New Animal Drugs; Ractopamine, 72714-72715 [E8-28384]
Download as PDF
<![CDATA[
72714
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Rules and Regulations
VIII. Effective Date and Congressional
Notification
151. These regulations will become
effective December 31, 2008.
List of Subjects in 18 CFR Part 284
Continental shelf, Natural gas, and
Reporting and recordkeeping
requirements.
By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
In consideration of the foregoing, the
Commission amends Part 284, Chapter I,
Title 18, Code of Federal Regulations, as
follows:
■
PART 284—CERTAIN SALES AND
TRANSPORTATION OF NATURAL GAS
UNDER THE NATURAL GAS POLICY
ACT OF 1978 AND RELATED
AUTHORITIES
1. The authority citation for part 284
continues to read as follows:
■
Authority: 15 U.S.C. 717–717w, 3301–
3432; 42 U.S.C. 7101–7352; 43 U.S.C. 1331–
1356.
2. Amend § 284.8 as follows:
a. Paragraphs (b) and (h) are revised to
read as follows:
■
■
§ 284.8 Release of firm capacity on
interstate pipelines.
erowe on PROD1PC63 with RULES
*
*
*
*
*
(b)(1) Firm shippers must be
permitted to release their capacity, in
whole or in part, on a permanent or
short-term basis, without restriction on
the terms or conditions of the release. A
firm shipper may arrange for a
replacement shipper to obtain its
released capacity from the pipeline. A
replacement shipper is any shipper that
obtains released capacity.
(2) The rate charged the replacement
shipper for a release of capacity may not
exceed the applicable maximum rate,
except that no rate limitation applies to
the release of capacity for a period of
one year or less if the release is to take
effect on or before one year from the
date on which the pipeline is notified of
the release. Payments or other
consideration exchanged between the
releasing and replacement shippers in a
release to an asset manager as defined
in paragraph (h)(3) of this section are
not subject to the maximum rate.
*
*
*
*
*
(h)(1) The following releases need not
comply with the bidding requirements
of paragraphs (c) through (e) of this
section:
(i) A release of capacity to an asset
manager as defined in paragraph (h)(4)
of this section;
(ii) A release of capacity to a marketer
participating in a state-regulated retail
VerDate Aug<31>2005
14:32 Nov 28, 2008
Jkt 217001
access program as defined in paragraph
(h)(5) of this section;
(iii) A release for more than one year
at the maximum tariff rate; and
(iv) A release for any period of 31
days or less.
(v) If a release is exempt from bidding
under paragraph (h)(1) of this section,
notice of the release must be provided
on the pipeline’s Internet Web site as
soon as possible, but not later than the
first nomination, after the release
transaction commences.
(2) When a release of capacity is
exempt from bidding under paragraph
(h)(1)(iv) of this section, a firm shipper
may not roll over, extend or in any way
continue the release to the same
replacement shipper using the 31 days
or less bidding exemption until 28 days
after the first release period has ended.
The 28-day hiatus does not apply to any
re-release to the same replacement
shipper that is posted for bidding or that
qualifies for any of the other exemptions
from bidding in paragraph (h)(1) of this
section.
(3) A release to an asset manager
exempt from bidding requirements
under paragraph (h)(1)(i) of this section
is any pre-arranged release that contains
a condition that the releasing shipper
may call upon the replacement shipper
to deliver to, or purchase from, the
releasing shipper a volume of gas up to
100 percent of the daily contract
demand of the released transportation or
storage capacity, as provided in
paragraphs (h)(3)(i) through (h)(3)(iii) of
this paragraph.
(i) If the capacity release is for a
period of one year or less, the asset
manager’s delivery or purchase
obligation must apply on any day
during a minimum period of the lesser
of five months (or 155 days) or the term
of the release.
(ii) If the capacity release is for a
period of more than one year, the asset
manager’s delivery or purchase
obligation must apply on any day
during a minimum period of five
months (or 155 days) of each twelvemonth period of the release, and on fivetwelfths of the days of any additional
period of the release not equal to twelve
months.
(iii) If the capacity release is a release
of storage capacity, the asset manager’s
delivery or purchase obligation need
only be up to 100 percent of the daily
contract demand under the release for
storage withdrawals or injections, as
applicable.
