### 37294 Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations

of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Hamilton Municipal Airport, Hamilton, TX. List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment

■ In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows:
**PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR**  **TRAFFIC SERVICE ROUTES; AND REPORTING POINTS** 

■ 1. The authority citation for 14 CFR Part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389.
**§ 71.1 [Amended]**

■ 2. The incorporation by reference in 14 CFR Part 71.1 of the Federal Aviation Administration Order 7400.9T, Airspace Designations and Reporting Points, signed August 27, 2009, and effective September 15, 2009 is amended as follows: Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface. * * * * *
ASW TX E5 Hamilton, TX [Amended] Hamilton Municipal Airport, TX

(Lat. 31 ° 39 ′ 57′′ N., long. 98 ° 08 ′ 55 ′′ W.) Hamilton NDB

(Lat. 31 ° 37 ′ 13 ′′ N., long. 98 ° 08 ′ 51 ′′ W.) That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Hamilton Municipal Airport, and within 3.7 miles each side of the 009 ° bearing from the airport extending from the 6.4-mile radius to 8.6 miles north of the airport, and within 4 miles each side of the 189 ° bearing from the airport extending from the 6.4-mile radius to 9.6 miles south of the airport, and within 8 miles east and 4 miles west of the 170 ° bearing from the Hamilton NDB extending from the NDB to 16 miles south of the NDB.

Issued in Fort Worth, Texas on June 16, 2010. Anthony D. Roetzel, Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2010–15672 Filed 6–28–10; 8:45 am]

**BILLING CODE 4910–13–P DEPARTMENT OF TRANSPORTATION** 

**Federal Aviation Administration**

**14 CFR Part 71 [Docket No. FAA–2009–1135; Airspace**  **Docket No. 09–ANM–20] Modification of Class E Airspace;**  **Kelso, WA**

**AGENCY :**  Federal Aviation Administration (FAA), DOT.
**ACTION :**  Final rule.

**SUMMARY :**  This action will amend existing Class E airspace at Kelso, WA, to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedure (SIAP) at Southwest Washington Regional Airport. This will improve the safety and management of Instrument Flight Rules (IFR) operations at the airport.
**DATES :**  Effective date, 0901 UTC, September 23, 2010. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
**FOR FURTHER INFORMATION CONTACT :**  Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203–4537.
**SUPPLEMENTARY INFORMATION :**  History

On April 19, 2010, the FAA published in the Federal Register a notice of proposed rulemaking to amend controlled airspace at Kelso, WA (75 FR 20322). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9T signed August 27, 2009, and effective September 15, 2009, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.
The Rule

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E airspace extending upward from 700 feet above the surface, at Southwest Washington Regional Airport, providing adequate controlled airspace to accommodate IFR aircraft executing new RNAV GPS SIAP’s at the airport. This action is necessary for the safety and management of IFR operations.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA’s authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it provides additional controlled airspace at Southwest Washington Regional Airport, Kelso, WA. List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment

■ In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
**PART 71–DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR**  **TRAFFIC SERVICE ROUTES; AND REPORTING POINTS** 

■ 1. The authority citation for 14 CFR part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389.
**§ 71.1 [Amended]**

■ 2. The incorporation by reference in 14 CFR 71.1 of the Federal Aviation Administration Order 7400.9T, Airspace Designations and Reporting Points,


### 37295 Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations

signed August 27, 2009, and effective September 15, 2009 is amended as follows:
Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface of the earth. * * * * * ANM WA, ES Kelso, WA [Modified] Southwest Washington Regional Airport, WA

(Lat. 46 ° 07 ′05 ′′ N., long. 122 ° 53 ′ 54′′ W.) * * * * *

That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of the Southwest Washington Regional Airport, and 2.4 miles each side of the 290 ° bearing of the airport extending 9.1 miles west, and 4.3 miles each side of the 337 ° bearing of the airport extending 22.2 miles northwest, and 5.8 miles west and 3 miles east of the 012 ° bearing of the airport extending 18.2 miles north of the airport.

