8586 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 

1Enclosure (3) to Navigation and Vessel 

Inspection Circular 04–08, Medical and Physical 

Evaluation Guidelines for Merchant Mariner 

Credentials, Item number 179, specifies that sleep 

apnea and other sleep disorders are subject to 

further review. Obstructive sleep apnea (OSA) is 

one specific type of sleep apnea and is, therefore, 

subject to further review under the same item 

number. 

the collection action’’ occurs when the 

agency has terminated collection action 

in accordance with the FCCS or other 

applicable standards. In any event, 

termination of the collection action will 

be deemed to have occurred if the 

agency has not received any payments 

to satisfy the debt from the particular 

debtor whose wages were subject to 

garnishment, in whole or in part, for a 

period of 1 year. 

Dated: February 3, 2015. 

Eric H. Holder, Jr. 

Attorney General. 

[FR Doc. 2015–02587 Filed 2–17–15; 8:45 am] 

BILLING CODE 4410–AR–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Part 10 

[Docket No. USCG–2015–0090] 

Medical Waivers for Merchant Mariner 

Credential Applicants With the 

Following Conditions: 

Cardiomyopathy; Diabetes Mellitus; 

Narcolepsy; and Obstructive Sleep 

Apnea 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed policy 

clarification and request for comments. 

SUMMARY: The Coast Guard is seeking 

public comment on the policy 

clarification proposed in this document 

regarding the specific medical 

documentation the Coast Guard will 

consider in determining whether a 

medical waiver is warranted for 

merchant mariners with 

cardiomyopathy, diabetes mellitus, or 

obstructive sleep apnea. Additionally, 

the proposed policy clarification 

specifies that narcolepsy, idiopathic 

hypersomnia, and other hypersomnias 

of central origin, are medically 

disqualifying and generally not 

waiverable due to significant risk of 

sudden and unpredictable 

incapacitation of individuals who have 

these conditions. 

DATES: Comments and related material 

must either be submitted to our online 

docket via http://www.regulations.gov 

on or before May 19, 2015 or reach the 

Docket Management Facility by that 

date. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2015–0090 using any one of the 

following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251. 

(3) Mail: 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. 

(4) Hand delivery: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

To avoid duplication, please use only 

one of these four methods. See the 

‘‘Public Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

document, call or email Lieutenant 

Ashley Holm, Mariner Credentialing 

Program Policy Division (CG–CVC–4), 

U.S. Coast Guard, telephone 202–372– 

2357, email MMCPolicy@uscg.mil. If 

you have questions on viewing material 

in the docket, call Docket Operations at 

202–366–9826. 

SUPPLEMENTARY INFORMATION: 

I. Public Participation 

You may submit comments and 

related material regarding whether the 

policy clarification proposed in this 

document should be incorporated into 

final policy on the medical evaluation 

guidelines for mariners with 

cardiomyopathy, diabetes mellitus, 

narcolepsy or obstructive sleep apnea. 

All comments received will be posted, 

without change, to http://

www.regulations.gov and will include 

any personal information you have 

provided. 

Submitting comments: If you submit a 

comment, please include the docket 

number for this document (USCG– 

2015–0090) and provide a reason for 

each suggestion or recommendation. 

You may submit your comments and 

material online or by fax, mail or hand 

delivery, but please use only one of 

these means. 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 

we have questions regarding your 

submission. 

To submit your comment online, go to 

http://www.regulations.gov, type the 

docket number (USCG–2015–0090) in 

the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on ‘‘Submit a 

Comment’’ on the line associated with 

this document. 

If you submit your comments by mail 

or hand delivery, submit them in an 

unbound format, no larger than 8 1⁄2 by 

11 inches, suitable for copying and 

electronic filing. If you submit them by 

mail and would like to know that they 

reached the Facility, please enclose a 

stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period. 

Viewing comments and documents: 

To view comments, go to http://

www.regulations.gov, type the docket 

number (USCG–2015–0090) in the 

‘‘SEARCH’’ box and click ‘‘SEARCH.’’ 

