[Federal Register Volume 65, Number 137 (Monday, July 17, 2000)]
[Rules and Regulations]
[Pages 43995-44010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17970]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Parts 1, 2, 15, 90 and 95

[ET Docket No. 99-255; PR Docket No. 92-235; FCC 00-211]


Wireless Medical Telemetry Service

AGENCY: Federal Communications Commission.

ACTION: Final rule.

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SUMMARY: This document allocates new spectrum and establishes rules for 
a Wireless Medical Telemetry Service (WMTS) that allows potentially 
life-critical equipment to operate on an interference-protected basis. 
Medical telemetry equipment is used in hospitals and health care 
facilities to transmit patient measurement data, such as pulse and 
respiration rates to a nearby receiver, permitting greater patient 
mobility and increased comfort. This action will increase the 
reliability of medical telemetry equipment.

DATES EFFECTIVE: October 16, 2000.

FOR FURTHER INFORMATION CONTACT: Hugh Van Tuyl, Office of Engineering 
and Technology, (202) 418-7506.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report 
and Order, ET Docket 99-255 and PR Docket 92-235, FCC 00-211, adopted 
June 8, 2000, and released June 12, 2000. The full text of this 
Commission decision is available for inspection and copying during 
normal business hours in the FCC Reference Information Center, Room CY-
A257, 445 12th Street, SW, Washington, DC, and also may be purchased 
from the Commission's duplication contractor, International 
Transcription Service, (202) 857-3800, 1231 20th Street, NW, 
Washington, DC 20036.

Summary of the Report and Order

    1. The Report and Order establishes a new Wireless Medical 
Telemetry Service (WMTS) which will enhance the ability of health care 
providers to offer high quality and cost-effective care to patients 
with acute and chronic health care needs. This action addresses 
consumer concerns that medical telemetry devices are increasingly at 
risk of harmful interference due to more extensive use of spectrum 
resources by other applications. The Commission allocates 14 Megahertz 
(MHz) to WMTS on a primary basis, which will allow potentially life-
critical medical telemetry equipment to operate on an interference-
protected basis. The Commission also adopts service rules for WMTS that 
``license by rule'' to minimize regulatory procedures to facilitate 
rapid deployment. Medical telemetry equipment is used in hospitals and 
health care facilities to transmit patient measurement data, such as 
pulse and respiration rates to a nearby receiver, permitting greater 
patient mobility and increased comfort. As this service permits remote 
monitoring of several patients simultaneously it could also potentially 
decrease health care costs. The Commission's action will improve the 
reliability of this vital service.
    2. In the Notice of Proposed Rule Making (NPRM), 64 FR 41891, 
August 2, 1999, in this proceeding, we proposed to allocate spectrum 
where medical telemetry equipment could operate on a primary basis. We 
also proposed to establish a new Wireless Medical Telemetry Service 
(WMTS) under part

[[Page 43996]]

95 of the rules. The Commission's proposal was based on recommendations 
provided by the American Hospital Association's (AHA) Medical Telemetry 
Task Force, which was established in coordination with the FDA, in 
response to the incidence of interference to medical telemetry 
equipment from a DTV station.

Spectrum Allocation

    3. We are making available 14 MHz of spectrum in three blocks 
located at 608-614 MHz, 1395-1400 MHz, and 1429-1432 MHz for wireless 
medical telemetry. In making available 14 MHz of spectrum, we note that 
these bands each have significant constraints, such that the entire 
allocation is unlikely to be available in any individual market. The 
608-614 MHz band is constrained as a result of radio astronomy quiet 
zones, including some sites in large markets, and interference from 
adjacent TV channels. The remaining 8 MHz that we are allocating is 
constrained by adjacent band interference from high power radars 
located below 1390 MHz and grandfathered protected Federal sites. 
However, this allocation ensures that at least 6 MHz is available for 
WMTS in all locations, consistent with the AHA needs assessment, with 
at least some additional spectrum available to accommodate long term 
needs. We note that this is in fact significantly less than the amount 
of spectrum that is currently available to medical telemetry on an 
unprotected basis. However, we find that the benefits of a primary 
allocation dedicated to this service compensates for the reduced 
availability of spectrum. We wish to underscore that we do not 
anticipate any further allocations for medical telemetry devices and 
expect manufacturers and the health care community to ensure that this 
spectrum is used efficiently to meet long term needs. We also wish to 
note that this medical telemetry allocation is an exception to the 
approach we have been taking toward more flexible allocations that are 
not service specific. A specific allocation is necessary in this case 
to protect the public safety by providing spectrum where medical 
telemetry equipment can operate without interference. Further, it will 
resolve conflicts that have delayed the land mobile refarming and that 
are affecting the deployment of DTV.

Frequency Bands

    4. The Notice proposed the following two options for frequency 
bands to be allocated to the WMTS:

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                 Option 1                             Option 2
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608-614 MHz...............................  608-614 MHz
1395-1400 MHz.............................  1391-1400 MHz
1429-1432 MHz.............................
------------------------------------------------------------------------

The 608-614 MHz band corresponds to TV channel 37, which is not used 
for TV stations and is currently reserved for radio astronomy. It is 
available for medical telemetry under part 15 of the rules on an 
unlicensed basis. The other proposed bands are former government bands 
that were reallocated for non-government use under the Omnibus Budget 
Reconciliation Act of 1993. Government operations in those bands may 
continue at certain sites around the country for a number of years.
    5. We conclude that it is necessary to allocate spectrum where 
medical telemetry equipment can operate on a primary basis. Based on 
the record, we also conclude that WMTS's planned use is best 
accommodated by making three blocks of spectrum available in the 608-
614 MHz, 1395-1400 MHz, and 1429-1432 MHz bands. We will coordinate the 
frequency allocations with Canadian and Mexican governments as 
appropriate. Given the low-power nature of this equipment, we do not 
anticipate any interference issues in border areas.
    6. 608-614 MHz. We find the 608-614 MHz band to be suitable for 
WMTS because, other than radio astronomy, it is only used for medical 
telemetry under part 15 of the rules. We also note that no commenters 
opposed the use of this band. Accordingly, we allocate this band to 
medical telemetry equipment on a co-primary basis with radio astronomy. 
Operation of medical telemetry equipment in this band must not cause 
interference to sensitive radio astronomy operations, and users will be 
required to coordinate their operation with radio astronomy facilities. 
We note that medical telemetry service providers operating on 608-614 
MHz (television channel 37) currently must accept adjacent channel 
interference from broadcast television stations operating on channels 
36 and 38. With this allocation, we are not requiring television 
broadcasters to protect WMTS from adjacent band interference. We 
believe that the multi-band approach that we are adopting provides 
sufficient flexibility to WMTS. WMTS providers can operate on one of 
the other bands that we are making available in situations where a 
hospital is in close proximity to a television station operating on 
channels 36 or 38. Furthermore, WMTS providers can design equipment to 
provide sufficient protection from adjacent channel interference as is 
current practice.
    7. 1395-1400 MHz and 1429-1432 MHz. In addition to the 608-614 MHz 
band, we are allocating the 1395-1400 MHz and 1429-1432 MHz bands for 
medical telemetry. Allocating the 1395-1400 MHz band instead of the 
alternative band we proposed will result in a 4 MHz greater frequency 
separation between medical telemetry and government radars operating 
below 1385 MHz, thereby reducing the risk of interference to medical 
telemetry equipment. We find that the frequency separation between the 
1395-1400 MHz and the 1429-1432 MHz bands will give greater flexibility 
for medical telemetry by making the bands more useful for two-way 
communications than a single contiguous band at 1391-1400 MHz.

