Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5443

§ 150.20 [Amended]

2. In § 150.20, paragraph (b)(1), first

sentence, remove the words ‘‘Except as

specified in paragraph (c) of this

section, shall’’, add in their place

‘‘shall’’ and remove paragraphs (c) and

(d).

Dated at Rockville, Maryland, this 28th day

of December, 2000.

For the Nuclear Regulatory Commission.

Patricia G. Norry,

Acting Executive Director for Operations.

[FR Doc. 01–1079 Filed 1–18–01; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Parts 740, 742, and 748

[Docket No. 010112014–1014–01]

RIN 0694–AC41

Implementation of Presidential

Announcement of January 10, 2001:

Revisions to License Exception CTP

AGENCY: Bureau of Export

Administration, Commerce.

ACTION: Final rule.

SUMMARY: The Bureau of Export

Administration (BXA) is amending the

Export Administration Regulations

(EAR) by revising License Exception

CTP to reflect rapid technological

advances in computing capability. This

rule implements the President’s sixth

revision to U.S. export controls on high

performance computers (HPCs),

announced January 10, 2001. License

Exception CTP is revised by removing

Computer Tier 2 and merging its

countries into Computer Tier 1. All

HPCs continue to be eligible for export

to a Computer Tier 1 country under

License Exception CTP. Additionally,

HPCs with CTP up to 85,000 MTOPS

can be exported to Computer Tier 3

countries under License Exception CTP,

and beginning March 20, 2001,

exporters will no longer be required to

submit National Defense Authorization

Act (NDAA) advance notifications for

HPCs with CTP exceeding 85,000

MTOPS. The NDAA advance

notification will not be required for

these computers, because exporters will

be submitting a license for exports to

Computer Tier 3 countries of HPCs with

CTP exceeding 85,000 MTOPS. This

rule also moves Lithuania from

Computer Tier 3 to Computer Tier 1,

effective May 19, 2001. The President’s

action will promote our national

security, enhance the effectiveness of

our export control system and ease

unnecessary regulatory burdens on both

government and industry.

DATES: This rule is effective January 19,

2001.

FOR FURTHER INFORMATION CONTACT:

Tanya Hodge Mottley in the Office of

Strategic Trade and Foreign Policy

Controls, Bureau of Export

Administration, at (202) 482–1837.

SUPPLEMENTARY INFORMATION:

Background

On January 10, 2001, the President

announced significant changes to U.S.

export control policy for HPCs. The new

policy continues the Administration’s

commitment, as announced on July 1,

1999, to review and update its HPC

policy every six months in order to

reflect rapid advancements in computer

hardware, as well as identify any risk

posed by HPC exports to certain endusers and countries. This policy

strengthens America’s high tech

competitiveness, while maintaining

export controls to protect U.S. national

security.

The Administration, in consultation

with the national security community

and industry, has determined that

additional adjustments are warranted.

Effective immediately, all countries in

Computer Tier 2 have been moved to

Computer Tier 1. Computer Tier 2 has

been deleted. Those countries formerly

in Computer Tier 2 do not pose

proliferation or security threats to the

United States.

This rule implements the

Administration’s decision to increase

License Exception CTP eligibility for

HPC exports to countries in Computer

Tier 3 by raising the CTP level to 85,000

MTOPS, to reflect the widespread

availability of computers, including

high performance computing capability

attained by clustering numerous lower

level personal computers together.

Effective March 20, 2001, this rule

raises the advance notification

requirement level for HPC exports to

Computer Tier 3 countries from 28,000

to 85,000 MTOPS. As required by the

NDAA, changes in the advance

notification level for HPC exports to

Tier 3 destinations are only effective 60

days following the President’s

submission of a report to Congress. In

addition, this rule revises the support

documentation requirements for

computers exported to the People’s

Republic of China.

This rule removes Lithuania from

Computer Tier 3 and places it in

Computer Tier 1. However, due to the

requirements in the 1998 National

Defense Authorization Act (NDAA),

removing Lithuania from Computer Tier

3 is not effective until 120 days after the

Congress receives a report justifying

such a removal.

