33592 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Proposed Rules

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

Spruce Creek Airport

(Lat. 29°04′49′′ N, long. 81°03′27′′ W)

Ormond Beach Municipal Airport

(Lat. 29°18′04′′ N, long. 81°06′50′′ W)

That airspace extending upward from 700

feet or more above the surface of the earth

within a 10-mile radius of Daytona Beach

International Airport, within a 6.4-mile

radius of Spruce creek Airport and within a

7.3-mile radius of Ormond Beach Municipal

Airport.

* * * * *

Issued in College Park, Georgia, on June 10,

1998.

Nancy B. Shelton,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 98–16354 Filed 6–18–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 334

[Docket No. 78N–036L]

RIN 0910–AA01

Laxative Drug Products for Over-theCounter Human Use; Proposed

Amendment to the Tentative Final

Monograph

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is reopening the

administrative record and proposing to

amend the tentative final monograph

(proposed rule) for over-the-counter

(OTC) laxative drug products to

reclassify the stimulant laxative

ingredients aloe, bisacodyl, cascara

sagrada, and senna (including

sennosides A and B) from Category I

(generally recognized as safe and

effective and not misbranded) to

Category III (further testing is required).

FDA is issuing this proposed

rulemaking after considering data and

information on the safety of bisacodyl,

senna, and two related stimulant

laxative ingredients, danthron and

phenolphthalein. This proposal is part

of the ongoing review of OTC drug

products conducted by FDA.

DATES: Submit written comments by

September 17, 1998. Written comments

on the agency’s economic impact

determination by September 17, 1998.

New data by June 21, 1999. Comments

on the new data by August 19, 1999.

ADDRESSES: Submit written comments

and new data to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2307.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 21,

1975 (40 FR 12902), FDA published,

under § 330.10(a)(6) (21 CFR

330.10(a)(6)), an advance notice of

proposed rulemaking to establish a

monograph for OTC laxative,

antidiarrheal, emetic, and antiemetic

drug products, together with the

recommendations of the Advisory

Review Panel on OTC Laxative,

Antidiarrheal, Emetic, and Antiemetic

Drug Products (the Panel), which was

the advisory review panel responsible

for evaluating data on the active

ingredients in these classes. In the

advance notice of proposed rulemaking,

the Panel recommended Category I

status for the OTC stimulant laxative

ingredients aloe, bisacodyl, cascara

sagrada preparations, danthron,

phenolphthalein, and senna

preparations (40 FR 12902 at 12908 to

12910). The agency concurred with the

Panel’s Category I classification of these

ingredients in the tentative final

monograph published in the Federal

Register of January 15, 1985 (50 FR 2124

at 2152 to 2156).

II. Danthron and Phenolphthalein

In the Federal Register of September

2, 1997 (62 FR 46223), the agency

reopened the administrative record for

this rulemaking, discussed the

carcinogenic risk of danthron and

phenolphthalein, and proposed to

reclassify these two anthraquinone

laxative ingredients from Category I to

Category II (not generally recognized as

safe and effective or misbranded). The

agency is evaluating the data and

comments submitted in response to that

proposal and will discuss this subject

further in a future issue of the Federal

Register.

III. Bisacodyl

The FDA Center for Drug Evaluation

and Research (CDER) Carcinogenicity

Assessment Committee (CAC) has

recommended that the anthraquinone

laxatives (aloe, cascara sagrada, and

senna) and bisacodyl be tested in the

standard battery of genotoxicity tests

and under the test conditions by which

phenolphthalein was found to be

positive (Ref. 1). Phenolphthalein and

bisacodyl are diphenylmethane

derivatives with a similar chemical

structure and pharmacological

characteristics. The CAC recommended

the Syrian Hamster Embryo (SHE) cell

transformation assay as an early screen

for bisacodyl and, based on its results,

either the p53 transgenic mouse assay or

another in vivo alternative assay, as

appropriate, follow. Two-year

carcinogenicity studies would then be

contingent upon the results of these

assays.

