New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin, 25182-25184 [2013-10152]
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25182
Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Rules and Regulations
with a comment period of February 8,
2013 through March 11, 2013 (78 FR
9330). No comments on the proposed
regulatory amendments were received
by AMS. The proposed rule may be
viewed at www.regulations.gov.
List of Subjects in 7 CFR Part 27
Commodity futures, Cotton.
For the reasons set forth in the
preamble, 7 CFR part 27 is amended as
follows:
PART 27—[Amended]
1. The authority citation for 7 CFR
part 27 continues to read as follows:
■
§ 27.94 Spot Markets for Contract
Settlement Purposes.
*
*
*
*
*
(a) For cotton delivered in settlement
of any No. 2 contract on the
Intercontinental Exchange (ICE);
Southeastern, North and South Delta,
Eastern Texas and Oklahoma, West
Texas, and Desert Southwest.
*
*
*
*
*
Dated: April 25, 2013.
David R. Shipman,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2013–10114 Filed 4–29–13; 8:45 am]
BILLING CODE 3410–02–P
Authority: 7 U.S.C. 15b, 7 U.S.C. 473b, 7
U.S.C. 1622(g).
2. In § 27.93, definitions of the
Southeastern market and the East Texas
and Oklahoma market are revised to
read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 27.93
21 CFR Parts 522 and 558
■
*
*
Bona fide Spot Markets.
*
*
*
Food and Drug Administration
[Docket No. FDA–2013–N–0002]
Southeastern
All counties in the states of Alabama,
Florida, Georgia, North Carolina, South
Carolina, and Virginia and all counties
in the state of Tennessee east of and
including Stewart, Houston,
Humphreys, Perry, Wayne and Hardin
counties.
*
*
*
*
*
East Texas and Oklahoma
All counties in the states of Kansas
and Oklahoma and the Texas counties
east of and including Montague, Wise,
Parker, Erath, Comanche, Mills, San
Saba, Mason, Sutton, Edwards, Kinney,
Maverick, Webb, Zapata, Star and
Hidalgo counties.
*
*
*
*
*
■ 3. In § 27.94, paragraph (a) is revised
to read as follows:
New Animal Drugs; Dexmedetomidine;
Lasalocid; Melengestrol; Monensin;
and Tylosin
AGENCY:
Food and Drug Administration,
HHS.
Final rule, Technical
Amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications and abbreviated new
animal drug applications during March
2013. FDA is also informing the public
of the availability of summaries the
basis of approval and of environmental
review documents, where applicable.
DATES: This rule is effective April 30,
2013.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for new animal
drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) during March
2013, as listed in table 1. In addition,
FDA is informing the public of the
availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents 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. Persons with access to the
Internet may obtain these documents at
the CVM FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm.
In addition, the animal drug
regulations are being amended at 21
CFR 522.558 to add a new strength of
dexmedetomidine hydrochloride
injectable solution for use in dogs and
cats. This change is being made to
improve the accuracy 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.
SUPPLEMENTARY INFORMATION:
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH 2013
Sponsor
New animal drug product name
Action
200–532
Huvepharma AD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sophia,
Bulgaria.
TYLOVET 100 (tylosin phosphate)
and MGA (melegestrone acetate)
Type A medicated articles.
200–533
pmangrum on DSK3VPTVN1PROD with RULES
NADA/
ANADA
Huvepharma AD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sophia,
Bulgaria.
TYLOVET 100 (tylosin phosphate)
and RUMENSIN (monensin) and
DECCOX (decoquinate) Type A
medicated articles.
Original approval
as a generic
copy of NADA
139–192.
Original approval
as a generic
copy of NADA
141–149.
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21 CFR
section
30APR1
FOIA
summary
NEPA
review
558.342
yes ......
CE 1
558.195
yes ......
CE 1
25183
Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH 2013—Continued
NADA/
ANADA
Sponsor
New animal drug product name
Action
200–535
Huvepharma AD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sophia,
Bulgaria.
TYLOVET 100 (tylosin phosphate)
and BOVATEC (lasalocid) and
MGA
(melegestrone
acetate)
Type A medicated articles.
Original approval
as a generic
copy of NADA
138–992.
FOIA
summary
21 CFR
section
558.342
NEPA
review
yes ......
CE 1
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
List of Subjects
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
21 CFR Part 522
3. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Animal drugs.
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
21 CFR Part 558
Animal drugs, Animal feed.
Authority: 21 U.S.C. 360b, 371.
Authority: 21 U.S.C. 360b.
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 522 and 558 are amended as
follows:
§ 522.558
4. In § 558.195, in the table, in
paragraph (e)(2)(v), revise the last
sentence in the ‘‘Limitations’’ column
and revise the ‘‘Sponsor’’ column to
read as follows:
■
2. In § 522.558, revise paragraph (a) to
read as follows:
■
Dexmedetomidine.
(a) Specifications. Each milliliter of
solution contains 0.5 or 1.0 milligrams
dexmedetomidine hydrochloride.
*
*
*
*
*
§ 558.195
*
Decoquinate.