(4) A release to a marketer
participating in a state-regulated retail
access program exempt from bidding
requirements under paragraph (h)(1)(ii)
of this section is any prearranged
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
capacity release that will be utilized by
the replacement shipper to provide the
gas supply requirement of retail
consumers pursuant to a retail access
program approved by the state agency
with jurisdiction over the local
distribution company that provides
delivery service to such retail
consumers.
[FR Doc. E8–28217 Filed 11–28–08; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
[Docket No. FDA–2008–N–0039]
New Animal Drugs; Ractopamine
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 Elanco
Animal Health. The NADA provides for
use of ractopamine hydrochloride Type
A medicated articles to make Type B
and Type C medicated feeds used for
increased rate of weight gain and
improved feed efficiency in finishing
turkeys.
DATES:
This rule is effective December 1,
2008.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116,
e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed NADA
141–290 that provides for use of
TOPMAX 9 (ractopamine
hydrochloride) Type A medicated
article to make Type B and Type C
medicated feeds used for increased rate
of weight gain and improved feed
efficiency in finishing turkeys. The
NADA is approved as of November 12,
2008, and the regulations in 21 CFR
556.570 and 558.500 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
E:\FR\FM\01DER1.SGM
01DER1
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Rules and Regulations
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.
The agency has carefully considered
the potential environmental effects of
this action. FDA has concluded that the
action will not have a significant impact
on the human environment, and that an
environmental impact statement is not
required. The agency’s finding of no
significant impact and the evidence
supporting that finding, contained in an
environmental assessment, may be seen
in the Division of Dockets Management
(see address in the previous paragraph)
between 9 a.m. and 4 p.m., Monday
through Friday.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(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.
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
21 CFR Part 556
Animal drugs, Foods.
Ractopamine in
grams/ton
21 CFR Part 558
Animal drugs, Animal feeds.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 556 and 558 are amended as
follows:
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
Authority: 21 U.S.C. 342, 360b, 371.
2. In § 556.570, add paragraph (b)(3) to
read as follows:
■
Ractopamine.
*
*
*
*
*
(b) * * *
(3) Turkeys—(i) Liver (the target
tissue). The tolerance for ractopamine
(the marker residue) is 0.45 ppm.
(ii) Muscle. The tolerance for
ractopamine (the marker residue) is 0.1
ppm.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
4. In § 558.500:
Combination in
grams/ton
■
Ractopamine.
*
1. The authority citation for 21 CFR
part 556 continues to read as follows:
■
a. Revise paragraph (d)(1);
b. Redesignate paragraphs (d)(2) and
(d)(3) as paragraphs (d)(4) and (d)(5);
■ c. Add new paragraphs (d)(2) and
(d)(3);
■ d. In paragraph (e)(2)(i), in the
‘‘Limitations’’ column, remove ‘‘Not for
animals intended for breeding.’’; and
■ e. Add paragraph (e)(3).
The revisions and additions read as
follows:
■
§ 558.500
■
§ 556.570
72715
*
*
*
*
(d) * * *
(1) Labeling of Type B and Type C
feeds shall bear the following: ‘‘Not for
animals intended for breeding.’’
(2) Labeling of Type B and Type C
swine feeds shall bear the following:
(i) ‘‘No increased benefit has been
shown when ractopamine
concentrations in the diet are greater
than 4.5 g/ton.’’
(ii) ‘‘Ractopamine may increase the
number of injured and/or fatigued pigs
during marketing.’’
(3) Labeling of Type B and Type C
tom turkey feeds shall bear the
following: ‘‘No increased benefit has
been shown when ractopamine
concentrations in the diet are greater
than 4.6 g/ton.’’
*
*
*
*
*
(e) * * *
(3) Turkeys—
Indications for use
Limitations
(i) 4.6 to 11.8 (5 to 13 ppm)
Finishing hen turkeys: For increased rate of weight gain and
improved feed efficiency when
fed for the last 7 to 14 days prior
to slaughter.
Feed continuously as sole ration
during the last 7 to 14 days prior
to slaughter.
000986
(ii) 4.6 to 11.8 (5 to 13 ppm)
Finishing tom turkeys: For increased rate of weight gain and
improved feed efficiency when
fed for the last 14 days prior to
slaughter.
Feed continuously as sole ration
during the last 14 days prior to
slaughter. Feeding ractopamine
to tom turkeys during periods of
excessive heat can result in increased mortality.
