80 FR 78970 - New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 243 (December 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 243 (December 18, 2015)
| Page Range | 78970-78971 | |
| FR Document | 2015-31828 |
[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)] [Rules and Regulations] [Pages 78970-78971] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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
![78970 Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Rules and Regulations
Title 15—Commerce and Foreign Trade Current OMB SUMMARY: The Food and Drug
CFR part or section where
the information collection control No. (all Administration (FDA) is amending the
PART 902—NOAA INFORMATION requirement is located numbers begin animal drug regulations to reflect the
COLLECTION REQUIREMENT UNDER with 0648–)
withdrawal of approval of three new
THE PAPERWORK REDUCTION ACT: animal drug applications (NADAs)
* * * * *
OMB CONTROL NUMBERS 635.4(e)(4) ............................ ¥0205 providing for the use of nitarsone in
medicated feed for chickens and
■ 1. The authority citation for part 902 * * * * * turkeys. This action is being taken at the
continues to read as follows: sponsor’s request because these
Authority: 44 U.S.C. 3501 et seq. [FR Doc. 2015–31782 Filed 12–15–15; 11:15 am] products are no longer manufactured or
BILLING CODE 3510–22–P marketed.
■ 2. In § 902.1, in the table in paragraph
(b), under the entry ‘‘50 CFR’’, add an DATES: This rule is effective December
entry in alphanumeric order for 31, 2015.
DEPARTMENT OF HEALTH AND
‘‘635.4(e)(4)’’ to read as follows: HUMAN SERVICES FOR FURTHER INFORMATION CONTACT:
§ 902.1 OMB control numbers assigned Sujaya Dessai, Center for Veterinary
pursuant to the Paperwork Reduction Act. Food and Drug Administration Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
* * * * * 21 CFR Parts 556 and 558 Rockville, MD 20855, 240–402–5761,
(b) * * * sujaya.dessai@fda.hhs.gov.
[Docket No. FDA–2015–N–0002]
Current OMB SUPPLEMENTARY INFORMATION: Zoetis
CFR part or section where New Animal Drugs for Use in Animal
the information collection control No. (all Inc., 333 Portage St., Kalamazoo, MI
numbers begin Feed; Withdrawal of Approval of New 49007 has requested that FDA withdraw
requirement is located with 0648–) Animal Drug Applications; Nitarsone approval of the following NADAs that
AGENCY: Food and Drug Administration, provide for the use of nitarsone in
* * * * * HHS. medicated feed for chickens and turkeys
50 CFR ........................ because the products are no longer
ACTION: Final rule.
manufactured or marketed:
21 CFR
File No. Product name Section
007–616 ............ HISTOSTAT 50 (nitarsone) Type A Medicated Article ........................................................................................ 558.369
141–088 ............ HISTOSTAT 50 (nitarsone)/BMD (bacitracin methylene disalicylate) .................................................................. 558.369
141–132 ............ HISTOSTAT 50/ALBAC (bacitracin zinc) ............................................................................................................. 558.369
Elsewhere in this issue of the Federal PART 556—TOLERANCES FOR Dated: December 11, 2015.
Register, FDA gave notice that approval RESIDUES OF NEW ANIMAL DRUGS Bernadette Dunham,
of NADAs 007–616, 141–088, and 141– IN FOOD Director, Center for Veterinary Medicine.
132, and all supplements and [FR Doc. 2015–31827 Filed 12–17–15; 8:45 am]
amendments thereto, is withdrawn, ■ 1. The authority citation for 21 CFR
BILLING CODE 4164–01–P
effective December 31, 2015. As part 556 continues to read as follows:
provided in the regulatory text of this Authority: 21 U.S.C. 342, 360b, 371.
document, the animal drug regulations DEPARTMENT OF HEALTH AND
are amended to reflect these voluntary § 556.60 [Removed]
HUMAN SERVICES
withdrawals of approval. ■ 2. Remove § 556.60.
