New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone, 78970-78971 [2015-31828]
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Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Rules and Regulations
Title 15—Commerce and Foreign Trade
PART 902—NOAA INFORMATION
COLLECTION REQUIREMENT UNDER
THE PAPERWORK REDUCTION ACT:
OMB CONTROL NUMBERS
CFR part or section where
the information collection
requirement is located
*
*
*
635.4(e)(4) ............................
1. The authority citation for part 902
continues to read as follows:
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*
*
Current OMB
control No. (all
numbers begin
with 0648–)
*
¥0205
*
*
*
*
[FR Doc. 2015–31782 Filed 12–15–15; 11:15 am]
Authority: 44 U.S.C. 3501 et seq.
2. In § 902.1, in the table in paragraph
(b), under the entry ‘‘50 CFR’’, add an
entry in alphanumeric order for
‘‘635.4(e)(4)’’ to read as follows:
■
BILLING CODE 3510–22–P
Food and Drug Administration
*
21 CFR Parts 556 and 558
*
*
[Docket No. FDA–2015–N–0002]
CFR part or section where
the information collection
requirement is located
Current OMB
control No. (all
numbers begin
with 0648–)
New Animal Drugs for Use in Animal
Feed; Withdrawal of Approval of New
Animal Drug Applications; Nitarsone
AGENCY:
*
50 CFR
*
*
*
*
........................
This rule is effective December
31, 2015.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 902.1 OMB control numbers assigned
pursuant to the Paperwork Reduction Act.
*
*
(b) * * *
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of three new
animal drug applications (NADAs)
providing for the use of nitarsone in
medicated feed for chickens and
turkeys. This action is being taken at the
sponsor’s request because these
products are no longer manufactured or
marketed.
SUMMARY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of the following NADAs that
provide for the use of nitarsone in
medicated feed for chickens and turkeys
because the products are no longer
manufactured or marketed:
21 CFR
Section
File No.
Product name
007–616 ............
141–088 ............
141–132 ............
HISTOSTAT 50 (nitarsone) Type A Medicated Article ........................................................................................
HISTOSTAT 50 (nitarsone)/BMD (bacitracin methylene disalicylate) ..................................................................
HISTOSTAT 50/ALBAC (bacitracin zinc) .............................................................................................................
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADAs 007–616, 141–088, and 141–
132, and all supplements and
amendments thereto, is withdrawn,
effective December 31, 2015. As
provided in the regulatory text of this
document, the animal drug regulations
are amended to reflect these voluntary
withdrawals of approval.
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.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
1. The authority citation for 21 CFR
part 556 continues to read as follows:
■
558.369
558.369
558.369
Dated: December 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–31827 Filed 12–17–15; 8:45 am]
BILLING CODE 4164–01–P
Authority: 21 U.S.C. 342, 360b, 371.
§ 556.60
■
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Removed]
2. Remove § 556.60.
Food and Drug Administration
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
21 CFR Part 558
■
[Docket No. FDA–2015–N–0002]
List of Subjects
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
New Animal Drugs for Use in Animal
Feed; Withdrawal of Approval of New
Animal Drug Applications; Nitarsone
21 CFR Parts 556
§ 558.4
AGENCY:
asabaliauskas on DSK5VPTVN1PROD with RULES
21 CFR Parts 558
§ 558.76
Animal drugs, Animal feeds.
Jkt 238001
[Amended]
5. In § 558.76, remove and reserve
paragraph (d)(3)(xiii).
■
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 556 and 558 are amended as
follows:
17:22 Dec 17, 2015
[Amended]
4. In § 558.4(d), in the ‘‘Category II’’
table, remove the entry for ‘‘Nitarsone’’.
■
Animal drugs, Food.
VerDate Sep<11>2014
3. The authority citation for 21 CFR
part 558 continues to read as follows:
§ 558.78
[Amended]
6. In § 558.78, remove and reserve
paragraph (d)(3)(vii).
■
§ 558.369
■
[Removed]
7. Remove § 558.369.
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Fmt 4700
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Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of three new animal drug
applications (NADAs) providing for the
use of nitarsone in medicated feed for
chickens and turkeys. This action is
being taken at the sponsor’s request
because these products are no longer
manufactured or marketed.
SUMMARY:
E:\FR\FM\18DER1.SGM
18DER1
Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Rules and Regulations
Withdrawal of approval is
effective December 31, 2015.
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
DATES:
FOR FURTHER INFORMATION CONTACT:
Zoetis
Inc., 333 Portage St., Kalamazoo, MI
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
SUPPLEMENTARY INFORMATION:
49007 has requested that FDA withdraw
approval of the following NADAs that
provide for the use of nitarsone in
medicated feed for chickens and turkeys
because the products are no longer
manufactured or marketed:
21 CFR
Section
File No.
Product name
007–616 ............
141–088 ............
141–132 ............
HISTOSTAT 50 (nitarsone) Type A Medicated Article ........................................................................................
HISTOSTAT 50 (nitarsone)/BMD (bacitracin methylene disalicylate) ..................................................................
HISTOSTAT 50/ALBAC (bacitracin zinc) .............................................................................................................
