Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Proposed Rules 33595

PART 310—NEW DRUGS

1. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

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

371, 374, 375, 379e; 42 U.S.C. 216, 241,

242(a), 262, 263b-263n.

2. Section 310.545 is amended by

adding new paragraphs (a)(12)(iv)(C)

and (d)(30), and by revising paragraph

(d) introductory text to read as follows:

§ 310.545 Drug products containing active

ingredients offered over-the-counter (OTC)

for certain uses.

(a) * * *

(12) * * *

(iv)(C) Stimulant laxatives—

Approved as of (date of publication in

the Federal Register).

Aloe

Bisacodyl

Cascara sagrada in any form (e.g.,

casanthranol, cascara fluidextract

aromatic, cascara sagrada bark, cascara

sagrada extract, cascara sagrada

fluidextract)

Senna in any form (e.g., senna

fluidextract, senna fruit extract, senna

leaf powder, senna pod concentrate,

senna syrup, or sennosides A and B)

* * * * *

(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)(30) of this section.

* * * * *

(30) (Date 6 months after date of

publication in the Federal Register), for

products subject to paragraph

(a)(12)(iv)(C) of this section.

PART 334—LAXATIVE DRUG

PRODUCTS FOR OVER-THECOUNTER HUMAN USE

3. The authority citation for 21 CFR

part 334 is revised to read as follows:

Authority: 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 (a), (b), (c)(1)

through (c)(5), and (f) and redesignating

paragraphs (d) and (e) as paragraphs (a)

and (b), respectively.

§ 334.30 [Amended]

5. Section 334.30 Permitted

combinations of active laxative

ingredients is amended by removing and

reserving paragraphs (c), (e), (g), (h), and

(i).

§ 334.32 [Amended]

6. Section 334.32 Bowel cleansing

systems is amended by removing and

reserving paragraph (a).

§ 334.60 [Amended]

7. Section 334.60 Labeling of

stimulant laxative drug products is

amended by removing paragraphs (b)(3),

(d)(1) through (d)(7), (d)(10), and (d)(11),

by removing and reserving paragraph

(c), and by redesignating paragraphs

(d)(8) and (d)(9) as paragraphs (d)(1) and

(d)(2), respectively.

§ 334.66 [Amended]

8. Section 334.66 Labeling of bowel

cleansing systems identified in § 334.32

is amended in paragraph (a) by

removing ‘‘§ 334.32(a)’’ and adding in

its place ‘‘§ 334.32’’and by removing

and reserving paragraphs (c)(1) and

(d)(3)(iii)(A).

§ 334.80 [Amended]

9. Section 334.80 Professional

labeling is amended in paragraph (a)(2)

by removing the words ‘‘or bisacodyl

identified in § 334.18(b)’’, by removing

paragraphs (a)(4) and (c)(5) through

(c)(10), and by adding the word ‘‘or’’

after ‘‘§ 334.16(a)’’ in paragraph (a)(2),

and by redesignating paragraphs (c)(11),

(c)(12), and (c)(13) as paragraphs (c)(5),

(c)(6), (c)(7), respectively.

Dated: June 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16290 Filed 6–18–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[REG–209035–86]

RIN 1545–AI32

Foreign Liquidations and

Reorganizations

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Amendment to notice of

proposed rulemaking.

SUMMARY: This document removes from

an existing (1991) notice of proposed

rulemaking the special (August 26,

1991) effective date rule for the

definition of the all earnings and profits

amount. The IRS and the Treasury

Department believe that issues regarding

the all earnings and profits amount

should be studied; thus, when final

regulations under section 367(b) are

issued with respect to the all earnings

and profits amount, such regulations

will have a prospective effective date.

This modification may affect domestic

corporations in connection with an

acquisition of a foreign corporation in a

liquidation described in section 332 or

in an asset acquisition described in

section 368(a)(1)).

DATES: Written comments must be

received by September 17, 1998.