This rule revises the Export

Administration Regulations by

modifying computer exports under

License Exception CTP, as follows:

1. Moving all Computer Tier 2

countries to Computer Tier 1;

2. Raising the CTP limit for computers

eligible for License Exception CTP for

exports and reexports to Computer Tier

3 destinations from ‘‘28,000 MTOPS’’ to

‘‘85,000 MTOPS’’;

3. Moving Lithuania to Tier 1 as of

May 19, 2001;

4. Revising the CTP range for which

NDAA notification is required for

computers exported or reexported to

Computer Tier 3 countries;

5. Revising the CTP level of

computers for which PRC End-User

Certificates are required as support

documentation for export under License

Exception CTP; and

6. Revising the CTP level of the

computers that require post shipment

verification reports for exports to

Computer Tier 3 countries.

Rulemaking Requirements

1. This final rule has been determined

to be not significant for purposes of

Executive Order 12866.

2. Notwithstanding any other

provision of law, no person is required

to respond to nor be subject to a penalty

for failure to comply with a collection

of information subject to the

requirements of the Paperwork

Reduction Act unless that collection of

information displays a current valid

OMB Control Number. This regulation

involves collections previously

approved by the Office of Management

and Budget under control numbers

0694–0088, ‘‘Multi-Purpose

Application,’’ which carries a burden

hour estimate of 45 minutes per manual

submission and 40 minutes per

electronic submission. Miscellaneous

and recordkeeping activities account for

12 minutes per submission. Information

is also collected under OMB control

number 0694–0107, ‘‘National Defense

Authorization Act,’’ Advance

Notifications and Post-Shipment

Verification Reports, which carries a

burden hour estimate of 15 minutes per

report. This rule also involves

collections of information under OMB

control number 0694–0073, ‘‘Export

Controls of High Performance

Computers’’ and OMB control number

0694–0093, ‘‘Import Certificates and

End-User Certificates.’’

3. This rule does not contain policies

with Federalism implications as that

5444 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

term is defined in Executive Order

13132.

4. The provisions of the

Administrative Procedure Act requiring

notice of proposed rule making, the

opportunity for public participation,

and a delay in effective date, are

inapplicable because this regulation

involves a military or foreign affairs

function of the United States (see 5

U.S.C. 553(a)(1)). Further, no other law

requires that a notice of proposed rule

making and an opportunity for public

comment be given for this rule. Because

a notice of proposed rule making and

opportunities for public comment are

not required to be given for this rule by

5 U.S.C. 553, or by any other law, the

analytical requirements of the

Regulatory Flexibility Act, 5 U.S.C. 601

et seq., are inapplicable.

Therefore, this regulation is issued in

final form. Although there is no formal

comment period, public comments on

this regulation are welcome on a

continuing basis. Comments should be

submitted to Office of Exporter Services,

Bureau of Export Administration,

Department of Commerce, P.O. Box 273,

Washington, DC 20044.

List of Subjects

15 CFR Parts 740 and 748

Administrative practice and

procedure, Exports, Foreign trade,

Reporting and record keeping

requirements.

15 CFR Part 742

Exports, Foreign trade.

Accordingly, parts 740, 742 and 748

of the Export Administration

Regulations (15 CFR Parts 730–799) are

amended as follows:

1. The authority citation for 15 CFR

Part 740 is revised to read as follows:

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

L. No. 106–508; 50 U.S.C. 1701 et seq.; E.O.

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

917; E.O. 13026, 61 FR 58767, 3 CFR, 1996

Comp., p. 228; Notice of August 3, 2000 (65

FR 48347, August 8, 2000).

2. The authority citation for 15 CFR

Part 742 is revised to read as follows:

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

L. No. 106–508; Pub.L. No. 106–398; 50

U.S.C. 1701 et seq.; 18 U.S.C. 2510 et seq.;

22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; E.O.

12058, 43 FR 20947, 3 CFR, 1978 Comp., p.

