Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 28036-28037 [E8-10856]
Download as PDF
<![CDATA[
28036
Federal Register / Vol. 73, No. 95 / Thursday, May 15, 2008 / Rules and Regulations
your stepparent, if living with you and
your parent) to use some of his or her
income to take care of your needs.
*
*
*
*
*
(d) * * *
Date of admission to or date of entry
into the United States means the date
established by the U.S. Citizenship and
Immigration Services as the date the
alien is admitted for permanent
residence.
*
*
*
*
*
Ineligible child means your natural
child or adopted child, or the natural or
adopted child of your spouse, or the
natural or adopted child of your parent
or of your parent’s spouse (as the term
child is defined in § 416.1101 and the
term spouse is defined in § 416.1806),
who lives in the same household with
you, and is not eligible for SSI benefits.
*
*
*
*
*
I 3. Amend § 416.1165 by revising
paragraphs (g)(3) and (g)(4) to read as
follows:
§ 416.1165 How we deem income to you
from your ineligible parent(s).
yshivers on PROD1PC66 with RULES
*
*
*
*
*
(g) * * *
(3) Ineligible parent dies. If your
ineligible parent dies, we do not deem
that parent’s income to you to determine
your eligibility for SSI benefits
beginning with the month following the
month of death. In determining your
benefit amount beginning with the
month following the month of death, we
use only your own countable income in
a prior month, excluding any income
deemed to you in that month from your
deceased ineligible parent (see
§ 416.1160(b)(2)(iii)). If you live with
two ineligible parents and one dies, we
continue to deem income from the
surviving ineligible parent who is also
your natural or adoptive parent. If you
live with a stepparent following the
death of your natural or adoptive parent,
we do not deem income from the
stepparent.
(4) Ineligible parent and you no longer
live in the same household. If your
ineligible parent and you no longer live
in the same household, we do not deem
that parent’s income to you to determine
your eligibility for SSI benefits
beginning with the first month
following the month in which one of
you leaves the household. We also will
not deem income to you from your
parent’s spouse (i.e., your stepparent)
who remains in the household with you
if your natural or adoptive parent has
permanently left the household. To
determine your benefit amount if you
continue to be eligible, we follow the
rule in § 416.420 of counting your
VerDate Aug<31>2005
15:14 May 14, 2008
Jkt 214001
income including deemed income from
your parent and your parent’s spouse
(i.e., your stepparent) (if the stepparent
and parent lived in the household with
you) in the second month prior to the
current month.
*
*
*
*
*
Subpart L—[Amended]
4. The authority citation for subpart L
of part 416 continues to read as follows:
I
Authority: Secs. 702(a)(5), 1602, 1611,
1612, 1613, 1614(f), 1621, 1631, and 1633 of
the Social Security Act (42 U.S.C. 902(a)(5),
1381a, 1382, 1382a, 1382b, 1382c(f), 1382j,
1383, and 1383b); sec. 211, Pub. L. 93–66, 87
Stat. 154 (42 U.S.C. 1382 note).
5. Amend § 416.1202 by revising
paragraph (b)(1) to read as follows:
I
§ 416.1202
Deeming of resources.
*
*
*
*
*
(b) Child—(1) General. In the case of
a child (as defined in § 416.1856) who
is under age 18, such child’s resources
shall be deemed to include any
resources, not otherwise excluded under
this subpart, of an ineligible parent of
such child who is living in the same
household with such child (as described
in § 416.1851). Such child’s resources
also shall be deemed to include the
resources of an ineligible spouse of a
parent (stepparent), provided the
stepparent lives in the same household
as the child and the parent. The child’s
resources shall be deemed to include
the resources of the parent and
stepparent whether or not the resources
of the parent and stepparent are
available to the child, to the extent that
the resources of such parent (or parent
and stepparent), exceed the resource
limits described in § 416.1205 except as
provided in paragraph (b)(2) of this
section. (If the child is living with only
one parent, the resource limit for an
individual applies. If the child is living
with both parents, or the child is living
with one parent and the stepparent, the
resource limit for an individual and
spouse applies.) In addition to the
exclusions listed in § 416.1210, pension
funds which the parent or spouse of a
parent may have are also excluded. The
term ‘‘pension funds’’ is defined in
paragraph (a) of this section. As used in
this section, the term ‘‘parent’’ means
the natural or adoptive parent of a child
and the terms ‘‘spouse of a parent’’ and
‘‘stepparent’’ means the spouse (as
defined in § 416.1806) of such natural or
adoptive parent who is living in the
same household with the child and
parent.