ADDRESSES: Send submissions to:

CC:DOM:CORP:R (REG–209035–86),

Room 5228, Internal Revenue Service,

POB 7604, Ben Franklin Station,

Washington, DC 20044. In the

alternative, submissions may be hand

delivered between the hours of 8 a.m.

and 5 p.m. to: CC:DOM:CORP:R (REG–

209035–86), Courier’s Desk, Internal

Revenue Service, 1111 Constitution

Ave. NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Philip L. Tretiak at (202) 622–3860 (not

a toll-free call).

SUPPLEMENTARY INFORMATION:

Background

Section 367(b) was enacted in its

current form by the Tax Reform Act of

1976. On December 27, 1977, proposed

and temporary regulations §§ 7.367(b)–1

through 7.367(b)–12 were adopted (TD

7530, 1978–1 C.B. 92). Prior to the

issuance of a notice of proposed

rulemaking in 1991 (the 1991 proposed

regulations), discussed below, the

regulations under section 367(b) were

amended on several occasions. The

1991 proposed regulations, which were

published in the Federal Register on

August 26, 1991 (56 FR 41993), propose

to completely revise the regulations

under section 367(b), as well as the

rules under section 367(a) with respect

to certain transfers of stock or securities

by U.S. persons to foreign corporations.

Section 1.367(b)–6(a) of the proposed

regulations provides that the rules

contained in the section 367(b)

proposed regulations will be effective

for exchanges that occur on or after the

date that is 30 days after final

regulations are published. However, an

exception to the general effective date

provides that § 1.367(b)–2(d) (relating to

the definition and computation of the

‘‘all earnings and profits amount’’) is

effective for exchanges that occur on or

after August 26, 1991.

A package of final regulations,

published elsewhere in this issue of the

Federal Register, contains final rules

with respect to the section 367(a)

portion of the 1991 proposed

regulations (to the extent that such rules

were not previously finalized) and final
33596 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Proposed Rules

rules with respect to the section 367(b)

portion of the 1991 proposed

regulations, but generally only to the

extent that a particular transaction is

subject to both sections 367(a) and (b).

The final regulations do not address the

all earnings and profits amount.

The IRS and the Treasury Department

believe that issues regarding the all

earnings and profits amount should be

studied before final regulations are

promulgated. Moreover, the IRS and the

Treasury Department believe that the

final regulations concerning the all

earnings and profits amount should not

be subject to a special effective date.

Thus, this notice of proposed

rulemaking removes from the 1991

proposed regulations the special

(August 26, 1991) effective date rule for

the definition of the all earnings and

profits amount. When final regulations

under section 367(b) are issued with

respect to the all earnings and profits

amount, such regulations will have a

prospective effective date.

Special Analysis

It has been determined that this notice

of proposed rulemaking is not a

significant regulatory action as defined

in Executive Order 12866. Therefore, a

regulatory assessment is not required. It

has also been determined that this

regulation does not have a significant

impact on small entities because this

regulation, which only contains a

limited effective date rule, impacts only

U.S. corporations with investments in

foreign corporations. Thus, the

Regulatory Flexibility Act (5 U.S.C.

chapter 6) does not apply to these

regulations, and therefore, a Regulatory

Flexibility Analysis is not required.

Pursuant to section 7805(f) of the

Internal Revenue Code, this notice of

proposed rulemaking will be submitted

to the Chief Counsel for Advocacy of the

Small Business Administration for

comment on its impact on small

business.

Comments

Before these proposed regulations are

adopted as final regulations,

consideration will be given to any

written comments (a signed original and

eight (8) copies) that are submitted

timely to the Internal Revenue Service.

All comments will be available for

public inspection and copying.

Drafting Information

The principal author of these

proposed regulations is Philip L. Tretiak

of the Office of Associate Chief Counsel

(International), IRS. However, other

personnel from the IRS and the Treasury

Department participated in their

development.

