment on whether the 
operation of MMN devices in the 413-457 MHz band should be authorized 
in the same manner as other medical devices in the MedRadio Service--
namely, under part 95 of the rules, and thus providing for

[[Page 22493]]

license-by-rule operation pursuant to Section 307(e) of the 
Communications Act (Act).
    11. The Commission further seeks comment on whether this license-
by-rule framework would provide the most beneficial approach for MMN 
devices, but also asks whether other approaches would be preferable. If 
so, how would those alternative approaches be structured, and why? What 
would be the relative benefits and disadvantages compared with the 
license-by-rule approach?
    12. Definitions. The Commission seeks comment on what definitions 
should be included in its rules for MMN medical devices operating in 
the 413-457 MHz band. In addition, the Notice of Proposed Rule Making 
proposes the following definitions:
     Medical Micro-power Network (MMN): An ultra-low power 
radio service for the transmission of non-voice data to and from 
medical implant devices for the purpose of facilitating functional 
electric stimulation and sensing, a technique using electric currents 
to activate and monitor nerves and muscles. A MMN is comprised of 
multiple medical implant devices under the control of a MMN control 
transmitter.
     MMN control transmitter: A MMN transmitter that operates 
or is designed to operate outside of a human body for the purpose of 
communicating with a receiver connected to a MMN implant device or to 
another MMN transmitter associated with a MMN implant device, and is 
sometimes referred to as a Master Control Unit (MCU).
     MMN implant transmitter: A MMN transmitter that operates 
or is designed to operate within a human body for the purpose of 
facilitating communication from a medical implant device.
     MMN transmitter: A transmitter authorized to operate as 
part of a MMN.
    13. The Commission seeks comment on whether these definitions are 
suitable. Are they too broad or too narrow? Should alternative 
definitions be used? For example, should other components of wireless 
MMN networks also be identified and defined? would any current 
definitions included in the MedRadio Service rules need to be modified 
to accommodate wireless medical devices operating at 413-457 MHz?
    14. Permissible Communications and Operator Eligibility. The 
Commission seeks comment on adopting requirements for permissible MMN 
communications and MMN operator eligibility that are generally the same 
as those in place for the MedRadio Service. For example, the existing 
MedRadio rules provide that a medical implant device may be used by 
persons for diagnostic and therapeutic purposes, but only to the extent 
that such devices have been provided to a human patient under the 
direction of a duly authorized health care professional. Furthermore, 
transmissions are limited to non-voice data signals. In this Notice of 
Proposed Rule Making, the Commission states its belief that applying 
these same requirements would be central to maintaining the intended 
use of this spectrum primarily for devices that could serve as 
artificial nervous systems or components thereof. The Commission thus 
seeks comment on whether these same requirements would be appropriate 
for MMNs.
    15. The Commission also notes that the present MedRadio Service 
rules do not allow medical implant programmer/control transmitters to 
relay information to a receiver that is not included with a medical 
implant device. However, it observes that the MedRadio Service rules do 
allow medical implant programmer/control transmitters to be 
interconnected with other telecommunications systems including the 
public switched telephone network. The Commission seeks comment on 
whether, and why, similar requirements should also apply to the 
proposed MMN operations.
    16. The Commission seeks comment on whether implant-to-implant 
communication should be allowed, and whether there should be a 
requirement that each external master control unit (or MCU) must always 
control the transmitters implanted within a single patient. The 
Commission also asks several related questions. Should all implants in 
a single patient be controlled by a single MCU, thus comprising a 
single network, even if the implants control different functions within 
the patient? Or should implants that perform different functions within 
the patient be organized into separate networks, each controlled by its 
own MCU? Could one MCU control multiple implants in more than one 
patient? What would be the impact if multiple MCUs were to be used for 
a single patient?

