New Animal Drugs; Change of Sponsor, 27954-27959 [06-4505]
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27954
Federal Register / Vol. 71, No. 93 / Monday, May 15, 2006 / Rules and Regulations
The Rule
This amendment to 14 CFR part 97 is
effective upon publication of each
separate SIAP and/or Weather Takeoff
Minimums as contained in the
transmittal. Some SIAP and/or Weather
Takeoff Minimums amendments may
have been previously issued by the FAA
in a Flight Data Center (FDC) Notice to
Airmen (NOTAM) as an emergency
action of immediate flight safety relating
directly to published aeronautical
charts. The circumstances which
created the need for some SIAP, and/or
Weather Takeoff Minimums
amendments may require making them
effective in less than 30 days. For the
remaining SIAPs and/or Weather
Takeoff Minimums, an effective date at
least 30 days after publication is
provided.
Further, the SIAPs and/or Weather
Takeoff Minimums contained in this
amendment are based on the criteria
contained in the U.S. Standard for
Terminal Instrument Procedures
(TERPS). In developing these SIAPs
and/or Weather Takeoff Minimums, the
TERPS criteria were applied to the
conditions existing or anticipated at the
affected airports. Because of the close
and immediate relationship between
these SIAPs and/or Weather Takeoff
Minimums and safety in air commerce,
I find that notice and public procedure
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.
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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.
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21:49 May 12, 2006
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List of Subjects in 14 CFR Part 97
Air Traffic Control, Airports,
Incorporation by reference, and
Navigation (air).
Issued in Washington, DC on May 5, 2006.
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:
I
* * * Effective 08 June 2006
Magnolia, AR, Magnolia Muni, NDB RWY 36,
Amdt 1, CANCELLED
Atlanta, GA, Hartsfield-Jackson Atlanta Intl,
ILS OR LOC RWY 27R, Amdt 4
Pittsfield, MA, Pittsfield Muni, LOC RWY 26,
Amdt 7
St. Louis, MO, Lambert St. Louis Intl, RNAV
(GPS) RWY 11, Orig
St. Louis, MO, Lambert St. Louis Intl, RNAV
(GPS) RWY 12L, Amdt 1
Cleveland, OH, Burke Lakefront, Takeoff
Minimums and Textual DP, Amdt 4
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 25 approved new
animal drug applications (NADAs) and
16 approved abbreviated new animal
drug applications (ANADAs) for Type A
medicated articles and feed use
combinations from Intervet, Inc., to
Huvepharma AD.
DATES:
This rule is effective May 15,
2006.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, has informed FDA
that it has transferred ownership of, and
all rights and interest in, the following
25 approved NADAs and 16 approved
ANADAs for Type A medicated articles
and feed use combinations to
Huvepharma AD, 33 James Boucher
Blvd., Sophia 1407, Bulgaria:
SUPPLEMENTARY INFORMATION:
Application No.
Trade Name(s)
NADA 044–759
FLAVOMYCIN
(bambermycins) Type
A medicated article
NADA 095–543
AMPROL HI–E /
FLAVOMYCIN
NADA 095–547
AMPROL HI–E /
FLAVOMYCIN / 3–
NITRO
* * * Effective 03 August 2006
Destin, FL, Destin-Fort Walton Beach,
RADAR–1, Amdt 8, CANCELLED
Picayune, MS, Picayune Muni, NDB RWY 18,
Orig, CANCELLED
Picayune, MS, Picayune Muni, NDB RWY 36,
Orig, CANCELLED
St George, UT, St George Muni, RNAV (GPS)
RWY 34, Amdt 1
NADA 095–548
AMPROL / 3–NITRO /
FLAVOMYCIN
NADA 095–549
AMPROL PLUS / 3–
NITRO /
FLAVOMYCIN
NADA 098–340
FLAVOMYCIN /
MONENSIN
[FR Doc. 06–4474 Filed 5–12–06; 8:45 am]
NADA 098–341
FLAVOMYCIN / 3–
NITRO / COBAN
NADA 101–628
FLAVOMYCIN / 3–
NITRO / ZOALENE
NADA 101–629
FLAVOMYCIN /
ZOALENE
NADA 130–185
FLAVOMYCIN /
AMPROLIUM
NADA 130–661
FLAVOMYCIN / CARB–
O–SEP
NADA 130–951
STENOROL
(halofuginone
hydrobromide)
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
New Animal Drugs; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
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Federal Register / Vol. 71, No. 93 / Monday, May 15, 2006 / Rules and Regulations
Application No.
Trade Name(s)
Application No.
Trade Name(s)
NADA 137–483
FLAVOMYCIN /
STENOROL
ANADA 200–
095
SACOX / AUREOMYCIN
NADA 139–473
STENOROL / STAFAC
ANADA 200–
096
SACOX / TERRAMYCIN
NADA 140–339
FLAVOMYCIN /
NICARB
ANADA 200–
097
SACOX / 3–NITRO
ANADA 200–
143
SACOX / 3–NITRO /
BACIFERM
NADA 140–340
NADA 140–533
STENOROL /
LINCOMIX
STENOROL / 3–NITRO
/ BMD
NADA 140–584
STENOROL / BMD
NADA 140–824
STENOROL Type A
medicated article
NADA 140–843
MONTEBAN /
FLAVOMYCIN / 3–
NITRO
NADA 140–845
FLAVOMYCIN /
MONTEBAN
NADA 140–918
STENOROL /
FLAVOMYCIN
NADA 140–919
STENOROL / BMD
NADA 141–034
GAINPRO
(bambermycins) Type
A medicated article
AVATEC /
FLAVOMYCIN
ANADA 200–
075
SACOX (salinomycin sodium) Type A medicated article
ANADA 200–
080
SACOX / 3–NITRO /
FLAVOMYCIN
ANADA 200–
081
SACOX / 3–NITRO /
BMD
ANADA 200–
082
SACOX / BMD
ANADA 200–
083
SACOX / FLAVOMYCIN
ANADA 200–
086
SACOX / ALBAC / 3–
NITRO
ANADA 200–
089
SACOX / BACIFERM
ANADA 200–
090
SACOX / LINCOMIX /
3–NITRO
ANADA 200–
091
SACOX / 3–NITRO /
AUREOMYCIN
ANADA 200–
092
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NADA 141–129
SACOX / STAFAC
ANADA 200–
093
SACOX / LINCOMIX
ANADA 200–
094
SACOX / STAFAC / 3–
NITRO
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Accordingly, the agency is amending
the regulations in 21 CFR 558.55,
558.58, 558.95, 558.120, 558.265,
558.311, 558.355, 558.363, 558.366,
558.450, 558.550, and 558.680 to reflect
the transfer of ownership and a current
format.
