Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / Rules and Regulations 8955

1996, 1997, and 1998. We estimate that

the annual drug cost following

transplantation for a full time user of

immunosuppressive drugs will be as

follows:

ESTIMATED ANNUAL COST OF IMMUNOSUPPRESSIVE DRUGS FOR EACH

TRANSPLANT PATIENT

CY 1995 CY 1996 CY 1997

$5580 $5910 $6275

This final rule also differs from the

proposed rule in that the term

‘‘immunosuppressive drugs’’ has been

changed to ‘‘prescription drugs used in

immunosuppressive therapy’’ to

conform with section 4075 of OBRA ’87.

This expanded coverage will allow

payment for other necessary drugs used

in conjunction with

immunosuppressive drugs.

B. Regulatory Flexibility Act

Consistent with the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601

through 612), we prepare a regulatory

flexibility analysis unless the Secretary

certifies that a rule will not have a

significant economic impact on a

substantial number of small entities. For

purposes of the RFA, pharmacists,

physicians who perform transplantation

services, and manufacturers of covered

pharmaceuticals are considered to be

small entities. Although pharmaceutical

manufacturers are frequently not

considered to be small entities, the

possibility exists that certain

manufacturers affected by this final rule

may meet the definition of a small

entity.

In addition, section 1102(b) of the Act

requires the Secretary to prepare a

regulatory impact analysis if a rule may

have a significant impact on the

operations of a substantial number of

small rural hospitals. This analysis must

conform to the provisions of section 604

of the RFA. For purposes of section

1102(b) of the Act, we define a small

rural hospital as a hospital that is

located outside of a Metropolitan

Statistical Area and has fewer than 50

beds.

Because of the high cost of a majority

of the drugs used for

immunosuppressive therapy and the

extended time that beneficiaries are

required to take the drugs to ensure that

the transplanted organ is not rejected,

all Medicare transplant patients and

many small entities will benefit by this

regulation. In many cases, 1 year of

immunosuppressive therapy is not

sufficient. Also, it is possible that we

may avoid the additional cost of a

second transplant if a patient is kept on

immunosuppressive drug therapy

beyond the original 12 month coverage

period.

We are not preparing analyses for

either the RFA or section 1102(b) of the

Act because we have determined, and

the Secretary certifies, that this rule will

not have a significant economic impact

on a substantial number of small entities

or a significant impact on the operations

of a substantial number of small rural

hospitals.

In accordance with the provisions of

Executive Order 12866, this regulation

was not reviewed by the Office of

Management and Budget.

List of Subjects in 42 CFR Part 410

Medical and other health services,

Medicare.

For the reasons set forth in the

preamble, 42 CFR chapter IV, part 410

is amended as set forth below:

PART 410—SUPPLEMENTARY

MEDICAL INSURANCE (SMI)

BENEFITS

1. The authority citation continues to

read as follows:

Authority: Secs. 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and

1395hh).

2. In § 410.10, the introductory text is

republished and a new paragraph (u) is

added to read as follows:

§ 410.10 Medical and other health

services: Included services.

Subject to the conditions and

limitations specified in this subpart,

‘‘medical and other health services’’

includes the following services:

* * * * *

(u) Prescription drugs used in

immunosuppressive therapy.

3. A new § 410.31 is added to read as

follows:

§ 410.31 Prescription drugs used in

immunosuppressive therapy.

(a) Scope. Payment may be made for

prescription drugs used in

immunosuppressive therapy that have

been approved for marketing by the

FDA and that meet one of the following

conditions:

(1) The approved labeling includes

the indication for preventing or treating

the rejection of a transplanted organ or

tissue.

(2) The approved labeling includes

the indication for use in conjunction

with immunosuppressive drugs to

prevent or treat rejection of a

transplanted organ or tissue.

