Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 60307 

AIRAC 

date State City Airport FDC No. FDC date Subject 

21–Oct–10 CA HALF MOON BAY ......................... HALF MOON BAY ......................... 0/0656 9/7/10 RNAV (GPS) Y RWY 

30, ORIG. 

21–Oct–10 CA HALF MOON BAY ......................... HALF MOON BAY ......................... 0/0657 9/7/10 RNAV (GPS) Y RWY 

12, ORIG. 

21–Oct–10 CA HALF MOON BAY ......................... HALF MOON BAY ......................... 0/0658 9/7/10 RNAV (GPS) Z RWY 

12, ORIG. 

21–Oct–10 CA HALF MOON BAY ......................... HALF MOON BAY ......................... 0/0659 9/7/10 RNAV (GPS) Z RWY 

30, ORIG. 

21–Oct–10 RI BLOCK ISLAND ............................. BLOCK ISLAND STATE ................ 0/0748 9/7/10 RNAV (GPS) RWY 

10, ORIG–A. 

21–Oct–10 RI BLOCK ISLAND ............................. BLOCK ISLAND STATE ................ 0/0752 9/7/10 VOR/DME RWY 10, 

AMDT 5A. 

21–Oct–10 VA RICHMOND ................................... RICHMOND INTL .......................... 0/0805 9/7/10 VOR RWY 25, AMDT 

16A. 

21–Oct–10 VA RICHMOND ................................... RICHMOND INTL .......................... 0/0806 9/7/10 VOR RWY 20, AMDT 

1A. 

21–Oct–10 VA RICHMOND ................................... RICHMOND INTL .......................... 0/0807 9/7/10 VOR RWY 16, AMDT 

27A. 

21–Oct–10 GA GRIFFIN ......................................... GRIFFIN-SPALDING COUNTY ..... 0/2036 9/7/10 GPS RWY 14, ORIG– 

A. 

21–Oct–10 GA GRIFFIN ......................................... GRIFFIN-SPALDING COUNTY ..... 0/2037 9/7/10 GPS RWY 32, ORIG– 

A. 

21–Oct–10 VA FREDERICKSBURG ...................... SHANNON ..................................... 0/2537 9/7/10 GPS RWY 24, ORIG– 

B. 

21–Oct–10 VA FREDERICKSBURG ...................... SHANNON ..................................... 0/2539 9/7/10 NDB RWY 24, AMDT 

2B. 

21–Oct–10 AL TALLADEGA .................................. TALLADEGA MUNI ........................ 0/3032 9/7/10 VOR/DME RWY 3, 

AMDT 5. 

21–Oct–10 VA SALUDA ......................................... HUMMEL FIELD ............................ 0/4180 9/14/10 GPS RWY 1, ORIG– 

A. 

21–Oct–10 VA CHASE CITY ................................. CHASE CITY MUNI ....................... 0/4228 9/14/10 RNAV (GPS) RWY 

18, ORIG. 

21–Oct–10 VA CHASE CITY ................................. CHASE CITY MUNI ....................... 0/4229 9/14/10 RNAV (GPS) RWY 

36, ORIG–A. 

21–Oct–10 MA BOSTON ........................................ GEN EDWARD LAWRENCE 

LOGAN INTL.

0/5055 9/7/10 VOR/DME RWY 33L, 

AMDT 2C. 

21–Oct–10 MA BOSTON ........................................ GEN EDWARD LAWRENCE 

LOGAN INTL.

0/5057 9/7/10 VOR/DME RWY 27, 

AMDT 2B. 

21–Oct–10 MA BOSTON ........................................ GEN EDWARD LAWRENCE 

LOGAN INTL.

0/5058 9/7/10 VOR/DME RWY 15R, 

AMDT 2A. 

21–Oct–10 MA BOSTON ........................................ GEN EDWARD LAWRENCE 

LOGAN INTL.

0/5088 9/7/10 ILS RWY 22L, AMDT 

7. 

21–Oct–10 MA BOSTON ........................................ GEN EDWARD LAWRENCE 

LOGAN INTL.

0/5089 9/7/10 VOR/DME OR GPS 

A, ORIG–A. 

21–Oct–10 MA BOSTON ........................................ GEN EDWARD LAWRENCE 

LOGAN INTL.

0/5092 9/7/10 ILS RWY 27, AMDT 

2. 

21–Oct–10 FL TAMPA ........................................... TAMPA INTL .................................. 0/8288 9/13/10 RNAV (GPS) RWY 

36L, AMDT 1. 

21–Oct–10 CA HAYWARD ..................................... HAYWARD EXECUTIVE ............... 0/8839 9/7/10 LOC/DME RWY 28L, 

AMDT 1B. 

21–Oct–10 CA HAYWARD ..................................... HAYWARD EXECUTIVE ............... 0/8843 9/7/10 VOR/DME OR GPS 

B, AMDT 1C. 