Service Rules

    8. We adopt service rules for the new Wireless Medical Telemetry 
Service (WMTS). These service rules only apply to the WMTS that will 
operate at 608-614 MHz, 1395-1400 MHz, and 1429-1432 MHz, and not to 
the current medical telemetry operations permitted under parts 15 and 
90. The rules include licensing requirements and technical standards 
for the equipment, as well as a frequency coordination procedure.
    9. Definition. In the NPRM, 64 FR 41892, August 2, 1999, we 
proposed the following definition for medical telemetry:
    Wireless medical telemetry is defined as the measurement and 
recording of physiological parameters and other patient-related 
information via radiated bi- or unidirectional electromagnetic signals.
    10. We agree that allowing bi-directional transmissions could 
promote the development of more advanced medical telemetry equipment 
and encourage more efficient use of the spectrum. The split frequency 
allocation we are adopting in this item was selected in part to 
facilitate two-way communications. Accordingly, we are adopting a 
definition of medical telemetry that will allow bi-directional 
transmissions. We find it unnecessary to exclude voice and video 
transmissions in the definition for medical telemetry.
    11. Licensing. There were no comments opposing our proposal that 
WMTS equipment be ``licensed by rule'', rather than requiring 
individual operators'' licenses. Individual licensing is generally 
designed to give a licensee a protected service area, and thus 
establishes rights among competing entities in the same service. 
Operators in the WMTS will not be in competition

[[Page 43997]]

with each other as are parties in other radio services. The WMTS 
spectrum will be shared among medical telemetry users, and there will 
be no mutual exclusivity between users. In addition, ``licensing by 
rule'' will minimize regulatory procedures and thus facilitate 
deployment. We are therefore adopting our proposal that the WMTS exist 
as one of the Citizen's Band services contained in part 95 of the rules 
and that the equipment used in this service be ``licensed by rule''. 
The Commission has authority under Section 307(e) of the Communications 
Act to define the citizen's band radio services and to license them by 
rule.
    12. Eligibility. We proposed that only authorized health care 
providers be eligible to operate transmitters in the WMTS. For the 
purpose of this service, an ``authorized health care provider'' would 
be defined as (1) a physician or other individual authorized under 
state or federal law to provide health care services; (2) a health care 
facility operated by or employing individuals authorized under state or 
federal law to provide health care services; or (3) any trained 
technician under the supervision and control of an individual or health 
care facility authorized under state or federal law to provide health 
care services. We proposed to define a ``health care provider 
facility'' as a hospital or other establishment that offers services, 
facilities and beds for use beyond a 24 hour period in rendering 
medical treatment, and organizations regularly engaged in providing 
medical services through clinics, public health facilities and similar 
establishments, including government entities and agencies such as 
Veterans Administration Hospitals. Health care facilities on tribal 
lands would also be included under our proposed definition. A health 
care facility would not include an ambulance or other moving vehicle, 
and this definition would also not allow home use of WMTS equipment. We 
are adopting these eligibility definitions as proposed.
    13. Frequency coordination. The comments supported our proposal to 
designate a frequency coordinator to maintain a database of all WMTS 
equipment identified by location, operating frequency, emission type 
and output power. NTIA notes that a frequency coordinator would 
facilitate band sharing between hospitals and the remaining government 
operations at protected sites. Accordingly, we are adopting the 
proposal to designate a frequency coordinator to maintain a database of 
WMTS equipment. Without a database, there would be no record of WMTS 
usage because WMTS transmitters will not be individually licensed. The 
database will provide a record of the frequencies used by each facility 
or device to assist parties in selecting frequencies to avoid 
interference. The database will be used by eligible users and 
manufacturers to plan for specific frequency use within a geographic 
area, especially where numerous WMTS operations may occur.
    14. The frequency coordinator will not be a decision maker as to 
which frequency should be used. Rather, the coordinator will notify 
users of potential frequency conflicts, and users should be able to 
resolve any conflicts among themselves. We expect that there will be 
few conflicts between users of WMTS equipment due to its low operating 
power, but the Commission will make the final decision on a case-by-
case basis in disputes between users, if necessary. The coordinator 
must be familiar with the medical telemetry user community, and must 
make its services available to all parties on a first-come, first-
served and non-discriminatory basis. The frequency coordinator must be 
willing to serve a five-year term, which could be renewed by the 
Commission. In the event that a frequency coordinator does not wish to 
continue at the end of its term, it will have to transfer its database 
to another designated entity.
    15. The NPRM, 64 FR 41892, August 2, 1999, asked for comments on 
the following questions about the frequency coordinator: (1) any other 
qualifications that a frequency coordinator must have, (2) whether a 
single entity or multiple entities should be designated as frequency 
coordinator(s), (3) how the frequency records could be maintained with 
multiple coordinators, and (4) whether we should limit the fees the 
frequency coordinator(s) can charge.
    16. Several entities expressed an interest in being a frequency 
coordinator for WMTS. In the past the Commission has tried, where 
appropriate, to introduce market forces into the frequency coordination 
process. Therefore, rather than adopt a Commission rule restricting 
database management of WMTS spectrum to a single coordinator, we will 
leave the ultimate decision on the number of coordinators up to the 
Commission's Wireless Telecommunications Bureau (WTB). WTB already has 
delegated authority to select frequency coordinators in the services it 
administers. WTB will announce its coordination selection procedures in 
a Public Notice in the near future. We have not found it necessary to 
set limits on the fees charged by coordinators in other services, and 
we have no reason to believe that fee limits will be necessary in the 
WMTS. Accordingly, we will allow the designated coordinator to set the 
fee structure as necessary to recoup costs.
    17. The NPRM, 64 FR 41892, August 2, 1999, proposed that certain 
information be submitted to the frequency coordinator for inclusion on 
the database, including:
    (1) Frequency range(s) used
    (2) Modulation scheme used
    (3) Effective radiated power
    (4) Number of transmitters in use at the health care facility at 
the time of registration
    (5) Legal name of the authorized health care provider
    (6) Location of transmitter (coordinates, street address, building)
    (7) Point of contact for the authorized health care provider.
We find that including the equipment manufacturer and model number in 
the database could be useful for helping the frequency coordinator and 
users in determining the interference potential of WMTS equipment. This 
information could also assist the Commission or the FDA in locating 
certain devices in the event a question of compliance with the rules 
arose. Accordingly, we will specify that the equipment manufacturer and 
model number be submitted to the frequency coordinator for inclusion on 
the database. Much of the other information (fax numbers, e-mail 
addresses, assigned frequencies and occupied bandwidth) simply 
represents a more detailed description of the information we proposed. 
We agree with these recommendations and are including them in the final 
rules. We recognize that including the name of the health care provider 
and point of contact in the database could possibly make that 
information available to commercial entities. However, we find that 
this information is necessary to allow the coordinator and parties 
using the WMTS to contact other users to verify information and resolve 
potential conflicts. Thus, we will require the name of the health care 
provider and a point of contact to be included on the database. 
Including this information should not raise issues of privacy of 
patient information, because the database will not contain the patient 
names or other patient identification information.
    18. We find that requiring periodic equipment registration renewals 
from health care providers to be an unnecessary burden. Most hospitals 
would find it difficult to remember to renew their registrations after 
five years have passed, and requiring coordinators

