Withdrawal of Approval of Part of a New Animal Drug Application; Chlortetracycline, Procaine Penicillin, and Sulfamethazine, 63191 [2016-21984]
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Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices
63191
TABLE 5—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
UNDEFINED DURATIONS OF USE IN SHEEP
Indication/disease
Ingredient(s)
Vibrionic Abortion .....................................................................................
Enterotoxemia ...........................................................................................
Chlortetracycline.
Chlortetracycline.
TABLE 6—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
UNDEFINED DURATIONS OF USE IN HONEY BEES
Indication/disease
Ingredient(s)
Foulbrood ..................................................................................................
Dated: September 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21972 Filed 9–12–16; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0002]
Withdrawal of Approval of Part of a
New Animal Drug Application;
Chlortetracycline, Procaine Penicillin,
and Sulfamethazine
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal of
approval.
ACTION:
The Food and Drug
Administration (FDA) is withdrawing
approval of those parts of a new animal
drug application (NADA) for a 3-way,
fixed-ratio, combination drug Type A
medicated article that pertain to use of
the procaine penicillin component for
production indications in swine. This
action is being taken at the sponsor’s
request because the 3-way Type A
medicated article is no longer
manufactured.
SUMMARY:
Withdrawal of approval is
effective September 14, 2016.
DATES:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–402–
0817, cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmgate
LLC (Pharmgate), 1015 Ashes Dr., Suite
102, Wilmington, NC 28405 has
requested that FDA withdraw approval
of those parts of NADA 138–934 for
PENNCHLOR SP 500 (chlortetracycline,
VerDate Sep<11>2014
20:55 Sep 13, 2016
Jkt 238001
Oxytetracycline.
procaine penicillin, and sulfamethazine)
Type A medicated article that pertain to
use of the procaine penicillin
component for the production
indications of growth promotion and
increased feed efficiency in swine.
Pharmgate requested voluntary
withdrawal of approval of these
indications for use because
PENNCHLOR SP 500 Type A medicated
article is no longer manufactured.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Director of 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 those parts of NADA 138–
934 that pertain to use of procaine
penicillin for the production indications
of growth promotion and increased feed
efficiency in swine are hereby
withdrawn, effective September 14,
2016.
NADA 138–934 was 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.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the
withdrawal of approval of these parts of
NADA 138–934.
Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Vaccines and Related Biological
Products Advisory Committee;
Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the Vaccines
and Related Biological Products
Advisory Committee scheduled for
November 16, 2016, is cancelled. This
meeting was announced in the Federal
Register of August 30, 2016 (81 FR
59634).
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Sujata Vijh, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6128,
Silver Spring, MD 20993–0002, 240–
402–7107, sujata.vijh@fda.hhs.gov; or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), and follow
the prompts to the desired center or
product area. Please call the Information
Line for up-to-date information on this
meeting.
Dated: September 8, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–22051 Filed 9–13–16; 8:45 am]
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[FR Doc. 2016–21984 Filed 9–13–16; 8:45 am]
BILLING CODE 4164–01–P
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[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Page 63191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21984]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0002]
Withdrawal of Approval of Part of a New Animal Drug Application;
Chlortetracycline, Procaine Penicillin, and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal of approval.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of those parts of a new animal drug application (NADA) for a 3-way,
fixed-ratio, combination drug Type A medicated article that pertain to
use of the procaine penicillin component for production indications in
swine. This action is being taken at the sponsor's request because the
3-way Type A medicated article is no longer manufactured.
DATES: Withdrawal of approval is effective September 14, 2016.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0817,
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmgate LLC (Pharmgate), 1015 Ashes Dr.,
Suite 102, Wilmington, NC 28405 has requested that FDA withdraw
approval of those parts of NADA 138-934 for PENNCHLOR SP 500
(chlortetracycline, procaine penicillin, and sulfamethazine) Type A
medicated article that pertain to use of the procaine penicillin
component for the production indications of growth promotion and
increased feed efficiency in swine. Pharmgate requested voluntary
withdrawal of approval of these indications for use because PENNCHLOR
SP 500 Type A medicated article is no longer manufactured.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Director of 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 those parts of NADA 138-934 that pertain to use of procaine
penicillin for the production indications of growth promotion and
increased feed efficiency in swine are hereby withdrawn, effective
September 14, 2016.
NADA 138-934 was 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.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the withdrawal of approval of
these parts of NADA 138-934.
Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-21984 Filed 9-13-16; 8:45 am]
BILLING CODE 4164-01-P
