Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin, 19816 [2014-08010]

Download as PDF 19816 Federal Register / Vol. 79, No. 69 / Thursday, April 10, 2014 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES NADA Product name PEACE CORPS 099–468 1 Waynextra for Swine (tylosin phosphate). TYLAN Sulfa-G (tylosin phosphate and sulfamethazine). Ban-A-Worm II (pyrantel tartrate). 22 CFR Part 303 Food and Drug Administration 131–958 1 21 CFR Parts 510 and 558 132–136 ... [Docket No. FDA–2014–N–0002] Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin AGENCY: Food and Drug Administration, • Provimi North America, Inc., 6531 State Rte. 503, Lewisburg, OH 45338: NADA Proprietary name 103–089 1 TYLAN 5, 10, 20, or 40 (tylosin phosphate). WORM–BAN 5 or 10 (pyrantel tartrate). HYGROMIX 0.6 (hygromycin B). FLAVOMYCIN 0.4 or 2 (bambermycins). STAFAC 10 (virginiamycin). HHS. ACTION: 118–814 ... Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors’ request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective April 21, 2014. FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9079, john.bartkowiak@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following 5 sponsors have requested that FDA withdraw approval of the 19 NADAs listed in the following tables because the products are no longer manufactured or marketed: • ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115: SUMMARY: NADA 091–582 1 108–484 1 110–045 1 110–439 1 128–411 1 133–333 1 • Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137: NADA Proprietary name 013–214 1 PURINA HYGROMIX (hygromycin B) for Swine. PURINA Pork-Plus (tylosin phosphate and sulfamethazine). PURINA Hog Plus II (tylosin phosphate). PURINA TYLAN 40 (tylosin) Plus Sulfamethazine. PURINA Check-R-Ton Ll (lincomycin hydrochloride). 042–660 1 043–387 1 099–767 1 132–574 1 Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of Product name approval of application (21 CFR Gilt Edge TYLAN (tylosin phos- 514.116), notice is given that approval phate) Mix. of the NADAs listed in this document, HFA Tylosin-10 Plus Sulfa and all supplements and amendments (tylosin phosphate and thereto, is hereby withdrawn. sulfamethazine). Elsewhere in this issue of the Federal Good Life TYLAN 10 (tylosin Register, FDA is amending the animal phosphate) Premix. HFA HYGROMIX 0.48 drug regulations to reflect the voluntary (hygromycin B) Medicated withdrawal of approval of these Premix. applications. TYLAN 5 Sulfa (tylosin phosphate and sulfamethazine) Premix. • Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 79105: NADA ehiers on DSK2VPTVN1PROD with RULES 127–508 1 131–413 ... TYLAN 40 or 100 (tylosin phosphate). [FR Doc. 2014–08010 Filed 4–9–14; 8:45 am] BILLING CODE 4160–01–P Product name 138–187 1 Dated: April 4, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. • Ridley USA, Inc. d/b/a Ridley Feed Ingredients, 1609 1st Ave., P.O. Box 110, Mendota, IL 61342: VerDate Mar<15>2010 15:09 Apr 09, 2014 Jkt 232001 1 The NADAs listed were identified as being affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209’’, December 2013. PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 RIN 0420–AA29 Freedom of Information Act Administration Peace Corps. Final rule. AGENCY: ACTION: The final rule updates Peace Corps regulations on the Freedom of Information Act (FOIA) to implement guidance given by the President and the Attorney General regarding discretionary disclosures of records or information exempt from disclosure under the FOIA, whenever disclosure would not foreseeably harm an interest protected by a FOIA exemption. The final rule is based on language used by Department of Justice in its FOIA regulations. The Peace Corps received comments from the National Archives and Records Administration’s Office of Government Information Services (OGIS). SUMMARY: This final rule is effective May 12, 2014. FOR FURTHER INFORMATION CONTACT: Anne Hughes, Office of the General Counsel, Policy and Program Analyst, 1111 20th Street NW., Washington, DC 20526, and 202–692–2164. SUPPLEMENTARY INFORMATION: The revisions to the Peace Corps’ Freedom of Information Act (‘‘FOIA’’) regulations would incorporate the disclosure principles contained in President Obama’s January 21, 2009 Memorandum regarding FOIA, the Attorney General’s FOIA Guidelines to Favor Disclosure and Transparency dated March 19, 2009, and the Guide to the Freedom of Information Act promulgated by the Department of Justice’s Office of Information Policy. The final rule deletes unnecessary and superfluous language and ensures the rule is consistent with current law. The final rule inserts additional contact information for the filing of initial FOIA requests; inserts additional contact information for the filing of administrative appeals; and adds two FOIA exemptions: 5 U.S.C. 552(b)8, Contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; and (b)9, Geological and geophysical information and data, including maps, concerning wells. The Peace Corps FOIA regulations were last revised May 14, 2007 (72 FR 27055). DATES: E:\FR\FM\10APR1.SGM 10APR1

