[Federal Register Volume 81, Number 142 (Monday, July 25, 2016)]
[Rules and Regulations]
[Pages 48362-48363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17319]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Part 5

[ET Docket Nos. 10-236 and 06-155; FCC 16-86]


Radio Experimentation and Market Trials--Streamlining Rules

AGENCY: Federal Communications Commission.

ACTION: Final rule.

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SUMMARY: In this document, the Commission modifies its rules to permit 
program experimental radio licensees (program licensees) to experiment 
with radio frequency (RF)-based medical devices on certain restricted 
frequencies, if the medical device being tested is designed to comply 
with applicable Commission service rules. Adoption of this proposal 
facilitates access to spectrum that can be used under an experimental 
program license to improve the utility of this type of licensing scheme 
for those entities experimenting with RF-based medical devices, and 
thereby help to advance innovation in this area. This action will 
result in no harm to any qualified license applicant or licensee.

DATES: Effective August 24, 2016.

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

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Second 
Report and Order, ET Docket No. 10-236 and 06-155, FCC 16-86, adopted 
June 29, 2016, and released June 30, 2016. 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 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://apps.fcc.gov/edocs_public/Query.do?numberFld=16-86&numberFld2=&docket=&dateFld=&docTitleDesc.
    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).
    This document does not contain new or modified information 
collection requirements subject to the Paperwork Reduction Act of 1995 
(PRA), Public Law 104-13.

Synopsis

    1. In 2013, the Commission established in the Report and Order in 
this proceeding, 78 FR 25137, April 29, 2013, three new kinds of 
experimental licenses--including program licenses--designed to benefit 
the development of new technologies and expedite their introduction to 
the marketplace. In this Second Report and Order, the Commission adopts 
the proposal set forth in the Further NPRM, 80 FR 52437, August 31, 
2015, by modifying section 5.303 of its rules for program licenses to 
permit experimentation in the restricted frequency bands for medical 
devices that comply with the service rules in Part 18 (Industrial, 
Scientific, and Medical Equipment), Part 95 Subpart H (Wireless Medical 
Telemetry Service), or Part 95 Subpart I (Medical Device 
Radiocommunication Service). This rule change will establish parity 
between all qualified medical device manufacturers and developers--
whether they are health care institutions or medical device 
manufacturers--as to permissible frequencies of operation for 
conducting basic research and clinical trials with RF-based medical 
devices. Accordingly, because the Commission finds that the proposal 
will serve the public interest by promoting medical innovation with no 
detriment to the public, it adopts that proposal. Revised section 5.303 
of the rules is set forth at the end of this summary.

Regulatory Flexibility Certification

    2. The Regulatory Flexibility Act (RFA) \1\ requires that agencies 
prepare a regulatory flexibility analysis for notice-and-comment 
rulemaking proceedings, unless the agency certifies that ``the rule 
will not have a significant economic impact on a substantial number of 
small entities.'' \2\ Modification of section 5.303 of the Commission's 
Rules establishes parity between all qualified medical device 
manufacturers as to permissible frequencies of operation for conducting 
basic research and clinical trials with RF-based medical devices. The 
Commission previously determined that ``[t]he 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 section 15.205(a) of the rules, and such manufacturers are 
limited in number,'' and certified that the proposed rules would not 
have a significant economic impact on a substantial number of small 
entities. The Commission received no comments that addressed this 
determination or that claimed that the proposal requires additional RFA 
analysis. The Commission therefore certifies that the rule revisions 
set forth herein will not have a significant economic impact on a 
substantial number of small entities.
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    \1\ See 5 U.S.C. 604. The RFA, see 5 U.S.C. 601 et seq., has 
been amended by the Contract with America Advancement Act of 1996, 
Public Law 104-121, 110 Stat. 847 (1996) (CWAAA). Title II of the 
CWAAA is the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA).
    \2\ 5 U.S.C. 605(b).
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Congressional Review Act

    3. The Commission will send a copy of this Second Report and Order 
in a report to Congress and the Government Accountability Office 
pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

Ordering Clauses

    4. Accordingly, IT IS ORDERED, that, pursuant to sections 301 and 
303 of the Communications Act of 1934, as amended, 47 U.S.C. 301 and 
303, and Sec. Sec.  1.1 and 1.425 of the Commission's rules, 47 CFR 
1.1, 1.425, this Second Report and Order IS ADOPTED.
    5. IT IS FURTHER ORDERED that part 5 of the Commission's rules, 47 
CFR part 5, IS AMENDED, as set forth in the Rule Changes. These 
revisions will be effective August 24, 2016.
    6. IT IS FURTHER ORDERED that, if no applications for review are 
timely filed, this proceeding SHALL BE TERMINATED and the docket 
CLOSED.

[[Page 48363]]

List of Subjects in 47 CFR Part 5

    Radio, Reporting and recordkeeping requirements.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.

Rule Changes

    For the reasons set forth in the preamble the Federal 
Communications Commission amends 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; part 95, subpart H; or 
part 95, subpart I of this chapter.

[FR Doc. 2016-17319 Filed 7-22-16; 8:45 am]
 BILLING CODE 6712-01-P