New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 11509-11510 [2017-03595]
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Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
§ 558.68
16. In § 558.68, revise paragraph
(e)(1)(ii) to read as follows:
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Avilamycin.
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(e) * * *
(1) * * *
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Avilamycin in
grams/ton
Combination in
grams/ton
Indications for use
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(ii) 13.6 to 40.9 ........
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Monensin 90 to 110;
as provided by
No. 058198 in
§ 510.600(c) of
this chapter.
*
*
Broiler chickens: For the prevention of
mortality caused by necrotic enteritis
associated with Clostridium perfringens
in broiler chickens; and as an aid in the
prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and
E. maxima.
Limitations
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Withdrawal of
Approval of a New Animal Drug
Application
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03677 Filed 2–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
AGENCY:
Food and Drug Administration,
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of an abbreviated new animal
drug application (ANADA) at the
sponsor’s request because the product is
no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective March 6, 2017.
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: Putney,
Inc., One Monument Square, Suite 400,
Portland, ME 04101 has requested that
FDA withdraw approval of ANADA
200–524 for Mupirocin Ointment 2%
because the product is no longer
manufactured or marketed.
SUMMARY:
pmangrum on DSK3GDR082PROD with RULES
[FR Doc. 2017–03678 Filed 2–23–17; 8:45 am]
BILLING CODE 4164–01–P
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of 18 new animal drug
applications (NADAs) and 2 abbreviated
new animal drug applications
(ANADAs). These withdrawals of
SUMMARY:
File No.
LINCOMIX (lincomycin)/AMPROL PLUS (amprolium
and ethopabate).
approval of NADAs and ANADAs for
antimicrobial drugs of importance to
human medicine that are administered
to food-producing animals in medicated
feed are being made because the
products are no longer manufactured or
marketed. These actions are consistent
with the FDA Center for Veterinary
Medicine’s initiative for the Judicious
Use of Antimicrobials.
Withdrawal of approval is
effective February 24, 2017.
DATES:
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: FDA is
withdrawing approval of 18 NADAs and
2 ANADAs. These applications were
identified as being affected by guidance
for industry (GFI) #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 (https://www.fda.gov/downloads/
AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/UCM299624.pdf).
Their withdrawal of approval is
consistent with the FDA Center for
Veterinary Medicine’s initiative for the
Judicious Use of Antimicrobials.
Approval of the following
applications for new animal drugs
administered in medicated feed is being
voluntarily withdrawn at the sponsors’
requests because these products are no
longer manufactured or marketed:
Product name
044–820 ......................................
VerDate Sep<11>2014
14:13 Feb 23, 2017
Jkt 241001
PO 00000
Frm 00009
Fmt 4700
Sponsor
Sfmt 4700
Sponsor
*
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Feed as the sole ration for 21 consecu058198
tive days. To assure responsible antimicrobial drug use in broiler chickens,
treatment administration must begin on
or before 10 days of age. See
§ 558.355(d) of this chapter for additional required labeling.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of ANADA 200–524, and all
supplements and amendments thereto,
is hereby withdrawn, effective March 6,
2017.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of this
application.
*
11509
Zoetis Inc.
333 Portage St.
Kalamazoo, MI 49007 (Zoetis Inc.).
E:\FR\FM\24FER1.SGM
24FER1
11510
Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
File No.
Product name
Sponsor
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp., GlenPointe Centre East,
3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.).
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
044–972
047–261
047–262
048–954
091–513
......................................
......................................
......................................
......................................
......................................
LINCOMIX (lincomycin)/COYDEN (clopidol) ...............
LINCOMIX (lincomycin)/DECCOX (decoquinate) .......
LINCOMIX (lincomycin)/DECCOX (decoquinate) .......
LINCOMIX (lincomycin)/ZOAMIX (zoalene) ................
STAFAC (virginiamycin) Type A Medicated Article .....
092–482
093–106
101–689
122–481
122–608
122–822
......................................
......................................
......................................
......................................
......................................
......................................
141–110 ......................................
141–150 ......................................
