This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

38761

Vol. 63, No. 138

Monday, July 20, 1998

DEPARTMENT OF AGRICULTURE

Federal Crop Insurance Corporation

7 CFR Part 457

Common Crop Insurance Regulations;

Guaranteed Production Plan of Fresh

Market Tomato Crop Insurance

Provisions

AGENCY: Federal Crop Insurance

Corporation, USDA.

ACTION: Proposed rule.

SUMMARY: The Federal Crop Insurance

Corporation (FCIC) proposes to amend

the Guaranteed Production Plan of

Fresh Market Tomato Crop Insurance

Provisions to change the calendar date

for the end of the insurance period.

DATES: Written comments and opinions

on this proposed rule will be accepted

until close of business August 19, 1998

and will be considered when the rule is

to be made final.

ADDRESSES: Interested persons are

invited to submit written comments to

the Director, Product Development

Division, Federal Crop Insurance

Corporation, United States Department

of Agriculture, 9435 Holmes Road,

Kansas City, MO 64131. A copy of each

response will be available for public

inspection and copying from 7:00 a.m.

to 4:30 p.m., CDT, Monday through

Friday, except holidays, at the above

address.

FOR FURTHER INFORMATION CONTACT:

Louise Narber, Insurance Management

Specialist, Research and Development,

Product Development Division, Federal

Crop Insurance Corporation, at the

Kansas City, MO, address listed above,

telephone (816) 926–7730.

SUPPLEMENTARY INFORMATION:

Executive Order 12866

This rule has been determined to be

exempt for the purposes of Executive

Order 12866 and, therefore, has not

been reviewed by the Office of

Management and Budget (OMB).

Paperwork Reduction Act of 1995

Under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. chapter 35) there are no

information collection requirements

contained in this rule.

Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates

Reform of 1995 (UMRA) establishes

requirements for Federal agencies to

assess the effects of their regulatory

actions on State, local, and tribal

governments and the private sector.

This rule contains no Federal mandates

(under the regulatory provisions of title

II of UMRA) for State, local, and tribal

governments or the private sector.

Therefore, this rule is not subject to the

requirements of sections 202 and 205 of

UMRA.

Executive Order 12612

It has been determined under section

6(a) of Executive Order No. 12612,

Federalism, that this rule does not have

sufficient federalism implications to

warrant the preparation of a Federalism

Assessment. The provisions contained

in this rule will not have a substantial

direct effect on States or their political

subdivisions or on the distribution of

power and responsibilities among the

various levels of government.

Regulatory Flexibility Act

This regulation will not have a

significant economic impact on a

substantial number of small entities.

New provisions included in this rule

will not impact small entities to a

greater extent than large entities. The

amount of work required of the

insurance companies delivering and

servicing these policies will not increase

from the amount of work currently

required. Therefore, this action is

determined to be exempt from the

provisions of the Regulatory Flexibility

Act (5 U.S.C. 605) and no Regulatory

Flexibility Analysis was prepared.

Federal Assistance Program

This program is listed in the Catalog

of Federal Domestic Assistance under

No. 10.450.

Executive Order 12372

This program is not subject to the

provisions of Executive Order 12372

which require intergovernmental

consultation with State and local

officials. See the Notice related to 7 CFR

part 3015, subpart V, published at 48 FR

29115, June 24, 1983.

Executive Order 12988

This proposed rule has been reviewed

in accordance with Executive Order

12988 on civil justice reform. The

provisions of this rule will not have a

retroactive effect. The provisions of this

rule will preempt State and local laws

to the extent such State and local laws

are inconsistent herewith. The

administrative appeal provisions

published at 7 CFR part 11 must be

exhausted before any action for judicial

review of any determination made by

FCIC may be brought.

Environmental Evaluation

This action is not expected to have a

significant economic impact on the

quality of the human environment,

health, and safety. Therefore, neither an

Environmental Assessment nor an

Environmental Impact Statement is

needed.

Background

FCIC proposes to amend the Common

Crop Insurance Regulations (7 CFR part

457) by revising 7 CFR 457.128 effective

for the 1999 and succeeding crop years.

The only change to the provisions for

insuring guaranteed production plan of

fresh market tomatoes is to amend

section 10(b)(7) to change the calendar

date for the end of the insurance period

for certain states. The end of the

insurance period for Delaware,

Maryland, New Jersey, North Carolina,

and Virginia will be changed from

September 20 to October 15 of the crop

year. The end of the insurance period

for Florida, Georgia, and South Carolina

will be changed from September 20 to

November 10 of the crop year. A

September 20 ending date creates an

insurance period that is too short in

these states. Under the current crop

provisions, if the crop is planted during

the fall planting period in accordance

with the Special Provisions in effect for

the 1999 crop year, the crop will not

reach maturity before the end of the

insurance period. The proposed change

in the dates for the end of the insurance

period will allow for insurance coverage

from the time of planting until maturity

of the crop.

List of Subjects in 7 CFR Part 457

Crop insurance, Tomatoes.
38762 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Proposed Rules

Proposed Rule

Accordingly, as set forth in the

preamble, the Federal Crop Insurance

Corporation, proposes to amend 7 CFR

part 457 as follows:

PART 457—COMMON CROP

INSURANCE REGULATIONS;

REGULATIONS FOR THE 1998 AND

SUBSEQUENT CONTRACT YEARS

1. The authority citation for 7 CFR

part 457 continues to read as follows:

Authority: 7 U.S.C. 1506(l), 1506(p).