179; E.O. 12851, 58 FR 33181, 3 CFR, 1993

Comp., p. 608; E.O. 12924, 59 FR 43437, 3

CFR, 1994 Comp., p. 917; E.O. 12938, 59 FR

59099, 3 CFR, 1994 Comp., p. 950; E.O.

13026, 61 FR 58767, 3 CFR, 1996 Comp., p.

228; Notice of November 10, 1999, 64 FR

61767, 3 CFR, 1999 Comp., p. 318; Notice of

August 3, 2000 (65 FR 48347, August 8,

2000).

3. The authority citation for part 748

is revised to read as follows:

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

L. No. 106–508; 50 U.S.C. 1701 et seq.; E.O.

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

917; E.O. 13026, 61 FR 58767, 3 CFR, 1996

Comp., p. 228; Notice of August 3, 2000 (65

FR 48347, August 8, 2000).

PART 740—[AMENDED]

4. Part 740 is amended by revising

section 740.7, to read as follows:

§ 740.7 Computers (CTP).

(a) Scope. License Exception CTP

authorizes exports and reexports of

computers and specially designed

components therefor, exported or

reexported separately or as part of a

system for consumption in Computer

Tier countries as provided by this

section. (Related equipment controlled

under 4A003.d and .g is authorized

under this License Exception, only

when exported or reexported with these

computers as part of a system.) You may

not use this License Exception to export

or reexport items that you know will be

used to enhance the CTP beyond the

eligibility limit allowed to your country

of destination. When evaluating your

computer to determine License

Exception CTP eligibility, use the CTP

parameter to the exclusion of other

technical parameters for computers

classified under ECCN 4A003.a, .b and

.c, except of parameters specified as

Missile Technology (MT) concerns or

4A003.e (equipment performing analogto-digital conversions exceeding the

limits in ECCN 3A001.a.5.a). This

License Exception does not authorize

the export or reexport of graphic

accelerators or coprocessors, or of

computers controlled for MT reasons.

(b) Computer Tier 1. (1) Eligible

countries. The countries that are eligible

to receive exports under this License

Exception include Antigua and

Barbuda, Argentina, Australia, Austria,

Bahamas, Barbados, Bangladesh,

Belgium, Belize, Benin, Bhutan, Bolivia,

Botswana, Brazil, Brunei, Burkina Faso,

Burma, Burundi, Cameroon, Cape

Verde, Central African Republic, Chad,

Czech Republic, Chile, Colombia,

Congo, Costa Rica, Cote d’Ivoire,

Cyprus, Denmark, Dominica, Dominican

Republic, Ecuador, El Salvador,

Equatorial Guinea, Eritrea, Estonia,

Ethiopia, Fiji, Gabon, Finland, France,

Gambia (The), Germany, Ghana, Greece,

Grenada, Guatemala, Guinea, GuineaBissau, Guyana, Haiti, Honduras, Hong

Kong, Hungary, Iceland, Indonesia,

Ireland, Italy, Jamaica, Japan, Kenya,

Kiribati, Korea (Republic of), Lesotho,

Liberia, Liechtenstein, Luxembourg,

Madagascar, Malawi, Malaysia,

Maldives, Mali, Malta, Marshall Islands,

Mauritius, Mexico, Micronesia

(Federated States of), Monaco,

Mozambique, Namibia, Nauru, Nepal,

Netherlands, New Zealand, Nicaragua,

Niger, Nigeria, Norway, Palau, Panama,

Papua New Guinea, Paraguay, Peru,

Philippines, Poland, Portugal, Romania,

Rwanda, St. Kitts & Nevis, St. Lucia, St.

Vincent and Grenadines, Sao Tome &

Principe, San Marino, Senegal,

Seychelles, Sierra Leone, Singapore,

Slovakia, Slovenia, Solomon Islands,

Somalia, South Africa, Spain, Sri Lanka,

Surinam, Swaziland, Sweden,

Switzerland, Taiwan, Tanzania, Togo,

Tonga, Thailand, Trinidad and Tobago,

Turkey, Tuvalu, Uganda, United

Kingdom, Uruguay, Vatican City,

Venezuela, Western Sahara, Western

Samoa, Zaire, Zambia, and Zimbabwe.

