Certain Other Dosage Form New Animal Drugs; Oxytetracycline, 41139-41140 [05-14017]
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Federal Register / Vol. 70, No. 136 / Monday, July 18, 2005 / Rules and Regulations
(21) Payments made to individuals
who were captured and interned by the
Democratic Republic of Vietnam as a
result of participation in certain military
operations, pursuant to section 606 of
Public Law 105–78 and section 657 of
Public Law 104–201 (110 Stat. 2584).
(22) Payments made to certain
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bifida, pursuant to section 421 of Public
Law 104–204 (38 U.S.C. 1805(d)).
(23) Payments made to the children of
women Vietnam veterans who suffer
from certain birth defects, pursuant to
section 401 of Public Law 106–419, (38
U.S.C. 1833(c)).
(24) For the 9 months following the
month of receipt, any unspent portion of
any refund of Federal income taxes
under section 24 of the Internal Revenue
Code of 1986 (relating to the child care
tax credit), pursuant to section 431 of
Public Law 108–203 (118 Stat. 539).
12. Section 416.1248 is added to read
as follows:
I
§ 416.1248 Exclusion of gifts to children
with life-threatening conditions.
In determining the resources of an
individual who has not attained 18
years of age and who has a lifethreatening condition, we will exclude
any gifts from an organization described
in section 501(c)(3) of the Internal
Revenue Code of 1986 which is exempt
from taxation under section 501(a) of
such Code. We will exclude any in-kind
gift that is not converted to cash and
cash gifts to the extent that the total gifts
excluded pursuant to this paragraph do
not exceed $2000 in any calendar year.
In-kind gifts converted to cash are
considered under income counting rules
in the month of conversion.
13. Section 416.1249 is added to read
as follows:
I
§ 416.1249 Exclusion of payments
received as restitution for misuse of
benefits by a representative payee.
In determining the resources of an
individual (and spouse, if any), the
unspent portion of any payment
received by the individual as restitution
for title II, title VIII or title XVI benefits
misused by a representative payee
under § 404.2041, § 408.641 or
§ 416.641, respectively, is excluded for
9 months following the month of
receipt.
[FR Doc. 05–14050 Filed 7–15–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 529
Certain Other Dosage Form New
Animal Drugs; Oxytetracycline
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
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 Pfizer,
Inc. The supplemental NADA provides
for use of oxytetracycline hydrochloride
soluble powder for skeletal marking of
finfish fry and fingerlings by immersion.
DATES: This rule is effective July 18,
2005.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Pfizer,
Inc., 235 East 42d St., New York, NY
10017–5755, filed a supplement to
NADA 8–622 that provides for use of
TERRAMYCIN–343 (oxytetracycline
HCl) Soluble Powder for skeletal
marking of finfish fry and fingerlings by
immersion. The approval of this
supplemental NADA relied on publicly
available safety and effectiveness data
contained in Public Master File (PMF)
5667 which were compiled under
National Research Support Project-7
(NRSP–7), a national agricultural
research program for obtaining
clearances for use of new drugs in minor
animal species and for special uses. In
addition, the supplemental NADA
provides for the addition of statements
to product labeling warning against the
use of this product in drinking water of
lactating dairy cattle. The supplemental
NADA is approved as of June 13, 2005,
and the regulations in 21 CFR 529.1660
are amended to reflect the approval. The
basis of approval is discussed in the
freedom of information summary.
In addition, FDA has found that the
regulations contain incorrect statements
warning against the use of
oxytetracycline soluble powder in
calves intended for veal. Accordingly,
the regulations in 21 CFR 520.1660d are
amended to reflect appropriate warning
statements for this product. This action
is being taken to improve the accuracy
of the regulations.
PO 00000
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Fmt 4700
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41139
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, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
FDA has determined under 21 CFR
25.33(d)(4) 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 Parts 520 and
529
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
parts 520 and 529 are amended as
follows:
I
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.
2. Section 520.1660d is amended by
revising paragraph (d)(1)(iv)(C) to read as
follows:
I
§ 520.1660d Oxytetracycline hydrochloride
soluble powder.
*
*
*
*
*
(d) * * *
(1) * * *
(iv) * * *
(C) Limitations. Prepare a fresh
solution daily. Administer up to 14
days. Do not use for more than 14
consecutive days. Use as sole source of
oxytetracycline. Do not administer this
product with milk or milk replacers.
Administer 1 hour before or 2 hours
after feeding milk or milk replacers.