*
*
*
*
*
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
6. Amend § 416.1204 by revising the
first two sentences of the introductory
text to read as follows:
I
§ 416.1204 Deeming of resources of the
sponsor of an alien.
The resources of an alien who first
applies for SSI benefits after September
30, 1980, are deemed to include the
resources of the alien’s sponsor for 3
years after the alien’s date of admission
into the United States. The date of
admission is the date established by the
U.S. Citizenship and Immigration
Services as the date the alien is
admitted for permanent residence.* * *
*
*
*
*
*
Subpart R—[Amended]
7. The authority citation for subpart R
of part 416 continues to read as follows:
I
Authority: Secs. 702(a)(5), 1612(b),
1614(b), (c), and (d), and 1631(d)(1) and (e)
of the Social Security Act (42 U.S.C.
902(a)(5), 1382a(b), 1382c(b), (c), and (d), and
1383(d)(1) and (e)).
8. Amend § 416.1851 by revising the
first sentence of paragraph (c) and
adding a new second sentence to read
as follows:
I
§ 416.1851
child.
Effects of being considered a
*
*
*
*
*
(c) If you are under age 18 and live
with your parent(s) who is not eligible
for SSI benefits, we consider (deem) part
of his or her income and resources to be
your own. If you are under age 18 and
live with both your parent and your
parent’s spouse (stepparent) and neither
is eligible for SSI benefits, we consider
(deem) part of their income and
resources to be your own. * * *
[FR Doc. E8–10800 Filed 5–14–08; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
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 abbreviated
new animal drug application (ANADA)
filed by IVX Animal Health, Inc. The
E:\FR\FM\15MYR1.SGM
15MYR1
Federal Register / Vol. 73, No. 95 / Thursday, May 15, 2008 / Rules and Regulations
supplemental ANADA provides for the
veterinary prescription use of flunixin
meglumine solution by intravenous
injection in lactating dairy cattle for
control of pyrexia associated with acute
bovine mastitis.
DATES: This rule is effective May 15,
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, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
supplemental ANADA 200–124 that
provides for veterinary prescription use
of Flunixin Meglumine Injection
intravenously in lactating dairy cattle
for control of pyrexia associated with
acute bovine mastitis. The supplemental
ANADA is approved as of April 24,
2008, and the regulations are amended
in 21 CFR 522.970 to reflect the
approval.
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(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.
yshivers on PROD1PC66 with RULES
List of Subjects in 21 CFR Part 522
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 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
VerDate Aug<31>2005
15:14 May 14, 2008
Jkt 214001
Authority: 21 U.S.C. 360b.
2. In § 522.970, revise paragraphs
(b)(2) and (b)(4) to read as follows:
I
§ 522.970
Flunixin.
*
*
*
*
*
(b) * * *
(2) See Nos. 057561 and 061623 for
use as in paragraphs (e)(1), (e)(2)(i)(A),
(e)(2)(ii)(A), and (e)(2)(iii) of this
section.
*
*
*
*
*
(4) See Nos. 055529 and 059130 for
use as in paragraphs (e)(1) and (e)(2) of
this section.
*
*
*
*
*
Dated: May 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–10856 Filed 5–14–08; 8:45 am]
BILLING CODE 4160–01–S
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Parts 4022 and 4044
Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets
in Single-Employer Plans; Interest
Assumptions for Valuing and Paying
Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
SUMMARY: The Pension Benefit Guaranty
Corporation’s regulations on Benefits
Payable in Terminated Single-Employer
Plans and Allocation of Assets in
Single-Employer Plans prescribe interest
assumptions for valuing and paying
benefits under terminating singleemployer plans. This final rule amends
the regulations to adopt interest
assumptions for plans with valuation
dates in June 2008. Interest assumptions
are also published on the PBGC’s Web
site (https://www.pbgc.gov).