As of May 19, 2001, Lithuania is a

Computer Tier 1 country.

(2) Eligible computers. The computers

eligible for License Exception CTP to

Tier 1 destinations are those having a

Composite Theoretical Performance

(CTP) greater than 6,500 Millions of

Theoretical Operations Per Second

(MTOPS).

(c) [Reserved]

(d) Computer Tier 3. (1) Eligible

countries. The countries that are eligible

to receive exports and reexports under

this License Exception are Afghanistan,

Albania, Algeria, Andorra, Angola,

Armenia, Azerbaijan, Bahrain, Belarus,

Bosnia & Herzegovina, Bulgaria,

Cambodia, China (People’s Republic of),

Comoros, Croatia, Djibouti, Egypt,

Georgia, India, Israel, Jordan,

Kazakhstan, Kosovo (Serbian province

of), Kuwait, Kyrgyzstan, Laos, Latvia,

Lebanon, Lithuania, Macau, Macedonia

(The Former Yugoslav Republic of),

Mauritania, Moldova, Mongolia,

Montenegro, Morocco, Oman, Pakistan,

Qatar, Russia, Saudi Arabia, Serbia,

Tajikistan, Tunisia, Turkmenistan,

Ukraine, United Arab Emirates,

Uzbekistan, Vanuatu, Vietnam, and

Yemen. As of May 19, 2001, Lithuania

is moved to Computer Tier 1.

(2) Eligible computers. The computers

eligible for License Exception CTP to

Tier 3 destinations are those having a

CTP greater than 6,500 MTOPS, but less

than or equal to 85,000 MTOPS, subject

to the restrictions in paragraph (d)(3) of

this section.

(3) Eligible exports. Only exports and

reexports to permitted end-users and

end-uses located in countries in

Computer Tier 3. License Exception

CTP does not authorize exports and

reexports to Computer Tier 3 for

nuclear, chemical, biological, or missile

end-users and end-uses and military

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5445

end-users and end-uses subject to

license requirements under § 744.2,

§ 744.3, § 744.4, § 744.5, and § 744.12 of

the EAR. Such exports and reexports

will continue to require a license and

will be considered on a case-by-case

basis. Retransfers to these end-users and

end-uses in eligible countries are strictly

prohibited without prior authorization.

(4) Supporting documentation.

Exporters are required to obtain a

People’s Republic of China (PRC) EndUser Certificate before exporting

computers described by paragraph (d)(2)

of this section to the PRC, regardless of

value. (See § 748.10(b)(3) of the EAR for

information on obtaining the PRC EndUser Certificate.) Exporters are required

to provide the PRC End-User Certificate

Number to BXA as part of their postshipment report (see paragraph (d)(5)(v)

of this section). When providing the

PRC End-User Certificate Number to

BXA, you must identify the transaction

in the post shipment report to which

that PRC End-User Certificate Number

applies. The original PRC End-User

Certificate shall be retained in the

exporter’s files in accordance with the

recordkeeping provisions of § 762.2 of

the EAR.

(5) NDAA notification. (i) General

requirement and procedures. The

National Defense Authorization Act

(NDAA) of FY98 (Public Law 105–85,

111 Stat. 1629), enacted on November

18, 1997 requires advance notification

of certain exports and reexports of

computers to Computer Tier 3 countries.

For each such transaction destined to

Computer Tier 3, prior to using License

Exception CTP, you must first notify

BXA by submitting a completed

Multipurpose Application Form (BXA–

748P). The Multipurpose Application

Form must be completed including all

information required for a license

application according to the instructions

described in Supplement No. 1 to part

748 of the EAR, with two exceptions.

You (the applicant as listed in Block 14)

shall in Block 5 (Type of Application)

mark the box ‘‘Other.’’ This designator

will permit BXA to route the NDAA

notice into a special processing

procedure. (Blocks 6 and 7, regarding

support documentation, may be left

blank.) BXA will not initiate the

registration of an NDAA notice unless

all information on the Multipurpose

Application form is complete.

