40650 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations

PART 341—COLD, COUGH, ALLERGY,

BRONCHODILATOR, AND

ANTIASTHMATIC DRUG PRODUCTS

FOR OVER–THE–COUNTER HUMAN

USE

3. The authority citation for 21 CFR

part 341 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353,

355, 360, 371.

4. Section 341.20 is amended by

revising paragraph (b)(1) to read as

follows:

§ 341.20 Nasal decongestant active

ingredients.

* * * * *

(b) * * *

(1) Levmetamfetamine.

* * * * *

5. Section 341.80 is amended by

revising paragraphs (c)(2)(ii), (c)(2)(vii),

and (d)(2)(i), and the heading of

paragraph (d)(2)(viii) to read as follows:

§ 341.80 Labeling of nasal decongestant

drug products.

* * * * *

(c) * * *

(2) * * *

(ii) For products containing

levmetamfetamine identified in

§ 341.20(b)(1) when used in an inhalant

dosage form and when labeled for

adults. ‘‘Do not use this product for

more than 7 days. Use only as directed.

Frequent or prolonged use may cause

nasal congestion to recur or worsen. If

symptoms persist, ask a doctor.’’

* * * * *

(vii) For products containing

levmetamfetamine identified in

§ 341.20(b)(1) when used in an inhalant

dosage form and when labeled for

children under 12 years of age. ‘‘Do not

use this product for more than 7 days.

Use only as directed. Frequent or

prolonged use may cause nasal

congestion to recur or worsen. If

symptoms persist, ask a doctor.’’

* * * * *

(d) * * *

(2) * * *

(i) For products containing

levmetamfetamine identified in

§ 341.20(b)(1) when used in an inhalant

dosage form. The product delivers in

each 800 milliliters of air 0.04 to 0.150

milligrams of levmetamfetamine.

Adults: 2 inhalations in each nostril not

more often than every 2 hours. Children

6 to under 12 years of age (with adult

supervision): 1 inhalation in each

nostril not more often than every 2

hours. Children under 6 years of age:

ask a doctor.

* * * * *

(viii) Other required statements—For

products containing levmetamfetamine

or propylhexedrine identified in

§ 341.20(b)(1) or (b)(9) when used in an

inhalant dosage form. * * *

* * * * *

Dated: July 23, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20303 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. 98N–0513]

Medical Devices; Neurological

Devices; Classification of Cranial

Orthosis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

cranial orthosis into class II (special

controls). The special controls that will

apply to the cranial orthosis are

restriction to prescription use,

biocompatibility testing, and certain

labeling requirements. The agency is

taking this action in response to a

petition submitted under the Federal,

Food, Drug, and Cosmetic Act (the act)

as amended by the Medical Device

Amendments of 1976, the Safe Medical

Devices Act of 1990, and the Food and

Drug Administration Modernization Act

of 1997. The agency is classifying

cranial orthosis into class II (special

controls) in order to provide a

reasonable assurance of safety and

effectiveness of the device.

EFFECTIVE DATE: August 31, 1998.

FOR FURTHER INFORMATION CONTACT:

James E. Dillard, Center for Devices and

Radiological Health (HFZ–410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1184.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of

the act (21 U.S.C. 360c(f)(1)), devices

that were not in commercial distribution

before May 28, 1976, the date of

enactment of the Medical Device

Amendments of 1976 (the amendments),

generally referred to as postamendments

devices, are classified automatically by

statute into class III without any FDA

rulemaking process. These devices

remain in class III and require

premarket approval, unless and until

the device is classified or reclassified

into class I or II or FDA issues an order

finding the device to be substantially

equivalent, in accordance with section

513(i) of the act, to a predicate device

that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously marketed

devices by means of premarket

notification procedures in section 510(k)

of the act (21 U.S.C. 360(k)) and part 807

of the FDA regulations (21 CFR part

807).