2. In § 457.128 revise section 10(b)(7)

to read as follows:

§ 457.128 Guaranteed Production Plan of

Fresh Market Tomato Crop Insurance

Provisions.

10. Insurance Period.

* * * * *

(b) * * *

(7) October 15 of the crop year in

Delaware, Maryland, New Jersey, North

Carolina, and Virginia; October 31 of the

crop year in California; November 10 of

the crop year in Florida, Georgia, and

South Carolina; and September 20 of the

crop year in all other states.

Signed in Washington, DC, on July 13,

1998.

Kenneth D. Ackerman,

Manager, Federal Crop Insurance

Corporation.

[FR Doc. 98–19245 Filed 7–17–98; 8:45 am]

BILLING CODE 3410–08–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 341

[Docket No. 76N–052T]

RIN 0910–AA01

Cold, Cough, Allergy, Bronchodilator,

and Antiasthmatic Drug Products for

Over-the-Counter Human Use;

Proposed Amendment of Final

Monograph for OTC Antitussive Drug

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a notice

of proposed rulemaking that would

amend the final monograph for over-thecounter (OTC) antitussive drug products

(drug products that relieve cough) to

revise the labeling warnings and

directions for topical/inhalant products

containing the active ingredients

camphor and/or menthol. New

information indicates that use of these

drug products near an open flame, in

hot water, or in a microwave oven can

cause the products to catch on fire and

cause serious burns to the user.

Therefore, the agency is proposing

warnings and directions for safer use of

these drug products by informing

consumers not to expose the products to

flame, hot water, or a microwave oven.

This proposal is part of the ongoing

review of OTC drug products conducted

by FDA.

DATES: Submit written comments by

October 19, 1998; written comments on

the agency’s economic impact

determination by October 19, 1998. FDA

is proposing that any final rule that may

issue based on this proposal become

effective 12 months after its date of

publication in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Elizabeth A. Ryland, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

9, 1976 (41 FR 38312 at 38343), the

Advisory Review Panel on OTC Cold,

Cough, Allergy, Bronchodilator, and

Antiasthmatic Drug Products (the Panel)

recommended that the single

ingredients camphor and menthol for

topical/inhalant antitussive use be

classified in Category III (available data

are insufficient to classify as safe and

effective, and further testing is

required). The Panel based its

recommendations on a lack of

effectiveness data, but determined that

these products are safe (41 FR 38312 at

38344 and 38349 to 38352). The Panel

was not aware of and did not discuss

any information concerning possible

safety hazards occurring when these

products are placed near a flame, into

containers of hot water, or in a

microwave oven. The Panel

recommended the following directions

for topical/inhalant use for camphor and

menthol:

* * * 1 tablespoonful of solution per quart

of water is added directly to the water in a

hot steam vaporizer, bowl, or washbasin; or

2 teaspoonfuls of solution per pint of water

are added to an open container of boiling

water. Breathe in vapors during the period of

medicated steam generation. May be repeated

3 times daily.

In the final monograph for OTC

antitussive drug products (52 FR 30042

at 30045 to 30046, August 12, 1987), the

agency provided the following

directions in § 341.74(d)(2)(i) and

(d)(2)(ii) (21 CFR 341.74(d)(2)(i) and

(d)(2)(ii)) for products containing the

single ingredient camphor or menthol

for ointment vehicle use based on

additional clinical studies that

supported effectiveness:

* * * Adults and children 2 to under 12

years of age: Rub on the throat and chest as

a thick layer. The area of application may be

covered with a warm, dry cloth if desired.

However, clothing should be left loose about

the throat and chest to help the vapors rise

to reach the nose and mouth. Applications

may be repeated up to three times daily or

as directed by a doctor. Children under 2

years of age: consult a doctor.

For products containing the single

ingredient camphor or menthol for

steam inhalation use, the agency

provided the following directions in

§ 341.74(d)(2)(iv) and (d)(2)(v), based on

additional clinical studies that

supported effectiveness:

* * * Adults and children 2 to under 12

years of age: Add 1 tablespoonful of solution,

for each quart of water, directly to the water

in a hot steam vaporizer, bowl, or wash

basin; or add 11⁄2 teaspoonsful of solution, for

each pint of water, to an open container of

boiling water. Breathe in the medicated

vapors. May be repeated up to three times

daily or as directed by a doctor. Children

under 2 years of age: consult a doctor.

When the final monograph was

published, the agency was not aware of

safety problems occurring when

products containing camphor and/or

menthol are added to hot water. Since

that time, the agency has received new

information (Refs. 1, 2, and 3) that

indicates that the current warnings and

directions may not be adequate and that

safety concerns (e.g., burns caused by

flashing) could arise if these products

are heated near an open flame, in a

container of hot water, or in a

microwave oven. From 1983 to mid1997, 34 fire-related events from usage

of antitussive drug products containing

camphor and menthol were reported

(Refs. 2 and 3). Twenty-one fire-related

events concerned a combination of

camphor and menthol in an ointment

vehicle. This product when added to

hot water in a container on the stove, or

when added to water and heated in a

microwave oven, caused flashing and

severe burns. One of the 21 events

involved adding the product to hot

water in a vaporizer. An additional 11

events concerned heating products that

were combinations of camphor and

menthol in an alcohol-based solution.

These products, like the products in the

ointment vehicles, also caused flashing

and burns when placed in hot water or