Implantation or Injectable Dosage Form New Animal Drugs; Insulin, 66047-66048 [E9-29583]

Download as PDF 66047 Federal Register / Vol. 74, No. 238 / Monday, December 14, 2009 / Rules and Regulations MGB, inspect the tightening torque load of the 6 nuts on the flexible coupling-to-flange attachment bolts in accordance with paragraph 2.B.2.b. of the EASB, except you are not required to contact the manufacturer. (3) For MGB input flexible coupling flange assemblies that have more than 75 hours TIS since new or since a complete overhaul of the MGB, within the next 50 hours TIS, inspect the tightening torque load of the 6 nuts on the flexible coupling-to-flange attachment bolts, in accordance with paragraph 2.B.2.b. of the EASB, except you are not required to contact the manufacturer. (4) Prior to installing a MGB that contains an input flexible coupling flange assembly that has been modified per MOD 0752416 and MOD 0752419, you must comply with the provisions of this AD. material at NARA, call (202) 741–6030, or go to: http://www.archives.gov/federal-register/ cfr/ibr-locations.html. the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows: Issued in Fort Worth, Texas, on November 18, 2009. Gary B. Roach, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service. [FR Doc. E9–29424 Filed 12–11–09; 8:45 am] PART 510—NEW ANIMAL DRUGS Differences Between This AD and the MCAI AD (f) The MCAI AD uses the term ‘‘flight hours’’ instead of ‘‘hours time-in-service’’, as we have used in this AD. Also, the MCAI AD allows ‘‘use of later approved revisions’’ of the service information to comply with the MCAI AD. Our AD requires compliance in accordance with Eurocopter Emergency Alert Service Bulletin No. 05.95, dated March 3, 2008. Additionally, this AD requires ‘‘inspections’’ by a qualified mechanic instead of ‘‘checks’’, which we allow a pilot to do. Finally, this AD does not require you to contact Eurocopter Technical Support, which is required by the MCAI AD. 21 CFR Part 510 § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. [Docket No. FDA–2009–N–0665] * Other Information (g) Alternative Methods of Compliance (AMOCs): The Manager, Safety Management Group, Attn: DOT/FAA Southwest Region, Ed Cuevas, Aerospace Engineer, Rotorcraft Directorate, 2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222– 5355, fax (817) 222–5961, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. (h) European Aviation Safety Agency MCAI Airworthiness Directive No. 2009– 0049–E, dated March 3, 2008 (Corrected: March 7, 2008), contains related information. srobinson on DSKHWCL6B1PROD with RULES Joint Aircraft System/Component Code (i) JASC Code 6310: Engine/Transmission Coupling. Material Incorporated by Reference (j) You must use the specified portions of Eurocopter Emergency Alert Service Bulletin No. 05.95, dated March 3, 2008, to do the actions required. (1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51. (2) For service information identified in this AD, contact American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, TX 75053–4005, telephone (800) 232–0323, fax (972) 641–3710, or at http:// www.eurocopter.com. (3) You may review copies at the FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Fort Worth, Texas 76137; or at the National Archives and Records Administration (NARA). For information on the availability of this VerDate Nov<24>2008 18:27 Dec 11, 2009 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration New Animal Drugs; Change of Sponsor’s Name and Address Food and Drug Administration, Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Schering-Plough Animal Health Corp. to Intervet, Inc., and to change the sponsor’s mailing address. DATES: This rule is effective December 14, 2009. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, has informed FDA of a change of name and mailing address to Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes. 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 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. ■ Therefore, under the Federal Food, Drug and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to PO 00000 Frm 00019 Fmt 4700 2. In § 510.600, in the table in paragraph (c)(1), remove the entry for ‘‘Schering-Plough Animal Health Corp.’’ and alphabetically add a new entry for ‘‘Intervet, Inc.’’; and in the table in paragraph (c)(2), revise the entry for ‘‘000061’’ to read as follows: * * (c) * * * (1) * * * * * Sfmt 4700 Firm name and address Drug labeler code * HHS. ACTION: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. ■ BILLING CODE 4910–13–P AGENCY: 1. The authority citation for 21 CFR part 510 continues to read as follows: ■ * * * Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068 * * * * 000061 * * (2) * * * Drug labeler code * Firm name and address * 000061 * * * * Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068 * * * * Dated: December 8, 2009. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E9–29627 Filed 12–11–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA–2009–N–0665] Implantation or Injectable Dosage Form New Animal Drugs; Insulin AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\14DER1.SGM Final rule. 14DER1 srobinson on DSKHWCL6B1PROD with RULES 66048 Federal Register / Vol. 74, No. 238 / Monday, December 14, 2009 / Rules and Regulations SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for veterinary prescription use of an injectable suspension of protamine zinc recombinant human insulin for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. DATES: This rule is effective December 14, 2009. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506–2002, filed NADA 141–297 that provides for the veterinary prescription use of PROZINC (protamine zinc recombinant human insulin), an injectable suspension for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. The NADA is approved as of October 28, 2009, and the regulations are amended in 21 CFR 522.1160 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. The agency has determined under 21 CFR 25.33 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. ■ Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to VerDate Nov<24>2008 16:24 Dec 11, 2009 Jkt 220001 the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: DEPARTMENT OF THE TREASURY Internal Revenue Service PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 2. In § 522.1160, revise paragraphs (a), (b), and (c)(2)(i) to read as follows: ■ § 522.1160 Insulin. (a) Specifications—(1) Each milliliter (mL) of porcine insulin zinc suspension contains 40 international units (IU) of insulin. (2) Each mL of protamine zinc recombinant human insulin suspension contains 40 IU of insulin. (b) Sponsors. See sponsors in § 510.600 of this chapter for use as in paragraph (c) of this section. (1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section. (2) No. 000010 for use of product described in paragraph (a)(2) of this section as in paragraphs (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of this section. (c) * * * (2) Cats—(i) Amount—(A) Porcine insulin zinc. Administer an initial dose of 1 to 2 IU by subcutaneous injection. Injections should be given twice daily at approximately 12-hour intervals. For cats fed twice daily, the injections should be concurrent with or right after a meal. For cats fed ad libitum, no change in feeding is needed. Adjust the dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained. (B) Protamine zinc recombinant human insulin. Administer an initial dose of 0.1 to 0.3 IU/pound of body weight (0.2 to 0.7 IU/kilogram) every 12 hours. The dose should be given concurrently with or right after a meal. Re-evaluate the cat at appropriate intervals and adjust the dose based on both clinical signs and glucose nadirs until adequate glycemic control has been attained. * * * * * Dated: December 8, 2009. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E9–29583 Filed 12–11–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 26 CFR Part 1 [TD 9474] RIN 1545–BF14 Reduction in Taxable Income for Housing Hurricane Katrina Displaced Individuals AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and removal of temporary regulations. SUMMARY: This document contains final regulations relating to the reduction in taxable income under section 302 of the Katrina Emergency Tax Relief Act of 2005. The final regulations also reflect legislation under section 702 of the Heartland Disaster Tax Relief Act of 2008. The final regulations affect taxpayers who provide housing in their principal residences to individuals displaced by certain major disasters. Effective Date: These regulations are effective on December 14, 2009. Applicability Date: For date of applicability, see § 1.9300–1(h). FOR FURTHER INFORMATION CONTACT: Shareen S. Pflanz, 202–622–4920 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background and Explanation of Provisions This document contains final regulations that replace the temporary regulations in 26 CFR Part 1 relating to the reduction in taxable income for housing provided to displaced individuals under section 302 of the Katrina Emergency Tax Relief Act of 2005 (Pub. L. 109–73, 119 Stat. 2016) (KETRA). This document also applies these rules to individuals displaced in a Midwestern disaster area, as defined in section 702 of the Heartland Disaster Tax Relief Act of 2008 (Title VII of Division C of Pub. L. 110–343, 122 Stat. 3912) (HDTRA). On December 12, 2006, temporary regulations (TD 9301) were published in the Federal Register (71 FR 74467). A notice of proposed rulemaking (REG– 152043–05) cross-referencing the temporary regulations was also published in the Federal Register (71 FR 74482). No public hearing was requested or held. No written comments responding to the notice of proposed rulemaking were received. The proposed regulations are adopted as amended by this Treasury decision to implement section 702 of HDTRA. E:\FR\FM\14DER1.SGM 14DER1

