Intramammary Dosage Forms; Cephapirin Sodium, 3181 [E8-816]
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3181
Rules and Regulations
Federal Register
Vol. 73, No. 12
Thursday, January 17, 2008
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 526
information. Therefore, a freedom of
information summary is not required.
FDA 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
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.
Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E8–816 Filed 1–16–08; 8:45 am]
List of Subjects in 21 CFR Part 526
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
AGENCY:
Intramammary Dosage Forms;
Cephapirin Sodium
AGENCY:
Animal drugs.
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 supplemental new animal
drug applications (NADAs) filed by Fort
Dodge Animal Health, Division of
Wyeth. The supplemental NADAs
provide for revisions to the labeling of
two cephapirin sodium products
administered by intramammary infusion
to lactating cows for the treatment of
mastitis.
DATES:
This rule is effective January 17,
2008.
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8342, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, 800 Fifth St. NW., Fort Dodge,
IA 50501, filed supplements to NADA
97–222 that revise labeling of CEFALAK (cephapirin sodium) and TODAY
(cephapirin sodium) Intramammary
Infusion administered to lactating cows
for the treatment of mastitis. The
application is approved as of December
20, 2007, and the regulations are
amended in 21 CFR 526.365 to reflect
the approval and a current format.
Approval of these supplemental
NADAs did not require review of
additional safety or effectiveness data or
rfrederick on PROD1PC67 with RULES
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<31>2005
14:51 Jan 16, 2008
Jkt 214001
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 526 is amended as follows:
I
PART 526—INTRAMAMMARY DOSAGE
FORMS
1. The authority citation for 21 CFR
part 526 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 526.365, revise the section
heading and paragraph (d) to read as
follows:
I
§ 526.365
Cephapirin sodium.
*
*
*
*
*
(d) Conditions of use in lactating
cows—(1) Amount. Infuse one dose into
each infected quarter immediately after
the quarter has been completely milked
out. Do not milk out for 12 hours.
Repeat once only in 12 hours.
(2) Indications for use. For the
treatment of mastitis in lactating cows
caused by susceptible strains of
Streptococcus agalactiae and
Staphylococcus aureus including strains
resistant to penicillin.
(3) Limitations. If improvement is not
noted within 48 hours after treatment,
consult your veterinarian. Milk that has
been taken from animals during
treatment and for 96 hours after the last
treatment must not be used for food.
Treated animals must not be slaughtered
for food until 4 days after the last
treatment.
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
BILLING CODE 4160–01–S
DEPARTMENT OF THE INTERIOR
National Park Service
36 CFR Part 13
RIN 1024–AD38
National Park System Units in Alaska
ACTION:
National Park Service, Interior.
Final rule.
SUMMARY: This rule revises the special
regulations for the NPS-administered
areas in Alaska to update provisions
governing subsistence use of timber,
river management, ORV use, fishing,
and camping. The revision also updates
definitions, prohibits pets in certain
areas, and establishes wildlife viewing
distances in several park areas.
DATES: This rule is effective on February
19, 2008.
FOR FURTHER INFORMATION CONTACT:
National Park Service, Victor Knox,
Deputy Regional Director, Alaska
Regional Office, 240 West 5th Ave.,
Anchorage, AK 99501. Telephone: (907)
644–3501. E-mail:
akro_regulations@nps.gov. Fax: (907)
644–3816.
SUPPLEMENTARY INFORMATION:
Background
On December 27, 2006, the NPS
published in the Federal Register
proposed revised special regulations for
the NPS-administered areas in Alaska.
Each park area in Alaska has a
compendium consisting of the compiled
designations, closures, openings, permit
requirements, and other provisions
established by the Superintendent
under the discretionary authority
granted in 36 CFR 1.5 and elsewhere in
regulations. It is the policy of the NPS
to review these provisions on a regular
basis for possible addition to the general
and special park regulations in part 13.
The provisions in this final rule are
additions or changes to individual park
regulations in part 13, subparts H–W.
Where these provisions have
applicability to several or all Alaska
E:\FR\FM\17JAR1.SGM
17JAR1
]]>Agencies
[Federal Register Volume 73, Number 12 (Thursday, January 17, 2008)]
[Rules and Regulations]
[Page 3181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-816]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 73, No. 12 / Thursday, January 17, 2008 /
Rules and Regulations
[[Page 3181]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 526
Intramammary Dosage Forms; Cephapirin Sodium
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 supplemental new animal drug
applications (NADAs) filed by Fort Dodge Animal Health, Division of
Wyeth. The supplemental NADAs provide for revisions to the labeling of
two cephapirin sodium products administered by intramammary infusion to
lactating cows for the treatment of mastitis.
DATES: This rule is effective January 17, 2008.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
800 Fifth St. NW., Fort Dodge, IA 50501, filed supplements to NADA 97-
222 that revise labeling of CEFA-LAK (cephapirin sodium) and TODAY
(cephapirin sodium) Intramammary Infusion administered to lactating
cows for the treatment of mastitis. The application is approved as of
December 20, 2007, and the regulations are amended in 21 CFR 526.365 to
reflect the approval and a current format.
Approval of these supplemental NADAs did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
FDA 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 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 526
Animal drugs.
0
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 526 is
amended as follows:
PART 526--INTRAMAMMARY DOSAGE FORMS
0
1. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 526.365, revise the section heading and paragraph (d) to
read as follows:
Sec. 526.365 Cephapirin sodium.
* * * * *
(d) Conditions of use in lactating cows--(1) Amount. Infuse one
dose into each infected quarter immediately after the quarter has been
completely milked out. Do not milk out for 12 hours. Repeat once only
in 12 hours.
(2) Indications for use. For the treatment of mastitis in lactating
cows caused by susceptible strains of Streptococcus agalactiae and
Staphylococcus aureus including strains resistant to penicillin.
(3) Limitations. If improvement is not noted within 48 hours after
treatment, consult your veterinarian. Milk that has been taken from
animals during treatment and for 96 hours after the last treatment must
not be used for food. Treated animals must not be slaughtered for food
until 4 days after the last treatment.
Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E8-816 Filed 1-16-08; 8:45 am]
BILLING CODE 4160-01-S