In addition, Huvepharma AD has not
been previously listed in the animal
drug regulations as a sponsor of an
approved application. At this time, 21
CFR 510.600(c) is being amended to add
entries for the firm.
Also, FDA has found that the April 1,
2005, edition of Title 21, parts 500 to
599 of the Code of Federal Regulations
(CFR) does not accurately reflect the use
limitations for amprolium in singleingredient, medicated broiler chicken
feeds. The existing entry erroneously
includes limitations normally associated
with the use of arsenicals in feed. At
this time, the regulations are being
amended in § 558.55 to correct this
error. FDA is also taking this
opportunity to consolidate entries for
similar combination medicated feeds in
the same section of part 558, and to
eliminate duplicate entries. These
actions are being taken to improve the
accuracy and readability 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.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 510 and 558 are amended as
follows:
Frm 00007
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1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add an
entry for ‘‘Huvepharma AD’’; and in the
table in paragraph (c)(2) numerically
add an entry for ‘‘016592’’ to read as
follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
Sfmt 4700
*
*
Firm name and address
*
*
*
Huvepharma AD, 33
James Boucher
Blvd., Sophia 1407,
Bulgaria
*
*
*
Drug labeler
code
*
*
016592
*
*
(2) * * *
Drug labeler
code
*
Firm name and address
*
016592
*
*
*
*
Huvepharma AD, 33
James Boucher
Blvd., Sophia 1407,
Bulgaria
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.55
List of Subjects
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PART 510—NEW ANIMAL DRUGS
[Amended]
4. Amend § 558.55 as follows:
a. In the table in paragraph (d)(2)(ii),
in the ‘‘Limitations’’ column in the
entry for ‘‘Amprolium 72.6 to 113.5
grams per ton’’, remove the first
sentence;
I b. In the table in paragraph (d)(2)(iii),
in the ‘‘Limitations’’ column in the
entry for ‘‘Bambermycins 1 to 3 plus
roxarsone 22.8 to 34.1 (0.0025% to
0.00375%)’’, remove ‘‘057926’’ and add
in its place ‘‘016592’’; and in the
‘‘Sponsor’’ column add ‘‘016592’’ and
I c. In the table in paragraph (d)(2)(iii),
in the ‘‘Limitations’’ column and
‘‘Sponsor’’ column in the entry for
I
I
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‘‘Bambermycins 2 to 3 plus roxarsone
22.8 to 34.1’’, remove ‘‘057926’’ and add
in its place ‘‘016592’’; and in the
‘‘Sponsor’’ column add ‘‘016592’’; and
‘‘Bambermycins 1 to 4’’, remove
‘‘057926’’ and add in its place
‘‘016592’’.
I 5. Amend § 558.58 as follows:
I a. Revise paragraph (a);
I b. Redesignate paragraphs (b), (c), and
(d) as paragraphs (c), (d), and (e);
I c. Add new paragraph (b);
I d. In the table in newly redesignated
paragraph (e)(1)(i), add an entry for
‘‘Bambermycins 1 to 3 plus roxarsone
22.8 to 34.1’’;
I e. In the table in newly redesignated
paragraph (e)(1)(ii), in the ‘‘Limitations’’
column in the entries for
Amprolium and ethopabate in
grams per ton
(i) Amprolium 113.5
(0.0125%) and ethopabate
3.6 (0.0004%).
f. In the table in newly redesignated
paragraph (e)(1)(iii), in the
‘‘Limitations’’ column in the entries for
‘‘Bambermycins 1 to 3’’ and
‘‘Bambermycins 1 to 3 plus roxarsone
22.8 to 34.1’’, remove ‘‘057926’’ and add
in its place ‘‘016592’’; and in the
‘‘Sponsor’’ column add ‘‘016592’’.
I
The revisions and additions read as
follows:
Combination in
grams per ton
*
*
*
*
*
*
*
*
*
I 6. Amend § 558.95 as follows:
I a. In paragraphs (a)(1), (a)(2), and
(a)(5), remove ‘‘057926’’ and add in its
place ‘‘016592’’;
I b. Remove and reserve paragraph
(d)(1)(ii);
I c. Remove paragraphs (d)(1)(iii)
through (d)(1)(xiv) and paragraphs
(d)(3)(iii) and (d)(3)(iv); and
I d. Revise paragraph (d)(5).
The revision reads as follows:
§ 558.95
Bambermycins.
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*
*
*
*
*
(d) * * *
(5) Bambermycins may also be used in
combination with:
(i) Amprolium alone or with
roxarsone as in § 558.55.
(ii) Amprolium and ethopabate alone
or with roxarsone as in § 558.58.
(iii) Diclazuril as in § 558.198.
(iv) Halofuginone as in § 558.265.
(v) Lasalocid alone or with roxarsone
as in § 558.311.
(vi) Monensin alone or with roxarsone
as in § 558.355.
(vii) Narasin alone or with nicarbazin
or roxarsone as in § 558.363.
(viii) Nicarbazin as in § 558.366.
(ix) Salinomycin alone or with
roxarsone as in § 558.550.
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Limitations
*
*
(x) Zoalene alone or with roxarsone as
in § 558.680.
I 7. In § 558.120, add paragraph
(d)(1)(iv) and remove paragraph
(d)(2)(iii) to read as follows:
*
§ 558.265
016592
*
Halofuginone hydrobromide.
(a) Specifications. Type A medicated
articles containing 6 grams of
halofuginone hydrobromide per
kilogram.
Carbarsone (not U.S.P.).
*
*
*
*
*
(d) * * *
(1) * * *
(iv) Grams per ton. 227 carbarsone,
plus 1 or 4 grams per ton
bambermycins.
