New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin, 25182-25184 [2013-10152]

Download as PDF 25182 Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Rules and Regulations with a comment period of February 8, 2013 through March 11, 2013 (78 FR 9330). No comments on the proposed regulatory amendments were received by AMS. The proposed rule may be viewed at www.regulations.gov. List of Subjects in 7 CFR Part 27 Commodity futures, Cotton. For the reasons set forth in the preamble, 7 CFR part 27 is amended as follows: PART 27—[Amended] 1. The authority citation for 7 CFR part 27 continues to read as follows: ■ § 27.94 Spot Markets for Contract Settlement Purposes. * * * * * (a) For cotton delivered in settlement of any No. 2 contract on the Intercontinental Exchange (ICE); Southeastern, North and South Delta, Eastern Texas and Oklahoma, West Texas, and Desert Southwest. * * * * * Dated: April 25, 2013. David R. Shipman, Administrator, Agricultural Marketing Service. [FR Doc. 2013–10114 Filed 4–29–13; 8:45 am] BILLING CODE 3410–02–P Authority: 7 U.S.C. 15b, 7 U.S.C. 473b, 7 U.S.C. 1622(g). 2. In § 27.93, definitions of the Southeastern market and the East Texas and Oklahoma market are revised to read as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES § 27.93 21 CFR Parts 522 and 558 ■ * * Bona fide Spot Markets. * * * Food and Drug Administration [Docket No. FDA–2013–N–0002] Southeastern All counties in the states of Alabama, Florida, Georgia, North Carolina, South Carolina, and Virginia and all counties in the state of Tennessee east of and including Stewart, Houston, Humphreys, Perry, Wayne and Hardin counties. * * * * * East Texas and Oklahoma All counties in the states of Kansas and Oklahoma and the Texas counties east of and including Montague, Wise, Parker, Erath, Comanche, Mills, San Saba, Mason, Sutton, Edwards, Kinney, Maverick, Webb, Zapata, Star and Hidalgo counties. * * * * * ■ 3. In § 27.94, paragraph (a) is revised to read as follows: New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin AGENCY: Food and Drug Administration, HHS. Final rule, Technical Amendment. ACTION: SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. DATES: This rule is effective April 30, 2013. 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 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2013, 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 CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/ CentersOffices/OfficeofFoods/CVM/ CVMFOIAElectronicReadingRoom/ default.htm. In addition, the animal drug regulations are being amended at 21 CFR 522.558 to add a new strength of dexmedetomidine hydrochloride injectable solution for use in dogs and cats. This change 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: TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH 2013 Sponsor New animal drug product name Action 200–532 Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. TYLOVET 100 (tylosin phosphate) and MGA (melegestrone acetate) Type A medicated articles. 200–533 pmangrum on DSK3VPTVN1PROD with RULES NADA/ ANADA Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. TYLOVET 100 (tylosin phosphate) and RUMENSIN (monensin) and DECCOX (decoquinate) Type A medicated articles. Original approval as a generic copy of NADA 139–192. Original approval as a generic copy of NADA 141–149. VerDate Mar<15>2010 14:28 Apr 29, 2013 Jkt 229001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\30APR1.SGM 21 CFR section 30APR1 FOIA summary NEPA review 558.342 yes ...... CE 1 558.195 yes ...... CE 1 25183 Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH 2013—Continued NADA/ ANADA Sponsor New animal drug product name Action 200–535 Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. TYLOVET 100 (tylosin phosphate) and BOVATEC (lasalocid) and MGA (melegestrone acetate) Type A medicated articles. Original approval as a generic copy of NADA 138–992. FOIA summary 21 CFR section 558.342 NEPA review yes ...... CE 1 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 (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 PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 21 CFR Part 522 3. The authority citation for 21 CFR part 558 continues to read as follows: ■ Animal drugs. 1. The authority citation for 21 CFR part 522 continues to read as follows: ■ 21 CFR Part 558 Animal drugs, Animal feed. Authority: 21 U.S.C. 360b, 371. Authority: 21 U.S.C. 360b. 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 522 and 558 are amended as follows: § 522.558 4. In § 558.195, in the table, in paragraph (e)(2)(v), revise the last sentence in the ‘‘Limitations’’ column and revise the ‘‘Sponsor’’ column to read as follows: ■ 2. In § 522.558, revise paragraph (a) to read as follows: ■ Dexmedetomidine. (a) Specifications. Each milliliter of solution contains 0.5 or 1.0 milligrams dexmedetomidine hydrochloride. * * * * * § 558.195 * Decoquinate. * * (e) * * * (2) * * * * Decoquinate in grams per ton Combination in grams per ton Indications for use Limitations * * (v) * * * ................................... ...................... * ...................... * * * * * * * Monensin as provided by No. 000986, and tylosin as provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter. * * * * * ‘‘Limitations’’ column and revise the ‘‘Sponsor’’ column to read as follows: * * * * * 5. In § 558.342, in the table, in paragraphs (e)(1)(iv) and (e)(1)(ix), revise the last sentence in the ■ Sponsor * 016592, 046573 * § 558.342 * * Melengestrol. * * (e) * * * (1) * * * * * Combination in mg/head/ day Indications for use Limitations Sponsor * (iv) * * * ........... * ...................... ...................... * * * * * * * Lasalocid provided by No. 046573, and tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter. * 000009, 000986, 016592 * (ix) * * * ........... pmangrum on DSK3VPTVN1PROD with RULES Melengestrol acetate in mg/ head/day * ...................... ...................... * * * * Tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter. * 000009, 000986, 016592 * * * * Dated: April 25, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. * [FR Doc. 2013–10152 Filed 4–29–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:53 Apr 29, 2013 Jkt 229001 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\FR\FM\30APR1.SGM 30APR1 25184 Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Rules and Regulations DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 5, 200, 207, and 