Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 39249 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This proposed rule does not use 

technical standards. Therefore, we did 

not consider the use of voluntary 

consensus standards. 

Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Management Directive 023–01 

and Commandant Instruction 

M16475.lD, which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA)(42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions which do not individually or 

cumulatively have a significant effect on 

the human environment. A preliminary 

environmental analysis checklist 

supporting this determination is 

available in the docket where indicated 

under ADDRESSES. We expect this 

proposed rule to be categorically 

excluded from requirements for further 

environmental documentation under 

figure 2–1, paragraph (34)(g), of the 

Instruction because the rule would 

establish a safety zone. We seek any 

comments or information that may lead 

to the discovery of a significant 

environmental impact from this 

proposed rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Public Law 107–295, 116 Stat. 2064; 

Department of Homeland Security Delegation 

No. 0170.1. 

2. Add temporary § 165.T11–227 to 

read as follows: 

§ 165.T11–227 Safety zone; Sea World 

Labor Day Fireworks, Mission Bay, San 

Diego, California. 

(a) Location. The following area is a 

safety zone: All waters of Mission Bay, 

from surface to bottom, within a 600 

foot radius around the fireworks launch 

barge in an approximate position of 

32°46′03′′ N, 117°13′11′′ W (NAD 83). 

(b) Enforcement Period. This section 

will be enforced from 8 p.m. to 10 p.m. 

on December 12, 2009. If the event 

concludes prior to the scheduled 

termination time, the Captain of the Port 

will cease enforcement of this safety 

zone and will announce that fact via 

Broadcast Notice to Mariners. 

(c) Definitions. The following 

definition applies to this section: 

Designated representative, means any 

commissioned, warrant, or petty officers 

of the Coast Guard on board Coast 

Guard, Coast Guard Auxiliary, or local, 

state, or federal law enforcement vessels 

who have been authorized to act on the 

behalf of the Captain of the Port. 

(d) Regulations. (1) Entry into, transit 

through or anchoring within this safety 

zone is prohibited unless authorized by 

the Captain of the Port of San Diego or 

his designated on-scene representative. 

(2) Mariners requesting permission to 

transit through the safety zone may 

request authorization to do so from the 

Sector San Diego Command Center. The 

Command Center may be contacted on 

VHF–FM Channel 16. 

(3) All persons and vessels must 

comply with the instructions of the 

Coast Guard Captain of the Port or the 

designated representative. 

(4) Upon being hailed by U.S. Coast 

Guard patrol personnel by siren, radio, 

flashing light, or other means, the 

operator of a vessel must proceed as 

directed. 

(5) The Coast Guard may be assisted 

by other federal, state, or local agencies. 

Dated: July 22, 2009. 

T.H. Farris, 

Captain, U.S. Coast Guard, Captain of the 

Port San Diego. 

[FR Doc. E9–18755 Filed 8–5–09; 8:45 am] 

BILLING CODE 4910–15–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 2 and 95 

[ET Docket No. 08–59; FCC 09–57] 

Medical Body Area Network (MBAN) 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In this document the 

Commission seeks comment on 

allocating spectrum and establishing 

service and technical rules for the 

operation of Medical Body Area 

Network (or MBAN) systems using body 

sensor devices. MBAN systems would 

provide a flexible platform for the 

wireless networking of multiple body 

sensors used for monitoring a patient’s 

physiological data, primarily in health 

care facilities. Use of MBAN systems 

hold the promise of improved safety, 

quality, and efficiency of patient care by 

reducing or eliminating a wide array of 

hardwired, patient-attached cables used 

by present monitoring technologies. 

This Notice of Proposed Rulemaking 

reflects the Commission’s continuing 

desire to foster the availability and use 

of advanced medical devices using 

wireless technologies, which, in turn, 

should help to improve the health and 

well-being of the American public. 

DATES: Comments must be filed on or 

before October 5, 2009, and reply 

comments must be filed on or before 

November 4, 2009. 

ADDRESSES: You may submit comments, 

identified by ET Docket No. 08–59, by 

any of the following methods: 

■ Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

■ Federal Communications 

Commission’s Web Site: http:// 

www.fcc.gov/cgb/ecfs/. Follow the 

instructions for submitting comments. 

■ E-mail: [Optional: Include the Email address only if you plan to accept 

comments from the general public.] 

Include the docket number(s) in the 

subject line of the message. 

■ Mail: [Optional: Include the 

mailing address for paper, disk or CD– 

ROM submissions needed/requested by 

your Bureau or Office. Do not include 

the Office of the Secretary’s mailing 

address here.] 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
39250 Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 

■ People with Disabilities: Contact 

the FCC to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by e-mail: FCC504@fcc.gov 

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: Gary 

Thayer, Office of Engineering and 

Technology, (202) 418–2290, e-mail: 

Gary.Thayer@fcc.gov, TTY (202) 418– 

2989. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Notice of 

Proposed Rule Making, ET Docket No. 

08–59, FCC 09–57, adopted June 29, 

2009, and released June 29, 2009. The 

full text of this document is available for 

public inspection and copying during 

regular business hours in the 

Commission’s Reference Information 

Center, Portals II, 445 12th Street, SW., 

(Room CY–A257), Washington, DC 

20554. The complete text of this 

document also may be purchased from 

the Commission’s copy contractor, Best 

Copy and Printing, Inc., Portals II, 445 

12th Street, SW., Room CY–B402, 

Washington, DC 20554, telephone (202) 

488–5300, facsimile (202) 488–5563 or 

via e-mail 

FCC@BCPIWEB.com. The full text may 

also be downloaded at: http:// 

www.fcc.gov. 

Pursuant to §§ 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 the first 

page of this document. Comments may 

be filed using: (1) The Commission’s 

Electronic Comment Filing System 

(ECFS), (2) the Federal Government’s 

eRulemaking Portal, or (3) by filing 

paper copies. See Electronic Filing of 

Documents in Rulemaking Proceedings, 

63 FR 24121 (1998). 

■ Electronic Filers: Comments may 

be filed electronically using the Internet 

by accessing the ECFS: http:// 

www.fcc.gov/cgb/ecfs/ or the Federal 

eRulemaking Portal: http:// 

www.regulations.gov. Filers should 

follow the instructions provided on the 

Web site for submitting comments. 

■ For ECFS filers, if multiple docket 

or rulemaking numbers appear in the 

caption of this proceeding, filers must 

transmit one electronic copy of the 

comments for each docket or 

rulemaking number referenced in the 

caption. In completing the transmittal 

screen, filers should include their full 

name, U.S. Postal Service mailing 

address, and the applicable docket or 

rulemaking number. Parties may also 

submit an electronic comment by 

Internet e-mail. To get filing 

instructions, filers should send an email to ecfs@fcc.gov, and include the 

following words in the body of the 

message, ‘‘get form.’’ A sample form and 

directions will be sent in response. 

■ Paper Filers: Parties who choose to 

file by paper must file an original and 

four copies 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 

(although we continue to experience 

delays in receiving U.S. Postal Service 

mail). All filings must be addressed to 

the Commission’s Secretary, Office of 

the Secretary, Federal Communications 

Commission. 

■ The Commission’s contractor will 

receive hand-delivered or messengerdelivered paper filings for the 

Commission’s Secretary at 236 

Massachusetts Avenue, NE., Suite 110, 

Washington, DC 20002. The filing hours 

at this location are 8 a.m. to 7 p.m. All 

hand deliveries must be held together 

with rubber bands or fasteners. Any 

envelopes must be disposed of before 

entering the building. 

■ 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. 

■ U.S. Postal Service first-class, 

Express, and Priority mail should 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 e-mail to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice), 202– 

418–0432 (tty). 

Filings and comments are also 

available for public inspection and 

copying during regular business hours 

at the FCC Reference Information 

Center, Portals II, 445 12th Street, SW., 

Room CY–A257, Washington, DC 20554. 

They may also be purchased from the 

Commission’s duplicating contractor, 

Best Copy and Printing, Inc., Portals II, 

445 12th Street, SW., Room CY–B402, 

Washington, DC 20554, telephone: (202) 

488–5300, fax: (202) 488–5563, or via 

e-mail http://www.bcpiweb.com. 

Summary of Notice of Proposed 

Rulemaking 

1. In the Notice of Proposed 

Rulemaking (NPRM), the Commission 

seeks comment on allocating spectrum 

and establishing service and technical 

rules for the operation of Medical Body 

Area Network (or MBAN) systems using 

body sensor devices. The NPRM reflects 

the Commission’s continuing efforts to 

foster the availability and use of 

advanced medical devices using 

wireless technologies which, in turn, 

should help to improve the health and 

well-being of the American public. 

