Spectrum Requirements for Advanced Medical Technologies, 43682-43687 [E6-12500]

Agencies

• FEDERAL COMMUNICATIONS COMMISSION

[Federal Register Volume 71, Number 148 (Wednesday, August 2, 2006)]
[Proposed Rules]
[Pages 43682-43687]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12500]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Parts 2 and 95

[ET Docket No. 06-135; FCC 06-103]


Spectrum Requirements for Advanced Medical Technologies

AGENCY: Federal Communications Commission.

ACTION: Proposed rule.

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SUMMARY: This document focuses on ways to better accommodate the 
operation of implanted and body-worn medical transmitters in the 400 
MHz band. These devices use wireless technologies for increasingly 
sophisticated and beneficial health care applications. Such 
applications currently include cardiac defibrillators for heart 
patients and real-time blood sugar monitoring devices for diabetics, 
and may, in the future, include applications as diverse as brain, 
muscle and nerve stimulation techniques for treating an array of 
conditions from Parkinson's disease to severe chronic depression. The 
Commission tentatively concludes that modifying its current rules and 
designating an additional two megahertz of spectrum in the adjacent 
401-402 MHz and 405-406 MHz bands) would appropriately provide needed 
capacity and more flexible operating rules for beneficial medical radio 
communication devices and thereby serve the public interest.

DATES: Comments must be filed on or before October 31, 2006, and reply 
comments must be filed on or before December 4, 2006.

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

ADDRESSES: You may submit comments, identified by ET Docket No. 06-135 
by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Federal Communications Commission's Web Site: https://
www.fcc.gov/cgb/ecfs/. Follow the instructions for submitting comments.
     E-mail: [Optional: Include the E-mail address only if you 
plan to accept comments from the general public]. Include the docket 
number(s) in the subject line of the message.
     Mail: [Optional: Include the mailing address for paper, 
disk or CD-ROM submissions needed/requested by your Bureau or Office. 
Do not include the Office of the Secretary's mailing address here.]

[[Page 43683]]

     People with Disabilities: Contact the FCC to request 
reasonable accommodations (accessible format documents, sign language 
interpreters, CART, etc.) by e-mail: FCC504@fcc.gov or phone: 202-418-
0530 or TTY: 202-418-0432.
    For detailed instructions for submitting comments and additional 
information on the rulemaking process, see the SUPPLEMENTARY 
INFORMATION section of this document.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Notice 
of Proposed Rule Making and Notice of Inquiry, ET Docket No. 06-135, 
FCC 06-103, adopted July 13, 2006, and released July 18, 2006. The full 
text of this document 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 20554. The complete text of 
this document also may be purchased from the Commission's copy 
contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room, 
CY-B402, Washington, DC 20554. The full text may also be downloaded at: 
https://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).
     Electronic Filers: Comments may be filed electronically 
using the Internet by accessing the ECFS: https://www.fcc.gov/cgb/ecfs/ or the Federal eRulemaking Portal: https://www.regulations.gov. Filers 
should follow the instructions provided on the Web site for submitting 
comments.
     For ECFS filers, if multiple docket or rulemaking numbers 
appear in the caption of this proceeding, filers must transmit one 
electronic copy of the comments for each docket or rulemaking number 
referenced in the caption. In completing the transmittal screen, filers 
should include their full name, U.S. Postal Service mailing address, 
and the applicable docket or rulemaking number. Parties may also submit 
an electronic comment by Internet e-mail. To get filing instructions, 
filers should send an e-mail to ecfs@fcc.gov, and include the following 
words in the body of the message, ``get form.'' A sample form and 
directions will be sent in response.
     Paper Filers: Parties who choose to file by paper must 
file an original and four copies of each filing. If more than one 
docket or rulemaking number appears in the caption of this proceeding, 
filers must submit two additional copies for each additional docket or 
rulemaking number.
    Filings can be sent by hand or messenger delivery, by commercial 
overnight courier, or by first-class or overnight U.S. Postal Service 
mail (although we continue to experience delays in receiving U.S. 
Postal Service mail). All filings must be addressed to the Commission's 
Secretary, Office of the Secretary, Federal Communications Commission.
     The Commission's contractor will receive hand-delivered or 
messenger-delivered paper filings for the Commission's Secretary at 236 
Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing 
hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be 
held together with rubber bands or fasteners. Any envelopes must be 
disposed of before entering the building.
     Commercial overnight mail (other than U.S. Postal Service 
Express Mail and Priority Mail) must be sent to 9300 East Hampton 
Drive, Capitol Heights, MD 20743.
     U.S. Postal Service first-class, Express, and Priority 
mail should be addressed to 445 12th Street, SW., Washington DC 20554.
    People with Disabilities: To request materials in accessible 
formats for people with disabilities (braille, large print, electronic 
files, audio format), send an e-mail to fcc504@fcc.gov or call the 
Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-
418-0432 (tty).

