Oral Dosage Form New Animal Drugs; Change of Sponsor; Lincomycin Hydrochloride Soluble Powder; Penicillin G Potassium in Drinking Water; Tetracycline Powder, 20987-20988 [2012-8322]

Download as PDF 20987 Rules and Regulations Federal Register Vol. 77, No. 68 Monday, April 9, 2012 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2011–0959; Directorate Identifier 2011–NE–25–AD; Amendment 39– 16970; AD 2012–04–14] RIN 2120–AA64 Airworthiness Directives; Rolls-Royce plc Turbofan Engines Federal Aviation Administration (FAA), DOT. ACTION: Final rule; correction. AGENCY: The FAA is correcting an airworthiness directive (AD) that published in the Federal Register. That AD applies to RB211–Trent 800 series turbofan engines. The last comment response in the preamble and the first sentence of regulatory text paragraph (g)(1) are incorrect. The repetitive inspection interval should be 2,000 flight cycles, not 1,000 flight cycles. This document corrects those errors. In all other respects, the original document remains the same. DATES: This final rule is effective April 11, 2012. ADDRESSES: You may examine the AD docket on the Internet at https:// www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800–647–5527) is Document Management Facility, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Alan Strom, Aerospace Engineer, Engine pmangrum on DSK3VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:49 Apr 06, 2012 Jkt 226001 Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; email: alan.strom@faa.gov; phone: 781– 238–7143; fax: 781–238–7199. SUPPLEMENTARY INFORMATION: AD 2012– 04–14, Amendment 39–16970 (77 FR 13485, March 7, 2012), currently requires inspecting the front combustion liner head section for cracking, and if found cracked, removing the front combustion liner head section from service at the next shop visit. As published, the last comment response in the preamble, and the first sentence of regulatory text paragraph (g)(1), are incorrect. No other part of the preamble or regulatory text has been changed; therefore, only the changed portions of the final rule is being published in the Federal Register. The effective date of this AD remains April 11, 2012. Correction of Non-Regulatory Text In the Federal Register of March 7, 2012, AD 2012–04–14; Amendment 39– 16970, is corrected to read as follows: On page 13486, in the 3rd column, under the heading Need to Show All Acceptable Means of Completing the On-Wing Inspection, the 2nd sentence in the 1st paragraph is corrected to read ‘‘We changed the 2nd sentence of paragraphs (f)(1) and (g)(1) of the proposed AD from:’’ On page 13486, in the 3rd column, under the heading Need to Show All Acceptable Means of Completing the On-Wing Inspection, the 1st sentence in the 2nd and 3rd paragraphs, is deleted. Correction of Regulatory Text § 39.13 [Corrected] In the Federal Register of March 7, 2012, AD 2012–04–14; Amendment 39– 16970, on page 13487, in the first column, in paragraph (g)(1), the first sentence is corrected to read as follows: * * * * * (g)(1) At intervals not to exceed 2,000 FCs, inspect the front combustion liner head section for cracking. * * * * * ■ Issued in Burlington, Massachusetts, on March 30, 2012. Colleen D’Alessandro, Assistant Manager, Engine & Propeller Directorate, Aircraft Certification Service. [FR Doc. 2012–8289 Filed 4–6–12; 8:45 am] BILLING CODE 4910–13–P PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA–2012–N–0002] Oral Dosage Form New Animal Drugs; Change of Sponsor; Lincomycin Hydrochloride Soluble Powder; Penicillin G Potassium in Drinking Water; Tetracycline Powder AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) for lincomycin hydrochloride; penicillin G potassium, USP; and tetracycline hydrochloride soluble powders administered in drinking water from Teva Animal Health, Inc., to Quo Vademus, LLC. DATES: This rule is effective April 9, 2012. FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200–136 for Tetracycline Hydrochloride Soluble Powder 324; ANADA 200–303 for Lincomycin Hydrochloride Soluble Powder; and ANADA 200–347 for Penicillin G Potassium, USP, all soluble powders administered in drinking water to Quo Vademus, LLC, 277 Faison West McGowan Rd., Kenansville, NC 28349. Accordingly, the Agency is amending the regulations in part 520 (21 CFR part 520) to reflect the transfer of ownership and a current format. In addition FDA has noticed two errors in § 520.1696 Penicillin oral dosage forms. At this time, § 520.1696a is being removed because no sponsor is listed, and an obsolete drug labeler code is being removed from § 520.1696d. SUMMARY: E:\FR\FM\09APR1.SGM 09APR1 20988 Federal Register / Vol. 77, No. 68 / Monday, April 9, 2012 / Rules and Regulations These actions are being taken to improve the accuracy of the 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. 