This rule does not meet the definition Food and Drug Administration
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because PART 558—NEW ANIMAL DRUGS FOR
it is a rule of ‘‘particular applicability.’’ USE IN ANIMAL FEEDS 21 CFR Part 558
Therefore, it is not subject to the ■ 3. The authority citation for 21 CFR [Docket No. FDA–2015–N–0002]
congressional review requirements in 5 part 558 continues to read as follows:
U.S.C. 801–808. New Animal Drugs for Use in Animal
Authority: 21 U.S.C. 354, 360b, 360ccc, Feed; Withdrawal of Approval of New
List of Subjects 360ccc–1, 371.
Animal Drug Applications; Nitarsone
21 CFR Parts 556 § 558.4 [Amended] AGENCY: Food and Drug Administration,
■ 4. In § 558.4(d), in the ‘‘Category II’’ HHS.
Animal drugs, Food.
table, remove the entry for ‘‘Nitarsone’’.
ACTION: Notification of withdrawal.
21 CFR Parts 558
§ 558.76 [Amended]
SUMMARY: The Food and Drug
Animal drugs, Animal feeds. 5. In § 558.76, remove and reserve
asabaliauskas on DSK5VPTVN1PROD with RULES
■
Administration (FDA) is withdrawing
Therefore, under the Federal Food, paragraph (d)(3)(xiii). approval of three new animal drug
Drug, and Cosmetic Act and under § 558.78 [Amended] applications (NADAs) providing for the
authority delegated to the Commissioner ■ 6. In § 558.78, remove and reserve use of nitarsone in medicated feed for
of Food and Drugs and redelegated to paragraph (d)(3)(vii). chickens and turkeys. This action is
the Center for Veterinary Medicine, 21 being taken at the sponsor’s request
CFR parts 556 and 558 are amended as § 558.369 [Removed] because these products are no longer
follows: ■ 7. Remove § 558.369. manufactured or marketed.
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![Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Rules and Regulations 78971
DATES: Withdrawal of approval is Administration, 7519 Standish Pl., 49007 has requested that FDA withdraw
effective December 31, 2015. Rockville, MD 20855, 240–402–5761, approval of the following NADAs that
sujaya.dessai@fda.hhs.gov. provide for the use of nitarsone in
FOR FURTHER INFORMATION CONTACT:
medicated feed for chickens and turkeys
Sujaya Dessai, Center for Veterinary SUPPLEMENTARY INFORMATION: Zoetis because the products are no longer
Medicine (HFV–212), Food and Drug Inc., 333 Portage St., Kalamazoo, MI manufactured or marketed:
21 CFR
File No. Product name Section
007–616 ............ HISTOSTAT 50 (nitarsone) Type A Medicated Article ........................................................................................ 558.369
141–088 ............ HISTOSTAT 50 (nitarsone)/BMD (bacitracin methylene disalicylate) .................................................................. 558.369
141–132 ............ HISTOSTAT 50/ALBAC (bacitracin zinc) ............................................................................................................. 558.369
Therefore, under authority delegated 2011. These final regulations affect value of eligible employer-sponsored
to the Commissioner of Food and Drugs individuals who enroll in qualified plans have been reserved and will be
and redelegated to the Center for health plans through Affordable finalized separately under REG–
Veterinary Medicine, and in accordance Insurance Exchanges (Exchanges, 119850–15. Two paragraphs on
with 21 CFR 514.116 Notice of sometimes called Marketplaces) and minimum value have been re-proposed,
withdrawal of approval of application, claim the health insurance premium tax see REG–143800–14 (80 FR 52678)
notice is given that approval of NADAs credit, and Exchanges that make (2015 proposed minimum value
007–616, 141–088, and 141–132, and all qualified health plans available to regulations), are finalized in part, and
supplements and amendments thereto, individuals and employers. will be finalized in part under REG–
is hereby withdrawn, effective DATES: Effective Date: These regulations 143800–14.
December 31, 2015. are effective on December 18, 2015.