DATES: Effective June 1, 2008.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion, Manager, Regulatory
and Policy Division, Legislative and
Regulatory Department, Pension Benefit
Guaranty Corporation, 1200 K Street,
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll-free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: The
PBGC’s regulations prescribe actuarial
assumptions—including interest
assumptions—for valuing and paying
plan benefits of terminating singleemployer plans covered by title IV of
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
28037
the Employee Retirement Income
Security Act of 1974. The interest
assumptions are intended to reflect
current conditions in the financial and
annuity markets.
Three sets of interest assumptions are
prescribed: (1) A set for the valuation of
benefits for allocation purposes under
section 4044 (found in Appendix B to
Part 4044), (2) a set for the PBGC to use
to determine whether a benefit is
payable as a lump sum and to determine
lump-sum amounts to be paid by the
PBGC (found in Appendix B to Part
4022), and (3) a set for private-sector
pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using the PBGC’s historical
methodology (found in Appendix C to
Part 4022).
This amendment (1) adds to
Appendix B to Part 4044 the interest
assumptions for valuing benefits for
allocation purposes in plans with
valuation dates during June 2008, (2)
adds to Appendix B to Part 4022 the
interest assumptions for the PBGC to
use for its own lump-sum payments in
plans with valuation dates during June
2008, and (3) adds to Appendix C to
Part 4022 the interest assumptions for
private-sector pension practitioners to
refer to if they wish to use lump-sum
interest rates determined using the
PBGC’s historical methodology for
valuation dates during June 2008.
For valuation of benefits for allocation
purposes, the interest assumptions that
the PBGC will use (set forth in
Appendix B to part 4044) will be 5.68
percent for the first 20 years following
the valuation date and 4.75 percent
thereafter. These interest assumptions
represent a decrease (from those in
effect for May 2008) of 0.13 percent for
the first 20 years following the valuation
date and 0.13 percent for all years
thereafter.
The interest assumptions that the
PBGC will use for its own lump-sum
payments (set forth in Appendix B to
part 4022) will be 3.25 percent for the
period during which a benefit is in pay
status and 4.00 percent during any years
preceding the benefit’s placement in pay
status. These interest assumptions
represent no change from those in effect
for May 2008. For private-sector
payments, the interest assumptions (set
forth in Appendix C to part 4022) will
be the same as those used by the PBGC
for determining and paying lump sums
(set forth in Appendix B to part 4022).
The PBGC has determined that notice
and public comment on this amendment
are impracticable and contrary to the
public interest. This finding is based on
the need to determine and issue new
interest assumptions promptly so that
E:\FR\FM\15MYR1.SGM
15MYR1
]]>Agencies
[Federal Register Volume 73, Number 95 (Thursday, May 15, 2008)]
[Rules and Regulations]
[Pages 28036-28037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10856]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
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 abbreviated new
animal drug application (ANADA) filed by IVX Animal Health, Inc. The
[[Page 28037]]
supplemental ANADA provides for the veterinary prescription use of
flunixin meglumine solution by intravenous injection in lactating dairy
cattle for control of pyrexia associated with acute bovine mastitis.
DATES: This rule is effective May 15, 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 supplemental ANADA 200-124
that provides for veterinary prescription use of Flunixin Meglumine
Injection intravenously in lactating dairy cattle for control of
pyrexia associated with acute bovine mastitis. The supplemental ANADA
is approved as of April 24, 2008, and the regulations are amended in 21
CFR 522.970 to reflect the approval.
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(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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.970, revise paragraphs (b)(2) and (b)(4) to read as
follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(2) See Nos. 057561 and 061623 for use as in paragraphs (e)(1),
(e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii) of this section.
* * * * *
(4) See Nos. 055529 and 059130 for use as in paragraphs (e)(1) and
(e)(2) of this section.
* * * * *
Dated: May 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-10856 Filed 5-14-08; 8:45 am]
BILLING CODE 4160-01-S
