Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57171

County Municipal Airport revealed it 

does not meet the criteria for 700 feet 

AGL airspace required for diverse 

departures as specified in FAA Order 

7400.2E, Procedures for Handling 

Airspace Matters. The criteria in FAA 

Order 7400.2E for an aircraft to reach 

1200 feet AGL, taking into consideration 

rising terrain, is based on a standard 

climb gradient of 200 feet per mile plus 

the distance from the airport reference 

point to the end of the outermost 

runway. Any fractional part of a mile is 

converted to the next higher tenth of a 

mile. Additionally, the examination 

revealed the dimensions of the 

extension to the airspace area were not 

in compliance with FAA Order 

8260.19C, Flight Procedures and 

Airspace. This amendment expands the 

airspace area from a 6-mile radius to a 

7.3-mile radius of Cheyenne County 

Municipal Airport, decreases the length 

of the extension ot the Class E airspace 

area from 7.4 to 7 miles from the St. 

Francis nondirectional radio beacon 

(NDB), decreases the width of the 

extension from 2.6 to 1.9 miles each 

side of the centerline and brings the 

legal description of the St. Francis, KS 

Class E airspace area into compliance 

with FAA OPrders 7400.2E and 

8260.19C. This area will be depicted on 

appropriate aeronautical charts. Class E 

airspace areas extending upward from 

700 feet or more above the surface of the 

earth are published in paragraph 6005 of 

FAA Order 7400.9M, Airspace 

Designations and Reporting Points, 

dated August 30, 2004, and effective 

September 16, 2004, which is 

incorporated by reference in 14 CFR 

71.1. The Class E airspace designation 

listed in this document will be 

published subsequently in the Order.

The Direct Final Rule Procedure 

The FAA anticipates that this 

regulation will not result in adverse or 

negative comment and, therefore, is 

issuing it as a direct final rule. Previous 

actions of this nature have not been 

controversial and have not resulted in 

adverse comments or objections. Unless 

a written adverse or negative comment, 

or a written notice of intent to submit 

an adverse or negative comment is 

received within the comment period, 

the regulation will become effective on 

the date specified above. After the close 

of the comment period, the FAA will 

publish a document in the Federal 

Register indicating that no adverse or 

negative comments were received and 

confirming the date on which the final 

rule will become effective. If the FAA 

does receive, within the comment 

period, an adverse or negative comment, 

or written notice of intent to submit 

such a comment, a document 

withdrawing the direct final rule will be 

published in the Federal Register, and 

a notice of proposed rulemaking may be 

published with a new comment period. 

Comments Invited 

Interested parties are invited to 

participate in this rulemaking by 

submitting such written data, views, or 

arguments, as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers and be submitted in 

triplicate to the address listed above. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this notice must submit with those 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to 

Docket No. FAA–2004–18821/Airspace 

Docket No. 04–ACE–47.’’ The postcard 

will be date/time stamped and returned 

to the commenter. 

Agency Findings 

The regulations adopted herein will 

not have a substantial direct effect 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, it is 

determined that this final rule does not 

have federalism implications under 

Executive Order 13132. 

The FAA has determined that this 

regulation is noncontroversial and 

unlikely to result in adverse or negative 

comments. For the reasons discussed in 

the preamble, I certify that this 

regulation (1) is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034, 

February 26, 1979); and (3) if 

promulgated, will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, 

Navigation (air).

Adoption of the Amendment

■ Accordingly, the Federal Aviation 

Administration amends 14 CFR part 71 

as follows:

PART 71—DESIGNATION OF CLASS A, 

CLASS B, CLASS C, CLASS D, AND 

CLASS E AIRSPACE AREAS, 

AIRWAYS; ROUTES; AND REPORTING 

POINTS

■ 1. The authority citation for 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 Federal Aviation 

Administration Order 7400.9M, dated 

August 30, 2004, and effective 

September 15, 2004, is amended as 

follows:

* * * * *

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth.

