Document ID: FDA-2012-N-0002-0012
Agency: fda
Document Type: Rule
Title: New Animal Drugs Altrenogest Dexamethasone Florfenicol
Posted Date: 2012-05-31T04:00Z

[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Rules and Regulations]
[Pages 32010-32013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13095]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, and 558

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

New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol

AGENCY: Food and Drug Administration, HHS.

[[Page 32011]]

ACTION: Final rule.

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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 April 2012. FDA is also informing the public of the 
availability of summaries of the basis of approval and of environmental 
review documents, where applicable.

DATES: This rule is effective May 31, 2012.

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's Center for Veterinary Medicine (CVM) 
is adopting use of a monthly Federal Register document to codify 
approval actions for new animal drug applications (NADAs) and 
abbreviated new animal drug applications (ANADAs). CVM will no longer 
publish a separate rule for each action. This approach will allow a 
more efficient use of available resources.
    In this document, FDA is amending the animal drug regulations to 
reflect the original and supplemental approval actions during April 
2012, as listed in table 1 of this document. FDA is also informing the 
public of the availability, where applicable, of environmental review 
documents 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 CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
    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.

                                     Table 1--Original and Supplemental NADAs and ANADAs Approved During April 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                New animal drug
      NADA/ANADA              Sponsor            product name             Action            21 CFR Section        FOIA  summary         NEPA  review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-246..............  Intervet, Inc., 556   AQUAFLOR              Supplemental          516.1215, 558.261..  yes.................  EA/FONSI.\1\
                        Morris Ave.,          (florfenicol) Type    approval to: (1)
                        Summit, NJ 07901.     A medicated article.  Increase the
                                                                    permitted
                                                                    concentrations in
                                                                    Type C feeds; (2)
                                                                    add an indication
                                                                    for the control of
                                                                    mortality due to
                                                                    columnaris disease
                                                                    associated with
                                                                    Flavobacterium
                                                                    columnare; (3) add
                                                                    an indication for
                                                                    the control of
                                                                    mortality due to
                                                                    streptococcal
                                                                    septicemia
                                                                    associated with
                                                                    Streptococcus iniae
                                                                    in freshwater-
                                                                    reared warmwater
                                                                    finfish; and (4)
                                                                    increase the
                                                                    withdrawal period
                                                                    to 15 days. This
                                                                    approval renders
                                                                    Sec.   516.1215
                                                                    obsolete.
200-456..............  Med-Pharmex, Inc.,    Dexamethasone         Original approval of  522.540............  yes.................  CE.\2\
                        2727 Thompson Creek   Injectable Solution.  a generic copy of
                        Rd., Pomona, CA                             NADA 012-559.
                        91767-1861.
200-481..............  Ceva Sante Animale,   ALTRESYN              Original approval of  520.48.............  yes.................  CE.\2\
                        10 Avenue de la       (altrenogest)         a generic copy of
                        Ballasti[egrave]re,   Solution 0.22%.       NADA 131-310.
                        33500 Libourne,
                        France.
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\1\ Based on its review of an environmental assessment (EA) submitted by the sponsor, the Agency has concluded that this action will not have a
  significant impact on the human environment and that an environmental impact statement is not required. A finding of no significant impact (FONSI) has
  been prepared.
\2\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an EA or an
  environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human
  environment.

List of Subjects

21 CFR Part 510

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

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

[[Page 32012]]

21 CFR Parts 520 and 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, 
516, 520, 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.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Ceva Sante Animale''; and in the table in paragraph 
(c)(2), numerically add an entry for ``013744'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re,           013744
 33500 Libourne, France.................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
013744..............................  Ceva Sante Animale, 10 Avenue de
                                       la Ballasti[egrave]re, 33500
                                       Libourne, France.
 
                                * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for 21 CFR part 516 continues to read as 
follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

Sec.  516.1215  [Removed]

0
4. Remove Sec.  516.1215.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
6. In Sec.  520.48, revise paragraph (b) to read as follows:

Sec.  520.48  Altrenogest.

* * * * *
    (b) Sponsors. See sponsor listings in Sec.  510.600(c) of this 
chapter:
    (1) No. 000061 for use as in paragraph (d) of this section.
    (2) No. 013744 for use as in paragraph (d)(1) of this section.
* * * * *

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

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

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

0
8. In Sec.  522.540, revise the section heading and paragraphs 
(a)(2)(ii) and (a)(3)(iii) to read as follows:

Sec.  522.540  Dexamethasone.

    (a) * * *
    (2) * * *
    (ii) Sponsors. See Nos. 054925 and 058005 for use as in paragraphs 
(a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this 
section.
    (3) * * *
    (iii) Do not use in horses intended for human food. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
* * * * *

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.

0
10. In Sec.  558.261, revise paragraphs (a)(2) and (c)(2)(i), and the 
table in paragraph (e)(2) to read as follows:

Sec.  558.261  Florfenicol.

