81556 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to approve the 

State Implementation Plan (SIP) 

revision submitted by the 

Commonwealth of Pennsylvania. This 

SIP revision includes amendments to 

the Allegheny County Health 

Department (ACHD) Rules and 

Regulations, Article XXI, Air Pollution 

Control, and meets the requirement to 

adopt Reasonably Available Control 

Technology (RACT) for sources covered 

by EPA’s Control Techniques 

Guidelines (CTG) standards for the 

following categories: Large appliance 

and metal furniture; flat wood paneling; 

and paper, film, and foil surface coating 

processes. In the Final Rules section of 

this Federal Register, EPA is approving 

the Commonwealth’s SIP submittal as a 

direct final rule without prior proposal 

because the Agency views this as a 

noncontroversial submittal and 

anticipates no adverse comments. A 

more detailed description of the State 

submittal and EPA’s evaluation are 

included in a Technical Support 

Document (TSD) prepared in support of 

this rulemaking action. A copy of the 

TSD is available, upon request, from the 

EPA Regional Office listed in the 

ADDRESSES section of this document. If 

no adverse comments are received in 

response to this action, no further 

activity is contemplated. If EPA receives 

adverse comments, the direct final rule 

will be withdrawn and all public 

comments received will be addressed in 

a subsequent final rule based on this 

proposed rule. EPA will not institute a 

second comment period. Any parties 

interested in commenting on this action 

should do so at this time. 

DATES: Comments must be received in 

writing by January 27, 2011. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2010–0857 by one of the 

following methods: 

A. http://www.regulations.gov. Follow 

the on-line instructions for submitting 

comments. 

B. E-mail: powers.marilyn@epa.gov. 

C. Mail: EPA–R03–OAR–2010–0857, 

Marilyn Powers, Acting Associate 

Director, Office of Air Program 

Planning, Mailcode 3AP30, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2010– 

0857. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the 

electronic docket are listed in the 

http://www.regulations.gov index. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in http:// 

www.regulations.gov or in hard copy 

during normal business hours at the Air 

Protection Division, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. Copies of the State submittal are 

available at the Pennsylvania 

Department of Environmental 

Protection, Bureau of Air Quality 

Control, P.O. Box 8468, 400 Market 

Street, Harrisburg, Pennsylvania 17105 

or the Allegheny County Health 

Department, Bureau of Environmental 

Quality, Division of Air Quality, 301 

39th Street, Pittsburgh, Pennsylvania 

15201. 

FOR FURTHER INFORMATION CONTACT: 

Irene Shandruk, (215) 814–2166, or by 

e-mail at shandruk.irene@epa.gov. 

SUPPLEMENTARY INFORMATION: For 

further information, please see the 

information provided in the direct final 

action, with the same title, ‘‘Approval 

and Promulgation of Air Quality 

Implementation Plans; Pennsylvania; 

Allegheny County’s Adoption of Control 

Techniques Guidelines for Large 

Appliance and Metal Furniture; Flat 

Wood Paneling; Paper, Film, and Foil 

Surface Coating Processes; and 

Revisions to Definitions and an Existing 

Regulation,’’ that is located in the ‘‘Rules 

and Regulations’’ section of this Federal 

Register publication. Please note that if 

EPA receives adverse comment on an 

amendment, paragraph, or section of 

this rule and if that provision may be 

severed from the remainder of the rule, 

EPA may adopt as final those provisions 

of the rule that are not the subject of an 

adverse comment. 

Dated: December 14, 2010. 

W.C. Early, 

Acting Regional Administrator, Region III. 

[FR Doc. 2010–32489 Filed 12–27–10; 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 

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 assure consideration, public 

comments must be delivered to the 

address provided below by no later than 

5 p.m. on February 28, 2011. 