Agencies

[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Rules and Regulations]
[Page 19816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08010]



[[Page 19816]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

[Docket No. FDA-2014-N-0002]


Withdrawal of Approval of New Animal Drug Applications; 
Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and 
Sulfamethazine; Virginiamycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 19 new animal drug applications (NADAs) for certain Type A medicated 
articles and Type B medicated feeds. This action is being taken at the 
sponsors' request because these products are no longer manufactured or 
marketed.

DATES: Withdrawal of approval is effective April 21, 2014.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9079, john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following 5 sponsors have requested that 
FDA withdraw approval of the 19 NADAs listed in the following tables 
because the products are no longer manufactured or marketed:
     ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, 
IL 62305-3115:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
091-582 \1\.......................  Gilt Edge TYLAN (tylosin phosphate)
                                     Mix.
108-484 \1\.......................  HFA Tylosin-10 Plus Sulfa (tylosin
                                     phosphate and sulfamethazine).
110-045 \1\.......................  Good Life TYLAN 10 (tylosin
                                     phosphate) Premix.
110-439 \1\.......................  HFA HYGROMIX 0.48 (hygromycin B)
                                     Medicated Premix.
128-411 \1\.......................  TYLAN 5 Sulfa (tylosin phosphate and
                                     sulfamethazine) Premix.
------------------------------------------------------------------------

     Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 
79105:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
138-187 \1\.......................  TYLAN 40 or 100 (tylosin phosphate).
------------------------------------------------------------------------

     Ridley USA, Inc. d/b/a Ridley Feed Ingredients, 1609 1st 
Ave., P.O. Box 110, Mendota, IL 61342:

------------------------------------------------------------------------
               NADA                             Product name
------------------------------------------------------------------------
099-468 \1\.......................  Waynextra for Swine (tylosin
                                     phosphate).
131-958 \1\.......................  TYLAN Sulfa-G (tylosin phosphate and
                                     sulfamethazine).
132-136...........................  Ban-A-Worm II (pyrantel tartrate).
------------------------------------------------------------------------

     Provimi North America, Inc., 6531 State Rte. 503, 
Lewisburg, OH 45338:

------------------------------------------------------------------------
               NADA                           Proprietary name
------------------------------------------------------------------------
103-089 \1\.......................  TYLAN 5, 10, 20, or 40 (tylosin
                                     phosphate).
118-814...........................  WORM-BAN 5 or 10 (pyrantel
                                     tartrate).
127-508 \1\.......................  HYGROMIX 0.6 (hygromycin B).
131-413...........................  FLAVOMYCIN 0.4 or 2 (bambermycins).
133-333 \1\.......................  STAFAC 10 (virginiamycin).
------------------------------------------------------------------------

     Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137:

------------------------------------------------------------------------
               NADA                           Proprietary name
------------------------------------------------------------------------
013-214 \1\.......................  PURINA HYGROMIX (hygromycin B) for
                                     Swine.
042-660 \1\.......................  PURINA Pork-Plus (tylosin phosphate
                                     and sulfamethazine).
043-387 \1\.......................  PURINA Hog Plus II (tylosin
                                     phosphate).
099-767 \1\.......................  PURINA TYLAN 40 (tylosin) Plus
                                     Sulfamethazine.
132-574 \1\.......................  PURINA Check-R-Ton Ll (lincomycin
                                     hydrochloride).
------------------------------------------------------------------------

     
---------------------------------------------------------------------------

    \1\ The NADAs listed were identified as being affected by 
guidance for industry (GFI) 213, ``New Animal Drugs and New 
Animal Drug Combination Products Administered in or on Medicated 
Feed or Drinking Water of Food-Producing Animals: Recommendations 
for Drug Sponsors for Voluntarily Aligning Product Use Conditions 
With GFI 209'', December 2013.
---------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of the 
NADAs listed in this document, and all supplements and amendments 
thereto, is hereby withdrawn.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of these applications.

    Dated: April 4, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-08010 Filed 4-9-14; 8:45 am]
BILLING CODE 4160-01-P
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