(a) Indications for use. As an aid in
the prevention of blackhead; and for
increased rate of weight gain (4 grams
per ton bambermycins) or improved
feed efficiency (1 gram per ton
bambermycins).
(b) Limitations. Feed continuously 2
weeks before blackhead is expected and
continue as long as prevention is
needed. Withdraw 5 days before
slaughter. As sole source of organic
arsenic. Bambermycins provided by No.
046573 in § 510.600(c) of this chapter.
*
*
*
*
*
I 8. In § 558.265, revise paragraph (a);
redesignate paragraphs (b) and (c) as
paragraphs (c) and (d); and add new
paragraph (b) to read as follows:
PO 00000
*
Feed continuously as the sole ration; as
sole source of amprolium and organic
arsenic; withdraw 5 d before slaughter; roxarsone provided by No.
046573, bambermycins by No.
016592 in § 510.600(c) of this chapter.
*
§ 558.120
Sponsor
*
Broiler chickens: As an aid in
the prevention of coccidiosis;
and for increased rate of
weight gain, improved feed efficiency, and improved pigmentation.
*
Amprolium and ethopabate.
(a) Specifications. Type A medicated
articles containing:
(1) 25 percent amprolium and 8
percent ethopabate or 5 percent
amprolium and 1.6 percent ethopabate;
(2) 25 percent amprolium and 0.8
percent ethopabate or 5 percent
amprolium and 0.16 percent ethopabate.
(b) Approvals. See No. 050604 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(e) * * *
(1) * * *
Indications for use
Bambermycins, 1
to 3; plus
roxarsone, 22.8
to 34.1
*
§ 558.58
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(b) Approvals. See No. 016592 in
§ 510.600(c) of this chapter.
*
*
*
*
*
9. Amend § 558.311 as follows:
I a. In the table in paragraph (e)(1)(ii) in
the entry in the ‘‘Combination in grams
per ton’’ column for ‘‘Roxarsone 45.4
plus bambermycins 1’’, in the
‘‘Limitations’’ column remove ‘‘012799’’
and add in its place ‘‘016592’’;
I b. In the table in paragraph (e)(1)(ii)
following the entry in the ‘‘Combination
in grams per ton’’ column for
‘‘Roxarsone 45.4 plus bambermycins 1’’,
add an entry for ‘‘Bambermycins 1 to 2’’;
and
I c. Remove and reserve paragraph
(e)(5)(ii).
The addition reads as follows:
I
§ 558.311
*
Lasalocid.
*
*
(e) * * *
(1) * * *
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*
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Federal Register / Vol. 71, No. 93 / Monday, May 15, 2006 / Rules and Regulations
Lasalocid in grams
per ton
Combination in grams per
ton
*
*
(ii) 68 (0.0075 pct)
to 113 (0.0125
pct).
*
*
*
Indications for use
*
*
*
*
*
*
*
*
10. In § 558.355, in paragraphs (b)(10),
(f)(2)(v)(b), and (f)(2)(vi)(b), remove
‘‘057926’’ and add in its place
‘‘016592’’; and revise paragraphs
(f)(1)(vi), (f)(1)(vii), and (f)(1)(xvii) to
read as follows:
I
§ 558.355
Monensin.
*
*
*
*
*
(f) * * *
(1) * * *
(vi) Amount per ton. Monensin, 90 to
110 grams; plus bambermycins, 1 to 2
grams.
(a) Indications for use. For increased
rate of weight gain and improved feed
efficiency; and as an aid in the
prevention of coccidiosis caused by E.
necatrix, E. tenella,E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as
sole ration; do not feed to laying
chickens. Bambermycins provided by
No. 016592 in § 510.600(c) of this
chapter.
(vii) Amount per ton. Monensin, 90 to
110 grams; plus bambermycins, 1 gram;
plus roxarsone, 22.7 to 45.4 grams
(a) Indications for use. For increased
rate of weight gain and improved feed
Nicarbazin in grams
per ton
*
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*
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*
*
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*
*
*
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016592
*
a. In paragraphs (a)(4), (a)(5), and
(d)(1)(vii)(B), remove ‘‘057926’’ and add
in its place ‘‘016592’’;
I b. In paragraph (d)(1)(iv)(B) add a new
sentence at the end of the paragraph;
and
I c. Remove paragraph (d)(1)(xii).
The addition reads as follows:
I
§ 558.363
Narasin.
*
*
*
*
*
(d) * * *
(1) * * *
(iv) * * *
(B) * * * Narasin as provided by No.
000986; bambermycins by No. 016592
in § 510.600(c) of this chapter.
*
*
*
*
*
12. In the table in paragraph (d) of
§ 558.366, alphabetically add new
entries for ‘‘Narasin 27 to 45, and
bambermycins 1 to 2’’ and
‘‘Bambermycins 1 to 2’’ to read as
follows:
I
§ 558.366
*
Nicarbazin.
*
*
(d) * * *
*
Limitations
*
*
*
Feed continuously as sole ration. Bambermycins provided by No. 016592 in
§ 510.600(c) of this chapter.
Indications for use
Narasin 27 to 45, and
bacitracin methylene
disalicylate 50, and
roxarsone 22.7 to 45.4
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*
*
*
*
efficiency; and as an aid in the
prevention of coccidiosis caused by E.
necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as
sole ration; use as sole source of organic
arsenic; withdraw 5 d before slaughter;
do not feed to laying chickens.
Bambermycins provided by No. 016592
in § 510.600(c) of this chapter; roxarsone
provided by No. 046573.
*
*
*
*
*
(xvii) Amount per ton.
Bambermycins, 1 to 2 grams plus
monensin, 90 to 110 grams plus
roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. For increased
rate of weight gain; and as an aid in
prevention of coccidiosis caused by E.
necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as
sole ration; use as sole source of organic
arsenic; withdraw 5 d before slaughter;
do not feed to laying chickens.
Bambermycins provided by No. 016592
in § 510.600(c) of this chapter; roxarsone
provided by No. 046573.
*
*
*
*
*
I 11. Amend § 558.363 as follows:
Combination in grams per
ton
*
*
*
Sponsor
*
Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for increased
rate of weight gain and improved feed efficiency.
