Federal Register / Vol. 73, No.
35 / Thursday, February 21, 2008 / Rules and Regulations
radius of Williamsport-Lycoming County
Airport extending clockwise from a 025°
bearing to a 067° bearing from the airport and
within a 12.6-mile radius of Williamsport-
Lycoming County Airport extending
clockwise from a 067° bearing to a 099°
bearing from the airport and within a 6.7-
mile radius of Williamsport-Lycoming
County Airport extending clockwise from a
099° bearing to a 270° bearing from the
airport and within a 17.9-mile radius of
Williamsport-Lycoming County Airport
extending clockwise from a 270° bearing to
a 312° bearing from the airport and within a
19.6-mile radius of Williamsport-Lycoming
County Airport extending clockwise from a
312° bearing to a 350° bearing from the
airport and within a 6.7-mile radius of
Williamsport-Lycoming County Airport
extending clockwise from a 350° bearing to
a 025° bearing from the airport and within
4.4 miles each side of the Williamsport-
Lycoming County Airport ILS localizer east
course extending from the Picture Rocks NDB
to 11.3 miles east of the NDB; and that
airspace within a 6-mile radius of the point
in space (Lat. 41°14′43″ N., long. 77°00′04″
W.) serving the Williamsport Hospital.
* * * * * of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
Issued in College Park, GA, on February 7,
2008.
Barry A. Knight,
Acting Manager, System Support Group,
Eastern Service Center.
[FR Doc. 08–728 Filed 2–20–08; 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;
Altrenogest
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
Intervet, Inc. The supplemental NADA
provides for revised food safety labeling
for altrenogest oral solution used in
horses.
DATES: This rule is effective February
21, 2008.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
ebenthall on PRODPC61 with RULES
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337,
e-mail: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
VerDate Aug<31>2005 14:36 Feb 20, 2008 Jkt 214001
9455
Millsboro, DE 19966, filed a supplement
to NADA 131–310 for REGU-MATE
(altrenogest), an oral solution
administered to mares for suppression
of estrus. The supplemental application
provides for a revised warning
statement on product labeling. The
supplemental NADA is approved as of
January 18, 2008, and 21 CFR 520.48 is
amended to reflect the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(a)(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
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. In § 520.48, revise the section
heading and paragraph (d)(1)(iii) to read
as follows:
§ 520.48 Altrenogest.
* * * * * In accordance with the freedom of
(d) * * *
(1) * * *
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
* * * * * 1061, Rockville, MD 20852, between 9
Dated: February 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–3265 Filed 2–20–08; 8:45 am]
BILLING CODE 4160–01–S
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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.
Final rule; technical
ACTION:
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by IVX Animal Health, Inc. The
supplemental ANADA provides revised
labeling for ivermectin oral liquid used
in horses.
DATES: This rule is effective February
21, 2008.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
a supplement to ANADA 200–202 for
PHOENECTIN (ivermectin) Liquid for
Horses. The supplemental application
provides for the addition of indications
for use and minor revisions to product
labeling that conform to the pioneer
product labeling. The supplemental
ANADA is approved as of January 24,
2008, and 21 CFR 520.1195 is amended
to reflect the approval.
In addition, the regulation is being
amended to add the drug labeler code
for another approved generic product
(69 FR 24958, May 5, 2004), which was
removed in error in the Federal Register
of September 24, 2004 (69 FR 57173).
This action is being taken to improve
the accuracy of the regulations.
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, rm.
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
21FER1
 9456 Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Rules and Regulations
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. In § 520.1195, revise paragraphs
(b)(1) and (b)(2) to read as follows:
§ 520.1195 Ivermectin liquid.
* * * * * or planned by another agency;
(b) * * *
(1) Nos. 050604, 054925, and 059130
for use of product described in
paragraph (a)(1) of this section as in
paragraphs (e)(1)(i), (e)(1)(ii)(A), and
(e)(1)(iii) of this section.
(2) Nos. 058005 and 058829 for use of
product described in paragraph (a)(1) of
this section as in paragraphs (e)(1)(i),
(e)(1)(ii)(B), and (e)(1)(iii) of this section.
