[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