000986
Dated: November 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–28384 Filed 11–28–08; 8:45 am]
PENSION BENEFIT GUARANTY
CORPORATION
BILLING CODE 4160–01–S
Benefits Payable in Terminated SingleEmployer Plans
29 CFR Part 4022
Pension Benefit Guaranty
Corporation.
erowe on PROD1PC63 with RULES
AGENCY:
ACTION:
Final rule.
SUMMARY: This rule amends Appendix D
to the Pension Benefit Guaranty
Corporation’s regulation on Benefits
VerDate Aug<31>2005
14:32 Nov 28, 2008
Jkt 217001
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
Sponsor
Payable in Terminated Single-Employer
Plans by adding the maximum
guaranteeable pension benefit that may
be paid by the PBGC with respect to a
plan participant in a single-employer
pension plan that terminates in 2009.
The amendment is necessary because
the maximum guarantee amount
changes each year, based on changes in
the contribution and benefit base under
section 230 of the Social Security Act.
The effect of the amendment is to advise
plan administrators, participants and
E:\FR\FM\01DER1.SGM
01DER1
]]>Agencies
[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Rules and Regulations]
[Pages 72714-72715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28384]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
[Docket No. FDA-2008-N-0039]
New Animal Drugs; Ractopamine
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 Elanco Animal Health. The NADA provides for use of
ractopamine hydrochloride Type A medicated articles to make Type B and
Type C medicated feeds used for increased rate of weight gain and
improved feed efficiency in finishing turkeys.
DATES: This rule is effective December 1, 2008.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA
141-290 that provides for use of TOPMAX 9 (ractopamine hydrochloride)
Type A medicated article to make Type B and Type C medicated feeds used
for increased rate of weight gain and improved feed efficiency in
finishing turkeys. The NADA is approved as of November 12, 2008, and
the regulations in 21 CFR 556.570 and 558.500 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
[[Page 72715]]
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.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Division
of Dockets Management (see address in the previous paragraph) between 9
a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (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.
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
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and
558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
2. In Sec. 556.570, add paragraph (b)(3) to read as follows:
Sec. 556.570 Ractopamine.
* * * * *
(b) * * *
(3) Turkeys--(i) Liver (the target tissue). The tolerance for
ractopamine (the marker residue) is 0.45 ppm.
(ii) Muscle. The tolerance for ractopamine (the marker residue) is
0.1 ppm.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In Sec. 558.500:
0
a. Revise paragraph (d)(1);
0
b. Redesignate paragraphs (d)(2) and (d)(3) as paragraphs (d)(4) and
(d)(5);
0
c. Add new paragraphs (d)(2) and (d)(3);
0
d. In paragraph (e)(2)(i), in the ``Limitations'' column, remove ``Not
for animals intended for breeding.''; and
0
e. Add paragraph (e)(3).
The revisions and additions read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(d) * * *
(1) Labeling of Type B and Type C feeds shall bear the following:
``Not for animals intended for breeding.''
(2) Labeling of Type B and Type C swine feeds shall bear the
following:
(i) ``No increased benefit has been shown when ractopamine
concentrations in the diet are greater than 4.5 g/ton.''
(ii) ``Ractopamine may increase the number of injured and/or
fatigued pigs during marketing.''
(3) Labeling of Type B and Type C tom turkey feeds shall bear the
following: ``No increased benefit has been shown when ractopamine
concentrations in the diet are greater than 4.6 g/ton.''
* * * * *
(e) * * *
(3) Turkeys--
------------------------------------------------------------------------
Combination
Ractopamine in grams/ Indications Limitations Sponsor
in grams/ton ton for use
------------------------------------------------------------------------
(i) 4.6 to ............ Finishing hen Feed 000986
11.8 (5 to turkeys: For continuously
13 ppm) increased as sole
rate of ration during
weight gain the last 7 to
and improved 14 days prior
feed to slaughter.
efficiency
when fed for
the last 7 to
14 days prior
to slaughter.
------------------------------------------------------------------------
(ii) 4.6 to ............ Finishing tom Feed 000986
11.8 (5 to turkeys: For continuously
13 ppm) increased as sole
rate of ration during
weight gain the last 14
and improved days prior to
feed slaughter.
efficiency Feeding
when fed for ractopamine
the last 14 to tom
days prior to turkeys
slaughter. during
periods of
excessive
heat can
result in
increased
mortality.
------------------------------------------------------------------------
Dated: November 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-28384 Filed 11-28-08; 8:45 am]
BILLING CODE 4160-01-S
