[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF STATE
22 CFR Part 121
[Public Notice: 6364]
Amendment to the International Traffic in Arms Regulations: U.S.
Munitions List Interpretation
AGENCY: Department of State.
ACTION: Final rule.
SUMMARY: The Department of State is amending the International Traffic
in Arms Regulations (ITAR) to clarify that certain anti-tumor drugs are
not within the definition of ``chemical agents.''
DATES: Effective Date: This rule is effective September 19, 2008.
ADDRESSES: Interested parties may submit comments at any time by any of
the following methods:
E-mail: DDTCResponseTeam@state.gov with an appropriate
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.
Persons with access to the Internet may also view this notice by
going to the regulations.gov Web site at: http://www.regulations.gov/
FOR FURTHER INFORMATION CONTACT: Lisa Wenger, Office of Defense Trade
Controls Policy, Department of State; Telephone 202-663-2171 or FAX
202-261-8199; e-mail: DDTCResponseTeam@state.gov. ATTN: Regulatory
SUPPLEMENTARY INFORMATION: In this regulatory change, we clarify that
certain anti-tumor drugs are not considered defense articles under this
subchapter; however, the know-how for production of nitrogen mustards
or their salts is specifically retained on the U.S. Munitions List.
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 contained in 5
U.S.C. 553 and 554.
Regulatory Flexibility Act
Because this final rule is exempt from notice and comment
rulemaking under 5 U.S.C. 553, it is exempt from the provisions of
section 603 and 604 of the Regulatory Flexibility Act (5 U.S.C. 603 and
Unfunded Mandates Act of 1995
This amendment does not involve a mandate that will result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100 million or more in any year and it
will not significantly or uniquely affect small governments. Therefore,
no actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
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
Executive Orders 12372 and 13132
This amendment will not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Therefore, in accordance with Executive
Order 13132, it is determined that this amendment does not have
sufficient federalism implications to require consultations or warrant
the preparation of a federalism summary impact statement. Executive
Order 12372, regarding intergovernmental consultation on Federal
programs and activities, does not apply to this amendment.
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 subject to the Paperwork Reduction Act, 44 U.S.C. Chapter
List of Subjects in 22 CFR Part 121
Arms and munitions, Exports, U.S. Munitions List.
Accordingly, for the reasons set forth above, Title 22, Chapter I,
Subchapter M, part 121 is amended as follows:
PART 121--THE UNITED STATES MUNITIONS LIST
1. The authority citation for part 121 continues to read as follows:
Authority: Secs. 2, 38, and 71, Pub.L. 90-629, 90 Stat. 744 (22
U.S.C. 2752, 2778, 2797); E.O. 11958, 42 FR 4311; 3 CFR, 1977 Comp.
p. 79; 22 U.S.C. 2658; Pub.L. 105-261, 112 Stat. 1920.
2. In Sec. 121.1, paragraph (c) Category XIV is amended by adding NOTE
5 to read as follows:
Sec. 121.1 General. The United States Munitions List.
* * * * *
(c) * * *
* * * * *
Category XIV--Toxicological Agents, Including Chemical Agents,
Biological Agents, and Associated Equipment
* * * * *
Note 5: Pharmacological formulations containing nitrogen
mustards and certain reference standards for these drugs are not
considered to be chemical agents and are licensed by the Department
of Commerce when:
(1) The drug is in the form of a final medical product; or
(2) The reference standard contains salts of HN2 [bis(2-
chloroethyl) methylamine], the quantity to be shipped is 150
milligrams or less, and individual shipments do not exceed twelve
per calendar year per end user.
Technical data for the production of HN1 [bis(2-
chloroethyl)ethylamine]; HN2 [bis(2-chloroethyl)methylamine], HN3
[tris(2-chloroethyl)amine]; or salts of these, such as tris (2-
chloroethyl)amine hydrochloride, remains controlled under this
* * * * *
Dated: September 3, 2008.
Frank J. Ruggiero,
Acting Assistant Secretary for Political-Military Affairs, Department
[FR Doc. E8-21832 Filed 9-18-08; 8:45 am]
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