Click on ‘‘Open Docket Folder’’ on the 

line associated with this rulemaking. 

You may also visit the Docket 

Management Facility in Room W12–140 

on the ground floor of the Department 

of Transportation West Building, 1200 

New Jersey Avenue SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. We have an agreement with 

the Department of Transportation to use 

the Docket Management Facility. 

Privacy Act: Anyone can search the 

electronic form of comments received 

into any of our dockets by the name of 

the individual submitting the comment 

(or signing the comment, if submitted 

on behalf of an association, business, 

labor union, etc.). You may review a 

Privacy Act system of records notice 

regarding our public dockets in the 

January 17, 2008, issue of the Federal 

Register (73 FR 3316). 

Background and Purpose 

46 CFR 10.302 contains the medical 

standards that merchant mariners must 

meet prior to being issued a merchant 

mariner credential (MMC). In cases 

where the mariner does not meet the 

medical standards in 46 CFR 10.302, 

waivers may be granted when the Coast 

Guard determines that extenuating 

circumstances warrant special 

consideration. See 46 CFR 10.303. 

Current Coast Guard guidance in 

Enclosure (3) to Navigation and Vessel 

Inspection Circular 04–08, Medical and 

Physical Evaluation Guidelines for 

Merchant Mariner Credentials (NVIC 

04–08), which is available at http://

www.uscg.mil/hq/cg5/nvic/pdf/2008/

NVIC%2004-08%20CH%201%20with%

20Enclosures%2020130607.pdf.), states 

that the conditions of cardiomyopathy, 

diabetes mellitus, narcolepsy and 

obstructive sleep apnea 1 require further 

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Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 8587 

2NVIC 04–08 Condition #81, Anti-tachycardia 

devices or implantable cardioverter defibrillators 

directs that conditions requiring use of these 

devices are ‘‘generally not waiverable.’’ Enclosure 

(7) to NVIC 04–08 contains the criteria for 

consideration for a medical waiver for conditions 

requiring use of these devices. The criteria are 

summarized as follows: (1) The applicant does not 

have a diagnosis of a cardiac channelopathy 

affecting the electrical conduction of the heart (to 

include Brugada syndrome, Long QT syndrome, 

etc.); (2) The applicant does not have a prior history 

of ventricular fibrillation or episodes of sustained 

ventricular tachycardia within the last three years; 

(3) The ICD or anti-tachycardia device was 

implanted more than three years ago; (4) The ICD 

has not fired nor has the applicant required antitachycardia pacing therapy within the last three 

years; (5) There are no additional risk factors for 

inappropriate shock such as uncontrolled atrial 

fibrillation; (6) The applicant’s left ventricular 

ejection fraction is greater than 35% with a steady 

or improving trend; (7) There is no history of any 

symptomatic or clinically significant heart failure in 

the past two years; (8) There is no evidence of 

significant reversible ischemia on myocardial 

perfusionimaging exercise stress testing; (9) The 

applicant’s exercise capacity on formal stress 

testing (using standard Bruce Protocol) is greater 

than or equal to the 8 METs (metabolic equivalents); 

(10) The applicant’s treating cardiologist or 

electrophysiologist provides a written assessment of 

the individual that supports a determination that 

the mariner is at low risk for future arrhythmia, 

adverse cardiac event or sudden incapacitation 

based upon objective testing and standard 

evaluation tools; (11) The applicant does not have 

any other medical conditions which may alone, or 

incombination with an ICD or anti-tachycardia 

device, affect the mariner’s fitness. 

3Recent, severe hypoglycemic episode is an 

episode of hypoglycemia within the prior 12 

months resulting in seizure, loss of consciousness 

or altered consciousness, or requiring assistance 

from another person for treatment. 

review. The same guidance publishes 

the ‘‘recommended evaluation data’’ 

that should be submitted for each 

condition; however it does not specify 

the medical criteria that the Coast Guard 

will consider in evaluating whether the 

risks associated with these conditions 

are low enough to warrant a medical 

waiver. 