Technical Rules

    17. Emission Bandwidth. The Commission seeks comment on the maximum 
emission bandwidth that should be permitted for MMN devices. The 
Commission notes that each of the four segments of the 413-457 MHz band 
under consideration in this Notice of Proposed Rule Making for use by 
MMN devices occupies six megahertz of spectrum. Thus, it tentatively 
concludes that specifying a maximum emission bandwidth of six megahertz 
would appear to be a reasonable option because it would be to allow 
each MMN device to fully utilize the available spectrum in each band 
segment. By comparison, however, Alfred Mann suggests limiting the 
maximum emission bandwidth of MMNs to approximately five megahertz. The 
Commission notes that a six megahertz maximum emission bandwidth would 
afford some degree of flexibility for manufacturers in identifying the 
center frequency of MMN transmissions but it also could have an adverse 
impact on spectrum use efficiency. Thus, in the alternative, the 
Commission seeks comment on whether an even smaller maximum emission 
bandwidth (e.g., three megahertz) would be sufficient for MMN purposes 
and might serve to further improve spectrum use efficiency. In this 
regard, the Commission asks commenters to address these questions in 
the context of the following expected operational needs of MMN devices: 
(1) To transmit large amounts of data necessary to perform complex 
biomedical functions; (2) to transmit heavily coded messages necessary 
to permit detection and correction of errors; and (3) to conserve 
battery power while minimizing the size of the battery and thus the 
size of the implantable microstimulator. Commenters are also invited to 
address the potential impact of any particular emission bandwidth with 
respect to the potential for increased or decreased compatibility with 
incumbent users.
    18. Channelization. The Commission proposes to adopt rules that do 
not specify any particular channeling plan for MMN device operation, 
thereby following the approach used with the MedRadio Service. Under 
this approach, a ``channel'' would be loosely defined as the maximum 
bandwidth occupied by the transmissions from a MMN device in the course 
of a MMN communications session. The Commission seeks comment on 
whether the potential benefit of more efficient spectrum use under this 
approach would be outweighed by an increased risk of adverse mutual 
interactions between MMN devices using differing center frequencies and 
bandwidths. The Commission seeks comment on what other factors should 
be considered under this option, and whether other more specific 
channeling plans might be considered.
    19. Contention protocol requirement. The Commission seeks comment 
on whether a contention protocol should be applied to MMN transmitting 
devices, and if so, how such a protocol might be

[[Page 22494]]

developed. In particular, it seeks comment on whether a contention 
protocol should be applied to MMN transmitting devices, and if so, how 
such a protocol might be developed. The Commission also invites comment 
on whether it should rely upon the general definition of contention-
based protocol recently adopted by the Commission in another rulemaking 
proceeding for the operation of wireless devices under part 90 of the 
rules in the 3650 MHz band Thus, the proposed definition would reads as 
follows.

    ``Contention-based protocol. A protocol that allows multiple 
users to share the same spectrum by defining the events that must 
occur when two or more transmitters attempt to simultaneously access 
the same channel and establishing rules by which a transmitter 
provides reasonable opportunities for other transmitters to operate. 
Such a protocol may consist of procedures for initiating new 
transmissions, procedures for determining the state of the channel 
(available or unavailable), and procedures for managing 
retransmissions in the event of a busy channel.''