Summary of Notice of Proposed Rulemaking and Notice of Inquiry

    1. The Notice of Proposed Rule Making (NPRM) and Notice of Inquiry 
(Inquiry), focuses on ways to better accommodate the operation of 
implanted and body-worn medical transmitters in the 400 MHz band. These 
devices use wireless technologies for increasingly sophisticated and 
beneficial health care applications. Such applications currently 
include cardiac defibrillators for heart patients and real-time blood 
sugar monitoring devices for diabetics, and may, in the future, include 
applications as diverse as brain, muscle and nerve stimulation 
techniques for treating an array of conditions from paralysis to 
Parkinson's disease to severe chronic depression. The Commission 
tentatively concludes that modifying its current rules and designating 
an additional two megahertz of spectrum would appropriately provide 
increased capacity and more flexible operating rules for beneficial 
medical radio communication devices and thereby serve the public 
interest.
    2. Medtronic, Inc., filed a Petition for Rulemaking (Medtronic 
petition) proposing to establish a new service for implantable and 
body-worn medical radiocommunication devices in two megahertz of 
spectrum (at 401-402 MHz and 405-406 MHz) adjacent to the 402-405 MHz 
band currently authorized for the Medical Implant Communications 
Service (MICS). Medtronic states that this new allocation would 
complement the existing MICS allocation and support advances in medical 
sensor technology and the expected proliferation of such devices, 
especially those used for lower-cost medical monitoring and non-
emergency reporting applications. Biotronik, Inc., has also filed a 
petition for rulemaking with proposals that conflict with those in the 
Medtronic petition, and that petition is also being considered.
    3. As demonstrated by developments in the industry and by the 
response to the Medtronic petition for rulemaking, there is significant 
interest in using the 401-406 MHz MICS band for new diagnostic, 
therapeutic, and monitoring medical technologies. Based on the 
information provided by all parties, the FCC is proposing to add two 
additional megahertz of spectrum for implanted and body-worn medical 
transmitters to the existing MICS allocation at 402-405 MHz. It 
specifically proposes to add the 401-402 MHz and 405-406 MHz (``wing 
bands'') to the existing MICS allocation. These bands appear well-
suited for implanted and body-worn medical radio devices for the same 
reasons 402-405 MHz was originally designated for MICS, i.e., 
propagation characteristics, availability, and compatibility with other 
users. It asserts that the provision of contiguous spectrum will 
provide for the maximum efficiency of design and operation.
    4. The FCC proposes to maintain the existing MICS rules in this 
spectrum, and continue to license use of MICS devices by rule. It 
further proposes to permit non-implanted antennas connected through the 
body to implanted devices under these rules. Accordingly, it will 
henceforth refer to this service as ``Medical Device Radiocommunication 
Service,'' (``MedRadio''), to eliminate the implication that it is 
intended exclusively for implanted radios or implanted devices. It 
seeks comment on whether the various current MICS rules would continue 
to be appropriate for