Section 513(f)(2) of the act provides

that any person who submits a

premarket notification under section

510(k) of the act for a device that has not

previously been classified may, within

30 days after receiving an order

classifying the device in class III under

section 513(f)(1), request FDA to classify

the device under the criteria set forth in

section 513(a)(1). FDA shall, within 60

days of receiving such a request, classify

the device by written order. This

classification shall be the initial

classification of the device. Within 30

days after the issuance of an order

classifying the device, FDA must

publish a notice in the Federal Register

announcing such classification.

In accordance with section 513(f)(1) of

the act, FDA issued an order on March

12, 1998, classifying the Dynamic

Orthotic Cranioplasty (DOCTM Band) in

class III, because it was not substantially

equivalent to a device that was

introduced or delivered for introduction

into interstate commerce for commercial

distribution before May 28, 1976, or a

device which was subsequently

reclassified into class I or class II. On

March 31, 1998, Cranial Technologies,

Inc., submitted a petition requesting

classification of the DOCTM Band under

section 513(f)(2) of the act. The

manufacturer recommended that the

device be classified into class II.

In accordance with 513(f)(2) of the

act, FDA reviewed the petition in order

to classify the device under the criteria

for classification set forth in 513(a)(1) of

the act. Devices are to be classified into

class II if general controls, by

themselves, are insufficient to provide

reasonable assurance of safety and

effectiveness, but there is sufficient

information to establish special controls

to provide reasonable assurance of the

safety and effectiveness of the device for

its intended use. After review of the

information submitted in the petition

and the medical literature, FDA

determined that the DOCTM Band can be
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations 40651

classified in class II with the

establishment of special controls. FDA

believes these special controls will

provide reasonable assurance of safety

and effectiveness of the device.

The device is assigned the generic

name ‘‘cranial orthosis,’’ and it is

identified as a device intended for use

on infants from 3 to 18 months of age

with moderate to severe nonsynostotic

positional plagiocephaly, including

infants with plagiocephalic-,

brachycephalic-, and scaphocephalicshaped heads. The device is intended

for medical purposes to apply pressure

to prominent regions of an infant’s

cranium in order to improve cranial

symmetry and/or shape.

FDA identified the following risks to

health associated with this type of

device: (1) Skin irritation, skin

breakdown and subsequent infection

due to excessive pressure on the skin;

(2) head and neck trauma due to

alteration of the functional center of

mass of the head and the additional

weight of the device especially with an

infant who is still developing the ability

to control his/her head and neck

movements; (3) impairment of brain

growth and development from

mechanical restriction of cranial growth;

(4) asphyxiation due to mechanical

failure, poor fit, and/or excessive weight

that alters the infant’s ability to lift the

head; (5) eye trauma due to mechanical

failure, poor construction and/or

inappropriate fit; and (6) contact

dermatitis due to the materials used in

the construction of the device.

FDA believes that the special controls

described below address these risks and

provide reasonable assurance of the

safety and effectiveness of the device.

Therefore, on May 29, 1998, FDA issued

an order to the petitioner classifying the

cranial orthosis as described previously

into class II subject to the special

controls described below. Additionally,

FDA is codifying the classification of

this device by adding new § 882.5970.

In addition to the general controls of

the act, the cranial orthosis is subject to

the following special controls in order

to provide reasonable assurance of the

safety and effectiveness of the device:

(1) The sale, distribution, and use of this

device are restricted to prescription use

in accordance with 21 CFR 801.109; (2)

the labeling of the device must include:

(a) Contraindications for the use of the

device on infants with synostosis or

with hydrocephalus; (b) warnings

indicating the need to: (i) Evaluate head

circumference measurements and

neurological status at intervals

appropriate to the infant’s age and rate

of head growth and to describe steps

that should be taken in order to reduce

the potential for restriction of cranial

growth and possible impairment of

brain growth and development and (ii)

evaluate the skin at frequent intervals,

e.g., every 3 to 4 hours, and to describe

steps that should be taken if skin

irritation or breakdown occurs; (c)

precautions indicating the need to: (i)

