15830 Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

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

360j, 371. 

■ 2. Section 866.3305 is revised to read 

as follows: 

§ 866.3305 Herpes simplex virus 

serological assays. 

(a) Identification. Herpes simplex 

virus serological assays are devices that 

consist of antigens and antisera used in 

various serological tests to identify 

antibodies to herpes simplex virus in 

serum. Additionally, some of the assays 

consist of herpes simplex virus antisera 

conjugated with a fluorescent dye 

(immunofluorescent assays) used to 

identify herpes simplex virus directly 

from clinical specimens or tissue 

culture isolates derived from clinical 

specimens. The identification aids in 

the diagnosis of diseases caused by 

herpes simplex viruses and provides 

epidemiological information on these 

diseases. Herpes simplex viral 

infections range from common and mild 

lesions of the skin and mucous 

membranes to a severe form of 

encephalitis (inflammation of the brain). 

Neonatal herpes virus infections range 

from a mild infection to a severe 

generalized disease with a fatal 

outcome. 

(b) Classification. (1) Class II (special 

controls). The device is classified as 

class II (special controls) if the herpes 

simplex virus serological assay is type 1 

and/or 2. The special control for the 

device is FDA’s guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological 

Assays.’’ For availability of the guidance 

document, see § 866.1(e). 

(2) Class III (premarket approval). The 

device is classified as class III if the 

herpes simplex virus serological assay is 

a type other than type 1 and/or 2. 

(c) Date PMA or notice of completion 

of a PDP is required. No effective date 

has been established for the requirement 

for premarket approval for the devices 

described in paragraph (b)(2) of this 

section. See § 866.3. 

Dated: March 23, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–6167 Filed 4–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Part 126 

[Public Notice: 5740] 

Amendment of the International Traffic 

in Arms Regulations: Policy With 

Respect to Vietnam 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: Notice is hereby given that 

the Department of State is amending the 

International Traffic in Arms 

Regulations (ITAR) regarding Vietnam at 

22 CFR 126.1 to make it United States 

policy to consider on a case-by-case 

basis licenses, other approvals, exports 

or imports of non-lethal defense articles 

and defense services destined for or 

originating in Vietnam. The United 

States will deny licenses, other 

approvals, exports or imports of lethal 

defense articles and services destined 

for or originating in Vietnam. Under this 

policy, the exports of lethal-end items, 

components of lethal-end items (unless 

those components are non-lethal, safetyof-use spare parts for lethal-end items), 

non-lethal crowd control defense 

articles and defense services, and night 

vision devices to end-users with a role 

in ground security will not be approved. 

DATES: Effective Date: This rule is 

effective April 3, 2007. 

ADDRESSES: Interested parties may 

submit comments at any time by any of 

the following methods: 

• E-mail: 

DDTCResponseTeam@state.gov with an 

appropriate subject line. 

• Mail: Department of State, 

Directorate of Defense Trade Controls, 

Office of Defense Trade Controls Policy, 

ATTN: Regulatory Change, 12th Floor, 

SA–1, Washington, DC 20522–0112. 

• Fax: 202–261–8199. 

• Hand Delivery or Courier (regular 

work hours only): Department of State, 

Directorate of Defense Trade Controls, 

Office of Defense Trade Controls Policy, 

ATTENTION: Regulatory Change, SA–1, 

12th Floor, 2401 E Street, NW., 

Washington, DC 20037. 

Persons with access to the Internet 

may also view this notice by going to 

the regulations.gov Web site at: http:// 

www.regulations.gov/index.cfm. 

FOR FURTHER INFORMATION CONTACT: Ann 

K. Ganzer, Office of Defense Trade 

Controls Policy, Department of State, 

12th Floor, SA–1, Washington DC 

20522–0112; Telephone 202–663–2792 

or FAX 202–261–8199; e-mail: 

DDTCResponseTeam@state.gov. ATTN: 

Regulatory Change. 

SUPPLEMENTARY INFORMATION: On 

November 2, 2006, the Secretary of State 

modified the U.S. arms transfer policy 

toward Vietnam allowing the sale, lease, 

export, or other transfer of non-lethal 

defense articles and defense services to 

the country. Subsequently, the President 

issued a determination December 29, 

2006 that the furnishing of defense 

articles and services to Vietnam would 

strengthen the security of the United 

States and promote world peace. 