[[Page 43998]]

to send out periodic renewal notices and process renewal applications 
could significantly increase their workload. However, we will not 
preclude coordinators from verifying the continued use of registered 
equipment on an ``as needed'' basis, such as when the database shows a 
conflict between a registered user and a new user. Accordingly, we are 
adopting our proposal that equipment registrations will remain valid 
until the health care provider requests cancellation. Restricting 
access to the database to certain parties would be difficult and 
burdensome for the coordinator because the coordinator would have to 
verify that each and every party accessing the database has a need for 
the information that is related to health care. Such restrictions could 
make it difficult for parties with legitimate needs for information to 
view the database. We therefore find that the database should be open 
to all parties.
    19. Permissible communications. We proposed that the WMTS could be 
used for all types of communications, except for voice or video 
transmissions. We proposed to exclude these types of transmissions 
because we were concerned that video could occupy a significant portion 
of the spectrum allocated to the WMTS, and that allowing voice 
transmissions could encourage the equipment to be used as a form of 
wireless intercom.
    20. We find that the transmission of waveform information such as 
electrocardiograms (ECGs) is within the intended purpose of the WMTS, 
which is to transmit vital patient data. Accordingly, we will permit 
the transmission of waveform information in the WMTS. However, allowing 
the general purpose use of video in the WMTS could potentially result 
in video occupying a large portion of the available spectrum. This is a 
greater concern initially because portions of the WMTS spectrum will be 
unavailable for a number of years in parts of the country due to 
grandfathered government operations. We are not persuaded that there is 
currently a need for voice capabilities in telemetry equipment, and we 
reiterate our concern that allowing such capabilities could encourage 
use of the equipment for other than its intended purpose of 
transmitting patient data. Accordingly, we will prohibit voice and 
video transmissions in the WMTS at this time, but we may revisit the 
issue at a later date after government operations cease in the WMTS 
bands.
    21. Technical Standards. We proposed only minimal technical 
standards for WMTS equipment to give manufacturers the flexibility to 
develop different applications for medical telemetry. We did not 
propose a specific channelization scheme for the 1395-1400 MHz and 
1429-1432 MHz bands. However, to prevent users from monopolizing the 
608-614 MHz band, we proposed that equipment using broadband 
technologies, such as spread spectrum, be capable of operating on 
channels of 1.5 MHz each, up to a maximum of 6 MHz. Such equipment 
would operate on the minimum number of channels necessary, and must 
have the capability of being ``throttled back'' so it will occupy as 
little as one 1.5 MHz channel, if necessary, to allow multiple users to 
share that band. There were no objections to the proposed requirement 
on maximum channel usage in the 608-614 MHz band, so we are adopting 
this requirement which will allow the WMTS spectrum to be used more 
efficiently.
    22. We proposed the following field strength limits for 
transmitters in the WMTS.

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                                 Maximum field         Measurement          Measurement
       Frequency band               strength             distance            bandwidth        Detector function
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608-614 MHz                   200 mV/m             3 meters             120 +/-20 kHz        CISPR QP.
1395-1400 MHz                 740 mV/m             3 meters             1 MHz                Average.
1429-1432 MHz                 740 mV/m             3 meters             1 MHz                Average.
----------------------------------------------------------------------------------------------------------------

    23. We proposed the same out-of-band field strength limits for 
transmitters in the WMTS bands that are used for most intentional 
radiators under part 15 of the rules. We have found those limits to be 
effective at controlling interference. There were no objections to 
applying the part 15 out-of-band emission limits to WMTS equipment, and 
we are adopting them.
    24. Protection of other existing services. The WMTS must not cause 
interference to radio astronomy operations, and to certain 
grandfathered government operations. We are therefore adopting rules 
requiring the coordination of WMTS operations in the 608-614 MHz band 
with radio astronomy operations, which are the same as the coordination 
requirements currently found in part 15. The rules also require 
operators in the 1395-1400 MHz and 1429-1432 MHz bands to protect 
certain government operations. Finally, parties using WMTS equipment 
should be aware that the operation of transmitters in close proximity 
to medical equipment could cause interference to the operation of the 
medical equipment. The rules provide a warning to this effect, which is 
the same warning found in part 15.
    25. RF Safety. We do not currently require the routine evaluation 
of medical telemetry equipment for compliance with the radiofrequency 
(RF) radiation safety guidelines in our rules due to the low power of 
the equipment. The NPRM, 64 FR 41892, August 2, 1999 did not propose to 
require RF safety measurements for WMTS equipment because such 
equipment would also operate at relatively low power levels.
    26. Our rules for RF safety classify equipment into two categories: 
(1) mobile devices, which normally operate with at least a 20 
centimeter separation from the radiating element to the body of the 
user or a nearby person , and (2) portable devices, which normally 
operate with less than a 20 centimeter separation from the radiating 
element to the body of the user. Based upon our analysis, we agree that 
portable WMTS equipment could possibly exceed the RF safety guidelines 
in our rules. Accordingly, we will require routine environmental 
evaluation for RF exposure of portable WMTS equipment prior to 
equipment authorization or use. We expect that the majority of WMTS 
equipment will be classified as ``portable'' because medical telemetry 
transmitters are typically worn on the body. However, we realize that 
there may be some applications where the transmitter is separated from 
the body by more than 20 centimeters, such as a unit mounted on a bed 
or incorporated within a separate device. Consistent with the RF safety 
requirements for other services, mobile WMTS equipment will be 
categorically excluded from routine environmental evaluation because 
WMTS equipment complying with the technical requirements we are 
adopting will operate with an effective radiated power (ERP) of less 
than 1.5 watts, which is the threshold for the exclusion of equipment 
operating below 1.5 GHz.
    27. Equipment authorization requirement. The NPRM, 64 FR 41892,

[[Page 43999]]

August 2, 1999 proposed authorizing WMTS transmitters through the 
Declaration of Conformity (DoC) procedure in part 2 of the rules. DoC 
is a manufacturer's self-approval procedure where the equipment is 
tested to ensure it complies with the Commission's technical standards, 
and may then be marketed without an approval by the Commission.
    28. The certification procedure requires the manufacturer to file 
electronically a test report showing the equipment complies with the 
rules along with other supporting documentation to the Commission or to 
a designated Telecommunication Certification Body (TCB). The equipment 
may not be marketed until an approval has been received from the 
Commission or a TCB. Upon further consideration, we agree that 
certification is the appropriate authorization procedure for WMTS 
equipment. WMTS equipment involves new technologies, and the majority 
will be subject to routine environmental evaluation for RF safety. 
Requiring certification is consistent with the actions we have taken in 
similar cases, such as the Medical Implant Communication Service (MICS) 
in part 95. However, we note that procedures for making the RF exposure 
measurements are currently under development. When such procedures are 
developed, we may consider relaxing the certification requirement for 
medical telemetry equipment.

Transition Provisions

    29. Equipment authorization. We proposed that all new medical 
telemetry equipment that receives an equipment authorization starting 
two years after the adoption of final rules must operate in the newly 
authorized frequency bands. Two years is a reasonable timetable for 
requiring manufacturers to produce equipment to operate in the new 
bands. Based on the comments received, we are confident that 
manufacturers will be able to meet this deadline. We decline to allow 
equipment approved after that deadline to have the capability of 
operating in the current part 15 and part 90 bands. Our goal in this 
proceeding is to not only provide spectrum where medical telemetry he 
Commission has taken, such as the freeze in the 450-470 MHz band and 
the requirement for DTV stations to notify nearby health care 
facilities, affect other parties. We therefore wish to encourage 
medical telemetry users to migrate out of the current frequency bands 
and into the new frequency bands. Allowing the development of new 
equipment that can operate in the old bands after the transition date 
would discourage the eventual migration to the new bands.
    30. Grandfathering. Requiring the replacement of functional medical 
telemetry systems that are not subject to interference would be an 
unnecessary financial burden on hospitals. Accordingly, we will permit 
medical telemetry equipment that has received an equipment 
authorization to operate in current part 15 and part 90 bands prior to 
the two year transition date to be manufactured, imported, marketed and 
operated without a cutoff date. This action will ensure that 
manufacturers will be able to make replacement parts for systems 
operating in the old bands, and that hospitals will be permitted to 
operate their existing systems as long as possible until replacement is 
necessary due to age or interference concerns.
    31. Existing equipment registration. We find it unlikely that a 
complete database of all part 15 and part 90 medical telemetry 
transmitters could be developed prior to the transition to the new 
frequency bands. However, placing even some transmitters in a database 
could possibly assist parties in avoiding cases of interference. We 
therefore have no objection to allowing the voluntary registration of 
existing part 15 and part 90 medical telemetry devices. The rules we 
are adopting allow frequency coordinators to process voluntary requests 
to register equipment operating under parts 15 and 90.