    20. The Commission observes that, depending upon such factors as 
the transmit/receive reliability, or quality of service requirements of 
a particular use, a practical contention protocol could take a variety 
of forms, such as listen-before-talk (LBT) frequency monitoring, time 
slot synchronization, or frequency hopping among others. The system 
described by Alfred Mann in its petition, for example, appears to 
depend upon time slot sharing to avoid interference with individual 
microstimulator devices and associated device networks. The Commission 
seeks comment on the advantages and disadvantages of such an approach. 
Would a time slot synchronization protocol of this nature present 
compatibility issues with respect to other protocols that might be used 
by alternative MMN devices? Another option would be to follow the 
existing approach of the MedRadio service whereby the medical 
transmitting device must incorporate a LBT frequency monitoring 
mechanism to monitor the channel or channels that the medical device 
transmitters intend to occupy. The Commission notes that one potential 
benefit of this latter approach would be that the LBT protocol of the 
MedRadio Service is already clearly defined in the rules and appears to 
be successful in allowing a number of uncoordinated devices to share 
the same spectrum.
    21. In this regard, The Commission encourages commenters to discuss 
what kinds of contention protocols should or should not be utilized, 
and seeks detailed responses to the following questions. If 
implemented, how should such protocols be defined? Would the protocol 
be open-source or proprietary? Would more than one protocol be 
permitted? Should the same protocol be required for all devices, and 
how would this be accomplished? How should such protocols be 
established--by rule, by industry standard setting procedures, or other 
approaches? Would any of these protocols be expected to interact either 
favorably or adversely with incumbent users?
    22. The Commission also seeks comment on the technical parameters 
associated with frequency monitoring protocols that can be used to 
facilitate sharing with the incumbent federal users. How should the 
frequency monitoring threshold power level be established? How should 
the minimum time for monitoring a channel for an incumbent signal be 
established? What effect will the different types of incumbent signals 
have on frequency monitoring capabilities? Once a channel is determined 
to be occupied by an incumbent should a minimum time be established 
before the channel can be monitored? Can a single frequency monitoring 
capability be implemented that can detect both pulsed radar signals and 
non-pulsed analog and digital land mobile radio signals?
    23. Transmitter power and duty cycle. The Commission seeks comment 
on what measurement methods would be appropriate for establishing 
compliance with maximum EIRP limits for MMN devices. With respect to 
the potential for interference to federal operations, the Commission 
seeks specific comments on several issues: What, if any, duty cycle 
limits should be imposed; or would the inherent duty cycle 
characteristics of MMN devices be sufficient to minimize the potential 
for interference to those incumbent systems? In assessing the potential 
impact on incumbent systems, what other operational factors should be 
considered? Should there be an upper limit on the number of devices 
that might comprise a single MMN network, or should the individual EIRP 
of a significant number of devices be aggregated in some manner? Are 
there any other interference mitigation factors that should be 
considered in this regard?
    24. With respect to the potential for interference to MMN devices 
from federal government operations, the Commission seeks specific 
comment on what interference mitigation techniques could be employed 
with a sufficiently high degree of confidence by systems using FES or 
other similar techniques. The Commission states that it is particularly 
interested in comments relating to error detection and correction 
coding, dynamic channel switching, and spectral notching that could be 
used by MMN devices and whether any of these, or other such techniques, 
would be effective, either alone or in combination.
    25. Unwanted emissions. The Commission observes that the existing 
MedRadio rules under part 95 set forth limits on unwanted emissions 
(including limits on both in-band and out-of-band radiation) from 
medical transmitting devices operating in the 401-406 MHz band. 
Following this framework, the Commission seeks comment on whether such 
limits should be applied to MMN devices operating in the 413-457 MHz 
band.
    26. Under this approach, emissions 500 kHz or less above or below 
any particular authorized bandwidth must be attenuated by at least 20 
dB below the transmitter output power. In addition, emissions more than 
500 kHz outside of the authorized bandwidth must attenuated to a level 
no greater than the following signal strengths at 3 m: (a) Between 30-
88 MHz, 100 [mu]V/m, (b) between 88-216 MHz, 150 [mu]V/m, (c) between 
216-960 MHz, 200 [mu]V/m, and (d) 960 MHz and above, 500 [mu]V/m. The 
Commission seeks comment on the suitability of these proposed limits on 
out-of-band and spurious emissions and whether they would be adequate 
to protect incumbent operations, while fostering efficient spectrum use 
by MMN devices.
    27. Frequency stability. The Commission seeks comment on whether 
each MMN transmitter should be required to maintain a frequency 
stability of +/- 100 ppm of the operating frequency over the range: (1) 
25 [deg]C to 45 [deg]C in the case of MMNS implant transmitters; and 
(2) 0 [deg]C to 55 [deg]C in the case of MMNS control transmitters.
    28. Antenna locations. The Commission seeks comment on whether to 
require that no antenna for a MMN control transmitter may be configured 
for permanent outdoor use. Under such a provision, any MMN control 
transmitter used outdoors would not be allowed to 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. This would replicate the same 
requirement that applies to the MedRadio Service.
    29. RF safety. In this proceeding, the Commission only seeks 
comment on whether MMN implant and control transmitters should be 
deemed as portable devices subject to Sections 2.1093 and 1.1307 of the 
existing rules.