(A) Prior to February 26, 2001,

advance notification is required for all

exports and reexports of computers with

a CTP greater than 12,500 but less than

or equal to 85,000 MTOPS to Computer

Tier 3 destinations. You must also

provide a notice using this procedure

prior to exporting or reexporting items

that you know will be used to enhance

the CTP of a previously exported or

reexported computer beyond 12,500

MTOPS, but less than or equal to 85,000

MTOPS.

(B) Beginning on February 26, 2001

but prior to March 20, 2001, advanced

notification is required for export and

reexport of computers with a CTP

greater than 28,000 MTOPS, but less

than or equal to 85,000 MTOPS to

Computer Tier 3 destinations. You must

also provide a notice using this

procedure prior to exporting or

reexporting items that you know will be

used to enhance the CTP of a previously

exported or reexported computer

beyond 28,000 MTOPS, but less than or

equal to 85,000 MTOPS.

(ii) Action by BXA. Within 24 hours

of the registration of the NDAA notice,

BXA will refer the notice for interagency

review. Registration is defined as the

point at which the notice is entered into

BXA’s electronic system.

(iii) Review by other departments or

agencies. The Departments of Defense,

Energy, and State have the authority to

review the NDAA notice. Objections by

any department or agency must be

received by the Secretary of Commerce

within nine days of the referral. Unlike

the provisions described in § 750.4(b) of

the EAR, there are no provisions for

stopping the processing time of the

NDAA notice. If, within 10 days after

the date of registration, any reviewing

agency provides a written objection to

the export or reexport of a computer,

License Exception CTP may not be used.

In such cases, you will be notified that

a license is required for the export or

reexport. The NDAA notice will then be

processed by BXA as a license

application in accordance to the

provisions described in § 750.4 of the

EAR, and the licensing policies set forth

in the Export Administration

Regulations. Its NDAA notice number

will be changed to a license application

number. BXA may at this time request

additional information to properly

review the license application. If BXA

confirms that no objection has been

raised within the 10-day period (as

described in paragraph (d)(5)(iv) of this

section), you may proceed with the

transaction on the eleventh day

following date of registration. (Note that

the fact that you have been advised to

proceed with the transaction does not

exempt you from other licensing

requirements under the EAR, such as

those based on knowledge of a

prohibited end-use or end-user as

referenced in general prohibition five

(part 736 of the EAR) and set forth in

part 744 of the EAR.)

(iv) Status of pending advance

notification requests. You must contact

BXA’s System for Tracking Export

License Applications (‘‘STELA’’) at

(202) 482–2752. (See § 750.5 of the EAR

for procedures to access information on

STELA.) STELA will provide the date of

registration of the NDAA notice. If no

departments or agencies raise objections

within the 10-day period, STELA will

provide you on the eleventh day

following date of registration with

confirmation that no objections have

been raised and you may proceed with

the transaction. BXA will subsequently

issue written confirmation to you. If a

license is required, STELA will notify

you that an objection has been raised

and a license is required. The NDAA

notice will be processed as a license

application. In addition, BXA may

provide notice of an objection by

telephone, fax, courier service, or other

means.

(v) Post-shipment verification. This

section outlines special post-shipment

reporting requirements for exporters of

certain computers to destinations in

Computer Tier 3. Post-shipment reports

must be submitted in accordance with

the provisions of this paragraph

(d)(5)(v), and all relevant records of

such exports must be kept in accordance

with part 762 of the EAR.

(A) Exporters must file post-shipment

reports for computer exports, as well as

exports of items used to enhance

previously exported or reexported

computers, according to the following

schedule:

(1) For exports occurring prior to

February 26, 2001, where the CTP is

greater than 12,500 MTOPS; and

(2) For exports on or after February

26, 2001, but prior to March 20, 2001,

where the CTP is greater than 28,000

MTOPS.