(3) Have been determined by a carrier

(in accordance with part 421, subpart C

of this chapter), in processing a

Medicare claim, to be reasonable and

necessary for the specific purpose of

preventing or treating the rejection of a

patient’s transplanted organ or tissue, or

for use in conjunction with

immunosuppressive drugs for the

purpose of preventing or treating the

rejection of a patient’s transplanted

organ or tissue. (In making these

determinations, the carriers may

consider factors such as authoritative

drug compendia, current medical

literature, recognized standards of

medical practice, and professional

medical publications.)

(b) Period of eligibility. Coverage is

available only for prescription drugs

used in immunosuppressive therapy,

furnished to an individual who receives

an organ or tissue transplant for which

Medicare payment is made, for the

following periods:

(1) For drugs furnished before 1995,

for a period of up to 1 year beginning

with the date of discharge from the

hospital during which the covered

transplant was performed.

(2) For drugs furnished during 1995,

within 18 months after the date of

discharge from the hospital during

which the covered transplant was

performed.

(3) For drugs furnished during 1996,

within 24 months after the date of

discharge from the hospital during

which the covered transplant was

performed.

(4) For drugs furnished during 1997,

within 30 months after the date of

discharge from the hospital during

which the covered transplant was

performed.

(5) For drugs furnished after 1997,

within 36 months after the date of

discharge from the hospital during

which the covered transplant was

performed.

(c) Coverage. Drugs are covered under

this provision irrespective of whether

they can be self-administered.

(Catalog of Federal Domestic Assistance

Program No. 93.774, Medicare—

Supplementary Medical Insurance)

Dated: January 9, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Approved: February 9, 1995.

Donna E. Shalala,

Secretary.

[FR Doc. 95–3835 Filed 2–15–95; 8:45 am]

BILLING CODE 4120–01–P
8956 Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / Rules and Regulations

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Public Land Order 7115

[UT–942–1430–01; UTU–52338]

Partial Revocation of Executive Order

of April 17, 1926, Public Water Reserve

107 Withdrawal; Utah

AGENCY: Bureau of Land Management.

ACTION: Public land order.

SUMMARY: This order revokes Executive

Order of April 17, 1926, insofar as it

affects 40.84 acres of public land

withdrawn as a public water reserve.

The land is no longer needed for the

purpose of the withdrawal, and the

revocation is needed to permit disposal

of the land through a land exchange

under the authority of the Federal Land

Policy and Management Act of 1976.

This action will open the land to surface

entry, and to mining for

nonmetalliferous minerals. The land has

been and will remain open to mineral

leasing and mining for metalliferous

minerals.

EFFECTIVE DATE: March 20, 1995.

FURTHER FOR FURTHER INFORMATION

CONTACT: Randy Massey, BLM Utah

State Office, P.O. Box 45155, Salt Lake

City, Utah 84145–0155.

By virtue of the authority vested in

the Secretary of the Interior by Section

204 of the Federal Land Policy and

Management Act of 1976, 43 U.S.C.

1714 (1988), it is ordered as follows:

1. Executive Order of April 17, 1926,

which withdrew public land containing

springs and water holes as public water

reserves, is hereby revoked insofar as it

affects the following described land:

Salt Lake Meridian

T. 11 N., R. 19 W.,

Sec. 4, lot 1;

The area described contains 40.84 acres in

Box Elder County.

The land described above is no longer

needed for the purpose for which

withdrawn. There is no water on the

parcel, nor evidence of any in the past.

2. At 9 a.m. on March 20, 1995, the

land will be opened to the operation of

the public land laws generally, subject

to valid existing rights, the provision of

existing withdrawals, other segregations

of record, and the requirements of

applicable law. All valid applications

received at or prior to 9 a.m. on March

20, 1995 shall be considered as

simultaneously filed at that time. Those

received thereafter shall be considered

in the order of filing.

3. At 9 a.m. on March 20, 1995 the

land will be opened to location and

entry for nonmetalliferous minerals

under the United States mining law,

subject to valid existing rights, the

provision of existing withdrawals, other

segregations of record, and the

requirements of applicable law.