*
*
*
*
Bambermycins 1 to 2
*
*
Limitations
Sponsor
*
*
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*
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Federal Register / Vol. 71, No. 93 / Monday, May 15, 2006 / Rules and Regulations
Nicarbazin in grams
per ton
Combination in grams per
ton
Narasin 27 to 45, and
bambermycins 1 to 2
*
*
113.5 (0.0125 pct)
*
Indications for use
Limitations
Broiler chickens: As an aid in
preventing outbreaks of cecal
(Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E.
brunetti) coccidiosis; and for
increased rate of weight gain
and improved feed efficiency.
Feed continuously as sole ration from time
chicks are placed on litter until past the
time when coccidiosis is ordinarily a
hazard; do not use as a treatment for
coccidiosis; do not use in flushing
mashes; do not feed to laying hens;
withdraw 4 days before slaughter.
Bambermycins provided by No. 016592;
nicarbazin and narasin by No. 066104 in
§ 510.600(c) of this chapter..
*
*
Bambermycins 1 to 2
*
13. In the table in paragraph (d)(1)(vii)
of § 558.450, remove the entry for
‘‘Salinomycin 40 to 60 g/ton’’; and add
paragraph (d)(3)(v) to read as follows:
Oxytetracycline.
*
*
*
*
*
(d) * * *
(3) * * *
(v) Salinomycin as in § 558.550.
I 14. In § 558.550, in paragraphs
(d)(1)(xv)(c) and (d)(1)(xvi)(c), remove
‘‘057926’’ and add in its place
‘‘016592’’; add paragraphs (d)(1)(xxiii)
and (d)(1)(xxiv); and revise paragraphs
(b)(2) and (d)(4) to read as follows:
§ 558.550
Salinomycin.
dsatterwhite on PROD1PC76 with RULES
*
*
*
*
*
(b) * * *
(2) No. 016592 for use as in
paragraphs (d)(1)(i), (d)(1)(iii) through
(d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv),
(d)(2)(i), (d)(3)(i), and (d)(4) of this
section.
*
*
*
*
*
(d) * * *
(1) * * *
(xxiii) Amount per ton. Salinomycin,
40 to 60 grams; plus bambermycins, 1 to
3 grams.
(a) Indications for use. Broiler
chickens: For prevention of coccidiosis
caused by Eimeria tenella, E. necatrix,
E. acervulina, E. maxima, E. brunetti,
VerDate Aug<31>2005
21:49 May 12, 2006
Jkt 208001
*
*
*
*
*
*
*
*
*
*
*
Broiler chickens: For prevention
of coccidiosis caused by
Eimeria tenella, E. necatrix,
E. acervulina, E. brunetti, E.
mivati, and E. maxima; and
for increased rate of weight
gain and improved feed efficiency.
*
I
§ 558.450
*
000986
*
Bacitracin zinc 4 to 50
*
*
Sponsor
*
Feed continuously as sole ration.
Bambermycins provided by No. 016592
in § 510.600(c) of this chapter.
*
and E. mivati; and for improved feed
efficiency.
(b) Limitations. Feed continuously as
sole ration. Do not feed to laying
chickens; not approved for use with
pellet binders; may be fatal if
accidentally fed to adult turkeys or
horses. Salinomycin as provided by
Nos. 046573 and 016592; bambermycins
by No. 016592 in § 510.600(c) of this
chapter.
(xxiv) Amount per ton. Salinomycin,
40 to 60 grams; plus bambermycins, 1 to
2 grams; plus roxarsone, 45.4 grams.
(a) Indications for use. Broiler
chickens: For prevention of coccidiosis
caused by Eimeria tenella, E. necatrix,
E. acervulina, E. maxima, E. brunetti,
and E. mivati, including some field
strains of E. tenella that are more
susceptible to roxarsone combined with
salinomycin than salinomycin alone;
and for improved feed efficiency.
(b) Limitations. Feed continuously as
sole ration. Do not feed to laying
chickens; as sole source or organic
arsenic; withdraw 5 days before
slaughter; not approved for use with
pellet binders; may be fatal if
accidentally fed to adult turkeys or
horses; Salinomycin as provided by
Nos. 046573and 016592; bambermycins
by No. 016592; roxarsone by No. 046573
in § 510.600(c) of this chapter.
*
*
*
*
*
PO 00000
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Fmt 4700
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*
016592
*
(4) Chickens: It is used in chicken
feed as follows:
(i) Amount per ton. Salinomycin, 40
to 60 grams; plus oxytetracycline, 500
grams.
(a) Indications for use. For prevention
of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati; and for
reduction of mortality due to air
sacculitis (air-sac-infection) caused by
Escherichia coli susceptible to
oxytetracycline.
(b) Limitations. Feed continuously for
5 days; do not feed to chickens
producing eggs for human consumption;
withdraw 24 hours before slaughter; in
low calcium feeds withdraw 3 d before
slaughter. Salinomycin as provided by
Nos. 046573 and 016592;
oxytetracycline as provided by No.
066104 in § 510.600(c) of this chapter.
(ii) [Reserved]
15. In § 558.680, alphabetically add
two entries to the table in paragraph
(d)(1)(ii); and revise paragraph (d)(2) to
read as follows:
I
§ 558.680
Zoalene.
*
*
*
(d) * * *
(1) * * *
E:\FR\FM\15MYR1.SGM
15MYR1
*
*
27959
Federal Register / Vol. 71, No. 93 / Monday, May 15, 2006 / Rules and Regulations
Combination in
grams per ton
Zoalene in grams per ton
(ii) 113.5 (0.0125%).
*
Indications for use
*
*
Limitations
*
*
*
*
*
*
Bacitracin 100
to 500
*
*
*
Bambermycins
1
Feed continuously as sole ration. Do
not feed to chickens over 14 weeks
of age. Bambermycins as provided
by No. 016592 in § 510.600(c) of this
chapter.
Bambermycins
1 plus
roxarsone
22.7
*
Broiler chickens: As an aid in the prevention and control of coccidiosis;
and for increased rate of weight gain
and improved feed efficiency.
Broiler chickens: As an aid in the prevention and control of coccidiosis;
and for increased rate of weight gain
and improved feed efficiency.
