Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Rules and Regulations 63819 

This schedule supersedes the 

previously published schedule for 

enforcement of 33 CFR 165.930 due to 

the installation of a new permanent fish 

barrier (USCG 2011–0228, published in 

the Federal Register June 16, 2014 at 79 

FR 34231). The Captain of the Port 

suspends this previously issued 

schedule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this document, 

call or email MST1 John Ng, Waterways 

Department, Coast Guard Marine Safety 

Unit Chicago, telephone 630–986–2155, 

email address john.h.ng@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce a segment of the 

Safety Zone; Brandon Road Lock and 

Dam to Lake Michigan including Des 

Plaines River, Chicago Sanitary and 

Ship Canal, Chicago River, CalumetSaganashkee Channel, Chicago, IL, 

listed in 33 CFR 165.930. Specifically, 

the Coast Guard will enforce this safety 

zone on all waters of the Chicago 

Sanitary and Ship Canal between Mile 

Marker 296.1 to Mile Marker 296.7. 

Enforcement will occur intermittently 

from 7 a.m. to 4 p.m. on Monday 

through Friday, from October 8, 2014 

through November 26, 2014. 

This enforcement action is necessary 

because the Captain of the Port Lake 

Michigan, has determined that the U.S. 

Army Corps of Engineers’ installation of 

a new permanent fish barrier poses risks 

to life and property. Because of these 

risks, it is necessary to control vessel 

movement during the operations to 

prevent injury and property loss. 

In accordance with the general 

regulations in § 165.23 of this part, entry 

into, transiting, mooring, laying up, or 

anchoring within the enforced area of 

this safety zone by any person or vessel 

is prohibited unless authorized by the 

Captain of the Port Lake Michigan or his 

or her designated representative. 

Vessels that wish to transit through 

the safety zone may request permission 

from the Captain of the Port Lake 

Michigan or a designated on scene 

representative. Requests must be made 

in advance and approved by the Captain 

of the Port before transits will be 

authorized. Approvals will be granted 

on a case by case basis. The Captain of 

the Port representative may be contacted 

via U.S. Coast Guard Sector Lake 

Michigan on VHF channel 16. 

This document is issued under 

authority of 33 CFR 165.930 and 5 

U.S.C. 552(a). In addition to this 

publication in the Federal Register, the 

Captain of the Port Lake Michigan, will 

also provide notice through other 

means, which may include Broadcast 

Notice to Mariners, Local Notice to 

Mariners, local news media, distribution 

in leaflet form, and on-scene oral notice. 

Additionally, the Captain of the Port 

Lake Michigan, may notify 

representatives from the maritime 

industry through telephonic and email 

notifications. 

Dated: October 8, 2014. 

K.M. Moser, 

Commander, U.S. Coast Guard, Acting 

Captain of the Port, Lake Michigan. 

[FR Doc. 2014–25501 Filed 10–24–14; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AP15 

Copayments for Medications in 2015 

AGENCY: Department of Veterans Affairs. 

ACTION: Interim final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) amends its medical 

regulations concerning the copayment 

required for certain medications. But for 

this rulemaking, beginning on January 1, 

2015, the copayment amount would 

increase based on a formula set forth in 

regulation. The maximum annual 

copayment amount payable by veterans 

would also increase. This rulemaking 

freezes copayments for 2015 at the 

current rate for veterans in priority 

categories 2 through 8, and thereafter 

resumes increasing copayments in 

accordance with the regulatory formula. 

DATES: Effective Date: This rule is 

effective on October 27, 2014. 

Comment date: Comments must be 

received on or before December 26, 

2014. 

ADDRESSES: Written comments may be 

submitted by email through http://

www.regulations.gov; by mail or handdelivery to Director, Regulation Policy 

and Management (02REG), Department 

of Veterans Affairs, 810 Vermont 

Avenue NW., Room 1068, Washington, 

DC 20420; or by fax to (202) 273–9026. 

(This is not a toll-free number.) 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AP15—Copayments for Medications in 

2015.’’ Copies of comments received 

will be available for public inspection in 

the Office of Regulation Policy and 

Management, Room 1068, between the 

hours of 8:00 a.m. and 4:30 p.m. 

Monday through Friday (except 

holidays). Please call (202) 461–4902 for 

an appointment. (This is not a toll-free 

number.) In addition, during the 

comment period, comments may be 

viewed online through the Federal 

Docket Management System (FDMS) at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Kristin Cunningham, Director, Business 

Policy, Chief Business Office, 

Department of Veterans Affairs, 810 

Vermont Avenue NW., Washington, DC 

20420, (202) 382–2508. (This is not a 

toll-free number.) 

