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6 August 2009
[Federal Register: August 6, 2009 (Volume 74, Number 150)]
[Proposed Rules]
[Page 39249-39259]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au09-16]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Parts 2 and 95
[ET Docket No. 08-59; FCC 09-57]
Medical Body Area Network (MBAN)
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
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SUMMARY: In this document the Commission seeks comment on allocating
spectrum and establishing service and technical rules for the operation
of Medical Body Area Network (or MBAN) systems using body sensor
devices. MBAN systems would provide a flexible platform for the
wireless networking of multiple body sensors used for monitoring a
patient's physiological data, primarily in health care facilities. Use
of MBAN systems hold the promise of improved safety, quality, and
efficiency of patient care by reducing or eliminating a wide array of
hardwired, patient-attached cables used by present monitoring
technologies. This Notice of Proposed Rulemaking reflects the
Commission's continuing desire to foster the availability and use of
advanced medical devices using wireless technologies, which, in turn,
should help to improve the health and well-being of the American
public.
DATES: Comments must be filed on or before October 5, 2009, and reply
comments must be filed on or before November 4, 2009.
ADDRESSES: You may submit comments, identified by ET Docket No. 08-59,
by any of the following methods:
[squf] Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
[squf] Federal Communications Commission's Web Site: http://
www.fcc.gov/cgb/ecfs/. Follow the instructions for submitting comments.
[squf] E-mail: [Optional: Include the E-mail address only if you
plan to accept comments from the general public.] Include the docket
number(s) in the subject line of the message.
[squf] 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.]
[[Page 39250]]
[squf] 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.
FOR FURTHER INFORMATION CONTACT: Gary Thayer, Office of Engineering and
Technology, (202) 418-2290, e-mail: Gary.Thayer@fcc.gov, TTY (202) 418-
2989.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Notice
of Proposed Rule Making, ET Docket No. 08-59, FCC 09-57, adopted June
29, 2009, and released June 29, 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 Sec. Sec. 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).
[squf] 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 Web site for submitting
comments.
[squf] 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.
[squf] 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.
[squf] 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.
[squf] 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.
[squf] 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).
Filings and comments are also available for public inspection and
copying during regular business hours at the FCC Reference Information
Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC
20554. They may also be purchased from the Commission's duplicating
contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street,
SW., Room CY-B402, Washington, DC 20554, telephone: (202) 488-5300,
fax: (202) 488-5563, or via e-mail http://www.bcpiweb.com.
Summary of Notice of Proposed Rulemaking
1. In the Notice of Proposed Rulemaking (NPRM), the Commission
seeks comment on allocating spectrum and establishing service and
technical rules for the operation of Medical Body Area Network (or
MBAN) systems using body sensor devices. The NPRM reflects the
Commission's continuing efforts to foster the availability and use of
advanced medical devices using wireless technologies which, in turn,
should help to improve the health and well-being of the American
public.
2. MBAN systems, as contemplated by the NPRM, could provide a
flexible platform for the wireless networking of multiple body sensors
used for monitoring a patient's physiological data, primarily in health
care facilities as well as in other health care monitoring situations.
Use of MBAN systems hold the promise of improved safety, quality, and
efficiency of patient care by reducing or eliminating a wide array of
hardwired, patient-attached cables used by present monitoring
technologies.
3. Given these significant health care benefits offered by MBAN
systems, the Commission tentatively concludes that providing spectrum
for MBAN operations would serve the public interest.
4. Against this backdrop, the Commission addresses a petition filed
by GE Healthcare (hereinafter the ``GEHC petition'') to allocate up to
40 megahertz of spectrum in the 2360-2400 MHz band, which is used on a
primary basis by Federal and non-Federal Aeronautical Mobile Telemetry
(AMT), Federal Radiolocation, and non-Federal Amateur services. In
addition, the Commission seeks comment on an alternative recommendation
by the Aerospace and Flight Test Radio Coordinating Council (AFTRCC) to
accommodate MBAN operations in the 2300-2305 MHz and 2395-2400 MHz
bands. Finally, the Commission seeks comment on whether other bands
such as the 2400-2483.5 MHz or 5150-5250 MHz bands could be used to
support MBAN operations.
5. The Commission also addresses several spectrum compatibility
concerns with respect to incumbent operations in accommodating MBAN
operations. Thus, the Commission seeks comment on the potential for
interference caused either to incumbents, or to MBAN systems, and how
any such concerns might be mitigated. In addition, the Commission seeks
comment more generally on whether allocating spectrum and establishing
rules to allow
[[Page 39251]]
the operation of MBAN systems for the purposes described herein would
serve the public interest.
6. Finally, the Commission seeks comment on what licensing
approaches would be appropriate for MBAN operations in the various
frequency bands under consideration, as well as service and technical
rules for MBAN operation. This includes a discussion of whether MBANs
should be authorized on a licensed basis under part 95, a ``licensing-
lite'' approach under part 90, or an unlicensed basis under part 15.
The tentative service and technical rules discussed in the NPRM follow
the general framework of the recently adopted rules for the MedRadio
Service.
A. Frequency Allocation
1. 2300-2305 MHz and 2360-2400 MHz Frequency Bands
7. The Commission seeks comment on whether to allow MBAN operations
on up to 40 megahertz of spectrum in the 2360-2400 MHz band on a
secondary basis. This option reflects the initial recommendation set
forth in the GEHC petition. In this context, the Commission recognizes
the necessity of affording interference protection to incumbent primary
users, particularly AMT operations. In addition, the NPRM considers the
potential for interference to MBAN devices and the attendant risk to
patients using MBAN systems.
8. The Commission also seeks additional comment on the amount of
spectrum required to support MBAN operations, and what factors
(including the number and types of incumbent users) should be taken
into account in determining the amount of spectrum required.
9. Regarding the potential for interference from MBAN devices to
incumbent operations, the Commission seeks comment on whether the
potential for sharing between MBAN systems and incumbent AMT and
radiolocation operations could be facilitated if geographic exclusion
zones were to be established around AMT test flight sites in the 2360-
2395 MHz band to protect those sites from harmful interference. In
addition to or in lieu of exclusion zones, MBAN operators and AMT
licensees may be able to coordinate their operations. The Commission
further observes in the NPRM that sharing between MBAN systems and
incumbents AMT and radiolocation operations could be facilitated if
MBAN operations in the 2360-2390 MHz band, which is allocated for AMT
operations, are limited to indoor use within health care facilities as
defined in the WMTS. The Commission believes that this requirement
would limit the incidence of MBAN operations and effectively reduce the
likelihood that they would occur near AMT flight test sites. Because
MBAN systems would be used indoors, building structures would attenuate
MBAN signals and further reduce the likelihood of interference to AMT.
