Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations 7349

part 71) modifies Class E airspace at

Monticello, IN to accommodate aircraft

executing the GPS Runway 18 SIAP and

the GPS Runway 36 SIAP at White

County Airport. Controlled airspace

extending upward from 700 to 1200 feet

AGL is needed to contain aircraft

executing the approach. The area will be

depicted on appropriate aeronautical

charts thereby enabling pilots to

circumnavigate the area or otherwise

comply with IFR procedures.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this regulation—(1)

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—[AMENDED]

1. The Authority citation for 14 part

71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AGL IN E5 Monticello, IN [Revised]

White County Airport, IN

(Lat. 40°42′32′′ N, long. 86°46′00′′ W)

That airspace extending upward from 700

feet above the surface within a 6.4-mile

radius of White County Airport and within

2.7 miles each side of the 185° bearing from

the airport extending from the 6.4-mile

radius to 7.4 miles south of the airport.

* * * * *

Issued in Des Plaines, Illinois on February

5, 1997.

Maureen Woods,

Manager, Air Traffic Division.

[FR Doc. 97–4069 Filed 2–18–97; 8:45 am]

BILLING CODE 4910–13–M

14 CFR Part 73

[Airspace Docket No. 96–AGL–16]

RIN 2120–AA66

Amendment to Time of Designation for

Restricted Area R–4305, Lake Superior,

MN

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This rule amends the time of

designation for Restricted Area 4305 (R–

4305), Lake Superior, MN, by reducing

the requirement for the issuance of a

Notice to Airmen (NOTAM) from 12

hours in advance to 4 hours in advance

of activation of the airspace. The U.S.

Air Force requested this amendment to

permit greater flexibility in scheduling

R–4305.

EFFECTIVE DATE: 0901 UTC, May 22,

1997.

FOR FURTHER INFORMATION CONTACT:

Steve Brown, Airspace and Rules

Division, ATA–400, Office of Air Traffic

Airspace Management, Federal Aviation

Administration, 800 Independence

Avenue, SW., Washington, DC 20591;

telephone: (202) 267–8783.

SUPPLEMENTARY INFORMATION:

History

On November 5, 1996, the FAA

proposed to amend Title 14 of the Code

of Federal Regulations part 73 (14 CFR

part 73) to amend the time of

designation for R–4305 from the current

‘‘Intermittent by NOTAM, 12 hours in

advance,’’ to ‘‘Intermittent by NOTAM,

2 hours in advance.’’ (61 FR 56927).

Interested parties were invited to

participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments objecting to the proposal

were received. However, the FAA

determined that 2 hours advance notice

did not allow enough time for the

NOTAM to be processed and still have

adequate lead time for airspace users to

become aware of the activation prior to

their flights. Therefore, the time of

designation will now read: ‘‘Intermittent

by NOTAM, 4 hours in advance.’’ The

FAA’s Great Lakes Region coordinated

this change with the regional U.S. Air

Force representative and, on January 27,

1997, the U.S. Air Force formally

accepted the modification to their

proposal. Except for editorial changes

and the time of designation change from

‘‘Intermittent by NOTAM, 2 hours in

advance’’ to ‘‘Intermittent by NOTAM, 4

hours in advance,’’ this amendment is

the same as that proposed in the notice.

Section 73.43 of part 73 of the Federal

Aviation Regulations was republished

in FAA Order 7400.8D dated July 11,

1996.

The Rule

This amendment to part 73 of the

Federal Aviation Regulations (14 CFR

part 73) amends the time of designation

for R–4305 from the current

‘‘Intermittent by NOTAM, 12 hours in

advance,’’ to ‘‘Intermittent by NOTAM,

4 hours in advance.’’ The current 12-

hour in advance NOTAM requirement

does not permit the using agency

sufficient flexibility to efficiently

accomplish its mission in the event of

maintenance or weather delays, or other

operational factors. This action will not

alter the existing boundaries, altitudes,

or designated purpose of R–4305.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. It, therefore—(1) Is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

Environmental Review

This action will not affect the existing

boundaries, altitudes, or activities

conducted in R–4305. There will be no

change from current operations and no

new air traffic procedures will be

necessary as a result of this rule.

Therefore, the FAA has determined that

this action is not subject to

environmental assessments and

procedures in accordance with FAA

Order 1050.1D, ‘‘Policies and

Procedures for Considering

Environmental Impacts.’’
7350 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Rules and Regulations

List of Subjects in 14 CFR Part 73

Airspace, Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 73 as follows:

PART 73—[AMENDED]

1. The authority citation for part 73

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 73.43 [Amended]

R–4305 Lake Superior, MN [Amended]

By removing ‘‘Time of Designation.

Intermittent by NOTAM, 12 hours in

advance,’’ and substituting ‘‘Time of

designation. Intermittent by NOTAM, 4

hours in advance.’’

Issued in Washington, DC, on February 7,

1997.