The agency has informed industry

that additional testing for bisacodyl will

be necessary (Ref. 2). Subsequently,

industry submitted data from two

mutagenicity studies (Ames test and rat

bone marrow micronucleus assay) and a

chromosomal aberration study in

Chinese hamster ovary cells. The agency

has reviewed these studies and

determined that the results of all of the

tests were negative (Ref. 3).

Phenolphthalein was tested in two of

these tests and was found negative in

one (Ames test). However, findings from

further studies indicated that

phenolphthalein presents a potential

carcinogenic risk. Thus, because of the

chemical similarity of bisacodyl to

phenolphthalein and the lack of

previous carcinogenicity testing of

bisacodyl, the agency is requesting that

bisacodyl undergo further testing to

assess its carcinogenic potential.

Industry has completed dose range

finding studies intended to select

bisacodyl doses for a 6-month oral

gavage carcinogenicity study in the p53

transgenic mouse (Ref. 4).

IV. Senna

The agency has reviewed metabolic,

genotoxicity, and carcinogenicity data

on senna and its components (Ref. 5).

Senna contains a number of

components, including but not limited

to: Sennosides A and B, sennosides C

and D, rhein (including rhein anthrone8-monoglucoside and rhein-8-

monoglucoside), chrysophanol, emodin,

and aloe-emodin. The metabolic studies

show that varying amounts of senna and

its metabolites are absorbed into the
Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Proposed Rules 33593

systemic circulation. The data do not

present conclusive absorption

information, nor indicate whether any

of the metabolites present a safety

hazard, if absorbed.

The agency believes that there are

sufficient mutagenicity (Ames test) data

in the literature on the senna extracts

sennosides A and B, aloe-emodin,

chrysophanol, and emodin. The data

indicate that sennosides A and B are

negative, while the senna extracts aloeemodin, emodin, and chrysophanol are

positively genotoxic (Ref. 5). Thus,

senna preparations containing any of

these components (or kaempferol or

quercetin) may have mutagenic

properties. These potentially mutagenic

anthrones are found in the dried leaves

and pods of senna. Therefore, until

manufacturers can show that

commercially available senna

preparations do not contain mutagenic/

genotoxic components, the agency is

unable to state that sennosides A and B

do not pose a relative risk to humans.

The agency also reviewed a 2-year

carcinogenicity study with sennosides

in the rat (Ref. 6). However, the agency

found this study deficient because of the

limited and incomplete histopathologic

examination of tissues (Ref. 5). The

agency concludes that further testing is

necessary to assess the carcinogenic

potential of senna products. In these

studies, specific analysis of the test

substance should be done to enable

quantitative estimation of each

component of the preparation. The

senna dose selection should be based on

a 1-month dose ranging study for an

alternative assay or a 3-month dose

ranging study for a 2-year

carcinogenicity study in the rodent

species and strains selected for the

carcinogenicity studies. Histopathologic

examination of all tissues from all

groups of animals should be conducted

(Ref. 5).

V. Aloe and Cascara Sagrada

Preparations

Aloe and cascara sagrada are other

anthraquinone ingredients. Cascara

sagrada ingredients included in the

tentative final monograph are

casanthranol, cascara fluidextract

aromatic, cascara sagrada bark, cascara

sagrada extract, and cascara sagrada

fluidextract (50 FR 2124 at 2152). The

agency has not received any

mutagenicity, genotoxicity, or

carcinogenicity data for these

ingredients. The agency concludes that

these ingredients need to have these

types and other toxicity data using tests

similar to those used and found positive

for phenolphthalein.

VI. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Comment No. MM13, Docket No. 78N–

036L, Dockets Management Branch.

2. Letter from D. Bowen, FDA, to R. W.

Soller, Nonprescription Drug Manufacturers

Association (NDMA), coded LET111, Docket

No. 78N–036L, Dockets Management Branch.

3. Letter from D. Bowen, FDA, to L.

Totman, NDMA, coded LET175, Docket No.

78N–036L, Dockets Management Branch.

4. Comment No. C178, Docket No. 78N–

036L, Dockets Management Branch.