Thus, the Commission seeks comment on whether permitting MBAN systems
to operate in the 2360-2395 MHz band under the limitations proposed
would provide interference protection to incumbent users.
10. Regarding interference from AMT to MBAN operations, the
Commission seeks comment on whether MBAN devices could avoid receiving
interference from AMT or other incumbent users by employing a
contention-based protocol or some other techniques. In this regard, the
Commission seeks comment on whether transmissions from incumbent
stations, as well as flight test stations using future technologies
(which might include the use of high-power, omnidirectional uplink and
downlink transmissions) could adversely affect the operation of MBAN
devices--possibly resulting in adverse effects to patients.
11. To address recommendations made in comments filed by AFTRCC,
the Commission seeks comment on limiting MBAN operations to the 2300-
2305 MHz and 2395-2400 MHz bands. It specifically seeks comment on the
ability of MBAN devices to utilize these two blocks of spectrum that
are separated by 90 megahertz. The Commission also seeks comment on
whether it should consider a secondary allocation for MBAN operations
in these two bands, or if allocating these bands on a primary basis
would allow MBAN devices to more effectively use the spectrum since
they would not have to avoid AMT users. The Commission seeks comment as
to whether MBAN operations can exist compatibly with the incumbent
Amateur service users in the 2300-2305 MHz and 2390-2400 MHz bands. The
Commission further seeks comment as to whether, in the 2390-2395 MHz
band it should consider allowing MBAN and AMT operations to operate on
a co-primary basis and what the sharing rules between them should be.
Additionally, the Commission seeks comment on whether any additional
MBAN spectrum would be needed if it were to reallocate the 2390-2395
MHz band to remove the AMT allocation in order to provide a total of up
to 15 megahertz of spectrum for use by MBAN operations on a primary
basis.
12. To the extent that MBAN operation might ultimately be
authorized in any portion of the 2300-2305 MHz or 2360-2400 MHz bands,
the Commission proposes including a new U.S. footnote to the Table of
Allocations in part 2 of the rules for the specific band. The
Commission would also require that MBANs not cause harmful interference
to and accept interference from Federal and non-Federal stations
operating in accordance with the Table of Frequency Allocations. The
Commission seeks comment on this approach.
2. 2400-2483.5 MHz Frequency Band
13. The Commission seeks comment on whether MBAN devices could
operate in the 2400-2483.5 MHz band. The 2400-2483.5 MHz band is used
by Industrial, Scientific and Medical (ISM) equipment operating under
part 18 of the Commission's rules. Any equipment or services operating
in ISM bands are obliged to accept interference from ISM equipment. In
its petition, GEHC has asserted that manufacturers could leverage
available technology used for ISM equipment in this band to develop
low-cost MBAN devices.
14. In addition to present use by ISM, the Commission observes that
various radio services are also allocated in this band. Among these,
the 2400-2417 MHz band is allocated to the Amateur service on a primary
basis. The 2417-2450 MHz band is allocated to the Amateur service on a
secondary basis, and to the Federal radiolocation service on a
secondary basis. Such Federal operations may be authorized on a non-
interference basis, but may not constrain the implementation of any
non-Federal operations. The 2450-2483.5 MHz band is allocated to the
non-Federal fixed and mobile services on a primary basis, and to the
non-Federal radiolocation service on a secondary basis. The Federal
radiolocation service is also permitted in this band on condition that
harmful interference is not caused to non-Federal services. The 2400-
2483.5 MHz band is also used by unlicensed devices operating under Part
15 of the Commission's Rules. These unlicensed devices include WiFi,
cordless phones, and Bluetooth, among various other types of uses.
15. The Commission seeks comment on whether the widespread success
of the unlicensed devices described in the preceding paragraph would
provide manufacturers the opportunity to leverage these technologies
for the development of low cost MBAN devices within the 2400-2483.5 MHz
band. More particularly, the Commission seeks comment as to whether
MBAN devices could be certified and operate under the current part 15
rules, whether
[[Page 39252]]
a new subpart under part 15 might be required, or whether it should
consider licensed operation of MBAN devices under part 95 of the
Commission's rules. If it is determined that licensed operation is
appropriate, would the technical and service rules discussed for the
2360-2400 MHz band be applicable for MBAN operation in the 2400-2483.5
MHz band? If not, what technical and service rules would apply? What
amount of bandwidth would MBAN devices require to operate in this band
and in what portion of the band would they operate? The Commission also
seeks comment regarding whether MBAN operations can exist compatibly
with the incumbent Amateur service users who operate in this band.
16. The Commission also cautions that any MBAN equipment operating
in these bands would have no protection from interference from ISM
equipment operating under part 18 of the rules or other low power
transmitters operating under part 15 of the rules. The Commission seeks
information as to whether the ISM bands are still used by medical
telemetry devices, and comment as to whether MBAN operations would fit
within this category of use.
3. Other Frequency Bands
17. The Commission seeks comment on whether there are other
frequency bands where MBAN manufacturers could leverage existing
technologies to implement such devices and achieve economies of scale.
For example, the Commission seeks comment on whether the 5150-5250 MHz
band offers similar opportunities for MBAN operation as may be
achievable in or near the 2400 MHz band as described. The 5150-5250 MHz
band is allocated to the Federal and non-Federal aeronautical
radionavigation service. The band is also allocated to the non-Federal
fixed-satellite service. In addition to these allocated services, the
band is also used by unlicensed national information infrastructure (U-
NII) devices operating under subpart E of the Commission's part 15
rules.
18. U-NII devices use digital modulation techniques and provide a
wide array of high data rate mobile and fixed communications
applications. U-NII devices operating in the 5250-5350 MHz and 5470-
5725 MHz bands must employ Dynamic Frequency Selection (DFS) to avoid
operating on the same channels as radars. However, the 5150-5250 MHz
band does not require DFS and is limited to indoor operation only,
which would appear to be consistent with GEHC's proposed MBAN devices.