[[Page 43684]]

operations under the new allocation, on the explicit inclusion of non-
implanted transmitters, on whether or how to divide the spectrum 
between frequency agile and non-frequency-agile devices, and on whether 
certain medical devices as contemplated herein would be better served 
by a licensed operation regime.
    5. In addition, the Commission seeks comment on whether there are 
some functions for which a narrower bandwidth is appropriate, and why, 
and whether there is sufficient justification for the more stringent 
attenuation limits described in the Medtronic petition. Commenters 
supporting emission limits other than those currently in the rules 
should provide technical analysis and practical rationale explaining 
why other limits would be more appropriate, and the relative difficulty 
or cost of compliance associated with their proposed limits. Commenters 
proposing a reduced field strength for body-worn transmitters should 
also provide technical analysis supporting their position.
    6. The Commission also proposes to adopt rules for the 401-402 MHz 
and 405-406 MHz bands that would permit body-worn and implant 
transmitters having low-power and low duty cycles to operate without 
frequency monitoring capability, as suggested by Medtronic and 
supported by several commenters. Because such devices would pose a 
small risk of causing harmful interference, the Commission believes 
that permitting the operation of such devices without frequency 
monitoring could simplify devices, reduce their size, and extend their 
operational life. This could help lower the cost of medical data 
collection and therapy in both the care center and home environments, 
as well as provide physicians with an easy and accurate way to make 
routine adjustments to internal and external medical radio devices such 
as neural stimulators and insulin pumps. It suggests that providing 
additional spectrum for deployment of these devices could prove 
beneficial in keeping otherwise healthy individuals out of hospital 
beds and nursing facilities and allow many more individuals to live 
independently for a longer period of time. It seeks comment on the 
potential benefits of expanding the authority for operation of 400 MHz 
medical devices that do not employ frequency agility capabilities.
    7. Specifically, it proposes to allow medical implant or body-worn 
devices and associated control station devices that operate without 
frequency agility at 401-402 MHz and 405-406 MHz to operate with an 
EIRP that does not exceed 250 nanowatts (nW) and a duty cycle that does 
not exceed 0.1% during any one-hour interval. Based on the information 
available to us, this proposal appears to reflect a reasonable balance 
between the operational capabilities needed for devices to function 
properly and the need to minimize the risk of interference to other 
devices in the band. The Commission seeks comment on this proposal, 
including whether other power and duty cycle thresholds would be more 
appropriate, and what trade-offs they would entail.
    8. It also notes Biotronik's contention that there is ample 
capacity in the current MICS allocation for a variety and large number 
of devices, and seeks additional comment on whether the additional 
spectrum proposed is needed for future medical devices, or whether such 
devices should be accommodated in the existing 402-405 MHz allocations, 
with appropriate modifications to the operational rules (100nw and 
0.1%/day duty cycle), such as those proposed by Biotronik in its 
rulemaking petition. It also invites comment on whether the 401-406 MHz 
band should be apportioned differently among the various types of 
operation than as proposed, both in relative amounts of spectrum 
designated, and in the specific frequencies permitted for each type of 
operation. For instance, should a portion of spectrum be exclusively 
designated for non-frequency-monitoring devices, and if so, how much? 
Can the provision of exclusive spectrum for frequency monitoring 
devices be made unnecessary by appropriate restrictions on other 
devices? Is additional spectrum beyond that proposed above needed for 
implanted and body-worn medical radio devices? Comments suggesting the 
allocation of additional spectrum should discuss the basis for 
projecting future types of uses and needs.
    9. While the present MICS rules can be read to have assumed that an 
implant transmitter, as part of an implant device, would be located 
under the skin, it is now apparent that transmitters for implanted 
devices can, in many cases, be located on the surface of the skin. 
Additionally, it appears that there are body-worn devices that can 
perform critical diagnostic, therapeutic, and monitoring functions, and 
the Commission proposes to accommodate such devices in our rules. In 
both cases, the Commission believes that it is the location of the 
transmitter, not the medical device, that should dictate its 
operational parameters, as it is the location that will determine its 
communication capability and its interference potential. It proposes to 
modify the rules to so provide. It also seeks comment on Medtronic's 
proposed definition of a body-worn transmitter as one ``intended to be 
placed on or in very close proximity (six centimeters or less) to the 
human body used to facilitate communications from a medical body-worn 
or implanted device.
    10. The Commission proposes to focus on providing flexibility in 
the use of spectrum for implanted and body-worn medical radio devices. 
The Commission notes that the Medtronic petition suggests distinctions 
depending upon factors such as whether a device uses spectrum 
intensively or is used for life-critical applications. The Commission 
asserts that it is neither its role, nor its area of expertise, to 
adopt rules that would define operating criteria based upon such 
determinations. Instead, medical device manufacturers should be 
cognizant of the potential health and safety risks that could arise if 
implanted or body-worn medical radiocommunication devices are subjected 
to various levels of RF interference in a dynamic and unpredictable RF 
environment, and design their products with appropriate safeguards and 
robustness as is appropriate to their function. It further suggest that 
such concerns are more appropriately taken into consideration and 
evaluated as part of the FDA medical device approval process. 
Therefore, the it declines to propose any rules based upon such 
criteria, and seeks comment on this position.
    11. Part 15 of the FCC's rules restricts radiation from unlicensed 
devices in certain frequency bands (``restricted bands'') to spurious 
emissions only. The 90-110 kHz band is included among the restricted 
bands in order to protect incumbent the Loran-C operations.
    12. Guidant Corporation (Guidant) (now Boston Scientific) states 
that it is unclear how induction devices fit under the Commission's 
restricted band prohibition of Sec.  15.205, and asks the Commission to 
amend the part 95 rules to include medical implant devices such as 
those made by Guidant that use inductive telemetry in the 90-110 kHz 
band. More specifically, it requests that the Commission provide a 
narrow exception to the part 15 restricted band prohibitions for 
medical implants or, preferably, amend the MICS rules to expressly 
include all implants, including those that operate inductively in the 
90-110 kHz band.
    13. The FCC seeks comment on whether inductive devices such as 
those made by Guidant should be authorized to operate if they produce 
RF energy in the 90-110 kHz band. It asks

