19798 Federal Register / Vol. 63, No. 77 /Wednesday, April 22, 1998 /Rules and Regulations

action is warranted to relieve

restrictions.

Because prior notice and other public

procedures with respect to this action

are impracticable and contrary to the

public interest under these conditions,

we find good cause under 5 U.S.C. 553

to make it effective upon signature. We

will consider comments that are

received within 60 days of publication

of this rule in the Federal Register.

After the comment period closes, we

will publish another document in the

Federal Register. It will include a

discussion of any comments we receive

and any amendments we are making to

the rule as a result of the comments.

Executive Order 12866 and Regulatory

Flexibility Act

This rule has been reviewed under

Executive Order 12866. For this action,

the Office of Management and Budget

has waived its review process required

by Executive Order 12866.

This interim rule amends the Medfly

regulations by removing an area in

Hillsborough County, FL, from

quarantine for Medfly. This action

affects the interstate movement of

regulated articles from this area. There

are approximately 292 small entities

that could be affected, including 3

transportation terminals, 65 fruit stands,

36 flea markets, 39 farmers markets, 134

food stores, and 15 garbage service

firms.

These small entities comprise less

than 1 percent of the total number of

similar small entities operating in the

State of Florida. In addition, most of

these small entities sell regulated

articles primarily for local intrastate, not

interstate movement, and the sale of

these articles would not be affected by

this interim rule.

Therefore, termination of the

quarantine in Hillsborough County, FL,

should have a minimal economic effect

on the small entities operating in this

area. We anticipate that the economic

impact of lifting the quarantine, though

positive, will be no more significant

than was the minimal impact of its

imposition.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action will not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

Executive Order 12988

This rule has been reviewed under

Executive Order 12988, Civil Justice

Reform. This rule: (1) Preempts all State

and local laws and regulations that are

inconsistent with this rule; (2) has no

retroactive effect; and (3) does not

require administrative proceedings

before parties may file suit in court

challenging this rule.

Paperwork Reduction Act

This rule contains no new

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

List of Subjects in 7 CFR Part 301

Agricultural commodities,

Incorporation by reference, Plant

diseases and pests, Quarantine,

Reporting and recordkeeping

requirements, Transportation.

Accordingly, 7 CFR part 301 is

amended as follows:

PART 301—DOMESTIC QUARANTINE

NOTICES

1. The authority citation for part 301

continues to read as follows:

Authority: 7 U.S.C. 147a, 150bb, 150dd,

150ee, 150ff, 161, 162, and 164–167; 7 CFR

2.22, 2.80, and 371.2(c).

2. Section 301.78–3, paragraph (c), is

revised to read as follows:

§ 301.78–3 Quarantined areas.

* * * * *

(c) The areas described below are

designated as quarantined areas:

Mediterranean fruit fly is not known to

exist in the continental United States.

Done in Washington, DC, this 17th day of

April 1998.

Charles P. Schwalbe,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 98–10661 Filed 4–21–98; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–CE–98–AD; Amendment 39–

10367; AD 98–05–06]

RIN 2120–AA64

Airworthiness Directives; Pilatus

Aircraft Ltd. Model PC–12 Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Direct final rule; confirmation of

effective date.

SUMMARY: This action confirms the

effective date of Airworthiness Directive

(AD) 98–05–06, which applies to Pilatus

Aircraft Ltd. (Pilatus) Model PC–12

airplanes. AD 98–05–06 requires

inspecting the elevator for incorrect

rivet lengths and installing new rivets if

incorrect rivet lengths are found. This

AD also requires inspecting the elevator

to assure that an excessive gap (more

than .004 inches or .1 millimeters (mm))

does not exist in the rivet shanks, and

installing a shim between the rib and

skin to fill any excessive gap. This AD

is the result of mandatory continuing

airworthiness information (MCAI)

issued by the airworthiness authority for

Switzerland. The actions specified in

this AD are intended to prevent fatigue

damage to the elevator, which could

result in structural failure and eventual

loss of control of the airplane.

EFFECTIVE DATE: May 29, 1998.

FOR FURTHER INFORMATION CONTACT: Mr.

Roman T. Gabrys, Aerospace Engineer,

Small Airplane Directorate, Airplane

Certification Service, FAA, 1201

Walnut, suite 900, Kansas City, Missouri

64106; telephone: (816) 426–6932;

facsimile: (816) 426–2169.

SUPPLEMENTARY INFORMATION: The FAA

published this direct final rule with

request for comments in the Federal

Register on March 3, 1998 (63 FR

10299). The FAA uses the direct final

rulemaking procedure for a noncontroversial rule where the FAA

anticipates that there will be no adverse

public comment. This direct final rule

advised the public that no adverse

comments were anticipated, and that

unless a written adverse comment, or a

written notice of intent to submit such

an adverse comment, was received

within the comment period, the

regulation would become effective on

May 29, 1998. No adverse comments

were received, and thus this notice

confirms that this final rule will become

effective on that date.
Federal Register / Vol. 63, No. 77 /Wednesday, April 22, 1998 /Rules and Regulations 19799

Issued in Kansas City, Missouri, on April

14, 1998.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certfication Service.

