Oral Dosage Form New Animal Drugs; Kanamycin, Bismuth Subcarbonate, Activated Attapulgite, 43967-43968 [E6-12568]

Download as PDF Federal Register / Vol. 71, No. 149 / Thursday, August 3, 2006 / Rules and Regulations Related Information (l) Information related to the subject of this AD can be found in Rolls-Royce Corporation Alert Commercial Engine Bulletins (CEBs), all at Revision 1, and all dated August 30, 2004, listed in the following Table 5: TABLE 5.—RELATED ALERT COMMERCIAL ENGINE BULLETINS CEB–A–313 ................... CEB–A–73–2075 ........... CEB–A–1394 ................. CEB–A–73–3118 ........... CEB–A–73–4056 ........... CEB–A–73–5029 CEB–A–73–6041 TP CEB–A–183 TP CEB–A–1336 TP CEB–A–73– 2032 Issued in Burlington, Massachusetts, on July 27, 2006. Francis A. Favara, Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E6–12420 Filed 8–2–06; 8:45 am] Following these changes of sponsorship, Rhodia UK Ltd. is no longer the sponsor of an approved application. In addition, Nicholas Piramal India Ltd. UK is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Rhodia UK Ltd. to add entries for Nicholas Piramal India Ltd. UK. 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. 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 510 and 529 are amended as follows: 21 CFR Parts 510 and 529 New Animal Drugs; Change of Sponsor; Isoflurane PART 529—OTHER DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 529 continues to read as follows: I Authority: 21 U.S.C. 360b. I Isoflurane. (a) Specifications. The drug is a clear, colorless, stable liquid. * * * * * (c) Conditions of use. Administer by inhalation: * * * * * (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. I Food and Drug Administration, HHS. Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. Dated: July 24, 2006. Bernadette A. Dunham, Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–12570 Filed 8–2–06; 8:45 am] BILLING CODE 4160–01–S PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an abbreviated new animal drug application (ANADA) for isoflurane, U.S.P., from Rhodia UK Ltd. to Nicholas Piramal India Ltd. UK. DATES: This rule is effective August 3, 2006. FOR FURTHER INFORMATION CONTACT: rwilkins on PROD1PC63 with RULES * § 529.1186 I Food and Drug Administration David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Rhodia UK Ltd., P.O. Box 46, St. Andrews Rd., Avonmouth, Bristol BS11 9YF, England, UK, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200–237 for isoflurane, U.S.P., to Nicholas Piramal India Ltd. UK, 1st Floor, Alpine House, Unit II, Honeypot Lane, London, NW99RX, England, UK. Accordingly, the regulations are amended in 21 CFR 529.1186 to reflect this change of sponsorship and a current format. 16:16 Aug 02, 2006 * * * * Nicholas Piramal India Ltd. UK, 1st Floor, Alpine House, Unit II, Honeypot Lane, London, NW99RX, England, UK * * * Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 529 VerDate Aug<31>2005 * 21 CFR Part 510 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: * 066112 Firm name and address 4. In § 529.1186, in paragraph (b), remove ‘‘059258’’ and numerically add ‘‘066112’’; and revise paragraph (a), the introductory text of paragraph (c), and paragraph (c)(3) to read as follows: List of Subjects BILLING CODE 4910–13–P AGENCY: Drug labeler code 43967 Jkt 208001 2. In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for ‘‘Nicholas Piramal India Ltd. UK’’ and remove the entry for ‘‘Rhodia UK Limited’’; and in the table in paragraph (c)(2) remove the entry for ‘‘059258’’ and numerically add an entry for ‘‘066112’’ to read as follows: I DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. Oral Dosage Form New Animal Drugs; Kanamycin, Bismuth Subcarbonate, Activated Attapulgite * AGENCY: * * (c) * * * (1) * * * * * * * * Nicholas Piramal India Ltd. UK, 1st Floor, Alpine House, Unit II, Honeypot Lane, London, NW99RX, England, UK. * * * Drug labeler code * 066112 * * * (2) * * * Frm 00013 Final rule; technical amendment. ACTION: Firm name and address PO 00000 Food and Drug Administration, HHS. Fmt 4700 Sfmt 4700 SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to remove inactive ingredients from the specifications for an oral suspension and for tablets containing kanamycin, bismuth subcarbonate, and activated attapulgite; and to consolidate and reformat these sections. These actions are being taken to improve the accuracy E:\FR\FM\03AUR1.SGM 03AUR1 43968 Federal Register / Vol. 71, No. 149 / Thursday, August 3, 2006 / Rules and Regulations and readability of the animal drug regulations. DATES: This rule is effective August 3, 2006. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–827–4567, e-mail: george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations in part 520 (21 CFR part 520) in §§ 520.1204 and 520.1205 to remove aminopentamide hydrogen sulfate and pectin from the specifications for an oral suspension and for tablets containing kanamycin, bismuth subcarbonate, and activated attapulgite. These ingredients have been declared inactive or have been removed from the formulations. In addition, these sections are being reformatted and consolidated. These actions are being taken to improve the accuracy and readability of the animal drug regulations. 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 520 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 520 is amended as follows: 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. In § 520.1204, revise the section heading and paragraphs (a) and (c) to read as follows: I rwilkins on PROD1PC63 with RULES § 520.1204 Kanamycin, bismuth subcarbonate, activated attapulgite. (a) Specifications—(1) Each 5 milliliters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite (aluminum magnesium silicate). (2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite. * * * * * (c) Conditions of use in dogs—(1) Amount. 5 mL of suspension or 1 tablet per 20 pounds body weight every 8 VerDate Aug<31>2005 16:16 Aug 02, 2006 Jkt 208001 hours. Maximum dose: 5 mL of suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of suspension or 1/2 tablet every 8 hours. A recommended initial loading dose should be twice the amount of a single dose. (2) Indications for use. For the treatment of bacterial enteritis caused by organisms susceptible to kanamycin and the symptomatic relief of the associated diarrhea. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. § 520.1205 I [Removed] 3. Remove § 520.1205. Dated: July 21, 2006. Daniel G. McChesney, Director, Office of Surveillance and Compliance, Center for Veterinary Medicine. [FR Doc. E6–12568 Filed 8–2–06; 8:45 am] BILLING CODE 4160–02–S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9279] RIN 1545–BF86 Reporting Rules for Widely Held Fixed Investment Trusts Internal Revenue Service (IRS), Treasury. ACTION: Final and Temporary regulations. Paperwork Reduction Act These final and temporary regulations amend § 1.671–5. The collection of information contained in these regulations is in § 1.671–5 and has been previously reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) under control number 1545–1540. Response to this collection of information is mandatory. This information is required to be reported to beneficial owners of trust interests to enable them to correctly report their share of the items of income, deduction, and credit of the WHFIT in which they have invested. This information is also required to be reported to the IRS to enable the IRS to verify that trustees and middlemen are accurately reporting information to beneficial owners of trust interests and that beneficial owners are properly reporting their ownership of a trust interest. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained as long as their contents might become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. AGENCY: Background SUMMARY: This document contains final and temporary regulations amending § 1.671–5, a provision which provides reporting rules for widely held fixed investment trusts (WHFITs). These regulations clarify and simplify reporting for trustees and middlemen of non-mortgage widely held fixed investment trusts (NMWHFITs). The text of these final and temporary regulations also serves, in part, as the text of the proposed regulations set forth in the notice of proposed rulemaking (REG–125071–06) on this subject in this issue of the Federal Register. DATES: Effective Date: These regulations are effective July 28, 2006. Applicability Date: For dates of applicability see § 1.671–5(m). FOR FURTHER INFORMATION CONTACT: Faith Colson, 202–622–3060 (not a tollfree number). SUPPLEMENTARY INFORMATION: This document contains amendments to 26 CFR part 1. On January 24, 2006, the Internal Revenue Service (IRS) and the Treasury Department published final regulations (TD 9241) (final regulations) under § 1.671–5 in the Federal Register (71 FR 4002) providing reporting rules for WHFITs. On February 23, 2006, in response to comments received subsequent to the publication of the final regulations, the IRS and the Treasury Department issued Notice 2006–29 (2006–12 I.R.B. 644). Notice 2006–29 informed trustees and middlemen of NMWHFITs that § 1.671– 5 would be amended to extend the availability of the qualified NMWHFIT exception (discussed in section I) beyond February 23, 2006, the cut-off date provided in the final regulations for funding a NMWHFIT that satisfied the exception, and to clarify the application of certain provisions in the final regulations to NMWHFITs. On May 25, 2006, the IRS and Treasury Department issued Notice 2006–30 (2006–24 I.R.B. 1044) stating that the IRS and the PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\03AUR1.SGM 03AUR1