Appropriation of any of the land

described in this order under the

general mining laws prior to the date

and time of restoration is unauthorized.

Any such attempted appropriation,

including attempted adverse possession

under 30 U.S.C. 38 (1988), shall vest no

rights against the United States. Acts

required to establish a location and to

initiate a right of possession are

governed by State law where not in

conflict with Federal law. The Bureau of

Land Management will not intervene in

disputes between rival locators over

possessory rights since Congress has

provided for such determinations in

local courts.

Dated: February 6, 1995.

Bob Armstrong,

Assistant Secretary of the Interior.

[FR Doc. 95–3893 Filed 2–15–95; 8:45 am]

BILLING CODE 4310–DQ–P

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 227

[Docket No. 950201033–5033–01; I.D.

041294E]

RIN 0648–AG37

Sea Turtle Conservation; Shrimp

Trawling Requirements

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Final rule.

SUMMARY: This final rule allows nonFederal entities to apply for, and NMFS

to issue, permits for the incidental take

of threatened species of sea turtles

consistent with section 10(a) of the

Endangered Species Act (ESA). Under

existing regulations, the prohibitions of

section 9 of the ESA apply to both

endangered and threatened species, but

section 10 incidental take permits may

be authorized for endangered, but not

threatened, species of sea turtles. This

regulation corrects this discrepancy in

the application of sections 9 and 10 to

threatened species of sea turtles.

EFFECTIVE DATE: March 20, 1995.

ADDRESSES: Requests for copies of the

Environmental Assessment (EA) for the

proposed rule, should be addressed to

Endangered Species Division, Office of

Protected Resources, NMFS, 1315 EastWest Highway, Silver Spring, MD

20910.

FOR FURTHER INFORMATION CONTACT:

Heather Weiner, Endangered Species

Division, 301–713–1401; Doug Beach,

Protected Species Program Coordinator,

NMFS Northeast Regional Office, 508–

281–9254; or Charles A. Oravetz, Chief,

Protected Species Program, NMFS

Southeast Regional Office, 813–570–

5312.

SUPPLEMENTARY INFORMATION:

Background

All sea turtles that occur in U.S.

waters are listed as either endangered or

threatened under the ESA. Kemp’s

ridley (Lepidochelys kempii),

leatherback (Dermochelys coriacea) and

hawksbill (Eretmochelys imbricata)

turtles are listed as endangered.

Loggerhead (Caretta caretta), green

(Chelonia mydas) and olive ridley

(Lepidochelys olivacea) turtles are listed

as threatened, except for breeding

populations of green turtles in Florida

and on the Pacific Coast of Mexico, and

the breeding population of olive ridley

turtles on the Pacific Coast of Mexico,

which are listed as endangered.

In a proposed rule published on July

21, 1994 (59 FR 37213), NMFS proposed

to extend existing incidental-take permit

regulations to all threatened species of

sea turtles as authorized under section

10(a)(1)(B) of the ESA. Section 10

authorizes the Secretary of Commerce to

permit under such terms and conditions

as he or she may prescribe, any taking

otherwise prohibited by section

9(a)(1)(B) of the ESA, if the taking is

incidental to, and not the purpose of,

carrying out an otherwise lawful

activity. NMFS implemented

regulations for the application and

issuance of incidental-take permits,

under section 10(a) of the ESA, which

appear at 50 CFR parts 220 and 222, and

allow the Assistant Administrator for

Fisheries, NOAA, (AA) to issue permits

to incidentally take endangered marine

species during otherwise lawful

activities.

Comments and Responses on the

Proposed Rule

NMFS received responses from four

commenters, including the U.S.

Department of the Interior, regarding the

proposed rule. Commenters were

generally supportive of the proposed

rule, but expressed some concerns about

permit issuance and review. NMFS

reviewed all comments in detail and

combined their common concerns for

response.