37040 Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Rules and Regulations

to comment to do so at the earliest

possible time to permit the fullest

consideration of their views.

The period for submission of

comments will close on July 13, 2000.

The Department will consider all

comments received before the close of

the comment period in developing final

regulations. Comments received after

the end of the comment period will be

considered if possible, but their

consideration cannot be assured. The

Department will not accept public

comments accompanied by a request

that a part or all of the material be

treated confidentially because of its

business proprietary nature or for any

other reason. The Department will

return such comments and materials to

the person submitting the comments

and will not consider them in the

development of final regulations. All

public comments on these regulations

will be a matter of public record and

will be available for public inspection

and copying. In the interest of accuracy

and completeness, the Department

requires comments in written form.

Oral comments must be followed by

written memoranda, which will also be

a matter of public record and will be

available for public review and copying.

Communications from agencies of the

United States Government or foreign

governments will not be made available

for public inspection.

The public record concerning these

regulations will be maintained in the

Bureau of Export Administration

Freedom of Information Records

Inspection Facility, Room 6883,

Department of Commerce, 14th Street

and Pennsylvania Avenue, NW.,

Washington, DC 20230. Records in this

facility, including written public

comments and memoranda

summarizing the substance of oral

communications, may be inspected and

copied in accordance with regulations

published in Part 4 of Title 15 of the

Code of Federal Regulations.

Information about the inspection and

copying of records at the facility may be

obtained from the Bureau of Export

Administration Freedom of Information

Officer at the above address or by

calling (202) 482–0500.

List of Subjects in 15 CFR Part 774

Exports, Foreign trade.

Accordingly, part 774 of the Export

Administration Regulations (15 CFR

parts 730 through 799) is amended as

follows:

1. The authority citation for part 774

is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.

7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C.

287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004;

Sec. 201, Pub. L. 104–58, 109 Stat. 557 (30

U.S.C. 185(s)); 30 U.S.C. 185(u); 42 U.S.C.

2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 46

U.S.C. app. 466c; 50 U.S.C. app. 5; E.O.

12924, 59 FR 43437, 3 CFR, 1994 Comp., p.

917; E.O. 13020, 61 FR 54079, 3 CFR, 1996

Comp., p. 219; E.O. 13026, 61 FR 58767, 3

CFR, 1996 Comp., p. 228; Notice of August

10, 1999 (3 CFR, 1999 Comp. 302 (2000)).

PART 774—AMENDED

Supplement No. 1 to Part 774—

Amended

2. In Supplement No. 1 to part 774

(the Commerce Control List), Category

3—Electronics, Export Control

Classification Number (ECCN) 3A001 is

amended by revising the License

Exceptions section to read as follows:

3A001 Electronic components, as

follows (see List of Items Controlled).

* * * * *

License Exceptions

LVS: N/A for MT

$1500: 3A001.c

$3000: 3A001.b.1, b.2, b.3, .d, .e and .f

$5000: 3A001.a, and .b.4 to b.7

GBS: Yes, except 3A001.a.1.a, b.1, b.3 to

b.7, .c to .f

CIV: Yes, except 3A001.a.1, a.2, a.3.a

(for processors with a CTP greater

than 4500 Mtops), a.5, a.6, a.9, a.10,

and a.12, .b, .c, .d, .e, and .f

* * * * *

3. In Supplement No. 1 to part 774

(the Commerce Control List), Category

4—Computers, Export Control

Classification Number (ECCN) 4A003 is

amended by revising the License

Exceptions section to read as follows:

4A003 ‘‘Digital computers’’,

‘‘electronic assemblies’’, and related

equipment therefor, and specially

designed components therefor.

* * * * *

License Exceptions

LVS: $5000; N/A for MT and ‘‘digital’’

computers controlled by 4A003.b and

having a CTP exceeding 10,000

MTOPS; or ‘‘electronic assemblies’’

controlled by 4A003.c and capable of

enhancing performance by

aggregation of ‘‘computing elements’’

so that the CTP of the aggregation

exceeds 10,000 MTOPS.

GBS: Yes, for 4A003.d, .e, and .g and

specially designed components

therefor, exported separately or as

part of a system.

CTP: Yes, for computers controlled by

4A003.a, .b and .c, to the exclusion of

other technical parameters, with the

exception of parameters specified as

controlled for Missile Technology

(MT) concerns and 4A003.e

(equipment performing analog-todigital or digital-to-analog

conversions exceeding the limits of

3A001.a.5.a). See § 740.7 of the EAR.