200–092 ......................................
LINCOMIX (lincomycin)/COBAN (monensin) ..............
LINCOMIX (lincomycin)/ROBENZ (robenidine) ...........
LINCOMIX (lincomycin)/AVATEC (lasalocid) ..............
STAFAC (virginiamycin)/COBAN (monensin) .............
STAFAC (virginiamycin)/AVATEC (lasalocid) .............
STAFAC (virginiamycin)/AMPROL PLUS (amprolium
and ethopabate).
LINCOMIX (lincomycin)/BIO–COX (salinomycin) ........
TYLAN
(tylosin)/RUMENSIN
(monensin)/MGA
(melengestrol acetate).
STAFAC (virginiamycin)/BIO–COX (salinomycin) .......
TYLAN
(tylosin)/BOVATEC
(lasalocid)/MGA
(melengestrol acetate).
STAFAC (virginiamycin)/COBAN (monensin) .............
STAFAC (virginiamycin)/AVATEC (lasalocid) .............
STAFAC (virginiamycin)/SACOX (salinomycin) ..........
200–093 ......................................
LINCOMIX (lincomycin)/SACOX (salinomycin) ...........
137–537 ......................................
138–792 ......................................
138–828 ......................................
138–904 ......................................
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADAs 044–820, 044–972, 047–261,
047–262, 048–954, 091–513, 092–482,
093–106, 101–689, 122–481, 122–608,
122–822, 137–537, 138–792, 138–828,
138–904, 141–110, 141–150, 200–092,
and 200–093, and all supplements and
amendments thereto, is hereby
withdrawn, effective February 24, 2017.
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: February 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03595 Filed 2–23–17; 8:45 am]
pmangrum on DSK3GDR082PROD with RULES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
14:13 Feb 23, 2017
Jkt 241001
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp.
Zoetis Inc.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov
Str., 1113 Sophia, Bulgaria (Huvepharma EOOD).
Huvepharma EOOD.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs for Use in Animal
Feed; Approval of New Animal Drug
Applications; Withdrawal of Approval
of New Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of eight supplemental new
animal drug applications (NADAs). The
effect of these supplemental
applications will be to change the
marketing status from over-the-counter
(OTC) use to use by veterinary feed
directive (VFD) for these antimicrobial
drugs of importance to human
medicine, administered to foodproducing animals in medicated feed.
Where applicable, FDA is also
withdrawing approval of those parts of
the NADAs that pertain to use of these
antimicrobial drugs for production
indications. These actions are being
taken at the sponsors’ requests because
these particular medicated feeds will no
longer be manufactured or marketed.
These applications were submitted in
voluntary compliance with the goals of
FDA Center for Veterinary Medicine’s
SUMMARY:
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
(CVM’s) Judicious Use Initiative. In
addition, the animal drug regulations
are being amended to reflect the
voluntary withdrawal of approval of
certain entire NADAs and abbreviated
new animal drug applications
(ANADAs) that were affected by this
initiative.
DATES: This rule is effective February
24, 2017.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Supplemental Approval of Revised
Labeling and Withdrawal of Approval
of Portions of NADAs Pertaining to
Production Indications
FDA is amending the animal drug
regulations to reflect approval of eight
supplemental NADAs for revised
labeling reflecting a change in marketing
status from OTC use to use by VFD for
antimicrobial drugs of importance to
human medicine administered to foodproducing animals in medicated feed.
Where applicable, FDA is also
withdrawing approval of those parts of
the NADAs that pertain to use of these
antimicrobial drugs for production
indications. These actions are being
taken at the sponsors’ requests because
these particular medicated feeds will no
longer be manufactured or marketed.
These applications were identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
E:\FR\FM\24FER1.SGM
24FER1
]]>Agencies
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11509-11510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03595]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 18 new animal drug applications (NADAs) and 2 abbreviated new animal
drug applications (ANADAs). These withdrawals of approval of NADAs and
ANADAs for antimicrobial drugs of importance to human medicine that are
administered to food-producing animals in medicated feed are being made
because the products are no longer manufactured or marketed. These
actions are consistent with the FDA Center for Veterinary Medicine's
initiative for the Judicious Use of Antimicrobials.