[FR Doc. 2010–24109 Filed 9–29–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation or Injectable Dosage 

Form New Animal Drugs; 

Dexmedetomidine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by Orion 

Corp. The supplemental NADA 

provides for veterinary prescription use 

of dexmedetomidine hydrochloride 

injectable solution as a preanesthetic to 

general anesthesia in cats. 

DATES: This rule is effective September 

30, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 


jdjones on DSK8KYBLC1PROD with RULES
60308 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Orion 

Corp., Orionintie 1, 02200 Espoo, 

Finland, filed a supplement to NADA 

141–267 for DEXDOMITOR 

(dexmedetomidine hydrochloride). The 

supplemental NADA provides for 

veterinary prescription use of 

dexmedetomidine hydrochloride 

injectable solution as a preanesthetic to 

general anesthesia in cats. The 

supplemental application is approved as 

of August 16, 2010, and the regulations 

in 21 CFR 522.558 are amended to 

reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), 

summaries of the safety and 

effectiveness data and information 

submitted to support approval of these 

applications may be seen in the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852, between 9 a.m. and 4 p.m., 

Monday through Friday. 

Under section 512(c)(2)(F)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(iii)), this 

approval qualifies for 3 years of 

marketing exclusivity beginning on the 

date of approval. 

The agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In § 522.558, revise paragraph 

(c)(2)(ii) to read as follows: 

§ 522.558 Dexmedetomidine. 

* * * * * 

(c) * * * 

(2) * * * 

(ii) Indications for use. For use as a 

sedative and analgesic to facilitate 

clinical examinations, clinical 

procedures, minor surgical procedures, 

and minor dental procedures; and as a 

preanesthetic to general anesthesia. 

* * * * * 

Dated: September 24, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–24494 Filed 9–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs for Use in Animal 

Feeds; Melengestrol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to more 

accurately reflect the recent approval of 

two supplemental new animal drug 

applications (NADAs) filed by 

Pharmacia & Upjohn Co., a Division of 

Pfizer, Inc. The supplemental NADAs 

provided for increased levels of 

monensin in two-way Type C medicated 

feeds containing melengestrol acetate 

and monensin, and in three-way Type C 

medicated feeds containing 

melengestrol acetate, monensin, and 

tylosin phosphate for heifers fed in 

confinement for slaughter. These 

amendments are being made to improve 

the accuracy of the regulations. 

DATES: This rule is effective September 

30, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne J. Sechen, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8105, 

email: suzanne.sechen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc., 

235 East 42d St., New York, NY 10017, 

filed supplements to NADA 125–476 for 

use of liquid MGA 500 (melengestrol 

acetate) and RUMENSIN (monensin, 

USP) single-ingredient Type A 

medicated articles to make two-way 

Type C medicated feeds and to NADA 

138–870 for use of liquid MGA 500, 

RUMENSIN, and TYLAN (tylosin 

phosphate) single-ingredient Type A 

medicated articles to make three-way 

Type C medicated feeds for heifers fed 

in confinement for slaughter. The 

supplemental NADAs provided for use 

of increased levels of monensin, 

previously approved for singleingredient monensin Type C medicated 

feeds under NADA 95–735 (72 FR 653, 

January 8, 2007). The supplements were 

approved in October 2009 and the 

regulations were amended in § 558.342 

(21 CFR 558.342) (74 FR 59911, 

November 19, 2009; 74 FR 61029, 

November 23, 2009). 

Labeling submitted with these 

supplements also provided for use of a 

dry MGA 200 Type A medicated article 

in formulating both the two-way and 

three-way combination feeds with 

increased levels of monensin. This was 

consistent with the February 2009 

supplemental approvals under NADA 

125–476 and NADA 138–870 of these 

same two-way and three-way 

combinations using dry MGA 200 for 

conditions of use that had been 

originally approved under Pharmacia & 

Upjohn Co.’s NADA 124–309 and 

NADA 138–792. Approval of these 

supplements in this manner was 

intended, in part, to simplify 

administration of the two-way and 

three-way combinations under a single 

NADA file for each combination and to 

treat Pharmacia & Upjohn’s applications 

in a manner consistent with similar 

applications held by other sponsors. As 

of February 2009, NADA 124–309 and 

NADA 138–792 no longer contained the 

most current approved labeling and 

were administratively considered part of 

NADA 125–476 and NADA 138–870, 

respectively. 

FDA has noticed that the regulations 

in § 558.342 contain entries for use of 

monensin in these two-way and threeway combinations at the lower use 

levels. At this time, the regulations are 

being amended to reflect the conditions 

of use described in labeling approved in 

October 2009 under NADA 125–476 and 

NADA 138–870. These amendments are 

being made to improve the accuracy of 

the regulations. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 558 

Animal drugs, Animal feeds. 


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