54314 Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

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: 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 Sa ́nchez, 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 

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: http:// 

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. 

■ 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 § 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 

* * * * * 


yshivers on PROD1PC62 with RULES
Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Rules and Regulations 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 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 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

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 

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 

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. 


yshivers on PROD1PC62 with RULES