232 [Docket No. FR–5465–F–03] RIN–2502–AJ05 Federal Housing Administration (FHA): Section 232 Healthcare Facility Insurance Program—Strengthening Accountability and Regulatory Revisions Update Final Rule Amendment—Revision of Date of Applicability Federal Housing Commissioner, Office of the Assistant Secretary for Housing, HUD. ACTION: Final rule amendment. AGENCY: On September 7, 2012, HUD published a final rule that revised the regulations governing the insurance of healthcare facilities under section 232 of the National Housing Act (Section 232). HUD’s Section 232 program insures mortgage loans to facilitate the construction, substantial rehabilitation, purchase, and refinancing of nursing homes, intermediate care facilities, board and care homes, and assistedliving facilities. The amendments made by the September 7, 2012, final rule updated the Section 232 regulations to reflect current policy and practices, improve accountability and strengthen risk management in the program. The final rule provided an applicability date of April 9, 2013, for certain of the updated requirements. This final rule amendment changes the applicability date to July 12, 2013, for the purpose of allowing more time to transition to the new requirements. DATES: Effective date: May 30, 2013. FOR FURTHER INFORMATION CONTACT: Kelly Haines, Director, Office of Residential Care Facilities, Office of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 6264, Washington, DC 20410–8000; telephone number 202–708–0599 (this is not a toll-free number). Persons with hearing- or speech-impairments may access this number through TTY by calling the toll-free Federal Relay Service at 1–800–877–8339. SUPPLEMENTARY INFORMATION: pmangrum on DSK3VPTVN1PROD with RULES SUMMARY: I. Background On September 7, 2012, at 77 FR 55120, HUD published in the Federal Register a final rule that revised its Section 232 program regulations to bring the regulations up-to-date to VerDate Mar<15>2010 17:32 Apr 29, 2013 Jkt 229001 reflect current policy and practices in healthcare facility transactions and to strengthen risk management and improve accountability in the program. The September 7, 2012, final rule followed a proposed rule published in the Federal Register on May 3, 2012, at 77 FR 26218, in which HUD submitted its proposed revisions for public comment. The final rule took effect on October 9, 2012. However, to allow time to transition to the updated requirements, the final rule established an applicability date of April 9, 2013 for certain of the requirements. On May 3, 2012, at 77 FR 26304, HUD also published a notice that proposed revisions to documents used in the insurance of healthcare facilities, and solicited public comment for a period of 60 days. This notice was issued in accordance with the Paperwork Reduction Act of 1995, and was followed by a second notice, published on November 21, 2012, at 77 FR 69870, that solicited public comment for a period of 30 days. The Office of Management and Budget approved the Section 232 documents under the Paperwork Reduction Act in March 2013, and the approval was announced by notice published in the Federal Register on March 14, 2013, at 78 FR 16279. Following issuance of the March 14, 2013, notice, lenders and other parties that would be involved in upcoming Section 232 program transactions stated that the delayed approval presented barriers to full compliance with some of the requirements in the revised Section 232 regulations that would become applicable on April 9, 2013. The affected parties involved in upcoming financing or refinancing of a loan to be insured under Section 232 advised that they have already expended substantial time and expense in preparing the transaction based on reasonable reliance on the previously applicable Section 232 documents. II. This Final Rule Given that the delayed approval of the Section 232 documents has caused difficulties for parties involved in upcoming Section 232 healthcare facility transactions to comply with the updated requirements in the Section 232 regulations because of the April 9, 2013, applicability date, this final rule changes the applicability date to July 12, 2013. An additional delayed applicability date of over 90 days following publication of this final rule should allow parties involved in Section 232 healthcare facility transactions to PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 prepare for such transactions based on the new Section 232 regulations and related Section 232 documents. III. Justification for Final Rulemaking In general, HUD publishes a rule for public comment before issuing a rule for effect, in accordance with HUD’s regulations on rulemaking at 24 CFR part 10. Part 10, however, provides in § 10.1 for exceptions from that general rule where HUD finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when the prior public procedure is ‘‘impracticable, unnecessary or contrary to the public interest.’’ HUD finds that good cause exists to publish this rule for effect without first soliciting public comment because prior public comment would be contrary to the public interest. HUD’s Section 232 program plays an important role in today’s economy as the need for residential care facilities has increased and requests to FHA to provide mortgage insurance for such facilities also increased. By reducing the cost of capital needed by residential care facilities to finance the construction, renovation, acquisition, or refinancing of facilities, the Section 232 program helps to improve access to quality healthcare and decrease overall healthcare costs. Affected parties involved in upcoming Section 232 transactions have advised that efforts to comply with the April 9, 2013, applicability date would result in a delay in completion of a Section 232 transaction and considerable increased expense due to delay. Given the need for quality and affordable care in many communities across the country, HUD recognizes that a delay in completion of a Section 232 transaction whether for acquisition or refinancing for a healthcare facility not only affects the parties involved in the transaction but the community in which the healthcare facility would be purchased, constructed, or refinanced. For this reason, HUD extends the applicability date in the September 7, 2012, final rule from April 9, 2013, to July 12, 2013. IV. Findings and Certifications Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory E:\FR\FM\30APR1.SGM 30APR1

