[Federal Register Volume 78, Number 228 (Tuesday, November 26, 2013)]
[Notices]
[Page 70623]
[FR Doc No: 2013-28298]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-1999-6439, Notice No. 24]

Adjustment of Nationwide Significant Risk Threshold

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of adjustment of Nationwide Significant Risk Threshold.

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SUMMARY: In accordance with appendix D to title 49 Code of Federal
Regulations (CFR) part 222, Use of Locomotive Horns at Public Highway-
Rail Grade Crossings, FRA is updating the Nationwide Significant Risk
Threshold (NSRT). This action is needed to ensure that the public has
the proper threshold of permissible risk for calculating quiet zones
established in relationship to the NSRT. This is the sixth update to
the NSRT, which is increasing from 13,722 to 14,347.

DATES: The effective date of this notice is November 26, 2013.

FOR FURTHER INFORMATION CONTACT: Mr. Ronald Ries, Office of Railroad
Safety, FRA, 1200 New Jersey Avenue SE., Washington, DC 20590, (202)
493-6299<EMAIL_ADDRESS>or Kathryn Shelton, Office of Chief
Counsel, FRA, 1200 New Jersey Avenue SE., Washington, DC 20590, (202)
493-6038<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The NSRT is an average of the risk indexes for gated public
crossings nationwide where train horns are routinely sounded. FRA
developed this risk index to serve as one threshold of permissible risk
for quiet zones established across the nation under 49 CFR part 222,
Use of Locomotive Horns at Public Highway-Rail Grade Crossings. Thus, a
community that is trying to establish and/or maintain its quiet zone,
pursuant to 49 CFR part 222, can compare the Quiet Zone Risk Index
calculated for its specific crossing corridor to the NSRT to determine
whether sufficient measures have been taken to compensate for the
excess risk that results from prohibiting routine sounding of the
locomotive horn. (In the alternative, a community can establish its
quiet zone in comparison to the Risk Index With Horns, which is defined
in 49 CFR 222.9 as a measure of risk to the motoring public when
locomotive horns are routinely sounded at every public highway-rail
grade crossing within a quiet zone.)
    FRA has been updating the NSRT since 2006, when it was calculated
to be 17,030 (71 FR 47614, August 17, 2006). In 2007, FRA recalculated
the NSRT to be 19,047 (72 FR 14850, March 29, 2007). In 2008, FRA
recalculated the NSRT to be 17,610 (73 FR 30661, May 28, 2008). In
2009, FRA recalculated the NSRT to be 18,775 (74 FR 45270, September 1,
2009). In 2010, FRA recalculated the NSRT to be 14,007 (75 FR 82136,
December 29, 2010). FRA's last update to the NSRT was made in 2012,
when it was calculated to be 13,722 (77 FR 546, January 5, 2012).

New NSRT

    Using collision data over a five-year period from 2008 to 2012, FRA
has recalculated the NSRT based on formulas identified in appendix D to
49 CFR part 222. In making this recalculation, FRA noted that the total
number of gated crossings nationwide where train horns are routinely
sounded was 42,544.
[GRAPHIC] [TIFF OMITTED] TN26NO13.204

    Applying the fatality rate and injury rate to the probable number
of fatalities and casualties predicted to occur at each of the 42,544
identified crossings and the predicted cost of the associated injuries
and fatalities, FRA calculates the NSRT to be 14,347. Accordingly, this
updated NSRT value will serve as one threshold of permissible risk for
quiet zones established across the nation pursuant to 49 CFR part 222.

    Issued in Washington, DC on November 21, 2013.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2013-28298 Filed 11-25-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 104 (Wednesday, May 30, 2012)]
[Rules and Regulations]
[Pages 31722-31724]
[FR Doc No: 2012-13010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Change of Sponsor; Estradiol; Estradiol
Benzoate and Testosterone Propionate; Progesterone and Estradiol
Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol;
Melengestrol; Ractopamine; Zilpaterol

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 a change of sponsor for 17 new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) for various steroid ear implants for cattle and for
melengestrol acetate liquid Type A medicated article and use in
combination medicated feeds for heifers fed in confinement for
slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc.,
to Elanco Animal Health, Division of Eli Lilly & Co.

DATES: This rule is effective May 30, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal
Health, Inc., 8857 Bond St., Overland Park, KS 66214, has informed FDA
that it has transferred ownership of, and all rights and interest in,
the NADAs and ANADAs in this table to Elanco Animal Health, Division of
Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285.