SUPPLEMENTARY INFORMATION: Under 38 

U.S.C. 1722A(a), VA must require 

veterans to pay a $2 copayment for each 

30-day supply of medication furnished 

on an outpatient basis for the treatment 

of a non-service-connected disability or 

condition unless a veteran has a serviceconnected disability rated 50 percent or 

more, is a former prisoner of war, or has 

an annual income at or below the 

maximum annual rate of VA pension 

that would be payable if the veteran 

were eligible for pension. Under 38 

U.S.C. 1722A(b), VA ‘‘may,’’ by 

regulation, increase that copayment 

amount and establish a maximum 

annual copayment amount (a ‘‘cap’’). 

We have consistently interpreted 

section 1722A(b) to mean that VA has 

discretion to determine the appropriate 

copayment amount and annual cap 

amount for medication furnished on an 

outpatient basis for covered treatment, 

provided that any decision by VA to 

increase the copayment amount or 

annual cap amount is the subject of a 

rulemaking proceeding. We have 

implemented this statute in 38 CFR 

17.110. 

Under 38 CFR 17.110(b)(1), veterans 

are obligated to pay VA a copayment for 

each 30-day or less supply of 

medication provided by VA on an 

outpatient basis (other than medication 

administered during treatment). Under 

the current regulation, for the period 

from July 1, 2010, through December 31, 

2014, the copayment amount for 

veterans in priority categories 2 through 

6 of VA’s health care system is $8. 38 

CFR 17.110(b)(1)(i). For the period July 

1, 2010, through December 31, 2014, the 

copayment amount for veterans in 

priority categories 7 and 8 is $9. 38 CFR 

17.110(b)(1)(ii). Thereafter, the 

copayment amount for all affected 

veterans is to be established using a 

formula based on the prescription drug 

component of the Medical Consumer 

Price Index (CPI–P), set forth in 38 CFR 

17.110(b)(1)(iii). 

Current § 17.110(b)(2) also includes a 

‘‘cap’’ on the total amount of 

copayments in a calendar year for a 

veteran enrolled in one of VA’s health 

care enrollment system priority 

categories 2 through 6. Through 

December 31, 2014, the annual cap is set 


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63820 Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Rules and Regulations 

at $960. Thereafter, the cap is to 

increase ‘‘by $120 for each $1 increase 

in the copayment amount’’ applicable to 

veterans enrolled in one of VA’s health 

care enrollment system priority 

categories 2 through 6. 

On December 30, 2013, we published 

an interim final rulemaking that ‘‘froze’’ 

copayments for veterans in priority 

categories 2 through 6 at $8 and for 

veterans in priority categories 7 and 8 at 

$9, through December 31, 2014. 78 FR 

79317, Dec. 30, 2013. This interim final 

rule was made final on May 27, 2014. 

79 FR 30043, May 27, 2014. In these 

rulemakings, we stated that this freeze 

was appropriate because, as justified in 

prior rulemakings, higher copayments 

reduced the utilization of VA pharmacy 

benefits. 78 FR 79315. We continue to 

believe this to be the case. The ability 

to ensure that medications are taken as 

prescribed is essential to effective health 

care management. VA can monitor 

whether its patients are refilling 

prescriptions at regular intervals while 

also checking for medications that may 

interact with each other when these 

prescriptions are filled by VA. When 

non-VA providers are also issuing 

prescriptions, there is a greater risk of 

adverse interactions and harm to the 

patient because it is more difficult for 

each provider to assess if the patient is 

taking any other medications. 

Specifically, we are removing 

December 31, 2014, in each place it 

appears in paragraphs (b)(1)(i)–(iii) and 

(b)(2), and inserting December 31, 2015, 

to continue to keep copayment rates and 

caps at their current levels. 

At the end of calendar year 2015, 

unless additional rulemaking is 

initiated, VA will once again utilize the 

CPI–P methodology in § 17.110(b)(1)(iii) 

to determine whether to increase 

copayments and calculate any mandated 

increase in the copayment amount for 

veterans in priority categories 2 through 

8. At that time, CPI–P as of September 

30, 2015, will be divided by the index 

as of September 30, 2001, which was 

304.8. The ratio will then be multiplied 

by the original copayment amount of $7. 

The copayment amount of the new 

calendar year will be rounded down to 

the whole dollar amount. As mandated 

by current 17.110(b)(2), the annual cap 

will be calculated by increasing the cap 

by $120 for each $1 increase in the 

copayment amount. Any change in the 

copayment amount and cap, along with 

the associated calculations explaining 

the basis for the increase, will be 

published in a Federal Register notice. 