DATES: Withdrawal of approval is effective February 24, 2017.
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: FDA is withdrawing approval of 18 NADAs and
2 ANADAs. These applications were identified as being affected by
guidance for industry (GFI) #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 (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their
withdrawal of approval is consistent with the FDA Center for Veterinary
Medicine's initiative for the Judicious Use of Antimicrobials.
Approval of the following applications for new animal drugs
administered in medicated feed is being voluntarily withdrawn at the
sponsors' requests because these products are no longer manufactured or
marketed:
------------------------------------------------------------------------
File No. Product name Sponsor
------------------------------------------------------------------------
044-820..................... LINCOMIX Zoetis Inc.
(lincomycin)/AMPROL 333 Portage St.
PLUS (amprolium and Kalamazoo, MI 49007
ethopabate). (Zoetis Inc.).
[[Page 11510]]
044-972..................... LINCOMIX Zoetis Inc.
(lincomycin)/COYDEN
(clopidol).
047-261..................... LINCOMIX Zoetis Inc.
(lincomycin)/DECCOX
(decoquinate).
047-262..................... LINCOMIX Zoetis Inc.
(lincomycin)/DECCOX
(decoquinate).
048-954..................... LINCOMIX Zoetis Inc.
(lincomycin)/ZOAMIX
(zoalene).
091-513..................... STAFAC Phibro Animal Health
(virginiamycin) Corp., GlenPointe
Type A Medicated Centre East, 3d
Article. floor, 300 Frank W.
Burr Blvd., Suite
21, Teaneck, NJ
07666 (Phibro
Animal Health
Corp.).
092-482..................... LINCOMIX Zoetis Inc.
(lincomycin)/COBAN
(monensin).
093-106..................... LINCOMIX Zoetis Inc.
(lincomycin)/ROBENZ
(robenidine).
101-689..................... LINCOMIX Zoetis Inc.
(lincomycin)/AVATEC
(lasalocid).
122-481..................... STAFAC Phibro Animal Health
(virginiamycin)/ Corp.
COBAN (monensin).
122-608..................... STAFAC Phibro Animal Health
(virginiamycin)/ Corp.
AVATEC (lasalocid).
122-822..................... STAFAC Phibro Animal Health
(virginiamycin)/ Corp.
AMPROL PLUS
(amprolium and
ethopabate).
137-537..................... LINCOMIX Zoetis Inc.
(lincomycin)/BIO-
COX (salinomycin).
138-792..................... TYLAN (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
MGA (melengestrol
acetate).
138-828..................... STAFAC Phibro Animal Health
(virginiamycin)/BIO- Corp.
COX (salinomycin).
138-904..................... TYLAN (tylosin)/ Zoetis Inc.
BOVATEC (lasalocid)/
MGA (melengestrol
acetate).
141-110..................... STAFAC Phibro Animal Health
(virginiamycin)/ Corp.
COBAN (monensin).
141-150..................... STAFAC Phibro Animal Health
(virginiamycin)/ Corp.
AVATEC (lasalocid).
200-092..................... STAFAC Huvepharma EOOD, 5th
(virginiamycin)/ Floor, 3A Nikolay
SACOX (salinomycin). Haytov Str., 1113
Sophia, Bulgaria
(Huvepharma EOOD).
200-093..................... LINCOMIX Huvepharma EOOD.
(lincomycin)/SACOX
(salinomycin).
------------------------------------------------------------------------
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
044-820, 044-972, 047-261, 047-262, 048-954, 091-513, 092-482, 093-106,
101-689, 122-481, 122-608, 122-822, 137-537, 138-792, 138-828, 138-904,
141-110, 141-150, 200-092, and 200-093, and all supplements and
amendments thereto, is hereby withdrawn, effective February 24, 2017.
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: February 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03595 Filed 2-23-17; 8:45 am]
BILLING CODE 4164-01-P