450-470 MHz Freeze

    32. In 1995, the Commission adopted changes to part 90 of the rules 
to allow more efficient use of the spectrum for land mobile services. 
These changes permitted high power operations on channels in the 450-
470 MHz band. However, under the new channeling scheme, high-power 
primary users of the band would be able to operate on the same 
frequencies used for medical telemetry equipment. This could possibly 
result in interference to medical telemetry equipment. For this reason, 
on August 11, 1995, the Commission placed a freeze on the filing of 
applications for high power operation in the 450-470 MHz band on the 
12.5 kHz offset channels.
    33. 450-460 MHz band freeze. On October 20, 1999, the Commission 
issued a public notice asking parties operating medical telemetry 
equipment in the 450-460 MHz band to provide certain information to the 
Commission. We received responses from 25 parties around the country 
operating in this band. The majority of these users were operating a 
small number of devices on a limited number of frequencies around 457 
and 458 MHz. Based on the limited usage of the 450-460 MHz band for 
medical telemetry, we find that the freeze on high-power land mobile 
applications in the 450-460 MHz band can be lifted. Accordingly, the 
Wireless Telecommunications Bureau will issue a public notice 
announcing the lifting of the freeze in this band in the near future.
    34. 460-470 band freeze. We find that a five-year transition period 
is longer than is necessary to prepare for the lifting of the freeze in 
the 460-470 MHz band. The freeze was announced almost five years ago, 
so hospitals have been on notice that they may eventually have to 
change frequencies. Equipment is already available to operate in the 
608-614 MHz band we are allocating in this proceeding, and equipment to 
operate in the other bands allocated in this proceeding should become 
available over the next two years. Five more years should not be 
required for hospitals to make the transition. We will therefore lift 
the freeze on high power land mobile application in the 460-470 MHz 
band within three years from the effective date of final rules in this 
proceeding.
    35. The NPRM, 64 FR 41892, August 2, 1999, did not propose to 
preclude medical telemetry equipment from operating in the ISM bands 
under part 15 because only a small number of devices operate under 
these provisions. Therefore, there is not the same potential for a 
large number of cases of interference to medical telemetry equipment in 
these bands as there is for medical telemetry equipment operating in 
the TV and PLMR bands. We expect that the majority of medical telemetry 
equipment manufacturers will design equipment for the new bands 
allocated in this proceeding, and that only a small number of devices 
will continue to use the ISM bands. There, we will continue to allow 
medical telemetry equipment to operate in the ISM bands under part 15. 
While such operation will be permissible, manufacturers and users are 
cautioned that equipment operating in these bands has 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.
    36. Pursuant to sections 4(I), 11, 301, 302, 303(e), 303(f), 303(r) 
304, 307 and 332(b) of the Communications Act of 1934, as amended, 47 
U.S.C. 154(i), 161, 301, 302, 303(3), 303(f), 303(r), 304, 307 and 
332(b).

[[Page 44000]]

Final Regulatory Flexibility Analysis

    37. As required by the Regulatory Flexibility Act (RFA), \1\ an 
Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the 
Notice of Proposed Rule Making, Amendment of parts 2 and 95 of the 
Commission's Rules to Establish a Wireless Medical Telemetry Service. 
\2\ The Commission sought written public comment on the proposals in 
the Notice, including comment on the IRFA. The comments received are 
discussed below. This present Final Regulatory Flexibility Analysis 
(FRFA) conforms to the RFA. \3\
---------------------------------------------------------------------------

    \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 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 Notice of Proposed Rule Making in ET Docket 99-255, 64 
FR 41891, 41896 (August 2, 1999).
    \3\ See 5 U.S.C. 604.
---------------------------------------------------------------------------

A. Need for, and Objectives of, the Report and Order

    38. Medical telemetry equipment currently operates on an unlicensed 
basis on certain unused TV channels under part 15 of the rules, and on 
a secondary basis to private land mobile services in the 450-470 MHz 
band under part 90 of the rules. With the transition to digital TV 
service, both full power and low-power TV stations may begin operating 
on some of the vacant channels used by medical telemetry equipment. In 
addition, the new channelization scheme being implemented in the 450-
470 MHz band will allow high-power operation on the channels currently 
reserved for low-power use where medical telemetry equipment operates. 
Both of these changes could result in severe interference to medical 
telemetry equipment. The rules adopted in the Report and Order allocate 
new frequency bands where medical telemetry equipment can operate on a 
primary basis without receiving interference.

B. Summary of Significant Issues Raised by Public Comments in Response 
to the IRFA

    39. There were no timely filed comments in response to the IRFA. 
The Office of Advocacy, U.S. Small Business Administration (SBA) filed 
``reply comments'' after the comment deadline, but prior to the reply 
comment deadline. Because they do not respond to comments on the IRFA, 
they are in fact untimely filed comments. Nevertheless, we will address 
the issues raised by the SBA.
    40. The SBA claims two deficiencies on the part of the Commission 
in this proceeding. First, SBA states that the NPRM did not consider 
the impact of the proposed rules on small businesses. \4\ Second, SBA 
states that the IRFA does not describe the impact of the rules on small 
businesses and does not provide significant alternatives designed to 
minimize this impact. \5\
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    \4\ See SBA comments at 1-2.
    \5\ See SBA comments at 2-3.
---------------------------------------------------------------------------

    41. We believe SBA is clearly in error on the first point. The RFA 
only requires agencies to provide an analysis of the impact of the 
proposed rules on small businesses in the IRFA. \6\ There is no 
requirement in the RFA to provide such an analysis in the NPRM, which 
would unnecessarily duplicate the analysis in the IRFA. Thus we reject 
SBA's first claim.
---------------------------------------------------------------------------

    \6\ See 5 U.S.C. 603(a).
---------------------------------------------------------------------------

    42. We disagree with SBA on the second point as well. The RFA 
requires the Commission to provide an analysis that discusses 
significant alternatives such as (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 and 
reporting requirements under the rule for such 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 such small 
entities. \7\ These are merely examples of the type of information that 
should be included; this list is not a rigid checklist. The IRFA 
included with the NPRM in this proceeding did in fact include an 
analysis of the type required by the RFA. Specifically, it discussed 
the simplified compliance and reporting requirements we considered to 
minimize the impact of the rules on small businesses. We considered the 
effect on small business from the outset and made the rules apply 
equally to all parties. Thus, we consider the IRFA in this proceeding 
to be adequate. We further note that no other parties had any 
objections to the IRFA or considered it to be inadequate.
---------------------------------------------------------------------------

    \7\ See 5 U.S.C. 603(c).
---------------------------------------------------------------------------

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

    43. 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.\8\ Under the RFA, small 
entities may include small organizations, small businesses, and small 
governmental jurisdictions. 5 U.S.C. 601(6). The RFA, 5 U.S.C. 601(3), 
generally defines the term ``small business'' as having the same 
meaning as the term ``small business concern'' under the Small Business 
Act, 15 U.S.C. 632. 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. This standard also applies in determining whether an entity is a 
small business for purposes of the RFA.
---------------------------------------------------------------------------

    \8\ See 5 U.S.C. 603(b)(3).
---------------------------------------------------------------------------

    44. The Commission has not developed a definition of small entities 
applicable to RF Equipment Manufacturers. Therefore, the applicable 
definition of small entity is the definition under the SBA rules 
applicable to manufacturers of ``Radio and Television Broadcasting and 
Communications Equipment.'' According to the SBA's regulation, an RF 
manufacturer must have 750 or fewer employees in order to qualify as a 
small business.\9\ Census Bureau data indicates that there are 858 
companies in the United States that manufacture radio and television 
broadcasting and communications equipment, and that 778 of these firms 
have fewer than 750 employees and would be classified as small 
entities.\10\ Therefore, we believe that many of the companies that 
manufacture RF equipment would qualify as small entities.
---------------------------------------------------------------------------

