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Federal Register / Vol. 70, No.

102 / Friday, May 27, 2005 / Rules and Regulations 30625

part 71) establishes Class E airspace economic impact on a substantial That airspace extending upward from 700
designated as a surface area for an number of small entities under the feet above the surface within a 6.9-mile
airport at Chillicothe, MO. Controlled criteria of the Regulatory Flexibility Act. radius of Chillicothe Municipal Airport and
airspace extending upward from the This rulemaking is promulgated within 2.5 miles each side of the 335° bearing
from the Chillicothe NDB extending from the
surface of the earth is needed to contain under the authority described in
6.9-mile radius of the airport to 7 miles
aircraft executing instrument approach Subtitle VII, Part A, Subpart I, Section northwest of the NDB.
procedures to Chillicothe Municipal 40103. Under that section, the FAA is
Airport. Weather observations will be charged with prescribing regulations to * * * * *
provided by an automatic Weather assign the use of the airspace necessary Issued in Kansas City, MO, on May 17,
Observing/Reporting System (AWOS) to ensure the safety of aircraft and the 2005.
and communications will be direct with efficient use of airspace. This regulation Elizabeth S. Wallis,
Columbia Automated Flight Service is within the scope of that authority Acting Area Director, Western Flight Services
Station. since it contains aircraft executing Operations.
This rule also revises the Class E instrument approach procedures to [FR Doc. 05–10600 Filed 5–26–05; 8:45 am]
airspace area extending upward from Chillicothe Municipal Airport. BILLING CODE 4910–13–M
700 feet above the surface at Chillicothe,
MO. An examination of this Class E List of Subjects in 14 CFR Part 71
airspace area for Chillicothe, MO Airspace, Incorporation by reference,
DEPARTMENT OF HEALTH AND
revealed noncompliance with FAA Navigation (Air).
HUMAN SERVICES
directives. This corrects identified
Adoption of the Amendment
discrepancies by increasing the area Food and Drug Administration
from a 6.4-mile to a 6.9-mile radius of ■ In consideration of the foregoing, the
Chillicothe Municipal Airport, defining Federal Aviation Administration 21 CFR Part 520
the extension to the airspace area in amends 14 CFR part 71 as follows:
terms of the Chillicothe nondirectional Oral Dosage Form New Animal Drugs;
radio beacon (NDB), modifying the PART 71—DESIGNATION OF CLASS A, Carprofen
bearing of the extension, correcting CLASS B, CLASS C, CLASS D, AND
errors in the identified location of the CLASS E AIRSPACE AREAS; AGENCY: Food and Drug Administration,
Chillicothe NDB and defining airspace AIRWAYS; ROUTES; AND REPORTING HHS.
of appropriate dimensions to protect POINTS ACTION: Final rule.
aircraft departing and executing
■ 1. The authority citation for part 71 SUMMARY: The Food and Drug
instrument approach procedures to
continues to read as follows: Administration (FDA) is amending the
Chillicothe Municipal Airport. The
airspace area is brought into compliance Authority: 49 U.S.C. 106(g); 40103, 40113, animal drug regulations to reflect
with FAA directives. Both areas will be 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– approval of an abbreviated new animal