Agencies

[Federal Register Volume 74, Number 238 (Monday, December 14, 2009)]
[Rules and Regulations]
[Pages 66047-66048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29583]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]


Implantation or Injectable Dosage Form New Animal Drugs; Insulin

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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[[Page 66048]]

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an original new animal drug 
application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The 
NADA provides for veterinary prescription use of an injectable 
suspension of protamine zinc recombinant human insulin for the 
reduction of hyperglycemia and hyperglycemia-associated clinical signs 
in cats with diabetes mellitus.

DATES:  This rule is effective December 14, 2009.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Highway, St. Joseph, MO 64506-2002, filed NADA 141-297 that 
provides for the veterinary prescription use of PROZINC (protamine zinc 
recombinant human insulin), an injectable suspension for the reduction 
of hyperglycemia and hyperglycemia-associated clinical signs in cats 
with diabetes mellitus. The NADA is approved as of October 28, 2009, 
and the regulations are amended in 21 CFR 522.1160 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.
    The agency has determined under 21 CFR 25.33 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.  522.1160, revise paragraphs (a), (b), and (c)(2)(i) to read 
as follows:


Sec.  522.1160   Insulin.

    (a) Specifications--(1) Each milliliter (mL) of porcine insulin 
zinc suspension contains 40 international units (IU) of insulin.
    (2) Each mL of protamine zinc recombinant human insulin suspension 
contains 40 IU of insulin.
    (b) Sponsors. See sponsors in Sec.  510.600 of this chapter for use 
as in paragraph (c) of this section.
    (1) No. 000061 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (c)(1), (c)(2)(i)(A), (c)(2)(ii), and 
(c)(2)(iii) of this section.
    (2) No. 000010 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) 
of this section.
    (c) * * *
    (2) Cats--(i) Amount--(A) Porcine insulin zinc. Administer an 
initial dose of 1 to 2 IU by subcutaneous injection. Injections should 
be given twice daily at approximately 12-hour intervals. For cats fed 
twice daily, the injections should be concurrent with or right after a 
meal. For cats fed ad libitum, no change in feeding is needed. Adjust 
the dose at appropriate intervals based on clinical signs, urinalysis 
results, and glucose curve values until adequate glycemic control has 
been attained.
    (B) Protamine zinc recombinant human insulin. Administer an initial 
dose of 0.1 to 0.3 IU/pound of body weight (0.2 to 0.7 IU/kilogram) 
every 12 hours. The dose should be given concurrently with or right 
after a meal. Re-evaluate the cat at appropriate intervals and adjust 
the dose based on both clinical signs and glucose nadirs until adequate 
glycemic control has been attained.
* * * * *

    Dated: December 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29583 Filed 12-11-09; 8:45 am]
BILLING CODE 4160-01-S