24558 Federal Register / Vol. 63, No. 85 / Monday, May 4, 1998 / Notices

phase. These periods of time were

derived from the following dates:

1. The date a clinical investigation

involving this device was begun: April

18, 1986. FDA has verified the

applicant’s claim that the date the

investigational device exemption (IDE)

required under section 520(g) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360j(g)) for human tests to

begin became effective April 18, 1996,

the date that the IDE for a similar,

related product, LIPOSORBER LA–40

System, was approved.

Although the device was

subsequently modified, the results of

the initial clinical investigations on the

earlier model, LIPOSORBER LA–40

System were included in FDA’s analysis

of the approved product’s safety and

effectiveness. The test on the earlier

model is, therefore, part of the testing

phase.

Additionally, the product is of a type

which, under present regulations,

would require IDE approval prior to the

start of clinical investigations, and

normally the initiation of the testing

phase for a medical device is

determined by reference to the approval

phase of the relevant IDE.

2. The date an application was

initially submitted with respect to the

device under section 515 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360e): October 3, 1991. The applicant

claims March 24, 1988, as the date the

premarket approval application (PMA)

for the LIPOSORBER LA–40 System

(PMA 880019) was initially submitted,

which applicant argues should be used

in place of the PMA for LIPOSORBER

LA–15 System (PMA 910018). FDA

records indicate that PMA 880019 was

received by the agnecy on March 25,

1998, but this PMA was never filed, and

it was withdrawn by the applicant on

April 3, 1996. The applicant claims that

PMA 910018 was submitted on March

26, 1991, but FDA records indicate that

it was submitted on October 3, 1991.

The applicant argues that the PMA for

the LA–40 device should be used as the

start of the approval phase for the LA–

15 device, because its liposorber

technology and adsorbent are identical

to those described in the patent for

which applicant is requesting extension,

U.S. Patent No. 4,637,994. The LA–15

device contains additional components

of a plasma separator, the tubing system

for plasmaphereses and the apheresis

unit.

However, the patent term restoration

regulations define the approval phase of

medical device in terms of the actual

approved product, not an earlier tested

product. For example, while the patent

term restoration statute does define drug

product as the active ingredient of a

new drug, ‘‘product’’ for ‘‘medical

devices’’ has been defined as ‘‘[a]ny

medical device * * * subject to

regulation under the Federal Food,

Drug, and Cosmetic Act’’ (35 U.S.C.

156(f)). Given that the LA–40 device

was withdrawn by applicant from

further regulatory consideration, the

LA–15 device is the only applicable

medical device subject to FDA

regulations.

Regarding the definition of regulatory

review period for the start of the

approval phase of a medical device, the

regulations state ‘‘* * * the period

beginning on the date the application

was initially submitted with respect to

the device under section 515 and ending

on the date such application was

approved under such Act * * *’’ 35

U.S.C. 156(g)(3)(B); see also 21 CFR

60.22(c)(2)(i). In this case, the only PMA

which submitted, filed, and approved

under section 515 of the Federal Food,

Drug, and Cosmetic Act was PMA

P910018, which was submitted on

October 3, 1991, and is, therefore, the

appropriate date the approval

application was initially submitted for

LIPOSORBER LA–15 System.

3. The date the application was

approved: February 21, 1996. FDA has

verified the applicant’s claim that PMA

P9910018 was approved on February 21,

1996.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,825 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 6, 1998, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before November 2, 1998, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: March 31, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–11682 Filed 5–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Dental Plaque Subcommittee of the

Nonprescription Drugs Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Dental Plaque

Subcommittee of the Nonprescription

Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on May 27, 28, and 29, 1998, 8:30

a.m. to 5 p.m.

