Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin, 15540-15541 [2014-05883]
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15540
Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Rules and Regulations
markets) of Washington apricots was
approximately 6,700 tons, the average
price was $1,250 per ton, and the total
farm-gate value was approximately
$8,371,000. Based on these reports and
the number of apricot growers within
the production area, it is estimated that
the 2012 average revenue from the sale
of apricots was approximately $89,000.
In addition, based on information from
the USDA’s Market News Service, 2012
f.o.b. prices for WA No. 1 apricots
ranged from $16.00 to $24.00 per 24pound loose-pack container, and from
$18.00 to $27.00 for 2-layer tray-pack
containers. Using average price and
shipment information provided by the
Committee, it is determined that each of
the Washington apricot handlers
currently ship less than $7,000,000
worth of apricots on an annual basis. In
view of the foregoing, it is concluded
that the majority of growers and
handlers of Washington apricots may be
classified as small entities.
This rule continues in effect the
action that suspended the handling
regulations specified in §§ 922.111 and
922.321 for the remainder of the 2013–
2014 fiscal period and subsequent fiscal
periods. The suspension of these
handling regulations allows the
Washington apricot industry to market
apricots without regard to the minimum
grade, size, quality, maturity, and
inspection requirements prescribed
under the order. Authority for this
action is provided in § 922.53.
This action is not expected to increase
the costs associated with the order
requirements. Rather, this action allows
handlers to decrease their costs during
the 2013–2014 fiscal period and
subsequent fiscal periods by eliminating
the expense associated with mandatory
inspection. However, this rule does not
impede handlers from seeking
inspection on a voluntary basis if they
find inspection desirable. The
opportunities and benefits of this rule
are equally available to all Washington
apricot handlers and producers,
regardless of their size.
In accordance with the Paperwork
Reduction Act of 1995, (44 U.S.C.
Chapter 35), the order’s information
collection requirements have been
previously approved by the Office of
Management and Budget (OMB) and
assigned OMB No. 0581–0189. No
changes in those requirements as a
result of this action are necessary.
Should any changes become necessary,
they would be submitted to OMB for
approval.
This rule will not impose any
additional reporting or recordkeeping
requirements on either small or large
apricot handlers. As with all Federal
marketing order programs, reports and
forms are periodically reviewed to
reduce information requirements and
duplication by industry and public
sector agencies. In addition, USDA has
not identified any relevant Federal rules
that duplicate, overlap or conflict with
this rule.
Further, the Committee’s meeting was
widely publicized throughout the
Washington apricot industry and all
interested persons were invited to
attend the meeting and participate in
the Committee’s deliberations. Like all
Committee meetings, the May 13, 2013,
meeting was a public meeting. All
entities, both large and small, were able
to express their views on this issue.
Comments on the interim rule were
required to be received on or before
December 23, 2013. No comments were
received. Therefore, for the reasons
given in the interim rule, we are
adopting the interim rule as a final rule,
without change.
To view the interim rule, go to:
https://www.regulations.gov/
#!documentDetail;D=AMS-FV-13-00400001.
This action also affirms information
contained in the interim rule concerning
Executive Orders 12866, 12988, and
13563; the Paperwork Reduction Act
(44 U.S.C. Chapter 35); and the E-Gov
Act (44 U.S.C. 101), as well as the
findings in the interim rule that the
regulatory requirements no longer tend
to effectuate the declared policy of the
Act.
After consideration of all relevant
material presented, it is found that
finalizing the interim rule, without
change, as published in the Federal
Register (78 FR 62963, October 23,
2013) will tend to effectuate the
declared policy of the Act.
List of Subjects in 7 CFR Part 922
Apricots, Marketing agreements,
Reporting and recordkeeping
requirements.
ehiers on DSK2VPTVN1PROD with RULES
NADA/ANADA
039–077 ..............................
200–140 ..............................
200–167 ..............................
VerDate Mar<15>2010
PART 922—[AMENDED]
Accordingly, the interim rule that
amended 7 CFR part 922 and was
published at 78 FR 62963 on October
23, 2013, is adopted as a final rule,
without change.
■
Dated: February 26, 2014.
Rex A. Barnes,
Associate Administrator, Agricultural
Marketing Service.
[FR Doc. 2014–06084 Filed 3–19–14; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2014–N–0002]
Withdrawal of Approval of New Animal
Drug Applications; Chlortetracycline;
Sulfathiazole; Penicillin
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal of
approval.