2. MBAN systems, as contemplated by 

the NPRM, could provide a flexible 

platform for the wireless networking of 

multiple body sensors used for 

monitoring a patient’s physiological 

data, primarily in health care facilities 

as well as in other health care 

monitoring situations. Use of MBAN 

systems hold the promise of improved 

safety, quality, and efficiency of patient 

care by reducing or eliminating a wide 

array of hardwired, patient-attached 

cables used by present monitoring 

technologies. 

3. Given these significant health care 

benefits offered by MBAN systems, the 

Commission tentatively concludes that 

providing spectrum for MBAN 

operations would serve the public 

interest. 

4. Against this backdrop, the 

Commission addresses a petition filed 

by GE Healthcare (hereinafter the 

‘‘GEHC petition’’) to allocate up to 40 

megahertz of spectrum in the 2360–2400 

MHz band, which is used on a primary 

basis by Federal and non-Federal 

Aeronautical Mobile Telemetry (AMT), 

Federal Radiolocation, and non-Federal 

Amateur services. In addition, the 

Commission seeks comment on an 

alternative recommendation by the 

Aerospace and Flight Test Radio 

Coordinating Council (AFTRCC) to 

accommodate MBAN operations in the 

2300–2305 MHz and 2395–2400 MHz 

bands. Finally, the Commission seeks 

comment on whether other bands such 

as the 2400–2483.5 MHz or 5150–5250 

MHz bands could be used to support 

MBAN operations. 

5. The Commission also addresses 

several spectrum compatibility concerns 

with respect to incumbent operations in 

accommodating MBAN operations. 

Thus, the Commission seeks comment 

on the potential for interference caused 

either to incumbents, or to MBAN 

systems, and how any such concerns 

might be mitigated. In addition, the 

Commission seeks comment more 

generally on whether allocating 

spectrum and establishing rules to allow 


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the operation of MBAN systems for the 

purposes described herein would serve 

the public interest. 

6. Finally, the Commission seeks 

comment on what licensing approaches 

would be appropriate for MBAN 

operations in the various frequency 

bands under consideration, as well as 

service and technical rules for MBAN 

operation. This includes a discussion of 

whether MBANs should be authorized 

on a licensed basis under part 95, a 

‘‘licensing-lite’’ approach under part 90, 

or an unlicensed basis under part 15. 

The tentative service and technical rules 

discussed in the NPRM follow the 

general framework of the recently 

adopted rules for the MedRadio Service. 

A. Frequency Allocation 

1. 2300–2305 MHz and 2360–2400 MHz 

Frequency Bands 

7. The Commission seeks comment on 

whether to allow MBAN operations on 

up to 40 megahertz of spectrum in the 

2360–2400 MHz band on a secondary 

basis. This option reflects the initial 

recommendation set forth in the GEHC 

petition. In this context, the 

Commission recognizes the necessity of 

affording interference protection to 

incumbent primary users, particularly 

AMT operations. In addition, the NPRM 

considers the potential for interference 

to MBAN devices and the attendant risk 

to patients using MBAN systems. 

8. The Commission also seeks 

additional comment on the amount of 

spectrum required to support MBAN 

operations, and what factors (including 

the number and types of incumbent 

users) should be taken into account in 

determining the amount of spectrum 

required. 

9. Regarding the potential for 

interference from MBAN devices to 

incumbent operations, the Commission 

seeks comment on whether the potential 

for sharing between MBAN systems and 

incumbent AMT and radiolocation 

operations could be facilitated if 

geographic exclusion zones were to be 

established around AMT test flight sites 

in the 2360–2395 MHz band to protect 

those sites from harmful interference. In 

addition to or in lieu of exclusion zones, 

MBAN operators and AMT licensees 

may be able to coordinate their 

operations. The Commission further 

observes in the NPRM that sharing 

between MBAN systems and 

incumbents AMT and radiolocation 

operations could be facilitated if MBAN 

operations in the 2360–2390 MHz band, 

which is allocated for AMT operations, 

are limited to indoor use within health 

care facilities as defined in the WMTS. 

The Commission believes that this 

requirement would limit the incidence 

of MBAN operations and effectively 

reduce the likelihood that they would 

occur near AMT flight test sites. 

Because MBAN systems would be used 

indoors, building structures would 

attenuate MBAN signals and further 

reduce the likelihood of interference to 

AMT. Thus, the Commission seeks 

comment on whether permitting MBAN 

systems to operate in the 2360–2395 

MHz band under the limitations 

proposed would provide interference 

protection to incumbent users. 

10. Regarding interference from AMT 

to MBAN operations, the Commission 

seeks comment on whether MBAN 

devices could avoid receiving 

interference from AMT or other 

incumbent users by employing a 

contention-based protocol or some other 

techniques. In this regard, the 

Commission seeks comment on whether 

transmissions from incumbent stations, 

as well as flight test stations using 

future technologies (which might 

include the use of high-power, 

omnidirectional uplink and downlink 

transmissions) could adversely affect 

the operation of MBAN devices— 

possibly resulting in adverse effects to 

patients. 

11. To address recommendations 

made in comments filed by AFTRCC, 

the Commission seeks comment on 

limiting MBAN operations to the 2300– 

2305 MHz and 2395–2400 MHz bands. 

It specifically seeks comment on the 

ability of MBAN devices to utilize these 

two blocks of spectrum that are 

separated by 90 megahertz. The 

Commission also seeks comment on 

whether it should consider a secondary 

allocation for MBAN operations in these 

two bands, or if allocating these bands 

on a primary basis would allow MBAN 

devices to more effectively use the 

spectrum since they would not have to 

avoid AMT users. The Commission 

seeks comment as to whether MBAN 

operations can exist compatibly with 

the incumbent Amateur service users in 

the 2300–2305 MHz and 2390–2400 

MHz bands. The Commission further 

seeks comment as to whether, in the 

2390–2395 MHz band it should consider 

allowing MBAN and AMT operations to 

operate on a co-primary basis and what 

the sharing rules between them should 

be. Additionally, the Commission seeks 

comment on whether any additional 

MBAN spectrum would be needed if it 

were to reallocate the 2390–2395 MHz 

band to remove the AMT allocation in 

order to provide a total of up to 15 

megahertz of spectrum for use by MBAN 

operations on a primary basis. 

12. To the extent that MBAN 

operation might ultimately be 

authorized in any portion of the 2300– 

2305 MHz or 2360–2400 MHz bands, 

the Commission proposes including a 

new U.S. footnote to the Table of 

Allocations in part 2 of the rules for the 

specific band. The Commission would 

also require that MBANs not cause 

harmful interference to and accept 

interference from Federal and nonFederal stations operating in accordance 

with the Table of Frequency 

Allocations. The Commission seeks 

comment on this approach. 

2. 2400–2483.5 MHz Frequency Band 

13. The Commission seeks comment 

on whether MBAN devices could 

operate in the 2400–2483.5 MHz band. 

The 2400–2483.5 MHz band is used by 

Industrial, Scientific and Medical (ISM) 

equipment operating under part 18 of 

the Commission’s rules. Any equipment 

or services operating in ISM bands are 

obliged to accept interference from ISM 

equipment. In its petition, GEHC has 

asserted that manufacturers could 

leverage available technology used for 

ISM equipment in this band to develop 

low-cost MBAN devices. 

14. In addition to present use by ISM, 

the Commission observes that various 

radio services are also allocated in this 

band. Among these, the 2400–2417 MHz 

band is allocated to the Amateur service 

on a primary basis. The 2417–2450 MHz 

band is allocated to the Amateur service 

on a secondary basis, and to the Federal 

radiolocation service on a secondary 

basis. Such Federal operations may be 

authorized on a non-interference basis, 

but may not constrain the 

implementation of any non-Federal 

operations. The 2450–2483.5 MHz band 

is allocated to the non-Federal fixed and 

mobile services on a primary basis, and 

to the non-Federal radiolocation service 

on a secondary basis. The Federal 

radiolocation service is also permitted 

in this band on condition that harmful 

interference is not caused to nonFederal services. The 2400–2483.5 MHz 

band is also used by unlicensed devices 

operating under Part 15 of the 

Commission’s Rules. These unlicensed 

devices include WiFi, cordless phones, 

and Bluetooth, among various other 

types of uses. 

15. The Commission seeks comment 

on whether the widespread success of 

the unlicensed devices described in the 

preceding paragraph would provide 

manufacturers the opportunity to 

leverage these technologies for the 

development of low cost MBAN devices 

within the 2400–2483.5 MHz band. 

More particularly, the Commission 

seeks comment as to whether MBAN 

devices could be certified and operate 

under the current part 15 rules, whether 


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39252 Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 

a new subpart under part 15 might be 

required, or whether it should consider 

licensed operation of MBAN devices 

under part 95 of the Commission’s rules. 

