Oral Dosage Form New Animal Drugs; Amprolium, 38554 [2011-16501]
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Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations
IRMAA determinations based on a
beneficiary’s income for two out of three
successive years. However, because we
make determinations annually, a
beneficiary will not be subject to an
IRMAA in consecutive years unless the
MAGI amount used is above the
threshold in consecutive years. A onetime increase in MAGI should affect a
beneficiary’s IRMAA for only one year.
Additionally, the changes made to 20
CFR 418.1210 in the interim final rule
help address the scenario discussed by
the commenter. In the scenario, an
individual received a one-time gain in
income due to a forced sale of stock, but
experienced a loss of dividend income
in subsequent years because of the loss
of the stock. The changes we made to 20
CFR 418.1210 clarify that we do not
consider events that result in the loss of
dividend income to be major lifechanging events if the reasons for such
loss are due to the ordinary risk of
investment. Conversely, a loss of
income-producing financial securities, if
the circumstances causing the loss are
truly beyond a beneficiary’s or his or her
spouse’s control and do not involve the
ordinary risk of investment, may qualify
as a major life-changing event in the
form of a loss of income-producing
property under 20 CFR 418.1205(e).
Accordingly, the interim final rule
remains unchanged and we are adopting
it as final.
Regulatory Procedures
We have consulted with the Office of
Management and Budget (OMB) and
determined that this final rule meets the
criteria for a significant regulatory
action under Executive Order 12866 as
supplemented by Executive Order
13563. Thus, the final rule was
reviewed by OMB.
Regulatory Flexibility Act
We certify that these final rules will
not have a significant economic impact
on a substantial number of small
entities, because they affect individuals
only. Therefore, a regulatory flexibility
analysis is not required under the
Regulatory Flexibility Act, as amended.
mstockstill on DSK4VPTVN1PROD with RULES
Paperwork Reduction Act
OMB previously approved the new
public reporting requirements posed by
this rule under a separate Information
Collection Request (OMB No. 0960–
0735). We are therefore not seeking
OMB approval for these requirements
here under the Paperwork Reduction
Act.
16:02 Jun 30, 2011
List of Subjects in 20 CFR Part 418
Administrative practice and
procedure, Aged, Blind, Disability
benefits, Public assistance programs,
Reporting and recordkeeping
requirements, Supplemental Security
Income (SSI), Medicare subsidies.
Michael J. Astrue,
Commissioner of Social Security.
Accordingly, the interim rule
amending 20 CFR chapter III, part 418,
subpart B that was published at 75 FR
41084 on July 15, 2010, is adopted as a
final rule without change.
[FR Doc. 2011–16526 Filed 6–30–11; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA–2011–N–0003]
Oral Dosage Form New Animal Drugs;
Amprolium
AGENCY:
Jkt 223001
CORID (amprolium) 20% Soluble
Powder, approved under NADA 33–165.
The ANADA is approved as of May 23,
2011, and the regulations in 21 CFR
520.100 are amended to reflect the
approval.
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.
FDA 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
Food and Drug Administration,
Animal drugs.
HHS.
ACTION:
Executive Order 12866 as
Supplemented by Executive Order
13563
VerDate Mar<15>2010
(Catalog of Federal Domestic Assistance
Program Nos. 93.774 Medicare
Supplementary Medical Insurance; 96.002
Social Security—Retirement Insurance.)
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original abbreviated new
animal drug application (ANADA) filed
by Cross Vetpharm Group Ltd. The
ANADA provides for the use of
amprolium soluble powder as an aid in
the treatment and prevention of
coccidiosis in calves.
DATES: This rule is effective July 1,
2011.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–170), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197,
e-mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–464 for the use of
AMPROMED (amprolium) for Calves, a
water-soluble powder used as an aid in
the treatment and prevention of
coccidiosis caused by Eimeria bovis and
E. zuernii. Cross Vetpharm Group Ltd.’s
AMPROMED for Calves is approved as
a generic copy of Huvepharma AD’s
PO 00000
Frm 00008
Fmt 4700
Sfmt 9990
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 § 520.100, add paragraph (b)(4) to
read as follows:
■
§ 520.100
Amprolium.
*
*
*
*
*
(b) * * *
(4) No. 061623 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
*
*
*
*
*
Dated: June 24, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–16501 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\01JYR1.SGM
01JYR1
]]>Agencies
[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Rules and Regulations]
[Page 38554]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2011-N-0003]
Oral Dosage Form New Animal Drugs; Amprolium
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 an original abbreviated new
animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The
ANADA provides for the use of amprolium soluble powder as an aid in the
treatment and prevention of coccidiosis in calves.
DATES: This rule is effective July 1, 2011.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-464 for the use of
AMPROMED (amprolium) for Calves, a water-soluble powder used as an aid
in the treatment and prevention of coccidiosis caused by Eimeria bovis
and E. zuernii. Cross Vetpharm Group Ltd.'s AMPROMED for Calves is
approved as a generic copy of Huvepharma AD's CORID (amprolium) 20%
Soluble Powder, approved under NADA 33-165. The ANADA is approved as of
May 23, 2011, and the regulations in 21 CFR 520.100 are amended to
reflect the approval.
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.
FDA 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
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. 520.100, add paragraph (b)(4) to read as follows:
Sec. 520.100 Amprolium.
* * * * *
(b) * * *
(4) No. 061623 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(2) of this section.
* * * * *
Dated: June 24, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-16501 Filed 6-30-11; 8:45 am]
BILLING CODE 4160-01-P
