Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Proposed Rules 46227

the concerns associated with

phenolphthalein. Finally, the agency

considers the phenolphthalein portion

of this proposed rule to be a pressing

public health concern because the

ingredient is still being used in some

drug products and genetic damage and

risk of malignancy could occur at doses

that are likely to be used by humans.

FDA therefore finds that there is good

cause for a 30-day comment period and

an immediate effective date.

VIII. Paperwork Reduction Act of 1995

FDA tentatively concludes that

labeling requirements related to this

proposed rule are not subject to review

by the Office of Management and

Budget because they do not constitute a

‘‘collection of information’’ under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.). Rather, this

proposed rulemaking involves labeling

that is a ‘‘public disclosure of

information originally supplied by the

Federal government to the recipient for

the purpose of disclosure to the public’’

(5 CFR 1320.3(c)(2)).

IX. Environmental Impact

The agency has determined under 21

CFR 25.24(c)(6) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

X. Request for Comments

Interested persons may, on or before

October 2, 1997 submit written

comments on this proposed rule to the

Dockets Management Branch (address

above). Written comments on the

agency’s economic impact

determination may be submitted on or

before October 2, 1997 Three copies of

all comments or objections are to be

submitted, except that individuals may

submit one copy. Comments should be

identified with the docket number

found in brackets in the heading of this

document and may be accompanied by

a supporting memorandum or brief.

Received comments and objections may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

List of Subjects

21 CFR Part 310

Administrative practice and

procedure, Drugs, Labeling, Medical

devices, Reporting and recordkeeping

requirements.

21 CFR Part 334

Labeling, Over-the-counter drugs.

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 parts 310 and 334 (as proposed

in the Federal Register of January 15,

1985 (50 FR 2124)) be amended as

follows:

PART 310—NEW DRUGS

1. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 512–516, 520, 601(a), 701, 704,

705, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 355, 356, 357, 360b–360f, 360j, 361(a),

371, 374, 375, 379e); secs. 215, 301, 302(a),

351, 354–360F of the Public Health Service

Act (42 U.S.C. 216, 241, 242(a), 262, 263b–

263n).

2. Section 310.545 is amended by

redesignating the text of paragraph

(a)(12)(iv) as (a)(12)(iv)(A), by adding

new (a)(12)(iv)(B) heading and

paragraphs (a)(12)(iv)(B) and (d)(29),

and by revising paragraph (d)

introductory text and paragraph (d)(1) to

read as follows:

§ 310.545 Drug products containing

certain active ingredients offered over-thecounter (OTC) for certain uses.

(a) * * *

(12) * * *

(iv)(A) Stimulant laxatives—

Approved as of May 7, 1991. * * *

(B) Stimulant laxatives—Approved as

of (date of publication in the Federal

Register).

Danthron

Phenolphthalein

* * * * *

(d) Any OTC drug product that is not

in compliance with this section is

subject to regulatory action if initially

introduced or initially delivered for

introduction into interstate commerce

after the dates specified in paragraphs

(d)(1) through (d)(29) of this section.

(1) May 7, 1991, for products subject

to paragraphs (a)(1) through (a)(2)(i),

(a)(3) through (a)(4), (a)(6)(i)(A),

(a)(6)(ii)(A), (a)(7) (except as covered by

paragraph (d)(3) of this section), (a)(8)(i),

(a)(10)(i) through (a)(10)(iii), (a)(12)(i)

through (a)(12)(iv)(A), (a)(14) through

(a)(15)(i), and (a)(16) through (a)(18) of

this section.

* * * * *

(29) September 2, 1997 for products

subject to paragraph (a)(12)(iv)(B) of this

section.

PART 334—LAXATIVE DRUG

PRODUCTS FOR OVER-THECOUNTER HUMAN USE

3. The authority citation for 21 CFR

part 334 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

§ 334.18 [Amended]

4. Section 334.18 Stimulant laxative

active ingredients is amended by

removing paragraphs (e) and (g) and

redesignating paragraphs (f) and (h) as

paragraphs (e) and (f), respectively.