Thus, the intended effect of this rule is 

to temporarily prevent increases in 

copayment amounts and the copayment 

cap for veterans in priority categories 2 

through 8, following which copayments 

and the copayment cap will increase as 

prescribed in current § 17.110(b). 

Although we continue to believe that 

the CPI–P is one relevant indicator of 

the costs of prescriptions nationwide, 

and because VA has maintained 

copayment amounts at the same level 

since July 1, 2010, we are studying 

whether an alternative approach of 

determining pharmacy copayments 

would be appropriate. Until we are able 

to complete our study of whether the 

current methodology for establishing 

copayment amounts is appropriate for 

all veterans, consistent with our 

responsibility under 38 U.S.C. 1722A to 

require a copayment to control health 

care costs, we are extending the current 

copayment and cap amounts through 

2015. Any change in the copayment 

amount and cap, along with the 

associated basis for the change, would 

be made through a final rule published 

in the Federal Register. 

Administrative Procedure Act 

The Secretary of Veterans Affairs 

finds that there is good cause under 5 

U.S.C. 553(b)(B) and (d)(3) to dispense 

with the opportunity for advance notice 

and opportunity for public comment 

and good cause to publish this rule with 

an immediate effective date. As stated 

above, this rule freezes at current rates 

the prescription drug copayment that 

VA charges certain veterans. The 

Secretary finds that it is impracticable 

and contrary to the public interest to 

delay this rule for the purpose of 

soliciting advance public comment or to 

have a delayed effective date. Increasing 

the copayment amount on January 1, 

2015, might cause a significant financial 

hardship for some veterans and may 

decrease patient adherence to medical 

plans and have other unpredictable 

negative health effects. 

For the above reasons, the Secretary 

issues this rule as an interim final rule. 

VA will consider and address comments 

that are received within 60 days of the 

date this interim final rule is published 

in the Federal Register. 

Effect of Rulemaking 

Title 38 of the Code of Federal 

Regulations, as revised by this interim 

final rulemaking, represents VA’s 

implementation of its legal authority on 

this subject. Other than future 

amendments to this regulation or 

governing statutes, no contrary guidance 

or procedures are authorized. All 

existing or subsequent VA guidance 

must be read to conform with this 

rulemaking if possible or, if not 

possible, such guidance is superseded 

by this rulemaking. 

Paperwork Reduction Act 

This interim final rule contains no 

provisions constituting a collection of 

information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). 

Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and other advantages; 

distributive impacts; and equity). 

Executive Order 13563 (Improving 

Regulation and Regulatory Review) 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. Executive Order 

12866 (Regulatory Planning and 

Review) defines a ‘‘significant 

regulatory action,’’ requiring review by 

the Office of Management and Budget 

(OMB), unless OMB waives such 

review, as ‘‘any regulatory action that is 

likely to result in a rule that may: (1) 

Have an annual effect on the economy 

of $100 million or more or adversely 

affect in a material way the economy, a 

sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

or tribal governments or communities; 

(2) Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; (3) 

Materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) Raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in this Executive 

Order.’’ 

VA has examined the economic, 

interagency, budgetary, legal, and policy 

implications of this regulatory action 

and has concluded that it is an 

economically significant rule under 

Executive Order 12866 because it is 

likely to result in a regulatory action 

that may have an annual effect on the 

economy of $100 million or more. VA’s 

impact analysis can be found as a 

supporting document at http://

www.regulations.gov, usually within 48 

hours after the rulemaking document is 

published. Additionally, a copy of the 

rulemaking and its impact analysis are 

available on VA’s Web site at http://

www1.va.gov/orpm/, by following the 

link for ‘‘VA Regulations Published.’’ 


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Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Rules and Regulations 63821 

Congressional Review Act 

This regulatory action may be 

considered a major rule under the 

Congressional Review Act, 5 U.S.C. 

801–08, because it may result in an 

annual effect on the economy of $100 

million or more. Although this 

regulatory action may constitute a major 

rule within the meaning of the 

Congressional Review Act, 5 U.S.C. 