[[Page 22495]]

The Commission notes that portable devices are subject to Section 
2.1093 of the rules, pursuant to which an environmental assessment must 
be prepared under Section 1.1307. These rule sections also govern 
existing MedRadio devices. Devices covered by these rules are subject 
to routine environmental evaluation for RF exposure prior to equipment 
authorization of use.

Miscellaneous Provisions

    30. Finally, the Commission seeks comment on various provisions 
regarding equipment certification, authorized locations, station 
identification, station inspection, disclosure policy, labeling 
requirements and marketing limitations that mirror the existing 
MedRadio rules.
    31. Equipment Certification. First, the Commission seeks comment on 
whether it should require that each MMN transmitter authorized to 
operate in the 413-457 MHz band must be certificated except for such 
transmitters that are not marketed for use in the United States, but 
which otherwise comply with the applicable technical requirements and 
are operated in the United States by individuals who have traveled to 
the United States from abroad.
    32. Authorized Locations, Station Identification, and Inspections. 
For authorized locations, the Commission seeks comment on whether it 
should require that operation would be authorized anywhere CB station 
operation is authorized under Sec.  95.405. With respect to station 
identification, the Commission seeks comment on providing that a MMN 
station would not be required to transmit a station identification 
announcement. It also seeks comment on whether to provide that all non-
implanted MMN transmitter apparatus be made available for inspection 
upon request by an authorized FCC representative. Under such a 
provision, persons operating implanted MNN transmitters would be 
required to cooperate reasonably with duly authorized FCC 
representatives in the resolution of interference. The Commission seeks 
comment on all of these options.
    33. Disclosure Statement. The Commission seeks comment on whether 
to require that manufacturers of MMN transmitters include with each 
transmitting device the following disclosure statement: ``This 
transmitter is authorized by rule under the MedRadio Service (47 CFR 
Part 95). This transmitter must not cause harmful interference to 
stations authorized to operate on a primary basis in the 413-419 MHz, 
426-432 MHz, 438-444 MHz, and 451-457 MHz bands, 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 MedRadio 
Service. Analog 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.'' The Commission notes that 
this language tracks the existing MedRadio disclosure requirement.
    34. Labeling. The Commission further seeks comment on whether to 
require that MMN control transmitters be labeled and shall bear the 
following statement in a conspicuous location on the device: ``This 
device may not interfere with stations authorized to operate on a 
primary basis in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 
MHz bands, and must accept any interference received, including 
interference that may cause undesired operation.'' Where a MMN control 
transmitter is constructed in two or more sections connected by wire 
and marketed together, the statement specified in this section would be 
required to be affixed only to the main control unit. The Commission 
also seeks comment on whether to require that MMN implant transmitters 
be identified with a serial number. Under that plan, the Commission 
would allow the FCC ID number associated with the transmitter and the 
information required by Sec.  2.925 of the FCC rules to be placed in 
the instruction manual for the transmitter in lieu of being placed 
directly on the transmitter.
    35. Marketing Limitations. Finally, with respect to marketing 
limitations, the Commission seeks comment on requiring that MMN 
transmitters intended for operation in any portions of the 413-419 MHz, 
426-432 MHz, 438-444 MHz, and 451-457 MHz bands may be marketed and 
sold only for those permissible uses.

Initial Regulatory Flexibility Analysis

    36. As required by the Regulatory Flexibility Act (RFA),\1\ the 
Commission has prepared this present Initial Regulatory Flexibility 
Analysis (IRFA) of the possible significant economic impact on small 
entities by the policies and rules proposed in this Notice of Proposed 
Rule Making (NPRM). Written public comments are requested on this IRFA. 
Comments must be identified as responses to the IRFA and must be filed 
by the deadlines for comments provided in paragraph 60 of this NPRM. 
The Commission will send a copy of this NPRM, including this IRFA, to 
the Chief Counsel for Advocacy of the Small Business Administration 
(SBA).\2\
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    \1\ See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601-612, has been 
amended by the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA). Public Law 104-121, Title II, 110 Stat. 857 (1996).
    \2\ See 5 U.S.C. 603(a).
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A. Need for, and Objectives of, the Proposed Rules