(B) Information that must be included

in each post-shipment report. No later

than the last day of the month following

the month in which the export takes

place, the exporter must submit the

following information to BXA at the

address listed in paragraph (d)(5)(v)(C)

of this section:

(1) Exporter name, address, and

telephone number;

(2) NDAA notification number;

(3) Date of export;

(4) End-user name, point of contact,

address, telephone number;

(5) Carrier;

(6) Air waybill or bill of lading

number;

(7) Commodity description,

quantities—listed by model numbers,

serial numbers, and CTP level in

MTOPS; and

5446 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

(8) Certification line for exporters to

sign and date. The exporter must certify

that the information contained in the

report is accurate to the best of his or

her knowledge.

Note to paragraph (d)(5)(v)(B) of this

section: For exports authorized under

License Exception CTP to the People’s

Republic of China (PRC), you must submit

the PRC End-User Certificate Number

identifying the transaction for which the

End-User Certificate Number applies.

(C) Mailing address. A copy of the

post-shipment report[s] required under

paragraph (d)(5)(v) of this section shall

be delivered to one of the following

addresses. Note that BXA will not

accept reports sent C.O.D.

(1) For deliveries by U.S. postal service:

U.S. Department of Commerce,

Bureau of Export Administration, P.O.

Box 273, Washington, D.C. 20044,

Attn: Office of Enforcement Analysis

HPC Team, Room 4065.

(2) For courier deliveries: U.S.

Department of Commerce, Office of

Enforcement Analysis HPC Team,

14th Street and Constitution Ave.,

NW, Room 4065, Washington, DC

20230.

(e) Restrictions. (1) Access by certain

foreign nationals. Computers eligible for

License Exception CTP may not be

accessed either physically or

computationally by nationals of Cuba,

Iran, Iraq, Libya, North Korea, Sudan or

Syria, except commercial consignees

described in Supplement No. 3 to part

742 of the EAR are prohibited only from

giving such nationals user-accessible

programmability.

(2) Reexport and retransfers.

Computers eligible for License

Exception CTP may not be reexported/

retransferred without prior

authorization from BXA i.e., a license, a

permissive reexport, another License

Exception, or ‘‘No License Required’’.

This restriction must be conveyed to the

consignee, via the Destination Control

Statement, see § 758.6 of the EAR.

Additionally, the end-use and end-user

restrictions in paragraph (d)(3) of this

section must be conveyed to any

consignee in Computer Tier 3.

(f) Reporting requirements. In

addition to the reporting requirements

set forth in paragraph (d) of this section,

see § 743.1 of the EAR for additional

reporting requirements of certain items

under License Exception CTP.

PART 742—[AMENDED]

5. Section 742.12 is amended by

removing the second sentence in

paragraph (d); revising paragraph (a);

removing and reserving paragraph

(b)(2); and revising paragraph (b)(3) to

read as follows:

§ 742.12 High performance computers.

(a) License and recordkeeping

requirements. (1) This section contains

special provisions for exports, reexports,

and certain intra-country transfers of

high performance computers, including

software, and technology. This section

affects the following ECCNs: 4A001;

4A002; 4A003; 4D001; 4D002; and

4E001. Licenses are required under this

section for ECCN’s having an ‘‘XP’’

under ‘‘Reason for Control’’ when

License Exception CTP is not available

(see § 740.7 of the EAR). License

requirements reflected in this section

are based on particular destinations,

end-users, or end-uses. For the

calculation of CTP, see the Technical

Note that follows the Advisory Notes for

Category 4 in the Commerce Control

List. Note that License Exception CTP

contains restrictions on access by

nationals of certain countries, and on

reexports and transfers of computers.

(2) In recognition of the strategic and

proliferation significance of high

performance computers, a license is

required for the export or reexport of

high performance computers to

destinations, end-users, and end-uses,

as specified in this section and on the

CCL. These license requirements

supplement requirements that apply for

other control reasons, such as nuclear

nonproliferation provided in section

742.3 of the EAR. The license

requirements described in this section

742.12 are not reflected on the Country

Chart (Supplement No. 1 to part 738 of

the EAR). Three Computer Country

Tiers have been established for the

purposes of these controls. Countries

included in Computer Tiers 1 and 3 are

listed in License Exception CTP in

section 740.7 of the EAR. As of January

19, 2001 there is no longer a Computer

Tier 2, and countries that were in Tier

2 are incorporated into Computer Tier 1.