Withdraw 5 days prior to slaughter. A
milk discard period has not been
established for this product in lactating
dairy cattle. Do not use in female dairy
cattle 20 months of age or older.
*
*
*
*
*
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18JYR1
41140
Federal Register / Vol. 70, No. 136 / Monday, July 18, 2005 / Rules and Regulations
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 529 continues to read as follows:
I
consideration of all the comments, the
proposed regulations are adopted as
amended by this Treasury decision. The
revisions are discussed below.
Summary of Comments
The proposed regulations provided
that, for purposes of determining
§ 529.1660 [Amended]
whether the predeceased parent rule
I 4. Section 529.1660 is amended in
applies, an individual transferee’s
paragraph (b)(2) by removing ‘‘No.
059130’’ and by adding in its place ‘‘Nos. interest in property is established or
derived at the time the transferor who
000069 and 059130’’.
transferred the property is subject to
Dated: July 1, 2005.
either the gift or estate tax on the
Catherine P. Beck,
property. If the transferor will be subject
Acting Director, Center for Veterinary
to a transfer tax imposed on the
Medicine.
property transferred on more than one
[FR Doc. 05–14017 Filed 7–15–05; 8:45 am]
occasion, then the relevant time for
determining whether the predeceased
BILLING CODE 4160–01–S
parent rule applies is the earliest time
at which the transferor is subject to the
gift or estate tax. In the case of a trust
DEPARTMENT OF THE TREASURY
for which an election under section
2056(b)(7) (QTIP election) has been
Internal Revenue Service
made, the proposed regulations
provided that the interest of the
26 CFR Part 26
remainder beneficiary is considered as
[TD 9214]
established or derived when the QTIP
RIN 1545–BC60
trust was established. However, the
proposed regulations also included an
Predeceased Parent Rule
exception to this general rule by
providing that, to the extent of the QTIP
AGENCY: Internal Revenue Service (IRS),
(but not a reverse QTIP) election, the
Treasury.
remainder beneficiary’s interest is
ACTION: Final regulations.
deemed to have been established or
derived on the death of the transferor’s
SUMMARY: This document contains final
spouse (the income beneficiary), rather
regulations relating to the predeceased
than on the transferor’s earlier death.
parent rule, which provides an
One commentator indicated that this
exception to the general rules of section
exception is unnecessary. The
2651 of the Internal Revenue Code
commentator believes that the proposed
(Code) for determining the generation
regulations misinterpreted the statute
assignment of a transferee of property
because a remainder beneficiary’s
for generation-skipping transfer (GST)
interest in a trust that is subject to a
tax purposes. These regulations also
QTIP (but not a reverse QTIP) election
provide rules regarding a transferee
should always be deemed to have been
assigned to more than one generation.
established, not at the time of the trust’s
The regulations reflect changes to the
creation, but rather at the time when the
law made by the Taxpayer Relief Act of
income-beneficiary spouse is first
1997 and generally apply to individuals,
subject to gift or estate tax on the trust
trusts, and estates.
property. This position applies the
DATES: Effective Date: These regulations
definition of ‘‘transferor’’ in section
are effective July 18, 2005.
2652 in the context of the reference to
FOR FURTHER INFORMATION CONTACT: Lian ‘‘established and derived’’ in section
A. Mito at (202) 622–7830 (not a toll2651(e), and is based on the conclusion
free number).
that the tax in this situation is not
imposed on the same transferor on more
SUPPLEMENTARY INFORMATION:
than one occasion. Thus, because the
Background
donee or surviving spouse becomes the
transferor of a trust that is subject to a
On September 3, 2004, a notice of
proposed rulemaking (REG–145988–03) QTIP (but not reverse QTIP) election,
the remainder beneficiary’s interest in
relating to the predeceased parent rule
such a trust is established upon that
was published in the Federal Register
spouse’s gift of an interest in the trust
(69 FR 53862). The public hearing
or that spouse’s death, in each case the
scheduled for December 14, 2004, was
time at which gift or estate tax on the
cancelled because no requests to speak
trust is first imposed on that spouse.
were received. Written comments
Viewed from this perspective, this
responding to the notice of proposed
provision of the proposed regulations is
rulemaking were received. After
Authority: 21 U.S.C. 360b.
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not an exception. The Treasury
Department and the IRS agree, and the
final regulations adopt the suggested
change.
