New Animal Drugs For Use in Animal Feeds, 35792-35794 [06-55520]

Download as PDF 35792 Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Rules and Regulations actions must be done in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340–26–5008, dated January 31, 2005. The applicable corrective and other specified actions must be done before further flight. Inspection of the FMS in the BCRC (i) For airplanes identified in Table 4 of this AD, on which the date of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness is before October 2, 2004: Except as provided by paragraph (j) of this AD, within 2,400 flight hours after the effective date of this AD, do a one-time general visual inspection for anti-fretting material contamination of the Halon filters and plumbing parts of the FMS in the BCRC, do applicable corrective actions if necessary; and related investigative and other specified actions. The actions must be done in accordance with the applicable service bulletin in table 4 of this AD. The applicable corrective and related investigative and other specified actions must be done before further flight. TABLE 4.—SERVICE BULLETINS FOR INSPECTING FMS IN THE BCRC For airplanes identified in— On which— Do the actions in accordance with the Accomplishment Instructions of— (1) Paragraphs (c)(5) and (c)(6) of this AD ........ The BCRC was incorporated in production in accordance with any Airbus modification 47198, 47884, 48895, 48710, 49136, 50107, 50900, or 51320. The BCRC was incorporated in production in accordance with Airbus modification 50901. Airbus Service Bulletin A340–26–5009, dated January 31, 2005. (2) Paragraph (c)(4) of this AD .......................... Compliance Time Extension for Paragraphs (g), (h), and (i) of this AD (j) The inspection required by paragraphs (g), (h), and (i) of this AD may be done within 6,600 flight hours after the effective date of this AD, provided that you can conclusively determine from reviewing the airplane maintenance records that the fire extinguishing system has never been activated before the effective date of this AD. A log book entry is not acceptable for determining if a fire extinguishing bottle has been activated. accordance with the procedures found in 14 CFR 39.19. (2) Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Alternative Methods of Compliance (AMOCs) Related Information (l) French airworthiness directives F– 2005–019 R1 (for Model A330–200 and A330–300 series airplanes) and F–2005–020 R1 (for Model A340–200 and A340–300 series airplanes, and Model A340–541 and A340–642 airplanes), both issued May 11, 2005, also address the subject of this AD. (k)(1) The Manager, International Branch, ANM–116, has the authority to approve AMOCs for this AD, if requested in Material Incorporated by Reference (m) You must use the service information specified in Table 5 of this AD to perform the Airbus Service Bulletin A340–26–4035, dated February 22, 2005. actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL–401, Nassif Building, Washington, DC; on the Internet at https:// dms.dot.gov; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call (202) 741–6030, or go to https://www.archives.gov/federal_ register/code_of_federal_regulations/ ibr_locations.html. TABLE 5.—MATERIAL INCORPORATED BY REFERENCE Revision level Airbus Service Bulletin A330–26–3031 A340–26–4031 A340–26–4035 A340–26–5007 A340–26–5008 A340–26–5009 ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... ................................................................................................................................................... Date 02 ................ 02 ................ Original ........ Original ........ Original ........ Original ........ February 1, 2005. February 1, 2005. February 22, 2005. January 31, 2005. January 31, 2005. January 31, 2005. DEPARTMENT OF HEALTH AND HUMAN SERVICES § 558.76, paragraphs (a), (b), and (d)(1) are corrected to read as follows: Food and Drug Administration § 558.76 BILLING CODE 4910–13–P mstockstill on PROD1PC68 with RULES Issued in Renton, Washington, on June 13, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 06–5548 Filed 6–21–06; 8:45 am] New Animal Drugs For Use in Animal Feeds 21 CFR Part 558 CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2006, on page 391, in VerDate Aug<31>2005 15:23 Jun 21, 2006 Jkt 208001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 Bacitracin methylene disalicylate. (a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or 75 grams per pound to 046573 in § 510.600(c) of this chapter. (b) Special considerations. The quantities of antibiotics are expressed in terms of the equivalent amount of antibiotic standard. * * * * * (d) Conditions of use. (1) It is used as follows: E:\FR\FM\22JNR1.SGM 22JNR1 Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Rules and Regulations 35793 Bacitracin methylene disalicylate in grams per ton Combination in grams per ton Indications for use Limitations (i) 4 to 50 ........... .......................................... .................................................................. 046573 (ii) 5 to 20 .......... .......................................... .................................................................. 046573 (iii) 10 to 25 ....... .......................................... For first 7 months of production .............. 046573 (iv) 10 to 30 ....... .......................................... Chickens, turkeys, and pheasants; increased rate of weight gain and improved feed efficiency 1. Quail not over 5 weeks of age; increased rate of weight gain and improved feed efficiency 1. Chickens; for increased egg production and improved feed efficiency for egg production. Swine: for increased rate of weight gain and improved feed efficiency. Swine; for increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. Swine; for control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. For growing and finishing swine ............. 046573 Feed for not more than 14 days; bacitracin methylene disalicylate provided by No. 046573; chlortetracycline provided by Nos. 046573 and 048164 in § 510.600(c) of this chapter. 046573 048164 Feed for not more than 14 days; chlortetracycline and BMD as provided by 046573 in § 510.600(c) of this chapter. 