Computer Tier 4 consists of Cuba, Iran,

Iraq, Libya, North Korea, Sudan, and

Syria.

(3) Exporters must keep accurate

records of each export to countries not

included in Country Group A:1 (see

Supplement No. 1 to part 740 of the

EAR) of a computer with a CTP greater

than 6,500 MTOPS. These records must

be submitted semiannually to BXA and

must contain the information as

described in § 743.1 of the EAR.

(b) * * *

(1) * * *

(2) [Reserved]

(3) Computer Tier 3. (i) License

requirement. (A) A license is required to

export or reexport computers to

countries in Computer Tier 3 to nuclear,

chemical, biological, or missile endusers and end-uses and military endusers and end-uses subject to license

requirements under § 744.2, § 744.3,

§ 744.4, § 744.5, and § 744.12 of the EAR

in Computer Tier 3 countries.

(B) A license is required to export or

reexport computers with a CTP greater

than 85,000 MTOPS to a country in

Computer Tier 3.

(C) Prior to February 26, 2001, a

license may be required to export or

reexport computers with a CTP greater

than 12,500 MTOPS to countries in

Computer Tier 3 pursuant to the NDAA

(see § 740.7(d)(5) of the EAR). Beginning

on February 26, 2001 but prior to March

20, 2001, a license may be required to

export or reexport computers with a

CTP greater than 28,000 MTOPS but less

than or equal to 85,000 MTOPS to

countries in Computer Tier 3 pursuant

to the NDAA.

(ii) Licensing policy for nuclear,

chemical, biological, or missile endusers and end-uses and military endusers and end-uses. License

applications for exports and reexports to

nuclear, chemical, biological, or missile

end-users and end-uses and military

end-users and end-uses subject to

license requirements under § 744.2,

§ 744.3, § 744.4, § 744.5, and § 744.12 of

the EAR in countries in Computer Tier

3 will be reviewed on a case-by-case

basis using the following criteria:

(A) The presence and activities of

countries and end-users of national

security and proliferation concern and

the relationships that exist between the

government of the importing country

and such countries and end-users;

(B) The ultimate consignee’s

participation in, or support of, any of

the following:

(1) Activities that involve national

security concerns; or

(2) Nuclear, chemical, biological or

missile proliferation activities described

in part 744 of the EAR;

(C) The extent to which the importing

country is involved in nuclear,

chemical, biological, or missile

proliferation activities described in part

744 of the EAR;

(D) The end-user, whether the end-use

is single-purpose or multiple-purpose.

(iii) Licensing policy for other endusers and end-uses. License

applications for exports and reexports to

other end-uses and end-users located in

Computer Tier 3 countries will

generally be approved, except there is a

presumption of denial for all

applications for exports and reexports of

computers having a CTP greater than

6,500 MTOPS destined to Indian and

Pakistani entities determined to be

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5447

involved in nuclear, missile, or military

activities included in Supplement No. 4

to part 744 (Entity List). All license

applications for exports and reexports to

India and Pakistan not meeting these

criteria for presumption of denial will

be considered on a case-by-case basis

under other licensing policies set forth

in the EAR applicable to such

computers.

(iv) Post-shipment verification. This

section outlines special post-shipment

reporting requirements for exporters of

certain computers to destinations in

Computer Tier 3. Post-shipment reports

must be submitted in accordance with

the provisions of this paragraph

(b)(3)(iv), and all relevant records of

such exports must be kept in accordance

with part 762 of the EAR.

(A) Exporters must file post-shipment

reports for computer exports, as well as

exports of items used to enhance

previously exported or reexported

computers, according to the following

schedule:

(1) For exports occurring prior to

February 26, 2001, where the CTP is

greater than 12,500 MTOPS;

(2) For exports on or after February

26, 2001, but before March 20, 2001

where the CTP is greater than 28,000

MTOPS; and

(3) For exports on or after March 20,

2001 where the CTP is greater than

85,000 MTOPS.

