81 FR 48362 - Radio Experimentation and Market Trials-Streamlining Rules
FEDERAL COMMUNICATIONS COMMISSION Federal Register Volume 81, Issue 142 (July 25, 2016)
Federal Register Volume 81, Issue 142 (July 25, 2016)
| Page Range | 48362-48363 | |
| FR Document | 2016-17319 |
[Federal Register Volume 81, Number 142 (Monday, July 25, 2016)] [Rules and Regulations] [Pages 48362-48363] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17319] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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). --------------------------------------------------------------------------- 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
![48362 Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Rules and Regulations
limit within 45 days. You are not 2016. The full text of this document is Regulatory Flexibility Certification
required to conduct additional testing available for inspection and copying 2. The Regulatory Flexibility Act
for any exceedances that occur between during normal business hours in the (RFA) 1 requires that agencies prepare a
the time of the original exceedance and FCC Reference Center (Room CY–A257), regulatory flexibility analysis for notice-
the HCl emissions compliance test 445 12th Street SW., Washington, DC and-comment rulemaking proceedings,
required under this paragraph. 20554. The complete text of this unless the agency certifies that ‘‘the rule
(iv) HCl CPMS exceedances leading to document also may be purchased from will not have a significant economic
more than four required performance the Commission’s copy contractor, Best impact on a substantial number of small
tests in a 12-month process operating Copy and Printing, Inc., 445 12th Street entities.’’ 2 Modification of section 5.303
period (rolling monthly) constitute a SW., Room, CY–B402, Washington, DC of the Commission’s Rules establishes
presumptive violation of this subpart. 20554. The full text may also be parity between all qualified medical
* * * * * downloaded at: https://apps.fcc.gov/ device manufacturers as to permissible
■ 4. Section 63.1355 is amended by edocs_public/Query.do?numberFld=16- frequencies of operation for conducting
adding paragraph (e) to read as follows: 86&numberFld2=&docket=&dateFld= basic research and clinical trials with
&docTitleDesc. RF-based medical devices. The
§ 63.1355 Recordkeeping requirements.
People with Disabilities: To request Commission previously determined that
* * * * * ‘‘[t]he entities affected by the proposed
materials in accessible formats for
(e) You must keep records of the daily rule change are equipment
clinker production rates and kiln feed people with disabilities (braille, large
print, electronic files, audio format), manufacturers seeking to test medical
rates. equipment designed to operate in the
send an email to fcc504@fcc.gov or call
* * * * * the Consumer & Governmental Affairs restricted frequency bands listed in
[FR Doc. 2016–17293 Filed 7–22–16; 8:45 am] section 15.205(a) of the rules, and such
Bureau at 202–418–0530 (voice), 202–
BILLING CODE 6560–50–P
418–0432 (tty). manufacturers are limited in number,’’
and certified that the proposed rules
This document does not contain new would not have a significant economic
FEDERAL COMMUNICATIONS or modified information collection impact on a substantial number of small
COMMISSION requirements subject to the Paperwork entities. The Commission received no
Reduction Act of 1995 (PRA), Public comments that addressed this
47 CFR Part 5 Law 104–13. determination or that claimed that the
[ET Docket Nos. 10–236 and 06–155; FCC Synopsis proposal requires additional RFA
16–86] analysis. The Commission therefore
1. In 2013, the Commission certifies that the rule revisions set forth
Radio Experimentation and Market established in the Report and Order in herein will not have a significant
Trials—Streamlining Rules this proceeding, 78 FR 25137, April 29, economic impact on a substantial
2013, three new kinds of experimental number of small entities.
AGENCY: Federal Communications
Commission. licenses—including program licenses— Congressional Review Act
designed to benefit the development of
ACTION: Final rule. 3. The Commission will send a copy
new technologies and expedite their
SUMMARY: In this document, the introduction to the marketplace. In this of this Second Report and Order in a
Commission modifies its rules to permit Second Report and Order, the report to Congress and the Government
program experimental radio licensees Commission adopts the proposal set Accountability Office pursuant to the
(program licensees) to experiment with forth in the Further NPRM, 80 FR 52437, Congressional Review Act, see 5 U.S.C.
radio frequency (RF)-based medical August 31, 2015, by modifying section 801(a)(1)(A).