[[Page 43685]]

commenters to address the advantages and disadvantages of allowing or 
prohibiting such operation, including the resulting interference 
potential. If such operation were to be permitted, what approach should 
be taken? For example, similar to the modified MedRadio rules proposed 
herein, a secondary allocation for inductively coupled medical devices 
could be created in the 90-110 kHz band on a licensed-by-rule basis 
under part 95. Another option would be to provide an exception to the 
restricted band spurious emission limits for unlicensed medical devices 
that use inductive coupling in the 90-110 kHz band. Alternatively, a 
waiver could be granted that would permit manufacture, sale, and use of 
such devices for a limited period of time until devices fully compliant 
with the present rules can be developed. It invites commenters to 
address the relative merits of these options, and to suggest any other 
options. It also seeks comment on the more general question raised by 
Guidant concerning how to address emissions from medical implant 
devices that employ inductive coupling technology for communicating 
with associated external devices.
    14. The Commission also begins an Inquiry into additional 
developments that are anticipated in the medical devices field and 
their likely spectrum requirements that will enable us to subsequently 
develop proposals for additional rules as may be appropriate for their 
operation, based on the input received. Increasing numbers of implanted 
and body-worn medical devices will rely upon wireless 
radiocommunication technologies for increasingly sophisticated 
therapies. These include devices to assist in everything from motor 
function to eyesight, significantly mitigating the effects of once 
debilitating injuries or diseases. Accordingly, we seek to develop a 
comprehensive record concerning the present and future RF spectrum 
requirements as well as device immunity issues with respect to these 
medical radio devices in order to better inform our current rulemaking 
effort and to provide a basis for further rule changes. The Commission 
seeks information concerning new and anticipated implant and body-worn 
medical radiocommunication technologies and how it can anticipate and 
proactively address the challenging array of RF spectrum sharing issues 
raised by their increasing use, including the protection of user health 
and safety when implants receive interference from primary allocated 
services in the band. The Commission seeks comment on the relative 
benefits and tradeoffs that should be considered with respect to both 
licensed and unlicensed approaches to authorizing the operation of 
these devices.
    15. Finally, the Commission also seeks comment on collaborative 
efforts between the Commission (FCC) and the U.S. Food and Drug 
Administration (FDA) regarding options for better educating device 
manufacturing industry leaders and RF wireless technology leaders about 
medical radio device electromagnetic compatibility (EMC) coexistence 
issues in an RF environment. The Commission's goal is to create an 
environment that fosters continuing advances in medical devices through 
flexible RF spectrum allocations with the minimum FCC regulatory 
requirements that are necessary for efficient use of the spectrum and 
to ensure patient safety.

