New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine, 21126-21127 [2014-08445]
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21126
Federal Register / Vol. 79, No. 72 / Tuesday, April 15, 2014 / Rules and Regulations
PART 1273—UNIFORM
ADMINISTRATIVE REQUIREMENTS
FOR GRANTS AND COOPERATIVE
AGREEMENTS TO STATE AND LOCAL
GOVERNMENTS
3. The authority citation for 14 CFR
part 1273 is revised to read as follows:
■
Authority: 51 U.S.C. 20113(e), Pub. L. 97–
258, 96 Stat. 1003 (31 U.S.C. 6301, et seq.),
and 2 CFR Part 200.
§§ 1273.50 and 1273.51
Reserved]
[Removed and
4. Sections 1273.50 and 1273.51 are
removed and reserved.
■
PART 1274—COOPERATIVE
AGREEMENTS WITH COMMERCIAL
FIRMS
5. The authority citation for 14 CFR
part 1274 is revised to read as follows:
■
Authority: 51 U.S.C. 20113(e), Pub. L. 97–
258, 96 Stat. 1003 (31 U.S.C. 6301, et seq.).
§§ 1274.803 and 1274.804
Reserved]
[Removed and
charges by interstate oil pipelines for
transportation in interstate commerce.
DATES: Effective May 15, 2014.
FOR FURTHER INFORMATION CONTACT:
Aaron Kahn (Technical Issues), 888
First Street, NE., Washington, DC 20426,
(202) 502–8339, aaron.kahn@ferc.gov.
SUPPLEMENTARY INFORMATION:
Notice Regarding Compliance Date
On June 14, 2013, the Commission
granted an indefinite extension of time
for compliance with the Final Rule in
Docket No. RM12–15–000 (May 16,
2013 Order) 1 pending final clearance
from the Office of Management and
Budget (OMB) and further notice from
the Commission. The Commission
received clearance from OMB on
September 30, 2013. Beginning May 15,
2014, covered entities are required to
comply with the terms of the Final Rule
published May 29, 2013 at 78 FR 32090.
Dated: April 9, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014–08510 Filed 4–14–14; 8:45 am]
6. Sections 1274.803 and 1274.804 are
removed and reserved.
■
BILLING CODE 6717–01–P
[FR Doc. 2014–08372 Filed 4–14–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 7510–01–P
DEPARTMENT OF ENERGY
Food and Drug Administration
Federal Energy Regulatory
Commission
21 CFR Part 522
18 CFR Part 341
New Animal Drugs; Ceftiofur Sodium;
Gentamicin; Xylazine
[Docket No. FDA–2014–N–0002]
[Docket Nos. RM12–15–000 and RM01–5–
000]
Final rule; technical
amendment.
ACTION:
Federal Energy Regulatory
Commission, DOE.
ACTION: Notice of extension of
compliance date.
AGENCY:
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The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during March 2014. FDA is
also informing the public of the
availability of summaries of the basis of
approval and of environmental review
SUMMARY:
This document revises the
date to comply with the terms of the
Final Rule (RM12–15–000) which was
published in the Federal Register of
Wednesday, May 29, 2013. The rule
amended regulations under the
Interstate Commerce Act to update
requirements governing the form,
composition and filing of rates and
VerDate Mar<15>2010
Food and Drug Administration,
HHS.
Filing, Indexing and Service
Requirements for Oil Pipelines
SUMMARY:
AGENCY:
1 Filing, Indexing and Service Requirements for
Oil Pipelines, Order No. 780, 78 FR 32090 (May 29,
2013), FERC Stats. & Regs. ¶ 31,347 (2013).
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
documents, where applicable. The
animal drug regulations are also being
amended to reflect a change of
sponsorship for an ANADA.
DATES:
This rule is effective April 15,
2014.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during March 2014, as listed
in table 1. In addition, FDA is informing
the public of the availability, where
applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents 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. Persons with
access to the Internet may obtain these
documents at the Center for Veterinary
Medicine FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/ApprovedAnimalDrug
Products/default.htm.
Also, the regulations are being
amended to reflect the previous
approval of revised food safety warnings
for ceftiofur sodium powder for
injection. This amendment is being
made to improve the accuracy of the
regulations.
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:
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Federal Register / Vol. 79, No. 72 / Tuesday, April 15, 2014 / Rules and Regulations
21127
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH 2014
NADA/
ANADA
Sponsor
New animal drug
product name
200–468 ...
Cross Vetpharm Group Ltd.,
Broomhill Rd., Tallaght,
Dublin 24, Ireland.
Cross Vetpharm Group Ltd.,
Broomhill Rd., Tallaght,
Dublin 24, Ireland.
GENTAMED–P for Poultry
(gentamicin sulfate) Injection.
XYLAMED (xylazine) Injection.
200–529 ...
21 CFR
Section
FOIA
Summary
ge101–
522.1044
yes ...........
CE.1 2
ge047–
522.2662
yes ...........
CE.1 2
Action
Original approval as a
neric copy of NADA
862.
Original approval as a
neric copy of NADA
956.
NEPA
Review
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
2 CE granted under 21 CFR 25.33(a)(1).
List of Subjects in 21 CFR Part 522
PENSION BENEFIT GUARANTY
CORPORATION
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
1. The authority citation for 21 CFR
part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
2. In 522.313c, revise paragraph (d) to
read as follows:
■
Ceftiofur sodium.
*
*
*
*
*
(d) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
Federal law prohibits extra-label use of
this drug in cattle, swine, chickens, and
turkeys for disease prevention purposes;
at unapproved doses, frequencies,
durations, or routes of administration;
and in unapproved major foodproducing species/production classes.