Agencies

[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Rules and Regulations]
[Pages 25182-25184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 558

[Docket No. FDA-2013-N-0002]


New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; 
Monensin; and Tylosin

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 and abbreviated new animal drug applications during March 
2013. FDA is also informing the public of the availability of summaries 
the basis of approval and of environmental review documents, where 
applicable.

DATES: This rule is effective April 30, 2013.

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 new animal drug applications (NADAs) 
and abbreviated new animal drug applications (ANADAs) during March 
2013, 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 CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
    In addition, the animal drug regulations are being amended at 21 
CFR 522.558 to add a new strength of dexmedetomidine hydrochloride 
injectable solution for use in dogs and cats. This change 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.

                                     Table 1--Original and Supplemental NADAs and ANADAs Approved During March 2013
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              New animal drug product                           21 CFR
            NADA/ANADA                      Sponsor                    name                   Action            section      FOIA summary    NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-532..........................  Huvepharma AD, 5th        TYLOVET 100 (tylosin      Original approval           558.342  yes...........  CE \1\
                                    Floor, 3A Nikolay         phosphate) and MGA        as a generic copy
                                    Haytov Str., 1113         (melegestrone acetate)    of NADA 139-192.
                                    Sophia, Bulgaria.         Type A medicated
                                                              articles.
200-533..........................  Huvepharma AD, 5th        TYLOVET 100 (tylosin      Original approval           558.195  yes...........  CE \1\
                                    Floor, 3A Nikolay         phosphate) and RUMENSIN   as a generic copy
                                    Haytov Str., 1113         (monensin) and DECCOX     of NADA 141-149.
                                    Sophia, Bulgaria.         (decoquinate) Type A
                                                              medicated articles.

[[Page 25183]]

 
200-535..........................  Huvepharma AD, 5th        TYLOVET 100 (tylosin      Original approval           558.342  yes...........  CE \1\
                                    Floor, 3A Nikolay         phosphate) and BOVATEC    as a generic copy
                                    Haytov Str., 1113         (lasalocid) and MGA       of NADA 138-992.
                                    Sophia, Bulgaria.         (melegestrone acetate)
                                                              Type A medicated
                                                              articles.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (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 522

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feed.

    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 522 and 
558 are 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 Sec.  522.558, revise paragraph (a) to read as follows:


Sec.  522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains 0.5 or 1.0 
milligrams dexmedetomidine hydrochloride.
* * * * *

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.  558.195, in the table, in paragraph (e)(2)(v), revise the 
last sentence in the ``Limitations'' column and revise the ``Sponsor'' 
column to read as follows:


Sec.  558.195  Decoquinate.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                               Combination in    Indications for
Decoquinate in grams per ton    grams per ton          use             Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(v) * * *...................  ................  ................  * * * Monensin as               016592, 046573
                                                                   provided by No.
                                                                   000986, and tylosin
                                                                   as provided by Nos.
                                                                   000986 and 016592
                                                                   in Sec.
                                                                   510.600(c) of this
                                                                   chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
5. In Sec.  558.342, in the table, in paragraphs (e)(1)(iv) and 
(e)(1)(ix), revise the last sentence in the ``Limitations'' column and 
revise the ``Sponsor'' column to read as follows:


Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
 Melengestrol acetate   Combination in mg/    Indications for
    in mg/head/day           head/day               use               Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) * * *............  ..................  ..................  * * * Lasalocid           000009, 000986, 016592
                                                                 provided by No.
                                                                 046573, and tylosin
                                                                 provided by Nos.
                                                                 000986 and 016592 in
                                                                 Sec.   510.600(c) of
                                                                 this chapter.
 
                                                  * * * * * * *
(ix) * * *............  ..................  ..................  Tylosin provided by       000009, 000986, 016592
                                                                 Nos. 000986 and
                                                                 016592 in Sec.
                                                                 510.600(c) of this
                                                                 chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: April 25, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-10152 Filed 4-29-13; 8:45 am]
BILLING CODE 4160-01-P