§ 334.30 [Amended]

5. Section 334.30 Permitted

combinations of active laxative

ingredients is amended by removing

paragraph (e)(4) and removing and

reserving paragraph (h)(2).

§ 334.32 [Amended]

6. Section 334.32 Bowel cleansing

systems is amended by removing and

reserving paragraph (b).

§ 334.60 [Amended]

7. Section 334.60 Labeling of

stimulant laxative drug products is

amended by removing paragraph (c)(2)

and redesignating paragraph (c)(3) as

paragraph (c)(2) and by removing

paragraphs (d)(9) and (d)(11) and

redesignating paragraphs (d)(10),

(d)(12), and (d)(13) as paragraphs (d)(9),

(d)(10), and (d)(11), respectively.

§ 334.66 [Amended]

8. Section 334.66 Labeling of bowel

cleansing systems identified in § 334.32

is amended by removing the words ‘‘and

(b)’’ in paragraph (a) and by removing

and reserving paragraphs (c)(2) and

(d)(3)(iii)(B).

Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23122 Filed 8–29–97; 8:45 am]

BILLING CODE 4160–01–F

NATIONAL INDIAN GAMING

COMMISSION

25 CFR Part 502

Indian Gaming Regulatory Act of 1988;

Definitions

AGENCY: National Indian Gaming

Commission.

ACTION: Advance notice of proposed

rulemaking.
46228 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Proposed Rules

SUMMARY: This notice announces the

initiation of the rulemaking process and

requests information relevant to

amending the National Indian Gaming

Commission’s (NIGC) definition

regulations located at 25 CFR 502.7 and

502.8. These regulations define key

terms in the Indian Gaming Regulatory

Act of 1988. The regulations are

intended to provide guidance to tribes,

their attorneys, enforcement personnel

and others interested in Indian gaming.

The Commission is inviting the public

to comment and assist the NIGC in

determining the need, if any, for

additional rules governing this area.

DATES: Comments in response to this

advance notice must be submitted by

November 3, 1997.

ADDRESSES: Commenters may submit

their comments by mail, facsimile, or

delivery to: Definition Rule Comments,

National Indian Gaming Commission,

Suite 9100, 1441 L Street NW.,

Washington, DC 20005. Fax number:

202–632–7066 (not a toll-free number).

Public comments may be delivered or

inspected from 9 a.m. until noon and

from 2 p.m. to 5 p.m. Monday through

Friday.

FOR FURTHER INFORMATION CONTACT:

Darla M. Silva at 202–632–7003, or by

facsimile at 202–632–7066 (not toll-free

numbers).

SUPPLEMENTARY INFORMATION:

1. Introduction

The Indian Gaming Regulatory Act

(IGRA, or the Act), 25 U.S.C. § 2701 et

seq., was signed into law on October 17,

1988. The Act established the National

Indian Gaming Commission (the

Commission). IGRA was enacted to

establish a comprehensive system for

regulating gambling activities on Indian

lands. IGRA divides gaming into three

categories or classes. Class I gaming

consists of social gaming for minimal

prizes and traditional gaming and is

regulated exclusively by the tribes. 25

U.S.C. 2703(6), 2710(a)(1). Class II

gaming consists of bingo, pull-tabs,

bingo-like games, and non-banking card

games. 25 U.S.C. 2703(7)(A). A tribe

may conduct, license, and regulate class

II gaming if: (1) The state in which the

tribe is located permits such gaming for

any purpose by any person,

organization, or entity; and (2) the

governing body of the tribe adopts a

gaming ordinance which is approved by

the Chairman of the National Indian

Gaming Commission. 25 U.S.C. 2710

(a)(2) and (b).