19. With respect to the 5150-5250 MHz band, the Commission seeks
comment as to whether MBAN devices could be certified and operate under
the current part 15 rules, whether a new subpart under part 15 might be
required, or whether it should consider licensed operation of MBAN
devices under part 95 of the Commission's rules. If it is determined
that licensed operation is appropriate, would the technical and service
rules discussed below for the 2360-2400 MHz band be applicable for MBAN
operation in the 5150-5250 MHz band? If not, what technical and service
rules would apply? What amount of bandwidth would MBAN devices require
to operate in this band and in what portion of the band would they
operate? Can MBAN devices operate compatibly with the incumbent
services in the 5150-5250 MHz band? Should MBAN operations be limited
to indoor locations, similar to the indoor restriction to U-NII devices
in Sec. 15.407(e)?
B. Service and Technical Rules
20. The tentative rules discussed in the NPRM focus upon the
overall framework of the MedRadio Service in part 95, but with modified
power and emission bandwidth requirements to accommodate the
anticipated bandwidth and EIRP needs of MBAN operations that might
apply in the 2360-2400 MHz band. At the same time, the Commission seeks
comment on other approaches, such as under part 90 or part 15, that
might be feasible. The Commission takes this approach in the NPRM
because the 2360-2400 MHz band was specifically addressed in the GEHC
petition and in both the comments and reply comments, The Commission
notes that, in any event, similar rules would also be required if MBAN
operations were to be authorized in either the 2400-2483.5 MHz or the
5150-5250 MHz bands under consideration.
1. Service Rules
21. Licensing. The Commission seeks comment on whether medical
device operations should be authorized in part 95 of our rules, thus
providing for license-by-rule operation pursuant to Section 307(e) of
the Communications Act (Act). Under this approach, medical devices
would operate in the band on a shared, non-exclusive basis with respect
to each other and without the need for MBAN systems to be individually
licensed. As the Commission determined when it adopted the MedRadio
Service rules, 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. The Commission seeks comment on whether the rules for MBANs
should be included in subpart I of part 95, which authorizes the
MedRadio Service, or whether the rules for MBANs should be included in
a new subpart under part 95.
22. Alternatively, the Commission seeks comment on whether MBAN
operations should be licensed on a non-exclusive basis under part 90.
In this context, the Commission also seeks comment on whether it would
be feasible to establish geographic exclusion zones around AMT
operational areas as an interference avoidance mechanism. At the same
time, the Commission seeks comment on whether the use of such exclusion
zones could frustrate the widespread use of MBAN devices--particularly,
for example, if such exclusion zones were so large as to encompass
major metropolitan areas where MBAN operations might be prohibited. As
discussed elsewhere in the NPRM, frequency coordination also could
facilitate sharing between the incumbent operations and MBAN devices.
Frequency coordination is required for WMTS operations authorized under
part 95, but does not involve as many sites as could be required for
MBAN and AMT coordination. Another licensing approach that the
Commission would consider for MBAN operation that includes coordination
is non-exclusive licensing under part 90. Under that approach, MBAN
operations would be licensed on a non-exclusive basis with respect to
each other for ten year license terms. The Commission seeks comment on
whether it should consider using the same approach here as it does with
wireless broadband services in the 3650-3700 MHz band, i.e., eligible
entities would apply for non-exclusive nationwide licenses and
subsequently register individual stations with the Commission. If the
Commission were to adopt this approach, should it require that
licensees register each individual MBAN system or, alternatively,
require them to register the individual health care facility at which
the licensee would be allowed to operate multiple MBAN systems? What
type of licensing and registration information for MBAN operations
would facilitate coordination with incumbent services? What would be
the relative benefits and disadvantages of licensing under part 90
[[Page 39253]]
compared with the license-by-rule approach under part 95?
23. Definitions. The Commission seeks comment on the definitions to
apply to MBAN systems and body sensor devices. Because MBAN systems may
be comprised of sensors that perform not only monitoring functions but
also diagnostic and therapeutic functions, definitions for MBAN and
body sensor networks should be consistent with definitions already in
the Commission's part 95 rules for wireless medical telemetry and body-
worn devices. The Commission seeks comment on the following proposed
definitions:
Medical body area device--a medical sensing device that is
placed on or in close proximity to the human body for the purpose of
measuring and recording physiological parameters and other patient
information or performing diagnostic or therapeutic functions via
radiated bi- or unidirectional electromagnetic signals. These devices
may only communicate as part of a medical body area network.
Medical body area network (MBAN)--a low-power independent
network comprised of multiple medical body area devices that transmit
or receive either non-voice medical data of a patient or related device
control commands. Transmissions to and from these multiple medical body
area devices are routed through a hub, which is placed on or in close
proximity to the patient's body, and which may communicate with a
remote monitoring location.
MBAN transmitter--A transmitter that operates as part of a
Medical Body Area Network, and is located either on the human body or
in close proximity to it.
MBAN control transmitter--A MBAN transmitter, which is
designed to be placed on or in close proximity to the patient's body,
that serves as a hub to control and coordinate communications with body
area devices, and which may also communicate with a remote monitoring
location.
24. The Commission requests comment as to whether these definitions
would be too broad or too narrow and whether alternative definitions
should be used. The Commission asks whether other components of
wireless MBAN systems should also be identified and defined. The
Commission is not proposing to include medical implant devices as part
of MBAN systems, although it recognizes that such devices could be used
for monitoring, diagnostic or therapeutic purposes. Parties that
believe medical implant devices should be allowed as part of MBAN
operations should address how such devices would co-exist with body
sensor devices and the technical rules that would apply to their
operation. The Commission also seeks comment on whether any other
current definitions included in the MedRadio Service rules need to be
modified to accommodate wireless MBAN devices.
25. Permissible Communications and Operator Eligibility. The
Commission proposes to establish requirements for permissible
communications and operator eligibility that are generally the same as
those in place for the MedRadio Service. The MedRadio rules provide
that a MedRadio 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. The Commission expects, based on
representations made in the GEHC petition, that wireless body sensor
devices configured as a MBAN would be used primarily for monitoring
patient data. The Commission believes it would be prudent to provide
flexibility so that MBAN systems can also be used for performing
diagnostic or therapeutic functions. The Commission seeks comment on
whether these requirements would be appropriate for MBAN operations.