ACTION:
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) and two
abbreviated new animal drug
applications (ANADAs) for three-way,
fixed-ratio combination drug Type A
medicated articles containing
chlortetracycline, sulfathiazole, and
penicillin. This action is being taken at
the sponsor’s request because these
products are no longer manufactured or
marketed.
DATES: Withdrawal of approval is
effective March 31, 2014.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843.
SUPPLEMENTARY INFORMATION: Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of the following NADA and
two ANADAs because the products are
no longer manufactured or marketed:
SUMMARY:
Proprietary name
CSP 250 (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL 500 Granular (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
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Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Rules and Regulations
The NADAs listed 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.
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 NADA 039–077, ANADA 200–140,
and ANADA 200–167, and all
supplements and amendments thereto,
is hereby withdrawn, effective March
31, 2014.
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: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–05883 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DATES:
ehiers on DSK2VPTVN1PROD with RULES
This rule is effective March 31,
2014.
[Docket No. FDA–2014–N–0002]
FOR FURTHER INFORMATION CONTACT:
Zoetis Inc., Withdrawal of Approval of
New Animal Drug Applications;
Chlortetracycline; Sulfathiazole;
Penicillin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of a new animal
SUMMARY:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843.
Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of the following NADA and
two ANADAs because the products are
no longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
Proprietary name
CSP 250 (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL 500 Granular (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
The NADAs listed 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.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 039–077, ANADA 200–140,
and ANADA 200–167, and all
supplements and amendments thereto,
is withdrawn, effective March 31, 2014.
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
voluntary withdrawals of approval.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
DEPARTMENT OF VETERANS
AFFAIRS
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
RIN 2900–AO85
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.4
2. In § 558.4(d), in the ‘‘Category II’’
table, remove the entry for
‘‘Sulfathiazole’’ and its respective
following entries.
■
§ 558.155
■
[Removed]
3. Remove § 558.155.
Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–05882 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
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38 CFR Part 17
VA Dental Insurance Program—
Federalism
Department of Veterans Affairs.
Direct final rule; confirmation of
effective date.
AGENCY:
ACTION:
[Amended]
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
VerDate Mar<15>2010
drug application (NADA) and two
abbreviated new animal drug
applications (ANADAs) for three-way,
fixed-ratio combination drug Type A
medicated articles containing
chlortetracycline, sulfathiazole, and
penicillin. This action is being taken at
the sponsor’s request because these
products are no longer manufactured or
marketed.
21 CFR Part 558
NADA/ANADA
039–077 ..............................
200–140 ..............................
200–167 ..............................
15541
The Department of Veterans
Affairs (VA) published a direct final rule
in the Federal Register on October 22,
2013, amending its regulations related
to the VA Dental Insurance Program
(VADIP), a pilot program to offer
premium-based dental insurance to
enrolled veterans and certain survivors
and dependents of veterans.
Specifically, this rule adds language to
clarify the limited preemptive effect of
certain criteria in the VADIP
regulations. VA received no comments
concerning this rule or its companion
substantially identical proposed rule
published in the Federal Register on
October 23, 2013. This document
confirms that the direct final rule
became effective on December 23, 2013.
In a companion document in this issue
SUMMARY:
E:\FR\FM\20MRR1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Rules and Regulations]
[Pages 15540-15541]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05883]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2014-N-0002]
Withdrawal of Approval of New Animal Drug Applications;
Chlortetracycline; Sulfathiazole; Penicillin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal of approval.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new animal drug application (NADA) and two abbreviated new animal
drug applications (ANADAs) for three-way, fixed-ratio combination drug
Type A medicated articles containing chlortetracycline, sulfathiazole,
and penicillin. This action is being taken at the sponsor's request
because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective March 31, 2014.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6843.
SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw approval of the following NADA
and two ANADAs because the products are no longer manufactured or
marketed:
------------------------------------------------------------------------
NADA/ANADA Proprietary name
------------------------------------------------------------------------
039-077................................... CSP 250 (chlortetracycline,
sulfathiazole, and
penicillin) Type A
medicated article.
200-140................................... AUREOZOL (chlortetracycline,
sulfathiazole, and
penicillin) Type A
medicated article.
200-167................................... AUREOZOL 500 Granular
(chlortetracycline,
sulfathiazole, and
penicillin) Type A
medicated article.
------------------------------------------------------------------------
[[Page 15541]]
The NADAs listed 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.
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 NADA
039-077, ANADA 200-140, and ANADA 200-167, and all supplements and
amendments thereto, is hereby withdrawn, effective March 31, 2014.
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: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05883 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P