Issued in Seattle, Washington, on June 14, 2010. Kevin Nolan, Acting Manager, Operations Support Group, Western Service Center. [FR Doc. 2010–15436 Filed 6–28–10; 8:45 am]

**BILLING CODE 4910–13–M**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 
**Food and Drug Administration**

**21 CFR Parts 312 and 314 [Docket No. FDA–2010–N–0010]**  **Change of Address; Abbreviated New Drug Applications; Technical**  **Amendment**

**AGENCY :**  Food and Drug Administration, HHS.
**ACTION :**  Final rule; technical amendment.

**SUMMARY :**  The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit abbreviated new drug applications (ANDAs) and ANDA amendments, supplements, and resubmissions. FDA is also updating the address for ANDA applicants to submit investigational new drug applications (INDs) for in vivo bioavailability and bioequivalence studies in humans that are intended to support ANDAs. This action is being taken to ensure accuracy and clarity in the agency’s regulations.
**DATES :**  This rule is effective August 1, 2010.

**FOR FURTHER INFORMATION CONTACT :**  Martin Shimer, Center for Drug Evaluation and Research, Food and Drug Administration, 7500 Standish Pl., MPN II, Rockville, MD 20855, 240–276– 8675.

**SUPPLEMENTARY INFORMATION :**  FDA is amending 21 CFR 314.440(a)(2) to update the address for applicants to submit ANDAs and ANDA amendments, supplements, and resubmissions. FDA is also amending 21 CFR 312.140(a)(1) to update the address for ANDA applicants to submit INDs for in vivo bioavailability and bioequivalence studies that are intended to support ANDAs. The new address for all these submissions is Office of Generic Drugs (HFD–600), Center for Drug Evaluation and Research, Food and Drug Administration, Metro Park North VII, 7620 Standish Pl., Rockville, MD 20855. This action is being taken to ensure accuracy and clarity in the agency’s regulations.

Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical changes to update an address for the submission of ANDAs; ANDA amendments, supplements, and resubmissions; and INDs related to ANDAs. List of Subjects

21 CFR Part 312

Drugs, Exports, Imports, Investigations, Labeling, Medical research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 314

Administrative practice and procedure, Confidential business information, Drugs, Reporting and recordkeeping requirements.

■ Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 312 and 314 are amended as follows:

**PART 312—INVESTIGATIONAL NEW DRUG APPLICATION** 

■ 1. The authority citation for 21 CFR part 312 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
**§ 312.140 [Amended]**

■ 2. Section 312.140 is amended in paragraph (a)(1) by removing ‘‘II, 7500 ’’ and adding in its place ‘‘VII, 7620 ’’

. **PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG** 

■ 3. The authority citation for 21 CFR part 314 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e. **§ 314.440 [Amended]**

■ 4. Section 314.440 is amended in the first sentence of paragraph (a)(2) by removing ‘‘II, 7500 Standish Place., rm. 150 ’’ and adding in its place ‘‘VII, 7620 Standish Pl. ’’

.

Dated: June 23, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–15711 Filed 6–28–10; 8:45 am]

**BILLING CODE 4160–01–S**

**DEPARTMENT OF JUSTICE**
**Drug Enforcement Administration**

**21 CFR Part 1308**
**[Docket No. DEA–305F]**

**RIN 1117–AB16**

**Control of Immediate Precursor Used in the Illicit Manufacture of Fentanyl as**  **a Schedule II Controlled Substance**

**AGENCY :**  Drug Enforcement Administration (DEA), Department of Justice.
**ACTION :**  Final Rule.

**SUMMARY :**  The Drug Enforcement Administration (DEA) is designating theprecursor chemical, 4-anilino-Nphenethyl-4-piperidine (ANPP) as an immediate precursor for the schedule II controlled substance fentanyl under the definition set forth in 21 U.S.C. 802(23). Furthermore, DEA is finalizing the control of ANPP as a schedule II substance under the Controlled Substances Act (CSA), pursuant to the authority in 21 U.S.C. 811(e), which states that an immediate precursor may be placed in the same schedule as the controlled substance it produces, without regard to the procedures required by 21 U.S.C. 811(a) and (b) and without regard to the findings required by 21 U.S.C. 811(a) and 812(b).

ANPP is the immediate chemical intermediary in the synthesis process currently used by clandestine laboratory operators for the illicit manufacture of the schedule II controlled substance fentanyl. In 2005 and 2006, the distribution of illicitly manufactured fentanyl caused an unprecedented outbreak of hundreds of fentanyl-related