25794 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules

Authority: 21 U.S.C. 321, 341, 343, 343–1,

348, 349, 371, 379e.

§ 165.110 [Amended]

2. Section 165.110 Bottled water is

amended in the table in paragraph

(b)(4)(iii)(A) by removing the

superscript ‘‘1’’ after the entries for

‘‘Antimony,’’ ‘‘Beryllium,’’ ‘‘Cyanide,’’

‘‘Nickel,’’ and ‘‘Thallium,’’ and by

removing the footnote to the table; in

the table in paragraph (b)(4)(iii)(C) by

removing the superscript ‘‘1’’ after the

entries for ‘‘Diquat,’’ ‘‘Endothall,’’

‘‘Glyphosate,’’ and ‘‘2,3,7,8–TCDD

(Dioxin),’’ and by removing the footnote

to the table; and by removing the note

that follows paragraph

(b)(4)(iii)(G)(3)(iv).

Dated: May 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12382 Filed 5–6–98; 3:57 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. 98N–0249]

Ear, Nose, and Throat Devices;

Classification of the Nasal Dilator, the

Intranasal Splint, and the Bone Particle

Collector

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

classify the nasal dilator, intranasal

splint, and the bone particle collector

into class I and exempt these devices

from premarket notification procedures.

FDA is also publishing the

recommendations of the Ear, Nose, and

Throat Devices Panel (the panel)

regarding the classification of the

devices. After considering public

comments on the proposed

classifications, FDA will publish a final

regulation classifying the devices. This

action is being taken under the Federal

Food, Drug, and Cosmetic Act (the act),

as amended by the Medical Device

Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (the SMDA), and the Food

and Drug Administration Modernization

Act of 1997 (FDAMA).

DATES: Written comments by August 10,

1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Harry R. Sauberman, Center for Devices

and Radiological Health (HFZ–420),

Food and Drug Administration, 9200

Corporate Blvd, Rockville, MD 20850,

301– 594–2080.

SUPPLEMENTARY INFORMATION:

I. Background

The act, as amended by the 1976

amendments (Pub. L. 94–295), the

SMDA (Pub. L. 101–629), and FDAMA

(Pub. L. 105–115), established a

comprehensive system for the regulation

of medical devices intended for human

use. Section 513 of the act (21 U.S.C.

360c) established three categories

(classes) of devices, depending on the

regulatory controls needed to provide

reasonable assurance of their safety and

effectiveness. The three categories of

devices are class I (general controls),

class II (special controls), and class III

(premarket approval). Under section 513

of the act, devices that were in

commercial distribution before May 28,

1976 (the date of enactment of the

amendments) are classified after FDA

has: (1) Received a recommendation

from a device classification panel (an

FDA advisory committee), (2) published

the panel’s recommendations for

comment, along with a proposed

regulation classifying the device, and (3)

published a final regulation classifying

the device. A device that is first offered

in commercial distribution after May 28,

1976, and which FDA determines to be

substantially equivalent to a device

classified under this scheme, is

classified into the same class as the

device to which it is substantially

equivalent. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and 21 CFR part 807

of the regulations.

A device that was not in commercial

distribution prior to May 28, 1976, and

that has not been found by FDA to be

substantially equivalent to a legally

marketed predicate device, is classified

automatically by statute (section 513(f)

of the act) into class III without any FDA

rulemaking process.

In the Federal Register of November

6, 1986 (51 FR 40378), FDA published

a final rule classifying ear, nose and

throat devices. At that time, FDA was

not aware that the nasal dilator, the

intranasal splint, and the bone particle

collector were preamendments devices

and inadvertently omitted classifying

them.

II. Device Descriptions

FDA is proposing the following

device descriptions based on the panel’s

recommendations (Ref. 1) and the

agency’s review:

(1) The nasal dilator is a device

intended to provide temporary relief

from breathing difficulties resulting

from structural abnormalities in the

nose. The external nasal dilator is

described as a device constructed from

layers of fabric material with a flat

plastic spring inserted between the

layers, with a skin adhesive applied to

adhere to the skin of the nose. The

device is placed externally on the lower

third of the nose. The external nasal

dilator acts with a pulling force to open

the nares and the nasal valves thereby

decreasing nasal airway resistance and

increasing nasal air flow. The internal

nasal dilator is constructed from metal

or plastic and is placed inside the

nostrils. It acts by pushing the nostrils

open or by gently pressing on the

columella, thereby decreasing nasal

airway resistance and increasing nasal

airflow;

(2) The intranasal splint is a device

intended to minimize bleeding and

edema and to prevent adhesions

between the septum and the nasal

cavity. The intranasal splint is

constructed from plastic, silicone, or

absorbent material and is placed in the

nasal cavity after surgery or trauma; and

(3) The bone particle collector is a

filtering device intended to be inserted

into the suction tube line during the

early stages of otologic surgery to collect

bone particles for future use.

III. Recommendations of the Panel

In a public meeting held on October

25, 1990, the panel made classification

recommendations for the nasal dilator,

the intranasal splint, and the bone

particle collector. The panel

recommended that the devices be

classified in class I (general controls).