If it is determined that licensed 

operation is appropriate, would the 

technical and service rules discussed for 

the 2360–2400 MHz band be applicable 

for MBAN operation in the 2400–2483.5 

MHz band? If not, what technical and 

service rules would apply? What 

amount of bandwidth would MBAN 

devices require to operate in this band 

and in what portion of the band would 

they operate? The Commission also 

seeks comment regarding whether 

MBAN operations can exist compatibly 

with the incumbent Amateur service 

users who operate in this band. 

16. The Commission also cautions 

that any MBAN equipment operating in 

these bands would have no protection 

from interference from ISM equipment 

operating under part 18 of the rules or 

other low power transmitters operating 

under part 15 of the rules. The 

Commission seeks information as to 

whether the ISM bands are still used by 

medical telemetry devices, and 

comment as to whether MBAN 

operations would fit within this 

category of use. 

3. Other Frequency Bands 

17. The Commission seeks comment 

on whether there are other frequency 

bands where MBAN manufacturers 

could leverage existing technologies to 

implement such devices and achieve 

economies of scale. For example, the 

Commission seeks comment on whether 

the 5150–5250 MHz band offers similar 

opportunities for MBAN operation as 

may be achievable in or near the 2400 

MHz band as described. The 5150–5250 

MHz band is allocated to the Federal 

and non-Federal aeronautical 

radionavigation service. The band is 

also allocated to the non-Federal fixedsatellite service. In addition to these 

allocated services, the band is also used 

by unlicensed national information 

infrastructure (U–NII) devices operating 

under subpart E of the Commission’s 

part 15 rules. 

18. U–NII devices use digital 

modulation techniques and provide a 

wide array of high data rate mobile and 

fixed communications applications. U– 

NII devices operating in the 5250–5350 

MHz and 5470–5725 MHz bands must 

employ Dynamic Frequency Selection 

(DFS) to avoid operating on the same 

channels as radars. However, the 5150– 

5250 MHz band does not require DFS 

and is limited to indoor operation only, 

which would appear to be consistent 

with GEHC’s proposed MBAN devices. 

19. With respect to the 5150–5250 

MHz band, the Commission seeks 

comment as to whether MBAN devices 

could be certified and operate under the 

current part 15 rules, whether a new 

subpart under part 15 might be required, 

or whether it should consider licensed 

operation of MBAN devices under part 

95 of the Commission’s rules. If it is 

determined that licensed operation is 

appropriate, would the technical and 

service rules discussed below for the 

2360–2400 MHz band be applicable for 

MBAN operation in the 5150–5250 MHz 

band? If not, what technical and service 

rules would apply? What amount of 

bandwidth would MBAN devices 

require to operate in this band and in 

what portion of the band would they 

operate? Can MBAN devices operate 

compatibly with the incumbent services 

in the 5150–5250 MHz band? Should 

MBAN operations be limited to indoor 

locations, similar to the indoor 

restriction to U–NII devices in 

§ 15.407(e)? 

B. Service and Technical Rules 

20. The tentative rules discussed in 

the NPRM focus upon the overall 

framework of the MedRadio Service in 

part 95, but with modified power and 

emission bandwidth requirements to 

accommodate the anticipated 

bandwidth and EIRP needs of MBAN 

operations that might apply in the 

2360–2400 MHz band. At the same time, 

the Commission seeks comment on 

other approaches, such as under part 90 

or part 15, that might be feasible. The 

Commission takes this approach in the 

NPRM because the 2360–2400 MHz 

band was specifically addressed in the 

GEHC petition and in both the 

comments and reply comments, The 

Commission notes that, in any event, 

similar rules would also be required if 

MBAN operations were to be authorized 

in either the 2400–2483.5 MHz or the 

5150–5250 MHz bands under 

consideration. 

1. Service Rules 

21. Licensing. The Commission seeks 

comment on whether medical device 

operations should be authorized in part 

95 of our rules, thus providing for 

license-by-rule operation pursuant to 

Section 307(e) of the Communications 

Act (Act). Under this approach, medical 

devices would operate in the band on a 

shared, non-exclusive basis with respect 

to each other and without the need for 

MBAN systems to be individually 

licensed. As the Commission 

determined when it adopted the 

MedRadio Service rules, this approach 

minimizes regulatory burdens and 

facilitates the expeditious deployment 

of new generations of beneficial wireless 

medical devices that can improve the 

quality of life for countless Americans, 

thus serving the public interest, 

convenience and necessity. The 

Commission seeks comment on whether 

the rules for MBANs should be included 

in subpart I of part 95, which authorizes 

the MedRadio Service, or whether the 

rules for MBANs should be included in 

a new subpart under part 95. 

22. Alternatively, the Commission 

seeks comment on whether MBAN 

operations should be licensed on a nonexclusive basis under part 90. In this 

context, the Commission also seeks 

comment on whether it would be 

feasible to establish geographic 

exclusion zones around AMT 

operational areas as an interference 

avoidance mechanism. At the same 

time, the Commission seeks comment 

on whether the use of such exclusion 

zones could frustrate the widespread 

use of MBAN devices—particularly, for 

example, if such exclusion zones were 

so large as to encompass major 

metropolitan areas where MBAN 

operations might be prohibited. As 

discussed elsewhere in the NPRM, 

frequency coordination also could 

facilitate sharing between the 

incumbent operations and MBAN 

devices. Frequency coordination is 

required for WMTS operations 

authorized under part 95, but does not 

involve as many sites as could be 

required for MBAN and AMT 

coordination. Another licensing 

approach that the Commission would 

consider for MBAN operation that 

includes coordination is non-exclusive 

licensing under part 90. Under that 

approach, MBAN operations would be 

licensed on a non-exclusive basis with 

respect to each other for ten year license 

terms. The Commission seeks comment 

on whether it should consider using the 

same approach here as it does with 

wireless broadband services in the 

3650–3700 MHz band, i.e., eligible 

entities would apply for non-exclusive 

nationwide licenses and subsequently 

register individual stations with the 

Commission. If the Commission were to 

adopt this approach, should it require 

that licensees register each individual 

MBAN system or, alternatively, require 

them to register the individual health 

care facility at which the licensee would 

be allowed to operate multiple MBAN 

systems? What type of licensing and 

registration information for MBAN 

operations would facilitate coordination 

with incumbent services? What would 

be the relative benefits and 

disadvantages of licensing under part 90 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 39253 

compared with the license-by-rule 

approach under part 95? 

23. Definitions. The Commission 

seeks comment on the definitions to 

apply to MBAN systems and body 

sensor devices. Because MBAN systems 

may be comprised of sensors that 

perform not only monitoring functions 

but also diagnostic and therapeutic 

functions, definitions for MBAN and 

body sensor networks should be 

consistent with definitions already in 

the Commission’s part 95 rules for 

wireless medical telemetry and bodyworn devices. The Commission seeks 

comment on the following proposed 

definitions: 

• Medical body area device—a 

medical sensing device that is placed on 

or in close proximity to the human body 

for the purpose of measuring and 

recording physiological parameters and 

other patient information or performing 

diagnostic or therapeutic functions via 

radiated bi- or unidirectional 

electromagnetic signals. These devices 

may only communicate as part of a 

medical body area network. 

• Medical body area network 

(MBAN)—a low-power independent 

network comprised of multiple medical 

body area devices that transmit or 

receive either non-voice medical data of 

a patient or related device control 

commands. Transmissions to and from 

these multiple medical body area 

devices are routed through a hub, which 

is placed on or in close proximity to the 

patient’s body, and which may 

communicate with a remote monitoring 

location. 

• MBAN transmitter—A transmitter 

that operates as part of a Medical Body 

Area Network, and is located either on 

the human body or in close proximity 

to it. 

• MBAN control transmitter—A 

MBAN transmitter, which is designed to 

be placed on or in close proximity to the 

patient’s body, that serves as a hub to 

control and coordinate communications 

with body area devices, and which may 

also communicate with a remote 

monitoring location. 

24. The Commission requests 

comment as to whether these definitions 

would be too broad or too narrow and 

whether alternative definitions should 

be used. The Commission asks whether 

other components of wireless MBAN 

systems should also be identified and 

defined. The Commission is not 

proposing to include medical implant 

devices as part of MBAN systems, 

although it recognizes that such devices 

could be used for monitoring, diagnostic 

or therapeutic purposes. Parties that 

believe medical implant devices should 

be allowed as part of MBAN operations 

should address how such devices would 

co-exist with body sensor devices and 

the technical rules that would apply to 

their operation. The Commission also 

seeks comment on whether any other 

current definitions included in the 

MedRadio Service rules need to be 

modified to accommodate wireless 

MBAN devices. 