Feed continuously as sole ration. Do
not feed to chickens over 14 weeks
of age; feed as sole source of organic arsenic; withdraw 5 days before slaughter. Bambermycins as
provided by No. 016592, roxarsone
by No. 046573 in § 510.600(c) of this
chapter.
*
*
(2) Zoalene may also be used in
combination with roxarsone as in
§ 558.530.
Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–4505 Filed 5–12–06; 8:45 am]
BILLING CODE 4160–01–S
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Parts 4022 and 4044
Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets
in Single-Employer Plans; Interest
Assumptions for Valuing and Paying
Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
dsatterwhite on PROD1PC76 with RULES
AGENCY:
SUMMARY: The Pension Benefit Guaranty
Corporation’s regulations on Benefits
Payable in Terminated Single-Employer
Plans and Allocation of Assets in
Single-Employer Plans prescribe interest
assumptions for valuing and paying
benefits under terminating singleemployer plans. This final rule amends
the regulations to adopt interest
assumptions for plans with valuation
dates in June 2006. Interest assumptions
are also published on the PBGC’s Web
site (https://www.pbgc.gov).
DATES: Effective June 1, 2006.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion, Attorney, Legislative
and Regulatory Department, Pension
Benefit Guaranty Corporation, 1200 K
VerDate Aug<31>2005
21:49 May 12, 2006
Jkt 208001
*
*
Street, NW., Washington, DC 20005,
202–326–4024. (TTY/TDD users may
call the Federal relay service toll-free at
1–800–877–8339 and ask to be
connected to 202–326–4024.)
SUPPLEMENTARY INFORMATION: The
PBGC’s regulations prescribe actuarial
assumptions—including interest
assumptions—for valuing and paying
plan benefits of terminating singleemployer plans covered by title IV of
the Employee Retirement Income
Security Act of 1974. The interest
assumptions are intended to reflect
current conditions in the financial and
annuity markets.
Three sets of interest assumptions are
prescribed: (1) A set for the valuation of
benefits for allocation purposes under
section 4044 (found in appendix B to
part 4044), (2) a set for the PBGC to use
to determine whether a benefit is
payable as a lump sum and to determine
lump-sum amounts to be paid by the
PBGC (found in appendix B to part
4022), and (3) a set for private-sector
pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using the PBGC’s historical
methodology (found in appendix C to
part 4022).
This amendment (1) adds to appendix
B to part 4044 the interest assumptions
for valuing benefits for allocation
purposes in plans with valuation dates
during June 2006, (2) adds to appendix
B to part 4022 the interest assumptions
for the PBGC to use for its own lumpsum payments in plans with valuation
dates during June 2006, and (3) adds to
appendix C to part 4022 the interest
assumptions for private-sector pension
practitioners to refer to if they wish to
PO 00000
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Fmt 4700
Sfmt 4700
*
*
use lump-sum interest rates determined
using the PBGC’s historical
methodology for valuation dates during
June 2006.
For valuation of benefits for allocation
purposes, the interest assumptions that
the PBGC will use (set forth in appendix
B to part 4044) will be 6.20 percent for
the first 20 years following the valuation
date and 4.75 percent thereafter. These
interest assumptions represent an
increase (from those in effect for May
2006) of 0.30 percent for the first 20
years following the valuation date and
are otherwise unchanged. These interest
assumptions reflect the PBGC’s recently
updated mortality assumptions, which
are effective for terminations on or after
January 1, 2006. See the PBGC’s final
rule published December 2, 2005 (70 FR
72205), which is available at https://
www.pbgc.gov/docs/05-23554.pdf.
Because the updated mortality
assumptions reflect improvements in
mortality, these interest assumptions are
higher than they would have been using
the old mortality assumptions.
The interest assumptions that the
PBGC will use for its own lump-sum
payments (set forth in Appendix B to
part 4022) will be 3.25 percent for the
period during which a benefit is in pay
status and 4.00 percent during any years
preceding the benefit’s placement in pay
status. These interest assumptions
represent an increase (from those in
effect for May 2006) of 0.25 percent for
the period during which a benefit is in
pay status and are otherwise unchanged.
For private-sector payments, the
interest assumptions (set forth in
Appendix C to part 4022) will be the
same as those used by the PBGC for
E:\FR\FM\15MYR1.SGM
15MYR1
]]>Agencies
[Federal Register Volume 71, Number 93 (Monday, May 15, 2006)]
[Rules and Regulations]
[Pages 27954-27959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4505]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
New Animal Drugs; Change of Sponsor
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 25 approved new
animal drug applications (NADAs) and 16 approved abbreviated new animal
drug applications (ANADAs) for Type A medicated articles and feed use
combinations from Intervet, Inc., to Huvepharma AD.