No recommendation was made to

exempt these devices.

IV. Summary of the Reasons for the

Recommendations

The panel concluded that the safety

and effectiveness of the nasal dilator,

intranasal splint, and bone particle

collector can be reasonably assured by

general controls. Specifically, the panel

believed that the safety and

effectiveness of the nasal dilator,
Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules 25795

intranasal splint, and the bone particle

collector can be reasonably assured by:

(1) Registration and listing (section 510

of the act), and (2) the general

requirements concerning reports (21

CFR 820.180), complaint files (21 CFR

820.198), and good manufacturing

practices requirements (section 520(f) of

the act (21 U.S.C. 360j(f)).

V. Risks to Health

The panel identified no specific risks

associated with the use of the intranasal

splint or the bone particle collector. The

panel identified two potential risks to

health associated with use of the nasal

dilator: (1) The device could be lost

inside a wide nose (internal dilator),

and (2) the device can cause ulceration

of skin or mucous membrane which

could lead to infection. The panel

further concluded that the risk of injury

resulting from a dislodged dilator or

from skin ulceration is low.

VI. Summary of the Data Upon Which

the Proposed Recommendation Is Based

The panel based its recommendations

on expert testimony presented to the

panel and on the panel members’

personal knowledge of and clinical

experience with the nasal dilator, the

intranasal splint, and the bone particle

collector.

VII. FDA’s Tentative Finding

FDA tentatively concurs with the

recommendations of the panel that the

nasal dilator, the intranasal splint, and

the bone particle collector should be

classified into class I (general controls)

because the agency believes that

sufficient information exists to

determine that general controls will

provide reasonable assurance of the

safety and effectiveness of the devices.

Consistent with the purpose of the act,

class I (general controls) as defined by

section 513(a)(1)(A) of the act would

provide the least amount of regulation

necessary to reasonably assure that

current and future nasal dilators,

intranasal splints, and bone particle

collectors are safe and effective.

On November 21, 1997, the President

signed FDAMA into law. Section 206 of

FDAMA, in part, added a new section

510(l) to the act (21 U.S.C. 360(l)).

Under section 501 of FDAMA, new

section 510(l) became effective on

February 19, 1998. New section 510(l)

provides that a class I device is exempt

from the premarket notification

requirements under section 510(k) of the

act, unless the device is intended for a

use which is of substantial importance

in preventing impairment of human

health or it presents a potential

unreasonable risk of illness or injury

(hereafter ‘‘reserved criteria’’). FDA has

determined that these devices do not

meet the reserved criteria and, therefore,

they are exempt from the premarket

notification requirements.

The agency, therefore, proposes to

classify the nasal dilator, the intranasal

splint, and the bone particle collector

into class I, and to exempt them from

the premarket notification requirements

.

VIII. Reference

The following reference has 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. Ear, Nose, and Throat Devices

Panel, 35th meeting, transcript and

meeting minutes, October 25–26, 1990.

IX. Environmental Impact

The agency has determined under 21

CFR 25.34(b) that this proposed

classification 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.

X. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612), as amended by

Subtitle D of the Small Business

Regulatory Fairness Act of 1996 (Pub. L.

104–121), 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 proposed rule

is consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed 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. As noted previously, FDA may

classify devices into one of three

regulatory classes according to the

degree of control needed to provide

reasonable assurance of safety and

effectiveness. For these three devices,

FDA is proposing that they be classified

into class I, the lowest level of control

allowed. In addition, FDA is proposing

to exempt them from premarket

notification requirements. These devices

would be subject to a minimal level of

control. The agency, therefore, certifies

that the proposed rule will not have a

significant economic impact on a

substantial number of small entities. In

addition, this proposed 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.

XI. Paperwork Reductions Act of 1995

FDA tentatively concludes that this

proposed 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.

XII. Comments

Interested persons may, on or before

August 10, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any 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. Received

comments may be seen in the office

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

Monday through Friday.

List of Subjects in 21 CFR Part 874

Medical devices.

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 part 874 be amended as follows:

PART 874—EAR, NOSE, AND THROAT

DEVICES

1. The authority citation for 21 CFR

part 874 continues to read as follows:

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

360j, 371.

2. Section 874.3900 is added to

subpart D to read as follows:

§ 874.3900 Nasal dilator.

(a) Identification. A nasal dilator is a

device intended to provide temporary

relief from breathing difficulties

resulting from structural abnormalities

in the nose. These devices decrease

airway resistance and increase nasal

airflow. The external nasal dilator is
25796 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules

constructed from layers of fabric

material with a flat plastic string

inserted between the layers, with a skin

adhesive applied to adhere to the skin

of the nose. The external dilator acts

with a pulling action to open the nares.

The internal nasal dilator is constructed

from metal or plastic and is placed

inside the nostrils. It acts by pushing the

nostrils open or by gently pressing on

the columella.

(b) Classification. Class I (general

controls). This device is exempt from

the premarket notification procedures in

subpart E of part 807 of this chapter.

3. Section 874.4780 is added to

subpart E to read as follows:

§ 874.4780 Intranasal splint.

