73186 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules 

procedure by submitting written 

comments in accordance with the 

instructions outlined earlier in this 

notice. 

V. Statutory and Executive Order 

Reviews 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this proposed 

action is not a ‘‘significant regulatory 

action’’ and therefore is not subject to 

review by the Office of Management and 

Budget. For this reason, this action is 

also not subject to Executive Order 

13211, ‘‘Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). This proposed action merely 

proposes to approve a redesignation to 

attainment and imposes no additional 

requirements beyond those imposed by 

state law. Redesignation of an area to 

attainment under section 107 of the 

Clean Air Act is an action that affects 

the attainment status of a geographical 

area and does not impose any new 

regulatory requirements on sources. 

Accordingly, the Administrator certifies 

that this proposed rule will not have a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.). Because this rule 

proposes to approve a redesignation to 

attainment and does not impose any 

additional enforceable duty beyond that 

required by state law, it 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). 

This proposed rule also does not have 

tribal implications because it will not 

have a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes, 

as specified by Executive Order 13175 

(65 FR 67249, November 9, 2000). This 

action also does not have Federalism 

implications because it does not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This action merely 

proposes to approve a redesignation to 

attainment and does not alter the 

relationship or the distribution of power 

and responsibilities established in the 

Clean Air Act. This proposed rule also 

is not subject to Executive Order 13045 

‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997), 

because it is not economically 

significant. 

Section 12(d) of the National 

Technology Transfer Advancement Act 

(NTTAA) of 1995, Public Law 104–113, 

section 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards (VCS) in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impracticable. VCS are 

technical standards (e.g., materials 

specifications, test methods, sampling 

procedures, and business practices) that 

are developed or adopted by VCS 

bodies. This action does not involve 

technical standards. Therefore, EPA did 

not consider the use of any VCS. This 

proposed rule does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). 

List of Subjects in 40 CFR Part 81 

Air pollution control, National parks, 

Wilderness areas. 

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

Dated: November 28, 2005. 

Robert E. Roberts, 

Regional Administrator, Region 8. 

[FR Doc. 05–23808 Filed 12–8–05; 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 (HIPAA) of 

1996, 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 7, 2006. 

ADDRESSES: Please mail or deliver your 

written comments to the following 

address: Office of Inspector General, 

Department of Health and Human 

Services, Attention: OIG–101–N, Room 

5246, Cohen Building, 330 

Independence Avenue, SW., 

Washington, DC 20201. 

We do not accept comments by 

facsimile (FAX) transmission. In 

commenting, please refer to file code 

OIG–101–N. Comments received timely 

will be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, in Room 5541 of the 

Office of Inspector General at 330 

Independence Avenue, SW., 

Washington, DC, on Monday through 

Friday of each week from 8 a.m. to 4:30 

p.m. 

FOR FURTHER INFORMATION CONTACT: Joel 

Schaer, (202) 619–0089, OIG 

Regulations Officer. 

SUPPLEMENTARY INFORMATION: 

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, the Medicare and 

Medicaid Patient and Program 

Protection Act of 1987, section 14 of 

Public Law 100–93, 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 

Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules 73187 

1The OIG Semiannual Report can be accessed 

through the OIG Web site at http://oig.hhs.gov/ 

publications/semiannual.html. 

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 any enforcement 

action under the anti-kickback statute or 

related administrative authorities. 

To date, OIG has developed and 

codified in 42 CFR 1001.952 a total of 

22 final safe harbors that describe 

practices that are sheltered from 

liability. 

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. To date, OIG has issued 12 

individual Special Fraud Alerts. 

C. Section 205 of Public Law 104–191 

Section 205 of Public Law 104–191 

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 Public Law 104–191, 

OIG last published a Federal Register 

solicitation notice for developing new 

safe harbors and Special Fraud Alerts on 

December 10, 2004 (69 FR 71766). As 

required under section 205, a status 

report of the public comments received 

in response to that notice is set forth in 

Appendix F to the OIG’s Semiannual 

Report covering the period April 1, 

2005, through September 30, 2005.1 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 proposed or modified 

safe harbor regulations and new Special 

Fraud Alerts beyond those summarized 

in Appendix F 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: November 30, 2005. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. 05–23624 Filed 12–8–05; 8:45 am] 

BILLING CODE 4150–04–P 

DEPARTMENT OF DEFENSE 

48 CFR Parts 208, 252, and 253 and 

Appendix B to Chapter 2 

[DFARS Case 2003–D072] 

Defense Federal Acquisition 

Regulation Supplement; Required 

Sources of Supply 

AGENCY: Department of Defense (DoD). 

ACTION: Proposed rule with request for 

comments. 

SUMMARY: DoD is proposing to amend 

the Defense Federal Acquisition 

Regulation Supplement (DFARS) to 

update text addressing acquisitions 

made through Government supply 

sources. This proposed rule is a result 

of a transformation initiative undertaken 

by DoD to dramatically change the 

purpose and content of the DFARS. 

DATES: Comments on the proposed rule 

should be submitted in writing to the 

address shown below on or before 

February 7, 2006, to be considered in 

the formation of the final rule. 

ADDRESSES: You may submit comments, 

identified by DFARS Case 2003–D072, 

using any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Defense Acquisition Regulations 

Web Site: http://emissary.acq.osd.mil/ 

dar/dfars.nsf/pubcomm. Follow the 

instructions for submitting comments. 

• E-mail: dfars@osd.mil. Include 

DFARS Case 2003–D072 in the subject 

line of the message. 

• Fax: (703) 602–0350. 

• Mail: Defense Acquisition 

Regulations Council, Attn: Ms. Robin 

Schulze, OUSD (AT&L) DPAP (DAR), 

IMD 3C132, 3062 Defense Pentagon, 

Washington, DC 20301–3062.