Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin, 3488-3489 [2011-1040]
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Federal Register / Vol. 76, No. 13 / Thursday, January 20, 2011 / Rules and Regulations
March 2010, the Federal Reserve
proposed to amend Regulation DD and
the official staff commentary. 75 FR
9126 (March 1, 2010). Based on
comments it received, the Federal
Reserve issued a final rule on June 4,
2010. 75 FR 31673 (June 4, 2010).
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II. Interim Final Rule
In compliance with TISA, NCUA
issued an interim final rule with request
for comment on July 29, 2010, that was
substantially similar to the Federal
Reserve’s June 2010 final rule. The
interim final rule also included
technical corrections to the aggregate
overdraft and returned item fees sample
form for formatting purposes. The Board
issued the rule as an interim final rule
because there is a strong public interest
in having consumer-oriented rules in
place that are consistent with those
recently promulgated by the Federal
Reserve. Additionally, as discussed
above, NCUA is statutorily required to
issue rules substantially similar to those
of the Federal Reserve within 90 days of
the effective date of the Federal
Reserve’s rules.
III. Summary of Comments
NCUA received three comments on
the interim final rule. Two comments
were from credit union trade
associations and one comment was from
a State credit union league. Each
commenter suggested some degree of
change to the final rule. As discussed
below, the three areas where comments
offered suggestions were use of the term
‘‘Total Overdraft Fees,’’ use of model
form B–12, and the mandatory
compliance date for the amendments to
§ 707.11(a)(1)(i).
First, all three commenters requested
the Board permit credit unions to use
terms other than ‘‘Total Overdraft Fees’’
in a member’s periodic statement. One
commenter argued that the use of ‘‘Total
Overdraft Fees’’ would actually result in
more confusion as a credit union’s
account opening and promotional
materials might use a different term
than the one required by the rule on
periodic statements. Another
commenter suggested that the Board
should allow credit unions to use the
term ‘‘Total Overdraft Fees for paid
items,’’ which, the commenter argues,
will further enhance the distinction
between fees paid for items that are
covered by the credit union and fees
paid because an item is returned for
insufficient funds. The third commenter
requested that the Board allow credit
unions to use a term that is substantially
similar to ‘‘Total Overdraft Fees,’’ which
the commenter argues is in line with the
Federal Reserve’s regulations. The
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16:17 Jan 19, 2011
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Board disagrees with these comments
and reiterates its position from the
interim final rule that permitting the use
of terminology other than ‘‘Total
Overdraft Fees’’ could be confusing to
members and potentially undermines
their ability to compare costs,
particularly if the member has accounts
at different credit unions that each use
different terminology. Further, the
Board notes that requiring credit unions
to use the term ‘‘Total Overdraft Fees’’ is
identical to the requirement in the
Federal Reserve’s rule and this term in
conjunction with the other provisions in
the current rule provide sufficient
distinction between overdraft fees and
fees for insufficient funds.
Two commenters provided
suggestions on the technical changes to
model form B–12. One commenter
asked for additional guidance on the
requirement that credit unions disclose
the information in model form B–12 in
a tabular format. Another commenter
requested that credit unions be required
to continue using the original form to
prevent them from needing to spend
money on reformatting periodic
disclosure forms. With regard to both
comments, the Board notes that
§ 707.11(a)(3) of NCUA’s regulations
requires credit unions to use a format
that is substantially similar to model
form B–12. With respect to the first
comment, the Board does not believe
that a non-tabular disclosure is
‘‘substantially similar’’ to model form
B–12 and, therefore, would be
impermissible under the rule. With
respect to the second comment,
however, the Board does believe using
model form B–12 without the interim
final rule’s technical corrections would
be considered substantially similar. The
technical corrections made in the
interim final rule do not change the
substance or purpose of the form, but
rather ensure conformity with the model
form used by the Federal Reserve. Credit
unions can continue to use the nonamended form until their supplies are
depleted.
Finally, one commenter requested the
Board extend the mandatory compliance
date for the use of the term ‘‘Total
Overdraft Fees’’ to provide credit unions
with sufficient time to implement this
change. Since the mandatory
compliance date has already passed and
credit unions are currently required to
use the term ‘‘Total Overdraft Fees,’’ this
comment is moot. Further, as noted in
the preamble to the interim final rule,
the Board did consider the burden on
credit unions and chose a date that
would allow compliance in conjunction
with the Federal Reserve while
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minimizing the inconvenience to credit
unions.