(a) Identification. An intranasal splint

is a device intended to minimize

bleeding and edema to prevent

adhesions between the septum and the

nasal cavity. The intranasal splint is

constructed between the septum and the

nasal cavity. The intranasal splint is

constructed from plastic, silicone, or

absorbent material and is placed in the

nasal cavity after surgery or trauma.

(b) Classification. Class I (general

controls). The device is exempted from

the premarket notification procedures in

subpart E of part 807 of this chapter.

4. Section 874.4800 is added to

subpart E to read as follows:

§ 874.4800 Bone particle collector.

(a) Identification. A bone particle

collector is a filtering device intended to

be inserted into the suction tube during

the early stages of otologic surgery to

collect bone particles for future use.

(b) Classification. Class I (general

controls). The device is exempt from the

premarket notification procedures in

subpart E of part 807 of this chapter.

Dated: May 1, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–12312 Filed 5–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[REG–209682–94]

RIN 1545–AS39

Adjustments Following Sales of

Partnership Interests

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Postponement of hearing and

requests to videoconference hearing.

SUMMARY: This document postpones the

public hearing on proposed regulations

relating to the optional adjustments to

the basis of partnership property

following certain transfers of

partnership interests under section 743,

the calculation of gain or loss under

section 751(a) following the sale or

exchange of a partnership interest, the

allocation of basis adjustments among

partnership assets under section 755,

the allocation of a partner’s basis in its

partnership interest to properties

distributed to the partner by the

partnership under section 732(c), and

the computation of a partner’s

proportionate share of the adjusted basis

of depreciable property (or depreciable

real property) under section 1017. In

addition, this document announces that

persons outside the Washington, DC

area who wish to testify at the public

hearing on the proposed regulations

may request that the Service

videoconference the public hearing to

their sites.

DATES: Requests to videoconference the

hearing to other sites must be received

by Friday, May 29, 1998.

ADDRESSES: Requests must be sent to:

CC:DOM:CORP:R (REG–209682–94),

room 5226, Internal Revenue Service,

POB 7604, Ben Franklin Station,

Washington, DC 20044. Requests may

also be hand delivered between the

hours of 8 a.m. and 5 p.m. to:

CC:DOM:CORP:R (REG–209682–94),

Courier’s Desk, Internal Revenue

Service, 1111 Constitution Avenue, NW,

Washington, DC. Alternatively,

taxpayers may submit requests

electronically via the internet by

selecting the ‘‘Tax Regs’’ option on the

IRS Home Page, or by submitting

requests directly to the IRS internet site

at http://www.irs.ustreas.gov/prod/

taxlregs/comments.html.

FOR FURTHER INFORMATION CONTACT:

LaNita VanDyke of the Regulations Unit,

Assistant Chief Counsel (Corporate),

(202) 622–7180 (not a toll-free number).

SUPPLEMENTARY INFORMATION: A notice

of proposed rulemaking and notice of

public hearing appearing in the Federal

Register on Thursday, January 29, 1998

(63 FR 4408), announced that a public

hearing with respect to proposed

regulations relating to adjustments to a

partner’s basis in its partnership interest

and a partnership’s basis in its assets

would be held on Wednesday, July 8,

1998, beginning at 10 a.m. in the IRS

Auditorium, Internal Revenue Building,

1111 Constitution Avenue, NW.,

Washington DC, and that requests to

speak and outlines of oral comments

should be received by Wednesday, June

24, 1998.

Subsequent to this announcement, the

Service received a request that the

hearing be videoconferenced. The

Service recognizes that other persons

outside the Washington, DC area may

also wish to testify through

videoconferencing. Those persons

should now request to do so.

Requests to include other

videoconferencing sites must be

received by Friday, May 29, 1998. If the

Service receives sufficient indications of

interest to warrant videoconferencing to

a particular city and if the Service has

videoconferencing facilities in that city,

the Service will accommodate the

requests.

Accordingly, the public hearing

originally scheduled for July 8, 1998, is

postponed. The Service will issue a

document in the Federal Register

announcing the new date, time, and any

videoconference sites of the public

hearing.

Cynthia Grigsby,

Chief, Regulations Unit, Assistant Chief

Counsel (Corporate).

[FR Doc. 98–12340 Filed 5–8–98; 8:45 am]

BILLING CODE 4830–01–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[LA–46–1–7384b; FRL–6008–9]

Approval and Promulgation of State

Implementation Plans; Louisiana: SiteSpecific Revision for the Exxon

Company Baton Rouge Refinery

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: In this action, the EPA

proposes to approve a site-specific

revision to the Louisiana 15% Rate-ofProgress State Implementation plan. The

revision extends the date of compliance

for the installation of particular Volatile

Organic Liquid storage tank controls for

storage tanks located at the Baton Rouge

Refinery of Exxon Company, U.S.A.

Specifically, the revision extends the

compliance date of the requirement for

the installation of guide pole sliding

cover gaskets on 33 storage tanks until

the earlier of the next scheduled

downtime of the subject tanks or

December 2005.

In the Rules and Regulations Section

of this Federal Register, the EPA is

approving the State’s SIP revision as a

direct final rule without prior proposal