25. Permissible Communications and 

Operator Eligibility. The Commission 

proposes to establish requirements for 

permissible communications and 

operator eligibility that are generally the 

same as those in place for the MedRadio 

Service. The MedRadio rules provide 

that a MedRadio device may be used by 

persons for diagnostic and therapeutic 

purposes, but only to the extent that 

such devices have been provided to a 

human patient under the direction of a 

duly authorized health care 

professional. Furthermore, 

transmissions are limited to non-voice 

data signals. The Commission expects, 

based on representations made in the 

GEHC petition, that wireless body 

sensor devices configured as a MBAN 

would be used primarily for monitoring 

patient data. The Commission believes 

it would be prudent to provide 

flexibility so that MBAN systems can 

also be used for performing diagnostic 

or therapeutic functions. The 

Commission seeks comment on whether 

these requirements would be 

appropriate for MBAN operations. 

26. In the MedRadio proceeding, the 

Commission declined to explicitly limit 

the use of some frequencies to lifecritical and time-sensitive applications, 

as the comments of some parties 

suggested, while allowing other 

frequencies to be used for non-lifecritical, non-time sensitive applications. 

The Commission concluded that the 

ultimate decision on which frequency 

band to use for each type of application 

was best left to health care professionals 

and medical device manufacturers, in 

concert with FDA-required risk 

management processes, as it would 

result in better and more flexible use of 

this scarce spectrum resource. The 

Commission seeks comment on whether 

a similar approach is appropriate for 

MBAN devices—i.e., permitting health 

care professionals and medical device 

manufacturers, in concert with FDArequired risk management processes, to 

decide whether MBAN devices should 

be used for life-critical and timesensitive applications even though these 

devices would not receive interference 

protection from radiocommunication 

services with a higher allocation status. 

Commenters who believe that the 

Commission should not allow MBAN 

devices for life-critical and timesensitive applications should suggest 

how the Commission should define 

these terms and types of applications. 

27. The Commission also notes that 

the current MedRadio Service rules do 

not allow programmer/control 

transmitters to relay information to a 

receiver that is not included with a 

MedRadio implant or body-worn device. 

However, the MedRadio Service rules 

do allow programmer/control 

transmitters to be interconnected with 

other telecommunications systems 

including the public switched telephone 

network. The Commission seeks 

comment on whether, and if so why, 

similar requirements should also apply 

here. The Commission also seeks 

comment on how spectrum might be 

used to perform backhaul from a single 

patient-based MBAN control transmitter 

to a monitoring station that receives and 

processes MBAN body sensor data from 

multiple patients and what spectrum 

should be used for that purpose. 

28. The Commission seeks comment 

on whether communications between 

MBAN body sensors, or other intraMBAN network communications, 

should be allowed, and whether there 

should be a requirement that each 

external MBAN control transmitter be 

limited to controlling the body sensor 

transmitters for a single patient. 

Alternatively, the Commission asks 

whether it should permit groups of 

MBAN body sensors for multiple 

patients to be coordinated by one 

central MBAN control transmitter and if 

so, whether any special protocols or 

other requirements should be applied to 

such communications. 

2. Technical Rules 

29. Channelization. The Commission 

seeks comment on adopting rules for 

MBAN operations that do not specify a 

particular channeling plan, thereby 

following the general approach used 

with the MedRadio Service. Under this 

approach, the ‘‘channel’’ occupied by a 

MBAN transmitter or transmission 

would be loosely defined as any 

continuous segment of spectrum that is 

equal to the largest bandwidth used by 

any MBAN transmitter that participates 

in a given single patient MBAN 

communications session. In this 

context, a MBAN ‘‘communication 

session’’ would be defined (analogous to 

the definition of a MedRadio 

communication session) as a collection 

of transmissions that may or may not be 

continuous and that take place between 

two or more MBAN devices in a single 

patient network. 

30. One benefit of this approach 

would be that networked MBAN devices 

could transmit on any center frequency 


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39254 Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 

within the MBAN band so long as the 

maximum emission bandwidth, out-ofband, and spurious emission limits 

adopted herein are met. This approach 

would also afford the flexibility for 

MBAN devices to subdivide the 

authorized frequency band(s) into adhoc device ‘‘channels’’ that could be 

tailored by manufacturers to meet 

device-specific spectrum requirements 

for a variety of medical monitoring, 

diagnostic and therapeutic functions. 

The Commission seeks comment on 

whether to apply the MedRadio 

approach of specifying only the 

maximum permitted bandwidth, but not 

any particular channel plan, with 

respect to MBAN devices in their 

authorized frequency band(s). In 

particular, the Commission seeks 

comment on whether the potential 

benefits described above might be 

outweighed by an increased risk of 

adverse mutual interactions between 

multiple MBAN devices or MBAN 

devices and incumbent users using 

differing center frequencies and 

bandwidths and whether there are other 

factors that should be considered under 

this option. 

31. Alternatively, the Commission 

seeks comment on whether a specific 

channeling plan would be needed. If so, 

what form might it take and what are 

the advantages that it would obtain over 

the proposed approach? 

32. Exclusion Zones. The Commission 

recognizes that the current record 

contains conflicting information relating 

to the appropriate models to be used for 

evaluating the potential for interference 

to AMT operations from MBAN devices 

and establishing the size of exclusion 

zones to protect those operations. 

Therefore, the Commission seeks 

comment on the feasibility of using 

exclusion zones as a means to prevent 

interference to incumbent operations in 

the 2360–2390 MHz band and, if 

exclusion zones are to be used, the 

appropriate radius to use for such 

exclusion zones. The Commission states 

that it is not convinced at this time that 

either the GEHC or AFTRCC analysis is 

appropriate for determining interference 

potential and the utility or size of 

exclusion zones. Thus, the Commission 

seeks comment on the analytic 

methodology that should be used and 

the assumptions that should be 

employed, including the methodologies 

and analyses used by AFTRCC and 

GEHC for determining an exclusion 

zone radius. The Commission also 

invites comment on other 

methodologies and analyses, including 

assumptions on which they rely, that 

could be used. The Commission also 

seeks comment on whether it is 

appropriate to use either interference 

criteria described herein, which are 

primarily intended for satellite and 

terrestrial sharing in the adjacent 

frequency band, for AMT and MBAN 

operations and invite suggestions for 

alternative approaches for determining 

the radius of potential exclusion zones. 

The Commission provides in Appendix 

A of the NPRM additional parameters 

for MBAN and AMT systems that 

parties should address, as appropriate, 

to support further technical analyses. 

33. The Commission also seeks 

comment on whether exclusion zones 

could always preclude operation of 

MBAN devices at some locations. If so, 

would it be in the public interest to 

preclude these technologies from certain 

health care facilities based on their 

location? Or should health care facilities 

located within an exclusion zone be 

permitted to coordinate MBAN use with 

AMT operations in that zone? 

34. If exclusion zones were to be 

established, what criteria should be 

used to identify those AMT sites in need 

of protection? Should only AMT test 

sites that now actually use the 2360– 

2390 MHz band be protected, or also 

those test sites that do not presently use 

the band but might prospectively do so? 

If protection were to be required of sites 

that AFTRCC claims are ‘‘entitled’’ to, 

but do not currently use the 2360–2390 

MHz band, how would the sites which 

are ‘‘entitled’’ to be protected be 

determined? Once existing test sites 

were determined, how would future test 

sites be protected if MBAN devices are 

already operating within the area that 

will be designated as a new exclusion 

zone? With respect to making these 

determinations, the NPRM notes that 

the Commission (for non-Federal users) 

and NTIA (for Federal users) maintain 

separate data bases containing 

geographic location and frequency 

information on users authorized to 

operate transmitters throughout the 

radio spectrum. Thus, if an exclusion 

zone approach permitting MBAN 

operation were to be adopted, the 

Commission would anticipate relying, 

to the extent possible, upon the 

information contained in the relevant 

Commission and NTIA data bases as a 

baseline for identifying facilities that 

require protection. If the Commission 

ultimately decides to protect sites that 

are not currently licensed to use the 

2360–2390 MHz band, how would 

information on exclusion zones be 

accurately maintained and timely 

updated in the Commission’s rules? The 

Commission seeks comment on these 

matters. 

35. The NPRM seeks comment on 

whether the distance for MBAN 

operations should be measured from the 

specified center point that establishes 

the incumbent’s area of operation or 

whether it should be measured from the 

edge of that area? How should 

incumbent sites be accounted for that 

are in close proximity to each other 

such that their areas of operation may 

overlap each other? Should further 

information be collected about 

incumbent operational locations and 

how should it be gathered? Regarding 

information about Federal sites, the 

Commission notes that it would intend 

to consult with NTIA about how to 

identify this information and make it 

available. The Commission also seeks 

comment on how it should account for 

future installations if a healthcare 

facility that is using MBANs is located 

in an area that would become part of an 

exclusion zone for the new site. 