    (a) * * *
    (2) 500 grams per kilogram for use as in paragraph (e)(2) of this 
section.
* * * * *
    (c) * * *
    (2) * * *
    (i) For freshwater-reared finfish, must not exceed 15 days from the 
date of issuance.
* * * * *
    (e) * * *
    (2) * * *

------------------------------------------------------------------------
 Florfenicol in grams/ton of    Indications for
             feed                     use               Limitations
------------------------------------------------------------------------
(i) 182 to 2,724.............  Catfish: For the   Feed as a sole ration
                                control of         for 10 consecutive
                                mortality due to   days to deliver 10 to
                                enteric            15 milligrams (mg)
                                septicemia of      florfenicol per
                                catfish            kilogram (kg) of
                                associated with    fish. Feed containing
                                Edwardsiella       florfenicol shall not
                                ictaluri.          be fed for more than
                                                   10 days. Following
                                                   administration, fish
                                                   should be reevaluated
                                                   by a licensed
                                                   veterinarian before
                                                   initiating a further
                                                   course of therapy. A
                                                   dose-related decrease
                                                   in hematopoietic/
                                                   lymphopoietic tissue
                                                   may occur. The time
                                                   required for
                                                   hematopoietic/
                                                   lymphopoietic tissues
                                                   to regenerate was not
                                                   evaluated. The
                                                   effects of
                                                   florfenicol on
                                                   reproductive
                                                   performance have not
                                                   been determined.
                                                   Feeds containing
                                                   florfenicol must be
                                                   withdrawn 15 days
                                                   prior to slaughter.
------------------------------------------------------------------------
(ii) 182 to 1,816............  Freshwater-reared  Feed as a sole ration
                                salmonids: For     for 10 consecutive
                                the control of     days to deliver 10 mg
                                mortality due to   florfenicol per kg of
                                coldwater          fish. Feed containing
                                disease            florfenicol shall not
                                associated with    be fed for more than
                                Flavobacterium     10 days. Following
                                psychrophilum      administration, fish
                                and furunculosis   should be reevaluated
                                associated with    by a licensed
                                Aeromonas          veterinarian before
                                salmonicida.       initiating a further
                                                   course of therapy.
                                                   The effects of
                                                   florfenicol on
                                                   reproductive
                                                   performance have not
                                                   been determined.
                                                   Feeds containing
                                                   florfenicol must be
                                                   withdrawn 15 days
                                                   prior to slaughter.
------------------------------------------------------------------------

[[Page 32013]]

 
(iii) 182 to 2,724...........  Freshwater-reared  Feed as a sole ration
                                finfish: For the   for 10 consecutive
                                control of         days to deliver 10 to
                                mortality due to   15 mg florfenicol per
                                columnaris         kg of fish for
                                disease            freshwater-reared
                                associated with    warmwater finfish and
                                Flavobacterium     10 mg florfenicol per
                                columnare.         kg of fish for other
                                                   freshwater-reared
                                                   finfish. Feed
                                                   containing
                                                   florfenicol shall not
                                                   be fed for more than
                                                   10 days. Following
                                                   administration, fish
                                                   should be reevaluated
                                                   by a licensed
                                                   veterinarian before
                                                   initiating a further
                                                   course of therapy.
                                                   For catfish, a dose-
                                                   related decrease in
                                                   hematopoietic/
                                                   lymphopoietic tissue
                                                   may occur. The time
                                                   required for
                                                   hematopoietic/
                                                   lymphopoietic tissues
                                                   to regenerate was not
                                                   evaluated. The
                                                   effects of
                                                   florfenicol on
                                                   reproductive
                                                   performance have not
                                                   been determined.
                                                   Feeds containing
                                                   florfenicol must be
                                                   withdrawn 15 days
                                                   prior to slaughter.
------------------------------------------------------------------------
(iv) 273 to 2,724............  Freshwater-reared  Feed as a sole ration
                                warmwater          for 10 consecutive
                                finfish: For the   days to deliver 15 mg
                                control of         florfenicol per kg of
                                mortality due to   fish. Feed containing
                                streptococcal      florfenicol shall not
                                septicemia         be fed for more than
                                associated with    10 days. Following
                                Streptococcus      administration, fish
                                iniae.             should be reevaluated
                                                   by a licensed
                                                   veterinarian before
                                                   initiating a further
                                                   course of therapy.
                                                   For catfish, a dose-
                                                   related decrease in
                                                   hematopoietic/
                                                   lymphopoietic tissue
                                                   may occur. The time
                                                   required for
                                                   hematopoietic/
                                                   lymphopoietic tissues
                                                   to regenerate was not
                                                   evaluated. The
                                                   effects of
                                                   florfenicol on
                                                   reproductive
                                                   performance have not
                                                   been determined.
                                                   Feeds containing
                                                   florfenicol must be
                                                   withdrawn 15 days
                                                   prior to slaughter.
------------------------------------------------------------------------

    Dated: May 24, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-13095 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P