*
*
(e) * * *
(2) * * *
*
Decoquinate in grams per ton
Combination
in grams per
ton
Indications
for use
Limitations
*
*
(v) * * * ...................................
......................
*
......................
*
*
*
*
* * * Monensin as provided by No. 000986, and
tylosin as provided by Nos. 000986 and 016592
in § 510.600(c) of this chapter.
*
*
*
*
*
‘‘Limitations’’ column and revise the
‘‘Sponsor’’ column to read as follows:
*
*
*
*
*
5. In § 558.342, in the table, in
paragraphs (e)(1)(iv) and (e)(1)(ix),
revise the last sentence in the
■
Sponsor
*
016592, 046573
*
§ 558.342
*
*
Melengestrol.
*
*
(e) * * *
(1) * * *
*
*
Combination
in mg/head/
day
Indications
for use
Limitations
Sponsor
*
(iv) * * * ...........
*
......................
......................
*
*
*
*
* * * Lasalocid provided by No. 046573, and tylosin provided by
Nos. 000986 and 016592 in § 510.600(c) of this chapter.
*
000009, 000986, 016592
*
(ix) * * * ...........
pmangrum on DSK3VPTVN1PROD with RULES
Melengestrol acetate in mg/
head/day
*
......................
......................
*
*
*
*
Tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of
this chapter.
*
000009, 000986, 016592
*
*
*
*
Dated: April 25, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
*
[FR Doc. 2013–10152 Filed 4–29–13; 8:45 am]
BILLING CODE 4160–01–P
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25184
Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Rules and Regulations
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Parts 5, 200, 207, and 232
[Docket No. FR–5465–F–03]
RIN–2502–AJ05
Federal Housing Administration (FHA):
Section 232 Healthcare Facility
Insurance Program—Strengthening
Accountability and Regulatory
Revisions Update Final Rule
Amendment—Revision of Date of
Applicability
Federal Housing
Commissioner, Office of the Assistant
Secretary for Housing, HUD.
ACTION: Final rule amendment.
AGENCY:
On September 7, 2012, HUD
published a final rule that revised the
regulations governing the insurance of
healthcare facilities under section 232 of
the National Housing Act (Section 232).
HUD’s Section 232 program insures
mortgage loans to facilitate the
construction, substantial rehabilitation,
purchase, and refinancing of nursing
homes, intermediate care facilities,
board and care homes, and assistedliving facilities. The amendments made
by the September 7, 2012, final rule
updated the Section 232 regulations to
reflect current policy and practices,
improve accountability and strengthen
risk management in the program. The
final rule provided an applicability date
of April 9, 2013, for certain of the
updated requirements. This final rule
amendment changes the applicability
date to July 12, 2013, for the purpose of
allowing more time to transition to the
new requirements.
DATES: Effective date: May 30, 2013.
FOR FURTHER INFORMATION CONTACT:
Kelly Haines, Director, Office of
Residential Care Facilities, Office of
Healthcare Programs, Office of Housing,
Department of Housing and Urban
Development, 451 7th Street SW., Room
6264, Washington, DC 20410–8000;
telephone number 202–708–0599 (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 Relay
Service at 1–800–877–8339.
SUPPLEMENTARY INFORMATION:
pmangrum on DSK3VPTVN1PROD with RULES
SUMMARY:
I. Background
On September 7, 2012, at 77 FR
55120, HUD published in the Federal
Register a final rule that revised its
Section 232 program regulations to
bring the regulations up-to-date to
VerDate Mar<15>2010
17:32 Apr 29, 2013
Jkt 229001
reflect current policy and practices in
healthcare facility transactions and to
strengthen risk management and
improve accountability in the program.
The September 7, 2012, final rule
followed a proposed rule published in
the Federal Register on May 3, 2012, at
77 FR 26218, in which HUD submitted
its proposed revisions for public
comment. The final rule took effect on
October 9, 2012. However, to allow time
to transition to the updated
requirements, the final rule established
an applicability date of April 9, 2013 for
certain of the requirements.
On May 3, 2012, at 77 FR 26304, HUD
also published a notice that proposed
revisions to documents used in the
insurance of healthcare facilities, and
solicited public comment for a period of
60 days. This notice was issued in
accordance with the Paperwork
Reduction Act of 1995, and was
followed by a second notice, published
on November 21, 2012, at 77 FR 69870,
that solicited public comment for a
period of 30 days. The Office of
Management and Budget approved the
Section 232 documents under the
Paperwork Reduction Act in March
2013, and the approval was announced
by notice published in the Federal
Register on March 14, 2013, at 78 FR
16279.
Following issuance of the March 14,
2013, notice, lenders and other parties
that would be involved in upcoming
Section 232 program transactions stated
that the delayed approval presented
barriers to full compliance with some of
the requirements in the revised Section
232 regulations that would become
applicable on April 9, 2013. The
affected parties involved in upcoming
financing or refinancing of a loan to be
insured under Section 232 advised that
they have already expended substantial
time and expense in preparing the
transaction based on reasonable reliance
on the previously applicable Section
232 documents.