* * * * * records and tells members of the public what
Dated: February 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–3266 Filed 2–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF DEFENSE
Department of the Air Force
32 CFR Part 903
[Docket No. USAF–2007–0001]
RIN 0701–AA72
Air Force Academy Preparatory School
AGENCY: DoD, USAF.
ACTION: Final rule.
ebenthall on PRODPC61 with RULES
SUMMARY: This final rule tells how to
apply for the Air Force Academy
Preparatory School. It also explains the
procedures for selection, disenrollment,
and assignment. This rule has been
VerDate Aug<31>2005 14:36 Feb 20, 2008 Jkt 214001
updated to identify USAFA’s revised
mission statement, new selection
criteria and updates of associated Air
Force Instructions.
DATES: Effective Date: This rule is
effective March 24, 2008.
FOR FURTHER INFORMATION CONTACT: Mr.
Scotty Ashley at (703) 695–3594,
scotty.Ashley@pentagon.af.mil.
SUPPLEMENTARY INFORMATION: The
proposed rule was published in the
Federal Register on July 12, 2007 (72 FR
10436–10438). No comments were
received.
Executive Order 12866, ‘‘Regulatory
Planning and Review’’
It has been determined that 32 CFR
part 903 is not a significant regulatory
action. This rule does not:
(1) Have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
state, local, or tribal governments or
communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
(3) Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs, or the rights and
obligations of the recipients thereof; or
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in this Executive Order.
Unfunded Mandates Reform Act (Sec.
202, Pub. L. 104–4)
It has been certified the 32 CFR part
903 does not contain a Federal Mandate
that may result in the expenditure by
State, local and tribal governments, in
aggregate, or by the private sector, of
$100 million or more in any one year.
Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. 601)
It has been determined that this rule
is not subject to the Regulatory
Flexibility Act (5 U.S.C. 601) because it
would not, if promulgated, have a
significant economic impact on a
substantial number of small entities.
Public Law 95–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
It has been certified that 32 CFR part
903 does not impose any reporting or
recordkeeping requirements under the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
Federalism (Executive Order 13132)
It has been certified that 32 CFR part
903 does not have federalism
PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\21FER1.SGM
implications, as set forth in Executive
Order 13132. This rule does not have
substantial direct effects on:
(1) The States;
(2) The relationship between the
National Government and the States; or
(3) The distribution of power and
responsibilities among the various
levels of government.
List of Subjects in 32 CFR Part 903
Military academy; Military personnel.
■ Therefore, for the reasons set forth in
the preamble, 32 CFR part 903 is revised
to read as follows:
PART 903—AIR FORCE ACADEMY
PREPARATORY SCHOOL
Sec.
903.1 Mission and responsibilities.
903.2 Eligibility requirements.
903.3 Selection criteria.
903.4 Application process and procedures.
903.5 Reserve enlistment procedures.
903.6 Reassignment of Air Force members
to become cadet candidates at the
preparatory school.
903.7 Reassignment of cadet candidates
who graduate from the Preparatory
School with an appointment to U.S. Air
Force Academy (USAFA).
903.8 Cadet candidate disenrollment.
903.9 Cadet records and reassignment
forms.
903.10 Information collections, records, and
forms or information management tools.
Authority: 5 U.S.C. 301, 10 U.S.C. 8013,
and 10 U.S.C. 9331 unless otherwise noted).
Note: This part is derived from AFI 36–
2021, September 12, 2006. Part 806 of this
chapter states the basic policies and
instructions governing the disclosure of
they must do to inspect or obtain copies of
the material referenced herein.
§ 903.1 Mission and responsibilities.
(a) Mission. To motivate, prepare, and
evaluate selected candidates in an
educational, military, moral, and
physical environment, to perform
successfully and enhance diversity at
USAFA.
(b) Responsibilities:
(1) Superintendent, USAFA (HQ
USAFA/CC). Ensures adequate oversight
of HQ USAFA/PL activities,
administration, and resources. Means of
oversight include but are not limited to:
(i) United States Air Force Academy
Instruction (USAFAI) 36–3502, USAFA
Assessment Board.
(ii) The Preparatory School Advisory
Committee, as established in USAFAI
36–2013, Superintendent’s Preparatory
School Advisory Committee of the
USAF Academy Preparatory School.
(iii) Annual Assessment, as
established in Department of Defense
21FER1