Oral Dosage Form New Animal Drugs; Ivermectin and Praziquantel Paste, 65834-65835 [05-21641]

Download as PDF 65834 Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Rules and Regulations before adopting these SIAPs and/or Weather Takeoff Minimums are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs and/or Weather Takeoff Minimums effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore (1) is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR part 97 Air Traffic Control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC on October 21, 2005. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, under Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and Weather Takeoff Minimums effective at 0901 UTC on the dates specified, as follows: I PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: I Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. 2. Part 97 is amended to read as follows: * * * Effective December 22, 2005 Atmore, AL, Atmore Muni, RNAV (GPS) RWY 18, Orig Atmore, AL, Atmore Muni, RNAV (GPS) RWY 36, Orig Atmore, AL, Atmore Muni, Takeoff Minimums & Textual DP, Orig St. Paul Island, AK, St. Paul Island, RNAV (GPS) RWY 36, Orig VerDate Aug<31>2005 15:13 Oct 31, 2005 Jkt 208001 St. Paul Island, AK, St. Paul Island, GPS RWY 36, Orig, CANCELLED St. Paul Island, AK, St. Paul Island, ILS OR LOC/DME RWY 36, Amdt 2 St. Paul Island, AK, St. Paul Island, LOC/ DME BC RWY 18, Amdt 3 St. Paul Island, AK, St. Paul Island, NDB–A, Amdt 1 St. Paul Island, AK, St. Paul Island, Takeoff Minimums & Textual DP, Amdt 2 Yakutat, AK, Yakutat, RNAV (GPS) RWY 11, Amdt 1 Yakutat, AK, Yakutat, RNAV (GPS) RWY 29, Amdt 1 Yakutat, AK, Yakutat, VOR/DME RWY 2, Amdt 3 Yakutat, AK, Yakutat, VOR/DME RWY 29, Amdt 2 Yakutat, AK, Yakutat, LOC/DME BC RWY 29, Amdt 4 Springdale, AR, Springdale Muni, RNAV (GPS) RWY 18, Amdt 1A Oakdale, CA, Oakdale, VOR–A, Orig Oakdale, CA, Oakdale, RNAV (GPS) RWY 10, Orig Oakdale, CA, Oakdale, RNAV (GPS) RWY 28, Orig Oakdale, CA, Oakdale, GPS RWY 10, Orig, CANCELLED Oakdale, CA, Oakdale, Takeoff Minimums and Textual DP, Orig Jacksonville, FL, Cecil Field, RADAR–1, Orig, CANCELLED Jacksonville, FL, Jacksonville Intl, RNAV (GPS) RWY 31, Amdt 1 Boise, ID, Boise Air Terminal/Gowen Fld, RNAV (GPS) RWY 28R, Amdt 1 Sheldon, IA, Sheldon Muni, RNAV (GPS) RWY 15, Orig Sheldon, IA, Sheldon Muni, RNAV (GPS) RWY 33, Orig Sheldon, IA, Sheldon Muni, NDB RWY 33, Amdt 7 Sheldon, IA, Sheldon Muni, VOR OR GPS RWY 33, Amdt 1A, CANCELLED Parsons, KS, Tri-City, NDB RWY 17, Amdt 9A London, KY, London-Corbin Arpt-Magee Fld, ILS RWY 6, Orig London, KY, London-Corbin Arpt-Magee Fld, Takeoff Minimums and Textual DP, Amdt 3 Paducah, KY, West Kentucky Airpark, GPS RWY 4, Orig, CANCELLED Paducah, KY, West Kentucky Airpark, GPS RWY 22, Orig, CANCELLED Grand Isle, LA, Grand Isle, VOR OR GPS–A, Amdt 8, CANCELLED Grand Isle, LA, Grand Isle, VOR/DME OR GPS–C, Amdt 7, CANCELLED Frankfort, MI, Frankfort Dow Memorial Field, VOR/DME–A, Orig Frankfort, MI, Frankfort Dow Memorial Field, VOR OR GPS–A, Amdt 3, CANCELLED Freemont, MI, Fremont Muni, RNAV (GPS) RWY 18, Orig Fremont, MI, Fremont Muni, RNAV (GPS) RWY 36, Orig Fremont, MI, Fremont Muni, VOR RWY 18, Orig Fremont, MI, Fremont Muni, VOR RWY 36, Amdt 7 Fremont, MI, Fremont Muni, GPS RWY 18, Orig, CANCELLED Kennett, MO, Kennett Memorial, RNAV (GPS) RWY 2, Orig PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 Kennett, MO, Kennett Memorial, RNAV (GPS) RWY 20, Orig Kennett, MO, Kennett Memorial, NDB RWY 2, Orig Kennett, MO, Kennett Memorial, NDB RWY 20, Orig Kennett, MO, Kennett Memorial, VOR/DME RWY 20, Orig Kennett, MO, Kennett Memorial, NDB OR GPS RWY 18, Amdt 3, CANCELLED Kennett, MO, Kennett Memorial, Takeoff Minimums and Textual DP, Amdt 1 Albuquerque, NM, Albuquerque Intl Sunport, ILS OR LOC RWY 3, Amdt 2 Eugene, OR, Mahlon Sweet Field, ILS OR LOC Y RWY 16R, Orig Eugene, OR, Mahlon Sweet Field, ILS OR LOC/DME Z RWY 16R, Amdt 35, ILS RWY 16R (CAT II), ILS RWY 16R (CAT III), Amdt 35 Portland, OR, Portland-Hillsboro, VOR/DME– C, Orig Portland, OR, Portland-Hillsboro, NDB–B, Amdt 2 Portland, OR, Portland-Hillsboro, VOR/DME OR GPS–A, Orig-B, CANCELLED Portland, OR, Portland-Hillsboro, Takeoff Minimums and Textual DP, Amdt 5 The Dalles, OR, Columbia Gorge Regional/ The Dalles Muni, RNAV (GPS)–A, Orig The Dalles, OR, Columbia Gorge Regional/ The Dalles Muni, VOR/DME OR