II. This Final Rule
Given that the delayed approval of the
Section 232 documents has caused
difficulties for parties involved in
upcoming Section 232 healthcare
facility transactions to comply with the
updated requirements in the Section
232 regulations because of the April 9,
2013, applicability date, this final rule
changes the applicability date to July 12,
2013. An additional delayed
applicability date of over 90 days
following publication of this final rule
should allow parties involved in Section
232 healthcare facility transactions to
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
prepare for such transactions based on
the new Section 232 regulations and
related Section 232 documents.
III. Justification for Final Rulemaking
In general, HUD publishes a rule for
public comment before issuing a rule for
effect, in accordance with HUD’s
regulations on rulemaking at 24 CFR
part 10. Part 10, however, provides in
§ 10.1 for exceptions from that general
rule where HUD finds good cause to
omit advance notice and public
participation. The good cause
requirement is satisfied when the prior
public procedure is ‘‘impracticable,
unnecessary or contrary to the public
interest.’’
HUD finds that good cause exists to
publish this rule for effect without first
soliciting public comment because prior
public comment would be contrary to
the public interest. HUD’s Section 232
program plays an important role in
today’s economy as the need for
residential care facilities has increased
and requests to FHA to provide
mortgage insurance for such facilities
also increased. By reducing the cost of
capital needed by residential care
facilities to finance the construction,
renovation, acquisition, or refinancing
of facilities, the Section 232 program
helps to improve access to quality
healthcare and decrease overall
healthcare costs.
Affected parties involved in
upcoming Section 232 transactions have
advised that efforts to comply with the
April 9, 2013, applicability date would
result in a delay in completion of a
Section 232 transaction and
considerable increased expense due to
delay. Given the need for quality and
affordable care in many communities
across the country, HUD recognizes that
a delay in completion of a Section 232
transaction whether for acquisition or
refinancing for a healthcare facility not
only affects the parties involved in the
transaction but the community in which
the healthcare facility would be
purchased, constructed, or refinanced.
For this reason, HUD extends the
applicability date in the September 7,
2012, final rule from April 9, 2013, to
July 12, 2013.
IV. Findings and Certifications
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) generally requires
an agency to conduct a regulatory
E:\FR\FM\30APR1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Rules and Regulations]
[Pages 25182-25184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10152]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol;
Monensin; and Tylosin
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 approval actions for new animal drug
applications and abbreviated new animal drug applications during March
2013. FDA is also informing the public of the availability of summaries
the basis of approval and of environmental review documents, where
applicable.
DATES: This rule is effective April 30, 2013.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for new animal drug applications (NADAs)
and abbreviated new animal drug applications (ANADAs) during March
2013, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents 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. Persons with access to the Internet may
obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
In addition, the animal drug regulations are being amended at 21
CFR 522.558 to add a new strength of dexmedetomidine hydrochloride
injectable solution for use in dogs and cats. This change is being made
to improve the accuracy 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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2013
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug product 21 CFR
NADA/ANADA Sponsor name Action section FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-532.......................... Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.342 yes........... CE \1\
Floor, 3A Nikolay phosphate) and MGA as a generic copy
Haytov Str., 1113 (melegestrone acetate) of NADA 139-192.
Sophia, Bulgaria. Type A medicated
articles.
200-533.......................... Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.195 yes........... CE \1\
Floor, 3A Nikolay phosphate) and RUMENSIN as a generic copy
Haytov Str., 1113 (monensin) and DECCOX of NADA 141-149.
Sophia, Bulgaria. (decoquinate) Type A
medicated articles.
[[Page 25183]]
200-535.......................... Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.342 yes........... CE \1\
Floor, 3A Nikolay phosphate) and BOVATEC as a generic copy
Haytov Str., 1113 (lasalocid) and MGA of NADA 138-992.
Sophia, Bulgaria. (melegestrone acetate)
Type A medicated
articles.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
assessment (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant
effect on the human environment.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feed.
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 522 and
558 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.558, revise paragraph (a) to read as follows:
Sec. 522.558 Dexmedetomidine.
(a) Specifications. Each milliliter of solution contains 0.5 or 1.0
milligrams dexmedetomidine hydrochloride.
* * * * *
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.
0
4. In Sec. 558.195, in the table, in paragraph (e)(2)(v), revise the
last sentence in the ``Limitations'' column and revise the ``Sponsor''
column to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Decoquinate in grams per ton grams per ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) * * *................... ................ ................ * * * Monensin as 016592, 046573
provided by No.
000986, and tylosin
as provided by Nos.
000986 and 016592
in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
5. In Sec. 558.342, in the table, in paragraphs (e)(1)(iv) and
(e)(1)(ix), revise the last sentence in the ``Limitations'' column and
revise the ``Sponsor'' column to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Melengestrol acetate Combination in mg/ Indications for
in mg/head/day head/day use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) * * *............ .................. .................. * * * Lasalocid 000009, 000986, 016592
provided by No.
046573, and tylosin
provided by Nos.
000986 and 016592 in
Sec. 510.600(c) of
this chapter.
* * * * * * *
(ix) * * *............ .................. .................. Tylosin provided by 000009, 000986, 016592
Nos. 000986 and
016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: April 25, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-10152 Filed 4-29-13; 8:45 am]
BILLING CODE 4160-01-P