The new policy will not permit the 

export or other transfer to Vietnam of: 

(a) Lethal end items, (b) components of 

lethal end items, unless those 

components are non-lethal, safety-of-use 

spare parts for lethal end items, (c) nonlethal crowd control defense articles 

and defense services, and (d) night 

vision devices to end-users with a role 

in ground security. 

Regulatory Analysis and Notices 

Administrative Procedure Act 

This amendment involves a foreign 

affairs function of the United States and, 

therefore, is not subject to the 

procedures required by 5 U.S.C. 553 and 

554. 

Regulatory Flexibility Act 

This rule does not require analysis 

under the Regulatory Flexibility Act. 

Unfunded Mandates Act of 1995 

This rule does not require analysis 

under the Unfunded Mandates Reform 

Act. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This amendment has been found not 

to be a major rule within the meaning 

of the Small Business Regulatory 

Enforcement Fairness Act of 1996. It 

will not have substantial direct effects 

on the States, the relationship between 

the national Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

Executive Orders 12372 and 13132 

It is determined that this rule does not 

have sufficient federalism implications 

to warrant application of the 

consultation provisions of Executive 

Orders 12372 and 13132. 

Executive Order 12866 

This amendment is exempt from 

review under Executive Order 12866, 

but has been reviewed internally by the 

Department of State to ensure 

consistency with the purposes thereof. 

Paperwork Reduction Act 

This rule does not impose any new 

reporting or recordkeeping requirements 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Rules and Regulations 15831 

subject to the Paperwork Reduction Act, 

44 U.S.C. Chapter 35. 

List of Subjects in 22 CFR Part 126 

Arms and munitions, Exports. 

■ Accordingly, for the reasons set forth 

above, Title 22, Chapter I, Subchapter 

M, part 126 is amended as follows: 

PART 126—GENERAL POLICIES AND 

PRACTICES 

■ 1. The authority citation for part 126 

continues to read as follows: 

Authority: Secs. 2, 38, 40, 42, and 71, Pub. 

L. 90–629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 

2780, 2791, and 2797); E.O. 11958, 42 FR 

4311; 3 CFR, 1977 Comp., p. 79; 22 U.S.C. 

2651a; 22 U.S.C. 287c; E.O. 12918, 59 FR 

28205, 3 CFR, 1994 Comp., p. 899; Sec.1225, 

Pub. L. 108–375. 

■ 2. Section 126.1 is amended by 

revising paragraph (a) and adding 

paragraph (l) to read as follows: 

§ 126.1 Prohibited exports and sales to 

certain countries. 

(a) General. It is the policy of the 

United States to deny licenses and other 

approvals for exports and imports of 

defense articles and defense services, 

destined for or originating in certain 

countries. This policy applies to 

Belarus, Cuba, Iran, North Korea, Syria, 

and Venezuela. This policy also applies 

to countries with respect to which the 

United States maintains an arms 

embargo (e.g., Burma, China, Liberia, 

Somalia, and Sudan) or whenever an 

export would not otherwise be in 

furtherance of world peace and the 

security and foreign policy of the United 

States. Information regarding certain 

other embargoes appears elsewhere in 

this section. Comprehensive arms 

embargoes are normally the subject of a 

State Department notice published in 

the Federal Register. The exemptions 

provided in the regulations in this 

subchapter, except § 123.17 of this 

subchapter, do not apply with respect to 

articles originating in or for export to 

any proscribed countries, areas, or 

persons in this § 126.1. 

* * * * * 

(l) Vietnam. It is the policy of the 

United Sates to deny licenses, other 

approvals, exports or imports of defense 

articles and defense services destined 

for or originating in Vietnam except, on 

a case-by-case basis, for: 

(1) Non-lethal defense articles and 

defense services, and 

(2) Non-lethal, safety-of-use defense 

articles (e.g., cartridge actuated devices, 

propellant actuated devices and 

technical manuals for military aircraft 

for purposes of enhancing the safety of 

the aircraft crew) for lethal end-items. 

For non-lethal defense end-items, no 

distinction will be made between 

Vietnam’s existing and new inventory. 

Dated: March 13, 2007. 

Stephen D. Mull, 

Acting Assistant Secretary for PoliticalMilitary Affairs, Department of State. 

