81 FR 36790 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 110 (June 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 110 (June 8, 2016)
| Page Range | 36790-36791 | |
| FR Document | 2016-13518 |
[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)] [Rules and Regulations] [Pages 36790-36791] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13518] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 558 [Docket No. FDA-2016-N-0002] New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective June 20, 2016. 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: The sponsors of the following applications have requested that FDA withdraw approval of the NADAs and ANADA listed in the following table because the products are no longer manufactured or marketed: ---------------------------------------------------------------------------------------------------------------- File No. Sponsor Product name 21 CFR section ---------------------------------------------------------------------------------------------------------------- 007-076 \1\.................. Cross Vetpharm Group Ltd., SULFA-NOX Liquid 520.2325a Broomhill Rd., Tallaght, (sulfaquinoxaline) 3.44% Dublin 24, Ireland. Solution. 008-244 \1\.................. Cross Vetpharm Group Ltd., SULFA-NOX Concentrate 520.2325a Broomhill Rd., Tallaght, (sulfaquinoxaline) 12.85% Dublin 24, Ireland. Solution. [[Page 36791]] 041-955 \1\.................. Cross Vetpharm Group Ltd., Erythromycin Medicated 558.248 Broomhill Rd., Tallaght, Premix. Dublin 24, Ireland. 049-729 \1\.................. Cross Vetpharm Group Ltd., PURINA Sulfa 522.2260a Broomhill Rd., Tallaght, (sulfamethazine) 12.5% Dublin 24, Ireland. Solution. 100-128 \1\.................. Cross Vetpharm Group Ltd., Supersweet Medipak TYLAN 10. 558.625 Broomhill Rd., Tallaght, Dublin 24, Ireland. 200-307 \1\.................. Vetoquinol N.-A., Inc., 2000 Penicillin G Potassium, USP, 520.1696b chemin Georges, Lavaltrie Soluble Powder. (PQ), Canada J5T 3S5. ---------------------------------------------------------------------------------------------------------------- \1\These NADAs were identified as being affected by guidance for industry #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,'' December 2013. Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with Sec. 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 007-076, 008-244, 041-955, 049-729, 100-128, and ANADA 200-307, and all supplements and amendments thereto, is hereby withdrawn, effective June 20, 2016. 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: May 31, 2016. Tracey Forfa, Acting Director, Center for Veterinary Medicine. [FR Doc. 2016-13518 Filed 6-7-16; 8:45 am] BILLING CODE 4164-01-P
![36790 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Rules and Regulations
§ 556.748 Tylvalosin. PART 558—NEW ANIMAL DRUGS FOR ■ 18. In § 558.4, in paragraph (d), in the
* * * * * USE IN ANIMAL FEEDS ‘‘Category I’’ table, add an entry in
alphabetical order for ‘‘Tylvalosin’’ to
(c) Related conditions of use. See
■ 17. The authority citation for part 558 read as follows:
§§ 520.2645 and 558.633 of this chapter.
continues to read as follows: § 558.4 Requirement of a medicated feed
Authority: 21 U.S.C. 354, 360b, 360ccc, mill license.
360ccc–1, 371. * * * * *
(d) * * *
CATEGORY I
Assay limits per-
Drug Assay limits percent Type A Type B maximum (200x) cent Type B/C
* * * * * * *
Tylvalosin ............................................... 90–110 3.86 g/lb 85–115
* * * * * * *
* * * * * (2) VFDs for tylvalosin shall not be ACTION: Notification of withdrawal.
refilled.
§ 558.248 [Amended] (3) An expiration date of 1 week is SUMMARY: The Food and Drug
■ 19. Effective June 20, 2016, in required for tylvalosin Type C Administration (FDA) is withdrawing
§ 558.248, revise paragraphs (a) and (b) medicated swine feeds in pelleted or approval of five new animal drug
and remove and reserve paragraph crumbled form. applications (NADAs) and an
(d)(1)(iii). (e) Conditions of use in swine—(1) abbreviated new animal drug
The revisions read as follows: Amount. Administer 38.6 grams
application (ANADA). This action is
tylvalosin per ton of Type C medicated
§ 558.248 Erythromycin. being taken at the sponsors’ request
feed (42.5 ppm) as the sole ration for 14
(a) Specifications. Type A medicated consecutive days. because these products are no longer
articles containing 5 or 10 percent (2) Indications for use. For the control manufactured or marketed.
erythromycin thiocyanate. of porcine proliferative enteropathy
(b) Sponsor. See No. 061623 in DATES: Withdrawal of approval is
(PPE) associated with Lawsonia effective June 20, 2016.