046573 .................................................................. 046573 Feed continuously as sole ration ............ 046573 .................................................................. 046573 Feed continuously as sole ration. Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/t). .................................................................. 046573 From Type A medicated articles containing 25, 40, or 50 grams of bacitracin methylene disalicylate. Feed continuously as the sole ration. As the sole ration. Not for use in swine weighing more than 250 pounds. Diagnosis should be confirmed by a veterinarian when results are not satisfactory. 046573 Chlortetracycline approximately 400, varying with body weight and food consumption to provide 10 milligrams per pound of body weight per day. (v) [Reserved] (vi) 50 ................ (vii)–(viii) [Reserved] (ix) 100 to 200 ... (x) 200 ............... mstockstill on PROD1PC68 with RULES (xi) 250 .............. .......................................... .......................................... .......................................... .......................................... Broiler chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Broiler chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Turkeys; as an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalicylate. Quail; for the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylene disalicylate. 1. Growing/Finishing Swine: For control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition. 2. Pregnant sows: For control of clostridial enteritis caused by C. perfringens in suckling piglets. As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory. Sponsor 046573 046573 ................ 1 These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information. VerDate Aug<31>2005 17:57 Jun 21, 2006 Jkt 208001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\22JNR1.SGM 22JNR1 35794 * Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Rules and Regulations * * * Background and Purpose * [FR Doc. 06–55520 Filed 6–21–06; 8:45 am] BILLING CODE 1505–01–D DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD09–06–054] RIN 1625–AA00 Safety Zone; Seneca River Days Fireworks, Baldwinsville, NY Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: SUMMARY: The Coast Guard is establishing a temporary safety zone encompassing the navigable waters of the Seneca River in Baldwinsville, NY on July 7, 2006. This safety zone is necessary to ensure the safety of spectators and vessels from the hazards associated with firework displays. This safety zone restricts vessel traffic from a portion of the Seneca River in Baldwinsville, NY. DATES: This rule is in effect from 9:30 p.m. (local) until 10:30 p.m. (local) on July 7, 2006. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of the docket [CGD09– 06–054], and are available for inspection or copying at U.S. Coast Guard Sector Buffalo, 1 Fuhrmann Blvd., Buffalo, New York 14203 between 8 a.m. and 4 p.m. (local), Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: LT Tracy Wirth, U.S. Coast Guard Sector Buffalo, at (716) 843–9573. SUPPLEMENTARY INFORMATION: mstockstill on PROD1PC68 with RULES Regulatory Information We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. This safety zone is temporary in nature and limited time existed for an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying this rule would be impracticable and contrary to public interest since immediate action is needed to minimize potential danger to the public during the fireworks demonstration. VerDate Aug<31>2005 15:23 Jun 21, 2006 Jkt 208001 Temporary safety zones are necessary to ensure the safety of vessels and spectators from the hazards associated with firework displays. Based on recent accidents that have occurred in other Captain of the Port zones and the explosive hazard of fireworks, the Captain of the Port Buffalo has determined firework launches in close proximity to watercraft pose significant risks to public safety and property. The likely combination of large numbers of recreational vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the locations of the launch platforms will help ensure the safety of persons and property at these events and help minimize the associated risk. The safety zone consists of all navigable waters of the Seneca River in a 600-foot radius around a point at approximate position: 43°09′25″ N, 076°20′21″ W (NAD 1983) in Baldwinsville, NY. The size of this zone was determined using the National Fire Prevention Association guidelines and local knowledge concerning wind, waves, and currents. All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or his designated onscene representative. The designated onscene representative will be the patrol commander. Entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated onscene representative may be contacted via VHF Channel 16. Regulatory Evaluation This rule is not a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed this rule under that Order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This determination is based on the minimal time that vessels will be restricted from the zone, and the zone is in areas where the Coast Guard PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 expects insignificant adverse impact to mariners from the zone’s activation. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we considered whether this rule would have a significant impact on a substantial number of small entities. The term ‘‘small entities’’ comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: the owners or operators of commercial vessels intending to transit or anchor in the activated safety zone. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reason: This safety zone is only in effect from 9:30 p.m. (local) until 10:30 p.m. (local) on July 7, 2006. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this rule so that they can better evaluate its effects and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact U.S. Coast Guard Sector Buffalo (see ADDRESSES). Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency’s responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1– 888–REG–FAIR (1–888–734–3247). E:\FR\FM\22JNR1.SGM 22JNR1