804(2), it is not subject to the 60-day 

delay in effective date applicable to 

major rules under 5 U.S.C. 801(a)(3) 

because the Secretary finds that good 

cause exists under 5 U.S.C. 808(2) to 

make this regulatory action effective on 

January 1, 2015, consistent with the 

reasons given for the publication of this 

interim final rule. Increasing the 

copayment amount on January 1, 2015, 

might cause a significant financial 

hardship for some veterans and may 

decrease patient adherence to medical 

plans and have other unpredictable 

negative health effects. Accordingly, the 

Secretary finds that additional advance 

notice and public procedure thereon are 

impracticable, unnecessary, and 

contrary to the public interest. In 

accordance with 5 U.S.C. 801(a)(1), VA 

will submit to the Comptroller General 

and to Congress a copy of this regulatory 

action and VA’s Regulatory Impact 

Analysis (RIA). 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

one year. This interim final rule will 

have no such effect on State, local, and 

tribal governments, or on the private 

sector. 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this interim final rule will not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612. This 

interim final rule will temporarily freeze 

the copayments that certain veterans are 

required to pay for prescription drugs 

furnished by VA. This rule directly 

affects individuals and will not directly 

affect small entities. Therefore, pursuant 

to 5 U.S.C. 605(b), this rulemaking is 

exempt from the initial and final 

regulatory flexibility analysis 

requirements of 5 U.S.C. 603 and 604. 

Catalog of Federal Domestic Assistance 

The Catalog of Federal Domestic 

Assistance numbers and titles for the 

programs affected by this document are 

as follows: 64.005, Grants to States for 

Construction of State Home Facilities; 

64.007, Blind Rehabilitation Centers; 

64.008, Veterans Domiciliary Care; 

64.009, Veterans Medical Care Benefits; 

64.010, Veterans Nursing Home Care; 

64.011, Veterans Dental Care; 64.012, 

Veterans Prescription Service; 64.013, 

Veterans Prosthetic Appliances; 64.014, 

Veterans State Domiciliary Care; 64.015, 

Veterans State Nursing Home Care; 

64.016, Veterans State Hospital Care; 

64.018, Sharing Specialized Medical 

Resources; 64.019, Veterans 

Rehabilitation Alcohol and Drug 

Dependence; 64.022, Veterans Home 

Based Primary Care; and 64.024, VA 

Homeless Providers Grant and Per Diem 

Program. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. Jose 

D. Riojas, Chief of Staff, Department of 

Veterans Affairs, approved this 

document on September 25, 2014, for 

publication. 

List of Subjects in 38 CFR Part 17 

Administrative practice and 

procedure, Alcohol abuse, Alcoholism, 

Claims, Day care, Dental health, Drug 

abuse, Foreign relations, Government 

contracts, Grant programs-health, Grant 

programs-veterans, Health care, Health 

facilities, Health professions, Health 

records, Homeless, Medical and dental 

schools, Medical devices, Medical 

research, Mental health programs, 

Nursing homes, Philippines, Reporting 

and recordkeeping requirements, 

Scholarships and fellowships, Travel 

and transportation expenses, Veterans. 

Dated: October 22, 2014. 

William F. Russo, 

Acting Director, Office of Regulation Policy 

& Management, Office of the General Counsel, 

U.S. Department of Veterans Affairs. 

For the reasons set out in the 

preamble, VA amends 38 CFR part 17 as 

follows: 

PART 17—MEDICAL 

■ 1. The authority citation for part 17 

continues to read as follows: 

Authority: 38 U.S.C. 501(a), and as noted 

in specific sections. 

§ 17.110 [Amended] 

■ 2. Amend § 17.110 as follows: 

■ a. In paragraphs (b)(1)(i), (ii), and (iii), 

remove all references to ‘‘December 31, 

2014’’ and adding in each place 

‘‘December 31, 2015’’. 

■ b. In paragraph (b)(2) remove all 

references to ‘‘December 31, 2014’’ and 

adding in each place ‘‘December 31, 

2015’’. 

[FR Doc. 2014–25454 Filed 10–24–14; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2014–0390; FRL–9914–56] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is promulgating 

significant new use rules (SNURs) under 

the Toxic Substances Control Act 

(TSCA) for 52 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Nine of 

these chemical substances are subject to 

TSCA section 5(e) consent orders issued 

by EPA. This action requires persons 

who intend to manufacture (including 

import) or process any of these 52 

chemical substances for an activity that 

is designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification will provide EPA 

with the opportunity to evaluate the 

intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs. 

DATES: This rule is effective on 

December 26, 2014. For purposes of 

judicial review, this rule shall be 

promulgated at 1 p.m. (e.s.t.) on 

November 10, 2014. 

Written adverse or critical comments, 

or notice of intent to submit adverse or 

critical comments, on one or more of 

these SNURs must be received on or 

before November 26, 2014 (see Unit VI. 

of the SUPPLEMENTARY INFORMATION). If 

EPA receives written adverse or critical 

comments, or notice of intent to submit 

adverse or critical comments, on one or 

more of these SNURs before November 

26, 2014, EPA will withdraw the 

relevant sections of this direct final rule 

before its effective date. 

For additional information on related 

reporting requirement dates, see Units 


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