    \9\ See 13 CFR 121.201, Standard Industrial Classification (SIC) 
Code 3663.
    \10\ See U.S. Department of Commerce, 1992 Census of 
Transportation, Communications and Utilities (issued May 1995), SIC 
category 3663.
---------------------------------------------------------------------------

    45. According to the SBA's regulations, nursing homes and hospitals 
must have annual gross receipts of $5 million or less in order to 
qualify as a small business concern. 13 CFR 121.201. There are 
approximately 11,471 nursing care firms in the nation, of which 7,953 
have annual gross receipts of $5 million or less.\11\ There are 
approximately 3,856 hospital firms in the nation, of which 294 have 
gross receipts of $5 million or less. Thus, the approximate number of 
small confined setting entities to which the Commission's new rules 
will apply is 8,247.
---------------------------------------------------------------------------

    \11\ See Small Business Administration Tabulation File, SBA Size 
Standards Table 2C, January 23, 1996, SBA, Standard Industrial Code 
(SIC) categories 8050 (Nursing and Personal Care Facilities) and 
8060 (Hospitals). (SBA Tabulation File)

---------------------------------------------------------------------------

[[Page 44001]]

D. Description of Projected Reporting, Recordkeeping, and Other 
Compliance Requirements

    46. WMTS equipment will be authorized through the certification 
procedure. The certification procedure requires the manufacturer to 
file electronically a test report showing the equipment complies with 
the rules along with other supporting documentation to the Commission 
or to a designated Telecommunication Certification Body (TCB). The 
equipment may not be marketed or operated until an approval has been 
received from the Commission or TCB. This is the same process adopted 
by the Commission for the Medical Implant Communication Service 
(MICS).\12\ We are requiring that all parties including small 
businesses have their equipment approved though the certification 
procedure because of concerns over radiofrequency radiation safety.
---------------------------------------------------------------------------

    \12\ See para. 53, supra.
---------------------------------------------------------------------------

    47. Parties operating the equipment will not be required to obtain 
an individual operator's license from the Commission, but they will 
have to register with a frequency coordinator designated by the 
Commission. The Commission may designate multiple coordinators to 
provide competition to keep costs at a minimum. The information 
submitted to the frequency coordinator will be:
    (1) Specific frequencies or frequency range(s) used;
    (2) Modulation scheme used (including occupied bandwidth);
    (3) Effective radiated power;
    (4) Number of transmitters in use at the health care facility as of 
the date of registration (including manufacturer name(s) and model 
numbers);
    (5) Legal name of the authorized health care provider;
    (6) Location of transmitter (coordinates, street address, 
building);
    (7) Point of contact for the authorized health care provider (name, 
title, office, phone number, fax number, e-mail address).

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

    48. We are not requiring individual operators' licenses for 
equipment in the WMTS. Instead, the equipment will be ``licensed by 
rule'', meaning that users are permitted to operate WMTS equipment that 
complies with rules without the need to apply for a license from the 
Commission. Licensing by rule benefits small businesses by eliminating 
the expense and delays that would result if parties were required to 
obtain individual operators' licenses.
    49. New equipment for the WMTS will not have to operate in the 
newly allocated frequency bands until two years after the effective 
date of the new rules. This will allow sufficient time for 
manufacturers to develop equipment for the new bands, thus reducing the 
development costs for small businesses. We are also allowing equipment 
in the old frequency bands that has received an equipment authorization 
before the two year transition date to be manufactured, imported, 
marketed and operated without a cutoff date. This will ensure that 
replacement parts are available for existing telemetry systems and that 
hospitals will be able to use their existing systems as long as 
possible before replacement is required, thus reducing expenses for 
small businesses.
    50. There is currently a freeze on high-power land mobile 
operations in the 450-470 MHz band. The freeze was put in effect in 
1995 to protect medical telemetry in that band from interference. We 
are providing a three-year transition period before lifting the freeze 
in the 460-470 MHz band. This will assist small businesses by providing 
adequate time for medical telemetry users to begin migration to the new 
frequency bands, if necessary. The freeze in the 450-460 MHz band will 
be lifted shortly after release of this Order because we have 
determined that little medical telemetry equipment operates in this 
portion of the band. Therefore, there will be little impact on small 
businesses.
    Report to Congress: The Commission will send a copy of the Report 
and Order, Amendment of parts 2 and 95 of the Commission's Rules to 
Establish a Wireless Medical Telemetry Service, including this FRFA, in 
a report to be sent to Congress pursuant to the SBREFA, see 5 U.S.C. 
801(a)(1)(A). In addition, the Commission will send a copy of the 
Report and Order, including FRFA, to the Chief Counsel for Advocacy of 
the SBA.

List of Subjects

47 CFR Part 1

    Reporting and recordkeeping requirements

47 CFR Part 2 and 95

    Communications equipment, Reporting and recordkeeping requirement.

47 CFR Part 15

    Communications equipment.

47 CFR Part 90

    Communications equipment, Emergency medical services.

Federal Communications Commission.
William F. Caton,
Deputy Secretary.

Rules Changes

    For the reasons discussed in the preamble, the Federal 
Communications Commission amends 47 CFR parts 1, 2, 15, 90, and 95 as 
follows:

PART 1--PRACTICE AND PROCEDURE

    1. The authority citation for part 1 continues to read as follows:

    Authority: 47 U.S.C. 151, 154(i), 154(j), 155, 225, 303(r), 309 
and 325(e).


    2. Section 1.1307 is amended by revising paragraph (b)(2) to read 
as follows:


Sec. 1.1307  Actions that may have a significant environmental effect, 
for which Environmental Assessments (EAs) must be prepared.

* * * * *
    (b) * * *
    (2) Mobile and portable transmitting devices that operate in the 
Cellular Radiotelephone Service, the Personal Communications Services 
(PCS), the Satellite Communications Services, the General Wireless 
Communications Service, the Wireless Communications Service, the 
Maritime Services (ship earth stations only) and the Specialized Mobile 
Radio Service authorized under Subpart H of parts 22, 24, 25, 26, 27, 
80, and 90 of this chapter are subject to routine environmental 
evaluation for RF exposure prior to equipment authorization or use, as 
specified in Secs. 2.1091 and 2.1093 of this chapter. Unlicensed PCS, 
unlicensed NII and millimeter wave devices are also subject to routine 
environmental evaluation for RF exposure prior to equipment 
authorization or use, as specified in Secs. 15.253(f), 15.255(g), 
15.319(i), and 15.407(f) of this chapter. Portable transmitting 
equipment for use in the Wireless Medical Telemetry Service (WMTS) is 
subject to routine environment evaluation as specified in Secs. 2.1093 
and 95.1125 of this chapter. Equipment authorized for use in the 
Medical Implant Communications Service (MICS) as a medical implant 
transmitter (as defined in Appendix 1 to Subpart E of part 95 of this 
chapter) is subject to routine environmental evaluation for RF exposure 
prior to equipment authorization, as specified in Sec. 2.1093 of this 
chapter by finite difference time domain computational

[[Page 44002]]

modeling or laboratory measurement techniques. Where a showing is based 
on computational modeling, the Commission retains the discretion to 
request that specific absorption rate measurement data be submitted. 
All other mobile, portable, and unlicensed transmitting devices are 
categorically excluded from routine environmental evaluation for RF 
exposure under Secs. 2.1091, 2.1093 of this chapter except as specified 
in paragraphs (c) and (d) of this section.
* * * * *

PART 2--FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL 
RULES AND REGULATIONS

    3. The authority citation for part 2 continues to read as follows:

    Authority: 47 U.S.C. 154, 302, 303, 307, 336, and 337, unless 
otherwise noted.


    4. Section 2.106 is amended as follows:
    a. Revise the entries for the MHz bands of the Table of Frequency 
Allocations to read as follows.
    b. In the United States (US) footnotes, revise footnote US246 and 
add footnotes US350, US351, and US352.
    c. In the Government (G) footnotes, revise footnotes G27, G30, and 
G114.
    The revisions and additions read as follows:


Sec. 2.106  Table of frequency allocations.