Agencies

[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Rules and Regulations]
[Pages 35792-35794]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-55520]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use in Animal Feeds

CFR Correction

In Title 21 of the Code of Federal Regulations, Parts 500 to 599,
revised as of April 1, 2006, on page 391, in Sec. 558.76, paragraphs
(a), (b), and (d)(1) are corrected to read as follows:

Sec. 558.76 Bacitracin methylene disalicylate.

(a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60,
or 75 grams per pound to 046573 in Sec. 510.600(c) of this chapter.
(b) Special considerations. The quantities of antibiotics are
expressed in terms of the equivalent amount of antibiotic standard.
* * * * *
(d) Conditions of use. (1) It is used as follows:

[[Page 35793]]

----------------------------------------------------------------------------------------------------------------
Bacitracin methylene
disalicylate in grams per Combination in grams Indications for use Limitations Sponsor
ton per ton
----------------------------------------------------------------------------------------------------------------
(i) 4 to 50................. ....................... Chickens, turkeys, and ...................... 046573
pheasants; increased
rate of weight gain
and improved feed
efficiency \1\.
(ii) 5 to 20................ ....................... Quail not over 5 weeks ...................... 046573
of age; increased
rate of weight gain
and improved feed
efficiency \1\.
(iii) 10 to 25.............. ....................... Chickens; for For first 7 months of 046573
increased egg production.
production and
improved feed
efficiency for egg
production.
(iv) 10 to 30............... ....................... Swine: for increased For growing and 046573
rate of weight gain finishing swine.
and improved feed
efficiency.
Chlortetracycline Swine; for increased Feed for not more than 046573
approximately 400, rate of weight gain 14 days; bacitracin 048164
varying with body and improved feed methylene
weight and food efficiency; for disalicylate provided
consumption to provide treatment of by No. 046573;
10 milligrams per bacterial enteritis chlortetracycline
pound of body weight caused by Escherichia provided by Nos.
per day. coli and Salmonella 046573 and 048164 in
choleraesuis and Sec. 510.600(c) of
bacterial pneumonia this chapter.
caused by Pasteurella
multocida susceptible
to chlortetracycline.
Swine; for control of Feed for not more than 046573
porcine proliferative 14 days;
enteropathies chlortetracycline and
(ileitis) caused by BMD as provided by
Lawsonia 046573 in Sec.
intracellularis 510.600(c) of this
susceptible to chapter.
chlortetracycline.
(v) [Reserved]
(vi) 50..................... ....................... Broiler chickens; as ...................... 046573
an aid in the
prevention of
necrotic enteritis
caused or complicated
by Clostridium spp.
or other organisms
susceptible to
bacitracin.
Replacement chickens; Feed continuously as 046573
as an aid in the sole ration.
prevention of
necrotic enteritis
caused or complicated
by Clostridium spp.
or other organisms
susceptible to
bacitracin.
(vii)-(viii) [Reserved]
(ix) 100 to 200............. ....................... Broiler chickens; as ...................... 046573
an aid in the control
of necrotic enteritis
caused or complicated
by Clostridium spp.
or other organisms
susceptible to
bacitracin.
Replacement chickens; Feed continuously as 046573
as an aid in the sole ration. Start at
control of necrotic first clinical signs
enteritis caused or of disease, vary
complicated by dosage based on
Clostridium spp. or severity of
other organisms infection, administer
susceptible to continuously for 5 to
bacitracin. 7 days or as long as
clinical signs
persist, then reduce
medication to
prevention level (50
g/t).
(x) 200..................... ....................... Turkeys; as an aid in ...................... 046573
the control of
transmissible
enteritis in growing
turkeys complicated
by organisms
susceptible to
bacitracin methylene
disalicylate.
Quail; for the From Type A medicated 046573
prevention of articles containing
ulcerative enteritis 25, 40, or 50 grams
in growing quail due of bacitracin
to Clostridium methylene
colinum susceptible disalicylate. Feed
to bacitracin continuously as the
methylene sole ration.
disalicylate.
(xi) 250.................... ....................... 1. Growing/Finishing As the sole ration. 046573
Swine: For control of Not for use in swine
swine dysentery weighing more than
associated with 250 pounds. Diagnosis
Treponema should be confirmed
hyodysenteriae on by a veterinarian
premises with a when results are not
history of swine satisfactory.
dysentery but where
signs of the disease
have not yet
occurred; or
following an approved
treatment of the
disease condition.
2. Pregnant sows: For As the sole ration. .........
control of Feed to sows from 14
clostridial enteritis days before through
caused by C. 21 days after
perfringens in farrowing on premises
suckling piglets. with a history of
clostridial scours.
Diagnosis should be
confirmed by a
veterinarian when
results are not
satisfactory.
----------------------------------------------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require
effectiveness data as specified by Sec. 514.111 of this chapter, but may require bioequivalency and safety
information.

[[Page 35794]]

* * * * *
[FR Doc. 06-55520 Filed 6-21-06; 8:45 am]
BILLING CODE 1505-01-D

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