CIV: Yes, for 4A003.d (having a 3–D

vector rate less than or equal to 100

M vectors/sec), .e, and .g.

* * * * *

Dated: June 8, 2000.

R. Roger Majak,

Assistant Secretary for Export

Administration.

[FR Doc. 00–14903 Filed 6–12–00; 8:45 am]

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 92F–0443]

Indirect Food Additives: Adhesives

and Components of Coatings;

Technical Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

food additives regulations to correct two

typographical errors in the Chemical

Abstracts Service (CAS) registry

number. This document corrects those

errors.

DATES: This rule is effective June 13,

2000.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 11, 2000

(65 FR 6889), the agency amended the

food additive regulations to provide for

the safe use of: (1) 1,2-dibromo-2,4-

dicyanobutane, and (2) a mixture of 5-

chloro-2-methyl-4-isothiazolin-3-one

and 2-methyl-4-isothiazolin-3-one,

optionally containing magnesium

nitrate, as antimicrobial agents in

emulsion-based silicone coating

formulations. The CAS registry number

for 2-methyl-4-isothiazol-3-one was

incorrectly published. The agency is

amending both 21 CFR 175.300 and

175.320 to correct those errors.

List of Subjects in 21 CFR Part 175

Adhesives, Food additives, Food

packaging.

Federal Register / Vol. 65, No. 114 / Tuesday, June 13, 2000 / Rules and Regulations 37041

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 175 is

amended as follows:

PART 175—INDIRECT FOOD

ADDITIVES: ADHESIVES AND

COMPONENTS OF COATINGS

1. The authority citation for 21 CFR

part 175 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

§ 175.300 [Amended]

2. Section 175.300 Resinous and

polymeric coatings is amended in

paragraph (b)(3)(xxxiii), under the entry

‘‘5-Chloro-2-methyl * * *’’, by

removing ‘‘(CAS Reg. No. 2628–20–4)’’

and adding in its place ‘‘(CAS Reg. No.

2682–20–4)’’.

3. Section 175.320 is amended in the

table in paragraph (b)(3) by revising the

entry under item (iii) for ‘‘5–Chloro-2-

methyl-4-isothiazolin-3-one’’ under the

headings ‘‘List of substances’’ and

‘‘Limitations’’ to read as follows:

§ 175.320 Resinous and polymeric

coatings for polyolefin films.

* * * * *

(b) * * *

(3) * * *

List of substances Limitations

*******

(iii) Adjuvants (release agents, waxes, and dispersants):

*******

5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172–55–4)

and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture, at a ratio of 3 parts to 1 part, respectively, manufactured from

methyl-3-mercaptopropionate (CAS Reg. No. 2935–90–2) and optionally containing magnesium nitrate (CAS Reg. No. 10377–60–3) at a

concentration equivalent to the isothiazolone active ingredients

(weight/weight).

For use only as an antimicrobial agent in emulsion-based silicone

coatings at a level not to exceed 50 milligrams per kilogram (based

on isothiazolone active ingredient) in the coating formulation.

*******

* * * * *

Dated: June 7, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–14905 Filed 6–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 99N–2099]

General Hospital and Personal Use

Devices; Classification of the

Subcutaneous, Implanted,

Intravascular Infusion Port and

Catheter and the Percutaneous,

Implanted, Long-term Intravascular

Catheter

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

subcutaneous, implanted, intravascular

(IV) infusion port and catheter, and the

percutaneous, implanted, long-term IV

catheter intended for repeated vascular

access into class II (special controls).

This action is being taken to establish

sufficient regulatory controls that will

provide reasonable assurance of the

safety and effectiveness of these devices.

DATES: This rule is effective July 13,

2000.

FOR FURTHER INFORMATION CONTACT: M.

Patricia Cricenti, Center for Devices and

Radiological Health (HFZ–480), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1287.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 301 et. seq.), as

amended by the Medical Device

Amendments of 1976 (the 1976

amendments) (Public Law 94–295), the

Safe Medical Devices Act of 1990 (the

SMDA) (Public Law 101–629), and the

Food and Drug Administration

Modernization Act of 1997 (FDAMA)

(Public Law 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 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. Those devices remain in class

III and require premarket approval,

unless and until: (1) The device is

reclassified into class I or II; (2) FDA

issues an order classifying the device

into class I or II in accordance with

section 513(f)(2) of the act, as amended

by FDAMA; or (3) 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 offered devices

by means of premarket notification

procedures in section 510(k) of the act