GPS–A, Amdt 4, CANCELLED Barnwell, SC, Barnwell County, RNAV (GPS) RWY 17, Amdt 1 Barnwell, SC, Barnwell County, NDB RWY 17, Orig Barnwell, SC, Barnwell County, NDB–A, Amdt 1, CANCELLED Barnwell, SC, Barnwell County, NDB RWY 4, Amdt 2A, CANCELLED Delta, UT, Delta Muni, RNAV (GPS) RWY 17, Orig Delta, UT, Delta Muni, RNAV (GPS) RWY 35, Orig Delta, UT, Delta Muni, VOR/DME RWY 17, Amdt 2 Delta, UT, Delta Muni, VOR RWY 35, Amdt 3 Delta, UT, Delta Muni, Takeoff Minimums and Textual DP, Orig Bremerton, WA, Bremerton National, ILS OR LOC RWY 19, Amdt 14 Pinedale, WY, Ralph Wenz Field, Takeoff Minimums and Textual DP, Amdt 1 Pinedale, WY, Ralph Wenz Field, RNAV (GPS) RWY 11, Orig Pinedale, WY, Ralph Wenz Field, RNAV (GPS) RWY 29, Orig Pinedale, WY, Ralph Wenz Field, NDB RWY 29, Amdt 1 * * * Effective February 16, 2006 Harrisburg, PA, Harrisburg International, COPTER ILS 128, Orig, CANCELLED Harrisburg, PA, Harrisburg International, COPTER ILS 308, Orig, CANCELLED [FR Doc. 05–21582 Filed 10–31–05; 8:45 am] BILLING CODE 4910–13–P E:\FR\FM\01NOR1.SGM 01NOR1 Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Ivermectin and Praziquantel Paste 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 Virbac AH, Inc. The supplemental NADA provides revised labeling for ivermectin and praziquantel oral paste used in horses for the treatment and control of various internal parasites. DATES: This rule is effective November 1, 2005. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov. SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, filed a supplement to NADA 141–215 for EQUIMAX (ivermectin 1.87%/praziquantel 14.03%) Paste for horses. This supplement amends product labeling to separate parasite life stages in the indications section. The supplemental NADA is approved as of September 16, 2005, and the regulations in 21 CFR 520.1198 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary. The current regulations for ivermectin and praziquantel paste are also being revised to remove redundant language. These changes are being made to improve the readability 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. The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, VerDate Aug<31>2005 15:13 Oct 31, 2005 Jkt 208001 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 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. Section 520.1198 is amended by revising paragraphs (d)(2)(i) and (d)(2)(ii) to read as follows: I § 520.1198 paste. Ivermectin and praziquantel * * * * * (d) * * * (2) * * * (i) Tapeworms—Anoplocephala perfoliata; Large strongyles (adults)— Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles—fourthstage larvae; Pinworms (adults and fourth-stage larvae)—Oxyuris equi; Ascarids (adults and third- and fourthstage larvae)—Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large-mouth Stomach Worms (adults)—Habronema muscae; Bots (oral and gastric stages)—Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intestinal Threadworms (adults)— Strongyloides westeri; Summer Sores PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 65835 caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. (ii) Tapeworms—Anoplocephala perfoliata; Large Strongyles (adults)— Strongylus vulgaris (also early forms in blood vessels), S.edentatus (also tissue stages), S. equinus, Triodontophorus spp.; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)—Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Largemouth Stomach Worms (adults)— Habronema muscae; Bots (oral and gastric stages)—Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intestinal Threadworms (adults)— Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. * * * * * Dated: October 14, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–21641 Filed 10–31–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [COTP Jacksonville 05–140] RIN 1625–AA87 Security Zone; Sea Buoy at the Entrance of St. Mary’s River to Kings Bay, GA Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: SUMMARY: The Coast Guard is establishing a temporary moving security zone around foreign naval submarines in transit within the area between 12 nautical miles offshore from the baseline, also known as the shoreline, at the mouth of the St. Mary’s River to the Kings Bay Naval Submarine Base, Kings Bay, GA. The security zone includes all waters within 500 yards in E:\FR\FM\01NOR1.SGM 01NOR1