26. In the MedRadio proceeding, the Commission declined to
explicitly limit the use of some frequencies to life-critical and time-
sensitive applications, as the comments of some parties suggested,
while allowing other frequencies to be used for non-life-critical, non-
time sensitive applications. The Commission concluded that the ultimate
decision on which frequency band to use for each type of application
was best left to health care professionals and medical device
manufacturers, in concert with FDA-required risk management processes,
as it would result in better and more flexible use of this scarce
spectrum resource. The Commission seeks comment on whether a similar
approach is appropriate for MBAN devices--i.e., permitting health care
professionals and medical device manufacturers, in concert with FDA-
required risk management processes, to decide whether MBAN devices
should be used for life-critical and time-sensitive applications even
though these devices would not receive interference protection from
radiocommunication services with a higher allocation status. Commenters
who believe that the Commission should not allow MBAN devices for life-
critical and time-sensitive applications should suggest how the
Commission should define these terms and types of applications.
27. The Commission also notes that the current MedRadio Service
rules do not allow programmer/control transmitters to relay information
to a receiver that is not included with a MedRadio implant or body-worn
device. However, the MedRadio Service rules do allow programmer/control
transmitters to be interconnected with other telecommunications systems
including the public switched telephone network. The Commission seeks
comment on whether, and if so why, similar requirements should also
apply here. The Commission also seeks comment on how spectrum might be
used to perform backhaul from a single patient-based MBAN control
transmitter to a monitoring station that receives and processes MBAN
body sensor data from multiple patients and what spectrum should be
used for that purpose.
28. The Commission seeks comment on whether communications between
MBAN body sensors, or other intra-MBAN network communications, should
be allowed, and whether there should be a requirement that each
external MBAN control transmitter be limited to controlling the body
sensor transmitters for a single patient. Alternatively, the Commission
asks whether it should permit groups of MBAN body sensors for multiple
patients to be coordinated by one central MBAN control transmitter and
if so, whether any special protocols or other requirements should be
applied to such communications.
2. Technical Rules
29. Channelization. The Commission seeks comment on adopting rules
for MBAN operations that do not specify a particular channeling plan,
thereby following the general approach used with the MedRadio Service.
Under this approach, the ``channel'' occupied by a MBAN transmitter or
transmission would be loosely defined as any continuous segment of
spectrum that is equal to the largest bandwidth used by any MBAN
transmitter that participates in a given single patient MBAN
communications session. In this context, a MBAN ``communication
session'' would be defined (analogous to the definition of a MedRadio
communication session) as a collection of transmissions that may or may
not be continuous and that take place between two or more MBAN devices
in a single patient network.
30. One benefit of this approach would be that networked MBAN
devices could transmit on any center frequency
[[Page 39254]]
within the MBAN band so long as the maximum emission bandwidth, out-of-
band, and spurious emission limits adopted herein are met. This
approach would also afford the flexibility for MBAN devices to
subdivide the authorized frequency band(s) into ad-hoc device
``channels'' that could be tailored by manufacturers to meet device-
specific spectrum requirements for a variety of medical monitoring,
diagnostic and therapeutic functions. The Commission seeks comment on
whether to apply the MedRadio approach of specifying only the maximum
permitted bandwidth, but not any particular channel plan, with respect
to MBAN devices in their authorized frequency band(s). In particular,
the Commission seeks comment on whether the potential benefits
described above might be outweighed by an increased risk of adverse
mutual interactions between multiple MBAN devices or MBAN devices and
incumbent users using differing center frequencies and bandwidths and
whether there are other factors that should be considered under this
option.
31. Alternatively, the Commission seeks comment on whether a
specific channeling plan would be needed. If so, what form might it
take and what are the advantages that it would obtain over the proposed
approach?
32. Exclusion Zones. The Commission recognizes that the current
record contains conflicting information relating to the appropriate
models to be used for evaluating the potential for interference to AMT
operations from MBAN devices and establishing the size of exclusion
zones to protect those operations. Therefore, the Commission seeks
comment on the feasibility of using exclusion zones as a means to
prevent interference to incumbent operations in the 2360-2390 MHz band
and, if exclusion zones are to be used, the appropriate radius to use
for such exclusion zones. The Commission states that it is not
convinced at this time that either the GEHC or AFTRCC analysis is
appropriate for determining interference potential and the utility or
size of exclusion zones. Thus, the Commission seeks comment on the
analytic methodology that should be used and the assumptions that
should be employed, including the methodologies and analyses used by
AFTRCC and GEHC for determining an exclusion zone radius. The
Commission also invites comment on other methodologies and analyses,
including assumptions on which they rely, that could be used. The
Commission also seeks comment on whether it is appropriate to use
either interference criteria described herein, which are primarily
intended for satellite and terrestrial sharing in the adjacent
frequency band, for AMT and MBAN operations and invite suggestions for
alternative approaches for determining the radius of potential
exclusion zones. The Commission provides in Appendix A of the NPRM
additional parameters for MBAN and AMT systems that parties should
address, as appropriate, to support further technical analyses.
33. The Commission also seeks comment on whether exclusion zones
could always preclude operation of MBAN devices at some locations. If
so, would it be in the public interest to preclude these technologies
from certain health care facilities based on their location? Or should
health care facilities located within an exclusion zone be permitted to
coordinate MBAN use with AMT operations in that zone?
34. If exclusion zones were to be established, what criteria should
be used to identify those AMT sites in need of protection? Should only
AMT test sites that now actually use the 2360-2390 MHz band be
protected, or also those test sites that do not presently use the band
but might prospectively do so? If protection were to be required of
sites that AFTRCC claims are ``entitled'' to, but do not currently use
the 2360-2390 MHz band, how would the sites which are ``entitled'' to
be protected be determined? Once existing test sites were determined,
how would future test sites be protected if MBAN devices are already
operating within the area that will be designated as a new exclusion
zone? With respect to making these determinations, the NPRM notes that
the Commission (for non-Federal users) and NTIA (for Federal users)
maintain separate data bases containing geographic location and
frequency information on users authorized to operate transmitters
throughout the radio spectrum. Thus, if an exclusion zone approach
permitting MBAN operation were to be adopted, the Commission would
anticipate relying, to the extent possible, upon the information
contained in the relevant Commission and NTIA data bases as a baseline
for identifying facilities that require protection. If the Commission
ultimately decides to protect sites that are not currently licensed to
use the 2360-2390 MHz band, how would information on exclusion zones be
accurately maintained and timely updated in the Commission's rules? The
Commission seeks comment on these matters.