devices on certain restricted 5.303 of its rules for program licenses to Ordering Clauses
frequencies, if the medical device being permit experimentation in the restricted
4. Accordingly, IT IS ORDERED, that,
tested is designed to comply with frequency bands for medical devices
pursuant to sections 301 and 303 of the
applicable Commission service rules. that comply with the service rules in
Communications Act of 1934, as
Adoption of this proposal facilitates Part 18 (Industrial, Scientific, and
amended, 47 U.S.C. 301 and 303, and
access to spectrum that can be used Medical Equipment), Part 95 Subpart H §§ 1.1 and 1.425 of the Commission’s
under an experimental program license (Wireless Medical Telemetry Service), rules, 47 CFR 1.1, 1.425, this Second
to improve the utility of this type of or Part 95 Subpart I (Medical Device Report and Order IS ADOPTED.
licensing scheme for those entities Radiocommunication Service). This rule 5. IT IS FURTHER ORDERED that part
experimenting with RF-based medical change will establish parity between all 5 of the Commission’s rules, 47 CFR
devices, and thereby help to advance qualified medical device manufacturers part 5, IS AMENDED, as set forth in the
innovation in this area. This action will and developers—whether they are Rule Changes. These revisions will be
result in no harm to any qualified health care institutions or medical effective August 24, 2016.
license applicant or licensee. device manufacturers—as to permissible 6. IT IS FURTHER ORDERED that, if
DATES: Effective August 24, 2016. frequencies of operation for conducting no applications for review are timely
FOR FURTHER INFORMATION CONTACT: basic research and clinical trials with filed, this proceeding SHALL BE
asabaliauskas on DSK3SPTVN1PROD with RULES
Rodney Small, Office of Engineering RF-based medical devices. Accordingly, TERMINATED and the docket CLOSED.
and Technology, 202–418–2452, because the Commission finds that the
Rodney.Small@fcc.gov. proposal will serve the public interest 1 See 5 U.S.C. 604. The RFA, see 5 U.S.C. 601 et
SUPPLEMENTARY INFORMATION: This is a by promoting medical innovation with seq., has been amended by the Contract with
summary of the Commission’s Second no detriment to the public, it adopts that America Advancement Act of 1996, Public Law
proposal. Revised section 5.303 of the 104–121, 110 Stat. 847 (1996) (CWAAA). Title II of
Report and Order, ET Docket No. 10– the CWAAA is the Small Business Regulatory
236 and 06–155, FCC 16–86, adopted rules is set forth at the end of this Enforcement Fairness Act of 1996 (SBREFA).
June 29, 2016, and released June 30, summary. 2 5 U.S.C. 605(b).
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![Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Rules and Regulations 48363
List of Subjects in 47 CFR Part 5 PART 5—EXPERIMENTAL RADIO exclusively allocated to the passive
SERVICE services (including the radio astronomy
Radio, Reporting and recordkeeping service). In addition, licensees may not
requirements. ■ 1. The authority citation for part 5 use any frequency or frequency band
Federal Communications Commission. continues to read as follows: below 38.6 GHz that is listed in
Marlene H. Dortch, Authority: Secs. 4, 302, 303, 307, 336 48 § 15.205(a) of this chapter.
Stat. 1066, 1082, as amended; 47 U.S.C. 154, (b) Exception: Licensees may use
Secretary. 302, 303, 307, 336. Interpret or apply sec.
301, 48 Stat. 1081, as amended; 47 U.S.C.
frequencies listed in § 15.205(a) of this
Rule Changes chapter for testing medical devices (as
301.
defined in § 5.402(b) of this chapter), if
For the reasons set forth in the ■ 2. Section 5.303 is revised to read as the device is designed to comply with
preamble the Federal Communications follows: all applicable service rules in part 18;
Commission amends 47 CFR part 5 as part 95, subpart H; or part 95, subpart
follows: § 5.303 Frequencies.
(a) Licensees may operate in any I of this chapter.
frequency band, including those above [FR Doc. 2016–17319 Filed 7–22–16; 8:45 am]
38.6 GHz, except for frequency bands BILLING CODE 6712–01–P
asabaliauskas on DSK3SPTVN1PROD with RULES
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Document Created: 2016-07-23 02:00:40
Document Modified: 2016-07-23 02:00:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | Effective August 24, 2016. | |
| Contact | Rodney Small, Office of Engineering and Technology, 202-418-2452, [email protected] | |
| FR Citation | 81 FR 48362 | |
| CFR Associated | Radio and Reporting and Recordkeeping Requirements |
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