36. Frequency Coordination. With 

respect to protecting AMT operations 

from MBAN interference in portions of 

the 2360–2400 MHz band, the 

Commission recognizes that 

coordination may be useful because 

MBAN operations might otherwise be 

excluded from large geographic areas 

that encompass medical facilities. In 

such cases coordination would provide 

a means for the parties to work together 

on some type of sharing arrangement for 

given locations. Thus, the Commission 

seeks comment on whether coordination 

of MBAN systems is needed and should 

be required and, if so, under what 

circumstances. The Commission also 

seeks comment on whether it should 

require AMT or other incumbent 

licensees to participate in frequency 

coordination with operators of MBAN 

systems in any portions of the band. If 

so, what approaches would be feasible, 

and what parties would be responsible 

for ensuring that such coordination 

takes place? 

37. For example, the Commission 

acknowledges the suggestion made in 

the GEHC petition that the Commission 

could require frequency coordination 

and device registration for MBAN 

operations such as is used for 

coordination of WMTS operation. 

There, the Commission designated a 

private entity to serve as the WMTS 

frequency coordinator and that entity 

maintains a database of all WMTS 

equipment in operation. 

38. However, in the case of MBAN 

systems, users may not need to 

coordinate their operations among 

themselves as do WMTS users, 

particularly if MBAN devices ultimately 

rely on a contention-based protocol as 

discussed below to promote intraservice sharing. Regarding coordination 

of MBAN operations with incumbent 


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users, the Commission also notes that 

MBAN devices would operate on a 

secondary basis, and a significantly 

large number of primary users must be 

accorded interference protection. Thus, 

the Commission seeks comment on 

whether the WMTS model would be 

feasible here. Parties supporting this 

approach should address what criteria 

would be used to determine if a MBAN 

system could operate without causing 

interference, what type of information 

should be contained in a database, who 

would have access to the database and 

on what terms, and how the 

Commission would designate a database 

administrator. 

39. Alternatively, the Commission 

could license MBAN operations on a 

non-exclusive basis under part 90, and 

would be responsible for facilitating 

coordination. For example, licensees in 

the Wireless Broadband Service in the 

3650–3700 MHz band are permitted to 

operate anywhere outside of specified 

150 km protection zones around 

incumbent non-Federal primary earth 

station facilities. Those wishing to 

operate within the protection zones 

must negotiate with the affected 

incumbents directly. To ensure 

compatibility with Federal stations, the 

Commission coordinates operations 

with NTIA through the Frequency 

Assignment Subcommittee of the 

Interdepartment Radio Advisory 

Committee for any station that requests 

registration of a site closer than 80 km 

from three specified radio location sites. 

The Commission further notes that our 

Universal Licensing System has the 

capability of screening for any terrestrial 

applications that might propose site 

coordinates located within the 80 km 

coordination zone and flag that 

application for any necessary 

coordination. 

40. The Commission notes that, in the 

present case proposed by GEHC, the 

circumstances under which Federal and 

non-Federal AMT spectrum use is 

coordinated is substantially different 

than those at 3650–3700 MHz. AFTRCC 

is the designated coordinator of all nonFederal AMT use, and is recognized as 

such by both the Commission and 

NTIA. Consequently, any Federal and 

non-Federal use of the 2360–2395 MHz 

band is referred to AFTRCC and 

coordination with them must be 

completed prior to operation. In 

addition, the Commission coordinates 

non-Federal use of this spectrum with 

NTIA. If the Commission were to follow 

this approach, any MBAN operation in 

the 2360–2395 MHz band segment 

would be referred to AFTRCC and to 

NTIA, which might delay deployment. 

At the same time, because the 

Commission would have the licensing 

and coordination information readily 

available, it could intercede in resolving 

disagreements more easily, as needed. 

Regarding spectrum sharing among 

MBAN operations, coordination under a 

non-exclusive licensing scheme does 

not appear to provide any additional 

benefits compared to the WMTS model. 

The Commission seeks comment on 

whether such an approach would be 

feasible here. Commenters should 

address the relative advantages and 

disadvantages of the approaches they 

support. 

41. Frequency Monitoring 

(Contention-based Spectrum Access 

Protocols). The Commission recognizes 

that low power operation and spread 

spectrum or similar technology may 

enable MBAN devices to operate in very 

close proximity to one another without 

any mutual interference and mitigate 

the potential for one body sensor 

network to block another’s access to the 

spectrum. The Commission also notes 

that GEHC claims that contention 

protocols could be applied as a way for 

MBAN devices to successfully coexist 

within the band, and also as a way to 

protect MBAN devices from interference 

from the primary AMT systems. The 

Commission invites comment on these 

observations and whether any rules 

should be adopted to ensure such 

sharing. In particular, it seeks comment 

on whether a contention-based protocol 

should be applied to MBAN 

transmitting devices, and if so, how 

such a protocol might be developed. If 

the Commission were to adopt a 

requirement for a contention-based 

protocol, it invites comment as to 

whether it should rely upon the general 

definition of contention-based protocol 

recently adopted by the Commission for 

the operation of wireless devices under 

part 90 of the rules in the 3650 MHz 

band, which reads as follows. 

‘‘Contention-based protocol. A protocol 

that allows multiple users to share the same 

spectrum by defining the events that must 

occur when two or more transmitters attempt 

to simultaneously access the same channel 

and establishing rules by which a transmitter 

provides reasonable opportunities for other 

transmitters to operate. Such a protocol may 

consist of procedures for initiating new 

transmissions, procedures for determining 

the state of the channel (available or 

unavailable), and procedures for managing 

retransmissions in the event of a busy 

channel.’’ 

42. The Commission encourages 

commenters supporting implementation 

of a contention-based protocol to 

discuss what kinds of contention 

protocols should or should not be 

utilized, and to explain in detail why or 

why not. How should such protocols be 

defined? Should the protocol be opensource or proprietary? Should more than 

one protocol be permitted? Should the 

same protocol be required for all 

devices, and how would this be 

accomplished? How should such 

protocols be established—by rule, by 

industry standard setting procedures, or 

other approaches? Would any of these 

protocols be expected to interact either 

favorably or adversely with incumbent 

users? 

43. Transmitter Power, Emission 

Bandwidth, and Duty Cycle. As 

recommended by GEHC, the 

Commission would limit individual 

MBAN devices to a maximum transmit 

power of 1 mW equivalent isotropic 

radiated power (EIRP) measured in a 1 

megahertz bandwidth, and a maximum 

emission bandwidth of 1 megahertz. In 

explaining this recommendation, GEHC 

indicates that, as presently conceived, a 

typical MBAN system would be 

comprised of a single network per 

patient/person with a gateway-hub 

device coordinating transmissions from 

multiple body worn sensors. It estimates 

that the suggested power and bandwidth 

limits would be sufficient to allow short 

burst messaging, which in turn would 

facilitate low power consumption from 

duty cycles less than 25 percent. 

44. While GEHC emphasizes the use 

of MBAN systems for monitoring patient 

physiological data, the Commission 

recognizes that the definition that it 

proposed for MBAN systems would also 

allow the operation of two or more 

networked medical devices to perform 

diagnostic and therapeutic functions. 

The Commission seeks comment on 

whether the power/bandwidth limits 

proposed above—which reflect GEHC’s 

recommendations—would be 

appropriate for such other purposes. 

The Commission specifically asks 

whether another combination of power 

and duty cycle limits would provide a 

better balance between affording 

interference protection to incumbent 

users and achieving sufficiently reliable 

MBAN system performance. The 

Commission requests that commenters 

suggesting other bandwidths should 

fully discuss their relative benefits and 

potential disadvantages in light of the 

considerations discussed herein. With 

respect to transmitter duty cycles, the 

Commission seeks comment on whether 

GEHC’s assumption of a 25 percent 

factor adequately characterizes 

operations that would be expected from 

real-world devices. For example, would 

the duty factor of MBAN transmitters 

used for diagnostic or therapeutic 

purposes, instead of patient monitoring, 

be more likely to require higher, lower, 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
39256 Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 

or the approximately the same duty 

cycles and, if so, should this be 

accounted for in the maximum duty 

cycle specification? What would be the 

relative advantages or disadvantages of 

specifying versus not specifying specific 

duty cycle limits for MBAN transmitters 

in the rules? Is a duty cycle limit needed 

to allow the functioning of a contentionbased spectrum access protocol and, if 

so, what is the maximum duty cycle that 

should be allowed in order to support 

such a protocol? Should the duty cycle 

apply to individual MBAN transmitters, 

whether located in a medical body area 

device or the MBAN control transmitter, 

or to the aggregate duty cycle of all 

transmitters comprising an MBAN, as 

the terms are proposed to be defined 

above? 

45. Channel aggregation. To the 

extent that device manufacturers might 

wish to aggregate multiple transmission 

channels in a single device, the 

Commission seeks comment on 

requiring only that the total emission 

bandwidth used by all devices in any 

single patient MBAN communication 

session not exceed the maximum 

authorized bandwidth of 1 megahertz. 