DATES: This rule is effective May 15, 2006.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, has informed FDA that it has transferred
ownership of, and all rights and interest in, the following 25 approved
NADAs and 16 approved ANADAs for Type A medicated articles and feed use
combinations to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407,
Bulgaria:
------------------------------------------------------------------------
Application No. Trade Name(s)
------------------------------------------------------------------------
NADA 044-759 FLAVOMYCIN (bambermycins) Type A
medicated article
------------------------------------------------------------------------
NADA 095-543 AMPROL HI-E / FLAVOMYCIN
------------------------------------------------------------------------
NADA 095-547 AMPROL HI-E / FLAVOMYCIN / 3-NITRO
------------------------------------------------------------------------
NADA 095-548 AMPROL / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
NADA 095-549 AMPROL PLUS / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
NADA 098-340 FLAVOMYCIN / MONENSIN
------------------------------------------------------------------------
NADA 098-341 FLAVOMYCIN / 3-NITRO / COBAN
------------------------------------------------------------------------
NADA 101-628 FLAVOMYCIN / 3-NITRO / ZOALENE
------------------------------------------------------------------------
NADA 101-629 FLAVOMYCIN / ZOALENE
------------------------------------------------------------------------
NADA 130-185 FLAVOMYCIN / AMPROLIUM
------------------------------------------------------------------------
NADA 130-661 FLAVOMYCIN / CARB-O-SEP
------------------------------------------------------------------------
NADA 130-951 STENOROL (halofuginone hydrobromide)
------------------------------------------------------------------------
[[Page 27955]]
NADA 137-483 FLAVOMYCIN / STENOROL
------------------------------------------------------------------------
NADA 139-473 STENOROL / STAFAC
------------------------------------------------------------------------
NADA 140-339 FLAVOMYCIN / NICARB
------------------------------------------------------------------------
NADA 140-340 STENOROL / LINCOMIX
------------------------------------------------------------------------
NADA 140-533 STENOROL / 3-NITRO / BMD
------------------------------------------------------------------------
NADA 140-584 STENOROL / BMD
------------------------------------------------------------------------
NADA 140-824 STENOROL Type A medicated article
------------------------------------------------------------------------
NADA 140-843 MONTEBAN / FLAVOMYCIN / 3-NITRO
------------------------------------------------------------------------
NADA 140-845 FLAVOMYCIN / MONTEBAN
------------------------------------------------------------------------
NADA 140-918 STENOROL / FLAVOMYCIN
------------------------------------------------------------------------
NADA 140-919 STENOROL / BMD
------------------------------------------------------------------------
NADA 141-034 GAINPRO (bambermycins) Type A medicated
article
------------------------------------------------------------------------
NADA 141-129 AVATEC / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-075 SACOX (salinomycin sodium) Type A
medicated article
------------------------------------------------------------------------
ANADA 200-080 SACOX / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-081 SACOX / 3-NITRO / BMD
------------------------------------------------------------------------
ANADA 200-082 SACOX / BMD
------------------------------------------------------------------------
ANADA 200-083 SACOX / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-086 SACOX / ALBAC / 3-NITRO
------------------------------------------------------------------------
ANADA 200-089 SACOX / BACIFERM
------------------------------------------------------------------------
ANADA 200-090 SACOX / LINCOMIX / 3-NITRO
------------------------------------------------------------------------
ANADA 200-091 SACOX / 3-NITRO / AUREOMYCIN
------------------------------------------------------------------------
ANADA 200-092 SACOX / STAFAC
------------------------------------------------------------------------
ANADA 200-093 SACOX / LINCOMIX
------------------------------------------------------------------------
ANADA 200-094 SACOX / STAFAC / 3-NITRO
------------------------------------------------------------------------
ANADA 200-095 SACOX / AUREOMYCIN
------------------------------------------------------------------------
ANADA 200-096 SACOX / TERRAMYCIN
------------------------------------------------------------------------
ANADA 200-097 SACOX / 3-NITRO
------------------------------------------------------------------------
ANADA 200-143 SACOX / 3-NITRO / BACIFERM
------------------------------------------------------------------------
------------------------------------------------------------------------
Accordingly, the agency is amending the regulations in 21 CFR
558.55, 558.58, 558.95, 558.120, 558.265, 558.311, 558.355, 558.363,
558.366, 558.450, 558.550, and 558.680 to reflect the transfer of
ownership and a current format.
In addition, Huvepharma AD has not been previously listed in the
animal drug regulations as a sponsor of an approved application. At
this time, 21 CFR 510.600(c) is being amended to add entries for the
firm.
Also, FDA has found that the April 1, 2005, edition of Title 21,
parts 500 to 599 of the Code of Federal Regulations (CFR) does not
accurately reflect the use limitations for amprolium in single-
ingredient, medicated broiler chicken feeds. The existing entry
erroneously includes limitations normally associated with the use of
arsenicals in feed. At this time, the regulations are being amended in
Sec. 558.55 to correct this error. FDA is also taking this opportunity
to consolidate entries for similar combination medicated feeds in the
same section of part 558, and to eliminate duplicate entries. These
actions are being taken to improve the accuracy and readability 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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 510 and
558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
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.
0
2. In Sec. 510.600, in the table in paragraph (c)(1) alphabetically
add an entry for ``Huvepharma AD''; and in the table in paragraph
(c)(2) numerically add an entry for ``016592'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Huvepharma AD, 33 James Boucher Blvd., 016592
Sophia 1407, Bulgaria
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
016592 Huvepharma AD, 33 James Boucher Blvd.,
Sophia 1407, Bulgaria
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.55 [Amended]
0
4. Amend Sec. 558.55 as follows:
0
a. In the table in paragraph (d)(2)(ii), in the ``Limitations'' column
in the entry for ``Amprolium 72.6 to 113.5 grams per ton'', remove the
first sentence;
0
b. In the table in paragraph (d)(2)(iii), in the ``Limitations'' column
in the entry for ``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1
(0.0025% to 0.00375%)'', remove ``057926'' and add in its place
``016592''; and in the ``Sponsor'' column add ``016592'' and
0
c. In the table in paragraph (d)(2)(iii), in the ``Limitations'' column
and ``Sponsor'' column in the entry for
[[Page 27956]]
``Bambermycins 1 to 4'', remove ``057926'' and add in its place
``016592''.
0
5. Amend Sec. 558.58 as follows:
0
a. Revise paragraph (a);
0
b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and
(e);
0
c. Add new paragraph (b);
0
d. In the table in newly redesignated paragraph (e)(1)(i), add an entry
for ``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1'';
0
e. In the table in newly redesignated paragraph (e)(1)(ii), in the
``Limitations'' column in the entries for ``Bambermycins 2 to 3 plus
roxarsone 22.8 to 34.1'', remove ``057926'' and add in its place
``016592''; and in the ``Sponsor'' column add ``016592''; and
0
f. In the table in newly redesignated paragraph (e)(1)(iii), in the
``Limitations'' column in the entries for ``Bambermycins 1 to 3'' and
``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1'', remove ``057926''
and add in its place ``016592''; and in the ``Sponsor'' column add
``016592''.
The revisions and additions read as follows:
Sec. 558.58 Amprolium and ethopabate.
(a) Specifications. Type A medicated articles containing:
(1) 25 percent amprolium and 8 percent ethopabate or 5 percent
amprolium and 1.6 percent ethopabate;
(2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent
amprolium and 0.16 percent ethopabate.