IV. Regulatory Procedures
Section III of the SUPPLEMENTARY
to the July 2009 final rule
sets forth the Board’s analyses under the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.), the Paperwork Reduction Act of
1995 (44 U.S.C. 3506; 5 CFR part 1320
Appendix A.1), the Small Business
Regulatory Enforcement Fairness Act
(Pub. L. 104–121), Executive Order
13132, and the Treasury and General
Government Appropriations Act (Pub.
L. 105–277, 112 Stat. 2681 1998). See 74
FR 36102–36106. Because the final
amendments are clarifications and do
not alter the substance of the analyses
and determinations accompanying that
final rule, the Board continues to rely on
those analyses and determinations for
purposes of this rulemaking.
INFORMATION
By the National Credit Union
Administration Board on January 13, 2010.
Mary F. Rupp,
Secretary of the Board.
List of Subjects in 12 CFR Part 707
Advertising, Credit unions, Consumer
protection, Reporting and recordkeeping
requirements, Truth in savings.
Accordingly, the interim final rule
amending 12 CFR Part 707, which was
published at 75 FR 47173 on August 5,
2010, is adopted as a final rule without
change.
[FR Doc. 2011–1091 Filed 1–19–11; 8:45 am]
BILLING CODE 7535–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2010–N–0002]
Implantation or Injectable Dosage
Form New Animal Drugs;
Oxytetracycline and Flunixin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Norbrook
Laboratories, Ltd. The NADA provides
for veterinary prescription use of a
combination drug injectable solution
containing oxytetracycline and flunixin
meglumine in cattle.
SUMMARY:
E:\FR\FM\20JAR1.SGM
20JAR1
Federal Register / Vol. 76, No. 13 / Thursday, January 20, 2011 / Rules and Regulations
DATES:
This rule is effective January 20,
2011.
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.
Norbrook
Laboratories, Ltd., Station Works,
Newry, BT35 6JP, Northern Ireland,
filed NADA 141–312 that provides for
veterinary prescription use of
HEXASOL (oxytetracycline and flunixin
meglumine) Injection for the treatment
of bacterial pneumonia associated with
Pasteurella spp. and for the control of
associated pyrexia in beef and nonlactating dairy cattle. The application is
approved as of November 29, 2010, and
the regulations in part 522 (21 CFR part
522) are revised by adding 21 CFR
522.1664.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between
9 a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(ii) of the
act (21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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.
SUPPLEMENTARY INFORMATION:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
■
jlentini on DSKJ8SOYB1PROD with RULES
27 CFR Parts 4, 9, and 70
2. Add § 522.1664 to read as follows:
RIN 1513–AB39
§ 522.1664
Oxytetracycline and flunixin.
(a) Specifications. Each milliliter (mL)
of solution contains 300 milligrams (mg)
oxytetracycline base as amphoteric
oxytetracycline and 20 mg flunixin base
as flunixin meglumine.
(b) Sponsor. See No. 055529 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.286
and 556.500 of this chapter.
(d) Conditions of use cattle—(1)
Amount. Administer once as an
intramuscular or subcutaneous injection
of 1 mL per 22 pounds (lb) body weight
(BW) (13.6 mg oxytetracycline and
0.9 mg flunixin per lb BW) where
retreatment of calves and yearlings for
bacterial pneumonia is impractical due
to husbandry conditions, such as cattle
on range, or where their repeated
restraint is inadvisable.
(2) Indications for use. For the
treatment of bacterial pneumonia
associated with Pasteurella spp. and for
the control of associated pyrexia in beef
and nonlactating dairy cattle.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Discontinue
treatment at least 21 days prior to
slaughter of cattle. Do not use in female
dairy cattle 20 months of age or older.
Use in this class of cattle may cause
milk residues. A withdrawal period has
not been established in preruminating
calves. Do not use in calves to be
processed for veal. Use of dosages other
than those indicated may result in
residue violations.
Dated: January 11, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–1040 Filed 1–19–11; 8:45 am]
BILLING CODE 4160–01–P
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 522 is amended as follows:
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Alcohol and Tobacco Tax and Trade
Bureau
[Docket No. TTB–2007–0068; T.D. TTB–90;
Re: Notice Nos. 78 and 80]
Animal drugs.
