78376 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Proposed Rules 

Division 264: Rules for Open Burning 

The revisions to OAR Chapter 340, 

Division 264 enhance the open burning 

rule in Oregon and the Klamath Falls 

NAA. Specifically, the revised rule 

includes language aligning open 

burning with ideal dispersion 

conditions; provides a description and 

map of the Klamath Basin Open Burning 

Control Area; and provides rules 

specific to the Klamath Falls NAA 

prohibiting open burning from 

industrial, commercial, construction 

and demolition operations. The rule 

revisions will reduce emissions through 

the prohibition of open burning within 

the Klamath Falls NAA. The EPA 

proposes to approve and IBR these rule 

revisions because they are permanent 

and enforceable measures that support 

attainment and maintenance of the 

NAAQS by reducing the amount of 

particulate matter in the area. 

Klamath County Clean Air Ordinances 

In its December 12, 2012 submittal, 

the ODEQ included as control measures 

the 2007 and 2012 Klamath County 

Clean Air Ordinances. These two 

ordinances establish permanent and 

enforceable control measures on sources 

that account for the majority of PM2.5

emissions in the Klamath Falls NAA. 

The 2007 Klamath County Clean Air 

Ordinance is more specifically 

identified as Chapter 406, Ordinance 

No. 63.05, enacted August 7, 2007 (2007 

Ordinance). The 2012 Klamath County 

Clean Air Ordinance is more 

specifically identified as Chapter 406, 

Ordinance No. 63.06, enacted December 

31, 2012 (2012 Ordinance). 

The 2007 and 2012 Ordinances were 

enacted to control emissions from home 

heating devices for the purpose of 

meeting the 2006 PM2.5 24-hr NAAQS. 

The 2007 ordinance provides for lower 

thresholds for yellow and red air quality 

advisory days which require the 

curtailment of wood burning and 

therefore reduce emissions of PM2.5 and 

PM2.5 precursors. With these lower 

thresholds, wood burning restrictions 

would be in place on days that most 

likely contribute to a 24-hour NAAQS 

violation. This provision, in conjunction 

with increased enforcement at the 

County level, is expected to be a core 

part of the area’s attainment plan. The 

2007 ordinance has provisions identical 

to the state wide Heat Smart Program 

that require removal of uncertified 

stoves upon sale of a home, and also 

provisions that reduce the number of 

available residential open burning days 

and prohibit the use of burn barrels. The 

2012 ordinance required new and 

retrofit fireplaces to meet lower 

emissions standards. 

The EPA proposes to approve and IBR 

the 2007 and 2012 Klamath Falls Clean 

Air Ordinances because they support 

attainment and maintenance of the 

NAAQS in the Klamath Falls NAA. 

III. Proposed Action 

The EPA proposes to approve the 

PM2.5 and PM2.5 precursor emissions 

inventory for the Klamath Falls NAA, 

submitted by ODEQ on December 12, 

2012, as meeting the emissions 

inventory requirements of section 

172(c)(3) of the CAA for 2006 PM2.5 24- 

hr NAAQS nonattainment area 

planning. The EPA also proposes to 

approve and incorporate into the SIP the 

specific control measures submitted by 

the ODEQ on December 12, 2012, to the 

extent set forth in this notice. These 

control measures are described in this 

action and are included in the docket 

for this proposed action. If approved, 

these specific control measures would 

become part of the Oregon SIP. The EPA 

is not taking action on certain aspects of 

the revisions submitted by the ODEQ. 

The EPA expects to take action on the 

remaining SIP revisions and any 

additional revisions that may be 

submitted by the ODEQ in the future. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, the 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely proposes to approve state law as 

meeting federal requirements and does 

not impose additional requirements 

beyond those imposed by State law. For 

that reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide the EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this SIP is not approved to 

apply on any Indian reservation land or 

in any other area where EPA or an 

Indian tribe has demonstrated that a 

tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), nor will it impose 

substantial direct costs on tribal 

governments or preempt tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Nitrogen dioxide, 

Incorporation by reference, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: December 3, 2014. 

Dennis J. McLerran, 

Regional Administrator, Region 10. 