* * * * *
BILLING CODE 6712-01-W

[[Page 44003]]

[GRAPHIC] [TIFF OMITTED] TR17JY00.033


[[Page 44004]]


[GRAPHIC] [TIFF OMITTED] TR17JY00.034


[[Page 44005]]


[GRAPHIC] [TIFF OMITTED] TR17JY00.035


[[Page 44006]]


[GRAPHIC] [TIFF OMITTED] TR17JY00.036

BILLING CODE 6712-01-C
* * * * *

[[Page 44007]]

United States (US) Footnotes

* * * * *
    US246  Except for medical telemetry equipment operating in the band 
608-614 MHz, no stations shall be authorized to transmit in the 
following bands: 608-614 MHz, 1400-1427 MHz, 1660.5-1668.4 MHz, 2690-
2700 MHz, 4990-5000 MHz, 10.68-10.70 GHz, 15.35-15.40 GHz, 23.6-24.0 
GHz, 31.3-31.8 GHz, 51.4-54.25 GHz, 58.2-59.0 GHz, 64-65 GHz, 86-92 
GHz, 100-102 GHz, 105-116 GHz, 164-168 GHz, 182-185 GHz and 217-231 
GHz. Medical telemetry equipment shall not cause harmful interference 
to radio astronomy operations in the band 608-614 MHz and shall be 
coordinated under the requirements found in 47 CFR 95.1119.
* * * * *
    US350  In the bands 608-614 MHz, 1395-1400 MHz, and 1429-1432, the 
land mobile service is limited to medical telemetry and telecommand 
operations. Additionally, the band 1429-1432 MHz may be used on 
secondary basis for non-Government land mobile telemetry and 
telecommand and fixed telemetry.
    US351  In the band 1390-1400 MHz, Government operations, except for 
medical telemetry operations in the sub-band 1395-1400 MHz, are on a 
non-interference basis to authorized non-Government operations and 
shall not hinder implementation of any non-Government operations. 
However, Government operations authorized as of March 22, 1995 at 17 
sites identified below will be continued on a fully protected basis 
until January 1, 2009.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Radius                                                                Radius
                Sites                             Lat/Long                 (km)              Sites                      Lat/Long                 (km)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Eglin AFB, FL.......................  30 deg.28'N/086 deg.31'W.......           80  Ft. Greely, AK........  63 deg.47'N/145 deg.52'W                  80
Dugway PG, UT.......................  40 deg.11'N/112 deg.53'W.......           80  Ft. Rucker, AL........  31 deg.13'N/085 deg.49'W                  80
China Lake, CA......................  35 deg.41'N/117 deg.41'W.......           80  Redstone, AL..........  34 deg.35'N/086 deg.35'W                  80
Ft. Huachuca, AZ....................  31 deg.33'N/110 deg.18'W.......           80  Utah Test Range, UT...  40 deg.57'N/113 deg.05'W                  80
Cherry Point, NC....................  34 deg.57'N/076 deg.56'W.......           80  WSM Range, NM.........  32 deg.10'N/106 deg.21'W                  80
Patuxent River, MD..................  38 deg.17'N/076 deg.25'W.......           80  Holloman AFB, NM......  33 deg.29'N/106 deg.50'W                  80
Aberdeen PG, MD.....................  39 deg.29'N/076 deg.08'W.......           80  Yuma, AZ..............  32 deg.29'N/114 deg.20'W                  80
Wright-Patterson AFB, OH............  39 deg.50'N/084 deg.03'W.......           80  Pacific Missile Range,  34 deg.07'N/119 deg.30'W                  80
                                                                                     CA.
Edwards AFB, CA.....................  34 deg.54'N/117 deg.53'W.......           80
--------------------------------------------------------------------------------------------------------------------------------------------------------

    US352  In the band 1429-1432 MHz, Government operations, except for 
medical telemetry operations, are on a non-interference basis to 
authorized non-Government operations and shall not hinder the 
implementation of any non-Government operations. However, Government 
operations authorized as of March 22, 1995 at 14 sites identified below 
will be continued on a fully protected basis until January 1, 2004.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Radius                                                                Radius
                Sites                             Lat/Long                 (km)              Sites                      Lat/Long                 (km)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patuxent River, MD..................  38 deg.17'N/076 deg.25'W                  70  Mountain Home AFB, ID.  43 deg.01'N/115 deg.50'W                 160
NAS Oceana, VA......................  36 deg.49'N/076 deg.02'W                 100  NAS Fallon, NV........  39 deg.24'N/118 deg.43'W                 100
MCAS Cherry Point, NC...............  34 deg.54'N/076 deg.52'W                 100  Nellis AFB, NV........  36 deg.14'N/115 deg.02'W                 100
Beaufort MCAS, SC...................  32 deg.26'N/080 deg.40'W                 160  NAS Lemore, CA........  36 deg.18'N/119 deg.47'W                 120
NAS Cecil Field, FL.................  30 deg.13'N/081 deg.52'W                 160  Yuma MCAS, AZ.........  32 deg.39'N/114 deg.35'W                 160
NAS Whidbey IS., WA.................  48 deg.19'N/122 deg.24'W                  70  China Lake, CA........  35 deg.29'N/117 deg.16'W                  80
Yakima Firing Ctr AAF, WA...........  46 deg.40'N/120 deg.15'W                  70  MCAS Twenty Nine        34 deg.15'N/116 deg.03'W                  80
                                                                                     Palms, CA.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    G27  In the bands 225-328.6, 335.4-399.9, and 1350-1395 MHz, the 
fixed and mobile services are limited to the military services.
    G30  In the bands 138-144, 148-149.9, 150.05-150.8, 1427-1429, and 
1432-1435 MHz, the fixed and mobile services are limited primarily to 
operations by the military services.
* * * * *
    G114  In the band 1350-1395 MHz, the frequency 1381.05 MHz with 
emissions limited to 12 MHz is also allocated to fixed and 
mobile satellite services (space-to-earth) for the relay of nuclear 
burst data.
* * * * *
    5. Section 2.1093 is amended by revising paragraph (c) to read as 
follows:


Sec. 2.1093  Radiofrequency radiation exposure evaluation: portable 
devices.

* * * * *
    (c) Portable devices that operate in the Cellular Radiotelephone 
Service, the Personal Communications Service (PCS), the Satellite 
Communications Services, the General Wireless Communications Service, 
the Wireless Communications Service, the Maritime Services, the 
Specialized Mobile Radio Service, the Wireless Medical Telemetry 
Service (WMTS) and the Medical Implant Communications Service (MICS), 
authorized under subpart H of part 22 of this chapter, part 24 of this 
chapter, part 25 of this chapter, part 26 of this chapter, part 27 of 
this chapter, part 80 of this chapter (ship earth station devices 
only), part 90 of this chapter, subparts H and I of part 95, and 
unlicensed personal communication service, unlicensed NII devices and 
millimeter wave devices authorized under subparts D and E, Sec. 15.253 
and Sec. 15.255 of part 15 of this chapter are subject to routine 
environmental evaluation for RF exposure prior to equipment 
authorization or use. All other portable transmitting devices are 
categorically excluded from routine environmental evaluation for RF 
exposure prior to equipment authorization or use, except as specified 
in Secs. 1.1307(c) and 1.1307(d) of this chapter. Applications for 
equipment authorization of portable transmitting devices subject to 
routine environmental evaluation must contain a statement confirming 
compliance with the limits specified in paragraph (d) of this section 
as part of their application. Technical information showing the basis 
for this statement must be

[[Page 44008]]

submitted to the Commission upon request.
* * * * *

PART 15--RADIO FREQUENCY DEVICES

    6. The authority citation for Part 15 continues to read as follows:

    Authority: 47 U.S.C. 154, 302, 303, 304, 307 and 544A.

    7. Section 15.37 is amended by adding a new paragraph (i).


Sec. 15.37  Transition provisions for compliance with the rules.