(b) Approvals. See No. 050604 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Amprolium and
ethopabate in grams Combination in grams Indications for use Limitations Sponsor
per ton per ton
----------------------------------------------------------------------------------------------------------------
(i) Amprolium 113.5 * * * * * *
(0.0125%) and
ethopabate 3.6
(0.0004%).
----------------------------------------------------------------------------------------------------------------
Bambermycins, 1 to Broiler chickens: As an Feed continuously as the 016592
3; plus roxarsone, aid in the prevention sole ration; as sole
22.8 to 34.1 of coccidiosis; and for source of amprolium and
increased rate of organic arsenic; withdraw
weight gain, improved 5 d before slaughter;
feed efficiency, and roxarsone provided by No.
improved pigmentation. 046573, bambermycins by
No. 016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
6. Amend Sec. 558.95 as follows:
0
a. In paragraphs (a)(1), (a)(2), and (a)(5), remove ``057926'' and add
in its place ``016592'';
0
b. Remove and reserve paragraph (d)(1)(ii);
0
c. Remove paragraphs (d)(1)(iii) through (d)(1)(xiv) and paragraphs
(d)(3)(iii) and (d)(3)(iv); and
0
d. Revise paragraph (d)(5).
The revision reads as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(5) Bambermycins may also be used in combination with:
(i) Amprolium alone or with roxarsone as in Sec. 558.55.
(ii) Amprolium and ethopabate alone or with roxarsone as in Sec.
558.58.
(iii) Diclazuril as in Sec. 558.198.
(iv) Halofuginone as in Sec. 558.265.
(v) Lasalocid alone or with roxarsone as in Sec. 558.311.
(vi) Monensin alone or with roxarsone as in Sec. 558.355.
(vii) Narasin alone or with nicarbazin or roxarsone as in Sec.
558.363.
(viii) Nicarbazin as in Sec. 558.366.
(ix) Salinomycin alone or with roxarsone as in Sec. 558.550.
(x) Zoalene alone or with roxarsone as in Sec. 558.680.
0
7. In Sec. 558.120, add paragraph (d)(1)(iv) and remove paragraph
(d)(2)(iii) to read as follows:
Sec. 558.120 Carbarsone (not U.S.P.).
* * * * *
(d) * * *
(1) * * *
(iv) Grams per ton. 227 carbarsone, plus 1 or 4 grams per ton
bambermycins.
(a) Indications for use. As an aid in the prevention of blackhead;
and for increased rate of weight gain (4 grams per ton bambermycins) or
improved feed efficiency (1 gram per ton bambermycins).
(b) Limitations. Feed continuously 2 weeks before blackhead is
expected and continue as long as prevention is needed. Withdraw 5 days
before slaughter. As sole source of organic arsenic. Bambermycins
provided by No. 046573 in Sec. 510.600(c) of this chapter.
* * * * *
0
8. In Sec. 558.265, revise paragraph (a); redesignate paragraphs (b)
and (c) as paragraphs (c) and (d); and add new paragraph (b) to read as
follows:
Sec. 558.265 Halofuginone hydrobromide.
(a) Specifications. Type A medicated articles containing 6 grams of
halofuginone hydrobromide per kilogram.
(b) Approvals. See No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
0
9. Amend Sec. 558.311 as follows:
0
a. In the table in paragraph (e)(1)(ii) in the entry in the
``Combination in grams per ton'' column for ``Roxarsone 45.4 plus
bambermycins 1'', in the ``Limitations'' column remove ``012799'' and
add in its place ``016592'';
0
b. In the table in paragraph (e)(1)(ii) following the entry in the
``Combination in grams per ton'' column for ``Roxarsone 45.4 plus
bambermycins 1'', add an entry for ``Bambermycins 1 to 2''; and
0
c. Remove and reserve paragraph (e)(5)(ii).
The addition reads as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(1) * * *
[[Page 27957]]
----------------------------------------------------------------------------------------------------------------
Lasalocid in Combination in grams
grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(ii) 68 (0.0075 * * * * * ...........
pct) to 113
(0.0125 pct).
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Bambermycins 1 to 2 Broiler chickens: For prevention Feed continuously as 016592
of coccidiosis caused by sole ration.
Eimeria tenella, E. necatrix, Bambermycins provided
E. acervulina, E. brunetti, E. by No. 016592 in Sec.
mivati, and E. maxima; and for 510.600(c) of this
increased rate of weight gain chapter.
and improved feed efficiency.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
10. In Sec. 558.355, in paragraphs (b)(10), (f)(2)(v)(b), and
(f)(2)(vi)(b), remove ``057926'' and add in its place ``016592''; and
revise paragraphs (f)(1)(vi), (f)(1)(vii), and (f)(1)(xvii) to read as
follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(1) * * *
(vi) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins,
1 to 2 grams.
(a) Indications for use. For increased rate of weight gain and
improved feed efficiency; and as an aid in the prevention of
coccidiosis caused by E. necatrix, E. tenella,E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; do not feed to
laying chickens. Bambermycins provided by No. 016592 in Sec.
510.600(c) of this chapter.
(vii) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins,
1 gram; plus roxarsone, 22.7 to 45.4 grams
(a) Indications for use. For increased rate of weight gain and
improved feed efficiency; and as an aid in the prevention of
coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; use as sole
source of organic arsenic; withdraw 5 d before slaughter; do not feed
to laying chickens. Bambermycins provided by No. 016592 in Sec.
510.600(c) of this chapter; roxarsone provided by No. 046573.
* * * * *
(xvii) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90
to 110 grams plus roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. For increased rate of weight gain; and as
an aid in prevention of coccidiosis caused by E. necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Feed continuously as sole ration; use as sole
source of organic arsenic; withdraw 5 d before slaughter; do not feed
to laying chickens. Bambermycins provided by No. 016592 in Sec.
510.600(c) of this chapter; roxarsone provided by No. 046573.
* * * * *
0
11. Amend Sec. 558.363 as follows:
0
a. In paragraphs (a)(4), (a)(5), and (d)(1)(vii)(B), remove ``057926''
and add in its place ``016592'';
0
b. In paragraph (d)(1)(iv)(B) add a new sentence at the end of the
paragraph; and
0
c. Remove paragraph (d)(1)(xii).
The addition reads as follows:
Sec. 558.363 Narasin.
