[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Proposed Rules]
[Pages 52437-52439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21294]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Part 5

[ET Docket Nos. 10-236, 06-155; FCC 15-76]


Radio Experimentation and Market Trials

AGENCY: Federal Communications Commission.

ACTION: Proposed rule.

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SUMMARY: In this document, the Commission proposes to modify the rules 
for program experimental licenses to permit experimentation for radio 
frequency (RF)-based medical devices, if the device being tested is 
designed to comply with all applicable service rules in Part 18, 
Industrial, Scientific, and Medical Equipment; Part 95, Personal Radio 
Services Subpart H--Wireless Medical Telemetry Service; or Part 95, 
Subpart I--Medical Device Radiocommunication Service. This proposal is 
designed to establish parity between all qualified medical device 
manufacturers for conducting basic research and clinical trials with 
RF-based medical devices as to permissible frequencies of operation.

DATES: Comments must be filed on or before September 30, 2015 and reply 
comments must be filed on or before October 15, 2015.

ADDRESSES: You may submit comments, identified by ET Docket Nos. 10-236 
and 06-155, by any of the following methods:
    [ssquf] Federal Communications Commission's Web site: http://apps.fcc.gov/ecfs/. Follow the instructions for submitting comments.
    [ssquf] People with Disabilities: Contact the FCC to request 
reasonable accommodations (accessible format documents, sign language 
interpreters, CART, etc.) by email: [email protected] 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.

FOR FURTHER INFORMATION CONTACT: Rodney Small, Office of Engineering 
and Technology, (202) 418-2452, email: [email protected], TTY (202) 
418-2989.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's 
Further Notice of Proposed Rulemaking (FNPRM), ET Docket Nos. 10-236 
and 06-155, FCC 15-76, adopted July 6, 2015, and released July 8, 2015. 
The full text of this document is available for inspection and copying 
during normal business hours in the FCC Reference Center (Room CY-
A257), 445 12th Street SW., Washington, DC 20554. The full text may 
also be downloaded at: www.fcc.gov. People with Disabilities: To 
request materials in accessible formats for people with disabilities 
(braille, large print, electronic files, audio format), send an email 
to [email protected] or call the Consumer & Governmental Affairs Bureau at 
202-418-0530 (voice), 202-418-0432 (tty).

Summary of Further Notice of Proposed Rulemaking

    1. In two April 2015 filings, Medtronic, Inc. (Medtronic) observes 
that program licenses ``may not be issued for operation on frequencies 
listed in Sec.  15.205 of the rules, which includes the 401-406 MHz 
Medical Device Radiocommunications Service (`MedRadio') band often 
employed by makers of implanted and body-worn medical devices.'' 
Medical testing licensees, on the other hand, may use those 
frequencies, if they comply with applicable service rules. Medtronic 
therefore argues that this disparity in frequencies contributes to 
program licensees being less flexible than medical testing licensees.
    2. As discussed in the companion Memorandum Opinion & Order in this 
proceeding, basic medical research and experimentation would be 
conducted under a program (or conventional) license by any manufacturer 
of RF-based medical devices, whether that manufacturer is eligible for 
a medical testing license or not. The Commission created the program 
experimental license to reduce regulatory delay and uncertainty and to 
promote innovation. A program license is granted for a five year term 
and allows the licensee to conduct multiple unrelated experiments 
within a broad range of frequencies. Because researchers can modify the 
scope of their experiments without having to obtain Commission 
permission to do so, the flexibility provided will accelerate 
innovation in RF technology, including RF-based medical devices. 
However, the program license rules do not permit experimentation in 
frequency bands that are restricted under Sec.  15.205(a) of the 
Commission's Rules to protect the many safety-of-life and passive 
services that operate in these bands.
    3. Medtronic rightly points out that the 401-406 MHz band is a 
restricted band under Sec.  15.205(a) and is not available for basic 
research under the program license rules. However, the 401-406 MHz band 
is used for implanted and body worn medical devices under the part 95 
MedRadio rules. Consequently, manufacturers of certain RF-based medical 
devices cannot take advantage of the benefits provided by a program 
license to advance innovation in this area, even though the devices 
they ultimately develop could be authorized for use under the 
Commission's rules. Because clinical trials conducted under the medical 
testing license or as a market trial may be tested in these bands, the 
Commission sees no reason to impose greater frequency restrictions on 
program licensees conducting basic research on the same devices.
    4. Accordingly, the Commission proposes to modify the rules for 
program licenses to permit experimentation on frequencies listed in 
Sec.  15.205(a) of the Commission's rules, provided that--comparable to 
the rules for medical testing licenses--the device being tested is 
designed to comply with all applicable service rules in part 18,