[FR Doc. 2014–30498 Filed 12–29–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1001 

Solicitation of New Safe Harbors and 

Special Fraud Alerts 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Notice of intent to develop 

regulations. 

SUMMARY: In accordance with section 

205 of the Health Insurance Portability 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Proposed Rules 78377 

and Accountability Act of 1996 

(HIPAA), this annual notice solicits 

proposals and recommendations for 

developing new and modifying existing 

safe harbor provisions under the Federal 

anti-kickback statute (section 1128B(b) 

of the Social Security Act), as well as 

developing new OIG Special Fraud 

Alerts. 

DATES: To ensure consideration, public 

comments must be delivered to the 

address provided below by no later than 

5 p.m. on March 2, 2015. 

ADDRESSES: In commenting, please refer 

to file code OIG–123–N. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (fax) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific 

recommendations and proposals 

through the Federal eRulemaking Portal 

at http://www.regulations.gov. 

2. By regular, express, or overnight 

mail. You may send written comments 

to the following address: Patrice Drew, 

Office of Inspector General, Regulatory 

Affairs, Department of Health and 

Human Services, Attention: OIG–123–N, 

Room 5541C, Cohen Building, 330 

Independence Avenue SW., 

Washington, DC 20201. Please allow 

sufficient time for mailed comments to 

be received before the close of the 

comment period. 

3. By hand or courier. If you prefer, 

you may deliver, by hand or courier, 

your written comments before the close 

of the comment period to Patrice Drew, 

Office of Inspector General, Department 

of Health and Human Services, Cohen 

Building, Room 5541C, 330 

Independence Avenue SW., 

Washington, DC 20201. Because access 

to the interior of the Cohen Building is 

not readily available to persons without 

Federal Government identification, 

commenters are encouraged to schedule 

their delivery with one of our staff 

members at (202) 619–1368. 

For information on viewing public 

comments, please see the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Patrice Drew, Congressional and 

Regulatory Affairs Liaison, Office of 

Inspector General, (202) 619–1368. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on 

recommendations for developing new or 

revised safe harbors and Special Fraud 

Alerts. Please assist us by referencing 

the file code OIG–123–N. 

Inspection of Public Comments: All 

comments received before the end of the 

comment period are available for 

viewing by the public. All comments 

will be posted on http://

www.regulations.gov after the closing of 

the comment period. Comments 

received timely will also be available for 

public inspection as they are received at 

Office of Inspector General, Department 

of Health and Human Services, Cohen 

Building, 330 Independence Avenue 

SW., Washington, DC 20201, Monday 

through Friday from 9:30 a.m. to 5 p.m. 

To schedule an appointment to view 

public comments, phone (202) 619– 

1368. 

I. Background 

A. OIG Safe Harbor Provisions 

Section 1128B(b) of the Social 

Security Act (the Act) (42 U.S.C. 1320a– 

7b(b)) provides criminal penalties for 

individuals or entities that knowingly 

and willfully offer, pay, solicit, or 

receive remuneration to induce or 

reward business reimbursable under the 

Federal health care programs. The 

offense is classified as a felony and is 

punishable by fines of up to $25,000 

and imprisonment for up to 5 years. OIG 

may also impose civil money penalties, 

in accordance with section 1128A(a)(7) 

of the Act (42 U.S.C. 1320a–7a(a)(7)), or 

exclusion from the Federal health care 

programs, in accordance with section 

1128(b)(7) of the Act (42 U.S.C. 1320a– 

7(b)(7)). 

Since the statute on its face is so 

broad, concern has been expressed for 

many years that some relatively 

innocuous commercial arrangements 

may be subject to criminal prosecution 

or administrative sanction. In response 

to the above concern, section 14 of the 

Medicare and Medicaid Patient and 

Program Protection Act of 1987, P.L. No. 

100–93, section 14, the Act, section 

1128B(b), 42 U.S.C. 1320a–7b(b), 

specifically required the development 

and promulgation of regulations, the socalled ‘‘safe harbor’’ provisions, 

specifying various payment and 

business practices that, although 

potentially capable of inducing referrals 

of business reimbursable under the 

Federal health care programs, would not 

be treated as criminal offenses under the 

anti-kickback statute and would not 

serve as a basis for administrative 

sanctions. OIG safe harbor provisions 

have been developed ‘‘to limit the reach 

of the statute somewhat by permitting 

certain non-abusive arrangements, while 

encouraging beneficial and innocuous 

arrangements’’ (56 FR 35952, July 29, 

1991). Health care providers and others 

may voluntarily seek to comply with 

these provisions so that they have the 

assurance that their business practices 

will not be subject to liability under the 

anti-kickback statute or related 

administrative authorities. The OIG safe 

harbor regulations are found at 42 CFR 

part 1001. 