5. Letter from D. Bowen, FDA, to J.

Conover, The Purdue Frederick Co., coded

LET173, Docket No. 78N–036L, Dockets

Management Branch.

6. Comment No. LET113, Docket No. 78N–

036L, Dockets Management Branch.

VII. Summary of the Agency’s Changes

to the Proposed Rule

The agency is proposing to reclassify

the stimulant laxative ingredients aloe,

bisacodyl, cascara sagrada (including

casanthranol), and senna (including

sennosides A and B) from Category I

(monograph) to Category III (more data

needed). The agency recommends that

persons interested in testing these drugs

consult the agency about

carcinogenicity study requirements and

protocols before initiating any studies. If

these data are not provided or are

inadequate for any of these ingredients,

these ingredients will be placed in

Category II (nonmonograph) in a final

rule. The agency will add any of these

ingredients that become nonmonograph

to the list of stimulant laxatives in

§ 310.545(a)(12)(iv) (21 CFR

310.545(a)(12)(iv)) in new

§ 310.545(a)(12)(iv)(C). The agency will

also amend proposed §§ 334.18, 334.30,

334.32, 334.60, 334.66, and 334.80 to

remove any of these ingredients and

their labeling if any of these ingredients

are not included in the final monograph.

VIII. Analysis of Impacts

FDA has examined the impacts of this

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612). 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). Under the

Regulatory Flexibility Act, if a rule has

a significant economic impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

impact of the rule on small entities.

Title II of the Unfunded Mandates

Reform Act (2 U.S.C. 1501 et seq.)

requires that agencies prepare a written

statement and economic analysis before

proposing any rule that may result in an

expenditure in any 1 year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation).

The agency believes that this

proposed rule is consistent with the

principles set out in the Executive Order

and in these two statutes. The purpose

of this proposed rule is to establish

conditions under which the OTC

stimulant laxative ingredients aloe,

bisacodyl, cascara sagrada, and senna

are or are not generally recognized as

safe and effective. If the ingredients are

determined to be safe and effective, no

product reformulation will be necessary.

If the ingredients are not determined to

be safe and effective, product

reformulation will be needed. There are

a number of other laxative ingredients

in proposed part 334 (50 FR 2124 at

2152) or one of these ingredients, if

found safe and effective, that could be

used if product reformulation becomes

necessary.

The cost to reformulate a product will

vary greatly depending on the nature of

the change in formulation, the product,

the process, and the size of the firm.

Because of the large number of

monograph active ingredients available

for substitution, no manufacturer should

need to change its dosage form;

however, a manufacturer would have to

redo the validation (product, process,

new supplier), conduct stability tests,

change master production records, and,

for some dosage forms, conduct

palatability tests. Competitive market

forces and increased public awareness

of a potential safety hazard of these

ingredients would most likely lead all

manufacturers to move to alternative

products over time.

Manufacturers of these products will

also incur costs to relabel their products

to reflect the new formulation. The

agency obtained estimates of relabeling

costs for the type of changes required by

this proposed rule ranging from $2,700

to $10,000 per standard stock keeping

unit (SKU) (individual products,

packages, and sizes) for nationally

branded products and from $500 to

$1,500 per SKU for private label

products. The agency estimates the

number of SKU’s that will need to be

relabeled as a result of reformulation as

between 500 and 1,000, depending if
33594 Federal Register / Vol. 63, No. 118 / Friday, June 19, 1998 / Proposed Rules

some or all of the involved ingredients

are not included in the final monograph

for OTC laxative drug products. Most of

these label changes will be made by

private label manufacturers that tend to

use simpler and less expensive labeling.

Finally, some manufacturers that do

not reformulate and validate their

products by the effective date of the

final rule may incur a loss of revenue.

Nevertheless, because of the large

number of substitute products that are

available, many in the same dosage

form, there should be no significant

drop in the overall consumption of

laxative drug products. Some

manufacturers already have other

laxative products. If products need to be

reformulated eventually, manufacturers

will be able to retain the same brand

names. Consumer loyalty to these

brands should lessen the revenue losses

to these firms.