Thus, for example, a single MBAN body 

sensor could be designed to operate 

nominally on two channels, each 

occupying up to 500 kHz (i.e., one-half 

the maximum authorized emission). In 

essence, this would also carry forward 

the existing channel use provisions of 

the MedRadio Service. As an additional 

example, the Commission further notes 

that this provision would not preclude 

full duplex or half duplex 

communications; provided that the total 

amount of bandwidth utilized by all of 

the channels employed by collection of 

a single patient, networked MBAN 

devices during a communications 

session does not exceed the maximum 

authorized 1 megahertz emission 

bandwidth. The Commission also 

requests comment on allowing any 

lesser emission bandwidths to be 

employed so long as the device 

complies with all other EIRP and 

unwanted emission limits. The 

Commission seeks comment on all of 

these issues. 

46. Unwanted emissions. The 

MedRadio rules under part 95 set forth 

limits on unwanted emissions from 

medical transmitting devices operating 

in the 401–406 MHz band. Those 

provisions include limits on both inband and out-of-band radiation. 

Specifically, emissions on frequencies 

500 kHz or less above or below any 

particular authorized bandwidth [are] 

required to be attenuated by at least 20 

dB below the transmitter output power. 

In addition, emissions more than 500 

kHz above or below any particular 

authorized bandwidth [are] required to 

be attenuated to a level no greater than 

the following signal strengths at 3 m: (a) 

between 30–88 MHz, 100 μV/m, (b) 

between 88–216 MHz, 150 μV/m, (c) 

between 216–960 MHz, 200 μV/m, and 

(d) 960 MHz and above, 500 μV/m. The 

Commission seeks comment on the 

appropriateness of applying the same 

general limits on MBAN operations in 

the 2300–2305 MHz and 2360–2400 

MHz bands. If parties suggest other outof-band emission limits for devices 

operating in this band, they should 

provide sufficient technical justification 

to support those limits. Under any 

approach, the Commission seeks to 

provide an RF environment that would 

be adequate to protect incumbent 

operations while fostering efficient 

spectrum use by MBAN devices. 

47. Frequency stability. Following the 

MedRadio rules, the Commission would 

require that MBAN transmitters 

maintain a frequency stability of +/¥ 

100 ppm of the operating frequency over 

the range: (1) 25 °C to 45 °C in the case 

of MBAN transmitters; and (2) 0 °C to 

55 °C in the case of MBAN control 

transmitters. The Commission seeks 

comment on these stability criteria. 

48. Antenna locations. The 

Commission seeks comment on whether 

it would be appropriate to restrict the 

use of MBAN transmitting antennas to 

indoor locations in certain frequency 

bands. For example, in light of the 

concerns discussed above regarding the 

interference potential between AMT and 

MBAN systems, should MBAN 

operations that might be permitted in 

the 2360–2390 MHz band be limited to 

indoor use (within healthcare facilities)? 

This would be similar to the WMTS 

approach noted herein, where 

transmitting antennas are restricted to 

indoor locations only. Alternatively, 

would it be more practical in other 

frequency bands to follow the approach 

of the present MedRadio rules by which 

temporary outdoor antennas are 

permitted? The Commission invites 

commenters to address the relative 

advantages and disadvantages of either 

approach for MBAN use in any of the 

frequency bands under consideration in 

this proceeding. 

49. RF safety. The Commission notes 

that portable devices are subject to 

§ 2.1093 of the rules, pursuant to which 

an environmental assessment must be 

prepared under § 1.1307. These rule 

sections also govern existing MedRadio 

devices. Devices covered by these rules 

are subject to routine environmental 

evaluation for RF exposure prior to 

equipment authorization. The 

Commission further notes, however, 

that in our ongoing RF safety proceeding 

(ET Docket No. 03–137) it anticipates 

dealing with proposed changes in our 

rules regarding human exposure to RF 

electromagnetic fields in a more 

comprehensive fashion. Thus, for the 

purposes of the instant proceeding and 

the Commission’s pending action in the 

RF safety proceeding in ET Docket No. 

03–137, the Commission only seeks 

comment here on whether MBAN 

transmitters should be deemed as 

portable devices subject to §§ 2.1093 

and 1.1307 of the Commission’s existing 

rules. To the extent that MBAN devices 

are deemed portable devices, they 

would then be subject to our RF 

exposure rules for such devices. 

50. Miscellaneous provisions. The 

Commission also seeks comment on 

various rule provisions regarding 

equipment certification, authorized 

locations, station identification, station 

inspection, disclosure policy, labeling 

requirements and marketing limitations 

that mirror the existing MedRadio rules. 

51. First, the Commission seeks 

comment on whether it should require 

that each authorized MBAN transmitter 

be certificated, except for such 

transmitters that are not marketed for 

use in the United States, but which 

otherwise comply with the applicable 

technical requirements and are operated 

in the United States by individuals who 

have traveled to the United States from 

abroad. 

52. The Commission also seeks 

comment on whether to specifically 

require that all non-implanted MBAN 

transmitter apparatus be made available 

for inspection upon request by an 

authorized FCC representative. Under 

such a provision, persons operating 

MBAN transmitters would be required 

to cooperate reasonably with duly 

authorized FCC representatives in the 

resolution of interference. 

53. The Commission request comment 

on requiring that manufacturers of 

MBAN transmitters include an 

appropriate disclosure statement 

analogous to that for MedRadio 

transmitters with each MBAN 

transmitting device. Such a statement 

would disclose the provision of the 

rules under which the device is 

authorized, along with a statement that 

the transmitter must not cause harmful 

interference to stations authorized to 

operate on a primary basis in the band, 

and must accept interference that may 

be caused by such stations, including 

interference that may cause undesired 

operation. Such a statement would also 

indicate that the transmitter shall be 

used only in accordance with the FCC 

rules, and that analog and digital voice 

communications are prohibited. The 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 39257 

1See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601 et 

seq., has been amended by the Contract With 

America Advancement Act of 1996, Public Law No. 

104–121, 110 Stat. 847 (1996) (CWAAA). Title II of 

the CWAAA is the Small Business Regulatory 

Enforcement Fairness Act of 1996 (SBREFA). 

2See 5 U.S.C. 603(a). 

3 5 U.S.C. 603(b)(3). 

4 5 U.S.C. 601(6). 

5 5 U.S.C. 601(3) (incorporating by reference the 

definition of ‘‘small business concern’’ in 15 U.S.C. 

632). Pursuant to the RFA, the statutory definition 

of a small business applies ‘‘unless an agency, after 

consultation with the Office of Advocacy of the 

Small Business Administration and after 

opportunity for public comment, establishes one or 

more definitions of such term which are 

appropriate to the activities of the agency and 

publishes such definition(s) in the Federal 

Register.’’ 5 U.S.C. 601(3). 

6Small Business Act, 15 U.S.C. 632 (1996). 

7See SBA, Office of Advocacy, ‘‘Frequently 

Asked Questions,’’ http://web.sba.gov/faqs 

(accessed Jan. 2009). 

8 5 U.S.C. 601(4). 

9 Independent Sector, The New Nonprofit 

Almanac & Desk Reference (2002). 

10 5 U.S.C. 601(5). 

11U.S. Census Bureau, Statistical Abstract of the 

United States: 2006, Section 8, page 272, Table 415. 

12We assume that the villages, school districts, 

and special districts are small, and total 48,558. See 

U.S. Census Bureau, Statistical Abstract of the 

United States: 2006, section 8, page 273, Table 417. 

For 2002, Census Bureau data indicate that the total 

Continued 

Commission seeks comment on this 

proposal. 

54. The Commission further seeks 

comment on whether to require that 

MBAN control transmitters (if allocated 

on a secondary basis) be labeled and 

bear the following statement in a 

conspicuous location on the device: 

‘‘This device may not interfere with 

stations authorized to operate on a 

primary basis and must accept any 

interference received, including 

interference that may cause undesired 

operation.’’ Where a MBAN control 

transmitter is constructed in two or 

more sections connected by wire and 

marketed together, the statement 

specified in this section would be 

required to be affixed only to the main 

control unit. The Commission also seeks 

comment on whether to require that 

MBAN transmitters be identified with a 

serial number. Under that plan, the 

Commission would allow the FCC ID 

number associated with the transmitter 

and the information required by § 2.925 

of the FCC rules to be placed in the 

instruction manual for the transmitter in 

lieu of being placed directly on the 

transmitter. 

55. Finally, with respect to marketing 

limitations, the Commission seeks 

comment on whether it should specify 

that MBAN transmitters may be 

marketed and sold only for those 

permissible uses described in the 

NPRM. 

