New Animal Drugs for Use in Animal Feed; Ractopamine, 54019-54020 [2010-22071]
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54019
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 522.956, revise paragraph (d)(2)
to read as follows:
■
§ 522.956
Florfenicol and flunixin.
*
*
*
*
*
(d) * * *
(2) Indications for use. For treatment
of bovine respiratory disease (BRD)
associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis, and control of BRD-associated
pyrexia in beef and non-lactating dairy
cattle.
*
*
*
*
*
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–22039 Filed 9–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2010–N–0002]
New Animal Drugs for Use in Animal
Feed; Ractopamine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
animal drug regulations to reflect
approval of two supplemental new
animal drug applications (NADAs) filed
by Elanco Animal Health, A Division of
Eli Lilly & Co. The supplemental
NADAs provide for administering a
Type C medicated feed containing
ractopamine hydrochloride as a top
dress on Type C medicated feeds
containing monensin, USP, or
monensin, USP, and tylosin phosphate
to cattle fed in confinement for
slaughter.
This rule is effective September
3, 2010.
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–225 that
provides for use of OPTAFLEXX
(ractopamine hydrochloride) and
RUMENSIN (monensin, USP) Type A
medicated articles to formulate two-way
combination drug Type C medicated
feeds for cattle fed in confinement for
slaughter. Elanco Animal Health also
filed a supplement to NADA 141–224
that provides for use of OPTAFLEXX
(ractopamine hydrochloride),
RUMENSIN (monensin, USP), and
TYLAN (tylosin phosphate) Type A
medicated articles to formulate threeway combination drug Type C
medicated feeds for cattle fed in
confinement for slaughter.
The supplemental NADAs provide for
administering ractopamine
hydrochloride Type C medicated feeds
as a top dress on Type C medicated
feeds containing monensin, USP, or
monensin, USP, and tylosin phosphate
to cattle fed in confinement for
slaughter as the means by which the
two-way or three-way combinations will
be created. Supplemental NADA 141–
224 is approved as of June 7, 2010;
DATES:
erowe on DSK5CLS3C1PROD with RULES
Ractopamine in
grams/ton
Combination in
grams/ton
*
(xii) Not to exceed 800; to
provide 70 to 400 mg/
head/day.
*
*
Monensin 10 to 40 to
provide 0.14 to 0.42
mg monensin/lb of
body weight, depending on severity of
coccidiosis challenge,
up to 480 mg/head/
day.
VerDate Mar<15>2010
17:12 Sep 02, 2010
Jkt 220001
PO 00000
supplemental NADA 141–225 is
approved as of June 17, 2010; and the
regulations in 21 CFR 558.500 are
amended to reflect the approvals.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summaries of safety and effectiveness
data and information submitted to
support approval of these applications
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 that these actions are of a
type that do 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 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
2. In § 558.500, add paragraphs
(e)(2)(xii) and (e)(2)(xiii) to read as
follows:
■
§ 558.500
*
Ractopamine.
*
*
(e) * * *
(2) * * *
Indications for use
*
*
Limitations
*
*
*
Cattle fed in confinement for
Top dress ractopamine in a minslaughter: As in paragraph
imum of 1.0 lb of medicated feed
(e)(2)(i) of this section; for preduring the last 28 to 42 days on
vention and control of coccidiosis
feed. Not for animals intended for
due to Eimeria bovis and E.
breeding. See § 558.355(d).
zuernii.
Frm 00015
Fmt 4700
Sfmt 4700
E:\FR\FM\03SER1.SGM
03SER1
Sponsor
*
000986
54020
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations
Ractopamine in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(xiii) Not to exceed 800; to
provide 70 to 400 mg/
head/day.
Monensin 10 to 40 to
provide 0.14 to 0.42
mg monensin/lb of
body weight, depending on severity of
coccidiosis challenge,
up to 480 mg/head/
day, plus tylosin 8 to
10.
Cattle fed in confinement for
slaughter: As in paragraph
(e)(2)(i) of this section; for prevention and control of coccidiosis
due to Eimeria bovis and E.
zuernii; and for reduction of incidence of liver abscesses caused
by Fusobacterium necrophorum
and Arcanobacterium
(Actinomyces) pyogenes.
Top dress ractopamine in a minimum of 1.0 lb of medicated feed
during the last 28 to 42 days on
feed. Not for animals intended for
breeding. See §§ 558.355(d) and
558.625(c).