Additionally treat torticollis, if the

positional plagiocephaly is associated

with torticollis; (ii) evaluate device fit

and to describe the steps that should be

taken in order to reduce the potential for

restriction of cranial growth, the

possible impairment of brain growth

and development and skin irritation

and/or breakdown; and (iii) evaluate the

structural integrity of the device and to

describe the steps that should be taken

to reduce the potential for the device to

slip out of place and cause asphyxiation

or trauma to the eyes or skin; (d) adverse

events, i.e., skin irritation and

breakdown that have occurred with the

use of the device; (e) clinician’s

instructions for casting the infant, for

fitting the device, and for care; and (f)

parent’s instructions for care and use of

the device; (3) the materials must be

tested for biocompatibility with testing

appropriate for long term direct skin

contact.

II. Environmental Impact

The agency has determined under 21

CFR 25.34(b) 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.

III. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) and the Unfunded

Mandates Reform Act of 1995 (Pub. L.

104–4). 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). The

agency believes that this final rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

final rule is not a significant regulatory

action as defined by the Executive Order

and so it is not subject to review under

the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Reclassification of these

devices from class III to class II will

relieve manufacturers of the device of

the cost of complying with the

premarket approval requirements of

section 515 of the act (21 U.S.C. 360e),

and may permit small potential

competitors to enter the marketplace by

lowering their costs. The agency

therefore, certifies that the final rule

will not have a significant impact on a

substantial number of small entities. In

addition, this final rule will not impose

costs of $100 million or more on either

the private sector or State, local, and

tribal governments in the aggregate, and,

therefore, a summary statement of

analysis under section 202(a) of the

Unfunded Mandates Reform Act is not

required.

IV. Paperwork Reduction Act of 1995

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

V. References

The following references have been

placed on display in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852,

and may be seen by interested persons

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

through Friday.

1. Petition from Cranial Technologies, Inc.,

dated March 31, 1998.

2. Hellbusch, J. L., L. C. Hellbusch, and R.

J. Bruneteau, ‘‘Active Counter-Positioning

Treatment of Deformational Plagiocephaly,’’

Nebraska Medical Journal, vol. 80, pp. 344 to

349, 1995.

3. Moss, S. D. et. al., ‘‘Diagnosis and

Management of the Misshapen Head in the

Neonate,’’ Pediatric Review, vol. 4, pp. 4 to

8, 1993.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 882 is

amended as follows:

List of Subjects in 21 CFR Part 882

Medical devices.

PART 882—NEUROLOGICAL DEVICES

1. The authority citation for 21 CFR

part 882 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 882.5970 is added to

subpart F to read as follows:

§ 882.5970 Cranial orthosis.

(a) Identification. A cranial orthosis is

a device that is intended for medical
40652 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations

purposes to apply pressure to prominent

regions of an infant’s cranium in order

to improve cranial symmetry and/or

shape in infants from 3 to 18 months of

age, with moderate to severe

nonsynostotic positional plagiocephaly,

including infants with plagiocephalic-,

brachycephalic-, and scaphocephalicshaped heads.

(b) Classification. Class II (special

controls) (prescription use in

accordance with § 801.109 of this

chapter, biocompatibility testing, and

labeling (contraindications, warnings,

precautions, adverse events,

instructions for physicians and

parents)).

Dated: July 21, 1998.

Elizabeth D. Jacobson,

Deputy Director for Science, Center for

Devices and Radiological Health.

[FR Doc. 98–20308 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD 05–98–063]

RIN 2115–AE 46

Special Local Regulations for Marine

Events; Prospect Bay, Maryland

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: Temporary special local

regulations are being adopted for the

‘‘Thunder on the Narrows’’ hydroplane

races to be held on the waters of

Prospect Bay near Kent Narrows,

Maryland. These regulations are needed

to protect boaters, spectators and

participants from the dangers associated

with the event. This action is intended

to enhance the safety of life and

property during the event.

DATES: This temporary final rule is

effective from 12 p.m. EDT (Eastern

Daylight Time) to 6 p.m. EDT on August

1 and August 2, 1998.