All forms of gaming not included in

either class I or class II, such as banking

card games (e.g., blackjack), casino

games, slot machines, and electronic

facsimiles of any game of chance are

designated as class III gaming under the

IGRA. 25 U.S.C. 2703(8). Class III

gaming may lawfully be conducted by

an Indian tribe if: (1) The state in which

the tribe is located permits such gaming

for any purpose by any person,

organization, or entity; (2) the tribe and

the state have negotiated a tribal-state

compact which has been approved by

the Secretary of the Interior; and (3) the

tribe has adopted a gaming ordinance

which has been approved by the

Chairman of the Commission. 25 U.S.C.

2710(d)(1).

The IGRA expressly authorizes the

Commission to ‘‘promulgate such

regulations and guidelines as it deems

appropriate to implement the provisions

of this [Act].’’ 25 U.S.C. 2706(b)(10). On

April 9, 1992, the Commission

published final rules (57 FR 12392)

defining key statutory terms, including

‘‘electronic, computer or other

technologic aid’’ and ‘‘electronic or

electromechanical facsimile’’. The

current definitions are as follows:

Electronic, computer or other technologic

aid means a device such as a computer,

telephone, cable, television, satellite or bingo

blower and that when used—

(a) Is not a game of chance but merely

assist a player or the playing of a game;

(b) Is readily distinguishable from the

playing of a game of chance on an electronic

or electromechanical facsimile; and

(c) Is operated according to applicable

Federal communications law. 25 CFR 502.7.

Electronic or Electromechanical facsimile

means any gambling device as defined in 15

U.S.C. § 1171(a) (2) or (3). 25 CFR 502.8.

Since the adoption of these

regulations, there has been controversy

regarding what constitutes an ‘‘aid’’ and

a ‘‘facsimile’’ and the difference

between them. The Commission is

requesting public comments to assist in

its evaluation of whether amendment of

its current regulations is necessary.

2. Advance Notice of Proposed

Rulemaking

After consideration of this issue, the

NIGC has determined that the

appropriate course of action is to

publish an Advance Notice of Proposed

Rulemaking to collect further

information. Concurrently with the

collection of this information, the

Agency will enforce existing

regulations.

The issue of how best to amend the

current regulations, if at all, is a

question with implications for tribal

governments, state governments and

other Federal officials. Before the

Commission proceeds in this area, it

intends to have the benefit of a full

airing of the issues through the public

comment process.

3. Request for Comments

Public comment is requested to assist

the NIGC in its evaluation of the

decision to amend its current definition

regulations. Comment is requested on

the following issues:

(1) The effectiveness of the current

regulations is distinguishing between a

class II aid and a class III facsimile;

(2) Any suggestions for alternative

definitions and/or interpretations.

4. Public Participation

Interested parties are invited to

submit comments on any or all of these

and other pertinent issues related to

amending the current definition

regulations by November 3, 1997, in

quadruplicate to the Definition Rule

Comments, National Indian Gaming

Commission, Suite 9100, 1441 L Street

NW., Washington, DC 20005. Fax

number: 202–632–7066 (not a toll-free

number). All written comments

submitted in response to this notice will

be available for inspection and copying

in the NIGC office from 9 a.m. until

noon and from 2 p.m. to 5 p.m. Monday

through Friday. All timely written

submissions will be considered in

determining the nature of any proposal.

Authority and Signature

This advance notice of proposed

rulemaking was prepared under the

direction of Tom Foley, Vice Chairman,

National Indian Gaming Commission,

1441 L St., NW., Suite 9100,

Washington, DC 20005.

Signed at Washington, DC this 21st day of

August, 1997.

Tom Foley,

Vice Chairman, National Indian Gaming

Commission.

[FR Doc. 97–22725 Filed 8–29–97; 8:45 am]

BILLING CODE 7565–01–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[MD040–3018b; FRL–5881–7]

Approval and Promulgation of Air

Quality Implementation Plans;

Maryland; Control of Volatile Organic

Compound Emissions From Sheet-Fed

and Web Lithographic Printing and

Paper Coatings

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to approve the

State Implementation Plan (SIP)

revision submitted by the State of