35. The NPRM seeks comment on whether the distance for MBAN
operations should be measured from the specified center point that
establishes the incumbent's area of operation or whether it should be
measured from the edge of that area? How should incumbent sites be
accounted for that are in close proximity to each other such that their
areas of operation may overlap each other? Should further information
be collected about incumbent operational locations and how should it be
gathered? Regarding information about Federal sites, the Commission
notes that it would intend to consult with NTIA about how to identify
this information and make it available. The Commission also seeks
comment on how it should account for future installations if a
healthcare facility that is using MBANs is located in an area that
would become part of an exclusion zone for the new site.
36. Frequency Coordination. With respect to protecting AMT
operations from MBAN interference in portions of the 2360-2400 MHz
band, the Commission recognizes that coordination may be useful because
MBAN operations might otherwise be excluded from large geographic areas
that encompass medical facilities. In such cases coordination would
provide a means for the parties to work together on some type of
sharing arrangement for given locations. Thus, the Commission seeks
comment on whether coordination of MBAN systems is needed and should be
required and, if so, under what circumstances. The Commission also
seeks comment on whether it should require AMT or other incumbent
licensees to participate in frequency coordination with operators of
MBAN systems in any portions of the band. If so, what approaches would
be feasible, and what parties would be responsible for ensuring that
such coordination takes place?
37. For example, the Commission acknowledges the suggestion made in
the GEHC petition that the Commission could require frequency
coordination and device registration for MBAN operations such as is
used for coordination of WMTS operation. There, the Commission
designated a private entity to serve as the WMTS frequency coordinator
and that entity maintains a database of all WMTS equipment in
operation.
38. However, in the case of MBAN systems, users may not need to
coordinate their operations among themselves as do WMTS users,
particularly if MBAN devices ultimately rely on a contention-based
protocol as discussed below to promote intra-service sharing. Regarding
coordination of MBAN operations with incumbent
[[Page 39255]]
users, the Commission also notes that MBAN devices would operate on a
secondary basis, and a significantly large number of primary users must
be accorded interference protection. Thus, the Commission seeks comment
on whether the WMTS model would be feasible here. Parties supporting
this approach should address what criteria would be used to determine
if a MBAN system could operate without causing interference, what type
of information should be contained in a database, who would have access
to the database and on what terms, and how the Commission would
designate a database administrator.
39. Alternatively, the Commission could license MBAN operations on
a non-exclusive basis under part 90, and would be responsible for
facilitating coordination. For example, licensees in the Wireless
Broadband Service in the 3650-3700 MHz band are permitted to operate
anywhere outside of specified 150 km protection zones around incumbent
non-Federal primary earth station facilities. Those wishing to operate
within the protection zones must negotiate with the affected incumbents
directly. To ensure compatibility with Federal stations, the Commission
coordinates operations with NTIA through the Frequency Assignment
Subcommittee of the Interdepartment Radio Advisory Committee for any
station that requests registration of a site closer than 80 km from
three specified radio location sites. The Commission further notes that
our Universal Licensing System has the capability of screening for any
terrestrial applications that might propose site coordinates located
within the 80 km coordination zone and flag that application for any
necessary coordination.
40. The Commission notes that, in the present case proposed by
GEHC, the circumstances under which Federal and non-Federal AMT
spectrum use is coordinated is substantially different than those at
3650-3700 MHz. AFTRCC is the designated coordinator of all non-Federal
AMT use, and is recognized as such by both the Commission and NTIA.
Consequently, any Federal and non-Federal use of the 2360-2395 MHz band
is referred to AFTRCC and coordination with them must be completed
prior to operation. In addition, the Commission coordinates non-Federal
use of this spectrum with NTIA. If the Commission were to follow this
approach, any MBAN operation in the 2360-2395 MHz band segment would be
referred to AFTRCC and to NTIA, which might delay deployment. At the
same time, because the Commission would have the licensing and
coordination information readily available, it could intercede in
resolving disagreements more easily, as needed. Regarding spectrum
sharing among MBAN operations, coordination under a non-exclusive
licensing scheme does not appear to provide any additional benefits
compared to the WMTS model. The Commission seeks comment on whether
such an approach would be feasible here. Commenters should address the
relative advantages and disadvantages of the approaches they support.
41. Frequency Monitoring (Contention-based Spectrum Access
Protocols). The Commission recognizes that low power operation and
spread spectrum or similar technology may enable MBAN devices to
operate in very close proximity to one another without any mutual
interference and mitigate the potential for one body sensor network to
block another's access to the spectrum. The Commission also notes that
GEHC claims that contention protocols could be applied as a way for
MBAN devices to successfully coexist within the band, and also as a way
to protect MBAN devices from interference from the primary AMT systems.
The Commission invites comment on these observations and whether any
rules should be adopted to ensure such sharing. In particular, it seeks
comment on whether a contention-based protocol should be applied to
MBAN transmitting devices, and if so, how such a protocol might be
developed. If the Commission were to adopt a requirement for a
contention-based protocol, it invites comment as to whether it should
rely upon the general definition of contention-based protocol recently
adopted by the Commission for the operation of wireless devices under
part 90 of the rules in the 3650 MHz band, which 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.''
42. The Commission encourages commenters supporting implementation
of a contention-based protocol to discuss what kinds of contention
protocols should or should not be utilized, and to explain in detail
why or why not. How should such protocols be defined? Should the
protocol be open-source or proprietary? Should 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?
43. Transmitter Power, Emission Bandwidth, and Duty Cycle. As
recommended by GEHC, the Commission would limit individual MBAN devices
to a maximum transmit power of 1 mW equivalent isotropic radiated power
(EIRP) measured in a 1 megahertz bandwidth, and a maximum emission
bandwidth of 1 megahertz. In explaining this recommendation, GEHC
indicates that, as presently conceived, a typical MBAN system would be
comprised of a single network per patient/person with a gateway-hub
device coordinating transmissions from multiple body worn sensors. It
estimates that the suggested power and bandwidth limits would be
sufficient to allow short burst messaging, which in turn would
facilitate low power consumption from duty cycles less than 25 percent.