Explanation of Revisions and Summary
Elsewhere in this issue of the Federal Applicability Dates: For dates of
applicability, see §§ 1.36B–1(o) and of Comments
Register, FDA is amending the animal
drug regulations to reflect the voluntary 1.36B–6(g). 1. Definition of Modified Adjusted Gross
withdrawal of approval of these FOR FURTHER INFORMATION CONTACT: For Income
applications. general questions on the premium tax
Section 36B(d)(2) provides that a
Dated: December 11, 2015. credit, Shareen Pflanz, (202) 317–4718;
taxpayer’s household income includes
Bernadette Dunham, for minimum value, Andrew Braden,
the modified adjusted gross income of
(202) 317–7006 (not toll-free numbers).
Director, Center for Veterinary Medicine. the taxpayer and the members of the
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–31828 Filed 12–17–15; 8:45 am] taxpayer’s tax family who are required
BILLING CODE 4164–01–P Background to file an income tax return. The 2012
This document contains final section 36B final regulations provide
regulations amending the Income Tax that, in computing household income,
DEPARTMENT OF THE TREASURY Regulations (26 CFR part 1) under whether a family member must file a tax
section 36B of the Internal Revenue return is determined without regard to
Internal Revenue Service Code (Code) relating to the health section 1(g)(7). Under section 1(g)(7), a
insurance premium tax credit. Section parent may elect to include a child’s
26 CFR Part 1 36B was enacted by the Patient gross income in the parent’s gross
Protection and Affordable Care Act, income if certain requirements are met.
[TD 9745]
Public Law 111–148 (124 Stat. 119 The proposed regulations removed
RIN 1545–BL43 (2010)), and the Health Care and ‘‘without regard to section 1(g)(7)’’ from
Education Reconciliation Act of 2010, the 2012 section 36B final regulations
Minimum Value of Eligible Employer- because that language implied that the
Sponsored Plans and Other Rules Public Law 111–152 (124 Stat. 1029
(2010)) (collectively, the Affordable Care child’s gross income is included in both
Regarding the Health Insurance the parent’s adjusted gross income and
Premium Tax Credit Act). Final regulations under section
36B (TD 9590) were published on May the child’s adjusted gross income in
AGENCY: Internal Revenue Service (IRS), 23, 2012 (77 FR 30377) (2012 section determining household income. Thus,
Treasury. 36B final regulations). On May 3, 2013, the proposed regulations clarified that
ACTION: Final regulations. a notice of proposed rulemaking (REG– when a parent makes an election under
125398–12) was published in the section 1(g)(7), household income
SUMMARY: This document contains final Federal Register (78 FR 25909). Written includes the child’s gross income
regulations on the health insurance comments responding to the proposed included on the parent’s return only.
premium tax credit enacted by the regulations were received. The These final regulations adopt that rule
Patient Protection and Affordable Care comments have been considered in without change and clarify that the
Act and the Health Care and Education connection with these final regulations modified adjusted gross income of a
asabaliauskas on DSK5VPTVN1PROD with RULES
Reconciliation Act of 2010, as amended and are available for public inspection parent who makes the section 1(g)(7)
by the Medicare and Medicaid at www.regulations.gov or on request. election includes the child’s modified
Extenders Act of 2010, the No public hearing was requested or adjusted gross income. Thus, the
Comprehensive 1099 Taxpayer held. After consideration of all the parent’s modified adjusted gross income
Protection and Repayment of Exchange comments, the proposed regulations are includes not only the child’s gross
Subsidy Overpayments Act of 2011, and adopted, in part, as amended by this income but also the child’s tax-exempt
the Department of Defense and Full- Treasury decision. Some rules proposed interest and nontaxable Social Security
Year Continuing Appropriations Act, under REG–125398–12 on the minimum income, which are excluded from gross
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Document Created: 2015-12-18 01:38:35
Document Modified: 2015-12-18 01:38:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of withdrawal. | |
| Dates | Withdrawal of approval is effective December 31, 2015. | |
| Contact | Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected] | |
| FR Citation | 80 FR 78970 |
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