    37. The Commission seeks comment on the feasibility of allowing up 
to 24 megahertz of spectrum in the 413-457 MHz band to be used on a 
secondary basis under the Medical Device Radiocommunication Service 
(MedRadio Service) in Part 95 of the Commission's rules. The Commission 
takes this action in response to a petition for rulemaking filed by 
Alfred Mann Foundation (Alfred Mann or AMF) and numerous supportive 
comments concerning groundbreaking advances in implantable 
neuromuscular microstimulation devices using wireless technologies.\3\ 
As described by Alfred Mann, a number of these implanted devices could 
be surgically injected in a patient and configured along with an 
external control unit to function as a wideband medical micro-power 
network--or MMN. MMNs using functional electric stimulation (or FES) 
techniques could serve as an artificial nervous system to restore 
sensation, mobility, and function to paralyzed limbs and organs.
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    \3\  See ``Amendment of Parts 2 and 95 of the Commission's Rules 
to Establish the Medical Micropower Network Service in the 413-457 
MHz band'', Petition for Rulemaking, filed September 5, 2007, by 
Alfred Mann Foundation, placed on Public Notice for comment October 
3, 2007, (Report No. 2835; RM-11404) (AMF Petition). See also 
``Investigation of the Spectrum Requirements for Advanced Medical 
Technologies, ET Docket No. 06-135; Amendment of Parts 2 and 95 of 
the Commission's Rules to Establish the Medical Device 
Radiocommunication Service at 401-402 and 405-406 MHz, RM-11271; 
DexCom, Inc., Request for Waiver of the Frequency Monitoring 
Requirements of the Medical Implant Communications Service Rules, ET 
Docket No. 05-213; Biotronik, Inc., Request for Waiver of the 
Frequency Monitoring Requirements of the Medical Implant 
Communications Service Rules, ET Docket No. 03-92, Report and Order, 
adopted March 19, 2009, released March 20, 2009, FCC 09-23. (setting 
forth rules for the MedRadio Service).
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B. Legal Basis

    38. The proposed action is authorized under Sections 4(i), 301, 
302, 303(e), 303(f), 303(r), 304 and 307 of the Communications Act of 
1934, as

[[Page 22496]]

amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), 303(r), 
304 and 307.

C. Description and Estimate of the Number of Small Entities to Which 
the Proposed Rules Will Apply

    39. 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\
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    \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).
    \7\ Small Business Act, 15 U.S.C. 632 (1996).
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    40. 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.
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    \8\ See 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).
    \12\ U.S. Census Bureau, Statistical Abstract of the United 
States: 2006, Section 8, page 272, Table 415.
    \13\ We 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.
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    41. Personal Radio Services. The Medical Device Radio 
Communications Services are being placed within part 95 of our rules 
(``Personal Radio Services''). Personal radio services provide short-
range, 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 definition that might be directly affected by the 
proposed rules.
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    \14\ 47 CFR Part 90.
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    42. The Commission does note, 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--maybe five or so) 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.
    43. 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\
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    \15\ NAICS code 334220.
    \16\ NAICS code 11210.
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    44. 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

[[Page 22497]]

category and size standard, the majority of firms can, again, be 
considered small.
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    \17\ 13 CFR 121.201, NAICS code 517211.
    \18\ 13 CFR 121.201, NAICS code 517212.
    \19\ U.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.''
    \21\ U.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.''
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    45. 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\
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    \23\ With 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).
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D. Description of Projected Reporting, Recordkeeping, and Other 
Compliance Requirements