* * * * *

ACE KS E5 St. Francis, KS 

St. Francis, Cheyenne County Municipal 

Airport, KS 

(Lat. 39°40′40′′ N., long. 101°47′45′′ W.) 

St. Francis NDB 

(Lat. 39°43′37′′ N., long. 101°45′54′′ W.)

That airspace extending upward from 700 

feet above the surface within a 7.3-mile 

radius of Cheyenne County Municipal 

Airport and within 1.9 miles each side of the 

144° bearing from the St. Francis NDB 

extending from the 7.3-mile radius of the 

airport to 7 miles southeast of the NDB.

* * * * *

Issued in Kansas City, MO, on September 

16, 2004. 

Paul J. Sheridan, 

Manager, Air Traffic Division, Central Region.

[FR Doc. 04–21528 Filed 9–23–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 71

[Docket No. FAA–2004–18823; Airspace 

Docket No. 04–ACE–49] 

Modification Class E Airspace; 

Burwell, NE

AGENCY: Federal Aviation 

Administration (FAA), DOT.

ACTION: Direct final rule; request for 

comments. 

SUMMARY: This action amends Title 14 

Code of Federal Regulations, part 71 (14 

57172 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

CFR 71) by revising Class E airspace at 

Burwell, NE. A review of controlled 

airspace for Cram Field revealed it does 

not comply with the criteria for 700 feet 

above ground level (AGL) airspace 

required for diverse departures. The 

area is modified and enlarged to 

conform to the criteria in FAA Orders.

DATES: This direct final rule is effective 

on 0901 UTC, January 20, 2005. 

Comments for inclusion in the Rules 

Docket must be received on or before 

November 1, 2004.

ADDRESSES: Send comments on this 

proposal to the Docket Management 

System, U.S. Department of 

Transportation, Room Plaza 401, 400 

Seventh Street, SW., Washington, DC 

20590–0001. You must identify the 

docket number FAA–2004–18823/

Airspace Docket No. 04–ACE–49, at the 

beginning of your comments. You may 

also submit comments on the Internet at 

http://dms.dot.gov. You may review the 

public docket containing the proposal, 

any comments received, and any final 

disposition in person in the Dockets 

Office between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. The Docket Office (telephone 

1–800–647–5527) is on the plaza level 

of the Department of Transportation 

NASSIF Building at the above address.

FOR FURTHER INFORMATION CONTACT:

Brenda Mumper, Air Traffic Division, 

Airspace Branch, ACE–520A, DOT 

Regional Headquarters Building, Federal 

Aviation Administration, 901 Locust, 

Kansas City, MO 64106; telephone: 

(819) 329–2524.

SUPPLEMENTARY INFORMATION: This 

amendment to 14 CFR 71 modifies the 

Class E airspace area extending upward 

from 700 feet above the surface at 

Burwell, NE. An examination of 

controlled airspace for Cram Field 

revealed it does not meet the criteria for 

700 feet AGL airspace required for 

diverse departures as specified in FAA 

Order 7400.2E, Procedures for Handling 

Airspace Matters. The criteria in FAA 

Order 7400.2E for an aircraft to reach 

1200 feet AGL, taking into consideration 

rising terrain, is based on a standard 

climb gradient of 200 feet per mile plus 

the distance from the airport reference 

point (ARP) to the end of the outermost 

runway. Any fractional part of a mile is 

converted to the next higher tenth of a 

mile. This amendment expands the 

airspace area from a 6-mile radius to an 

8.3-mile radius of Cram Field, 

eliminates the extension to the airspace 

area, deletes reference to the Burwell 

nondirectional radio beacon (NDB) in 

the legal description and brings the legal 

description of the Burwell, NE Class E 

airspace area into compliance with FAA 

Order 7400.2E. This area will be 

depicted on appropriate aeronautical 

charts. Class E airspace areas extending 

upward from 700 feet or more above the 

surface of the earth are published in 

paragraph 6005 of FAA Order 7400.9M, 

Airspace Designations and Reporting 

Points, dated August 30, 2004, and 

effective September 16, 2004, which is 

incorporated by reference in 14 CFR 

71.1. The Class E airspace designation 

listed in this document will be 

published subsequently in the Order.