[[Page 52438]]

Industrial, Scientific, and Medical Equipment; part 95, Personal Radio 
Services Subpart H--Wireless Medical Telemetry Service; or part 95, 
Subpart I--Medical Device Radiocommunication Service. The proposed rule 
changes are shown below. These changes would establish parity between 
all qualified medical device manufacturers for conducting basic 
research and clinical trials with RF-based medical devices (as defined 
in Sec.  5.402(b) of the Commission's Rules) as to permissible 
frequencies of operation.

Procedural Matters

A. Ex Parte Rules

    5. This proceeding shall continue to be treated as a ``permit-but-
disclose'' proceeding in accordance with the Commission's ex parte 
rules. Persons making ex parte presentations must file a copy of any 
written presentation or a memorandum summarizing any oral presentation 
within two business days after the presentation (unless a different 
deadline applicable to the Sunshine period applies). Persons making 
oral ex parte presentations are reminded that memoranda summarizing the 
presentation must (1) list all persons attending or otherwise 
participating in the meeting at which the ex parte presentation was 
made, and (2) summarize all data presented and arguments made during 
the presentation. If the presentation consisted in whole or in part of 
the presentation of data or arguments already reflected in the 
presenter's written comments, memoranda or other filings in the 
proceeding, the presenter may provide citations to such data or 
arguments in his or her prior comments, memoranda, or other filings 
(specifying the relevant page and/or paragraph numbers where such data 
or arguments can be found) in lieu of summarizing them in the 
memorandum. Documents shown or given to Commission staff during ex 
parte meetings are deemed to be written ex parte presentations and must 
be filed consistent with Sec.  1.1206(b). In proceedings governed by 
Sec.  1.49(f) or for which the Commission has made available a method 
of electronic filing, written ex parte presentations and memoranda 
summarizing oral ex parte presentations, and all attachments thereto, 
must be filed through the electronic comment filing system available 
for that proceeding, and must be filed in their native format (e.g., 
.doc, .xml, .ppt, searchable .pdf). Participants in this proceeding 
should familiarize themselves with the Commission's ex parte rules.