44. While GEHC emphasizes the use of MBAN systems for monitoring
patient physiological data, the Commission recognizes that the
definition that it proposed for MBAN systems would also allow the
operation of two or more networked medical devices to perform
diagnostic and therapeutic functions. The Commission seeks comment on
whether the power/bandwidth limits proposed above--which reflect GEHC's
recommendations--would be appropriate for such other purposes. The
Commission specifically asks whether another combination of power and
duty cycle limits would provide a better balance between affording
interference protection to incumbent users and achieving sufficiently
reliable MBAN system performance. The Commission requests that
commenters suggesting other bandwidths should fully discuss their
relative benefits and potential disadvantages in light of the
considerations discussed herein. With respect to transmitter duty
cycles, the Commission seeks comment on whether GEHC's assumption of a
25 percent factor adequately characterizes operations that would be
expected from real-world devices. For example, would the duty factor of
MBAN transmitters used for diagnostic or therapeutic purposes, instead
of patient monitoring, be more likely to require higher, lower,
[[Page 39256]]
or the approximately the same duty cycles and, if so, should this be
accounted for in the maximum duty cycle specification? What would be
the relative advantages or disadvantages of specifying versus not
specifying specific duty cycle limits for MBAN transmitters in the
rules? Is a duty cycle limit needed to allow the functioning of a
contention-based spectrum access protocol and, if so, what is the
maximum duty cycle that should be allowed in order to support such a
protocol? Should the duty cycle apply to individual MBAN transmitters,
whether located in a medical body area device or the MBAN control
transmitter, or to the aggregate duty cycle of all transmitters
comprising an MBAN, as the terms are proposed to be defined above?
45. Channel aggregation. To the extent that device manufacturers
might wish to aggregate multiple transmission channels in a single
device, the Commission seeks comment on requiring only that the total
emission bandwidth used by all devices in any single patient MBAN
communication session not exceed the maximum authorized bandwidth of 1
megahertz. Thus, for example, a single MBAN body sensor could be
designed to operate nominally on two channels, each occupying up to 500
kHz (i.e., one-half the maximum authorized emission). In essence, this
would also carry forward the existing channel use provisions of the
MedRadio Service. As an additional example, the Commission further
notes that this provision would not preclude full duplex or half duplex
communications; provided that the total amount of bandwidth utilized by
all of the channels employed by collection of a single patient,
networked MBAN devices during a communications session does not exceed
the maximum authorized 1 megahertz emission bandwidth. The Commission
also requests comment on allowing any lesser emission bandwidths to be
employed so long as the device complies with all other EIRP and
unwanted emission limits. The Commission seeks comment on all of these
issues.
46. Unwanted emissions. The MedRadio rules under part 95 set forth
limits on unwanted emissions from medical transmitting devices
operating in the 401-406 MHz band. Those provisions include limits on
both in-band and out-of-band radiation. Specifically, emissions on
frequencies 500 kHz or less above or below any particular authorized
bandwidth [are] required to be attenuated by at least 20 dB below the
transmitter output power. In addition, emissions more than 500 kHz
above or below any particular authorized bandwidth [are] required to be
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 appropriateness
of applying the same general limits on MBAN operations in the 2300-2305
MHz and 2360-2400 MHz bands. If parties suggest other out-of-band
emission limits for devices operating in this band, they should provide
sufficient technical justification to support those limits. Under any
approach, the Commission seeks to provide an RF environment that would
be adequate to protect incumbent operations while fostering efficient
spectrum use by MBAN devices.
47. Frequency stability. Following the MedRadio rules, the
Commission would require that MBAN transmitters 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 MBAN transmitters; and (2) 0
[deg]C to 55 [deg]C in the case of MBAN control transmitters. The
Commission seeks comment on these stability criteria.
48. Antenna locations. The Commission seeks comment on whether it
would be appropriate to restrict the use of MBAN transmitting antennas
to indoor locations in certain frequency bands. For example, in light
of the concerns discussed above regarding the interference potential
between AMT and MBAN systems, should MBAN operations that might be
permitted in the 2360-2390 MHz band be limited to indoor use (within
healthcare facilities)? This would be similar to the WMTS approach
noted herein, where transmitting antennas are restricted to indoor
locations only. Alternatively, would it be more practical in other
frequency bands to follow the approach of the present MedRadio rules by
which temporary outdoor antennas are permitted? The Commission invites
commenters to address the relative advantages and disadvantages of
either approach for MBAN use in any of the frequency bands under
consideration in this proceeding.
49. RF safety. The Commission notes that portable devices are
subject to Sec. 2.1093 of the rules, pursuant to which an
environmental assessment must be prepared under Sec. 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. The Commission further
notes, however, that in our ongoing RF safety proceeding (ET Docket No.
03-137) it anticipates dealing with proposed changes in our rules
regarding human exposure to RF electromagnetic fields in a more
comprehensive fashion. Thus, for the purposes of the instant proceeding
and the Commission's pending action in the RF safety proceeding in ET
Docket No. 03-137, the Commission only seeks comment here on whether
MBAN transmitters should be deemed as portable devices subject to
Sec. Sec. 2.1093 and 1.1307 of the Commission's existing rules. To the
extent that MBAN devices are deemed portable devices, they would then
be subject to our RF exposure rules for such devices.
50. Miscellaneous provisions. The Commission also seeks comment on
various rule provisions regarding equipment certification, authorized
locations, station identification, station inspection, disclosure
policy, labeling requirements and marketing limitations that mirror the
existing MedRadio rules.
51. First, the Commission seeks comment on whether it should
require that each authorized MBAN transmitter 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.
52. The Commission also seeks comment on whether to specifically
require that all non-implanted MBAN transmitter apparatus be made
available for inspection upon request by an authorized FCC
representative. Under such a provision, persons operating MBAN
transmitters would be required to cooperate reasonably with duly
authorized FCC representatives in the resolution of interference.