*
*
*
*
*
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–22071 Filed 9–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Ch. II
[Docket No. FR–5404–N–02]
Federal Housing Administration Risk
Management Initiatives: New Loan-toValue and Credit Score Requirements
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Final rule.
AGENCY:
On July 15, 2010, HUD issued
a notice seeking comment on three
initiatives that HUD proposed would
contribute to the restoration of the
Mutual Mortgage Insurance Fund
(MMIF) capital reserve account. This
document is limited to implementation
of HUD’s proposal to introduce a
minimum credit score threshold and
reduce the maximum LTV. At the end
of the public comment period on August
16, 2010, HUD received 902 comments.
The overwhelming majority of these
comments focused on HUD’s proposal
to cap seller concessions. HUD is
continuing to review and consider the
issues raised by commenters on capping
seller concessions as well as those
pertaining to HUD’s proposal to tighten
manual underwriting guidelines. HUD’s
final decision on these two proposals
will be addressed separately.
DATES: Effective Date: October 4, 2010.
FOR FURTHER INFORMATION CONTACT:
Karin Hill, Director, Office of Single
Family Program Development, Office of
Housing, Department of Housing and
Urban Development, 451 7th Street,
SW., Room 9278, Washington, DC
20410; telephone number 202–708–2121
erowe on DSK5CLS3C1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
19:43 Sep 02, 2010
Jkt 220001
(this is not a toll-free number). Persons
with hearing or speech impairments
may access this number through TTY by
calling the toll-free Federal Information
Relay Service at 800–877–8339.
SUPPLEMENTARY INFORMATION:
I. Background—HUD’s July 15, 2010
Notice
On July 15, 2010, at 75 FR 41217,
HUD issued a proposed rule seeking
comment on three initiatives that HUD
proposed would contribute to the
restoration of the Mutual Mortgage
Insurance Fund (MMIF) capital reserve
account. The proposed changes were
developed to preserve both the
historical role of the Federal Housing
Administration (FHA) in providing a
home financing vehicle during periods
of economic volatility and HUD’s social
mission of helping underserved
borrowers. In the July 15, 2010, notice,
HUD proposed the following: To reduce
the amount of closing costs a seller may
pay on behalf of a homebuyer
purchasing a home with FHA-insured
mortgage financing for the purposes of
calculating the maximum mortgage
amount; to introduce a credit score
threshold as well as reduce the
maximum loan-to-value (LTV) for
borrowers with lower credit scores who
represent a higher risk of default and
mortgage insurance claim; and to
tighten underwriting standards for
mortgage loan transactions that are
manually underwritten.
A recently issued independent
actuarial study shows that the MMIF
capital ratio has fallen below its
statutorily mandated threshold.1
1 On November 13, 2009, HUD released an
independent actuarial study that reported that FHA
will likely sustain significant losses from mortgage
loans made prior to 2009, due to the high
concentration of seller-financed downpayment
assistance mortgage loans and declining real estate
values nationwide, and that the MMIF capital
reserve relative to the amount of outstanding
insurance in force had fallen below the statutorily
mandated 2 percent ratio. The capital reserve
account serves as a back-up fund, where FHA holds
additional capital to cover unexpected losses. The
capital ratio generally reflects the reserves available
(net of expected claims and expenses), as a
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Fmt 4700
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000986
Consistent with HUD’s responsibility
under the National Housing Act to
ensure that the MMIF remains
financially sound, HUD published the
July 15, 2010 document and sought
public comment on the three proposals
described above designed to address
features of FHA mortgage insurance that
have resulted in high mortgage
insurance claim rates and present an
unacceptable risk of loss to FHA.
Over the past two years, the volume
of FHA insurance has increased rapidly
as private sources of mortgage finance
retreated from the market. FHA’s share
of the single-family mortgage market
today is approximately 30 percent—up
from 3 percent in 2007, and the dollar
volume of insurance written has jumped
from the $56 billion issued in that year
to more than $300 billion in 2009. The
growth in the MMIF portfolio over such
a short period of time coincided with
worsening economic conditions that
have seen high levels of defaults and
foreclosures, and consequently
unacceptable risks of loss to the MMIF.