Initial Regulatory Flexibility Analysis

    16. As required by the Regulatory Flexibility Act of 1980, as 
amended (RFA),\1\ the Commission has prepared this present Initial 
Regulatory Flexibility Analysis (IRFA) of the possible significant 
economic impact on a substantial number of small entities by the 
policies and rules proposed in the Notice of Proposed Rule Making 
(NPRM). Written public comments are requested on this IRFA. Comments 
must be identified as responses to the IRFA and must be filed by the 
deadlines for comments provided in paragraph 53 of the NPRM. The 
Commission will send a copy of the NPRM, including this IRFA, to the 
Chief Counsel for Advocacy of the Small Business Administration 
(SBA).\2\
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    \1\ See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601-612, has been 
amended by the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 847 (1996).
    \2\ See 5 U.S.C. 603(a).
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A. Need for, and Objectives of, the Proposed Rules

    17. In this proceeding, the Commission explores future spectrum 
requirements for advanced medical devices that use wireless 
radiocommunication technologies. Wireless technologies are increasingly 
being used in medical devices for a variety of purposes ranging from 
basic telemetry transmission to more sophisticated health care 
applications.\3\ Our focus in this proceeding is primarily on implanted 
and body-worn medical radiocommunication devices (MRDs) that serve to 
actively manage and maintain body function/health conditions.\4\ 
Technological advances in this field are evolutionizing health care for 
the benefit of all Americans. Our goal is to create an environment that 
fosters continuing advances through flexible RF spectrum allocations 
and reduced regulatory requirements.
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    \3\ Telemetry is the use of telecommunication for automatically 
indicating or recording measurements at a distance from the 
measuring instrument. 47 CFR 2.1.
    \4\ Part 95 of the Commission's rules define ``medical implant 
transmitter'' as a ``* * * transmitter that operates or is designed 
to operate within the human body for the purpose of facilitating 
communications from a medical implant device.'' See Appendix 1 to 
Subpart E of Part 95--Glossary of Terms (following 47 CFR 95.673). 
The term ``body-worn'' is not defined by our current rules, however, 
as discussed in Rulemaking herein, we propose to adopt an analogous 
definition for medical body-worn transmitters namely, a 
``transmitter intended to be placed on or in very close proximity 
(i.e., 6 centimeters or less) to the human body used to facilitate 
communications from a medical body-worn or implanted device.''
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    18. Based on the responses we have received to a Petition for 
Rulemaking from Medtronic, Inc., the Commission believes that there is 
need for additional spectrum in the 400 MHz range for implanted and 
body-worn MRDs. Thus, in the Rulemaking portion of this proceeding, the 
Commission proposes to allocate two megahertz of spectrum for use by 
MRDs in the 401-402 MHz and 405-406 MHz bands that are adjacent to the 
existing Medical Implant Communication Service (MICS) allocation in the 
402-505 MHz band. The Commission seeks comment on establishing a new 
Medical Data Service (MEDS) that would encompass all MRDs operating in 
the entire 401-406 MHz band.

