54936 Federal Register / Vol. 79, No. 178 / Monday, September 15, 2014 / Proposed Rules 

(iv) Labeling must include a detailed 

description of any special capabilities 

(e.g., overdrive pacing or automatic 

mode switching); and 

(v) Appropriate electromagnetic 

compatibility information must be 

included. 

■ 3. In Subpart D, add § 870.3605 to 

read as follows: 

§ 870.3605 Pacing system analyzer. 

(a) Identification. A pacing system 

analyzer (PSA) is a prescription device 

that combines the functionality of a 

pacemaker electrode function tester 

(§ 870.3720) and an external pacemaker 

pulse generator (EPPG) (§ 870.3600). It is 

connected to a pacemaker lead and uses 

a power supply and electronic circuits 

to supply an accurately calibrated, 

variable pacing pulse for measuring the 

patient’s pacing threshold and 

intracardiac R-wave potential. A PSA 

may be a single, dual, or triple chamber 

system and can simultaneously deliver 

pacing therapy while testing one or 

more implanted pacing leads. 

(b) Classification. Class II (special 

controls) for PSAs. The special controls 

for this device are: 

(1) Appropriate analysis/testing must 

validate electromagnetic compatibility 

(EMC) within a hospital environment. 

(2) Electrical bench testing must 

demonstrate device safety during 

intended use. This must include testing 

with the specific power source (i.e., 

battery power, AC mains connections, 

or both). 

(3) Non-clinical performance testing 

data must demonstrate the performance 

characteristics of the device. Testing 

must include the following: 

(i) Testing must demonstrate the 

accuracy of monitoring functions, 

alarms, measurement features, 

therapeutic features, and all adjustable 

or programmable parameters as 

identified in labeling; 

(ii) Mechanical bench testing of 

material strength must demonstrate that 

the device and connection cables will 

withstand forces or conditions 

encountered during use; 

(iii) Simulated use analysis/testing 

must demonstrate adequate user 

interface for adjustable parameters, 

performance of alarms, display screens, 

interface with external devices (e.g. data 

storage, printing), and indicator(s) 

functionality under intended use 

conditions; and 

(iv) Methods and instructions for 

cleaning the pulse generator and 

connection cables must be validated. 

(4) Appropriate software verification, 

validation, and hazard analysis must be 

performed. 

(5) Labeling must include the 

following: 

(i) The labeling must clearly state that 

these devices are intended for use in a 

hospital environment and under the 

supervision of a clinician trained in 

their use; 

(ii) Connector terminals should be 

clearly, unambiguously marked on the 

outside of the EPPG. The markings 

should identify positive (+) and negative 

(-) polarities. Dual chamber devices 

should clearly identify atrial and 

ventricular terminals. Triple chamber 

devices should clearly identify atrial, 

right ventricular, and left ventricular 

terminals; 

(iii) The labeling must list all pacing 

modes available in the device; 

(iv) Labeling must include a detailed 

description of any special capabilities 

(e.g., overdrive pacing or automatic 

mode switching); 

(v) Labeling must limit the use of 

external pacing to the implant 

procedure; and 

(vi) Appropriate electromagnetic 

compatibility information must be 

included. 

Dated: September 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–21814 Filed 9–12–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Part 41 

[145A2100DD.AADD001000.A0E501010.

999900] 

RIN 1076–AF08 

Grants to Tribally Controlled Colleges 

and Universities, Dine ́ College, and 

Tribally Controlled Postsecondary 

Career and Technical Institutions 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Notice of tribal consultation 

sessions. 

SUMMARY: The Bureau of Indian 

Education provides financial and 

technical assistance to tribally 

controlled colleges and universities and 

Dine ́ College. In collaboration with the 

American Indian Higher Education 

Consortium, we have prepared a 

discussion draft that updates the 

policies and procedures for 

administration and oversight of these 

assistance programs and revises 

regulatory language to conform to 

statutory amendments. This notice 

announces tribal consultation sessions 

and a comment period on the 

preliminary discussion draft. 

DATES: Comments must be received by 

November 15, 2014. See the 

SUPPLEMENTARY INFORMATION section of 

this notice for dates of the tribal 

consultation sessions. 

ADDRESSES: See the SUPPLEMENTARY

INFORMATION section of this notice for 

locations of the tribal consultation 

sessions and the Web site where the 

preliminary discussion draft is 

available. You may submit comments by 

either of the following methods: 

—Federal Rulemaking Portal: http://

www.regulations.gov. This rule is listed 

under the agency name ‘‘Bureau of 

Indian Affairs’’ and Docket ID ‘‘BIA– 

2011–0002.’’ 

—Mail or Hand-Delivery: Ms. Juanita 

Mendoza, Program Analyst, Bureau of 

Indian Education, U.S. Department of 

the Interior, 1951 Constitution Ave. 

NW., MS 312, Washington, DC 20240. 

Include ‘‘1076–AF08’’ on the cover of 

the submission. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Juanita Mendoza, Program Analyst, 

Bureau of Indian Education, U.S. 

Department of the Interior, 1951 

Constitution Ave. NW., MS 312, 

Washington, DC 20240; or email to 

juanita.mendoza@bie.edu. 

SUPPLEMENTARY INFORMATION: The BIE 

supports and encourages the 

establishment, operation, and 

improvement of tribally controlled 

colleges and universities (TCUs) to 

ensure continued and expanded 

educational opportunities for Indian 

students. The TCUs are both integral 

and essential to their communities, 

creating environments that foster 

American Indian culture, languages, and 

traditions. The TCUs serve a variety of 

people from young adults to senior 

citizens. The TCUs offer 358 total 

programs, including apprenticeships, 

diplomas, certificates, and degrees. 

