New Animal Drugs for Use in Animal Feeds; Tiamulin, 24138-24139 [2012-9708]
Download as PDF
<![CDATA[
24138
Federal Register / Vol. 77, No. 78 / Monday, April 23, 2012 / Rules and Regulations
78020, December 19, 2008 (the current
regulation), must be sent to the Office of
Foreign Labor Certification’s (OFLC’s)
Chicago National Processing Center
(CNPC) and postmarked no later than
midnight April 22, 2012, the last day
before the effective date of the H–2B
Final Rule. The guidance also provides
that applications postmarked on or after
April 23, 2012 will be adjudicated in
accordance with the requirements
described in the Final Rule.
The Department is revising its
guidance to clarify that the Final Rule
will not be operative until April 27,
2012. In accordance with the
Congressional Review Act, (CRA), 5
U.S.C. 801, et seq., April 27, 2012 is 60
days after February 27, 2012, the date on
which the rule was reported to
Congress, and the earliest date on which
the rule can become operative under the
CRA. See 5 U.S.C. 801(a)(3). While
section 801(a)(3) does not alter the date
a rule goes into effect, it prevents an
agency from enforcing the rule for 60
days after the rule is reported to
Congress.
Accordingly, applications filed under
the current regulation must be sent to
the CNPC and postmarked no later than
midnight April 26, 2012, and
applications postmarked on or after
April 27, 2012 will be adjudicated in
accordance with the requirements
described in the Final Rule. Any
application filed under the current
regulation that is postmarked on or after
April 27, 2012 will be returned, and the
employer (and its agent or attorney)
informed of the need to file a new
application in accordance with the
provisions of the new H–2B Final Rule.
Please note that, as provided in the
March 20th guidance, employers who
file H–2B applications with a start date
of need before October 1, 2013 will not
be required to obtain the pre-approved
H–2B registration under 20 CFR 655.15,
and the Department will continue to
adjudicate temporary need during the
processing of applications by reviewing
the employer’s statement of temporary
need in Section B of the ETA Form
9142. Employers with H–2B
applications postmarked on or after
April 27, 2012 with a start date of need
on or after October 1, 2013, must
comply with all the requirements
contained in the registration process
unless the OFLC publishes additional
guidance in the Federal Register.
Employers with questions are
encouraged to submit their questions to
H-2B.Regulation@dol.gov. The
Department will provide responses in
the form of Frequently Asked Questions
(FAQs) on its Web site.
Pl., Rockville, MD 20855, 240–276–
8341, email:
cindy.burnsteel@fda.hhs.gov.
21 CFR Part 558
Novartis
Animal Health US, Inc. (Novartis), 3200
Northline Ave., Suite 300, Greensboro,
NC 27408, filed a supplement to NADA
139–472 for DENAGARD (tiamulin
hydrogen fumarate) Type A medicated
articles for use of a new product
formulation in medicated swine feed.
The supplemental NADA is approved as
of January 6, 2012, and the regulations
in 21 CFR 558.4 and 558.600 are
amended to reflect the approval.
The Agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
[Docket No. FDA–2012–N–0002]
List of Subjects in 21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Tiamulin
Animal drugs, Animal feeds.
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 558 is amended as follows:
Signed in Washington, this 17th day of
April 2012.
Jane Oates,
Assistant Secretary, Employment and
Training Administration.
[FR Doc. 2012–9612 Filed 4–20–12; 8:45 am]
BILLING CODE 4510–FP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Novartis Animal Health US, Inc. The
supplemental NADA provides for
approval of a new concentration of a
Type A medicated article.
DATES: This rule is effective April 23,
2012.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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 paragraph (d) of § 558.4, in the
‘‘Category II’’ table, revise the entries for
‘‘Tiamulin’’ to read as follows:
■
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
(d) * * *
*
*
CATEGORY II
WREIER-AVILES on DSK5TPTVN1PROD with RULES
Drug
Assay limits
percent 1
Type A
Type B
maximum
(100x)
Assay limits
percent 1
Type B/C 2
*
*
*
*
Tiamulin hydrogen fumarate ............................................................................................
*
90–115
*
10 g/lb
*
90–115/70–130
*
*
*
*
*
*
1 Percent
*
of labeled amount.
given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a
Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for
the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.
2 Values
VerDate Mar<15>2010
13:37 Apr 20, 2012
Jkt 226001
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
E:\FR\FM\23APR1.SGM
23APR1
24139
Federal Register / Vol. 77, No. 78 / Monday, April 23, 2012 / Rules and Regulations
*
§ 558.600
■
(a) Specifications. Type A article
containing 363.2 grams of tiamulin
hydrogen fumarate per pound.
*
*
*
*
*
*
*
*
*
3. In § 558.600, revise paragraph (a)
and the heading of the first column in
the table in paragraph (e)(1) to read as
follows:
Tiamulin hydrogen fumarate in grams per ton
*
*
*
* * *
*
*
*
*
[FR Doc. 2012–9708 Filed 4–20–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 570
[Docket No. FR–5181–F–02]
RIN 2506–AC22
State Community Development Block
Grant Program: Administrative Rule
Changes
Office of the Assistant
Secretary for Community Planning and
Development, HUD.
ACTION: Final rule.
AGENCY:
This final rule makes changes
to several sections of the regulations for
the Community Development Block
Grant (CDBG) program for states (State
CDBG program). This final rule
streamlines and updates the regulations
to reflect statutory changes, clarifies the
program income requirements, provides
other clarifications to the State CDBG
program regulations, and makes a
conforming change to the regulations
applicable to the CDBG Entitlement
program. This final rule also provides
additional flexibility to states in their
administration of the program. The final
rule follows publication of an October
17, 2008, proposed rule and takes into
consideration the public comments
received on the proposed rule.
