Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 28036-28037 [E8-10856]

Download as PDF 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 (http://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]


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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.

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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