[Federal Register: January 11, 2010 (Volume 75, Number 6)]
[Rules and Regulations]
[Page 1275-1276]
[DOCID:fr11ja10-6]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

New Animal Drugs; Ractopamine

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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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 Elanco Animal Health, A Division of Eli
Lilly & Co. The supplemental NADA provides for administering
ractopamine hydrochloride Type C medicated feeds as a top dress to
cattle fed in confinement for slaughter.

DATES:  This rule is effective January 11, 2010.

FOR FURTHER INFORMATION CONTACT:  Suzanne J. Sechen, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 141-221 that provides for use of OPTAFLEXX 45
(ractopamine hydrochloride) Type A medicated articles to formulate Type
B and Type C medicated feeds administered to cattle fed in confinement
for slaughter for increased rate of weight gain and improved feed
efficiency during the last 28 to 42 days on feed. The supplement
provides for feeding ractopamine hydrochloride Type C medicated feed as
a top dress. The supplemental NADA is approved as of December 11, 2009,
and the regulations in 21 CFR 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 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 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental 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 in 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 part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority:  21 U.S.C. 360b, 371.

0
2. In Sec.  558.500, in paragraph (e)(2), in the heading of the first
table column, remove ``Ractopame'' and in its place add
``Ractopamine''; and add paragraph (e)(2)(xi) to read as follows:

Sec.  558.500   Ractopamine.

* * * * *
    (e) * * *
    (2) Cattle--

------------------------------------------------------------------------
Ractopamine in   Combination    Indications
   grams/ton     in grams/ton     for use      Limitations     Sponsor
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(xi) Not to     .............  Cattle fed in  Top dress in        000986
 exceed 800;                    confinement    a minimum of
 to provide 70                  for            1.0 lb of
 to 400 mg/                     slaughter:     medicated
 head/day.                      As in          feed.
                                paragraph
                                (e)(2)(i) of
                                this
                                section.
------------------------------------------------------------------------
                              * * * * * * *
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* * * * *

    Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-208 Filed 1-8-10; 8:45 am]
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[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Rules and Regulations]
[Pages 4890-4891]
[FR Doc No: 2012-2170]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 27 and 29

[Docket No. FAA-2009-0660; Amdt. Nos. 27-47A, 29-54A; and Docket No.
FAA-2009-0413; Amdt. No. 29-55A]
RIN 2120-AJ52, 2120-AJ51

Damage Tolerance and Fatigue Evaluation for Composite Rotorcraft
Structures, and Damage Tolerance and Fatigue Evaluation for Metallic
Structures; Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: The FAA is correcting two final rules, ``Damage Tolerance and
Fatigue Evaluation for Composite Rotorcraft Structures'' (76 FR 74655),
published December 1, 2011, and ``Damage Tolerance and Fatigue
Evaluation for Metallic Structures'' (76 FR 75435), published December
2, 2011. In the ``Composite Rotorcraft Structures'' rule, the FAA
amended its regulations to require evaluation of fatigue and residual
static strength of composite rotorcraft structures using a damage
tolerance evaluation, or a fatigue evaluation if the applicant
establishes that a damage tolerance evaluation is impractical. In the
``Metallic Structures'' rule, the FAA amended its regulations to
address advances in structural fatigue substantiation technology for
metallic structures to provide an increased level of safety by avoiding
or reducing the likelihood of the catastrophic fatigue failure of a
metallic structure. This document corrects errors in the preamble of
those two documents by adding a statement advising that affected
parties do not need to comply with the information collection
requirements until the Office of Management and Budget (OMB) approves
the collections.

DATES: This correction is effective February 1, 2012. The ``Composite
Rotorcraft Structures'' final rule becomes effective January 30, 2012.
The ``Metallic Structures'' final rule becomes effective January 31,
2012.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Sharon Y. Miles, Regulations and Policy Group,
Rotorcraft Directorate, ASW-111, Federal Aviation Administration, 2601
Meacham Boulevard, Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
facsimile<PHONE_NUMBER>; email

<EMAIL_ADDRESS>For legal questions concerning this action,
contact Steve C. Harold, Directorate Counsel, ASW-7G, Federal Aviation
Administration, 2601 Meacham Boulevard, Fort Worth, Texas 76137,
telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On December 1, 2011, the FAA published the final rule entitled,
``Damage Tolerance and Fatigue Evaluation for Composite Rotorcraft
Structures'' (76 FR 74655). On December 2, 2011, the FAA published the
final rule entitled, ``Damage Tolerance and Fatigue Evaluation for
Metallic Structures'' (76 FR 75435).
    In the ``Composite Rotorcraft Structures'' final rule, the FAA
amended its regulations to require evaluation of fatigue and residual
static strength of composite rotorcraft structures using a damage
tolerance evaluation, or a fatigue evaluation if the applicant
establishes that a damage tolerance evaluation is impractical.
    In the ``Metallic Structures'' final rule, the FAA amended its
regulations to address advances in structural fatigue substantiation
technology for metallic structures. This provides an increased level of
safety by avoiding or reducing the likelihood of the catastrophic
fatigue failure of a metallic structure. These increased safety
requirements help ensure that should serious accidental damage occur
during manufacturing or within the operational life of the rotorcraft,
the remaining structure could withstand, without failure, any fatigue
loads that are likely to occur, until the damage is detected or the
part is replaced.
    Both final rules included information collection requirements.
However, the FAA inadvertently neglected to include a statement
advising affected parties that they are not required to comply with
these portions of the regulations until the Office of Management and
Budget (OMB) approves the collections and assigns control numbers under
the Paperwork Reduction Act of 1995. The FAA will publish in the
Federal Register a notice of the control numbers assigned by OMB when
these information collection requirements are approved.

Corrections

    In FR Doc. 2011-30945, beginning on page 74655 in the Federal
Register of December 1, 2011, make the following correction:
    On page 74655, in the second column, after ``Dates: Effective
January 30, 2012.'', insert ``Affected parties, however, are not
required to comply with the information collection requirement in
Sec. Sec.  27.573 and 29.573 until the Office of Management and Budget
(OMB) approves the collection and assigns a control number under the
Paperwork Reduction Act of 1995. The FAA will publish in the Federal
Register a notice of the control number assigned by the Office of
Management and Budget (OMB) for this information collection
requirement.''
    In FR Doc. 2011-30941, beginning on page 75435 in the Federal
Register of December 2, 2011, make the following correction:
    On page 75435, in the second column, after ``Dates: Effective
January 31, 2012.'', insert ``Affected parties, however, are not
required to comply with the information collection requirement in Sec.
29.571 until the Office of Management and Budget (OMB) approves the
collection and assigns a control number under the Paperwork Reduction
Act of 1995. The FAA will publish in the Federal Register a notice of
the control number assigned by the Office of Management and Budget
(OMB) for this information collection requirement.''

    Issued in Washington, DC, on January 26, 2012.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. 2012-2170 Filed 1-27-12; 8:45 am]
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