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: 8. In § 520.1696d, revise the section heading and paragraph (b) and remove and reserve paragraph (c) to read as follows: ■ § 520.1696d * * * * (b) Sponsors. See Nos. 050604 and 053501 in § 510.600(c) of this chapter. * * * * * 9. In § 520.2345, revise the section heading to read as follows: ■ Tetracycline. * SUMMARY: * * * 2. In § 520.1263, revise the section heading to read as follows: § 520.1263 Lincomycin. * * * * * ■ 3. In § 520.1263c, revise the section heading and paragraph (b) to read as follows: § 520.1263c Dated: March 27, 2012. William T. Flynn, Acting Director, Center for Veterinary Medicine. Lincomycin powder. [FR Doc. 2012–8322 Filed 4–6–12; 8:45 am] * * * * * (b) Sponsors. See Nos. 000009, 046573, 054925, 061623, and 076475 in § 510.600(c) of this chapter for use as in paragraph (d) of this section. * * * * * ■ 4. In § 520.1696, revise the section heading to read as follows: § 520.1696 * * § 520.1696a * * 5. Remove and reserve § 520.1696a. ■ 6. In § 520.1696b, revise the section heading, paragraphs (a) and (b), and the heading for paragraph (c) to read as follows: ■ pmangrum on DSK3VPTVN1PROD with RULES Penicillin G powder. (a) Specifications. Each gram of powder contains penicillin G potassium equivalent to 1.54 million units of penicillin G. (b) Sponsors. See Nos. 010515, 046573, 053501, 059320, 061623 and 076475 in § 510.600(c) of this chapter. (c) Conditions of use in turkeys— * * * * * ■ 7. In § 520.1696c, revise the section heading and remove and reserve paragraph (c) to read as follows: § 520.1696c * * Penicillin V powder. * VerDate Mar<15>2010 * LIBRARY OF CONGRESS Copyright Office [Docket No. 2011–8] [Removed and Reserved] § 520.1696b BILLING CODE 4160–01–P 37 CFR Parts 201 and 202 Penicillin. * Tetracycline powder. * * * * (b) * * * (4) Nos. 054925, 057561, 061623, and 076475: 324 grams per pound as in paragraph (d) of this section. * * * * * Authority: 21 U.S.C. 360b. Discontinuance of Form CO in Registration Practices Correction In rule document 2012–7429 appearing on pages 18705–18707 in the issue of March 28, 2012, make the following corrections: 1. On page 18706, in the third column, in the 17th line from the bottom, ‘‘b.’’ should read ‘‘Å.’’. § 202.2 [Corrected] 2. On page 18707, in § 202.2, in the first column, in amendatory instruction 4, in the third line, ‘‘b’’ should read ‘‘Å’’. ■ [FR Doc. C1–2012–7429 Filed 4–6–12; 8:45 am] BILLING CODE 1505–01–D * 16:35 Apr 06, 2012 Jkt 226001 Suspension of Community Eligibility * * ■ [Docket ID FEMA–2012–0003; Internal Agency Docket No. FEMA–8225] § 520.2345 § 520.2345d 1. The authority citation for 21 CFR part 520 continues to read as follows: 44 CFR Part 64 Federal Emergency Management Agency, DHS. ACTION: Final rule. 10. In § 520.2345d, revise paragraph (b)(4) to read as follows: ■ Federal Emergency Management Agency Penicillin V tablets. * ■ PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS DEPARTMENT OF HOMELAND SECURITY PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 AGENCY: This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. DATES: The effective date of each community’s scheduled suspension is the third date (‘‘Susp.’’) listed in the third column of the following tables. FOR FURTHER INFORMATION CONTACT: If you want to determine whether a particular community was suspended on the suspension date or for further information, contact David Stearrett, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–2953. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. E:\FR\FM\09APR1.SGM 09APR1