[FR Doc. E7–6149 Filed 4–2–07; 8:45 am] 

BILLING CODE 4710–25–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Parts 538 and 560 

Sudanese Sanctions Regulations; 

Iranian Transactions Regulations 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Final rule. 

SUMMARY: The Office of Foreign Assets 

Control of the U.S. Department of the 

Treasury is amending the Sudanese 

Sanctions Regulations, 31 CFR part 538, 

and the Iranian Transactions 

Regulations, 31 CFR part 560, to 

authorize the exportation or 

reexportation, directly or indirectly, 

from the United States or by a U.S. 

person, wherever located, of any goods 

or technology to a third-country 

government, or to its contractors or 

agents, for shipment to, respectively, 

Sudan or Iran via a diplomatic pouch. 

DATES: Effective Date: April 3, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Assistant Director for Compliance 

Outreach & Implementation, tel.: 202/ 

622–2490, Assistant Director for 

Licensing, tel.: 202/622–2480, Assistant 

Director for Policy, tel.: 202/622–4855, 

or Chief Counsel, tel.: 202/622–2410, 

Office of Foreign Assets Control, 

Department of the Treasury, 

Washington, DC 20220. 

SUPPLEMENTARY INFORMATION: 

Electronic and Facsimile Availability 

This document and additional 

information concerning the Office of 

Foreign Assets Control are available 

from OFAC’s Web site (http:// 

www.treas.gov/ofac) or via facsimile 

through a 24-hour fax-on demand 

service, tel.: (202) 622–0077. 

Background 

The Sudanese Sanctions Regulations, 

31 CFR part 538 (the ‘‘SSR’’), were 

promulgated to implement Executive 

Order 13067 of November 3, 1997 (‘‘E.O. 

13067’’), in which the President 

declared a national emergency with 

respect to the policies and actions of the 

Government of Sudan. To deal with that 

emergency, E.O. 13067 imposed 

comprehensive trade sanctions with 

respect to Sudan and blocked all 

property and interests in property of the 

Government of Sudan in the United 

States or within the possession or 

control of United States persons. 

Subsequently, the President issued 

Executive Order 13412 of October 13, 

2006 (‘‘E.O. 13412’’), to take additional 

steps with respect to the emergency 

declared in E.O. 13067. While it 

exempted specific areas of Sudan from 

certain prohibitions in E.O. 13067, E.O. 

13412 continued the blocking of the 

Government of Sudan’s property and 

interests in property and imposed a 

prohibition on transactions relating to 

Sudan’s petroleum or petrochemical 

industries. E.O. 13412 also removed the 

regional government of Southern Sudan 

from the definition of the Government 

of Sudan. 

Existing § 538.516 of the SSR 

authorizes all transactions in connection 

with the importation into the United 

States from Sudan, or the exportation 

from the United States to Sudan, of 

diplomatic pouches and their contents. 

OFAC is amending this general license 

to expand the scope of authorized 

transactions relating to the importation 

and exportation of diplomatic pouches 

and their contents. Specifically, OFAC 

is revising § 538.516 of the SSR by redesignating the original section as 

§ 538.516(a) and by adding a new 

paragraph (b). New § 538.516(b) 

authorizes the exportation or 

reexportation, directly or indirectly, 

from the United States or by a U.S. 

person, wherever located, of any goods 

or technology to a third-country 

government, or to its contractors or 

agents, for shipment to Sudan via a 

diplomatic pouch. In addition, 

§ 538.516(b) clarifies that, to the extent 

necessary, the shipment by a thirdcountry government to Sudan of U.S.- 

origin goods or technology in a 

diplomatic pouch is authorized. 

The Iranian Transactions Regulations, 

31 CFR part 560 (the ‘‘ITR’’), implement 

a series of Executive orders, beginning 

with Executive Order 12957 of March 

15, 1995, in which the President 

declared a national emergency with 

respect to the actions and policies of the 

Government of Iran. To deal with that 

threat, Executive Order 12957 imposed 

prohibitions on certain transactions 

with respect to the development of 

Iranian petroleum resources. On May 6, 

1995, the President issued Executive 

Order 12959 imposing comprehensive 

trade sanctions to further respond to the 

threat, and on August 19, 1997, the 

President issued Executive Order 13059 


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