New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application; Penicillin G Procaine, 61298 [2015-25919]
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations
medicated feeds to use under a
veterinary feed directive (VFD) and the
professional supervision of a licensed
veterinarian. See § 558.6 of this chapter
for additional requirements.
(2) The expiration date of VFDs for
avilamycin medicated feeds must not
exceed 90 days from the date of
issuance. VFDs for avilamycin shall not
be refilled.
(d) Related tolerances. See § 556.68 of
this chapter.
(e) Conditions of use in swine—(1)
Amount. Feed at 73 grams avilamycin
per ton of Type C medicated feed (80
ppm) as the sole ration for 21
consecutive days. The veterinarian may
direct feeding for up to a total of 42
consecutive days, based on the clinical
assessment.
(2) Indications for use. Weaned pigs
less than 14 weeks of age: For the
reduction in incidence and overall
severity of diarrhea in the presence of
pathogenic Escherichia coli in groups of
weaned pigs.
(3) Limitations. Feed continuously as
the sole ration.
§ 558.460
[Amended]
21. In § 558.460, revise paragraphs (a)
and (b) to read as follows:
■
§ 558.460
Penicillin.
(a) Specifications. Type A medicated
articles containing 100 or 227 grams
penicillin procaine G or feed grade
penicillin procaine per pound.
(b) Sponsor: See No. 066104 in
§ 510.600(c) of this chapter.
*
*
*
*
*
§ 558.500
[Amended]
22. Amend § 558.500 as follows:
a. In paragraphs (e)(1)(ii), (iii), and
(iv), in the ‘‘Limitations’’ column,
remove the last sentence and in its place
add ‘‘Ractopamine as provided by Nos.
000986 or 054771; tylosin as provided
by Nos. 000986 or 016592 in
§ 510.600(c) of this chapter.’’.
■ b. In paragraphs (e)(2)(iv), (ix), and
(xiii), in the ‘‘Limitations’’ column,
remove the last sentence and in its place
add ‘‘Ractopamine as provided by Nos.
000986 or 054771 with monensin as
provided by No. 000986, and tylosin as
provided by Nos. 000986 or 016592 in
§ 510.600(c) of this chapter.’’.
■ c. In paragraph (e)(2)(x), in the
‘‘Limitations’’ column, to the last
sentence add ‘‘; or ractopamine as
provided by No. 054771 with monensin
as provided by No. 000986, tylosin
provided by No. 016592, and
melengestrol acetate provided by No.
054771 in § 510.600(c) of this chapter.’’
■
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■
VerDate Sep<11>2014
17:03 Oct 09, 2015
Jkt 238001
§ 558.618
[Amended]
23. In § 558.618, in paragraph (e)(2)(i),
in the ‘‘Sponsor’’ column, add ‘‘016592’’
after ‘‘000986’’.
■
Dated: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–25918 Filed 10–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 NADA
046–666, and all supplements and
amendments thereto, is hereby
withdrawn, effective October 23, 2015.
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.
Food and Drug Administration
Dated: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
21 CFR Part 558
[FR Doc. 2015–25919 Filed 10–9–15; 8:45 am]
[Docket No. FDA–2015–N–0002]
BILLING CODE 4164–01–P
New Animal Drugs for Use in Animal
Feed; Withdrawal of Approval of a New
Animal Drug Application; Penicillin G
Procaine
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
HHS.
ACTION:
21 CFR Part 890
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) providing for the
use of penicillin G procaine in
medicated feed of poultry and swine.
This action is being taken at the
sponsor’s request because this product
is no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective October 23, 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 NADA 046–666 that
provides for use of Type A medicated
articles containing penicillin G procaine
to manufacture medicated feeds
administered to poultry and swine. This
action is being taken at the sponsor’s
request because this product is no
longer manufactured or marketed. Note
this NADA was 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
SUMMARY:
PO 00000
Food and Drug Administration
Food and Drug Administration,
Frm 00022
Fmt 4700
Sfmt 4700
[Docket No. FDA–2012–N–0378]
Physical Medicine Devices;
Reclassification of Shortwave
Diathermy for All Other Uses,
Henceforth To Be Known as
Nonthermal Shortwave Therapy
AGENCY:
Food and Drug Administration,
HHS.
Final order; technical
correction.
ACTION:
The Food and Drug
Administration (FDA) is issuing a final
order to reclassify shortwave diathermy
(SWD) for all other uses, a
preamendments class III device, into
class II (special controls), and to rename
the device ‘‘nonthermal shortwave
therapy’’ (SWT). FDA is also making a
technical correction in the regulation for
the carrier frequency for SWD and SWT
devices.
DATES: This order is effective on October
13, 2015. See further discussion in
Section IV, ‘‘Implementation Strategy.’’
FOR FURTHER INFORMATION CONTACT:
Michael J. Ryan, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615,
Silver Spring, MD 20993, 301–796–
6283, michael.ryan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
E:\FR\FM\13OCR1.SGM
13OCR1
]]>Agencies
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Page 61298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25919]
-----------------------------------------------------------------------
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 a New Animal Drug Application; Penicillin G Procaine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new animal drug application (NADA) providing for the use of
penicillin G procaine in medicated feed of poultry and swine. This
action is being taken at the sponsor's request because this product is
no longer manufactured or marketed.
DATES: Withdrawal of approval is effective October 23, 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 NADA 046-666 that
provides for use of Type A medicated articles containing penicillin G
procaine to manufacture medicated feeds administered to poultry and
swine. This action is being taken at the sponsor's request because this
product is no longer manufactured or marketed. Note this NADA was
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 21 CFR 514.116 Notice of withdrawal of approval of
application, notice is given that approval of NADA 046-666, and all
supplements and amendments thereto, is hereby withdrawn, effective
October 23, 2015.
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.
Dated: October 6, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-25919 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P