B. OIG Special Fraud Alerts 

OIG has also periodically issued 

Special Fraud Alerts to give continuing 

guidance to health care providers with 

respect to practices OIG finds 

potentially fraudulent or abusive. The 

Special Fraud Alerts encourage industry 

compliance by giving providers 

guidance that can be applied to their 

own practices. OIG Special Fraud Alerts 

are intended for extensive distribution 

directly to the health care provider 

community, as well as to those charged 

with administering the Federal health 

care programs. 

In developing Special Fraud Alerts, 

OIG has relied on a number of sources 

and has consulted directly with experts 

in the subject field, including those 

within OIG, other agencies of the 

Department, other Federal and State 

agencies, and those in the health care 

industry. 

C. Section 205 of the Health Insurance 

Portability and Accountability Act of 

1996 

Section 205 of the Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA), Public Law 104–191, 

section 205, the Act, section 1128D, 42 

U.S.C. 1320a-7d, requires the 

Department to develop and publish an 

annual notice in the Federal Register 

formally soliciting proposals for 

modifying existing safe harbors to the 

anti-kickback statute and for developing 

new safe harbors and Special Fraud 

Alerts. 

In developing safe harbors for a 

criminal statute, OIG is required to 

thoroughly review the range of factual 

circumstances that may fall within the 

proposed safe harbor subject area so as 

to uncover potential opportunities for 

fraud and abuse. Only then can OIG 

determine, in consultation with the 

Department of Justice, whether it can 

effectively develop regulatory 

limitations and controls that will permit 

beneficial and innocuous arrangements 

within a subject area while, at the same 

time, protecting the Federal health care 

programs and their beneficiaries from 

abusive practices. 

II. Solicitation of Additional New 

Recommendations and Proposals 

In accordance with the requirements 

of section 205 of HIPAA, OIG last 

published a Federal Register 

solicitation notice for developing new 

safe harbors and Special Fraud Alerts on 


tkelley on DSK3SPTVN1PROD with PROPOSALS
78378 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Proposed Rules 

1The OIG Semiannual Report to Congress can be 

accessed through the OIG Web site at http://

oig.hhs.gov/publications/semiannual.asp. 

December 27, 2013 (78 FR 78807). As 

required under section 205, a status 

report of the public comments related to 

safe harbors received in response to that 

notice is set forth in Appendix F of 

OIG’s Fall 2014 Semiannual Report.1

OIG is not seeking additional public 

comment on the proposals listed in 

Appendix F at this time. Rather, this 

notice seeks additional 

recommendations regarding the 

development of new or modified safe 

harbor regulations and new Special 

Fraud Alerts beyond those summarized 

in Appendix F. 

A detailed explanation of 

justifications for, or empirical data 

supporting, a suggestion for a safe 

harbor or Special Fraud Alert would be 

helpful and should, if possible, be 

included in any response to this 

solicitation. 

A. Criteria for Modifying and 

Establishing Safe Harbor Provisions 

In accordance with section 205 of 

HIPAA, we will consider a number of 

factors in reviewing proposals for new 

or modified safe harbor provisions, such 

as the extent to which the proposals 

would affect an increase or decrease in: 

• Access to health care services, 

• the quality of health care services, 

• patient freedom of choice among 

health care providers, 

• competition among health care 

providers, 

• the cost to Federal health care 

programs, 

• the potential overutilization of 

health care services, and 

• the ability of health care facilities to 

provide services in medically 

underserved areas or to medically 

underserved populations. 

In addition, we will also consider 

other factors, including, for example, 

the existence (or nonexistence) of any 

potential financial benefit to health care 

professionals or providers that may take 

into account their decisions whether to 

(1) order a health care item or service or 

(2) arrange for a referral of health care 

items or services to a particular 

practitioner or provider. 