16:17 Jan 19, 2011
DEPARTMENT OF THE TREASURY
Authority: 21 U.S.C. 360b.
List of Subjects in 21 CFR Part 522
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3489
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Revision of American Viticultural Area
Regulations
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Final rule; Treasury decision.
AGENCY:
In this Treasury decision, the
Alcohol and Tobacco Tax and Trade
Bureau amends the regulations
concerning the establishment of
American viticultural areas (AVAs). The
changes provide clearer regulatory
standards for the establishment of AVAs
and clarify the rules for preparing,
submitting, and processing viticultural
area petitions.
DATES: Effective Date: This final rule is
effective on February 22, 2011.
FOR FURTHER INFORMATION CONTACT: Rita
D. Butler, Regulations and Rulings
Division, Alcohol and Tobacco Tax and
Trade Bureau, 1310 G Street, NW., Suite
200–E, Washington, DC 20220;
telephone: 202–453–2101.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
TTB Authority
Section 105(e) of the Federal Alcohol
Administration Act (FAA Act), 27
U.S.C. 205(e), authorizes the Secretary
of the Treasury to prescribe regulations
for the labeling of wine, distilled spirits,
and malt beverages. The FAA Act
provides that these regulations should,
among other things, prohibit consumer
deception and the use of misleading
statements on labels, and ensure that
labels provide the consumer with
adequate information as to the identity
and quality of the product. The Alcohol
and Tobacco Tax and Trade Bureau
(TTB) administers the regulations
promulgated under the FAA Act.
Part 4 of the TTB regulations (27 CFR
part 4) provides for the establishment of
definitive viticultural areas and for the
use of their names as appellations of
origin on wine labels and in wine
advertisements. Part 9 of the TTB
regulations (27 CFR part 9) prescribes
the standards for submitting a petition
to establish a new American viticultural
area (AVA) or to modify an existing
AVA, and it contains a list with
descriptions of all approved AVAs. Part
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20JAR1
]]>Agencies
[Federal Register Volume 76, Number 13 (Thursday, January 20, 2011)]
[Rules and Regulations]
[Pages 3488-3489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1040]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2010-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs;
Oxytetracycline and Flunixin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by Norbrook Laboratories, Ltd. The NADA provides for
veterinary prescription use of a combination drug injectable solution
containing oxytetracycline and flunixin meglumine in cattle.
[[Page 3489]]
DATES: This rule is effective January 20, 2011.
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: Norbrook Laboratories, Ltd., Station Works,
Newry, BT35 6JP, Northern Ireland, filed NADA 141-312 that provides for
veterinary prescription use of HEXASOL (oxytetracycline and flunixin
meglumine) Injection for the treatment of bacterial pneumonia
associated with Pasteurella spp. and for the control of associated
pyrexia in beef and non-lactating dairy cattle. The application is
approved as of November 29, 2010, and the regulations in part 522 (21
CFR part 522) are revised by adding 21 CFR 522.1664.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(ii) of the act (21 U.S.C.
360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing
exclusivity beginning on the date of approval.
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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Add Sec. 522.1664 to read as follows:
Sec. 522.1664 Oxytetracycline and flunixin.
(a) Specifications. Each milliliter (mL) of solution contains 300
milligrams (mg) oxytetracycline base as amphoteric oxytetracycline and
20 mg flunixin base as flunixin meglumine.
(b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. Sec. 556.286 and 556.500 of this
chapter.
(d) Conditions of use cattle--(1) Amount. Administer once as an
intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body
weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW)
where retreatment of calves and yearlings for bacterial pneumonia is
impractical due to husbandry conditions, such as cattle on range, or
where their repeated restraint is inadvisable.
(2) Indications for use. For the treatment of bacterial pneumonia
associated with Pasteurella spp. and for the control of associated
pyrexia in beef and nonlactating dairy cattle.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Discontinue treatment at least 21
days prior to slaughter of cattle. Do not use in female dairy cattle 20
months of age or older. Use in this class of cattle may cause milk
residues. A withdrawal period has not been established in preruminating
calves. Do not use in calves to be processed for veal. Use of dosages
other than those indicated may result in residue violations.
Dated: January 11, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-1040 Filed 1-19-11; 8:45 am]
BILLING CODE 4160-01-P
