Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules 65775

Regulatory Fairness Act of 1996 (Pub. L.

104–121), and the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4).

Executive Order 12866 directs agencies

to assess all costs and benefits of

available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety and other advantages

distributive impacts and equity). The

agency believes that this proposed rule

is consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Reclassification of this device

from class III to class II will relieve all

manufacturers of the device of the cost

of complying with the premarket

approval requirements in section 515 of

the act. Because reclassification will

reduce regulatory costs with respect to

this device, it will impose no significant

economic impact on any small entities,

and it may permit small potential

competitors to enter the marketplace by

lowering their costs. The agency

therefore certifies that the final rule will

not have a significant economic impact

on a substantial number of small

entities. The rule also does not trigger

the requirement for a written statement

under section 202(a) of the Unfunded

Mandates Reform Act because it does

not impose a mandate that results in an

expenditure of $100 million or more by

State, local, or tribal governments in the

aggregate, or by the private sector, in

any 1 year.

XII. Comments

Interested persons may, on or before

March 16, 1998 submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Part 876

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 876 be amended as follows:

PART 876—GASTROENTEROLOGYUROLOGY DEVICES

1. The authority citation for 21 CFR

part 876 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 360l, 371.

2. Section 876.3630 is revised to read

as follows:

§ 876.3630 Penile rigidity implant.

(a) Identification. A penile rigidity

implant is a device that consists of a

pair of semi-rigid rods implanted in the

corpora cavernosa of the penis to

provide rigidity. It is intended to be

used in men diagnosed as having

erectile dysfunction. (b) Classification.

Class II (special controls) (premarket

notification guidance).

Dated: November 11, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–32809 Filed 12-15-97; 8:45 am]

BILLING CODE 4160–01–F

NATIONAL INDIAN GAMING

COMMISSION

25 CFR Part 514

Annual Fees Payable By Indian

Gaming Operations

AGENCY: National Indian Gaming

Commission.

ACTION: Proposed rule.

SUMMARY: The National Indian Gaming

Commission is proposing to amend its

fee regulations to add class III gaming

revenues to the assessable gross revenue

base, increase the total amount of fees

that can be imposed, and provide for an

exemption for self-regulated tribes such

as the Mississippi Band of Choctaw.

This action is being taken pursuant to

recent amendments to the Indian

Gaming Regulatory Act. The primary

effect of this action is to increase the

funding for the National Indian Gaming

Commission.

DATES: Comments must be submitted on

or before January 15, 1998.

ADDRESSES: Comments may be mailed

to: Fee Regulation Comments, National

Indian Gaming Commission, 1441 L

Street, N.W., Suite 9100, Washington,

DC 20005, delivered to that address

between 8:30 a.m. and 5:30 p.m.,

Monday through Friday, or faxed to

202/632–7066 (this is not a toll-free

number). Comments received may be

inspected between 9 a.m. and noon, and

between 2 p.m. and 5 p.m.

FOR FURTHER INFORMATION CONTACT:

Fred W. Stuckwisch at 202/632–7003;

fax 202/632–7066 (these are not toll-free

numbers).

SUPPLEMENTARY INFORMATION: The

Indian Gaming Regulatory Act (IGRA),

enacted on October 17, 1988,

established the National Indian Gaming

Commission (Commission). The

Commission is charged with, among

other things, regulating gaming on

Indian lands. Pursuant to recent

amendments to the IGRA, these fee

regulations are being amended to:

(1) Add class III gaming revenues to

the assessable gross revenue base,

(2) Increase the total amount of fees

that can be imposed, and

(3) Provide an exemption for selfregulated tribes such as the Mississippi

Band of Choctaw.

As a result, gaming operations

offering only class III games must begin

reporting and paying fees, and gaming

operations offering both class II and III

games must begin reporting and paying

fees on their class III revenues.

The Commission has adopted a 30

day comment period for this proposed

rule because (1) the basic rule has been

in effect for six (6) years, (2) comments

were received and considered before the

basic rule was adopted, and (3) it is

important that the increased funding for

the Commission as enacted by Congress

be implemented as soon as possible.

The purpose of these regulations is to

implement those portions of IGRA that

provide for the payment of fees by

gaming operations and for the collection

and use of such fees by the Commission.

Gaming operations are the economic

entities that are licensed by a tribe,

operate the games, receive the revenues,

issue the prizes, and pay the expenses.