depicted on appropriate aeronautical 1963 Comp., p. 389. drug application (ANADA) filed by
charts. IMPAX Laboratories, Inc. The ANADA
§ 71.1 [Amended]
Class E airspace areas designated as provides for veterinary prescription use
surface areas are published in Paragraph ■ 2. The incorporation by reference in 14 of carprofen caplets in dogs for the relief
6002 of FAA Order 7400.9M, Airspace CFR 71.1 of Federal Aviation of pain and inflammation associated
Designations and Reporting points, Administration Order 7400.9M, dated with osteoarthritis.
dated August 30, 2004, and effective August 30, 2004, and effective DATES: This rule is effective May 27,
September 16, 2004, which is September 16, 2004, is amended as 2005.
incorporated by reference in 14 CFR follows:
FOR FURTHER INFORMATION CONTACT:
71.1. Class E airspace areas extending
upward from 700 feet or more above the Paragraph 6002 Class E Airspace Daniel A. Benz, Center for Veterinary
Designated as Surface Areas. Medicine (HFV–104), Food and Drug
surface of the earth are published in
Paragraph 6005 of the same Order. The * * * * * Administration, 7500 Standish Pl.,
Class E airspace designations listed in Rockville, MD 20855, 301–827–0223, e-
ACE MO E2 Chillicothe, MO
this document will be published mail: daniel.benz@fda.gov.
Chillicothe Municipal Airport, MO
subsequently in the Order. SUPPLEMENTARY INFORMATION: IMPAX
(Lat. 39°46′56″ N., long. 93°29′44″ W.)
The FAA has determined that this Chillicothe NDB Laboratories, Inc., 30831 Huntwood
regulation only involves an established (Lat. 39°46′38″ N., long. 93°29′39″ W.) Ave., Hayward, CA 94544, filed ANADA
body of technical regulations for which Within a 4.4-mile radius of Chillicothe 200–366 for veterinary prescription use
frequent and routine amendments are Municipal Airport and within 2.5 miles each of Carprofen Caplets in dogs for the
necessary to keep them operationally side of the 335° bearing from the Chillicothe relief of pain and inflammation
current. Therefore, this regulation—(1) NDB extending from the 4.4-mile radius of associated with osteoarthritis. IMPAX
is not a ‘‘significant regulatory action’’ the airport to 7 miles northwest of the NDB. Laboratories, Inc.’s Carprofen Caplets is
under Executive Order 12866; (2) is not * * * * * approved as a generic copy of Pfizer,
a ‘‘significant rule’’ under DOT Inc.’s RIMADYL Caplets, approved
Paragraph 6005 Class E airspace areas
Regulatory Policies and Procedures (44 extending upward from 700 feet or more
under NADA 141–053. ANADA 200–
FR 11034; February 26, 1979); and (3) above the surface of the earth. 366 is approved as of April 27, 2005,
does not warrant preparation of a and 21 CFR 520.309 is amended to
* * * * *
Regulatory Evaluation as the anticipated reflect the approval. The basis of
impact is so minimal. Since this is a ACE MO E5 Chillicothe, MO approval is discussed in the freedom of
routine matter that will only affect air Chillicothe Municipal Airport, MO information summary.
traffic procedures and air navigation, it (Lat. 39°46′56″ N., long. 93°29′44″ W.) In accordance with the freedom of
is certified that this rule, when Chillicothe NDB information provisions of 21 CFR part
promulgated, will not have a significant (Lat. 39°46′38″ N., long. 93°29′39″ W.) 20 and 21 CFR 514.11(e)(2)(ii), a