Under the proposed regulations, the
predeceased parent rule does not apply
to transfers to collateral heirs if, at the
time of the transfer, ‘‘the transferor (or
the transferor’s spouse or former spouse)
has any living lineal descendant.’’ Thus,
under the proposed regulations, if, at
the time of the transfer, the transferor
has no living lineal descendants but the
transferor’s spouse or former spouse
does, the predeceased parent rule will
not apply to any transfer by the
transferor to a collateral heir. A number
of commentators pointed out that the
parenthetical language is inconsistent
with the purpose and language of the
statute, and will inappropriately narrow
the application of the predeceased
parent rule with respect to collateral
heirs. The Treasury Department and the
IRS agree, and the parenthetical
language is removed in the final
regulations. Accordingly, the final
regulations require that, for the
predeceased parent rule to apply to
transfers to collateral heirs, only the
transferor must have no living lineal
descendants at the time of the transfer.
The proposed regulations provided an
exception to the general rule that
assigns an individual to the youngest of
the generations to which that individual
may be assigned. Under the exception,
an adopted individual will be treated as
a member of the generation that is one
generation below the adoptive parent for
purposes of determining whether a
transfer to the adopted individual from
the adoptive parent (or the spouse or
former spouse of the adoptive parent, or
a lineal descendant of a grandparent of
the adoptive parent) is subject to the
GST tax. The proposed regulations
defined an ‘‘adopted individual’’ as an
individual who is: (1) A descendant of
a parent of the adoptive parent (or the
spouse or former spouse of the adoptive
parent); and (2) under the age of 18 at
the time of the adoption.
Two commentators expressed concern
that this objective test (specifically, the
age at the time of the adoption) provides
a strong inducement to engage in a taxmotivated adoption, particularly in the
case of older minors, because of the
amount of GST tax that thereby may be
avoided. One commentator suggested
lowering the limit on the age of the
individual at the time of the adoption
for purposes of the test. The other
commentator recommended adding a
third element to the definition of
adopted individual, namely, that the
individual was not adopted primarily
for tax-avoidance purposes.
E:\FR\FM\18JYR1.SGM
18JYR1
]]>Agencies
[Federal Register Volume 70, Number 136 (Monday, July 18, 2005)]
[Rules and Regulations]
[Pages 41139-41140]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14017]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 529
Certain Other Dosage Form New Animal Drugs; Oxytetracycline
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
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 Pfizer, Inc. The supplemental NADA provides
for use of oxytetracycline hydrochloride soluble powder for skeletal
marking of finfish fry and fingerlings by immersion.
DATES: This rule is effective July 18, 2005.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017-5755, filed a supplement to NADA 8-622 that provides for use of
TERRAMYCIN-343 (oxytetracycline HCl) Soluble Powder for skeletal
marking of finfish fry and fingerlings by immersion. The approval of
this supplemental NADA relied on publicly available safety and
effectiveness data contained in Public Master File (PMF) 5667 which
were compiled under National Research Support Project-7 (NRSP-7), a
national agricultural research program for obtaining clearances for use
of new drugs in minor animal species and for special uses. In addition,
the supplemental NADA provides for the addition of statements to
product labeling warning against the use of this product in drinking
water of lactating dairy cattle. The supplemental NADA is approved as
of June 13, 2005, and the regulations in 21 CFR 529.1660 are amended to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
In addition, FDA has found that the regulations contain incorrect
statements warning against the use of oxytetracycline soluble powder in
calves intended for veal. Accordingly, the regulations in 21 CFR
520.1660d are amended to reflect appropriate warning statements for
this product. This action is being taken to improve the accuracy of the
regulations.
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, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA has determined under 21 CFR 25.33(d)(4) 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 Parts 520 and 529
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 parts 520 and
529 are 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. Section 520.1660d is amended by revising paragraph (d)(1)(iv)(C) to
read as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
* * * * *
(d) * * *
(1) * * *
(iv) * * *
(C) Limitations. Prepare a fresh solution daily. Administer up to
14 days. Do not use for more than 14 consecutive days. Use as sole
source of oxytetracycline. Do not administer this product with milk or
milk replacers. Administer 1 hour before or 2 hours after feeding milk
or milk replacers. Withdraw 5 days prior to slaughter. A milk discard
period has not been established for this product in lactating dairy
cattle. Do not use in female dairy cattle 20 months of age or older.
* * * * *
[[Page 41140]]
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1660 [Amended]
0
4. Section 529.1660 is amended in paragraph (b)(2) by removing ``No.
059130'' and by adding in its place ``Nos. 000069 and 059130''.
Dated: July 1, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-14017 Filed 7-15-05; 8:45 am]
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