53. The Commission request comment on requiring that manufacturers
of MBAN transmitters include an appropriate disclosure statement
analogous to that for MedRadio transmitters with each MBAN transmitting
device. Such a statement would disclose the provision of the rules
under which the device is authorized, along with a statement that the
transmitter must not cause harmful interference to stations authorized
to operate on a primary basis in the band, and must accept interference
that may be caused by such stations, including interference that may
cause undesired operation. Such a statement would also indicate that
the transmitter shall be used only in accordance with the FCC rules,
and that analog and digital voice communications are prohibited. The
[[Page 39257]]
Commission seeks comment on this proposal.
54. The Commission further seeks comment on whether to require that
MBAN control transmitters (if allocated on a secondary basis) be
labeled and 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 and must accept any interference received,
including interference that may cause undesired operation.'' Where a
MBAN 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 MBAN
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.
55. Finally, with respect to marketing limitations, the Commission
seeks comment on whether it should specify that MBAN transmitters may
be marketed and sold only for those permissible uses described in the
NPRM.
C. Other Matters and Conclusion
56. As noted in the Background discussion of the NPRM, BSI
(Broadcast Sports, Inc.) filed comments in which it proposes an ``Event
Radio Service'' as an alternative to the GEHC proposal for use of the
2360-2400 MHz band. The Commission finds that BSI has not provided
sufficient clarity to consider such an allocation or related service
rules. On its face, the BSI proposal appears to be intended to preserve
the ability to obtain access to additional spectrum for video coverage
of sports events that can already be obtained under STAs. There is no
evidence, however, to support the proposition that an allocation for
MBANS would constrain the ability to obtain STAs for video coverage of
sports events. Moreover, special temporary authority is precisely the
proper instrument for authorizing temporary operations at specific
locations. Furthermore, the Commission is not persuaded that an
allocation of spectrum and service rules limited to video coverage of
sports events represents the most efficient use of this spectrum nor
best serves the public interest as compared with devices that may have
significant benefits for health care. Accordingly, the Commission
declines to propose BSI's alternative allocation for an Event Radio
service.
57. The Commission seeks comment on all of the matters discussed in
this NPRM, and encourages commenters to address any other relevant
matters of concern that might serve to illuminate the record in this
proceeding.
Initial Regulatory Flexibility Analysis
58. 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 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 et seq., has
been amended by the Contract With America Advancement Act of 1996,
Public Law No. 104-121, 110 Stat. 847 (1996) (CWAAA). Title II of
the CWAAA is the Small Business Regulatory Enforcement Fairness Act
of 1996 (SBREFA).
\2\ See 5 U.S.C. 603(a).
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A. Need for, and Objectives of, the Proposed Rules
59. The Commission seeks comment on the feasibility of allocating
spectrum for the operation of Medical Body Area Network (or MBAN)
systems using body sensor devices. Under the service and technical
rules proposed herein, the Commission envisions that MBAN systems could
provide a flexible platform for the wireless networking of multiple
body sensors used for monitoring physiological patient data in health
care facilities. Use of MBAN systems should result in improved safety,
quality, and efficiency of patient care by reducing or eliminating a
wide array of hardwired, patient-attached cables used by present
monitoring technologies.
B. Legal Basis
60. 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 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 Would Apply
61. 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.\3\ The RFA generally
defines the term ``small entity'' as having the same meaning as the
terms ``small business,'' ``small organization,'' and ``small
governmental jurisdiction.'' \4\ In addition, the term ``small
business'' has the same meaning as the term ``small business concern''
under the Small Business Act.\5\ 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.\6\
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\3\ 5 U.S.C. 603(b)(3).
\4\ 5 U.S.C. 601(6).
\5\ 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).
\6\ Small Business Act, 15 U.S.C. 632 (1996).
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62. Nationwide, there are a total of approximately 27.2 million
small businesses, according to the SBA.\7\ A ``small organization'' is
generally ``any not-for-profit enterprise which is independently owned
and operated and is not dominant in its field.'' \8\ Nationwide, as of
2002, there were approximately 1.6 million small organizations.\9\ 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.''
\10\ Census Bureau data for 2002 indicate that there were 87,525 local
governmental jurisdictions in the United States.\11\ The Commission
estimates that, of this total, 84,377 entities were ``small
governmental jurisdictions.'' \12\ Thus, it estimates that
[[Page 39258]]
most governmental jurisdictions are small.
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\7\ See SBA, Office of Advocacy, ``Frequently Asked Questions,''
http://web.sba.gov/faqs (accessed Jan. 2009).
\8\ 5 U.S.C. 601(4).
\9\ Independent Sector, The New Nonprofit Almanac & Desk
Reference (2002).
\10\ 5 U.S.C. 601(5).
\11\ U.S. Census Bureau, Statistical Abstract of the United
States: 2006, Section 8, page 272, Table 415.
\12\ 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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63. Wireless Telecommunications Carriers (except Satellite). Since
2007, the Census Bureau has placed wireless firms within this new,
broad, economic census category.\13\ Prior to that time, such firms
were within the now-superseded categories of ``Paging'' and ``Cellular
and Other Wireless Telecommunications.'' \14\ Under the present and
prior categories, the SBA has deemed a wireless business to be small if
it has 1,500 or fewer employees.\15\ Because Census Bureau data are not
yet available for the new category, we will estimate small business
prevalence using the prior categories and associated data. For the
category of Paging, data for 2002 show that there were 807 firms that
operated for the entire year.\16\ Of this total, 804 firms had
employment of 999 or fewer employees, and three firms had employment of
1,000 employees or more.\17\ For the category of Cellular and Other
Wireless Telecommunications, data for 2002 show that there were 1,397
firms that operated for the entire year.\18\ Of this total, 1,378 firms
had employment of 999 or fewer employees, and 19 firms had employment
of 1,000 employees or more.\19\ Thus, we estimate that the majority of
wireless firms are small.
---------------------------------------------------------------------------
\13\ U.S. Census Bureau, 2007 NAICS Definitions, ``517210
Wireless Telecommunications Categories (Except Satellite)''; http://
www.census.gov/naics/2007/def/ND517210.HTM#N517210.
\14\ U.S. Census Bureau, 2002 NAICS Definitions, ``517211
Paging''; http://www.census.gov/epcd/naics02/def/NDEF517.HTM.; U.S.
Census Bureau, 2002 NAICS Definitions, ``517212 Cellular and Other
Wireless Telecommunications''; http://www.census.gov/epcd/naics02/
def/NDEF517.HTM.
