Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin, 53164-53165 [E9-24882]

Download as PDF 53164 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA’s authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it adds additional controlled airspace at MidWay Regional Airport, MidlothianWaxahachie, TX. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows: ■ PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS Issued in Fort Worth, Texas, on October 1, 2009. Walter L. Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center. [FR Doc. E9–24647 Filed 10–15–09; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 [Docket No. FDA–2009–N–0665] Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sometribove zinc suspension from Monsanto Co. to Elanco Animal Health, A Division of Eli Lilly & Co. DATES: This rule is effective October 16, Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. § 71.1 SUPPLEMENTARY INFORMATION: [Amended] 2. The incorporation by reference in 14 CFR Part 71.1 of the Federal Aviation Administration Order 7400.9T, Airspace Designations and Reporting Points, signed August 27, 2009, and effective September 15, 2009, is amended as follows: ■ Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface. CPrice-Sewell on DSKDVH8Z91PROD with RULES * * * * * ASW TX E5 Midlothian-Waxahachie, TX [Amended] Mid-Way Regional Airport, TX (Lat. 32°27′22″ N., long. 96°54′46″ W.) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Mid-Way Regional Airport and within 1.8 miles each side of the 184° bearing from the airport extending from the 6.5-mile radius to 9.8 miles south of the airport. * * * VerDate Nov<24>2008 * * 15:49 Oct 15, 2009 Jkt 220001 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 the Center for Veterinary Medicine, 21 CFR parts 510 and 522 are amended as follows: 1. The authority citation for 21 CFR part 510 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. In § 510.600, in the table in paragraph (c)(1) remove the entry for ‘‘Monsanto Co.’’; and in the table in paragraph (c)(2) remove the entry for ‘‘000911’’. ■ PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 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. 1. The authority citation for 14 CFR Part 71 continues to read as follows: ■ 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. PART 510—NEW ANIMAL DRUGS New Animal Drugs; Change of Sponsor; Sometribove Zinc Suspension AGENCY: List of Subjects Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 140– 872 for POSILAC (sometribove zinc suspension) to Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285. Accordingly, the regulations are amended in 21 CFR 522.2112 to reflect this change of sponsorship. Following this change of sponsorship, Monsanto Co. is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Monsanto Co. 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. PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 § 522.2112 [Amended] 4. In paragraph (b) of § 522.2112, remove ‘‘000911’’ and add in its place ‘‘000986’’. ■ Dated: October 9, 2009. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E9–24881 Filed 10–15–09; 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; Tulathromycin 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 E:\FR\FM\16OCR1.SGM 16OCR1 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of tulathromycin injectable solution for the control of swine respiratory disease (SRD) in groups of pigs where SRD has been diagnosed. DATES: This rule is effective October 16, 2009. FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276– 8341, e-mail: cindy.burnsteel@fda.hhs.gov. Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 141–244 for DRAXXIN (tulathromycin) Injectable Solution. The supplemental NADA provides for the use of tulathromycin injectable solution for control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. The application is approved as of September 8, 2009, and the regulations are amended in § 522.2630 (21 CFR 522.2630) to reflect the approval. In addition, FDA has noticed that the approved indications for use of this product in cattle (73 FR 58872, October 8, 2008) were inaccurately codified. At this time, § 522.2630 is being amended to correctly describe these indications for use. 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)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. The agency has determined under 21 CFR 25.33(d)(5) 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. CPrice-Sewell on DSKDVH8Z91PROD with RULES SUPPLEMENTARY INFORMATION: VerDate Nov<24>2008 15:49 Oct 15, 2009 Jkt 220001 53165 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES List of Subjects in 21 CFR Part 522 [Docket No. FDA–2009–N–0333] 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 522 is amended as follows: Medical Devices; Plastic Surgery Devices; Classification of Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive 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 § 522.2630, revise paragraphs (d)(1)(ii) and (d)(2)(ii) to read as follows: ■ § 522.2630 Tulathromycin. * * * * * (d) * * * (1) * * * (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. For the treatment of infectious bovine keratoconjunctivitis associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. * * * * * (2) * * * (ii) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with A. pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed. * * * * * Dated: September 30, 2009. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E9–24882 Filed 10–15–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 Food and Drug Administration 21 CFR Part 878 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the wound dressing with pDADMAC additive into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ‘‘Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive,’’ which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. DATES: This final rule is effective November 16, 2009. FOR FURTHER INFORMATION CONTACT: Sam Arepalli, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3612, Silver Spring, MD 20993, 301–796– 6434. SUPPLEMENTARY INFORMATION: I. What Is the Background of This Rulemaking? In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless the device is classified or reclassified into class I or class II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially E:\FR\FM\16OCR1.SGM 16OCR1

Agencies

[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Rules and Regulations]
[Pages 53164-53165]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24882]


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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; 
Tulathromycin

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

[[Page 53165]]

approval of a supplemental new animal drug application (NADA) filed by 
Pfizer, Inc. The supplemental NADA provides for veterinary prescription 
use of tulathromycin injectable solution for the control of swine 
respiratory disease (SRD) in groups of pigs where SRD has been 
diagnosed.

DATES: This rule is effective October 16, 2009.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed a supplement to NADA 141-244 for DRAXXIN (tulathromycin) 
Injectable Solution. The supplemental NADA provides for the use of 
tulathromycin injectable solution for control of SRD associated with 
Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma 
hyopneumoniae in groups of pigs where SRD has been diagnosed. The 
application is approved as of September 8, 2009, and the regulations 
are amended in Sec.  522.2630 (21 CFR 522.2630) to reflect the 
approval.
    In addition, FDA has noticed that the approved indications for use 
of this product in cattle (73 FR 58872, October 8, 2008) were 
inaccurately codified. At this time, Sec.  522.2630 is being amended to 
correctly describe these indications for use. 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    The agency has determined under 21 CFR 25.33(d)(5) 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.  522.2630, revise paragraphs (d)(1)(ii) and (d)(2)(ii) to 
read as follows:


Sec.  522.2630  Tulathromycin.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, Histophilus somni, and Mycoplasma bovis. For the control of 
respiratory disease in cattle at high risk of developing BRD associated 
with M. haemolytica, P. multocida, H. somni, and M. bovis. For the 
treatment of infectious bovine keratoconjunctivitis associated with 
Moraxella bovis. For the treatment of bovine foot rot (interdigital 
necrobacillosis) associated with Fusobacterium necrophorum and 
Porphyromonas levii.
* * * * *
    (2) * * *
    (ii) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, P. 
multocida, Bordetella bronchiseptica, Haemophilus parasuis, and 
Mycoplasma hyopneumoniae; and for the control of SRD associated with A. 
pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs 
where SRD has been diagnosed.
* * * * *

    Dated: September 30, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-24882 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S

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