Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol, 7348-7349 [E7-2580]

Download as PDF 7348 Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Rules and Regulations under the program developed pursuant to paragraph (d) of this section. * * * * * PART 1—DEFINITIONS AND ABBREVIATIONS 1. The authority citation for part 1 continues to read as follows: I Authority: 49 U.S.C. 106(g), 40113, 44701. 2. In § 1.1, revise the following definition, in alphabetical order, to read as follows: I § 1.1 * * * * * Extended Operations (ETOPS) means an airplane flight operation, other than an all-cargo operation in an airplane with more than two engines, during which a portion of the flight is conducted beyond a time threshold identified in part 121 or part 135 of this chapter that is determined using an approved one-engine-inoperative cruise speed under standard atmospheric conditions in still air. * * * * * PART 121—OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS 3. The authority citation for part 121 continues to read as follows: I Authority: 49 U.S.C. 106(g), 40113, 40119, 41706, 44101, 44701-44702, 44705, 44709– 44711, 44713, 44716–44717, 44722, 44901, 44903-44904, 44912, 45101–45105, 46105, 46301. 4. In § 121.374, revise paragraph (c) to read as follows: * * * * * (c) Limitations on dual maintenance. (1) Except as specified in paragraph (c)(2), the certificate holder may not perform scheduled or unscheduled dual maintenance during the same maintenance visit on the same or a substantially similar ETOPS Significant System listed in the ETOPS maintenance document, if the improper maintenance could result in the failure of an ETOPS Significant System. (2) In the event dual maintenance as defined in paragraph (c)(1) of this section cannot be avoided, the certificate holder may perform maintenance provided: (i) The maintenance action on each affected ETOPS Significant System is performed by a different technician, or (ii) The maintenance action on each affected ETOPS Significant System is performed by the same technician under the direct supervision of a second qualified individual; and (iii) For either paragraph (c)(2)(i) or (ii) of this section, a qualified individual conducts a ground verification test and any in-flight verification test required erjones on PRODPC74 with RULES I 14:51 Feb 14, 2007 5. The authority citation for part 135 continues to read as follows: I General definitions. VerDate Aug<31>2005 PART 135—OPERATING REQUIREMENTS; COMMUTER AND ON DEMAND OPERATION AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT Jkt 211001 Authority: 49 U.S.C. 106(g), 41706, 44113, 44701–44702, 44705, 44709, 44711–44713, 44715–44717, 44722. 6. In appendix G of part 135, revise section 135.2.7 to read as follows: I Appendix G to Part 135—Extended Operations (ETOPS) * * * * * G135.2.7 Fuel Requirements. No person may dispatch or release for flight an ETOPS flight unless, considering wind and other weather conditions expected, it has the fuel otherwise required by this part and enough fuel to satisfy each of the following requirements: (a) Fuel to fly to an ETOPS Alternate Airport. (1) Fuel to account for rapid decompression and engine failure. The airplane must carry the greater of the following amounts of fuel: (i) Fuel sufficient to fly to an ETOPS Alternate Airport assuming a rapid decompression at the most critical point followed by descent to a safe altitude in compliance with the oxygen supply requirements of § 135.157; (ii) Fuel sufficient to fly to an ETOPS Alternate Airport (at the one-engineinoperative cruise speed under standard conditions in still air) assuming a rapid decompression and a simultaneous engine failure at the most critical point followed by descent to a safe altitude in compliance with the oxygen requirements of § 135.157; or (iii) Fuel sufficient to fly to an ETOPS Alternate Airport (at the one-engineinoperative cruise speed under standard conditions in still air) assuming an engine failure at the most critical point followed by descent to the one engine inoperative cruise altitude. (2) Fuel to account for errors in wind forecasting. In calculating the amount of fuel required by paragraph G135.2.7(a)(1) of this appendix, the certificate holder must increase the actual forecast wind speed by 5% (resulting in an increase in headwind or a decrease in tailwind) to account for any potential errors in wind forecasting. If a certificate holder is not using the actual forecast wind based on a wind model accepted by the FAA, the airplane must carry additional fuel equal to 5% of the fuel required by paragraph G135.2.7(a) of this appendix, as reserve fuel to allow for errors in wind data. (3) Fuel to account for icing. In calculating the amount of fuel required by paragraph G135.2.7(a)(1) of this appendix, (after PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 completing the wind calculation in G135.2.7(a)(2) of this appendix), the certificate holder must ensure that the airplane carries the greater of the following amounts of fuel in anticipation of possible icing during the diversion: (i) Fuel that would be burned as a result of airframe icing during 10 percent of the time icing is forecast (including the fuel used by engine and wing anti-ice during this period). (ii) Fuel that would be used for engine antiice, and if appropriate wing anti-ice, for the entire time during which icing is forecast. (4) Fuel to account for engine deterioration. In calculating the amount of fuel required by paragraph G135.2.7(a)(1) of this appendix (after completing the wind calculation in paragraph G135.2.7(a)(2) of this appendix), the certificate holder must ensure the airplane also carries fuel equal to 5% of the fuel specified above, to account for deterioration in cruise fuel burn performance unless the certificate holder has a program to monitor airplane in-service deterioration to cruise fuel burn performance. (b) Fuel to account for holding, approach, and landing. In addition to the fuel required by paragraph G135.2.7 (a) of this appendix, the airplane must carry fuel sufficient to hold at 1500 feet above field elevation for 15 minutes upon reaching the ETOPS Alternate Airport and then conduct an instrument approach and land. (c) Fuel to account for APU use. If an APU is a required power source, the certificate holder must account for its fuel consumption during the appropriate phases of flight. * * * * * Issued in Washington, DC on February 9, 2007. Rebecca MacPherson, Assistant Chief Counsel, Regulations Division. [FR Doc. 07–704 Filed 2–12–07; 3:52 pm] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol 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 new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of an additional dose of trenbolone acetate and estradiol implant used for increased E:\FR\FM\15FER1.SGM 15FER1 Federal Register / Vol. 72, No. 31 / Thursday, February 15, 2007 / Rules and Regulations erjones on PRODPC74 with RULES rate of weight gain and improved feed efficiency in feedlot steers. DATES: This rule is effective February 15, 2007. FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary Medicine (HFV–126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0232, email: eric.dubbin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet Ln., Millsboro, DE 19966, filed NADA 141– 269 that provides for REVALOR XS (trenbolone acetate and estradiol), an ear implant, used for increased rate of weight gain and improved feed efficiency in steers fed in confinement for slaughter. The supplemental NADA is approved as of January 19, 2007, and the regulations are amended in § 522.2477 (21 CFR 522.2477) to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, FDA is revising the regulations in § 522.2477 to correctly reflect products approved for another sponsor. 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. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning January 19, 2007. 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. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner VerDate Aug<31>2005 14:51 Feb 14, 2007 Jkt 211001 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 Authority: 21 U.S.C. 360b. 2. In § 522.2477, revise paragraphs (b)(1), (b)(2), and (b)(3); and add paragraph (d)(1)(i)(G) to read as follows: I § 522.2477 estradiol. Trenbolone acetate and (b) * * * (1) No. 021641 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), (d)(1)(ii), (d)(1)(iii), (d)(2), and (d)(3) of this section. (2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii) of this section. (3) No. 000856 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii) of this section. (d) * * * (1) * * * (i) * * * (G) 200 milligram (mg) trenbolone acetate and 40 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose. Dated: February 6, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7–2580 Filed 2–14–07; 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 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 7349 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 March 2007. Interest assumptions are also published on the PBGC’s Web site (https://www.pbgc.gov). DATES: Effective March 1, 2007. 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 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 March 2007, (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 March 2007, 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 March 2007. 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 5.22 percent for the first 20 years following the valuation date and 4.89 percent thereafter. These interest assumptions E:\FR\FM\15FER1.SGM 15FER1