* * * * *
(d) * * *
(1) * * *
(iv) * * *
(B) * * * Narasin as provided by No. 000986; bambermycins by No.
016592 in Sec. 510.600(c) of this chapter.
* * * * *
0
12. In the table in paragraph (d) of Sec. 558.366, alphabetically add
new entries for ``Narasin 27 to 45, and bambermycins 1 to 2'' and
``Bambermycins 1 to 2'' to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(d) * * *
----------------------------------------------------------------------------------------------------------------
Nicarbazin in Combination in grams
grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Narasin 27 to 45, and * * * * *
bacitracin methylene
disalicylate 50, and
roxarsone 22.7 to
45.4
----------------------------------------------------------------------------------------------------------------
[[Page 27958]]
Narasin 27 to 45, and Broiler chickens: As an Feed continuously as sole 000986
bambermycins 1 to 2 aid in preventing ration from time chicks are
outbreaks of cecal placed on litter until past
(Eimeria tenella) and the time when coccidiosis is
intestinal (E. ordinarily a hazard; do not
acervulina, E. maxima, use as a treatment for
E. necatrix, and E. coccidiosis; do not use in
brunetti) coccidiosis; flushing mashes; do not feed
and for increased rate to laying hens; withdraw 4
of weight gain and days before slaughter.
improved feed Bambermycins provided by No.
efficiency. 016592; nicarbazin and narasin
by No. 066104 in Sec.
510.600(c) of this chapter..
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
113.5 (0.0125 * * * * * * *
pct)
----------------------------------------------------------------------------------------------------------------
Bacitracin zinc 4 to * * * * *
50
----------------------------------------------------------------------------------------------------------------
Bambermycins 1 to 2 Broiler chickens: For Feed continuously as sole 016592
prevention of ration. Bambermycins provided
coccidiosis caused by by No. 016592 in Sec.
Eimeria tenella, E. 510.600(c) of this chapter.
necatrix, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima; and for
increased rate of
weight gain and
improved feed
efficiency.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
13. In the table in paragraph (d)(1)(vii) of Sec. 558.450, remove the
entry for ``Salinomycin 40 to 60 g/ton''; and add paragraph (d)(3)(v)
to read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(d) * * *
(3) * * *
(v) Salinomycin as in Sec. 558.550.
0
14. In Sec. 558.550, in paragraphs (d)(1)(xv)(c) and (d)(1)(xvi)(c),
remove ``057926'' and add in its place ``016592''; add paragraphs
(d)(1)(xxiii) and (d)(1)(xxiv); and revise paragraphs (b)(2) and (d)(4)
to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(b) * * *
(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii)
through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i),
(d)(3)(i), and (d)(4) of this section.
* * * * *
(d) * * *
(1) * * *
(xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus
bambermycins, 1 to 3 grams.
(a) Indications for use. Broiler chickens: For prevention of
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati; and for improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Do not feed to
laying chickens; not approved for use with pellet binders; may be fatal
if accidentally fed to adult turkeys or horses. Salinomycin as provided
by Nos. 046573 and 016592; bambermycins by No. 016592 in Sec.
510.600(c) of this chapter.
(xxiv) Amount per ton. Salinomycin, 40 to 60 grams; plus
bambermycins, 1 to 2 grams; plus roxarsone, 45.4 grams.
(a) Indications for use. Broiler chickens: For prevention of
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati, including some field strains of E.
tenella that are more susceptible to roxarsone combined with
salinomycin than salinomycin alone; and for improved feed efficiency.
(b) Limitations. Feed continuously as sole ration. Do not feed to
laying chickens; as sole source or organic arsenic; withdraw 5 days
before slaughter; not approved for use with pellet binders; may be
fatal if accidentally fed to adult turkeys or horses; Salinomycin as
provided by Nos. 046573and 016592; bambermycins by No. 016592;
roxarsone by No. 046573 in Sec. 510.600(c) of this chapter.
* * * * *
(4) Chickens: It is used in chicken feed as follows:
(i) Amount per ton. Salinomycin, 40 to 60 grams; plus
oxytetracycline, 500 grams.
(a) Indications for use. For prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti,
and E. mivati; and for reduction of mortality due to air sacculitis
(air-sac-infection) caused by Escherichia coli susceptible to
oxytetracycline.
(b) Limitations. Feed continuously for 5 days; do not feed to
chickens producing eggs for human consumption; withdraw 24 hours before
slaughter; in low calcium feeds withdraw 3 d before slaughter.
Salinomycin as provided by Nos. 046573 and 016592; oxytetracycline as
provided by No. 066104 in Sec. 510.600(c) of this chapter.
(ii) [Reserved]
0
15. In Sec. 558.680, alphabetically add two entries to the table in
paragraph (d)(1)(ii); and revise paragraph (d)(2) to read as follows:
Sec. 558.680 Zoalene.
* * * * *
(d) * * *
(1) * * *
[[Page 27959]]
------------------------------------------------------------------------
Combination
Zoalene in grams in grams per Indications for Limitations
per ton ton use
------------------------------------------------------------------------
(ii) 113.5 * * * * * * *
(0.0125%).
------------------------------------------------------------------------
Bacitracin * * * * *
100 to 500
------------------------------------------------------------------------
Bambermycins Broiler chickens: Feed continuously
1 As an aid in the as sole ration.
prevention and Do not feed to
control of chickens over 14
coccidiosis; and weeks of age.
for increased Bambermycins as
rate of weight provided by No.
gain and improved 016592 in Sec.
feed efficiency. 510.600(c) of
this chapter.
------------------------------------------------------------------------
Bambermycins Broiler chickens: Feed continuously
1 plus As an aid in the as sole ration.
roxarsone prevention and Do not feed to
22.7 control of chickens over 14
coccidiosis; and weeks of age;
for increased feed as sole
rate of weight source of
gain and improved organic arsenic;
feed efficiency. withdraw 5 days
before
slaughter.
Bambermycins as
provided by No.
016592,
roxarsone by No.
046573 in Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(2) Zoalene may also be used in combination with roxarsone as in
Sec. 558.530.
Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-4505 Filed 5-12-06; 8:45 am]
BILLING CODE 4160-01-S