Agencies

[Federal Register Volume 70, Number 210 (Tuesday, November 1, 2005)]
[Rules and Regulations]
[Pages 65834-65835]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21641]



[[Page 65835]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin and Praziquantel 
Paste

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 Virbac AH, Inc. The supplemental NADA 
provides revised labeling for ivermectin and praziquantel oral paste 
used in horses for the treatment and control of various internal 
parasites.

DATES: This rule is effective November 1, 2005.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
melanie.berson@fda.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, filed a supplement to NADA 141-215 for EQUIMAX 
(ivermectin 1.87%/praziquantel 14.03%) Paste for horses. This 
supplement amends product labeling to separate parasite life stages in 
the indications section. The supplemental NADA is approved as of 
September 16, 2005, and the regulations in 21 CFR 520.1198 are amended 
to reflect the approval. The basis of approval is discussed in the 
freedom of information summary. The current regulations for ivermectin 
and praziquantel paste are also being revised to remove redundant 
language. These changes are being made to improve the readability 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.
    The agency has determined under 21 CFR 25.33(d)(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 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. Section 520.1198 is amended by revising paragraphs (d)(2)(i) and 
(d)(2)(ii) to read as follows:


Sec.  520.1198  Ivermectin and praziquantel paste.

* * * * *
    (d) * * *
    (2) * * *
    (i) Tapeworms--Anoplocephala perfoliata; Large strongyles 
(adults)--Strongylus vulgaris (also early forms in blood vessels), S. 
edentatus (also tissue stages), S. equinus, Triodontophorus spp. 
including T. brevicauda and T. serratus, and Craterostomum 
acuticaudatum; Small Strongyles (adults, including those resistant to 
some benzimidazole class compounds)--Coronocyclus spp. including C. 
coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. 
catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. 
leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus 
spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus, and Petrovinema poculatum; Small 
Strongyles--fourth-stage larvae; Pinworms (adults and fourth-stage 
larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-stage 
larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus axei; 
Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral and 
gastric stages)--Gasterophilus spp. including G. intestinalis and G. 
nasalis; Lungworms (adults and fourth-stage larvae)--Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults)--Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-
stage larvae; Dermatitis caused by neck threadworm microfilariae, 
Onchocerca sp.
    (ii) Tapeworms--Anoplocephala perfoliata; Large Strongyles 
(adults)--Strongylus vulgaris (also early forms in blood vessels), 
S.edentatus (also tissue stages), S. equinus, Triodontophorus spp.; 
Small Strongyles (adults, including those resistant to some 
benzimidazole class compounds)--Cyathostomum spp., Cylicocyclus spp., 
Cylicostephanus spp., Cylicodontophorus spp.; Small Strongyles--fourth-
stage larvae; Pinworms (adults and fourth-stage larvae)--Oxyuris equi; 
Ascarids (adults and third- and fourth-stage larvae)--Parascaris 
equorum; Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach 
Worms (adults)--Habronema muscae; Bots (oral and gastric stages)--
Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)--
Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--Strongyloides 
westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous 
third-stage larvae; Dermatitis caused by neck threadworm microfilariae, 
Onchocerca sp.
* * * * *

    Dated: October 14, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-21641 Filed 10-31-05; 8:45 am]
BILLING CODE 4160-01-S
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