Since the issuance of NVIC 04–08 on 

September 15, 2008, there have been 

several instances where mariners sought 

waivers for these conditions. In some 

cases, mariners with these conditions 

were granted waivers; in other cases, the 

conditions were deemed an 

unacceptable risk and medical 

certification was denied. Published 

guidance on the criteria that will be 

used in determining whether an 

applicant’s medical condition warrants 

a medical waiver will support Coast 

Guard efforts to consistently evaluate 

merchant mariners with these 

conditions and assess whether the risk 

associated with an applicant’s medical 

condition is sufficiently mitigated to 

warrant a medical waiver under 46 CFR 

10.303. 

Under the proposed policy, a medical 

waiver will be required for the 

conditions of cardiomyopathy, sleep 

apnea, and diabetes mellitus. 

In determining whether a mariner 

having one of the aforementioned 

conditions warrants a medical waiver 

under 46 CFR 10.303, the Coast Guard 

seeks public input on whether the Coast 

Guard should consider the following 

specific medical documentation and 

medical criteria: 

I. NVIC 04–08, Condition #77: Cardiac 

decompensation or cardiomyopathy. 

Individuals with these conditions may be 

denied medical certification unless they meet 

the criteria for a medical waiver. 

1. Submit a cardiology consultation, 

nuclear exercise stress test, echocardiogram 

and 24-hour Holter monitor. 

2. Criteria for consideration for a waiver 

include: a left ventricular ejection fraction of 

≥35%, no symptomatic or clinically 

significant heart failure in the past 2 years 

(must be New York Heart Association Class 

I), absence of significant ischemia on stress 

testing, exercise capacity of ≥8 METs, no 

history of syncope or ventricular arrhythmia 

in the past three years; and the written 

opinion of the treating cardiologist or 

electrophysiologist supports low risk for 

sudden death, ventricular arrhythmia, 

adverse cardiac event and sudden 

incapacitation based upon objective testing 

and standard evaluation tools. 

3. Note: Individuals with cardiomyopathy 

who have had an implantable cardioverter 

defibrillator (ICD) placed, will be evaluated 

under the criteria for condition #81, Antitachycardia devices or implantable 

defibrillators.2 Individuals with 

cardiomyopathy who have been advised to 

undergo placement of an ICD by their 

cardiologist, but have failed to comply, do 

not meet the low risk criteria for 

consideration for a medical waiver. These 

individuals may be denied medical 

certification. 

Justification: The Coast Guard recognizes 

that there is significant clinical variation 

within the population of individuals with 

cardiomyopathy, and that not all individuals 

with cardiomyopathy carry the same risks of 

sudden incapacitation or sudden death. 

These criteria seek to discern those 

individuals with cardiomyopathy who have 

factors that mitigate their risk, and who have 

prognostic indicators suggestive of a low risk 

of sudden incapacitation or adverse cardiac 

event. 

II. NVIC 04–08, Condition # 193: Diabetes 

mellitus treated with insulin or with history 

of diabetic ketoacidosis (DKA). Individuals 

with this condition may be denied medical 

certification unless they meet the criteria for 

a medical waiver: 

1. Submit an evaluation from the treating 

physician documenting interval history and 

two current glycated hemoglobin (HbA1c) 

levels separated by at least 90 days, the most 

recent of which is no more than 90 days old. 

An ophthalmology consultation may be 

required. Graded exercise testing may be 

required. 

2. If the evaluation of the treating 

physician supports good compliance with the 

treatment regimen, the absence of recent, 

severe hypoglycemic episodes,3 and the 

absence of impairing diabetic complications, 

then mariners with a consistent pattern of 

HbA1c levels of less than or equal to 10% 

may be considered for a waiver, with annual 

reporting requirements. 

3. Mariners with HbA1c levels greater than 

10% are generally not considered for a 

waiver unless extenuating circumstances 

confirm temporary irregularity due to acute 

illness, medication interaction, or other 

short-term occurrence that is not likely to 

recur. 