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30626 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Rules and Regulations

summary of safety and effectiveness Dated: May 13, 2005. FOR FURTHER INFORMATION CONTACT:
data and information submitted to Stephen F. Sundlof, James P. Ficaretta; Enforcement
support approval of this application Director, Center for Veterinary Medicine. Programs and Services; Bureau of
may be seen in the Division of Dockets [FR Doc. 05–10627 Filed 5–26–05; 8:45 am] Alcohol, Tobacco, Firearms, and
Management (HFA–305), Food and Drug BILLING CODE 4160–01–S Explosives; U.S. Department of Justice;
Administration, 5630 Fishers Lane, rm. 650 Massachusetts Avenue, NW.,
1061, Rockville, MD 20852, between 9 Washington, DC 20226, telephone (202)
a.m. and 4 p.m., Monday through DEPARTMENT OF JUSTICE 927–8203.
Friday. SUPPLEMENTARY INFORMATION:
The agency has determined under 21 Bureau of Alcohol, Tobacco, Firearms, I. Background
CFR 25.33(a)(1) that this action is of a and Explosives
type that does not individually or The Bureau of Alcohol, Tobacco,
cumulatively have a significant effect on 27 CFR Part 555 Firearms, and Explosives (ATF) is
the human environment. Therefore, responsible for implementing Title XI,
[Docket No. ATF 5F; AG Order No. 2766– Regulation of Explosives (18 United
neither an environmental assessment 2005]
nor an environmental impact statement States Code (U.S.C.) Chapter 40), of the
is required. RIN 1140–AA02 Organized Crime Control Act of 1970.
One of the stated purposes of the Act is
This rule does not meet the definition Identification Markings Placed on to reduce the hazards to persons and
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Imported Explosive Materials and property arising from the misuse of
it is a rule of ‘‘particular applicability.’’ Miscellaneous Amendments (2000R– explosive materials. Under section 847
Therefore, it is not subject to the 238P) of title 18, U.S.C., the Attorney General
congressional review requirements in 5 ‘‘may prescribe such rules and
U.S.C. 801–808. AGENCY: Bureau of Alcohol, Tobacco,
regulations as he deems reasonably
Firearms, and Explosives (ATF),
List of Subjects in 21 CFR Part 520 necessary to carry out the provisions of
Department of Justice.
this chapter.’’ Regulations that
Animal drugs. ACTION: Final rule.
implement the provisions of chapter 40
■ Therefore, under the Federal Food, SUMMARY: The Department of Justice is are contained in title 27, Code of
Drug, and Cosmetic Act and under amending the current regulations of the Federal Regulations (CFR), part 555
authority delegated to the Commissioner Bureau of Alcohol, Tobacco, Firearms, (‘‘Commerce in Explosives’’).
and Explosives (ATF) to require The term ‘‘explosive materials,’’ as
of Food and Drugs and redelegated to the
licensed importers to identify by defined in 27 CFR 555.11, means
Center for Veterinary Medicine, 21 CFR
marking all explosive materials they explosives, blasting agents, water gels,
part 520 is amended as follows:
import for sale or distribution. Licensed and detonators. The term includes, but
PART 520—ORAL DOSAGE FORM manufacturers currently are required to is not limited to, all items in the ‘‘List
NEW ANIMAL DRUGS place identification markings on of Explosive Materials’’ provided for in
explosive materials manufactured in the § 555.23. Section 555.202 provides for
■ 1. The authority citation for 21 CFR United States. Similar marking three classes of explosive materials: (1)
part 520 continues to read as follows: requirements, however, do not currently High explosives (e.g., dynamite, flash
powders, and bulk salutes), (2) low
Authority: 21 U.S.C. 360b. exist for imported explosive materials.
explosives (e.g., black powder, safety
Identification markings are needed on
■ 2. Section 520.309 is amended by fuses, igniters, igniter cords, fuse
explosives to help ensure that these
revising paragraphs (b) and (d)(2) to read materials can be effectively traced for lighters, and display fireworks (except
as follows: bulk salutes)), and (3) blasting agents
criminal enforcement purposes.
(e.g., ammonium nitrate-fuel oil and
§ 520.309 Carprofen. Although ATF does not have regulatory
certain water gels).
oversight over foreign manufacturers, it Section 555.109 requires licensed
* * * * *
does have authority over licensed manufacturers of explosive materials to
(b) Sponsors. See sponsors in importers of explosive materials. This
§ 510.600(c) of this chapter for uses as legibly identify by marking all explosive
rule will impose identification materials manufactured for sale or
in paragraph (d) of this section. requirements on licensed importers of distribution. The marks required by this
(1) No. 000069 for use of products explosive materials that are section include the identity of the
described in paragraph (a) of this substantially similar to the marking manufacturer and the location, date, and
section as in paragraph (d) of this requirements imposed on domestic shift of manufacture. This section also
section. manufacturers. provides that licensed manufacturers
(2) No. 000115 for use of product In addition, the final rule incorporates must place the required marks on each
described in paragraph (a)(1) of this into the regulations the provisions of cartridge, bag, or other immediate
section as in paragraphs (d)(1), (d)(2)(i), ATF Ruling 75–35, relating to methods container of explosive materials for sale
and (d)(3) of this section. of marking containers of explosive or distribution, as well as on the outside
* * * * * materials. This final rule also amends container, if any, used for their
the regulations to remove the packaging.
(d) * * * requirement that a licensee or permittee Exceptions to the marking
(2) Indications for use—(i) For the file for an amended license or permit in requirements are set forth in
relief of pain and inflammation order to change the class of explosive § 555.109(b). This section provides that
associated with osteoarthritis. materials described in their license or (1) licensed manufacturers of blasting
(ii) For the control of postoperative permit from a lower to a higher caps are only required to place the
pain associated with soft tissue and classification. required identification marks on the
orthopedic surgery. DATES: This rule is effective July 26, containers used for the packaging of
* * * * * 2005. blasting caps, (2) the Director may

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