*
*
*
*
*
§ 522.1044
[Amended]
3. In § 522.1044, in paragraph (b)(4),
remove ‘‘No. 000859’’ and in its place
add ‘‘Nos. 000859 and 061623’’.
■
§ 522.2662
[Amended]
4. In § 522.2662, in paragraph (b)(2),
remove ‘‘No. 000010’’ and in its place
add ’’ Nos. 000010 and 061623’’.
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■
Dated: April 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–08445 Filed 4–14–14; 8:45 am]
BILLING CODE 4160–01–P
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Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions
for Paying Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
This final rule amends the
Pension Benefit Guaranty Corporation’s
regulation on Benefits Payable in
Terminated Single-Employer Plans to
prescribe interest assumptions under
the regulation for valuation dates in
May 2014. The interest assumptions are
used for paying benefits under
terminating single-employer plans
covered by the pension insurance
system administered by PBGC.
DATES: Effective May 1, 2014.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion (Klion.Catherine@
pbgc.gov), Assistant General Counsel for
Regulatory Affairs, Pension Benefit
Guaranty Corporation, 1200 K Street
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll-free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: PBGC’s
regulation on Benefits Payable in
Terminated Single-Employer Plans (29
CFR Part 4022) prescribes actuarial
assumptions—including interest
assumptions—for paying plan benefits
under terminating single-employer
plans covered by title IV of the
Employee Retirement Income Security
Act of 1974. The interest assumptions in
the regulation are also published on
PBGC’s Web site (https://www.pbgc.gov).
PBGC uses the interest assumptions in
Appendix B to Part 4022 to determine
whether a benefit is payable as a lump
sum and to determine the amount to
pay. Appendix C to Part 4022 contains
interest assumptions for private-sector
SUMMARY:
■
§ 522.313c
29 CFR Part 4022
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Fmt 4700
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pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using PBGC’s historical
methodology. Currently, the rates in
Appendices B and C of the benefit
payment regulation are the same.
The interest assumptions are intended
to reflect current conditions in the
financial and annuity markets.
Assumptions under the benefit
payments regulation are updated
monthly. This final rule updates the
benefit payments interest assumptions
for May 2014.1
The May 2014 interest assumptions
under the benefit payments regulation
will be 1.50 percent for the period
during which a benefit is in pay status
and 4.00 percent during any years
preceding the benefit’s placement in pay
status. In comparison with the interest
assumptions in effect for April 2014,
these interest assumptions are
unchanged.
PBGC has determined that notice and
public comment on this amendment are
impracticable and contrary to the public
interest. This finding is based on the
need to determine and issue new
interest assumptions promptly so that
the assumptions can reflect current
market conditions as accurately as
possible.
Because of the need to provide
immediate guidance for the payment of
benefits under plans with valuation
dates during May 2014, PBGC finds that
good cause exists for making the
assumptions set forth in this
amendment effective less than 30 days
after publication.
PBGC has determined that this action
is not a ‘‘significant regulatory action’’
under the criteria set forth in Executive
Order 12866.
1 Appendix B to PBGC’s regulation on Allocation
of Assets in Single-Employer Plans (29 CFR Part
4044) prescribes interest assumptions for valuing
benefits under terminating covered single-employer
plans for purposes of allocation of assets under
ERISA section 4044. Those assumptions are
updated quarterly.
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]]>Agencies
[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Rules and Regulations]
[Pages 21126-21127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08445]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
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 actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during March 2014. FDA is also informing the public of the
availability of summaries of the basis of approval and of environmental
review documents, where applicable. The animal drug regulations are
also being amended to reflect a change of sponsorship for an ANADA.
DATES: This rule is effective April 15, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during March 2014, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents 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. Persons with access to the Internet may
obtain these documents at the Center for Veterinary Medicine FOIA
Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Also, the regulations are being amended to reflect the previous
approval of revised food safety warnings for ceftiofur sodium powder
for injection. This amendment is being made to improve the accuracy of
the regulations.
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.
[[Page 21127]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2014
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ ANADA Sponsor product name Action Section FOIA Summary NEPA Review
----------------------------------------------------------------------------------------------------------------
200-468........ Cross Vetpharm GENTAMED-P for Original 522.1044 yes........... CE.1 2
Group Ltd., Poultry approval as a
Broomhill Rd., (gentamicin generic copy of
Tallaght, sulfate) NADA 101-862.
Dublin 24, Injection.
Ireland.
200-529........ Cross Vetpharm XYLAMED Original 522.2662 yes........... CE.1 2
Group Ltd., (xylazine) approval as a
Broomhill Rd., Injection. generic copy of
Tallaght, NADA 047-956.
Dublin 24,
Ireland.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the
requirement to submit an environmental assessment or an environmental impact statement because it is of a type
that does not individually or cumulatively have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
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. In 522.313c, revise paragraph (d) to read as follows:
Sec. 522.313c Ceftiofur sodium.
* * * * *
(d) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian. Federal law prohibits
extra-label use of this drug in cattle, swine, chickens, and turkeys
for disease prevention purposes; at unapproved doses, frequencies,
durations, or routes of administration; and in unapproved major food-
producing species/production classes.
* * * * *
Sec. 522.1044 [Amended]
0
3. In Sec. 522.1044, in paragraph (b)(4), remove ``No. 000859'' and in
its place add ``Nos. 000859 and 061623''.
Sec. 522.2662 [Amended]
0
4. In Sec. 522.2662, in paragraph (b)(2), remove ``No. 000010'' and in
its place add '' Nos. 000010 and 061623''.
Dated: April 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-08445 Filed 4-14-14; 8:45 am]
BILLING CODE 4160-01-P