B. Initial Regulatory Flexibility Certification

    6. The Regulatory Flexibility Act (RFA) requires that an agency 
prepare a regulatory flexibility analysis for notice-and-comment 
rulemaking proceedings, unless the agency certifies that ``the rule 
will not, if promulgated, have a significant economic impact on a 
substantial number of small entities.'' The RFA generally defines 
``small entity'' as having the same meaning as the terms ``small 
business,'' ``small organization,'' and ``small governmental 
jurisdiction.'' In addition, the term ``small business'' has the same 
meaning as the term ``small business concern'' under the Small Business 
Act. 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 Small Business 
Administration (SBA).
    7. This FNPRM proposes only a single change to the rules adopted in 
the Report and Order in this proceeding (78 FR 25138, April 29, 2013), 
and that proposed change would merely make available to program 
experimental radio licensees that undertake experiments with medical 
devices the same frequencies that are currently available to medical 
testing experimental radio licensees. The entities affected by the 
proposed rule change are equipment manufacturers seeking to test 
medical equipment designed to operate in the restricted frequency bands 
listed in Sec.  15.205(a) of the Commission's rules, and such 
manufacturers are very limited in number. Thus, the proposal in the 
FNPRM will not have a substantial economic impact on a significant 
number of small entities.
    8. The Commission therefore certifies, pursuant to the RFA, that 
the proposal in this FNPRM, if adopted, will not have a significant 
economic impact on a substantial number of small entities. If 
commenters believe that the proposal discussed in the FNPRM requires 
additional RFA analysis, they should include a discussion of these 
issues in their comments and additionally label them as RFA comments. 
The Commission will send a copy of the FNPRM, including a copy of this 
initial certification, to the Chief Counsel for Advocacy of the SBA. In 
addition, a copy of the FNPRM and this initial certification will be 
published in the Federal Register.
    9. Initial Paperwork Reduction Act Analysis: This FNPRM does not 
contain a proposed information collection subject to the Paperwork 
Reduction Act of 1995, Public Law 104-13.
    10. Comment Filing Instructions: Pursuant to sections 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 this document. Comments may be filed using the 
Commission's Electronic Comment Filing System (ECFS). See Electronic 
Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).
    [ssquf] Electronic Filers: Comments may be filed electronically 
using the Internet by accessing the ECFS: http://fjallfoss.fcc.gov/ecfs2/.
    [ssquf] Paper Filers: Parties who choose to file by paper must file 
an original and one copy 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. All filings must be addressed to the Commission's Secretary, 
Office of the Secretary, Federal Communications Commission.
    [ssquf] All hand-delivered or messenger-delivered paper filings for 
the Commission's Secretary must be delivered to FCC Headquarters at 445 
12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 
8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with 
rubber bands or fasteners. Any envelopes and boxes must be disposed of 
before entering the building.
    [ssquf] 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.
    [ssquf] U.S. Postal Service first-class, Express, and Priority mail 
must 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 email to [email protected] or call the 
Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-
418-0432 (tty). Comments, reply comments, and ex parte submissions will 
be available for public inspection during regular business hours in the 
FCC Reference Center, Federal Communications Commission, 445 12th 
Street SW., CY-A257, Washington, DC 20554. These documents will also be 
available via ECFS. Documents will be

[[Page 52439]]

available electronically in ASCII, Microsoft Word, and/or Adobe 
Acrobat.

Ordering Clauses

    11. Pursuant to section 4(i), 301, 303 and 405 of the 
Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 303, and 
405 and Sec.  1.1, 1.2, and 1.429 of the Commission's rules, 47 CFR 
1.1, 1.2, and 1.429, this Further Notice of Proposed Rulemaking is 
adopted.
    12. The Commission's Consumer and Governmental Affairs Bureau, 
Reference Information Center, shall send a copy of this Further Notice 
of Proposed Rule Making, including the Initial Regulatory Flexibility 
Certification, to the Chief, Counsel for Advocacy of the Small Business 
Administration.

List of Subject in 47 CFR Part 5

    Radio, Reporting and recordkeeping requirements.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.

Proposed Rule Change

    For the reasons discussed in the preamble, the Federal 
Communications Commission proposes to amend 47 CFR part 5 as follows:

PART 5--EXPERIMENTAL RADIO SERVICE

0
1. The authority citation for part 5 continues to read as follows:

    Authority:  Secs. 4, 302, 303, 307, 336 48 Stat. 1066, 1082, as 
amended; 47 U.S.C. 154, 302, 303, 307, 336. Interpret or apply sec. 
301, 48 Stat. 1081, as amended; 47 U.S.C. 301.

0
2. Section 5.303 is revised to read as follows:


Sec.  5.303  Frequencies.

    (a) Licensees may operate in any frequency band, including those 
above 38.6 GHz, except for frequency bands exclusively allocated to the 
passive services (including the radio astronomy service). In addition, 
licensees may not use any frequency or frequency band below 38.6 GHz 
that is listed in Sec.  15.205(a) of this chapter.
    (b) Exception: Licensees may use frequencies listed in Sec.  
15.205(a) of this chapter for testing medical devices (as defined in 
Sec.  5.402(b) of this chapter), if the device is designed to comply 
with all applicable service rules in part 18, Industrial, Scientific, 
and Medical Equipment; part 95, Personal Radio Services Subpart H--
Wireless Medical Telemetry Service; or part 95, Subpart I--Medical 
Device Radiocommunication Service.

[FR Doc. 2015-21294 Filed 8-28-15; 8:45 am]
 BILLING CODE 6712-01-P