ADDRESSES: In commenting, please refer 

to file code OIG–118–N. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 81557 

1The OIG Semiannual Report to Congress can be 

accessed through the OIG Web site at http:// 

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

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: Office of 

Inspector General, Congressional and 

Regulatory Affairs, Department of 

Health and Human Services, Attention: 

OIG–118–N, Room 5541, 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 Office of 

Inspector General, Department of Health 

and Human Services, Cohen Building, 

Room 5541, 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) 

619–1343. 

For information on viewing public 

comments, please see the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Patrice Drew, Regulatory Officer, 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–118–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 as soon as possible 

after they have been received. 

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 in order 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, Public 

Law 100–93 § 14, the Act, § 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 which, 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 

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 these 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 

§ 205, the Act, § 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 

engage in a thorough review of 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 

December 29, 2009 (74 FR 68762). As 

required under section 205, a status 

report of the public comments received 

in response to that notice is set forth in 

an appendix to the OIG’s Semiannual 

Report to Congress covering the period 

April 1, 2010, through September 30, 

2010.1 OIG is not seeking additional 

public comment on the proposals listed 

in Appendix D at this time. Rather, this 

notice seeks additional 

recommendations regarding the 

development of proposed or modified 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
81558 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 

safe harbor regulations and new Special 

Fraud Alerts beyond those summarized 

in an appendix to the OIG Semiannual 

Report referenced above. 

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 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 the 

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 take into 

consideration 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 

also 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. 

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. 

Dated: December 22, 2010. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. 2010–32705 Filed 12–27–10; 8:45 am] 

BILLING CODE 4152–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 5 

[ET Docket No. 10–237; FCC 10–198] 

Promoting More Efficient Use of 

Spectrum Through Dynamic Spectrum 

Use Technologies 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In this document, the 

Commission seeks to promote and 

facilitate wireless innovation to ensure 

that the promise of dynamic spectrum 

access technologies can be fully realized 

and applied across more of the radio 

spectrum. A dynamic sharing approach 

would, for example, allow devices to 

identify and use slices of spectrum that 

are available in a particular location for 

a limited time—from as little as few 

seconds to as much as several days. 

Specifically, the Commission seeks 

comment on the variety of ways in 

which dynamic spectrum access radios 

and techniques can promote more 

intensive and efficient use of the radio 

spectrum, and the potential that these 

technological innovations have for 

enabling more effective management of 

spectrum. 

DATES: Comments must be filed on or 

before February 28, 2011, and reply 

comments must be filed on or before 

March 28, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Rodney Small, Office of Engineering 

and Technology, (202) 418–2452, email: Rodney.Small@fcc.gov, TTY (202) 

418–2989. 

ADDRESSES: You may submit comments, 

identified by ET Docket No. 10–237, 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.] 

• 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 of 

this document. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Notice of 

Inquiry, ET Docket No. 10–237, FCC 10– 

198, adopted and released on November 

30, 2010. The full text of this document 

is available for inspection and copying 

during normal business hours in the 

FCC Reference Center (Room CY–A257), 

445 12th Street, SW., Washington, DC 

20554. The complete text of this 

document also may be purchased from 

the Commission’s copy contractor, Best 

Copy and Printing, Inc., 445 12th Street, 

SW., Room, CY–B402, Washington, DC 

20554. The full text may also be 

downloaded at: http://www.fcc.gov. 

Pursuant to §§ 1.415, 1.419, and 1.430 

of the Commission’s rules, 47 CFR 

1.415, 1.419, and 1.430, 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:// 

fjallfoss.fcc.gov/ecfs2/ or the Federal 

eRulemaking Portal: http:// 

www.regulations.gov. 

• 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. All 

filings must be addressed to the 

Commission’s Secretary, Office of the 

Secretary, Federal Communications 

Commission. 

• All hand-delivered or messengerdelivered paper filings for the 

Commission’s Secretary must be 

delivered to FCC Headquarters at 445 

12th St., SW., Room TW–A325, 

Washington, DC 20554. The filing hours 

are 8 a.m. to 7 p.m. All hand deliveries 


emcdonald on DSK2BSOYB1PROD with PROPOSALS