Department of State.
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.”
Effective Date: This rule is effective September 19, 2008.
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.
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.Start Further Info
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 Change.End Further Info End Preamble Start Supplemental 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 604).
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 1996.
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 35.Start List of Subjects
List of Subjects in 22 CFR Part 121End List of Subjects Start Amendment Part
Accordingly, for the reasons set forth above, Title 22, Chapter I, Subchapter M, part 121 is amended as follows:End Amendment Part Start Part
PART 121—THE UNITED STATES MUNITIONS LISTEnd Part Start Amendment Part
1. The authority citation for part 121 continues to read as follows:End Amendment Part Start Amendment Part
2. In § 121.1, paragraph (c) Category XIV is amended by adding NOTE 5 to read as follows:End Amendment Part
(c) * * *
Category XIV—Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment
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 Category.
Dated: September 3, 2008.
Frank J. Ruggiero,
Acting Assistant Secretary for Political-Military Affairs, Department of State.
[FR Doc. E8-21832 Filed 9-18-08; 8:45 am]
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