FOR FURTHER INFORMATION CONTACT:

Chief Warrant Officer R. Houck, Marine

Events Coordinator, Commander, Coast

Guard Activities Baltimore, 2401

Hawkins Point Road, Baltimore

Maryland, 21226–1791, telephone

number (410) 576–2674.

SUPPLEMENTARY INFORMATION:

Regulatory History

In accordance with 5 U.S.C. 553, a

notice of proposed rulemaking was not

published for this regulation and good

cause exists for making it effective less

than 30 days after Federal Register

publication. The application for this

event was not received until June 24,

1998. Following normal rulemaking

procedures would have been

impractical since there is not sufficient

time remaining to publish a proposed

rule in advance of the event or to

provide for a delayed effective date.

Immediate action is needed to protect

vessel traffic from the potential hazards

associated with congested waterways.

Background and Purpose

The Kent Narrows Racing Association

has submitted a marine event

application to the U.S. Coast Guard for

the ‘‘Thunder on the Narrows’’

hydroplane races, to be held on the

waters of Prospect Bay on August 1 and

2, 1998. The event will consist of 75

hydroplanes racing in heats counterclockwise around an oval race course. A

large fleet of spectator vessels is

anticipated. Due to the need for vessel

control during the races, vessel traffic

will be temporarily restricted to provide

for the safety of spectators, participants

and transiting vessels.

Discussion of Regulations

The Coast Guard will establish

temporary special local regulations on

specified waters of Prospect Bay. The

temporary special local regulations will

be in effect from 12 p.m. EDT (Eastern

Daylight Time) to 6 p.m. EDT on August

1 and 2, 1998, and will restrict general

navigation in the regulated area during

the event. Except for persons or vessels

authorized by the Coast Guard Patrol

Commander, no person or vessel may

enter or remain in the regulated area.

These regulations are needed to control

vessel traffic during the marine event to

enhance the safety of participants,

spectators, and transiting vessels.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has been exempted from review

by the office of Management and Budget

under that order. It is not significant

under the regulatory policies and

procedures of the Department of

Transportation (DOT) (44 FR 11040;

February 26, 1979). The Coast Guard

expects the economic impact of this rule

to be so minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary. This conclusion is

based on the fact that the regulated areas

will only be in effect for a limited

amount of time, and extensive

advisories have been and will be made

to the affected Maritime Community so

that they may adjust their schedules

accordingly.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601–612), the Coast Guard

must consider whether this rule will

have a significant economic impact on

a substantial number of small entities.

‘‘Small entities’’ include independently

owned and operated small businesses

that are not dominant in their field and

that otherwise qualify as ‘‘small

business concerns’’ under section 3 of

the Small Business Act (15 U.S.C. 632).

Because it expects the impact of this

rule to be minimal, the Coast Guard

certifies under 5 U.S.C. 605(b) that this

temporary final rule will not have a

significant economic impact on a

substantial number of small entities

because of the event’s short duration.

Collection of Information

These regulations contain no

Collection of Information requirements

under the Paperwork Reduction Act (44

U.S.C. 3501–3520).

Federalism

The Coast Guard has analyzed this

rule under the principles and criteria

contained in Executive Order 12612 and

has determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this rule and

concluded that, under figure 2–1,

paragraph (34)(h) of COMDTINST

M16475.1C, this rule is categorically

excluded from further environmental

documentation. Special local

regulations issued in conjunction with a

regatta or marine parade are excluded

under that authority.

List of Subjects in 33 CFR Part 100

Marine Safety, Navigation (water),

Reporting and recordkeeping

requirements, Waterways.

Temporary Regulations

In consideration of the foregoing, Part

100 of Title 33, Code of Federal

Regulations is amended as follows:

PART 100—[AMENDED]

1. The authority citation for Part 100

continues to read as follows:

Authority: 33 U.S.C. 1233; 49 CFR 1.46 and

33 CFR 100.35.