B. Legal Basis

    19. The proposed action is authorized under sections 1, 4(i), 7(a), 
301, 303(f), 303(g), 303(r), 307, 316, and 332 of the Communications 
Act of 1934, as amended, 47 U.S.C. sections 151, 154(i), 157(a), 301, 
303(f), 303(g), 303(r), 307, 316, and 332.

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

    20. 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.\5\ The RFA generally 
defines the term ``small entity'' as having the same meaning as the 
terms ``small business,'' ``small organization,'' and ``small 
governmental jurisdiction.'' \6\ In addition, the term ``small 
business'' has the same meaning as the term ``small business concern''

[[Page 43686]]

under the Small Business Act.\7\ 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.\8\
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    \5\ 5 U.S.C. 603(b)(3).
    \6\ 5 U.S.C. 601(6).
    \7\ 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).
    \8\ Small Business Act, 15 U.S.C. 632 (1996).
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    21. Nationwide, there are a total of approximately 22.4 million 
small businesses, according to SBA data.\9\ A ``small organization'' is 
generally ``any not-for-profit enterprise which is independently owned 
and operated and is not dominant in its field.'' \10\ Nationwide, as of 
2002, there were approximately 1.6 million small organizations.\11\ 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.'' 
\12\ Census Bureau data for 2002 indicate that there were 87,525 local 
governmental jurisdictions in the United States.\13\ We estimate that, 
of this total, 84,377 entities were ``small governmental 
jurisdictions.'' \14\ Thus, we estimate that most governmental 
jurisdictions are small.
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    \9\ See SBA, Programs and Services, SBA Pamphlet No. CO-0028, at 
page 40 (July 2002).
    \10\ 5 U.S.C. 601(4).
    \11\ Independent Sector, The New Nonprofit Almanac & Desk 
Reference (2002).
    \12\ 5 U.S.C. 601(5).
    \13\ U.S. Census Bureau, Statistical Abstract of the United 
States: 2006, Section 8, page 272, Table 415.
    \14\ 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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    Personal Radio Services. We are proposing to place the MEDS within 
part 95 of our rules (``Personal Radio Services''). Personal radio 
services provide short-range, low power radio for personal 
communications, radio signaling, and business communications not 
provided for in other services. The Personal Radio Services include 
spectrum licensed under part 95 of our rules.\15\ Many of the licensees 
in these services are individuals, and thus are not small entities. In 
addition, due to the mostly unlicensed and shared nature of the 
spectrum utilized in many of these services, the Commission lacks 
direct information other than the census data above, upon which to base 
an estimation of the number of small entities under an SBA definition 
that might be directly affected by the proposed rules.
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    \15\ 47 CFR part 90.
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    Wireless Service Providers. The SBA has developed a small business 
size standard for wireless firms within the two broad economic census 
categories of ``Paging'' \16\ and ``Cellular and Other Wireless 
Telecommunications.'' \17\ Under both categories, the SBA deems a 
wireless business to be small if it has 1,500 or fewer employees. For 
the census category of Paging, Census Bureau data for 2002 show that 
there were 807 firms in this category that operated for the entire 
year.\18\ Of this total, 804 firms had employment of 999 or fewer 
employees, and three firms had employment of 1,000 employees or 
more.\19\ Thus, under this category and associated small business size 
standard, the majority of firms can be considered small. For the census 
category of Cellular and Other Wireless Telecommunications, Census 
Bureau data for 2002 show that there were 1,397 firms in this category 
that operated for the entire year.\20\ Of this total, 1,378 firms had 
employment of 999 or fewer employees, and 19 firms had employment of 
1,000 employees or more.\21\ Thus, under this second category and size 
standard, the majority of firms can, again, be considered small.
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    \16\ 13 CFR 121.201, NAICS code 517211.
    \17\ 13 CFR 121.201, NAICS code 517212.
    \18\ U.S. Census Bureau, 2002 Economic Census, Subject Series: 
``Information,'' Table 5, Employment Size of Firms for the United 
States: 2002, NAICS code 517211 (issued Nov. 2005).
    \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.''
    \20\ U.S. Census Bureau, 2002 Economic Census, Subject Series: 
``Information,'' Table 5, Employment Size of Firms for the United 
States: 2002, NAICS code 517212 (issued Nov. 2005).
    \21\ 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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    Public Safety Radio Services. Public Safety radio services include 
police, fire, local government, forestry conservation, highway 
maintenance, and emergency medical services.\22\ For small businesses 
in this category, the above small business size standard applies to 
1500 or fewer employees. There are a total of approximately 127,540 
licensees in these services. Governmental entities \23\ as well as 
private businesses comprise the licensees for these services. All 
governmental entities with populations of less than 50,000 fall within 
the definition of a small entity.\24\
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    \22\ With the exception of the special emergency service, these 
services are governed by Subpart B of part 90 of the Commission's 
Rules, 47 CFR 90.15-90.27. The police service includes approximately 
27,000 licensees that serve state, county, and municipal enforcement 
through telephony (voice), telegraphy (code) and teletype and 
facsimile (printed material). The fire radio service includes 
approximately 23,000 licensees comprised of private volunteer or 
professional fire companies as well as units under governmental 
control. The local government service that is presently comprised of 
approximately 41,000 licensees that are state, county, or municipal 
entities that use the radio for official purposes not covered by 
other public safety services. There are approximately 7,000 
licensees within the forestry service which is comprised of 
licensees from state departments of conservation and private forest 
organizations who set up communications networks among fire lookout 
towers and ground crews. The approximately 9,000 state and local 
governments are licensed to highway maintenance service provide 
emergency and routine communications to aid other public safety 
services to keep main roads safe for vehicular traffic. The 
approximately 1,000 licensees in the Emergency Medical Radio Service 
(EMRS) use the 39 channels allocated to this service for emergency 
medical service communications related to the delivery of emergency 
medical treatment. 47 CFR 90.15-90.27. The approximately 20,000 
licensees in the special emergency service include medical services, 
rescue organizations, veterinarians, handicapped persons, disaster 
relief organizations, school buses, beach patrols, establishments in 
isolated areas, communications standby facilities, and emergency 
repair of public communications facilities. 47 CFR 90.33-90.55.
    \23\ 47 CFR 1.1162.
    \24\ 5 U.S.C. 601(5).
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D. Description of Projected Reporting, Recordkeeping, and Other 
Compliance Requirements