C. Other Matters and Conclusion 

56. As noted in the Background 

discussion of the NPRM, BSI (Broadcast 

Sports, Inc.) filed comments in which it 

proposes an ‘‘Event Radio Service’’ as 

an alternative to the GEHC proposal for 

use of the 2360–2400 MHz band. The 

Commission finds that BSI has not 

provided sufficient clarity to consider 

such an allocation or related service 

rules. On its face, the BSI proposal 

appears to be intended to preserve the 

ability to obtain access to additional 

spectrum for video coverage of sports 

events that can already be obtained 

under STAs. There is no evidence, 

however, to support the proposition that 

an allocation for MBANS would 

constrain the ability to obtain STAs for 

video coverage of sports events. 

Moreover, special temporary authority 

is precisely the proper instrument for 

authorizing temporary operations at 

specific locations. Furthermore, the 

Commission is not persuaded that an 

allocation of spectrum and service rules 

limited to video coverage of sports 

events represents the most efficient use 

of this spectrum nor best serves the 

public interest as compared with 

devices that may have significant 

benefits for health care. Accordingly, 

the Commission declines to propose 

BSI’s alternative allocation for an Event 

Radio service. 

57. The Commission seeks comment 

on all of the matters discussed in this 

NPRM, and encourages commenters to 

address any other relevant matters of 

concern that might serve to illuminate 

the record in this proceeding. 

Initial Regulatory Flexibility Analysis 

58. As required by the Regulatory 

Flexibility Act (RFA),1 the Commission 

has prepared this present 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 (NPRM). Written 

public comments are requested on this 

IRFA. Comments must be identified as 

responses to the IRFA and must be filed 

by the deadlines for comments provided 

in this NPRM. The Commission will 

send a copy of this NPRM, including 

this IRFA, to the Chief Counsel for 

Advocacy of the Small Business 

Administration (SBA).2

A. Need for, and Objectives of, the 

Proposed Rules 

59. The Commission seeks comment 

on the feasibility of allocating spectrum 

for the operation of Medical Body Area 

Network (or MBAN) systems using body 

sensor devices. Under the service and 

technical rules proposed herein, the 

Commission envisions that MBAN 

systems could provide a flexible 

platform for the wireless networking of 

multiple body sensors used for 

monitoring physiological patient data in 

health care facilities. Use of MBAN 

systems should result in improved 

safety, quality, and efficiency of patient 

care by reducing or eliminating a wide 

array of hardwired, patient-attached 

cables used by present monitoring 

technologies. 

B. Legal Basis 

60. The proposed action is authorized 

under Sections 4(i), 301, 302, 303(e), 

303(f), 303(r), 304 and 307 of the 

Communications Act of 1934, as 

amended, 47 U.S.C. Sections 154(i), 301, 

302, 303(e), 303(f), 303(r), 304 and 307. 

C. Description and Estimate of the 

Number of Small Entities to Which the 

Proposed Rules Would Apply 

61. The RFA directs agencies to 

provide a description of and, where 

feasible, an estimate of the number of 

small entities that may be affected by 

the proposed rules, if adopted.3 The 

RFA generally defines the term ‘‘small 

entity’’ as having the same meaning as 

the terms ‘‘small business,’’ ‘‘small 

organization,’’ and ‘‘small governmental 

jurisdiction.’’ 4 In addition, the term 

‘‘small business’’ has the same meaning 

as the term ‘‘small business concern’’ 

under the Small Business Act.5 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 SBA.6

62. Nationwide, there are a total of 

approximately 27.2 million small 

businesses, according to the SBA.7 A 

‘‘small organization’’ is generally ‘‘any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field.’’ 8

Nationwide, as of 2002, there were 

approximately 1.6 million small 

organizations.9 The term ‘‘small 

governmental jurisdiction’’ is defined 

generally as ‘‘governments of cities, 

towns, townships, villages, school 

districts, or special districts, with a 

population of less than fifty 

thousand.’’ 10 Census Bureau data for 

2002 indicate that there were 87,525 

local governmental jurisdictions in the 

United States.11 The Commission 

estimates that, of this total, 84,377 

entities were ‘‘small governmental 

jurisdictions.’’ 12 Thus, it estimates that 


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number of county, municipal, and township 

governments nationwide was 38,967, of which 

35,819 were small. Id. 

13U.S. Census Bureau, 2007 NAICS Definitions, 

‘‘517210 Wireless Telecommunications Categories 

(Except Satellite)’’; http://www.census.gov/naics/ 

2007/def/ND517210.HTM#N517210. 

14U.S. Census Bureau, 2002 NAICS Definitions, 

‘‘517211 Paging’’; http://www.census.gov/epcd/ 

naics02/def/NDEF517.HTM.; U.S. Census Bureau, 

2002 NAICS Definitions, ‘‘517212 Cellular and 

Other Wireless Telecommunications’’; http:// 

www.census.gov/epcd/naics02/def/NDEF517.HTM. 

15 13 CFR 121.201, NAICS code 517210 (2007 

NAICS). The now-superseded, pre-2007 CFR 

citations were 13 CFR 121.201, NAICS codes 

517211 and 517212 (referring to the 2002 NAICS). 

16U.S. Census Bureau, 2002 Economic Census, 

Subject Series: Information, ‘‘Establishment and 

Firm Size (Including Legal Form of Organization,’’ 

Table 5, NAICS code 517211 (issued Nov. 2005). 

17 Id. The census data do not provide a more 

precise estimate of the number of firms that have 

employment of 1,500 or fewer employees; the 

largest category provided is for firms with ‘‘1000 

employees or more.’’ 

18U.S. Census Bureau, 2002 Economic Census, 

Subject Series: Information, ‘‘Establishment and 

Firm Size (Including Legal Form of Organization,’’ 

Table 5, NAICS code 517212 (issued Nov. 2005). 

19 Id. The census data do not provide a more 

precise estimate of the number of firms that have 

employment of 1,500 or fewer employees; the 

largest category provided is for firms with ‘‘1000 

employees or more.’’ 

20See 47 CFR 2.106. 

21For example, under the MedRadio rules, each 

transmitter must include a statement that ‘‘This 

transmitter is authorized by rule under the 

MedRadio Service. This transmitter must not cause 

harmful interference to stations authorized to 

operate on a primary basis in the 2360–2400 MHz 

band, and must accept interference that may be 

caused by such stations, including interference that 

may cause undesired operation. This transmitter 

shall be used only in accordance with the FCC 

Rules governing the MedRadio Service. Analog and 

digital voice communications are prohibited. 

Although this transmitter has been approved by the 

Federal Communications Commission, there is no 

guarantee that it will not receive interference or that 

any particular transmission from this transmitter 

will be free from interference.’’ 

most governmental jurisdictions are 

small. 

63. Wireless Telecommunications 

Carriers (except Satellite). Since 2007, 

the Census Bureau has placed wireless 

firms within this new, broad, economic 

census category.13 Prior to that time, 

such firms were within the nowsuperseded categories of ‘‘Paging’’ and 

‘‘Cellular and Other Wireless 

Telecommunications.’’ 14 Under the 

present and prior categories, the SBA 

has deemed a wireless business to be 

small if it has 1,500 or fewer 

employees.15 Because Census Bureau 

data are not yet available for the new 

category, we will estimate small 

business prevalence using the prior 

categories and associated data. For the 

category of Paging, data for 2002 show 

that there were 807 firms that operated 

for the entire year.16 Of this total, 804 

firms had employment of 999 or fewer 

employees, and three firms had 

employment of 1,000 employees or 

more.17 For the category of Cellular and 

Other Wireless Telecommunications, 

data for 2002 show that there were 1,397 

firms that operated for the entire year.18

Of this total, 1,378 firms had 

employment of 999 or fewer employees, 

and 19 firms had employment of 1,000 

employees or more.19 Thus, we estimate 

that the majority of wireless firms are 

small. 

D. Description of Projected Reporting, 

Recordkeeping, and Other Compliance 

Requirements 

64. The 2300–2305 MHz, 2360–2400 

MHz, 2400–2500 MHz and 5150–5250 

MHz bands are used by various Federal 

and non-Federal radiocommunication 

services. Thus, the Commission seeks 

comment related to the potential for 

interference caused either to 

incumbents, or to MBAN systems, and 

how any such concerns might be 

mitigated. 

65. The Commission thus seeks 

comment on allowing MBAN operations 

in any of the bands on a secondary 

basis, subject to the further condition 

that harmful interference is not caused 

to primary services allocated in the 

bands, or on allowing MBAN operations 

on a primary basis in the 2300–2305 

MHz and 2390–2400 MHz bands. We 

would further propose to provide for 

such use by including a U.S. footnote to 

the Table of Allocations in Part 2 of the 

Rules for the specific band segments.20

66. The Commission also seeks 

comment on various provisions 

regarding equipment certification, 

authorized locations, station 

identification, station inspection, 

disclosure policy, labeling requirements 

and marketing limitations that mirror 

the existing MedRadio rules. 