* * * * *
    (i) Effective October 16, 2002, an equipment approval may no longer 
be obtained for medical telemetry equipment operating under the 
provisions of Sec. 15.241 or Sec. 15.242. The requirements for 
obtaining an approval for medical telemetry equipment after this date 
are found in Subpart H of Part 95 of this chapter.

PART 90--PRIVATE LAND MOBILE RADIO SERVICES

    8. The authority citation for Part 90 continues to read as follows:

    Authority:  Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of 
the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 
303(g), 303(r), 332(c)(7).

    9. Section 90.203 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 90.203  Certification required.

    (a) * * *
    (1) Effective October 16, 2002, an equipment approval may no longer 
be obtained for in-hospital medical telemetry equipment operating under 
the provisions of this part. The requirements for obtaining an approval 
for medical telemetry equipment after this date are found in Subpart H 
of Part 95 of this chapter.

PART 95--PERSONAL RADIO SERVICES

    10. The authority citation for Part 95 continues to read as 
follows:

    Authority: Sections 4, 303, 48 Stat. 1066, 1082, as amended; 47 
U.S.C. 154, 303.


    11. Section 95.401 is amended by adding a new paragraph (d) to read 
as follows:


Sec. 95.401  (CB Rule 1) What are the Citizens Band Radio Services?

* * * * *
    (d) The Wireless Medical Telemetry Service (WMTS)--a private, short 
distance data communication service for the transmission of patient 
medical information to a central monitoring location in a hospital or 
other medical facility. Voice and video communications are prohibited. 
Waveforms such as electrocardiograms (ECGs) are not considered video. 
The rules for this service are contained in subpart H of this part.

    12. Section 95.601 is amended by revising the last sentence of the 
introductory text to read as follows:


Sec. 95.601  Basis and purpose.

    * * * The Personal Radio Services are the GMRS (General Mobile 
Radio Service)-subpart A, the Family Radio Service (FRS)-subpart B, the 
R/C (Radio Control Radio Service)-subpart C, the CB (Citizens Band 
Radio Service)-subpart D, the Low Power Radio Service (LPRS)-subpart G, 
the Wireless Medical Telemetry Service (WMTS)-subpart H, and the 
Medical Implants Communication Service (MICS)-subpart I.

    13. Section 95.630 is added to read as follows:


Sec. 95.630  WMTS transmitter frequencies.

    WMTS transmitters may operate in the frequency bands specified 
below:

608-614 MHz
1395-1400 MHz
1429-1432 MHz


    14. Section 95.631 is amended by adding a new paragraph (h) to read 
as follows:


Sec. 95.631  Emission types.

* * * * *
    (h) A WMTS station may transmit any emission type appropriate for 
communications in this service, except for video and voice. Waveforms 
such as electrocardiograms (ECGs) are not considered video.

    15. Section 95.639 is amended by adding a new paragraph (f) to read 
as follows:


Sec. 95.639  Maximum transmitter power.

* * * * *
    (f) The maximum field strength authorized for WMTS stations in the 
608-614 MHz band is 200 mV/m, measured at 3 meters. For stations in the 
1395-1400 MHz and 1429-1432 MHz bands, the maximum field strength is 
740 mV/m, measured at 3 meters.

    16. Section 95.649 is revised to read as follows:


Sec. 95.649  Power capability.

    No CB, R/C, LPRS, FRS, MICS or WMTS unit shall incorporate 
provisions for increasing its transmitter power to any level in excess 
of the limits specified in Sec. 95.639.

    17. Section 95.651 is revised to read as follows:


Sec. 95.651  Crystal control required.

    All transmitters used in the Personal Radio Services must be 
crystal controlled, except an R/C station that transmits in the 26-27 
MHz frequency band, a FRS unit, a LPRS unit, a MICS transmitter, or a 
WMTS unit.
    18. Appendix 1 to Subpart E to Part 95--Glossary of Terms is 
revised to add the term ``WMTS. Wireless Medical Telemetry Service.'' 
at the end of the list.
    19. A new Subpart H is added to Part 95 to read as follows:
Subpart H--Wireless Medical Telemetry Service (WMTS)

General Provisions

Sec.
95.1101   Scope.
95.1103   Definitions.
95.1105   Eligibility.
95.1107   Authorized locations.
95.1109   Equipment authorization requirement.
95.1111   Frequency coordination.
95.1113   Frequency coordinator.
95.1115   General technical requirements.
95.1117   Types of communications.
95.1119   Specific requirements for wireless medical telemetry 
devices operating in the 608-614 MHz band.
95.1121   Specific requirements for wireless medical telemetry 
devices operating in the 1395-1400 MHz and 1429-1432 MHz bands.
95.1123   Protection of medical equipment.
95.1125   RF Safety.
95.1127   Station identification.
95.1129   Station inspection.
* * * * *

Subpart H--Wireless Medical Telemetry Service (WMTS)

General Provisions


Sec. 95.1101  Scope.

    This part sets out the regulations governing the operation of 
Wireless Medical Telemetry Devices in the 608-614 MHz, 1395-1400 MHz 
and 1429-1432 MHz frequency bands.


Sec. 95.1103  Definitions.

    (a) Authorized health care provider. A physician or other 
individual authorized under state or federal law to provide health care 
services, or any other health care facility operated by or employing 
individuals authorized under state or federal law to provide health 
care services, or any trained technician operating under the 
supervision and control of an individual or health care facility 
authorized under state or federal law to provide health care services.

[[Page 44009]]

    (b) Health care facility. A health care facility includes hospitals 
and other establishments that offer services, facilities and beds for 
use beyond a 24 hour period in rendering medical treatment, and 
institutions and organizations regularly engaged in providing medical 
services through clinics, public health facilities, and similar 
establishments, including government entities and agencies such as 
Veterans Administration hospitals; except the term health care facility 
does not include an ambulance or other moving vehicle.
    (c) Wireless medical telemetry. The measurement and recording of 
physiological parameters and other patient-related information via 
radiated bi-or unidirectional electromagnetic signals in the 608-614 
MHz, 1395-1400 MHz, and 1429-1432 MHz frequency bands.


Sec. 95.1105  Eligibility.

    Authorized health care providers are authorized by rule to operate 
transmitters in the Wireless Medical Telemetry Service without an 
individual license issued by the Commission provided the coordination 
requirements in Sec. 95.1111 have been met. Manufacturers of wireless 
medical telemetry devices and their representatives are authorized to 
operated wireless medical telemetry transmitters in this service solely 
for the purpose of demonstrating such equipment to, or installing and 
maintaining such equipment for, duly authorized health care providers. 
No entity that is a foreign government or which is active in the 
capacity as a representative of a foreign government is eligible to 
operate a WMTS transmitter.


Sec. 95.1107  Authorized locations.

    The operation of a wireless medical telemetry transmitter under 
this part is authorized anywhere within a health care facility provided 
the facility is located anywhere a CB station operation is permitted 
under Sec. 95.405. This authority does not extend to mobile vehicles, 
such as ambulances, even if those vehicles are associated with a health 
care facility.


Sec. 95.1109  Equipment authorization requirement.

    (a) Wireless medical telemetry devices operating under this part 
must be authorized under the certification procedure prior to marketing 
or use in accordance with the provisions of Part 2, Subpart J of this 
chapter.
    (b) Each device shall be labeled with the following statement:
    Operation of this equipment requires the prior coordination with a 
frequency coordinator designated by the FCC for the Wireless Medical 
Telemetry Service.


Sec. 95.1111  Frequency coordination.