Agencies

[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Rules and Regulations]
[Pages 20987-20988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2012-N-0002]


Oral Dosage Form New Animal Drugs; Change of Sponsor; Lincomycin 
Hydrochloride Soluble Powder; Penicillin G Potassium in Drinking Water; 
Tetracycline Powder

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 a change of sponsor for three abbreviated 
new animal drug applications (ANADAs) for lincomycin hydrochloride; 
penicillin G potassium, USP; and tetracycline hydrochloride soluble 
powders administered in drinking water from Teva Animal Health, Inc., 
to Quo Vademus, LLC.

DATES: This rule is effective April 9, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, has informed FDA that it has 
transferred ownership of, and all rights and interest in, ANADA 200-136 
for Tetracycline Hydrochloride Soluble Powder 324; ANADA 200-303 for 
Lincomycin Hydrochloride Soluble Powder; and ANADA 200-347 for 
Penicillin G Potassium, USP, all soluble powders administered in 
drinking water to Quo Vademus, LLC, 277 Faison West McGowan Rd., 
Kenansville, NC 28349. Accordingly, the Agency is amending the 
regulations in part 520 (21 CFR part 520) to reflect the transfer of 
ownership and a current format.
    In addition FDA has noticed two errors in Sec.  520.1696 Penicillin 
oral dosage forms. At this time, Sec.  520.1696a is being removed 
because no sponsor is listed, and an obsolete drug labeler code is 
being removed from Sec.  520.1696d.

[[Page 20988]]

These actions are being taken to improve the accuracy of the 
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.

    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.  520.1263, revise the section heading to read as follows:


Sec.  520.1263  Lincomycin.

* * * * *

0
3. In Sec.  520.1263c, revise the section heading and paragraph (b) to 
read as follows:


Sec.  520.1263c  Lincomycin powder.

* * * * *
    (b) Sponsors. See Nos. 000009, 046573, 054925, 061623, and 076475 
in Sec.  510.600(c) of this chapter for use as in paragraph (d) of this 
section.
* * * * *

0
4. In Sec.  520.1696, revise the section heading to read as follows:


Sec.  520.1696  Penicillin.

* * * * *


Sec.  520.1696a  [Removed and Reserved]

0
5. Remove and reserve Sec.  520.1696a.

0
6. In Sec.  520.1696b, revise the section heading, paragraphs (a) and 
(b), and the heading for paragraph (c) to read as follows:


Sec.  520.1696b  Penicillin G powder.

    (a) Specifications. Each gram of powder contains penicillin G 
potassium equivalent to 1.54 million units of penicillin G.
    (b) Sponsors. See Nos. 010515, 046573, 053501, 059320, 061623 and 
076475 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in turkeys--
* * * * *

0
7. In Sec.  520.1696c, revise the section heading and remove and 
reserve paragraph (c) to read as follows:


Sec.  520.1696c  Penicillin V powder.

* * * * *

0
8. In Sec.  520.1696d, revise the section heading and paragraph (b) and 
remove and reserve paragraph (c) to read as follows:


Sec.  520.1696d  Penicillin V tablets.

* * * * *
    (b) Sponsors. See Nos. 050604 and 053501 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
9. In Sec.  520.2345, revise the section heading to read as follows:


Sec.  520.2345  Tetracycline.

* * * * *

0
10. In Sec.  520.2345d, revise paragraph (b)(4) to read as follows:


Sec.  520.2345d  Tetracycline powder.

* * * * *
    (b) * * *
    (4) Nos. 054925, 057561, 061623, and 076475: 324 grams per pound as 
in paragraph (d) of this section.
* * * * *

    Dated: March 27, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-8322 Filed 4-6-12; 8:45 am]
BILLING CODE 4160-01-P

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