The Direct Final Rule Procedure 

The FAA anticipates that this 

regulation will not result in adverse or 

negative comment and, therefore, is 

issuing it as a direct final rule. Previous 

actions of this nature have not been 

controversial and have not resulted in 

adverse comments or objections. Unless 

a written adverse or negative comment, 

or a written notice of intent to submit 

an adverse or negative comment is 

received within the comment period, 

the regulation will become effective on 

the date specified above. After the close 

of the comment period, the FAA will 

publish a document in the Federal 

Register indicating that no adverse or 

negative comments were received and 

confirming the date on which the final 

rule will become effective. If the FAA 

does receive, within the comment 

period, an adverse or negative comment, 

or written notice of intent to submit 

such a comment, a document 

withdrawing the direct final rule will be 

published in the Federal Register, and 

a notice of proposed rulemaking may be 

published with a new comment period. 

Comments Invited 

Interested parties are invited to 

participate in this rulemaking by 

submitting such written data, views, or 

arguments, as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers and be submitted in 

triplicate to the address listed above. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this notice must submit with those 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to 

Docket No. FAA–2004–18823/Airspace 

Docket No. 04–ACE–49.’’ The postcard 

will be date/time stamped and returned 

to the commenter. 

Agency Findings 

The regulations adopted herein will 

not have a substantial direct effect 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, it is 

determined that this final rule does not 

have federalism implications under 

Executive Order 13132. 

The FAA has determined that this 

regulation is noncontroversial and 

unlikely to result in adverse or negative 

comments. For the reasons discussed in 

the preamble, I certify that this 

regulation (1) is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034, 

February 26, 1979); and (3) if 

promulgated, will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, 

Navigation (air).

Adoption of the Amendment

■ Accordingly, the Federal Aviation 

Administration amends 14 CFR part 71 

as follows:

PART 71—DESIGNATION OF CLASS A, 

CLASS B, CLASS C, CLASS D, AND 

CLASS E AIRSPACE AREAS; 

AIRWAYS; ROUTES; AND REPORTING 

POINTS

■ 1. The authority citation for 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 Federal Aviation 

Administration Order 7400.9M, dated 

August 30, 2004, and effective 

September 16, 2004, is amended as 

follows:

* * * * *

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth.

* * * * *

ACE NE E5 Burwell, NE 

Burwell, Cram Field, NE 

(Lat. 41°46′36′′ N., long. 99°08′59′′ W.)

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57173

That airspace extending upward from 700 

feet above the surface within an 8.3-mile 

radius of Cram Field.

* * * * *

Issued in Kansas City, MO, on September 

16, 2004. 

Paul J. Sheridan, 

Manager, Air Traffic Division, Central Region.

[FR Doc. 04–21530 Filed 9–23–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; 

Ivermectin Liquid

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 Merial 

Ltd. The supplemental NADA provides 

revised labeling, including the addition 

of four new species of internal parasites, 

for ivermectin oral liquid used in 

horses.

DATES: This rule is effective September 

24, 2004.

FOR FURTHER INFORMATION CONTACT:

Martine Hartogensis, Center for 

Veterinary Medicine (HFV–216), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 301–827–

7815, e-mail: 

martine.hartogensis@fda.gov.