67. First, the Commission seeks 

comment on whether it should require 

that each MBAN transmitter must be 

certificated except for such transmitters 

that are not marketed for use in the 

United States, but which otherwise 

comply with the applicable technical 

requirements and are operated in the 

United States by individuals who have 

traveled to the United States from 

abroad. 

68. The Commission also seeks 

comment on whether to provide that all 

non-implanted MBAN transmitter 

apparatus be made available for 

inspection upon request by an 

authorized FCC representative. Under 

such a provision, persons operating 

MBAN transmitters would be required 

to cooperate reasonably with duly 

authorized FCC representatives in the 

resolution of interference. 

69. The Commission seeks comment 

on whether to require that 

manufacturers of MBAN transmitters 

include with each transmitting device 

(if allocated on a secondary basis) an 

appropriate disclosure statement 

analogous to that for MedRadio 

transmitters with each MBAN 

transmitting device.21 Such a statement 

would disclose the provision of the 

rules under which the device is 

authorized, along with a statement that 

the transmitter must not cause harmful 

interference to stations authorized to 

operate on a primary basis in the band, 

and must accept interference that may 

be caused by such stations, including 

interference that may cause undesired 

operation. Such statement would also 

indicate that the transmitter shall be 

used only in accordance with the FCC 

Rules, and that analog and digital voice 

communications are prohibited. 

70. The Commission further seeks 

comment on whether to require that 

MBAN control transmitters (if allocated 

on a secondary basis) be labeled and 

shall bear the following statement in a 

conspicuous location on the device: 

‘‘This device may not interfere with 

stations authorized to operate on a 

primary basis and must accept any 

interference received, including 

interference that may cause undesired 

operation.’’ Where a MBAN control 

transmitter is constructed in two or 

more sections connected by wire and 

marketed together, the statement 

specified in this section would be 

required to be affixed only to the main 

control unit. The Commission also seeks 

comment on whether to require that 

MBAN transmitters be identified with a 

serial number. Under that plan, it would 

allow the FCC ID number associated 

with the transmitter and the information 

required by § 2.925 of the FCC Rules to 

be placed in the instruction manual for 

the transmitter in lieu of being placed 

directly on the transmitter. 

71. Finally, with respect to marketing 

limitations, the Commission seeks 

comment on requiring that MBAN 

transmitters intended for operation in 

any portions of the 2360–2400 MHz 

band may be marketed and sold only for 

those permissible uses. 

72. Licensing. The Commission seeks 

comment on whether medical device 

operations in any portion of the 

frequency bands under consideration 

should be authorized under the 

MedRadio Service in part 95 of our 

Rules, thus providing for license-by-rule 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 150 / Thursday, August 6, 2009 / Proposed Rules 39259 

22See 47 CFR 95.401 (d). 

23Under Section 307(e) of the Act, the 

Commission may authorize the operation of radio 

stations by rule without individual licenses in 

certain specified radio services when the 

Commission determines that such authorization 

serves the public interest, convenience, and 

necessity. The services set forth in this provision for 

which the Commission may authorize operation by 

rule include: (1) The Citizens Band Radio Service, 

(2) the Radio Control Service, (3) the Aviation Radio 

Service, and (4) the Maritime Radio Service. See 47 

USC 307(e)(1). 

24See 47 CFR 90.1307. 25See 5 U.S.C. 603(c). 

operation 22 pursuant to section 307(e) 

of the Communications Act (Act).23

Under this approach, medical devices 

would operate in the band on a shared, 

non-exclusive basis with respect to each 

other and without the need for MBAN 

systems to be individually licensed. As 

the Commission determined when it 

adopted the MedRadio Service rules, 

this approach minimizes regulatory 

burdens and facilitates the expeditious 

deployment of new generations of 

beneficial wireless medical devices that 

can improve the quality of life for 

countless Americans, thus serving the 

public interest, convenience and 

necessity. 

73. Alternatively, the Commission 

also seeks comment on whether MBAN 

operations should be licensed on a nonexclusive basis under part 90. Under 

that approach, MBAN operations would 

be licensed on a non-exclusive basis 

with respect to each other for ten year 

license terms. The Commission seeks 

comment on whether it should consider 

using the same approach here as we do 

with wireless broadband services in the 

3650–3700 MHz band, i.e., eligible 

entities would apply for non-exclusive 

nationwide licenses and subsequently 

register individual stations with the 

Commission.24 If this approach were to 

be adopted, the Commission also seeks 

comment on whether it should require 

that licensees register each individual 

MBAN system or, alternatively, require 

them to register the individual health 

care facility at which the licensee would 

be allowed to operate multiple MBAN 

systems. In this regard, the Commission 

seeks comment on what type of 

licensing and registration information 

for MBAN operations would facilitate 

coordination with incumbent services; 

and what would be the relative benefits 

and disadvantages of licensing under 

part 90 compared with the license-byrule approach under part 95. 

E. Steps Taken To Minimize Significant 

Economic Impact on Small Entities, and 

Significant Alternatives Considered 

74. The RFA requires an agency to 

describe any significant alternatives that 

it has considered in reaching its 

proposed approach, which may include 

the following four alternatives (among 

others): (1) The establishment of 

differing compliance or reporting 

requirements or timetables that take into 

account the resources available to small 

entities; (2) the clarification, 

consolidation, or simplification of 

compliance or reporting requirements 

under the rule for small entities; (3) the 

use of performance, rather than design, 

standards; and (4) an exemption from 

coverage of the rule, or any part thereof, 

for small entities.25

75. The Commission also invites 

commenters to address the validity of 

the competing interference modeling 

studies that have already been placed 

into the record by GEHC and AFTRCC. 

Each party reaches opposite, alternative 

conclusions concerning whether MBAN 

operation would pose an undue 

interference risk to AMT operations in 

the 2360–2395 MHz band. The 

Commission asks commenters to 

address which aspects of these 

interference models would be 

appropriate, or not, to be relied upon 

under the particular factual 

circumstances herein. For example, 

should interference potential be 

evaluated in this instance by reference 

to worst-case static models or by other 

statistical simulations such as the Monte 

Carlo approach type relied upon by 

GEHC? Why or why not? Would some 

other interference modeling approaches 

give results providing a greater degree of 

confidence in their merit? 

F. Federal Rules That May Duplicate, 

Overlap, or Conflict With the Proposed 

Rules 

76. None. 

Ordering Clauses 

77. Pursuant to Sections 4(i), 301, 302, 

303(e), 303(f) and 303(r) of the 

Communications Act of 1934, as 

amended, 47 USC Sections 154(i), 301, 

302, 303(e), 303(f) and 303(r), this 

Notice of Proposed Rule Making is 

adopted. 

78. The Commission’s Consumer and 

Governmental Affairs Bureau, Reference 

Information Center, 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. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. E9–18859 Filed 8–5–09; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 09–1532; MB Docket No. 08–153; RM– 

11477] 

Television Broadcasting Services; 

Bangor, ME 

AGENCY: Federal Communications 

Commission. 

ACTION: Dismissal. 

SUMMARY: The Commission dismisses 

the pending rulemaking petition filed by 

Community Broadcasting Service 

(‘‘Community Broadcasting’’), the 

licensee of WABI–DT, digital channel 

19, Bangor, Maine, which requests the 

substitution of channel 12 for digital 

channel 19 at Bangor. Community 

Broadcasting’s proposed channel 

substitution requires coordination and 

concurrence with the Canadian 

government because the proposed 

facility is located within the Canadian 

coordination zone. The Canadian 

government has indicated that 

Community Broadcasting’s proposed 

channel substitution is not acceptable. 

Therefore, the Commission dismisses 

Community Broadcasting’s petition for 

rulemaking. 

FOR FURTHER INFORMATION CONTACT: 

Adrienne Y. Denysyk, Media Bureau, 

(202) 418–1600. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Order, 

MB Docket No. 08–153, adopted July 13, 

2009, and released July 14, 2009. The 

full text of this document is available for 

public inspection and copying during 

normal business hours in the FCC’s 

Reference Information Center at Portals 

II, CY–A257, 445 12th Street, SW., 

Washington, DC 20554. This document 

will also be available via ECFS (http:// 

www.fcc.gov/cgb/ecfs/). (Documents 

will be available electronically in ASCII, 

Word 97, and/or Adobe Acrobat.) This 

document may be purchased from the 

Commission’s duplicating contractor, 

Best Copy and Printing, Inc., 445 12th 

Street, SW., Room CY–B402, 

Washington, DC 20554, telephone 1– 

800–478–3160 or via e-mail http:// 

www.BCPIWEB.com. To request this 

document in accessible formats 

(computer diskettes, large print, audio 

recording, and Braille), send an e-mail 

to fcc504@fcc.gov or call the 

Commission’s Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). This document does not contain 

information collection requirements 

subject to the Paperwork Reduction Act 


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