Location: Holiday Inn, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: Robert L. Sherman or

Stephanie A. Mason, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD, 301–827–

5191, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12541. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On May 27, 1998, the

subcommittee will discuss: (1) The

safety and effectiveness of the

combination of stannous pyrophosphate

and zinc citrate; (2) the effectiveness of

the combination of hydrogen peroxide,

sodium lauryl sulfate, sodium citrate

and zinc chloride; (3) the safety and

effectiveness of hexetidine, soluble

pyrophosphate, nonsaponifiable fraction

of corn oil, bromchlorophene and

chlorhexidine digluconate; and (4) final

formulation testing. On May 28, 1998,

the subcommittee will discuss labeling
Federal Register / Vol. 63, No. 85 / Monday, May 4, 1998 / Notices 24559

of over-the-counter antiplaqueantigingivitis drug products. On May 29,

1998, the subcommittee will discuss

recommended therapeutic combinations

for antiplaque-antigingivitis drug

products.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by May 20, 1998. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 12 m. on May 27, 28, and 29,

1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before May 20, 1998, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 24, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–11742 Filed 5–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0191]

Testing for Skin Sensitization to

Chemicals in Latex Products; Draft

Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

document entitled ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products.’’ This draft guidance is

intended to provide alternative claims

for medical devices containing natural

rubber latex to the ‘‘hypoallergenic’’

claim that no longer will be acceptable

after September 30, 1998. The draft

guidance, which is not in effect at this

time, is being issued for comment. This

draft guidance was reviewed by the

General Hospital and Personal Use

Devices Panel in September 1997, and it

will be posted on the Internet.

DATES: Written comments concerning

this guidance must be received by

August 3, 1998.

ADDRESSES: Written comments

concerning the draft guidance must be

submitted to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Comments should be identified with the

docket number found in brackets in the

heading of this document. Submit

written requests for singles copies of the

draft guidance to the Division of Small

Manufacturers Assistance (DSMA),

Center for Devices and Radiological

Health (HFZ–220), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Chiu S. Lin, Center for Devices and

Radiological Health (HFZ–480), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8913.

SUPPLEMENTARY INFORMATION:

I. Background

This is the second draft of the

guidance entitled ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products,’’ and it replaces the July 28,

1997, version that was posted on the

Internet and distributed by DSMA to

manufacturers of medical devices made

of natural rubber to consumer groups

and other agencies of the Federal

Government for comment. This draft

guidance was also discussed during the

General Hospital and Personal Use

Devices Advisory Panel meeting on

September 15, 1997. This second draft

incorporates comments received from

the General Hospital and Personal Use

Devices Advisory Panel meeting,

consumer groups, and medical device

manufacturers. This draft guidance is

intended to provide alternative claims

for medical devices containing natural

rubber latex to replace the

‘‘hypoallergenic’’ claim. The

‘‘hypoallergenic’’ claim will no longer

be acceptable after September 30, 1998,

which is the effective date of the final

rule on medical devices containing

natural-rubber that published in the

Federal Register of September 30, 1997

(62 FR 51021). This draft guidance also

includes test methods for supporting

these claims. When this draft guidance

becomes final, the manufacturers of

latex containing medical devices may

use it to address label options and what

tests FDA regards as appropriate to

support statements that replace the

current ‘‘hypoallergenic’’ statement.

II. Significance of Guidance

The draft guidance represents the

agency’s recommended tests to support

label claims for reduced chemical

sensitivity during use of latex products

and label options. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

applicable statute, regulations, or both.

The agency has adopted Good Guidance

Practices (GGP’s), which set forth the

agency’s policies and procedures for the

development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). This guidance

document is being issued as a Level 1

guidance consistent with GGP’s.

III. Electronic Access

In order to receive the draft guidance

entitled ‘‘Testing for Skin Sensitization

to Chemicals in Latex Products’’ via

your fax machine, call the CDRH FactsOn-Demand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (944) followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

World Wide Web (WWW). The Center

for Devices and Radiological Health

(CDRH) maintains an entry on the

WWW for easy access to information

including text, graphics, and files that

may be downloaded to a personal

computer with access to the Web.

Updated on a regular basis, the CDRH

home page includes ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products,’’ device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. The draft

guidance entitled ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products’’ will be available at http://

www.fda.gov/cdrh/ode/ed—rp.html.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

1–800–222–0185 (terminal settings are

8/1/N). Once the modem answers, press