§ 510.600(c) of this chapter. intracellularis infection in groups of
* * * * * swine in buildings experiencing an FOR FURTHER INFORMATION CONTACT:
outbreak of PPE. Sujaya Dessai, Center for Veterinary
§ 558.625 [Amended]
Medicine (HFV–212), Food and Drug
■ 20. Effective June 20, 2016, in Dated: May 31, 2016.
Administration, 7519 Standish Pl.,
§ 558.625, remove paragraph (b)(3) and Tracey Forfa,
Rockville, MD 20855, 240–402–5761,
redesignate paragraphs (b)(4) and (5) as Acting Director, Center for Veterinary
Medicine.
sujaya.dessai@fda.hhs.gov.
paragraphs (b)(3) and (4).
■ 21. Add § 558.633 to read as follows: [FR Doc. 2016–13517 Filed 6–7–16; 8:45 am] SUPPLEMENTARY INFORMATION: The
BILLING CODE 4164–01–P sponsors of the following applications
§ 558.633 Tylvalosin.
have requested that FDA withdraw
(a) Specifications. Type A medicated approval of the NADAs and ANADA
articles containing 77.12 grams DEPARTMENT OF HEALTH AND listed in the following table because the
tylvalosin per pound as tylvalosin HUMAN SERVICES products are no longer manufactured or
tartrate.
(b) Sponsor. See No. 066916 in marketed:
Food and Drug Administration
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.748 21 CFR Parts 520 and 558
of this chapter.
(d) Special considerations—(1) [Docket No. FDA–2016–N–0002]
Federal law restricts tylvalosin
New Animal Drugs; Withdrawal of
medicated feeds to use under a
Approval of a New Animal Drug
veterinary feed directive (VFD) and the
Application
professional supervision of a licensed
veterinarian. See § 558.6 of this chapter AGENCY: Food and Drug Administration,
for additional requirements. HHS.
21 CFR
File No. Sponsor Product name section
ehiers on DSK5VPTVN1PROD with RULES
007–076 1 ............ Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, SULFA–NOX Liquid (sulfaquinoxaline) 3.44% Solution 520.2325a
Dublin 24, Ireland.
008–244 1 ............ Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, SULFA–NOX Concentrate (sulfaquinoxaline) 12.85% 520.2325a
Dublin 24, Ireland. Solution.
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![Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Rules and Regulations 36791
21 CFR
File No. Sponsor Product name section
041–955 1 ............ Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Erythromycin Medicated Premix ................................... 558.248
Dublin 24, Ireland.
049–729 1 ............ Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, PURINA Sulfa (sulfamethazine) 12.5% Solution ......... 522.2260a
Dublin 24, Ireland.
100–128 1 ............ Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Supersweet Medipak TYLAN 10 .................................. 558.625
Dublin 24, Ireland.
200–307 1 ............ Vetoquinol N.-A., Inc., 2000 chemin Georges, Penicillin G Potassium, USP, Soluble Powder ............ 520.1696b
Lavaltrie (PQ), Canada J5T 3S5.
1These NADAs were identified as being affected by guidance for industry #213, ‘‘New Animal Drugs and New Animal Drug Combination Prod-
ucts Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily
Aligning Product Use Conditions with GFI #209,’’ December 2013.
Therefore, under authority delegated Act) further amended the 1990 Act by decline in the real value of the penalty.
to the Commissioner of Food and Drugs requiring agencies to adjust CMPs, if To remedy this decline, the 2015 Act
and redelegated to the Center for necessary, pursuant to a ‘‘catch-up’’ (section 701 of Pub. L. 114–74) requires
Veterinary Medicine, and in accordance adjustment methodology prescribed by agencies to adjust the level of CMPs
with § 514.116 Notice of withdrawal of the 2015 Act, which mandates that the with an initial ‘‘catch-up’’ adjustment
approval of application (21 CFR catch up adjustment take effect no later through a rulemaking and to make
514.116), notice is given that approval than August 1, 2016. Additionally, the subsequent annual inflationary
of NADAs 007–076, 008–244, 041–955, 2015 Act requires agencies to make adjustments to their respective CMPs
049–729, 100–128, and ANADA 200– annual adjustments to their respective using a methodology mandated by the
307, and all supplements and CMPs in accordance with guidance legislation.