Given these conditions and concerns,
FHA, in managing the MMIF, must be
especially vigilant in monitoring the
performance of the portfolio, enhancing
risk controls, and tightening standards
to address portions of the business that
expose homeowners to excessive
financial risks. FHA’s authorizing
statute, the National Housing Act (12
U.S.C. 1701 et seq.), envisions that FHA
will adjust program standards and
practices, as necessary, to operate the
MMIF, with reasonable expectations of
financial loss. Within the past year,
FHA has adjusted several program
standards and practices so that the
MMIF is preserved and FHA is
operating the MMIF with acceptable
risks of financial loss, not unacceptable
risks.2
percentage of the current portfolio, to address
unexpected losses. The report can be found at:
https://www.hud.gov/offices/hsg/
fhafy09annualmanagementreport.pdf.
2 While the Federal Credit Reform Act of 1990
requires that FHA (and all other government credit
agencies) estimate and budget for the anticipated
cost of mortgage loan guarantees, the National
E:\FR\FM\03SER1.SGM
03SER1
]]>Agencies
[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Rules and Regulations]
[Pages 54019-54020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22071]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2010-N-0002]
New Animal Drugs for Use in Animal Feed; Ractopamine
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 two supplemental new animal
drug applications (NADAs) filed by Elanco Animal Health, A Division of
Eli Lilly & Co. The supplemental NADAs provide for administering a Type
C medicated feed containing ractopamine hydrochloride as a top dress on
Type C medicated feeds containing monensin, USP, or monensin, USP, and
tylosin phosphate to cattle fed in confinement for slaughter.
DATES: This rule is effective September 3, 2010.
FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail:
suzanne.sechen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 141-225 that provides for use of OPTAFLEXX
(ractopamine hydrochloride) and RUMENSIN (monensin, USP) Type A
medicated articles to formulate two-way combination drug Type C
medicated feeds for cattle fed in confinement for slaughter. Elanco
Animal Health also filed a supplement to NADA 141-224 that provides for
use of OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin, USP),
and TYLAN (tylosin phosphate) Type A medicated articles to formulate
three-way combination drug Type C medicated feeds for cattle fed in
confinement for slaughter.
The supplemental NADAs provide for administering ractopamine
hydrochloride Type C medicated feeds as a top dress on Type C medicated
feeds containing monensin, USP, or monensin, USP, and tylosin phosphate
to cattle fed in confinement for slaughter as the means by which the
two-way or three-way combinations will be created. Supplemental NADA
141-224 is approved as of June 7, 2010; supplemental NADA 141-225 is
approved as of June 17, 2010; and the regulations in 21 CFR 558.500 are
amended to reflect the approvals.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summaries of safety and
effectiveness data and information submitted to support approval of
these applications 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 that these actions are
of a type that do 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 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In Sec. 558.500, add paragraphs (e)(2)(xii) and (e)(2)(xiii) to
read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Ractopamine in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(xii) Not to exceed 800; to Monensin 10 to Cattle fed in Top dress ractopamine 000986
provide 70 to 400 mg/head/day. 40 to provide confinement for in a minimum of 1.0 lb
0.14 to 0.42 mg slaughter: As in of medicated feed
monensin/lb of paragraph (e)(2)(i) of during the last 28 to
body weight, this section; for 42 days on feed. Not
depending on prevention and control for animals intended
severity of of coccidiosis due to for breeding. See Sec.
coccidiosis Eimeria bovis and E. 558.355(d).
challenge, up zuernii.
to 480 mg/head/
day.
----------------------------------------------------------------------------------------------------------------
[[Page 54020]]
(xiii) Not to exceed 800; to Monensin 10 to Cattle fed in Top dress ractopamine 000986
provide 70 to 400 mg/head/day. 40 to provide confinement for in a minimum of 1.0 lb
0.14 to 0.42 mg slaughter: As in of medicated feed
monensin/lb of paragraph (e)(2)(i) of during the last 28 to
body weight, this section; for 42 days on feed. Not
depending on prevention and control for animals intended
severity of of coccidiosis due to for breeding. See Sec.
coccidiosis Eimeria bovis and E. Sec. 558.355(d) and
challenge, up zuernii; and for 558.625(c).
to 480 mg/head/ reduction of incidence
day, plus of liver abscesses
tylosin 8 to caused by
10. Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces)
pyogenes.
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22071 Filed 9-2-10; 8:45 am]
BILLING CODE 4160-01-S