    (a) Prior to operation, authorized health care providers who desire 
to use wireless medical telemetry devices must register all devices 
with a designated frequency coordinator. The registration must include 
the following information:
    (1) Specific frequencies or frequency range(s) used;
    (2) Modulation scheme used (including occupied bandwidth);
    (3) Effective radiated power;
    (4) Number of transmitters in use at the health care facility as of 
the date of registration including manufacturer name(s) and model 
numbers);
    (5) Legal name of the authorized health care provider;
    (6) Location of transmitter (coordinates, street address, 
building);
    (7) Point of contact for the authorized health care provider (name, 
title, office, phone number, fax number, e-mail address).
    (b) An authorized health care provider shall notify the frequency 
coordinator whenever a medical telemetry device is permanently taken 
out of service, unless the device is replaced with another transmitter 
utilizing the same technical characteristics as those reported on the 
effective registration. An authorized health care provider shall 
maintain the information contained in each registration current in all 
material respects, and shall notify the frequency coordinator when any 
change is made in the location or operating parameters previously 
reported which is material.


Sec. 95.1113  Frequency coordinator.

    (a) The Commission will designate a frequency coordinator(s) to 
manage the usage of the frequency bands for the operation of medical 
telemetry devices.
    (b) The frequency coordinator shall (1) Review and process 
coordination requests submitted by authorized health care providers as 
required in Sec. 95.1111; (2) maintain a database of WMTS use; (3) 
notify users of potential conflicts; and (4) coordinate WMTS operation 
with radio astronomy observatories and Federal Government radar systems 
as specified in Secs. 95.1119 and 95.1121.


Sec. 95.1115  General technical requirements.

    (a) Field strength limits. (1) In the 608-614 MHz band, the maximum 
allowable field strength is 200 mV/m, as measured at a distance of 3 
meters, using measuring instrumentation with a CISPR quasi-peak 
detector.
    (2) In the 1395-1400 MHz and 1429-1432 MHz bands, the maximum 
allowable field strength is 740 mV/m, as measured at a distance of 3 
meters, using measuring equipment with an averaging detector and a 1 
MHz measurement bandwidth.
    (b) Undesired emissions. (1) Out-of-band emissions below 960 MHz 
are limited to 200 /m, as measured at a distance of 3 meters, 
using measuring instrumentation with a CISPR quasi-peak detector.
    (2) Out-of-band emissions above 960 MHz are limited to 500 
m as measured at a distance of 3 meters using measuring 
equipment with an averaging detector and a 1 MHz measurement bandwidth.
    (c) Emission types. A wireless medical telemetry device may 
transmit any emission type appropriate for communications in this 
service, except for video and voice. Waveforms such as 
electrocardiograms (ECGs) are not considered video.
    (d) Channel use. (1) In the 1395-1400 MHz and 1429-1432 MHz bands, 
no specific channels are specified. Wireless medical telemetry devices 
may operate on any channel within the bands authorized for wireless 
medical telemetry use in this part.
    (2) In the 608-614 MHz band, wireless medical telemetry devices 
utilizing broadband technologies such as spread spectrum shall be 
capable of operating within one or more of the following channels of 
1.5 MHz each, up to a maximum of 6 MHz, and shall operate on the 
minimum number of channels necessary to avoid harmful interference to 
any other wireless medical telemetry devices.

608.0-609.5 MHz
609.5-611.0 MHz
611.0-612.5 MHz
612.5-614.0 MHz

    (3) Channel usage is on a co-primary shared basis only, and 
channels will not be assigned for the exclusive use of any entity.
    (4) Authorized health care providers, in conjunction with the 
equipment manufacturers, must cooperate in the selection and use of 
frequencies in order to reduce the potential for interference with 
other wireless medical telemetry devices, or other co-primary users. 
Operations in the 608-614 MHz band (television channel 37) are not 
protected from adjacent band interference from broadcast television 
operating on channels 36 and 38.
    (e) Frequency stability. Manufacturers of wireless medical 
telemetry devices are responsible for ensuring frequency stability such 
that an emission is maintained within the band of operation under all 
of the manufacturer's specified conditions.

[[Page 44010]]

Sec. 95.1117  Types of communications.

    (a) All types of communications except voice and video are 
permitted, on both a unidirectional and bidirectional basis, provided 
that all such communications are related to the provision of medical 
care. Waveforms such as electrocardiograms (ECGs) are not considered 
video.
    (b) Operations that comply with the requirements of this part may 
be conducted under manual or automatic control, and on a continuous 
basis.


Sec. 95.1119  Specific requirements for wireless medical telemetry 
devices operating in the 608-614 MHz band.

    For a wireless medical telemetry device operating within the 
frequency range 608-614 MHz and that will be located near the radio 
astronomy observatories listed below, operation is not permitted until 
a WMTS frequency coordinator specified in Sec. 95.1113 has coordinated 
with, and obtain the written concurrence of, the director of the 
affected radio astronomy observatory before the equipment can be 
installed or operated
    (a) Within 80 kilometers of:
    (1) National Astronomy and Ionosphere Center, Arecibo, Puerto Rico: 
18 deg.20'38.28" North Latitude, 66 deg. 45'09.42" West Longitude.
    (2) National Radio Astronomy Observatory, Socorro, New Mexico: 
34 deg. 04'43" North Latitude, 107 deg.37'04" West Longitude.
    (3) National Radio Astronomy Observatory, Green Bank, West 
Virginia: 38 deg.26'08" North Latitude, 79 deg.49'42" West Longitude.
    (b) Within 32 kilometers of the National Radio Astronomy 
Observatory centered on:

------------------------------------------------------------------------
 Very long baseline array stations  Latitude  (north)  Longitude  (west)
------------------------------------------------------------------------
Pie Town, NM......................  34 deg. 18'        108 deg. 07'
Kitt Peak, AZ.....................  31 deg. 57'        111 deg. 37'
Los Alamos, NM....................  35 deg. 47'        106 deg. 15'
Fort Davis, TX....................  30 deg. 38'        103 deg. 57'
North Liberty, IA.................  41 deg. 46'        91 deg. 34'
Brewster, WA......................  48 deg. 08'        119 deg. 41'
Owens Valley, CA..................  37 deg. 14'        118 deg. 17'
Saint Croix, VI...................  17 deg. 46'        64 deg. 35'
Mauna Kea, HI.....................  19 deg. 49'        155 deg. 28'
Hancock, NH.......................  42 deg. 56'        71 deg. 59'
------------------------------------------------------------------------

    The National Science Foundation point of contact for coordination 
is: Spectrum Manager, Division of Astronomical Sciences, NSF Room 1045, 
4201 Wilson Blvd., Arlington, VA 22230, telephone: 703-306-1823.


Sec. 95.1121  Specific requirements for wireless medical telemetry 
devices operating in the 1395-1400 MHz and 1429-1432 MHz bands.

    Due to the critical nature of communications transmitted under this 
part, the frequency coordinator in consultation with the National 
Telecommunications and Information Administration shall determine 
whether there are any federal government radar systems whose operations 
could affect, or could be affected by, proposed wireless medical 
telemetry operations in the 1395-1400 MHz and 1429-1432 MHz bands. The 
locations of government radar systems in these bands are specified in 
footnotes US351 and US352 of Sec. 2.106 of this chapter.


Sec. 95.1123  Protection of medical equipment.

    The manufacturers, installers and users of WMTS equipment are 
cautioned that the operation of this equipment could result in harmful 
interference to other nearby medical devices.


Sec. 95.1125  RF safety.

    Portable devices as defined in Sec. 2.1093(b) of this chapter 
operating in the WMTS are subject to radio frequency radiation exposure 
requirements as specified in Secs. 1.1307(b) and 2.1093 of this 
chapter. Applications for equipment authorization of WMTS devices must 
contain a statement confirming compliance with these requirements. 
Technical information showing the basis for this statement must be 
submitted to the Commission upon request.


Sec. 95.1127  Station identification.

    A WMTS station is not required to transmit a station identification 
announcement.


Sec. 95.1129  Station inspection.

    All WMTS transmitters must be available for inspection upon request 
by an authorized FCC representative.
[FR Doc. 00-17970 Filed 7-14-00; 8:45 am]
BILLING CODE 6712-01-U