    46. The Commission seeks comment on whether medical device 
operations in the 413-457 MHz band should be authorized, like other 
medical devices in the MedRadio Service under part 95 of its rules, 
thus providing for license-by-rule operation \26\ pursuant to Section 
307(e) of the Communications Act (Act).\27\ Under this approach, 
medical devices would operate in the band on a shared, non-exclusive 
basis with respect to each other. As the Commission determined when it 
adopted the MedRadio Service rules, it continues to believe that this 
approach minimizes regulatory burdens and facilitates the expeditious 
deployment of new generations of beneficial wireless medical devices 
that can improve the quality of life for countless Americans, thus 
serving the public interest, convenience and necessity.
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    \26\ See 47 CFR 95.401(d).
    \27\ Under Section 307(e) of the Act, the Commission may 
authorize the operation of radio stations by rule without individual 
licenses in certain specified radio services when the Commission 
determines that such authorization serves the public interest, 
convenience, and necessity. The services set forth in this provision 
for which the Commission may authorize operation by rule include: 
(1) The Citizens Band Radio Service, (2) the Radio Control Service, 
(3) the Aviation Radio Service, and (4) the Maritime Radio Service. 
See 47 USC Section 307(e)(1).
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    47. The Commission also seeks comment on whether this license-by-
rule framework would provide the most beneficial approach for MMN 
devices. Would other approaches be preferable? If so, how would those 
alternative approaches be structured, and why? What would be the 
relative benefits and disadvantages compared with the license-by-rule 
approach?
    48. The Commission also seeks comment on various provisions 
regarding equipment certification, authorized locations, station 
identification, station inspection, disclosure policy, labeling 
requirements and marketing limitations that mirror the existing 
MedRadio rules.
    49. The Commission seeks comment on whether to require that 
manufacturers of MMN transmitters include with each transmitting device 
the following disclosure statement: ``This transmitter is authorized by 
rule under the MedRadio Service (47 CFR part 95). This transmitter must 
not cause harmful interference to stations authorized to operate on a 
primary basis in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 
MHz bands, 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 MedRadio Service. Analog 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.'' The Commission seeks 
comment on this language, which mirrors the existing MedRadio 
requirement.
    50. The Commission also seeks comment on whether to require that 
MMN control transmitters be labeled and shall bear the following 
statement in a conspicuous location on the device: ``This device may 
not interfere with stations authorized to operate on a primary basis in 
the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands, and 
must accept any interference received, including interference that may 
cause undesired operation.'' Where a MMN control transmitter is 
constructed in two or more sections connected by wire and marketed 
together, the statement specified in this section would be required to 
be affixed only to the main control unit. It also seeks comment on 
whether to require that MMN implant transmitters be identified with a 
serial number. Under that plan, we would allow the FCC ID number 
associated with the transmitter and the information required by Sec.  
2.925 of the FCC Rules to be placed in the instruction manual for the 
transmitter in lieu of being placed directly on the transmitter.

E. Steps Taken To Minimize Significant Economic Impact on Small 
Entities, and Significant Alternatives Considered

    51. The RFA requires an agency to describe any significant 
alternatives that it has considered in reaching its proposed approach, 
which may include the following four alternatives (among others): (1) 
The establishment of differing compliance or reporting requirements or 
timetables that take into account the resources available to small 
entities; (2) the clarification, consolidation, or simplification of 
compliance or reporting requirements under the rule for small entities; 
(3) the use of performance, rather than design, standards; and (4) an 
exemption from coverage of the rule, or any part thereof, for small 
entities.\28\
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    \28\ See 5 U.S.C. 603(c).
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    52. In this proceeding, the Commission notes that the ``license by 
rule'' approach of the MedRadio service (and the related equipment 
certification, disclosure, and labeling requirements discussed above) 
that it proposes here for MMN operation already afford the benefit of 
minimal regulatory and economic impact on prospective users, including 
small entities. Nevertheless, in this Notice of Proposed Rulemaking, 
the Commission seeks further comment on whether the existing MedRadio 
regulatory framework should be retained, or whether any other 
approaches should be considered.

[[Page 22498]]

F. Federal Rules That May Duplicate, Overlap, or Conflict With the 
Proposed Rule

    53. None.

Ordering Clauses

    54. Pursuant to Sections 4(i), 301, 302, 303(e), 303(f) and 303(r) 
of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 
302, 303(e), 303(f) and 303(r), this Notice of Proposed Rule Making is 
adopted.
    55. The Commission's Consumer and Governmental Affairs Bureau, 
Reference Information Center, shall send a copy of this Notice of 
Proposed Rule Making, including the Initial Regulatory Flexibility 
Analysis to the Chief Counsel for Advocacy of the Small Business 
Administration.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. E9-11066 Filed 5-12-09; 8:45 am]
BILLING CODE 6712-01-P