(B) Information that must be included

in each post-shipment report. No later

than the last day of the month following

the month in which the export takes

place, the exporter must submit the

following information to BXA at the

address listed in paragraph (b)(3)(iv)(C)

of this section:

(1) Exporter name, address, and

telephone number;

(2) License number;

(3) Date of export;

(4) End-user name, point of contact,

address, telephone number;

(5) Carrier;

(6) Air waybill or bill of lading

number;

(7) Commodity description,

quantities—listed by model numbers,

serial numbers, and CTP level in

MTOPS; and

(8) Certification line for exporters to

sign and date. The exporter must certify

that the information contained in the

report is accurate to the best of his or

her knowledge.

(C) Mailing address. A copy of the

post-shipment report[s] required under

paragraph (b)(3)(iv)(A) of this section

shall be delivered to one of the

following addresses. Note that BXA will

not accept reports sent C.O.D.

(1) For deliveries by U.S. postal service:

U.S. Department of Commerce,

Bureau of Export Administration, P.O.

Box 273, Washington, D.C. 20044,

Attn: Office of Enforcement Analysis

HPC Team, Room 4065.

(2) For courier deliveries: U.S.

Department of Commerce, Office of

Enforcement Analysis HPC Team,

14th Street and Constitution Ave.,

NW, Room 4065, Washington, DC

20230.

* * * * *

PART 748—[AMENDED]

6. Section 748.10 is amended by

revising paragraph (b)(3) as follows:

§ 748.10 Import and end-user certificates.

* * * * *

(b) * * *

(3) Your transaction involves an

export to the People’s Republic of China

(PRC) of a computer. You must obtain

a PRC End-User Certificate, regardless of

dollar value, as follows:

(i) For exports of computers as

described by § 740.7(d)(2) of the EAR,

regardless of value, to the People’s

Republic of China. (See paragraph (c) of

this section for information on obtaining

the PRC End-User Certificate.) Exporters

are required to obtain a PRC End-User

Certificate before exporting computers

to the PRC. In addition, exporters are

required to provide the PRC End-User

Certificate Number to BXA as part of

their post-shipment report (see

§ 740.7(d)(5)(v) of the EAR). When

providing the PRC End-User Certificate

Number to BXA, you must identify the

transaction in the post shipment report

to which that PRC End-User Certificate

Number applies. The original PRC EndUser Certificate shall be retained in the

exporter’s files in accordance with the

recordkeeping provisions of § 762.2 of

the EAR.

(ii) For exports of computers that

require license applications.

* * * * *

Dated: January 16, 2001.

Matthew S. Borman,

Acting Deputy Assistant Secretary for Export

Administration.

[FR Doc. 01–1623 Filed 1–16–01; 4:49 pm]

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 207, 807, and 1271

[Docket No. 97N–484R]

Human Cells, Tissues, and Cellular and

Tissue-Based Products; Establishment

Registration and Listing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to require human cells, tissue, and

cellular and tissue-based product

establishments to register with the

agency and list their human cells,

tissues, and cellular and tissue-based

products. FDA is also amending the

registration and listing regulations that

currently apply to human cells, tissues,

and cellular and tissue-based products

regulated as drugs, devices, and/or

biological products. These actions are

being taken to establish a unified

registration and listing program for

human cells, tissues, and cellular and

tissue-based products.

DATES: The regulation is effective April

4, 2001, except for 21 CFR 207.20(f),

807.20(d), and 1271.3(d)(2), which are

effective on January 21, 2003.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Introduction

We, FDA, are putting in place a

comprehensive new system of

regulation for human cells, tissues, and

cellular and tissue-based products. The

goal of the new approach is to improve

protection of the public health without

imposing unnecessary restrictions on

research, development, or the

availability of new products. Under the

new system, the regulation of different

types of human cells, tissues, and

cellular and tissue-based products will

be commensurate with the public health

risks presented, enabling us to use our

resources more effectively.

Consolidating the regulation of human

cells, tissues, and cellular and tissuebased products into one regulatory

program is expected to lead to increased

consistency and greater efficiency.

Together, these planned improvements

will increase the safety of human cells,