Agencies

[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Rules and Regulations]
[Pages 43967-43968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Kanamycin, Bismuth 
Subcarbonate, Activated Attapulgite

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 remove inactive ingredients from the specifications 
for an oral suspension and for tablets containing kanamycin, bismuth 
subcarbonate, and activated attapulgite; and to consolidate and 
reformat these sections. These actions are being taken to improve the 
accuracy

[[Page 43968]]

and readability of the animal drug regulations.

DATES: This rule is effective August 3, 2006.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
in part 520 (21 CFR part 520) in Sec. Sec.  520.1204 and 520.1205 to 
remove aminopentamide hydrogen sulfate and pectin from the 
specifications for an oral suspension and for tablets containing 
kanamycin, bismuth subcarbonate, and activated attapulgite. These 
ingredients have been declared inactive or have been removed from the 
formulations. In addition, these sections are being reformatted and 
consolidated. These actions are being taken to improve the accuracy and 
readability of the animal drug regulations.
    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 520

    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 520 is 
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. In Sec.  520.1204, revise the section heading and paragraphs (a) and 
(c) to read as follows:


Sec.  520.1204  Kanamycin, bismuth subcarbonate, activated attapulgite.

    (a) Specifications--(1) Each 5 milliliters (mL) of suspension 
contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth 
subcarbonate, and 500 mg activated attapulgite (aluminum magnesium 
silicate).
    (2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg 
bismuth subcarbonate, and 500 mg activated attapulgite.
* * * * *
    (c) Conditions of use in dogs--(1) Amount. 5 mL of suspension or 1 
tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of 
suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of 
suspension or 1/2 tablet every 8 hours. A recommended initial loading 
dose should be twice the amount of a single dose.
    (2) Indications for use. For the treatment of bacterial enteritis 
caused by organisms susceptible to kanamycin and the symptomatic relief 
of the associated diarrhea.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  520.1205  [Removed]

0
3. Remove Sec.  520.1205.

    Dated: July 21, 2006.
Daniel G. McChesney,
Director, Office of Surveillance and Compliance, Center for Veterinary 
Medicine.
[FR Doc. E6-12568 Filed 8-2-06; 8:45 am]
BILLING CODE 4160-02-S

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