These programs include 181 associate 

degree programs at 23 TCUs, 40 

bachelor’s degree programs at 11 TCUs, 

and 5 master’s degree programs at 2 

TCUs. 

The BIE is revising the regulations at 

25 CFR Part 41 and has prepared a 

preliminary discussion draft. Subpart B 

of the preliminary discussion draft 

concerns financial and technical 

assistance to tribal colleges and 

universities funded under the Tribally 

Controlled Colleges and Universities 

Assistance Act of 1978, as amended (25 

U.S.C. 1801 et seq.). Subpart B does not 

concern financial assistance to Dine ́

College or to tribally controlled 

postsecondary career and technical 

institutions. Subpart C of the 


rmajette on DSK2TPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 178 / Monday, September 15, 2014 / Proposed Rules 54937 

preliminary discussion draft applies to 

financial assistance to Dine ́ College 

under the Navajo Nation Higher 

Education Act of 2008. Subpart A 

includes general provisions and applies 

to both subparts B and C. 

This notice announces the availability 

of the preliminary discussion draft of 

potential revisions for public view at 

www.bie.edu/consultation/index.htm. 

Comments on the preliminary 

discussion draft are due by the date 

indicated in the DATES section of this 

notice. BIE will host five meetings to 

obtain input on the preliminary 

discussion draft. 

The meetings to obtain input will be 

held on the dates and at the locations 

shown below. All times are local. 

Date Time Location Venue 

October 16, 2014 ................. 5:00 p.m.–8:00 p.m ..... Anchorage, Alaska .............. NIEA Conference, Anchorage Convention Center, Room 

TBD, Anchorage, AK 99501. 

October 20, 2014 ................. 12 p.m.–3 p.m ............. Webinar ............................... Register at web link: https://dcma100.webex.com/

dcma100/k2/j.php?MTID=tf8923c96f8b2d86dc

23136f450688e77. 

October 22, 2014 ................. 12 p.m.–3 p.m ............. Gallup, NM .......................... Navajo Regional Office, Bureau of Indian Affairs, Conference Room 162, 301 West Hill Street, Gallup, NM 

87301. 

October 27, 2014 ................. 9 a.m.–12 p.m ............. Billings, MT .......................... Department of Interior Building, 2021 4th Avenue North, 

4th Floor, Plenty Coup Room, Billings, MT 59101. 

October 29, 2014 ................. 9 a.m.–12 p.m ............. Bloomington, MN ................. Bureau of Indian Education, Associate Deputy Director’s 

Office, 2001 Killebrew Dr., Ste. 122, Bloomington, MN 

55425. 

Following the first round of 

consultation, we will review the 

comments received and then prepare a 

proposed rule for publication in the 

Federal Register. This will open a 

second round of consultation and a 

formal comment period to allow for 

further refining of the proposed rule 

before we publish a final rule. 

Dated: September 10, 2014. 

Kevin K. Washburn, 

Assistant Secretary—Indian Affairs. 

[FR Doc. 2014–21966 Filed 9–12–14; 8:45 am] 

BILLING CODE 4310–W7–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2013–0040] 

RIN 1625–AA87 

Revision of Safety/Security Zone 

Regulations; 2014 Tampa Bay; Captain 

of the Port St. Petersburg Zone, FL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard is proposing 

to consolidate three security zone 

regulations into one regulation. In 

addition, the Coast Guard is proposing 

to disestablish two safety zone 

regulations, and convert those safety 

zones into security zones for all 

navigable waterways of Big Bend, Boca 

Grande, Crystal River, East Bay, 

Hillsborough Bay, MacDill Air Force 

Base, Manbirtee Key, Old Port Tampa, 

Port Manatee, Port Tampa, Port St. 

Petersburg, Port Sutton, Rattlesnake, 

and Weedon Island, FL. The purpose of 

these revisions is to ensure the security 

of vessels, facilities, and the 

surrounding areas within these zones. 

Entry into the area encompassed by 

these revised security zones is 

prohibited without permission of the 

Captain of the Port St. Petersburg or a 

designated representative. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before October 15, 2014. 

ADDRESSES: You may submit comments 

identified by docket number using any 

one of the following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251. 

(3) Mail or Delivery: Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590–0001. Deliveries 

accepted between 9 a.m. and 5 p.m., 

Monday through Friday, except federal 

holidays. The telephone number is (202) 

366–9329. 

See the ‘‘Public Participation and 

Request for Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for further instructions on 

submitting comments. To avoid 

duplication, please use only one of 

these three methods. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LTJG Brett Sillman, Sector St. 

Petersburg Waterways Management 

Division, U.S. Coast Guard; telephone 

(813) 228–2191, email brett.s.sillman@

uscg.mil. If you have questions on 

viewing or submitting material to the 

docket, call Cheryl Collings, Program 

Manager, Docket Operations, telephone 

(202) 366–9826. 

SUPPLEMENTARY INFORMATION: 

Table of Acronyms 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of Proposed Rulemaking 

A. Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted 

without change to http://

www.regulations.gov and will include 

any personal information you have 

provided. 

1. Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking, indicate the specific section 

of this document to which each 

comment applies, and provide a reason 

for each suggestion or recommendation. 

You may submit your comments and 

material online at http://

www.regulations.gov, or by fax, mail, or 

hand delivery, but please use only one 

of these means. If you submit a 

comment online, it will be considered 

received by the Coast Guard when you 

successfully transmit the comment. If 

you fax, hand deliver, or mail your 

comment, it will be considered as 

having been received by the Coast 

Guard when it is received at the Docket 

Management Facility. We recommend 

that you include your name and a 

mailing address, an email address, or a 

telephone number in the body of your 

document so that we can contact you if 


rmajette on DSK2TPTVN1PROD with PROPOSALS