\15\ 13 CFR 121.201, NAICS code 517210 (2007 NAICS). The now-
superseded, pre-2007 CFR citations were 13 CFR 121.201, NAICS codes
517211 and 517212 (referring to the 2002 NAICS).
\16\ U.S. Census Bureau, 2002 Economic Census, Subject Series:
Information, ``Establishment and Firm Size (Including Legal Form of
Organization,'' Table 5, NAICS code 517211 (issued Nov. 2005).
\17\ 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.''
\18\ U.S. Census Bureau, 2002 Economic Census, Subject Series:
Information, ``Establishment and Firm Size (Including Legal Form of
Organization,'' Table 5, NAICS code 517212 (issued Nov. 2005).
\19\ 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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D. Description of Projected Reporting, Recordkeeping, and Other
Compliance Requirements
64. The 2300-2305 MHz, 2360-2400 MHz, 2400-2500 MHz and 5150-5250
MHz bands are used by various Federal and non-Federal
radiocommunication services. Thus, the Commission seeks comment related
to the potential for interference caused either to incumbents, or to
MBAN systems, and how any such concerns might be mitigated.
65. The Commission thus seeks comment on allowing MBAN operations
in any of the bands on a secondary basis, subject to the further
condition that harmful interference is not caused to primary services
allocated in the bands, or on allowing MBAN operations on a primary
basis in the 2300-2305 MHz and 2390-2400 MHz bands. We would further
propose 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.\20\
---------------------------------------------------------------------------
\20\ See 47 CFR 2.106.
---------------------------------------------------------------------------
66. 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.
67. First, the Commission seeks comment on whether it should
require that each MBAN transmitter 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.
68. The Commission also seeks comment on whether to provide that
all non-implanted MBAN transmitter apparatus be made available for
inspection upon request by an authorized FCC representative. Under such
a provision, persons operating MBAN transmitters would be required to
cooperate reasonably with duly authorized FCC representatives in the
resolution of interference.
69. The Commission seeks comment on whether to require that
manufacturers of MBAN transmitters include with each transmitting
device (if allocated on a secondary basis) an appropriate disclosure
statement analogous to that for MedRadio transmitters with each MBAN
transmitting device.\21\ Such a statement would disclose the provision
of the rules under which the device is authorized, along with a
statement that the transmitter must not cause harmful interference to
stations authorized to operate on a primary basis in the band, and must
accept interference that may be caused by such stations, including
interference that may cause undesired operation. Such statement would
also indicate that the transmitter shall be used only in accordance
with the FCC Rules, and that analog and digital voice communications
are prohibited.
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\21\ For example, under the MedRadio rules, each transmitter
must include a statement that ``This transmitter is authorized by
rule under the MedRadio Service. This transmitter must not cause
harmful interference to stations authorized to operate on a primary
basis in the 2360-2400 MHz band, 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.''
---------------------------------------------------------------------------
70. The Commission further seeks comment on whether to require that
MBAN control transmitters (if allocated on a secondary basis) 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 and must accept any
interference received, including interference that may cause undesired
operation.'' Where a MBAN 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 MBAN transmitters be identified with a serial number.
Under that plan, it 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.
71. Finally, with respect to marketing limitations, the Commission
seeks comment on requiring that MBAN transmitters intended for
operation in any portions of the 2360-2400 MHz band may be marketed and
sold only for those permissible uses.
72. Licensing. The Commission seeks comment on whether medical
device operations in any portion of the frequency bands under
consideration should be authorized under the MedRadio Service in part
95 of our Rules, thus providing for license-by-rule
[[Page 39259]]
operation \22\ pursuant to section 307(e) of the Communications Act
(Act).\23\ Under this approach, medical devices would operate in the
band on a shared, non-exclusive basis with respect to each other and
without the need for MBAN systems to be individually licensed. As the
Commission determined when it adopted the MedRadio Service rules, 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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\22\ See 47 CFR 95.401 (d).
\23\ 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 307(e)(1).
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73. Alternatively, the Commission also seeks comment on whether
MBAN operations should be licensed on a non-exclusive basis under part
90. Under that approach, MBAN operations would be licensed on a non-
exclusive basis with respect to each other for ten year license terms.
The Commission seeks comment on whether it should consider using the
same approach here as we do with wireless broadband services in the
3650-3700 MHz band, i.e., eligible entities would apply for non-
exclusive nationwide licenses and subsequently register individual
stations with the Commission.\24\ If this approach were to be adopted,
the Commission also seeks comment on whether it should require that
licensees register each individual MBAN system or, alternatively,
require them to register the individual health care facility at which
the licensee would be allowed to operate multiple MBAN systems. In this
regard, the Commission seeks comment on what type of licensing and
registration information for MBAN operations would facilitate
coordination with incumbent services; and what would be the relative
benefits and disadvantages of licensing under part 90 compared with the
license-by-rule approach under part 95.
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\24\ See 47 CFR 90.1307.
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E. Steps Taken To Minimize Significant Economic Impact on Small
Entities, and Significant Alternatives Considered
74. 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.\25\
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\25\ See 5 U.S.C. 603(c).
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75. The Commission also invites commenters to address the validity
of the competing interference modeling studies that have already been
placed into the record by GEHC and AFTRCC. Each party reaches opposite,
alternative conclusions concerning whether MBAN operation would pose an
undue interference risk to AMT operations in the 2360-2395 MHz band.
The Commission asks commenters to address which aspects of these
interference models would be appropriate, or not, to be relied upon
under the particular factual circumstances herein. For example, should
interference potential be evaluated in this instance by reference to
worst-case static models or by other statistical simulations such as
the Monte Carlo approach type relied upon by GEHC? Why or why not?
Would some other interference modeling approaches give results
providing a greater degree of confidence in their merit?
F. Federal Rules That May Duplicate, Overlap, or Conflict With the
Proposed Rules
76. None.
Ordering Clauses
77. Pursuant to Sections 4(i), 301, 302, 303(e), 303(f) and 303(r)
of the Communications Act of 1934, as amended, 47 USC Sections 154(i),
301, 302, 303(e), 303(f) and 303(r), this Notice of Proposed Rule
Making is adopted.
78. 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. E9-18859 Filed 8-5-09; 8:45 am]
BILLING CODE 6712-01-P