Justification: Although poorly controlled 

diabetes can lead to long term diabetic 

complications, the consequences of 

hypoglycemia pose an immediate threat of 

sudden incapacitation with a greater risk to 

public and maritime safety. 

III. NVIC 04–08, Condition #194: Diabetes 

requiring oral medication. 

1. Submit an evaluation from the treating 

physician documenting interval history and 

two current glycated hemoglobin (HbA1c) 

levels separated by at least 90 days, the most 

recent of which is no more than 90 days old. 

Ophthalmology consultation may be 

required. Graded exercise testing may be 

required. 

2. If the evaluation of the treating 

physician supports good compliance with the 

treatment regimen, the absence of recent, 

severe hypoglycemic (*) episodes, and the 

absence of impairing diabetic complications, 

then mariners with a consistent pattern of 

HbA1c levels of less than 8% may be 

considered for a waiver with biennial (every 

two years) reporting requirements; and 

mariners with HbA1c levels between 8%– 

10% inclusive may be considered for a 

waiver, with annual reporting requirements. 

3. Mariners with HbA1c levels of greater 

than 10% are generally not considered for 

waiver unless extenuating circumstances 

confirm temporary irregularity due to acute 

illness, medication interaction, or other 

short-term occurrence that is not likely to 

recur. 

Justification: Although poorly controlled 

diabetes can lead to long term diabetic 

complications, the consequences of 

hypoglycemia pose an immediate threat of 

sudden incapacitation with risk to public and 

maritime safety. 

IV. NVIC 04–08, Condition # 179: 

Obstructive Sleep Apnea, Central Sleep 

Apnea, Narcolepsy, Periodic Limb 

Movement, Restless Leg Syndrome or other 

sleep disorders. 

1. Submit all pertinent medical 

information, including sleep studies and a 

status report. If surgically treated, please 

submit a post-operative polysomnogram to 

document cure. 

2. Narcolepsy,idiopathic hypersomnia and 

other hypersomnias of central origin: Due to 

the significant risk of sudden and 

unpredictable incapacitation of individuals 

who have these conditions, narcolepsy, 

idiopathic hypersomnia and other 

hypersomnias of central origin are 

considered disqualifying. Additionally, the 

Coast Guard does not consider the conditions 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

8588 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 

of narcolepsy,idiopathic hypersomnia, or 

other hypersomnias of central origin, as low 

enough risk to warrant consideration for a 

medical waiver. 

3. Obstructive Sleep Apnea (OSA): 

A. Medical waivers for OSA require 

submission of an annual sleep specialist 

evaluation that documents treatment efficacy, 

the patient’s treatment compliance and an 

assessment for symptoms of daytime 

sleepiness. If treated with CPAP/BiPAP, the 

evaluation should include a compliance 

information report from the positive airway 

pressure device that covers the preceding 12 

months. For OSA treated by other means, 

submit a polysomnogram demonstrating the 

effectiveness of the alternative therapy. 

B. For purposes of receiving or maintaining 

a medical waiver, minimum compliance with 

positive airway pressure therapy is defined 

as: 

(i) Proper use of the CPAP/BiPAP device 

for at least four hours per night (or per major 

sleep period) during all major sleep periods 

while acting under the authority of the 

mariner credential, and 

(ii) Proper use of the CPAP/BiPAP device 

for at least four hours per night (or per major 

sleep period) on at least 70% of all nights (or 

major sleep periods). 

Authority: This document is issued under 

the authority of 5 U.S.C. 552(a) and 46 U.S.C. 

7101 et seq. 

Dated: February 10, 2015. 

J.C. Burton, 

Captain, U.S. Coast Guard, Director of 

Inspections & Compliance. 

[FR Doc. 2015–03109 Filed 2–17–15; 8:45 am] 

BILLING CODE 9110–04–P 

mstockstill on DSK4VPTVN1PROD with PROPOSALS