[Federal Register: March 3, 1999 (Volume 64, Number 41)] [Proposed Rules] [Page 10266-10267] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr03mr99-26] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 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