Because these products must be

manufactured in compliance with the

pharmaceutical current good

manufacturing practices (21 CFR parts

210 and 211), all firms have the

necessary skills and personnel to

perform the tasks of reformulation,

validation, and relabeling either inhouse or by contractual arrangement.

The rule will not require any new

reporting and recordkeeping activities.

No additional professional skills are

needed. There are no other Federal rules

that duplicate, overlap, or conflict with

this rule.

Small business impact. The U.S.

Small Business Administration

designates an entity as small if it

employs less than 750 employees. The

agency does not believe that any small

firms will be conducting genotoxicity or

carcinogenicity studies on any of the

laxative ingredients included in this

proposal. Small firms that may have to

reformulate their products could incur

significant costs as a result of this rule.

The agency is attempting to reduce this

burden by keeping industry informed of

the findings of new research on these

products through public meetings and

letters to manufacturers of products

containing these ingredients. In this

manner, manufacturers should be aware

of which ingredients are likely to be

included or excluded from the final

monograph and can make their

marketing decisions accordingly.

The agency considered but rejected

the following alternatives: (1) Fewer

testing requirements, and (2) an

exemption from coverage for small

entities. The agency does not consider

either of these approaches acceptable

because they do not assure that

consumers will have safe and effective

OTC laxative drug products at the

earliest possible time. The agency does

not believe that there are any significant

alternatives to the proposed rule that

would adequately provide for the safe

and effective use of these OTC drug

products.

The agency expects that this proposed

rule will not be economically significant

under Executive Order 12866, nor

would it impose an Unfunded Mandate

(as that term is described in the

Unfunded Mandate Act). The agency

also believes that it is undertaking steps

to reduce the burden to small entities.

Nevertheless, some entities may incur

significant impacts, especially

manufacturers that may have to

reformulate their products and, to a

lesser extent, private label

manufacturers that provide labeling for

a number of the affected products. Thus,

this economic analysis, together with

other relevant sections of this

document, serves as the agency’s initial

regulatory flexibility analysis, as

required under the Regulatory

Flexibility Act.

Finally, the agency specifically invites

public comment regarding any

substantial or significant economic

impact that this rulemaking would have

on OTC laxative drug products

containing aloe, bisacodyl, cascara

sagrada, and senna, particularly the

costs associated with reformulation.

Comments regarding the impact of this

rulemaking on OTC laxative drug

products containing any of these

ingredients should be accompanied by

appropriate documentation. The agency

will evaluate any comments and

supporting data that are received and

will reassess the economic impact of

this rulemaking in the preamble to the

final rule.

IX. 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)).

X. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that is categorically excluded from the

preparation of an environmental

assessment because these actions, as a

class, will not result in the production

or distribution of any substance and

therefore will not result in the

production of any substance into the

environment.

XI. Request for Comments

Interested persons may, on or before

September 17, 1998, submit written

comments on the proposed regulation to

the Dockets Management Branch

(address above). Written comments on

the agency’s economic impact

determination may be submitted on or

before September 17, 1998. Three copies

of all 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 and may be accompanied by

a supporting memorandum or brief.

Received comments may be seen in the

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

Monday through Friday.

Interested persons may also submit

new data demonstrating the safety of

any of those conditions not classified in

Category I on or before June 21, 1999.

Written comments on the new data may

be submitted on or before August 19,

1999. Three copies of all data and

comments should be submitted as stated

previously, and received data and

comments may be seen as stated

previously. In establishing a final

monograph, the agency will ordinarily

consider only data submitted prior to

the closing of the administrative record

on August 19, 1999. Data submitted

after the closing of the administrative

record will be reviewed by the agency

only after a final monograph is

published in the Federal Register,

unless the Commissioner of Food and

Drugs finds good cause has been shown

that warrants earlier consideration.

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), September 2, 1993

(58 FR 46589), and September 2, 1997

(62 FR 46223)) be amended as follows:
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