Gaming operations may be operated by

a tribe directly, by a management

contractor, or in the case of certain

grandfathered class II gaming

operations, by an individual owner/

operator.

These regulations provide for a

system of fee assessment and payment

that is self-administered by the gaming

operations. Briefly, the Commission

adopts and communicates the

assessment rates; the gaming operations

apply those rates to their revenues,

compute the fees to be paid, and report

and remit the fees to the Commission on

a quarterly basis.

Annual fees are payable quarterly

each calendar year based on the

previous calendar year’s class II and III

assessable gross revenues from the

gaming operations.
65776 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules

The Commission will adopt

preliminary annual fee rate(s) during the

first quarter of each calendar year and

final annual fee rate(s) for that year

during the fourth quarter. Separate rates

may be established for assessable gross

revenue amounts under $1,500,000 (1st

tier) and amounts over $1,500,000 (2nd

tier). The rates when adopted will be

published in the Federal Register.

Under the proposed rule, selfregulated tribes such as the Mississippi

Band of Choctaw will be exempt from

the payment of fees pursuant to the

fiscal year 1998 Interior Appropriations

Act. The definitions of self-regulation

and self-regulated and the requirements

for obtaining a certificate of selfregulation and designation as selfregulated will be developed and added

to the regulations in later rulemakings.

Gaming operations are to apply the

rates adopted to their assessable gross

revenues from the preceding calendar

year to determine to amount of fees to

be paid. The gaming operations are to

report the amounts of assessable gross

revenues, the fees to be paid, and their

calculations to the Commission when

they remit their quarterly payments.

Remittances and reports are due no later

than March 31, June 30, September 30,

and December 31, of each calendar year.

Examples of computations are

included in the regulations.

By passing the fees on the previous

year’s assessable gross revenues,

sufficient time is provided to the gaming

operations to finalize and submit

adjusted numbers before the end of the

third quarter of the calendar year.

Furthermore, by providing for the

adoption of preliminary and final rates

by the Commission, it is intended that

sufficient time be provided the

Commission to ascertain the assessable

gross revenue base before finalizing the

rates for each calendar year.

These regulations are applicable to all

gaming operations under the

jurisdiction of the Commission. New

gaming operations (with no gaming

revenues generated in the previous

calendar year) must file reports

quarterly even though no fees will be

due.

Penalties and interest may be assessed

for failures to file quarterly statements

and to pay fees when due, and required

approvals may be withheld, denied or

revoked for failures to pay fees,

penalties and interest.

Regulatory Flexibility Act

This proposed rule will not have a

significant economic impact on a

substantial number of small business

entities under the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.). The

additional entities becoming subject to

these regulations as a result of the

changes now being made are generally

larger than those entities presently

covered. Furthermore, the fees that will

be paid by the entities presently covered

will be less than the fees they are

presently paying.

National Environmental Policy Act

The Commission has determined that

this proposed rule does not constitute a

major Federal action significantly

affecting the quality of the human

environment and that no detailed

statement is required pursuant to the

National Environmental Policy Act of

1969.

Tadd M. Johnson,

Chairman, National Indian Gaming

Commission.

List of Subjects in 25 CFR Part 514

Gambling, Indians-lands, Reporting

and recordkeeping requirements.

Accordingly, 25 CFR Part 514 is

proposed to be amended as follows:

PART 514—FEES

1. The authority for Part 514

continues to read as follows:

Authority: 25 U.S.C. 2706, 2708, 2710,

2717, 2717a.

2. Section 514.1 is amended by

revising paragraphs (a) introductory

text, (a)(4), (b) introductory text, (b)(4),

(c) introductory text, (c)(1), (c)(2), (c)(5)

introductory text, (c)(8), (d) introductory

text, and (g) and by adding paragraph

(a)(6), to read as follows:

§ 514.1 Annual Fees.

(a) Each gaming operation under the

jurisdiction of the Commission shall pay

to the Commission annual fees as

established by the Commission. The

Commission, by a vote of not less than

two of its members, shall adopt the rates

of fees to be paid.

* * * * *

(4) The rates of fees imposed shall

be—

(i) No more than 2.5 percent of the

first $1,500,000 (1st tier), and

(ii) No more than 5 percent of

amounts in excess of the first $1,500,000

(2nd tier) of the assessable gross

revenues from each gaming operation

regulated by the Commission.