List of Subjects in 26 CFR Part 1

Income tax, Reporting and

recordkeeping requirements.

Proposed Amendments to the

Regulations

Accordingly, 26 CFR part 1 is

proposed to be amended as follows:

PART 1—INCOME TAXES

Paragraph 1. The authority citation

for part 1 continues to read in part as

follows:

Authority: 26 U.S.C. 7805. * * *

§ 1.367(b)–6 [Amended]

Par. 2. Section 1.367(b)–6, as

proposed to be added on Monday,

August 26, 1991 (56 FR 42015), is

amended by removing the last sentence

of paragraph (a).

Michael P. Dolan,

Deputy Commissioner of Internal Revenue.

[FR Doc. 98–15453 Filed 6–18–98; 8:45 am]

BILLING CODE 4830–01–U

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD07–98–033]

RIN 2115–AE46

Special Local Regulations; St. Johns

River, Jacksonville, Florida

AGENCY: Coast Guard, DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Coast Guard is proposing

to amend the permanent special local

regulations for the Annual Greater

Jacksonville Kingfish Tournament, by

increasing the size of the No Wake Zone

on the waters of the St. Johns River and

establishing the annual date of the event

during the second full week of July. The

increased size of the zone is needed to

safeguard the increasingly larger

number of participants and other vessels

transiting the St. Johns River and Sisters

Creek during the Annual Greater

Jacksonville Kingfish Tournament.

Vessel operators should use minimum

speed in this area to avoid creating

wakes, unless otherwise authorized by

the Captain of the Port.

DATES: Comments must be received on

or before July 9, 1998.

ADDRESSES: Comments may be mailed to

Commander, U.S. Coast Guard Group

Mayport, 4200 Ocean Street, Mayport,

FL 32233, or may be delivered to the

operations office at the same address

between 7:30 a.m. and 3:30 p.m.,

Monday through Friday, except federal

holidays. Comments will become a part

of the public docket and will be

available for copying and inspection at

the same address.

FOR FURTHER INFORMATION CONTACT:

Ensign Gary Watson, Group Mayport,

Tel: (904) 247–7318.

SUPPLEMENTARY INFORMATION:

Request for Comments

The Coast Guard encourages

interested persons to participate in this

rulemaking by submitting written views,

data, or arguments. Persons submitting

comments should include their names,

addresses, identify this rulemaking

(CGD07–98–033), and the specific

section of this proposal to which their

comments apply, and give reasons for

each comment.

The Coast Guard will consider all

comments received during the comment

period. The regulations may be changed

in view of the comments received. The

Coast Guard plans no public hearing.

Persons may request a public hearing by

writing to the address under ADDRESSES

and stating why a hearing would be

beneficial. The comment period of

twenty days is justified because the

persons affected by this rulemaking are

within the greater Jacksonville area and

additional efforts are being made to

notify that community of the

rulemaking so they may be able to

comment within the shortened period.

Background and Purpose

The event requiring this regulation is

the Annual Greater Jacksonville

Kingfish Tournament, which will be

held annually during the second full

week in July. It will begin in 1998 on

July 14 in the Sisters Creek Marina,

Sisters Creek, Jacksonville, Florida, at 6

a.m. and terminate at 4 p.m. each day

until July 19. Due to the large number

of participants and spectator craft, a

larger No Wake Zone has been proposed

on the waters of the St. Johns River

lying between the eastern boundary

formed by St. Johns River Lighted Buoy

7 position 30–23.56N, 081–23.04W, and

Lighted Buoy 8 position 30–24.03N,

081–23.01W, and the western boundary

formed by Lighted Buoy 25 position 30–

23.40N, 081–28.26W, and Short Cut

Light 26 position 30–23.46N, 081–

28.16W with the northern and southern

boundaries formed by the banks of the

St. Johns River and extended north from

the boundary formed by the St. Johns

River and the Intracoastal Waterway,

Sisters Creek, to Lighted Buoy 83 on the