[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Proposed Rules]
[Page 22491-22498]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my09-18]
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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: http://www.regulations.gov.
Follow the instructions for submitting comments.
Federal Communications Commission's Web Site: http://
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: http://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: http://www.fcc.gov/cgb/ecfs/
or the Federal eRulemaking Portal: http://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