Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution, 14926 [E8-5598]

Download as PDF 14926 Federal Register / Vol. 73, No. 55 / Thursday, March 20, 2008 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES information. Therefore, a freedom of information summary is not required. The agency 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. Food and Drug Administration List of Subjects in 21 CFR Part 522 Aviation Administration withdraws the direct final rule published in the Federal Register February 11, 2008 (73 FR 7667). * * * * * Issued in Fort Worth, TX, on March 5, 2008. Donald R. Smith, Manager, System Support Group, ATO Central Service Center. [FR Doc. E8–5164 Filed 3–19–08; 8:45 am] BILLING CODE 4910–13–M Animal drugs. 21 CFR Part 522 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 new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL) strength oxytetracycline injectable solution. DATES: This rule is effective March 20, 2008. Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8342, e-mail: joan.gotthardt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, Newry, BT35 6JP, Northern Ireland, filed a supplement to NADA 141–143 for TETRADURE 300 (oxytetracycline) Injection used for the treatment of various bacterial diseases of cattle and swine. The supplemental NADA provides for changing a bovine pathogen genus from Haemophilus to Histophilus on product labeling. The supplemental NADA is approved as of February 8, 2008, and the regulations are amended in 21 CFR 522.1660b to reflect the approval. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or ebenthall on PRODPC61 with RULES FOR FURTHER INFORMATION CONTACT: VerDate Aug<31>2005 13:27 Mar 19, 2008 Jkt 214001 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: I Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution 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 § 522.1660, revise the section heading to read as follows: I § 522.1660 Oxytetracycline injectable dosage forms. 3. In § 522.1660a, revise the section heading to read as follows: I § 522.1660a Oxytetracycline solution, 200 milligrams/milliliter. § 522.1660b [Amended] 4. In § 522.1660b, in the section heading, remove ‘‘injection, 300 milligram/milliliter’’ and in its place add ‘‘solution, 300 milligrams/ milliliter’’; in paragraph (e)(1)(i)(A), remove ‘‘Haemophilus spp.’’ and in its place add ‘‘Histophilus spp.’’; and in the fourth sentence in paragraph (e)(1)(ii), remove ‘‘in cattle’’. I Dated: March 6, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–5598 Filed 3–19–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 DEPARTMENT OF STATE 22 CFR Parts 41 and 42 [Public Notice: 6135] Visas: Documentation of Immigrants and Nonimmigrants —Visa Classification Symbols State Department. Final rule. AGENCY: ACTION: SUMMARY: The Department is amending its regulations to add new classification symbols to the immigrant and nonimmigrant classification tables. The amendment is necessary to implement legislation that has created additional immigrant and nonimmigrant classifications as described herein. Additionally, the Department is removing immigrant classifications that have become obsolete as a result of either their deletion from the Immigration and Nationality Act ‘‘INA’’ or the expiration of legislative provisions that had temporarily authorized them. This rule also corrects typographical errors noted in the tables. DATES: This rule is effective March 20, 2008. FOR FURTHER INFORMATION CONTACT: Barbara J. Kennedy, Legislation and Regulations Division, Visa Services, U.S. Department of State, Washington, DC 20520–0106, phone (202) 663–1206. SUPPLEMENTARY INFORMATION: Which immigrant classifications are being added? The new immigrant classification symbols listed are for children residing habitually in Hague Adoption Convention countries who have been or will be adopted by U.S. citizens who are habitually residents in the United States (IH3, IH4), and for two additional classes of special immigrants: certain nationals of Afghanistan and Iraq employed by the U.S. Government in Afghanistan or Iraq as translators or interpreters (SI1, SI2, SI3), and certain Iraqis employed by or on behalf of the U.S. Government in Iraq (SQ1, SQ2, SQ3). Which nonimmigrant classifications are being added? Added to the nonimmigrant classification tables are symbols for certain nationals of Australia in a specialty occupation (E3), spouses and children accompanying or following to join E3 principal aliens (E3D), E3 principal aliens who are applying for a new visa when there has been uninterrupted continuity of employment (E3R); treaty aliens from E:\FR\FM\20MRR1.SGM 20MRR1

Agencies

[Federal Register Volume 73, Number 55 (Thursday, March 20, 2008)]
[Rules and Regulations]
[Page 14926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5598]


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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; 
Oxytetracycline Solution

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 new animal drug 
application (NADA) filed by Norbrook Laboratories, Ltd. The 
supplemental NADA provides for changing scientific nomenclature for a 
bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL) 
strength oxytetracycline injectable solution.

DATES: This rule is effective March 20, 2008.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry, BT35 6JP, Northern Ireland, filed a supplement to NADA 141-143 
for TETRADURE 300 (oxytetracycline) Injection used for the treatment of 
various bacterial diseases of cattle and swine. The supplemental NADA 
provides for changing a bovine pathogen genus from Haemophilus to 
Histophilus on product labeling. The supplemental NADA is approved as 
of February 8, 2008, and the regulations are amended in 21 CFR 
522.1660b to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency 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.  522.1660, revise the section heading to read as follows:


Sec.  522.1660  Oxytetracycline injectable dosage forms.

0
3. In Sec.  522.1660a, revise the section heading to read as follows:


Sec.  522.1660a  Oxytetracycline solution, 200 milligrams/milliliter.


Sec.  522.1660b  [Amended]

0
4. In Sec.  522.1660b, in the section heading, remove ``injection, 300 
milligram/milliliter'' and in its place add ``solution, 300 milligrams/
milliliter''; in paragraph (e)(1)(i)(A), remove ``Haemophilus spp.'' 
and in its place add ``Histophilus spp.''; and in the fourth sentence 
in paragraph (e)(1)(ii), remove ``in cattle''.

    Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5598 Filed 3-19-08; 8:45 am]
BILLING CODE 4160-01-S