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with 21 CFR 514.116 Notice of
withdrawal of approval of application,
notice is given that approval of NADAs
007–616, 141–088, and 141–132, and all
supplements and amendments thereto,
is hereby withdrawn, effective
December 31, 2015.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: December 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–31828 Filed 12–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9745]
RIN 1545–BL43
Minimum Value of Eligible EmployerSponsored Plans and Other Rules
Regarding the Health Insurance
Premium Tax Credit
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
This document contains final
regulations on the health insurance
premium tax credit enacted by the
Patient Protection and Affordable Care
Act and the Health Care and Education
Reconciliation Act of 2010, as amended
by the Medicare and Medicaid
Extenders Act of 2010, the
Comprehensive 1099 Taxpayer
Protection and Repayment of Exchange
Subsidy Overpayments Act of 2011, and
the Department of Defense and FullYear Continuing Appropriations Act,
asabaliauskas on DSK5VPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
17:22 Dec 17, 2015
Jkt 238001
2011. These final regulations affect
individuals who enroll in qualified
health plans through Affordable
Insurance Exchanges (Exchanges,
sometimes called Marketplaces) and
claim the health insurance premium tax
credit, and Exchanges that make
qualified health plans available to
individuals and employers.
DATES: Effective Date: These regulations
are effective on December 18, 2015.
Applicability Dates: For dates of
applicability, see §§ 1.36B–1(o) and
1.36B–6(g).
FOR FURTHER INFORMATION CONTACT: For
general questions on the premium tax
credit, Shareen Pflanz, (202) 317–4718;
for minimum value, Andrew Braden,
(202) 317–7006 (not toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
This document contains final
regulations amending the Income Tax
Regulations (26 CFR part 1) under
section 36B of the Internal Revenue
Code (Code) relating to the health
insurance premium tax credit. Section
36B was enacted by the Patient
Protection and Affordable Care Act,
Public Law 111–148 (124 Stat. 119
(2010)), and the Health Care and
Education Reconciliation Act of 2010,
Public Law 111–152 (124 Stat. 1029
(2010)) (collectively, the Affordable Care
Act). Final regulations under section
36B (TD 9590) were published on May
23, 2012 (77 FR 30377) (2012 section
36B final regulations). On May 3, 2013,
a notice of proposed rulemaking (REG–
125398–12) was published in the
Federal Register (78 FR 25909). Written
comments responding to the proposed
regulations were received. The
comments have been considered in
connection with these final regulations
and are available for public inspection
at www.regulations.gov or on request.
No public hearing was requested or
held. After consideration of all the
comments, the proposed regulations are
adopted, in part, as amended by this
Treasury decision. Some rules proposed
under REG–125398–12 on the minimum
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558.369
558.369
558.369
value of eligible employer-sponsored
plans have been reserved and will be
finalized separately under REG–
119850–15. Two paragraphs on
minimum value have been re-proposed,
see REG–143800–14 (80 FR 52678)
(2015 proposed minimum value
regulations), are finalized in part, and
will be finalized in part under REG–
143800–14.
Explanation of Revisions and Summary
of Comments
1. Definition of Modified Adjusted Gross
Income
Section 36B(d)(2) provides that a
taxpayer’s household income includes
the modified adjusted gross income of
the taxpayer and the members of the
taxpayer’s tax family who are required
to file an income tax return. The 2012
section 36B final regulations provide
that, in computing household income,
whether a family member must file a tax
return is determined without regard to
section 1(g)(7). Under section 1(g)(7), a
parent may elect to include a child’s
gross income in the parent’s gross
income if certain requirements are met.
The proposed regulations removed
‘‘without regard to section 1(g)(7)’’ from
the 2012 section 36B final regulations
because that language implied that the
child’s gross income is included in both
the parent’s adjusted gross income and
the child’s adjusted gross income in
determining household income. Thus,
the proposed regulations clarified that
when a parent makes an election under
section 1(g)(7), household income
includes the child’s gross income
included on the parent’s return only.
These final regulations adopt that rule
without change and clarify that the
modified adjusted gross income of a
parent who makes the section 1(g)(7)
election includes the child’s modified
adjusted gross income. Thus, the
parent’s modified adjusted gross income
includes not only the child’s gross
income but also the child’s tax-exempt
interest and nontaxable Social Security
income, which are excluded from gross
E:\FR\FM\18DER1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Rules and Regulations]
[Pages 78970-78971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31828]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2015-N-0002]
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval
of New Animal Drug Applications; Nitarsone
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three new animal drug applications (NADAs) providing for the use of
nitarsone in medicated feed for chickens and turkeys. This action is
being taken at the sponsor's request because these products are no
longer manufactured or marketed.
[[Page 78971]]
DATES: Withdrawal of approval is effective December 31, 2015.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw approval of the following NADAs
that provide for the use of nitarsone in medicated feed for chickens
and turkeys because the products are no longer manufactured or
marketed:
------------------------------------------------------------------------
21 CFR
File No. Product name Section
------------------------------------------------------------------------
007-616.................... HISTOSTAT 50 (nitarsone) 558.369
Type A Medicated Article.
141-088.................... HISTOSTAT 50 (nitarsone)/ 558.369
BMD (bacitracin methylene
disalicylate).
141-132.................... HISTOSTAT 50/ALBAC 558.369
(bacitracin zinc).
------------------------------------------------------------------------
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with 21 CFR 514.116 Notice of withdrawal of approval of
application, notice is given that approval of NADAs 007-616, 141-088,
and 141-132, and all supplements and amendments thereto, is hereby
withdrawn, effective December 31, 2015.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: December 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31828 Filed 12-17-15; 8:45 am]
BILLING CODE 4164-01-P