------------------------------------------------------------------------
                                 Proprietary name
         NADA/ANADA             (established name)      21 CFR section
------------------------------------------------------------------------
110-315.....................  COMPONENT E-C                     522.1940
                               (progesterone and
                               estradiol benzoate)
                               with TYLAN (tylosin
                               tartrate).
                              COMPONENT E-S
                               (progesterone and
                               estradiol benzoate)
                               with TYLAN (tylosin
                               tartrate).
118-123.....................  COMPONENT 200
                               (estradiol benzoate).
                              ENCORE (COMPUDOSE 400)             522.840
                               (estradiol benzoate).
135-906.....................  COMPONENT E-H                      522.842
                               (estradiol benzoate
                               and testosterone
                               propionate) with
                               TYLAN (tylosin
                               tartrate).
200-221.....................  COMPONENT TE-IS                   522.2477
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-S
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-G
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-IS
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-S
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-G
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-ID
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
200-224.....................  COMPONENT T-H                     522.2476
                               (trenbolone acetate)
                               with TYLAN (tylosin
                               tartrate).
                              COMPONENT T-S
                               (trenbolone acetate)
                               with TYLAN (tylosin
                               tartrate).
200-343.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix.
200-346.....................  COMPONENT TE-H                    522.2477
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-H
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
                              COMPONENT TE-IH
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-200
                               (trenbolone acetate
                               and estradiol).
                              COMPONENT TE-200
                               (trenbolone acetate
                               and estradiol) with
                               TYLAN (tylosin
                               tartrate).
200-375.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix/RUMENSIN
                               (monensin)/TYLAN
                               (tylosin phosphate).
200-422.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix plus RUMENSIN
                               (monensin).
200-424.....................  HEIFERMAX 500                      558.500
                               (melengestrol
                               acetate) Liquid
                               Premix/OPTAFLEXX
                               (ractopamine HCI)/
                               RUMENSIN (monensin)/
                               TYLAN (tylosin
                               phosphate).
200-427.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix plus TYLAN
                               (tylosin phosphate).
200-430.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix/BOVATEC
                               (lasalocid)/TYLAN
                               (tylosin phosphate).
200-448.....................  HEIFERMAX 500                      558.500
                               (melengestrol
                               acetate) Liquid
                               Premix/OPTAFLEXX
                               (ractopamine HCl)/
                               RUMENSIN (monensin).
200-451.....................  HEIFERMAX 500                      558.342
                               (melengestrol
                               acetate) Liquid
                               Premix plus BOVATEC
                               (lasalocid).
200-479.....................  HEIFERMAX 500                      558.665
                               (melengestrol
                               acetate) Liquid
                               Premix/ZILMAX
                               (zilpaterol)/RUMENSIN
                               (monensin).
200-480.....................  HEIFERMAX 500                      558.665
                               (melengestrol
                               acetate) Liquid
                               Premix/ZILMAX
                               (zilpaterol)/RUMENSIN
                               (monensin)/TYLAN
                               (tylosin phosphate).
200-483.....................  HEIFERMAX 500                      558.665
                               (melengestrol
                               acetate) Liquid
                               Premix plus ZILMAX
                               (zilpaterol).
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in parts 522
and 558 (21 CFR parts 522, and 558) to reflect the transfer of
ownership.
    Following these changes of sponsorship, Ivy Laboratories, Division
of Ivy Animal Health, Inc., is no longer the sponsor of an approved
application. Accordingly, Sec.  510.600 (21 CFR 510.600) is being
amended to remove the entries for this firm.
    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 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    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 parts 510,
522, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

    2. In Sec.  510.600, in the table in paragraph (c)(l), remove the
entry for ``Ivy Laboratories, Div. of Ivy Animal Health, Inc.''; and in
the table in paragraph (c)(2), remove the entry for ``021641''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as
follows:

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

Sec.  522.840  [Amended]

0
4. In paragraph (b) of Sec.  522.840, remove ``021641'' and in its
place add ``000986''.

Sec.  522.842  [Amended]

0
5. In paragraph (a)(2) of Sec.  522.842, remove ``021641'' and in its
place add ``000986''.

Sec.  522.1940  [Amended]

0
6. In paragraph (a)(2) of Sec.  522.1940, remove ``021641'' and in its
place add ``000986''.

Sec.  522.2476  [Amended]

0
7. In paragraph (b)(l) of Sec.  522.2476, remove ``021641'' and in its
place add ``000986''.

Sec.  522.2477  [Amended]

0
8. In paragraph (b)(l) of Sec.  522.2477, remove ``021641'' and in its
place add ``000986''.

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

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

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

Sec.  558.342  [Amended]

0
10. In Sec.  558.342, in paragraph (b)(2) and in the ``Sponsor'' column
of the table, in paragraphs (e)(l)(i), (e)(1)(ii), (e)(l)(iii), and
(e)(l)(ix) remove ``021641''

and in its place add ``000986''; in paragraphs (e)(1)(iv) and (e)(1)(x)
add ``000986''; and in paragraph (e)(1)(xi), remove ``02164'' and in
its place add ``000986''.

Sec.  558.500  [Amended]

0
11. In Sec.  558.500, in the ``Sponsor'' column of the table, in
paragraphs (e)(2)(viii) and (e)(2)(x), remove ``021641''.

Sec.  558.665  [Amended]

0
12. In Sec.  558.665, in the ``Sponsor'' column of the table, in
paragraphs (e)(2), (e)(4), and (e)(6), remove ``021641'' and in its
place add ``000986''.

    Dated: May 23, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2012-13010 Filed 5-29-12; 8:45 am]
BILLING CODE 4160-01-P