DATES: Effective Date: May 23, 2012.
FOR FURTHER INFORMATION CONTACT: Eva
C. Fontheim, Community Planning and
Development Specialist, Office of
Community Planning and Development,
Department of Housing and Urban
Development, 451 Seventh Street SW.,
Room 7182, Washington, DC 20410;
telephone number 202–708–1322 (this
number is not toll-free). Individuals
WREIER-AVILES on DSK5TPTVN1PROD with RULES
SUMMARY:
13:37 Apr 20, 2012
Jkt 226001
(e) * * *
(1) * * *
* * *
*
Dated: April 17, 2012.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
VerDate Mar<15>2010
Tiamulin.
*
* * *
*
with speech or hearing impairments
may access this number through TTY by
calling the toll-free Federal Relay
Service at 800–877–8339.
SUPPLEMENTARY INFORMATION:
I. Background
On October 17, 2008, at 73 FR 61757,
HUD published for public comment a
proposed rule that would revise HUD’s
regulations for the State CDBG program
in 24 CFR part 570, subpart I, in order
to conform the regulations to current
statutory requirements concerning
program income, and to provide
additional flexibility to states in
implementing their programs. Title I of
the Housing and Community
Development Act of 1974 (42 U.S.C.
5301–5320) (HCDA) established the
statutory framework for the CDBG
program. The primary statutory
objective of the CDBG program is to
develop viable communities, by
providing decent housing and a suitable
living environment and by expanding
economic opportunities, principally for
persons of low- and moderate-income.
HUD’s regulations implementing the
CDBG program are located in 24 CFR
part 570 (entitled ‘‘Community
Development Block Grants’’).
Under the State CDBG program, states
have the opportunity to administer
CDBG funds for nonentitlement areas.
Nonentitlement areas include those
units of general local government that
do not receive CDBG funds directly.
States participating in the State CDBG
program award grants only to units of
general local government that carry out
development activities. Annually, each
state develops funding priorities and
criteria for selecting projects. HUD’s role
under the State CDBG program is to
ensure state compliance with federal
laws, regulations, and policies. The
regulations for the State CDBG program
are codified in subpart I of the part 570
regulations.
The proposed regulatory amendments
described in the October 17, 2008,
proposed rule were designed to clarify
how HUD will administer the State
CDBG program. HUD proposed to
streamline and update the regulations to
PO 00000
Frm 00003
Fmt 4700
* * *
Sfmt 4700
*
*
reflect statutory changes, clarify the
program income requirements, and
provide other clarifications to the State
CDBG regulations that will provide
states with additional flexibility in their
administration of the program.
Interested readers should refer to the
preamble to the October 17, 2008,
proposed rule for additional information
on the proposed regulatory changes to
the State CDBG program.
II. This Final Rule; Changes to the
October 17, 2008, Proposed Rule
This final rule follows publication of
the October 17, 2008, proposed rule and
takes into consideration the public
comments received on the proposed
rule. The public comment period on the
proposed rule closed on December 16,
2008. HUD received eight responses.
Commenters included one public
interest group and seven units of local
government. Most of the public
comments pertained to the provisions of
the proposed rule concerning program
income requirements.
After careful consideration of the
issues raised by the commenters, HUD
has decided to adopt an amended
version of the proposed rule.
Specifically, HUD has made the
following changes to the October 17,
2008, proposed rule:
1. Administrative Expense Cap Time
Period. The final rule clarifies, at
§ 570.489(a)(1), that the program income
included in the calculation determining
the amount of allowable administrative
and technical assistance per program
year is all of the program income
received in the program year, regardless
of the fiscal year in which the state grant
funds were appropriated that generated
the program income.
2. Identifies Parties in the Grant
Agreement for Calculating Program
Income. Section 570.489(e)(2)(v) of the
final rule specifies that the grant
agreement referred to in this section is
between the state and the unit of general
local government.
3. Entitlement Jurisdictions Receive
Only an Incidental Benefit From State
CDBG Program Expenditures. The final
rule, at § 570.486(c), no longer mandates
E:\FR\FM\23APR1.SGM
23APR1
]]>Agencies
[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Rules and Regulations]
[Pages 24138-24139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9708]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs for Use in Animal Feeds; Tiamulin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Novartis Animal Health US, Inc. The
supplemental NADA provides for approval of a new concentration of a
Type A medicated article.
DATES: This rule is effective April 23, 2012.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, email:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc. (Novartis),
3200 Northline Ave., Suite 300, Greensboro, NC 27408, filed a
supplement to NADA 139-472 for DENAGARD (tiamulin hydrogen fumarate)
Type A medicated articles for use of a new product formulation in
medicated swine feed. The supplemental NADA is approved as of January
6, 2012, and the regulations in 21 CFR 558.4 and 558.600 are amended to
reflect the approval.
The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In paragraph (d) of Sec. 558.4, in the ``Category II'' table,
revise the entries for ``Tiamulin'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type Type B maximum percent \1\ Type
A (100x) B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Tiamulin hydrogen fumarate............................. 90-115 10 g/lb 90-115/70-130
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
medicated feed with lower assay limits to make a Type C medicated feed.
[[Page 24139]]
* * * * *
0
3. In Sec. 558.600, revise paragraph (a) and the heading of the first
column in the table in paragraph (e)(1) to read as follows:
Sec. 558.600 Tiamulin.
(a) Specifications. Type A article containing 363.2 grams of
tiamulin hydrogen fumarate per pound.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Tiamulin hydrogen fumarate in
grams per ton * * * * * * * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: April 17, 2012.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2012-9708 Filed 4-20-12; 8:45 am]
BILLING CODE 4160-01-P
