[Federal Register Volume 64, Number 41 (Wednesday, March 3, 1999)]
[Proposed Rules]
[Pages 10266-10267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5217]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Parts 2 and 95
[WT Docket No. 99-66, RM-9157, FCC 99-23]
Establishment of a Medical Implant Communications Service in the
402-405 MHz Band
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish a Medical Implant
Communications Service (``MICS'') operating in the 402-405 MHz band.
MICS operations would consist of high-speed, ultra low power, nonvoice
transmissions to and from implanted medical devices such as cardiac
pacemakers and defibrillators. This document also proposes to allocate
the 402-405 MHz band to the mobile service on a shared basis, designate
this allocation for use by the MICS, and to amend the Commission's
Rules to codify service rules for the MICS. The proposed rules will
allow use of newly-developed, life-saving medical technology without
harming other users of the frequency band.
DATES: Comments are due on or before April 9, 1999, and Reply Comments
are due on or before April 26, 1999.
FOR FURTHER INFORMATION CONTACT: Gene Thomson, Policy and Rules Branch,
Public Safety and Private Wireless Telecommunications Bureau, (202)
418-0680.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Notice
of Proposed Rule Making (``Notice''), WT Docket No. 99-66, FCC 99-23,
adopted
[[Page 10267]]
February 12, 1999, and released February 24, 1999. The full text of
this Notice is available for inspection and copying during normal
business hours in the FCC Reference Center, Room 246, 1919 M Street NW,
Washington, DC. The complete text may be purchased from the
Commission's copy contractor, ITS, Inc., 1231 20th St. NW, Washington,
DC 20036, telephone (202) 857-3800. The complete (but official) text is
also available on the Commission's Internet site at www.fcc.gov/
Bureaus/Wireless/Notices/1999/index.html>under the file name
``fcc9923.txt'' in ASCII text and ``fcc9923.wp'' in Word Perfect
format.
Summary of Notice of Proposed Rule Making
1. The Commission has released a Notice of Proposed Rule Making
that proposes to amend the Table of Frequency Allocations in Section
2.106 of the Commission's Rules, to allocate the 402-405 MHz band on a
shared basis and designate this share allocation for use by the Medical
Implant Communications Service (MICS), and to revise part 95 of the
Commission's Rules to permit the operation of ultra low power MICS
transmitters in the 402-405 MHz band without an individual license
issued by the Commission.
Administrative Matters
Initial Regulatory Flexibility Analysis
2. As required by the Regulatory Flexibility Act (``RFA''), the
Commission has prepared this Initial Regulatory Flexibility Analysis
(``IRFA'') of the possible significant economic impact on small
entities by the policies and rules proposed in this Notice of Proposed
Rule Making (``Notice''). Written public comments are requested on this
IRFA. Comments must be identified as responses to IRFA and must be
filed by the deadlines for comments on this Notice. The Commission will
send a copy of the Notice, including this IRFA, to the Chief Counsel
for Advocacy of the Small Business Administration.
A. Need for, and Objectives of, the Proposed Rules
3. In this proceeding, the Commission proposes to amend parts 2 and
95 of the Commission's Rules to establish the MICS as a shared
allocation in the Non-Government 402-405 MHz band, and to codify the
service rules for the MICS. The proposed rules would allow use of
newly-developed, life-saving medical technology without harming other
users of the applicable frequency bands.
B. Legal Basis
4. Authority for issuance of this Notice of Proposed Rule Making is
contained in Sections 4(i) and 303(r) of the Communications Act of
1934, as amended, 47 U.S.C. 154(i) and 303(r).
C. Description and Estimate of the Number of Small Entities to Which
the Proposed Rules Will Apply
5. The proposed rules apply to manufacturers of medical implant
devices and users of the proposed MICS equipment, such as hospitals and
clinics. The RFA also includes small governmental entities as a part of
the regulatory flexibility analysis. The definition of a small
governmental entity is one with a population of less than 50,000. There
are 85,006 governmental entities in the nation. This number includes
such entities as states, counties, cities, utility districts, and
school districts. There are no figures available on what portion of
this number has populations of fewer than 50,000. However, this number
includes 38,978 counties, cities, and towns, and of those 37,566, or 96
percent, have populations of fewer than 50,000. The Census Bureau
estimates that this ratio is approximately accurate for all
governmental entities. Of the estimated 85,006 governmental entities,
many are hospitals and health care facilities. We ask for comments on
what percentage of local government health care facilities are small
entities that may be affected by the proposed rules.
D. Description of Projected Reporting, Recordkeeping and Other
Compliance Requirements
6. No reporting or recordkeeping requirements would be imposed as a
result of the actions proposed in this rule making proceeding.
Manufacturers of medical implant transmitters would be required to
follow the Commission's normal equipment authorization procedures.
E. Steps Taken to Minimize Significant Economic Impact on Small
Entities and Significant Alternatives Considered
7. By making frequency spectrum available, the proposed rules could
have a beneficial economic impact on those small business entities that
would either manufacture, or contribute to the manufacturing of
equipment used in the Medical Implant Communications Service.
Individuals who are the recipients of implanted MICS devices would be
the greatest beneficiaries economically. While a precise determination
of the cost savings is difficult to calculate, two examples are useful.
First, over $15M dollars per year would be saved by eliminating the
need to conduct quarterly interrogation of implanted cardiac
defibrillators in the clinical setting. This estimate does not include
the interrogation of pacemakers, which are implanted at a much higher
rate than defibrillators. Second, over $37B is currently spent annually
on hospitalization due to heart failure. When devices currently under
development for the management of heart failure incorporate the MICS
technology, it is expected that there will be a meaningful reduction in
hospitalization costs. Assuming this impact is as small as 5%, the
savings would be nearly $2B per year. We seek comment on our tentative
conclusions.
F. Federal Rules That May Duplicate, Overlap, or Conflict With the
Proposed Rules
8. None.
Ordering Clauses
9. Accordingly, It is ordered that, pursuant to Sections 4(i), and
303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i),
and 303(r), notice is hereby given of proposed amendments to parts 2
and 95 of the Commission's Rules, 47 CFR Parts 2 and 95.
10. It is further ordered that the Commission's Office of Public
Affairs, Reference Operations Division, Shall send a copy of this
Notice of Proposed Rule Making, including the Initial Regulatory
Flexibility Analysis to the Chief Counsel for Advocacy of the Small
Business Administration.
List of Subjects in 47 CFR Parts 2 and 95
Communications equipment, Radio.
Federal Communications Commission.
Magalie Roman Salas,
Secretary.
[FR Doc. 99-5217 Filed 3-2-99; 8:45 am]
BILLING CODE 6712-01-M