* * * * *

(6) If a tribe is determined to be selfregulated pursuant to the provisions of

25 U.S.C. 2717(a)(2)(C), no fees shall be

imposed.

(b) For purposes of computing fees,

assessable gross revenues for each

gaming operation are the annual total

amount of money wagered on class II

and III games, admission fees (including

table or card fees), less any amounts

paid out as prizes or paid for prizes

awarded, and less an allowance for

amortization of capital expenditures for

structures.

* * * * *

(4) All class II and III revenues from

gaming operations are to be included.

(c) Each gaming operation regulated

by the Commission shall file with the

Commission quarterly a statement

showing its assessable gross revenues

for the previous calendar year.

(1) These quarterly statements shall

show the amounts derived from each

type of game, the amounts deducted for

prizes, and the amounts deducted for

the amortization of structures;

(2) These quarterly statements shall be

filed no later than March 31, June 30,

September 30, and December 31, of each

calendar year the gaming operation is

subject to the jurisdiction of the

Commission, beginning in September

1991. Any changes or adjustments to the

previous year’s assessable gross revenue

amounts from one quarter to the next

shall be explained.

* * * * *

(5) Each gaming operation shall

determine the amount of fees to be paid

and remit them with the statement

required in paragraph (c) of this section.

The fees payable shall be computed

using—

* * * * *

(8) Quarterly statements, remittances

and communications about fees shall be

transmitted to the Commission at the

following address: Office of Finance,

National Indian Gaming Commission,

1441 L Street, N.W., Suite 9100,

Washington, DC 20005. Checks should

be made payable to the National Indian

Gaming Commission (do not remit

cash).

* * * * *

(d) The total amount of all fees

imposed during any fiscal year shall not

exceed $8,000,000. The Commission

shall credit pro-rata any fees collected

in excess of this amount against

amounts otherwise due at the end of the

quarter following the quarter during

which the Commission makes such

determination.

* * * * *

(g) The information collection

requirements contained in paragraph (c)

of this section have been approved by

the Office of Management and Budget

under 44 U.S.C. 3501 et seq. and

assigned clearance number 3200–0011.

The information is being collected to

determine the assessable gross revenues

of each gaming operation and the
Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Proposed Rules 65777

aggregate assessable gross revenues of

all gaming operations. The information

will be used to set and adjust fee rates

and to verify the computations of fees

paid by each gaming operation.

Response is mandatory.

[FR Doc. 97–32662 Filed 12–15–97; 8:45 am]

BILLING CODE 7565–01–M

DEPARTMENT OF LABOR

Mine Safety and Health Administration

30 CFR Parts 56, 57, 62, 70, and 71

RIN–AA53

Health Standards for Occupational

Noise Exposure in Coal, Metal and

Nonmetal Mines

AGENCY: Mine Safety and Health

Administration (MSHA), Labor.

ACTION: Proposed rule; Availability of

report.

SUMMARY: This notice announces the

availability of a report from the National

Institute for Occupational Safety and

Health (NIOSH) entitled ‘‘Prevalence of

Hearing Loss For Noise-Exposed Metal/

Nonmetal Miners.’’ The report, which

MSHA received on October 15, 1997, is

cumulative evidence concerning the risk

to metal and nonmetal miners of noise

induced hearing loss (NIHL). The report

is relevant to the magnitude of the risk

of NIHL among miners. The Agency,

therefore, will supplement the

rulemaking record with this report and

make it available to interested parties

upon request.

ADDRESSES: Copies of the report are

available from the Office of Standards,

Regulations, and Variances, 703–235–

1910.

FOR FURTHER INFORMATION CONTACT:

Patricia W. Silvey, Director, MSHA,

Office of Standards, Regulations, and

Variances, 703–235–1910.

SUPPLEMENTARY INFORMATION: On

December 17, 1996, MSHA published a

proposed rule in the Federal Register

(61 FR 66348) revising its health

standards for occupational noise

exposure in coal and metal and

nonmetal mines. In this proposal,

MSHA stated that current scientific

evidence demonstrates that NIHL

constitutes a serious hazard, that

evidence exists of continuing harm to

miners, and that MSHA standards no

longer reflect experience and expert

advice. The Agency concluded that

regulatory action was necessary to

address the continued excess risk of

NIHL resulting from mining

employment.