[FR Doc. 98–10596 Filed 4–21–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket Nos. 75N–183F, 75N–183D, and

80N–0280]

RIN 0910–AA01

Status of Certain Additional Over-theCounter Drug Category II and III Active

Ingredients

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule stating that certain ingredients in

over-the-counter (OTC) drug products

are not generally recognized as safe and

effective or are misbranded. FDA is

issuing this final rule after considering

the reports and recommendations of

various OTC drug advisory review

panels and public comments on

proposed agency regulations, which

were issued in the form of a tentative

final monograph (proposed rule). Based

on the absence of substantive comments

in opposition to the agency’s proposed

nonmonograph status for these

ingredients, as well as the failure of

interested parties to submit new data or

information to FDA under the

regulation, the agency has determined

that the presence of these ingredients in

an OTC drug product would result in

that drug product not being generally

recognized as safe and effective or

would result in misbranding. This final

rule is part of the ongoing review of

OTC drug products conducted by FDA.

DATES: Effective October 19, 1998.

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 November

7, 1990 (55 FR 46914), FDA published

under § 330.10(a)(7)(ii) (21 CFR

330.10(a)(7)(ii)), a final rule on the

status of certain OTC drug Category II

and III active ingredients. That final rule

declared as not generally recognized as

safe and effective certain active

ingredients that had been proposed as

nonmonograph (Category II or Category

III) under the agency’s OTC drug review.

The periods for submission of

comments and new data following the

publication of a notice of proposed

rulemaking (NPRM) had closed and no

significant comments or new data had

been submitted to upgrade the status of

these ingredients. In each instance, a

final rule for the class of ingredients

involved had not been published to

date.

In the Federal Register of May 10,

1993 (58 FR 27636), FDA published a

final rule establishing that certain

additional active ingredients in OTC

drug products are not generally

recognized as safe and effective or are

misbranded. That final rule included

active ingredients from a number of

OTC drug rulemakings that were not

covered by the November 7, 1990, final

rule. (See Table I (58 FR 27636 at 27639

to 27641) for a list of OTC drug

rulemakings and active ingredients

covered by that final rule.)

At that time, there were other OTC

drug review rulemakings for which the

period for submission of comments and/

or new data was still pending. Those

periods have now closed, and there are

a number of active ingredients for which

no significant comments or new data

were submitted. In each instance, a final

rule for the class of ingredients involved

has not been published to date. This

final rule addresses some of the

Category II and Category III active

ingredients in those classes of

ingredients, specifically active

ingredients considered in the

rulemakings for OTC vaginal

contraceptive, first aid antiseptic, and

antimicrobial diaper rash drug products.

In the advance notice of proposed

rulemaking (ANPRM) for OTC vaginal

contraceptive drug products (45 FR

82014, December 12, 1980), the

Advisory Review Panel on OTC

Contraceptives and Other Vaginal Drug

Products placed phenylmercuric acetate

and phenylmercuric nitrate in Category

II for safety and placed dodecaethylene

glycol monolaurate (polyethylene glycol

600 monolaurate), laureth 10S, and

methoxypolyoxyethyleneglycol 550

laurate in Category III for efficacy. In the

tentative final monograph (TFM) for

OTC vaginal contraceptive drug

products (60 FR 6892, February 3,

1995), the agency proposed that all of

these ingredients be nonmonograph. In

response to this TFM (NPRM), the

agency received no comments or data

relating to the safety and effectiveness of

these ingredients.

In the ANPRM for mercury-containing

drug products for OTC topical

antimicrobial use (47 FR 436, January 5,

1982), the Advisory Review Panel on

OTC Miscellaneous External Drug

Products placed all mercury compounds

in Category II for topical antimicrobial

use. This included the following

ingredients: Ammoniated mercury;

calomel (mercurous chloride);

merbromin (mercurochrome); mercuric

chloride (bichloride of mercury,

mercury chloride); mercufenol chloride

(ortho-chloromercuriphenol, orthohydroxyphenylmercuric chloride);

mercuric salicylate; mercuric sulfide

(red mercuric sulfide); mercuric oxide,

yellow; mercury; mercury chloride;

mercury oleate; nitromersol; parachloromercuriphenol; phenylmercuric

nitrate; thimerosal; vitromersol; and

zyloxin. In the NPRM for OTC first aid

antiseptic drug products (56 FR 33644,

July 22, 1991), the agency proposed that

all of these ingredients were either

Category II or Category III. In response

to this NPRM, the agency received no

comments or data relating to the safety

and effectiveness of these ingredients.

In an amendment to the proposed

rulemaking for OTC topical

antimicrobial drug products (55 FR

25246, June 20, 1990), the agency

proposed that p-chloromercuriphenol

and all other ingredients containing

mercury were Category II for the

treatment and prevention of diaper rash.

In response to this NPRM, the agency

received no comments or data relating

to the safety and effectiveness of these

ingredients.

II. Affected Rulemakings and Category

II and III Ingredients

Table I of this document lists the titles

and docket numbers of the specific

rulemakings containing active

ingredients that are addressed in this

document, together with the publication

dates of the ANPRM and the NPRM, as

well as the closing dates for comments

and submission of new data for each

rulemaking. FDA advises that the active

ingredients discussed in this document

(see Table II of section II of this

document) will not be included in the

relevant final monographs because they

have not been shown to be generally

recognized as safe and effective for their

intended use. The agency further

advises that these ingredients should be

eliminated from OTC drug products 6

months after the date of publication in

the Federal Register of this final rule

regardless of whether further testing is

undertaken to justify future use.