Oral Dosage Form New Animal Drugs; Oxfendazole Suspension, 45610 [E8-18092]
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Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations
(vi) Payment of fees must be by check
or money order made payable to the
U.S. Treasury.
(vii) Requesters may not file multiple
requests at the same time, each seeking
portions of a document or documents,
solely in order to avoid payment of fees.
When the Commission reasonably
believes that a requester, or a group of
requesters acting in concert, is
attempting to break a request down into
a series of requests for the purpose of
evading assessment of fees, or otherwise
reasonably believes that two or more
requests constitute a single request, the
Commission may aggregate any such
requests accordingly. The Commission
will not aggregate multiple requests on
unrelated subjects from a requester.
Aggregated requests may qualify for an
extension of time under § 388.110(b).
(3) Fees for unsuccessful search. The
Commission may assess charges for time
spent searching, even if it fails to locate
the records, or if records located are
determined to be exempt from
disclosure. If the Commission estimates
that search charges are likely to exceed
$25, it will notify the requester of the
estimated amount of search fees, unless
the requester has indicated in advance
willingness to to pay fees as high as
those anticipated. The requester can
meet with Commission personnel with
the object of reformulating the request to
meet his or her needs at a lower cost.
(4) Interest—notice and rate. The
Commission will assess interest charges
on an unpaid bill starting on the 31st
day following the day on which the
billing was sent. Interest will be at the
rate prescribed in 31 U.S.C. 3717 and
will accrue from the date of the billing.
(5) Advance payments. The
Commission will require a requester to
make an advance payment, i.e.,
payments before work is commenced or
continued on a request, if:
(i) The Commission estimates or
determines that allowable charges that a
requester may be required to pay are
likely to exceed $250. The Commission
will notify the requester of the estimated
cost and either require satisfactory
assurance of full payment where the
requester has a history of prompt
payment of fees, or require advance
payment of charges if a requester has no
history of payment; or
(ii) A requester has previously failed
to pay a fee charged in a timely fashion.
The Commission will require the
requester to pay the full amount owed
plus any applicable interest, and to
make an advance payment of the full
amount of the estimated fee before the
Commission will begin to process a new
request or a pending request from that
requester. When the Commission
VerDate Aug<31>2005
13:49 Aug 05, 2008
Jkt 214001
requires advance payment or an
agreement to pay under this paragraph,
or under § 388.108(a)(5), the
administrative time limits prescribed in
this part will begin only after the
Commission has received the required
payments, or agreements.
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Kimberly D. Bose,
Secretary.
[FR Doc. E8–18040 Filed 8–5–08; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. 2008–N–0039]
Oral Dosage Form New Animal Drugs;
Oxfendazole Suspension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
FOR FURTHER INFORMATION CONTACT:
Donald A. Prater, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, 800 Fifth St. NW., Fort Dodge,
IA 50501, filed a supplement to NADA
140–854 for SYNANTHIC (oxfendazole)
Bovine Dewormer Suspension,
approved for oral use in cattle for the
removal of various internal parasites.
The supplemental NADA provides for
revised scientific nomenclature for a
parasite. The supplemental application
is approved as of July 7, 2008, and the
regulations are amended in 21 CFR
520.1630 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.
Frm 00006
Fmt 4700
List of Subjects in 21 CFR Part 520
Animal drugs.
I 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:
I
Authority: 21 U.S.C. 360b.
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 Fort
Dodge Animal Health, Division of
Wyeth. The supplemental NADA
provides for revised scientific
nomenclature for an internal parasite for
which oxfendazole suspension is used
orally in cattle.
DATES: This rule is effective August 6,
2008.
SUMMARY:
PO 00000
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
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.
Sfmt 4700
2. In § 520.1630, in paragraph
(e)(2)(ii), remove ‘‘C. mcmasteri’’ and in
its place add ‘‘C. surnabada’’; and revise
paragraph (e)(2)(iii) to read as follows:
I
§ 520.1630
Oxfendazole suspension.
*
*
*
*
*
(e) * * *
(2) * * *
(iii) Limitations. Cattle must not be
slaughtered until 7 days after treatment.
Because a withdrawal time in milk has
not been established, do not use in
female dairy cattle of breeding age.
Dated: July 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–18092 Filed 8–5–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2008–N–0039]
Oral Dosage Form New Animal Drugs;
Amprolium
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
E:\FR\FM\06AUR1.SGM
06AUR1
]]>Agencies
[Federal Register Volume 73, Number 152 (Wednesday, August 6, 2008)]
[Rules and Regulations]
[Page 45610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18092]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. 2008-N-0039]
Oral Dosage Form New Animal Drugs; Oxfendazole Suspension
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 Fort Dodge Animal Health, Division of
Wyeth. The supplemental NADA provides for revised scientific
nomenclature for an internal parasite for which oxfendazole suspension
is used orally in cattle.
DATES: This rule is effective August 6, 2008.
FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail:
donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA
140-854 for SYNANTHIC (oxfendazole) Bovine Dewormer Suspension,
approved for oral use in cattle for the removal of various internal
parasites. The supplemental NADA provides for revised scientific
nomenclature for a parasite. The supplemental application is approved
as of July 7, 2008, and the regulations are amended in 21 CFR 520.1630
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 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.
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.1630, in paragraph (e)(2)(ii), remove ``C. mcmasteri''
and in its place add ``C. surnabada''; and revise paragraph (e)(2)(iii)
to read as follows:
Sec. 520.1630 Oxfendazole suspension.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations. Cattle must not be slaughtered until 7 days
after treatment. Because a withdrawal time in milk has not been
established, do not use in female dairy cattle of breeding age.
Dated: July 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-18092 Filed 8-5-08; 8:45 am]
BILLING CODE 4160-01-S