SUPPLEMENTARY INFORMATION: Merial 

Ltd., 3239 Satellite Blvd., Bldg. 500, 

Duluth, GA 30096–4640, filed a 

supplement to NADA 140–439 for 

EQVALAN (ivermectin) Oral Liquid for 

Horses. The supplemental application 

provides for revisions to the labeled 

indications. Specifically, the 

supplement provides for the use of 

ivermectin oral liquid for the treatment 

and control of Craterostomum 

acuticaudatum, Petrovinema 

poculatum, and Coronocyclus spp., 

including Coronocyclus coronatus and 

Coronocyclus labratus. The label 

descriptions of some currently approved 

parasite genera are also being revised to 

add included species for which data 

already exists in the NADA file and to 

reflect changes in scientific 

nomenclature. In addition, under the 

sub-heading ‘‘Small Strongyles,’’ the 

labeling has been revised to separate the 

listing of adult species from the fourthstage larvae. The supplemental NADA is 

approved as of August 9, 2004, and 21 

CFR 520.1195 is amended to reflect the 

approval. The basis of approval is 

discussed in the freedom of information 

summary.

In accordance with the freedom of 

information provisions of 21 CFR part 

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

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, 

Room 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 

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

August 9, 2004. This marketing 

exclusivity only applies to the parasites 

for which new data were required.

The agency has determined under 21 

CFR 25.33(d)(1) 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 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows:

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

■ 2. Section 520.1195 is amended by 

revising paragraphs (b), (e)(1)(ii), and 

(e)(1)(iii) to read as follows:

§ 520.1195 Ivermectin liquid.

* * * * *

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter.

(1) No. 050604 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(1)(i), 

(e)(1)(ii)(A), and (e)(1)(iii) of this 

section.

(2) Nos. 051259, 058829, and 059130 

for use of product described in 

paragraph (a)(1) of this section as in 

paragraph (e)(1)(i), (e)(1)(ii)(B), and 

(e)(1)(iii) of this section.

(3) Nos. 050604 and 058829 for use of 

product described in paragraph (a)(2) of 

this section as in paragraph (e)(2) of this 

section.

* * * * *

(e) * * *

(1) * * *

(ii) Indications for use. For treatment 

and control of:

(A) Large Strongyles (adults): 

Strongylus vulgaris (also early forms in 

blood vessels), S. edentatus (also tissue 

stages), S. equinus, Triodontophorus

spp. including T. brevicauda and T. 

serratus, and Craterostomum 

acuticaudatum; Small Strongyles 

(adults, including those resistant to 

some benzimidazole class compounds): 

Coronocyclus spp. including C. 

coronatus, C. labiatus, and C. labratus, 

Cyathostomum spp. including C. 

catinatum and C. pateratum, 

Cylicocyclus spp. including C. insigne, 

C. leptostomum, C. nassatus, and C. 

brevicapsulatus, Cylicodontophorus

spp., Cylicostephanus spp. including C. 

calicatus, C. goldi, C. longibursatus, and 

C. minutus, and Petrovinema 

poculatum; Small Strongyles (fourthstage larvae); Pinworms (adults and 

fourth stage larvae): Oxyuris equi; 

Ascarids (adults and third- and fourthstage larvae): Parascaris equorum; 

Hairworms (adults): Trichostrongylus 

axei; Large mouth Stomach Worms 

(adults): Habronema muscae; Bots (oral 

and gastric stages): Gasterophilus spp. 

including G. intestinalis and G. nasalis; 

Lungworms (adults and fourth-stage 

larvae): Dictyocaulus arnfieldi; 

Intestinal Threadworms (adults), 

Strongyloides westeri; Summer Sores 

caused by Habronema and Draschia

spp. cutaneous third-stage larvae; 

Dermatitis caused by neck threadworm 

microfilariae, Onchocerca sp.

(B) Large Strongyles (Strongylus 

equinus (adult), S. vulgaris (adult and 

arterial larval stages), S. endentatus

(adult and migrating tissue stages), 

Triodontophorus spp. (adult)); Small 

Strongyles including those resistant to 

some benzimidazole class compounds 

(Cyathostomum spp. (adult and fourthstage larvae), Cylicocyclus spp., 

Cylicodontophorus spp., 

Cylicostephanus spp.); Pinworms 

(Oxyuris equi (adult and fourth-stage 

larvae)); Ascarids (Parascaris equorum

(adult and third- and fourth-stage 

larvae)); Hairworms (Trichostongylus