Oral Dosage Form New Animal Drugs; Tetracycline Powder, 12981 [2010-5925]
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Federal Register / Vol. 75, No. 52 / Thursday, March 18, 2010 / Rules and Regulations
AIRAC date
State
City
Airport
FDC No.
FDC date
8–Apr–10 ......
AL
TUSCALOOSA .......
TUSCALOOSA REGIONAL ....
0/6915
2/23/10
8–Apr–10 ......
MI
SAGINAW ...............
MBS INTL ................................
0/7049
2/23/10
[FR Doc. 2010–5284 Filed 3–17–10; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2010–N–0002]
Oral Dosage Form New Animal Drugs;
Tetracycline Powder
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Final rule; technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Alpharma, Inc. The supplemental
NADA provides for revised labeling for
a 25 gram per pound concentration of
tetracycline hydrochloride soluble
powder used to make medicated
drinking water for calves, swine,
chickens, and turkeys for the treatment
and control of various bacterial diseases.
DATES: This rule is effective March 18,
2010.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
Alpharma,
Inc., 440 Rte. 22, Bridgewater, NJ 08807
filed a supplement to NADA 65–140
that provides for revised labeling for
DURAMYCIN–10 (tetracycline
hydrochloride), a soluble powder
containing 25 grams of tetracycline
hydrochloride per pound used to make
medicated drinking water for calves,
swine, chickens, and turkeys for the
treatment and control of various
bacterial diseases. The supplemental
application is approved as of January
12, 2010, and the regulations are
amended in 21 CFR 520.2345d to reflect
the approval.
In addition, FDA has noticed that this
approved concentration of tetracycline
soluble powder has not been codified
mstockstill on DSKH9S0YB1PROD with RULES
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
17:27 Mar 17, 2010
Jkt 220001
for this sponsor. At this time, the
regulations are being amended to reflect
approval of this product. This change is
being made to improve the accuracy of
the animal drug regulations.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
List of Subjects in 21 CFR Part 520
Animal drugs.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 520.2345d, revise paragraphs
(b)(2) and (b)(3); remove paragraph
(b)(4); and redesignate paragraph (b)(5)
as paragraph (b)(4) to read as follows:
■
§ 520.2345d
Tetracycline powder.
*
*
*
*
*
(b)* * *
(2) No. 000010: 102.4 and 324 grams
per pound as in paragraph (d) of this
section.
(3) No. 046573: 25, 102.4, and 324
grams per pound as in paragraph (d) of
this section.
*
*
*
*
*
Dated: March 5, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–5925 Filed 3–17–10; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
12981
Subject
VOR OR TACAN RWY
AMDT 14C.
ILS RWY 23, AMDT 4A.
22,
POSTAL SERVICE
39 CFR Part 111
Eligibility for Commercial Flats Failing
Deflection
Postal ServiceTM.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Postal Service published
a proposed rule regarding eligibility for
commercial flats failing deflection in the
Federal Register on December 14, 2009.
This final rule provides revised mailing
standards and price eligibility for
commercial flats of all classes that fail
to meet the deflection standard.
DATES: Basic standards effective June 7,
2010, with price consequences effective
October 3, 2010.
FOR FURTHER INFORMATION CONTACT: Bill
Chatfield, 202–268–7278.
SUPPLEMENTARY INFORMATION: This final
rule contains modifications to the
original proposal, in response to
customer comments. The final rule does
not include changes to the deflection
standards, but to the pricing eligibility.
In response to the original deflection
proposal and scheduled implementation
in May 2009, customers expressed
concerns about the potential additional
postage due for pieces failing the
deflection standards. Based on these
concerns and to align with other quality
efforts, in December 2009 the Postal
Service proposed to change the price
eligibilities applicable for pieces that
fail the deflection standards.
In this final rule notice we provide
background, summary of the comments
received, our response to the comments,
a summary of the changes and revisions
to the applicable prices for pieces that
do not meet the deflection standards,
followed by changes to the mailing
standards in Mailing Standards of the
United States Postal Service, Domestic
Mail Manual (DMM®).
Background
The Postal Service’s final rule for new
mailing standards to be effective in May
2009 was published in the Federal
Register (74 FR 15380–15384) on April
6, 2009. The final rule included new
deflection standards, previously
applicable only to automation flats, for
all commercial flat-size mail except
saturation and high-density Periodicals
and Standard Mail® flats, as a basic
E:\FR\FM\18MRR1.SGM
18MRR1
]]>Agencies
[Federal Register Volume 75, Number 52 (Thursday, March 18, 2010)]
[Rules and Regulations]
[Page 12981]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5925]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2010-N-0002]
Oral Dosage Form New Animal Drugs; Tetracycline Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Alpharma, Inc. The supplemental NADA
provides for revised labeling for a 25 gram per pound concentration of
tetracycline hydrochloride soluble powder used to make medicated
drinking water for calves, swine, chickens, and turkeys for the
treatment and control of various bacterial diseases.
DATES: This rule is effective March 18, 2010.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ
08807 filed a supplement to NADA 65-140 that provides for revised
labeling for DURAMYCIN-10 (tetracycline hydrochloride), a soluble
powder containing 25 grams of tetracycline hydrochloride per pound used
to make medicated drinking water for calves, swine, chickens, and
turkeys for the treatment and control of various bacterial diseases.
The supplemental application is approved as of January 12, 2010, and
the regulations are amended in 21 CFR 520.2345d to reflect the
approval.
In addition, FDA has noticed that this approved concentration of
tetracycline soluble powder has not been codified for this sponsor. At
this time, the regulations are being amended to reflect approval of
this product. This change is being made to improve the accuracy of the
animal drug regulations.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
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.
List of Subjects in 21 CFR Part 520
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.2345d, revise paragraphs (b)(2) and (b)(3); remove
paragraph (b)(4); and redesignate paragraph (b)(5) as paragraph (b)(4)
to read as follows:
Sec. 520.2345d Tetracycline powder.
* * * * *
(b)* * *
(2) No. 000010: 102.4 and 324 grams per pound as in paragraph (d)
of this section.
(3) No. 046573: 25, 102.4, and 324 grams per pound as in paragraph
(d) of this section.
* * * * *
Dated: March 5, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-5925 Filed 3-17-10; 8:45 am]
BILLING CODE 4160-01-S