    22. We propose a licensing approach for the 401-402 MHz and 405-406 
MHz wing bands identical to that used for the existing MICS center 
band. Thus, rather than require individual transmitter licensing, we 
propose to authorize operation by rule within the Citizens Band (CB) 
Radio Service under part 95 of our rules and pursuant to section 307(e) 
of the Communications Act.\25\ Under this proposal, licensing would be 
accomplished through adherence to applicable technical standards and 
other operating rules (unlicensed operations). We tentatively conclude 
that this approach is beneficial because it would minimize the 
administrative burden on prospective licensees as compared with an 
individual licensing. We seek comment on this proposal. Commenters

[[Page 43687]]

are invited to address whether other licensing approaches should be 
considered and discuss the relative benefits and disadvantages compared 
to our proposal.
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    \25\ See Medtronic Petition at i, 16, and Appendix A, at 
proposed section 95.1601. We note that 47 U.S.C. 307(e)(3) provides 
that the term ``citizens band radio service'' shall have the meaning 
given it by the Commission by rule. 47 U.S.C. 307(e)(1) provides 
that upon determination by the Commission that an authorization 
serves the public interest, convenience, and necessity, the 
Commission may by rule authorize the operation of radio stations 
without individual licenses in the citizens band radio service.
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Steps Taken To Minimize Significant Economic Impact on Small Entities, 
and Significant Alternatives Considered