B. Criteria for Developing Special Fraud 

Alerts 

In determining whether to issue 

additional Special Fraud Alerts, we will 

consider whether, and to what extent, 

the practices that would be identified in 

a new Special Fraud Alert may result in 

any of the consequences set forth above, 

as well as the volume and frequency of 

the conduct that would be identified in 

the Special Fraud Alert. 

Dated: December 18, 2014. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. 2014–30156 Filed 12–29–14; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Part 6 

[FAR Case 2014–020; Docket No. 2014– 

0020; Sequence No. 1] 

RIN 9000–AM86 

Federal Acquisition Regulation; 

Clarification on Justification for Urgent 

Noncompetitive Awards Exceeding 

One Year 

AGENCY: Department of Defense (DoD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Proposed rule. 

SUMMARY: DoD, GSA, and NASA are 

proposing to amend the Federal 

Acquisition Regulation (FAR) to clarify 

that a determination of exceptional 

circumstances is needed when a 

noncompetitive contract awarded on the 

basis of unusual and compelling 

urgency exceeds one year, either at time 

of award or due to post-award 

modifications. 

DATES: Interested parties should submit 

written comments to the Regulatory 

Secretariat at one of the addresses 

shown below on or before March 2, 

2015 to be considered in the formation 

of the final rule. 

ADDRESSES: Submit comments in 

response to FAR Case 2014–020 by any 

of the following methods: 

• Regulations.gov: http://

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

searching for ‘‘FAR Case 2014–020’’. 

Select the link ‘‘Comment Now’’ that 

corresponds with ‘‘FAR Case 2014– 

020’’. Follow the instructions provided 

at the ‘‘Comment Now’’ screen. Please 

include your name, company name (if 

any), and ‘‘FAR Case 2014–020’’ on your 

attached document. 

• Fax: 202–501–4067. 

• Mail: General Services 

Administration, Regulatory Secretariat 

(MVCB), ATTN: Ms. Flowers, 1800 F 

Street NW., 2nd Floor, Washington, DC 

20405. 

Instructions: Please submit comments 

only and cite FAR Case 2014–020, in all 

correspondence related to this case. All 

comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal and/or business confidential 

information provided. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Michael O. Jackson, Procurement 

Analyst, at 202–208–4949, for 

clarification of content. For information 

pertaining to status or publication 

schedules, contact the Regulatory 

Secretariat at 202–501–4755. Please cite 

FAR Case 2014–020. 

SUPPLEMENTARY INFORMATION: 

I. Background 

DoD, GSA, and NASA are revising the 

FAR in response to a Government 

Accountability Office (GAO) report, 

GAO–14–304, Federal Contracting: 

Noncompetitive Contracts Based on 

Urgency Need Additional Oversight, 

dated March 2014. On October 14, 2009, 

the FAR was amended to implement 

section 862 of the Duncan Hunter 

National Defense Authorization Act 

(NDAA) for Fiscal Year (FY) 2009 (Pub. 

L. 110–417) which restricted the length 

of contracts awarded noncompetitively 

under unusual and compelling urgency 

circumstances. Such contracts may not 

exceed one year unless the head of the 

executive agency determines that 

exceptional circumstances apply. 

GAO found that agencies did not 

make the required determination for the 

ten contracts in GAO’s sample that had 

a period of performance of more than 

one year. As a result, GAO 

recommended that DoD, U.S. 

Department of State and U.S. Agency for 

International Development provide 

guidance to improve data reliability and 

oversight for contracts awarded using 

the urgency exception. 

Additionally, GAO recommended that 

the Director of the Office of 

Management and Budget, through the 

Office of Federal Procurement Policy, 

provide guidance to clarify when 

determinations of exceptional 

circumstances are needed when a 

noncompetitive contract awarded on the 

basis of unusual and compelling 

urgency exceeds one year, either at the 

time of award or because it was 

modified after contract award. 

This rule clarifies that a 

determination of exceptional 

circumstances is needed whenever the 

period of performance of a 

noncompetitive contract awarded on the 

basis of unusual and compelling 

urgency is extended beyond a year. 


tkelley on DSK3SPTVN1PROD with PROPOSALS