MSHA evaluated evidence related to

the risk to miners from exposure to

harmful levels of noise, and evidence on

the level of that risk. MSHA determined

that with respect to mine safety and

health, any definition of material

impairment of hearing should relate to

a permanent, measurable loss of hearing

which, unchecked, will limit the ability

to understand speech, as it is spoken in

everyday social (noisy) conditions. This

is because speech comprehension is

essential for mine safety.

The Agency reviewed the major

studies on the level of risk at different

noise exposures. The studies

consistently indicated that the risk of

developing a material impairment

became significant over a working

lifetime when workplace exposure

exceeded average sound levels of 85

dBA. The data further indicated that

while lowering exposure from an eighthour time-weighted average (TWA8) of

90 dBA to one of 85 dBA did not

eliminate the risk, it did reduce the risk

by approximately half. MSHA also

reviewed a large body of data on the

effects of varying industrial sound levels

on worker hearing. These studies were

supportive of the same conclusion. The

Agency also focused on the harm that

can occur at lower sound levels by

reviewing studies of workers in other

countries.

To confirm the magnitude of the risks

of NIHL among miners, MSHA

examined evidence of reported hearing

loss among miners from a variety of

sources audiometric data bases tracking

hearing acuity among coal miners,

individual commenter data, hearing loss

data reported to MSHA, and workers’

compensation data. MSHA also asked

NIOSH to examine a body of

audiometric data which tracked hearing

acuity among coal miners and one

which tracked hearing acuity among

metal and nonmetal miners. NIOSH

completed its analysis of the

audiometric data on coal miners and

issued a report to MSHA entitled

‘‘Analysis of Audiograms for a Large

Cohort of Noise-Exposed Miners,’’

(Franks, 1996) which is a part of the

existing rulemaking record.

NIOSH has now issued its report to

MSHA which analyzes audiometric data

on metal and nonmetal miners. This

report is entitled ‘‘Prevalence of Hearing

Loss For Noise-Exposed Metal/

Nonmetal Miners.’’ The NIOSH analysis

supports the conclusion from earlier

scientific studies that miners are losing

their hearing sensitivity faster than the

general population. It indicates that

49% of the male population of metal

and nonmetal miners have a hearing

impairment by age 50 as compared with

only 9% of the general population.

The report is available to interested

members of the public and may be

obtained upon request by electronic

mail, fax, phone, or mail as follows: (1)

Electronic mail: psilvey@msha.gov, (2)

Fax: MSHA, Office of Standards,

Regulations, and Variances, 703–235–

5551, (3) Phone: Patricia W. Silvey,

703–235–1910, and (4) Mail: Mine

Safety and Health Administration,

Office of Standards, Regulations, and

Variances, 4015 Wilson Boulevard,

Room 631, Arlington, VA 22203–1984.

Dated: December 9, 1997.

J. Davitt McAteer,

Assistant Secretary for Mine Safety and

Health.

[FR Doc. 97–32709 Filed 12–15–97; 8:45 am]

BILLING CODE 4510–43–P

LIBRARY OF CONGRESS

Copyright Office

37 CFR Part 253

[Docket No. 96–6 CARP NCBRA]

Noncommercial Educational

Broadcasting Compulsory License

AGENCY: Copyright Office, Library of

Congress.

ACTION: Notice of proposed rulemaking;

correction.

SUMMARY: This document clarifies the

dates for filing comments and Notices of

Intent to Participate published in the

Federal Register notice of December 1,

1997, announcing the proposed

rulemaking for adjusting the royalty

rates for the noncommercial educational

broadcasting compulsory license.

FOR FURTHER INFORMATION CONTACT:

Tanya M. Sandros, Attorney Advisor,

Copyright Arbitration Royalty Panel

(CARP), P.O. Box 70977, Southwest

Station, Washington, D.C. 20024.

Telephone (202) 707–8380. Telefax:

(202) 707–8366.

SUPPLEMENTARY INFORMATION: The notice

of proposed rulemaking concerning the

adjustment of royalty rates for

compulsory license governing the use of

certain copyrighted works in connection

with noncommercial broadcasting

contains two dates for filing comments

and Notices of Intent to Participate. The

correct date, December 29, 1997, is

announced in the date caption. The

second date, December 31, 1997, stated

in the section entitled, Comments and

Notices of Intent to Participate, page

63504, second column, first paragraph,