amendments thereto, is hereby issued by the Office of Management and The 1990 Act defines civil monetary
withdrawn, effective June 20, 2016. Budget. The revised CMP adjustments penalty as any penalty, fine, or other
Elsewhere in this issue of the Federal in this rule will apply only to those sanction that:
Register, FDA is amending the animal penalties assessed after its effective • Is for a specific monetary amount as
drug regulations to reflect the voluntary date; subsequent annual adjustments are provided for in federal law; or has a
withdrawal of approval of these to be published not later than January maximum amount provided for by
applications. 15 of each year. In keeping with federal law; and
Dated: May 31, 2016. guidance provided by the Office of • is assessed or enforced by an agency
Management and Budget, the new as pursuant to federal law; and,
Tracey Forfa,
penalty levels will apply to all • is assessed or enforced pursuant to
Acting Director, Center for Veterinary assessments made on or after August 1, an administrative proceeding or a civil
Medicine.
2016, regardless of the date on which action in the federal courts.
[FR Doc. 2016–13518 Filed 6–7–16; 8:45 am] Within the Department of State (Title
the underlying facts or violations
BILLING CODE 4164–01–P occurred. 22, Code of Federal Regulations), this
rule affects four areas:
DATES: This final rule is effective August
(1) Part 35, which implements the
1, 2016.
DEPARTMENT OF STATE Program Fraud Civil Remedies Act of
FOR FURTHER INFORMATION CONTACT: 1986 (PFCRA), codified at 31 U.S.C.
22 CFR Parts 35, 103, 127, and 138 Alice Kottmyer, Attorney-Adviser, 3801–3812;
Office of Management, kottmyeram@ (2) Part 103, which implements the
[Public Notice: 9536]
state.gov. ATTN: Regulatory Change, Chemical Weapons Convention
RIN 1400–AD94 CMP Adjustments, (202) 647–2318. Implementation Act of 1998 (CWC Act);
SUPPLEMENTARY INFORMATION: The 1990 (3) Part 127, which implements the
Civil Monetary Penalties Inflationary Act (Pub. L. 101–410) provided for the penalty provisions of sections 38(e),
Adjustment regular evaluation of CMPs by federal 39A(c), and 40(k) of the Arms Export
AGENCY: Department of State. agencies. Periodic inflationary Control Act (AECA) (22 U.S.C. 2778(e),
ACTION: Final rule. adjustments of CMPs ensure that the 2779a(c), 2780(k)); and
consequences of statutory violations (4) Part 138, which implements
SUMMARY: This final rule is issued to adequately reflect the gravity of such Section 319 of Public Law 101–221,
adjust the civil monetary penalties offenses and that CMPs are properly codified at 31 U.S.C. 1352, and prohibits
(CMP) for regulatory provisions accounted for and collected by the recipients of federal contracts, grants,
maintained and enforced by the federal government. In April 1996, the and loans from using appropriated
Department of State. The Federal Civil 1990 Act was amended by the 1996 Act funds for lobbying the Executive or
Penalties Inflation Adjustment Act of (Pub. L. 104–134), which required Legislative Branches of the federal
1990 (the 1990 Act), as amended by the federal agencies to adjust their CMPs at government in connection with a
Debt Collection Improvement Act of least once every four years. However, specific contract.
1996 (the 1996 Act), required the head because inflationary adjustments to The 2015 Act instructs agencies to
of each agency to adjust its CMPs for CMPs were statutorily capped at ten make a one-time catch-up adjustment to
ehiers on DSK5VPTVN1PROD with RULES
inflation no later than October 23, 1996 percent of the maximum penalty CMPs using the maximum penalty level
and required agencies to make amount, but only required to be or range of minimum and maximum
adjustments at least once every four calculated every four years, CMPs in penalties as they were ‘‘most recently
years thereafter. The Federal Civil many cases did not correspond with the established or adjusted under a
Penalties Inflation Adjustment Act true measure of inflation over the provision of law other than [the 1990]
Improvements Act of 2015 (the 2015 preceding four year period, leading to a Act.’’ Nevertheless, the 2015 Act
VerDate Sep<11>2014 14:36 Jun 07, 2016 Jkt 238001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\08JNR1.SGM 08JNR1](https://thefederalregister.org/doc/81_FR_36900/page/2.svg)
Document Created: 2016-06-08 03:10:44
Document Modified: 2016-06-08 03:10:44
| 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 June 20, 2016. | |
| 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 | 81 FR 36790 | |
| CFR Citation | 21
CFR
520 21 CFR 558 |
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