    23. 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.\26\
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    \26\ See 5 U.S.C. 603(c).
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    24. We propose to establish a new Medical Data Service (MEDS) under 
Part 95 that would encompass all medical devices permitted to operate 
in the entire 401-406 MHz band. We seek comment on options concerning 
whether and how the five megahertz of spectrum that would comprise this 
proposed MEDS band could be divided among the evolving varieties of 
implanted and body-worn medical transmitters, including low-power, low-
duty-cycle (LPLDC) devices without listen-before-talk (LBT).
    25. For example, should both implantable and body-worn transmitters 
be permitted to operate in all, or just selected portions, of the five 
megahertz of the proposed 401-406 MHz MEDS band? Should the same 
technical standards that govern the existing MICS center band 
transmitters be applied uniformly across the entire band? Should an 
adjustment in the permissible operating power of body-worn transmitters 
be made to account for difference in body tissue attenuation as 
compared with implantable devices? Similarly, should LPLDC devices 
without LBT be permitted to operate throughout the entire five 
megahertz of the proposed MEDS band or be limited to segments such as 
the 401-402 MHz and 405-406 wing bands? Why or why not? Commenters 
should explain the rationale, and corresponding benefits and 
disadvantages, for whatever approach is recommended. Are there any 
other factors that should be considered with respect to distinguishing 
the applicable rules for implantable, body-worn devices, and LPLDC 
transmitters? Should other types of medical radiocommunication devices 
be considered for operation in this proposed MEDS band? We especially 
seek small entity comment on these issues.

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

    26. None.
Initial Paperwork Reduction Analysis
    27. The Notice of Proposed Rule Making contains proposed new or 
modified information collection requirements. The Commission, as part 
of its continuing effort to reduce paperwork burdens, invites the 
general public and the Office of Management and Budget (OMB) to comment 
on the information collection requirements contained in this document, 
as required by the Paperwork Reduction Act of 1995, Public Law 104-13. 
Public and agency comments are due 60 days after the date of 
publication in the Federal Register. Comments should address: (a) 
Whether the proposed collection of information is necessary for the 
proper performance of the functions of the Commission, including 
whether the information shall have practical utility; (b) the accuracy 
of the Commission's burden estimates; (c) ways to enhance the quality, 
utility, and clarity of the information collected; and (d) ways to 
minimize the burden of the collection of information on the 
respondents, including the use of automated collection techniques or 
other forms of information technology. In addition, pursuant to the 
Small Business Paperwork Relief Act of 2002, we seek specific comment 
on how we might ``further reduce the information collection burden for 
small business concerns with fewer than 25 employees.''
Ordering Clauses
    28. Pursuant to sections 1, 4(i), 7(a), 301, 303(f), 303(g), 
303(r), 307, 316, and 332 of the Communications Act of 1934, as 
amended, 47 U.S.C. sections 151, 154(i), 157(a), 301, 303(f), 303(g), 
303(r), 307, 316, and 332, the Notice of Proposed Rule Making and 
Notice of Inquiry, is adopted.
    29. The Biotronik Request for Extension of Waiver, is granted until 
one year from the effective date of final rules adopted in this 
proceeding.
    30. The Commission's Consumer and Governmental Affairs Bureau, 
Reference Information Center, shall send a copy of the Notice of 
Proposed Rule Making and Notice of Inquiry, including the Initial 
Regulatory Flexibility Analysis to the Chief Counsel for Advocacy of 
the Small Business Administration.

List of Subjects in Parts 2 and 95

    Communications equipment, Radio, Reporting and recordkeeping 
requirements.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. E6-12500 Filed 8-1-06; 8:45 am]
BILLING CODE 6712-01-P