Agencies

[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Rules and Regulations]
[Pages 7348-7349]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2580]


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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; 
Trenbolone Acetate and Estradiol

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 new animal drug application 
(NADA) filed by Intervet, Inc. The NADA provides for use of an 
additional dose of trenbolone acetate and estradiol implant used for 
increased

[[Page 7349]]

rate of weight gain and improved feed efficiency in feedlot steers.

DATES: This rule is effective February 15, 2007.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: eric.dubbin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet 
Ln., Millsboro, DE 19966, filed NADA 141-269 that provides for REVALOR 
XS (trenbolone acetate and estradiol), an ear implant, used for 
increased rate of weight gain and improved feed efficiency in steers 
fed in confinement for slaughter. The supplemental NADA is approved as 
of January 19, 2007, and the regulations are amended in Sec.  522.2477 
(21 CFR 522.2477) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, FDA is revising the regulations in Sec.  522.2477 to 
correctly reflect products approved for another sponsor. 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning January 19, 2007.
    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 the 
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.  522.2477, revise paragraphs (b)(1), (b)(2), and (b)(3); and 
add paragraph (d)(1)(i)(G) to read as follows:


Sec.  522.2477  Trenbolone acetate and estradiol.

    (b) * * *
    (1) No. 021641 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), 
(d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), (d)(1)(ii), 
(d)(1)(iii), (d)(2), and (d)(3) of this section.
    (2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), 
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), 
(d)(3)(ii), and (d)(3)(iii) of this section.
    (3) No. 000856 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(D), 
(d)(1)(ii), (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii) of 
this section.
    (d) * * *
    (1) * * *
    (i) * * *
    (G) 200 milligram (mg) trenbolone acetate and 40 mg estradiol (one 
implant consisting of 10 pellets, each pellet containing 20 mg 
trenbolone acetate and 4 mg estradiol) per implant dose.

    Dated: February 6, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-2580 Filed 2-14-07; 8:45 am]
BILLING CODE 4160-01-S

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