Jeff Griffith,

Program Director for Air Traffic Airspace

Management.

[FR Doc. 97–4068 Filed 2–18–97; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Part 1008

RIN 0991–AA85

Medicare and State Health Care

Programs: Fraud and Abuse; Issuance

of Advisory Opinions by the OIG

AGENCY: Office of Inspector General

(OIG), HHS

ACTION: Interim final rule with comment

period.

SUMMARY: In accordance with section

205 of the Health Insurance Portability

and Accountability Act of 1996, this

final rule establishes a new part 1008 in

42 CFR chapter V to address the new

OIG advisory opinion process.

Specifically, these regulations set forth

the specific procedures by which the

Office of Inspector General, in

consultation with the Department of

Justice, will issue advisory opinions to

outside parties regarding the

interpretation and applicability of

certain statutes relating to the Medicare

and State health care programs.

DATES: Effective Date: This rule is

effective on February 21, 1997.

Comment Period: To assure

consideration, public comments must be

delivered to the first address provided

under ADDRESSES by no later than 5 p.m.

on April 21, 1997. Comments will be

available for public inspection March 5,

1997 at the second address provided

under ADDRESSES on Monday through

Friday of each week from 8:00 a.m. to

4:30 p.m., (202) 619–0089.

ADDRESSES: Please mail or deliver your

written comments to the following

address: Office of Inspector General,

Department of Health and Human

Services, Attention: OIG–10–IFC, Room

5246, Cohen Building, 330

Independence Avenue, SW.,

Washington, DC 20201.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

OIG–10–IFC.

FOR FURTHER INFORMATION CONTACT: Joel

Schaer, (202) 619–0089, OIG

Regulations Officer.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Medicare Anti-Kickback Statute

Section 1128B(b) of the Social

Security 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

business reimbursed under the

Medicare or State 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.

This provision is quite broad. The

types of remuneration covered

specifically include kickbacks, bribes,

and rebates, whether made directly or

indirectly, overtly or covertly, or in cash

or in kind. In addition, prohibited

conduct includes not only remuneration

intended to induce referrals of patients,

but remuneration intended to induce

the purchasing, leasing, ordering, or

arranging for any good, facility, service,

or item paid for by Medicare or State

health care programs.

Since the statute on its face is so

broad, concern has been expressed for

many years that some relatively

innocuous commercial arrangements are

technically covered by the statute and

are, therefore, subject to criminal

prosecution.

B. Safe Harbors and Fraud Alerts

As a response to the above concern,

the Medicare and Medicaid Patient and

Program Protection Act of 1987, Public

Law 100–93, specifically required the

development and promulgation of

regulations, the so-called ‘‘safe harbor’’

provisions, designed to specify various

payment and business practices which,

although potentially capable of inducing

referrals of business under the Medicare

and State health care programs, would

not be treated as criminal offenses under

the anti-kickback statute (section

1128B(b) of the Social Security Act; 42

U.S.C. 1320b(b)) and would not serve as

a basis for a program exclusion under

section 1128(b)(7) of the Social Security

Act; 42 U.S.C. 1320a–7(b)(7).

The OIG safe harbor provisions have

been developed to permit individuals

and entities to freely engage in business

practices and arrangements that

encourage competition, innovation and

economy. Health care providers and

others may voluntarily seek to comply

with these provisions so that they have

the assurance that their business

practices are not subject to any

enforcement action under the antikickback statute or program exclusion

authority. The 13 final safe harbor

provisions, which specify practices

which are expressly made legal, are

codified at 42 CFR 1001.952.

In addition, the OIG has also

periodically issued Special Fraud Alerts

to give continuing guidance to health

care providers with respect to practices

the OIG regards as unlawful. Eight

individual Special Fraud Alerts were

published in the Federal Register on

December 19, 1994 (59 FR 65372),

August 10, 1995 (60 FR 40847) and June

17, 1996 (61 FR 30623). Thus, for many

years the OIG has been publishing

substantial guidance indicating what

practices are lawful and what practices

the OIG considers unlawful under the

anti-kickback statute.

C. Advisory Opinions: Section 205 of

Public Law 104–191

The Health Insurance Portability and

Accountability Act of 1996, Public Law

104–191, effective August 21, 1996, now

requires the Department to provide

additional formal guidance regarding

the application of the anti-kickback

statute and the safe harbor provisions,

as well as other OIG health care fraud

and abuse sanctions. Among the

provisions set forth in section 205 of

Public Law 104–191 is the requirement

that the Department, in consultation

with the Department of Justice (DoJ),

issue written advisory opinions to

particular parties with regard to: (1)

What constitutes prohibited

remuneration under the anti-kickback

statute; (2) whether an arrangement or

proposed arrangement satisfies the

criteria in section 1128B(b)(3) of the

Social Security Act, or established by

regulation, for activities which do not

result in prohibited remuneration; (3)

what constitutes an inducement to