Amendment to the International Traffic in Arms Regulations: U.S. Munitions List Interpretation, 54314-54315 [E8-21832]

Download as PDF 54314 Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Rules and Regulations Arms Regulations (ITAR) to clarify that certain anti-tumor drugs are not within the definition of ‘‘chemical agents.’’ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Effective Date: This rule is effective September 19, 2008. DATES: 21 CFR Parts 16, 610, 640, 812, 814, 822, and 860 [Docket No. FDA–2008–N–0423] FDA Regulations; Technical Amendment; Correction AGENCY: Food and Drug Administration, HHS. ACTION: 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: https:// www.regulations.gov/index.cfm. ADDRESSES: Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, August 25, 2008 (73 FR 49941). The final rule made technical amendments to several FDA regulations. The document was published with two inaccurate citations in the first paragraph of the Background Section under Supplementary Information. This document corrects that error. DATES: September 19, 2008. FOR FURTHER INFORMATION CONTACT: ´ Denise Sanchez, 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: In FR Doc. E8–19654, appearing on page 49941 in the Federal Register of Monday, August 25, 2008 (73 FR 49941), the following correction is made: On page 49941, in the first paragraph of the Background section under Supplementary Information, ‘‘21 CFR 610.51’’ is corrected to read as ‘‘21 CFR 610.53’’ and ‘‘21 CFR 640.53’’ is corrected to read as ‘‘21 CFR 640.51’’. Dated: September 15, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–21966 Filed 9–18–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF STATE 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. FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: 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. [Public Notice: 6364] yshivers on PROD1PC62 with RULES Amendment to the International Traffic in Arms Regulations: U.S. Munitions List Interpretation Department of State. ACTION: Final rule. AGENCY: SUMMARY: The Department of State is amending the International Traffic in VerDate Aug<31>2005 15:21 Sep 18, 2008 Jkt 214001 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. 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 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). 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. Unfunded Mandates Act of 1995 22 CFR Part 121 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. 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. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 1. The authority citation for part 121 continues to read as follows: 2. In § 121.1, paragraph (c) Category XIV is amended by adding NOTE 5 to read as follows: ■ § 121.1 General. The United States Munitions List. * * * (c) * * * * * * * * * * Category XIV—Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment * E:\FR\FM\19SER1.SGM * * 19SER1 * * Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Rules and Regulations 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(2chloroethyl)methylamine], HN3 [tris(2chloroethyl)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 PoliticalMilitary Affairs, Department of State. [FR Doc. E8–21832 Filed 9–18–08; 8:45 am] BILLING CODE 4710–25–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2008–0915] RIN 1625–AA00 Temporary Safety Zone; Wreckage of the M/V NEW CARISSA, Pacific Ocean 3 Nautical Miles North of the Entrance to Coos Bay, OR Coast Guard, DHS. Temporary final rule. AGENCY: yshivers on PROD1PC62 with RULES ACTION: SUMMARY: The Coast Guard is establishing a temporary safety zone on the waters of the Pacific Ocean encompassed in the 1,000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 nautical miles north of the entrance to Coos Bay, Oregon. The Captain of the Port Portland is taking this action to safeguard individuals and vessels involved in a salvage operation involving the M/V NEW CARISSA. Entry into this safety zone is prohibited unless authorized by the Captain of the Port or his designated representative. DATES: This regulation is effective from 12:01 p.m. August 31, 2008, to 12 p.m. September 30, 2008. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket USCG–2008– 0915 and are available online at www.regulations.gov. They are also available for inspection or copying at VerDate Aug<31>2005 15:21 Sep 18, 2008 Jkt 214001 two locations: the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and Coast Guard Sector Portland, 6767 N. Basin Ave., Portland, OR 97217, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary rule, call MST1 Jaime Sayers, Waterways Management, at (503) 240– 9311. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826. SUPPLEMENTARY INFORMATION: Regulatory Information The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency, for good cause, finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because immediate action is necessary to protect human safety of those involved in the salvage operations of the NEW CARISSA. Such action will be taken by limiting public access to the salvage area. For those same reasons under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Background and Purpose This rule is related to the safety zone published in the Federal Register on June 27, 2008 (73 FR 36433). In that rule the Coast Guard established a temporary safety zone on the waters of the Pacific Ocean encompassed in the 1,000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 nautical miles north of the entrance to Coos Bay, Oregon. The Captain of the Port Portland took that action to safeguard individuals and vessels involved in a salvage operation involving the wreck of the M/V NEW CARISSA. With this rule, for the same reasons as stated above, the Coast Guard is establishing a safety zone in the same area because individuals involved in the PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 54315 salvage operation of the NEW CARISSA have not completed their task. Entry into this safety zone is prohibited from 12:01 p.m. August 31, 2008 to 12 p.m. September 30, 2008, unless authorized by the Captain of the Port or his designated representative. This safety zone will be enforced by representatives of the Captain of the Port Portland. The Captain of the Port may be assisted by other federal, state, and local agencies. Discussion of Rule This rule, for safety concerns, will control vessels, personnel, and individual movements on the waters of the Pacific Ocean encompassed in the 1,000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 nautical miles north of the entrance to Coos Bay, Oregon. Entry into this safety zone is prohibited unless authorized by the Captain of the Port or his designated representative. Coast Guard Personnel and local law enforcement will enforce this safety zone. Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders. Regulatory Planning and Review This rule is not a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. Although this regulation restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; (ii) the safety zone is of limited size; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term ‘‘small entities’’ comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. E:\FR\FM\19SER1.SGM 19SER1

Agencies

DEPARTMENT OF STATE

[Federal Register Volume 73, Number 183 (Friday, September 19, 2008)]
[Rules and Regulations]
[Pages 54314-54315]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21832]


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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 
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: https://www.regulations.gov/
index.cfm.

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.

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 
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.

List of Subjects in 22 CFR Part 121

    Arms and munitions, Exports, U.S. Munitions List.

0
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

0
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.


0
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

* * * * *


[[Page 54315]]


    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 
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]
BILLING CODE 4710-25-P

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