Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone, 52536 [2013-20541]

Download as PDF 52536 Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices amendments thereto, is hereby withdrawn.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: August 20, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013–20615 Filed 8–22–13; 8:45 am] BILLING CODE 4160–01–P with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADA 098–371, NADA 098–374, and NADA 123–116, and all supplements and amendments thereto, is hereby withdrawn.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 withdrawal of approval of these applications. Dated: August 19, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–20541 Filed 8–22–13; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2013–N–0835] Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) at the sponsors’ request because the products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective September 3, 2013. FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6843, email: david.alterman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Phibro Animal Health Corp., 65 Challenger Rd., 3d Floor, Ridgefield Park, NJ 07660 has requested that FDA withdraw approval of NADA 098–371 for use of nicarbazin, penicillin, and roxarsone in 3-way, combination drug Type C medicated feeds for broiler chickens and NADA 098–374 for use of nicarbazin and penicillin in 2-way, combination drug Type C medicated feeds for broiler chickens because the products are no longer manufactured or marketed. R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518 has requested that FDA withdraw approval of NADA 123–116 for Diethylcarbamazine Citrate Capsules used in dogs for the prevention of heartworm disease because the product is no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:28 Aug 22, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received within 60 days of this notice. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Information Collection Request Title: Combating Autism Act Initiative Evaluation (OMB No. 0915–0335 [Revision] Abstract: In response to the growing need for research and resources devoted to autism spectrum disorders (ASD) and other developmental disabilities (DD), the U.S. Congress passed the Combating Autism Act (CAA) in 2006. The Act included funding for the U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) to increase awareness, reduce barriers to screening and diagnosis, promote evidence-based interventions, train health care professionals to screen for, diagnose or rule out, and provide evidence-based interventions for ASD and other DD. In 2011, the Combating Autism Reauthorization Act (CARA) was signed into law, reauthorizing funding for the CAA’s programs for an additional 3 years at the existing funding levels. Through the CARA, HRSA is tasked with increasing awareness of ASD and other DD, reducing barriers to screening and diagnosis, promoting evidence-based interventions, and training health care professionals in the use of valid and reliable screening and diagnostic tools. Need and Proposed Use of the Information: HRSA’s activities under the CARA legislation are delegated to the Maternal and Child Health Bureau (MCHB), which is implementing the Combating Autism Act Initiative (CAAI) in response to the legislative mandate. The purpose of this evaluation is to design and implement an evaluation to assess the effectiveness of MCHB’s activities in meeting the goals and objectives of the CAAI, and to provide sufficient data to inform MCHB and the Congress as to the utility of the grant programs funded under the Initiative. The evaluation will focus on indicators related to: (1) Increasing awareness of ASD and other DD among health care providers, other MCH professionals, and the general public; (2) reducing barriers to screening and diagnosis; (3) supporting research on evidence-based interventions; (4) promoting the development of evidence-based guidelines and tested/validated intervention tools; (5) training professionals; and (6) building capacity for systems of services in states. Likely Respondents: Grantees funded by HRSA under the CAAI will be the respondents for this data collection activity. The programs to be evaluated are listed below. E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Page 52536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0835]


Withdrawal of Approval of New Animal Drug Applications; 
Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADAs) at the sponsors' request 
because the products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective September 3, 2013.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843, email: david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Phibro Animal Health Corp., 65 Challenger 
Rd., 3d Floor, Ridgefield Park, NJ 07660 has requested that FDA 
withdraw approval of NADA 098-371 for use of nicarbazin, penicillin, 
and roxarsone in 3-way, combination drug Type C medicated feeds for 
broiler chickens and NADA 098-374 for use of nicarbazin and penicillin 
in 2-way, combination drug Type C medicated feeds for broiler chickens 
because the products are no longer manufactured or marketed.
    R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518 
has requested that FDA withdraw approval of NADA 123-116 for 
Diethylcarbamazine Citrate Capsules used in dogs for the prevention of 
heartworm disease because the product is no longer manufactured or 
marketed.
    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 NADA 
098-371, NADA 098-374, and NADA 123-116, 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 withdrawal of approval of 
these applications.

    Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20541 Filed 8-22-13; 8:45 am]
BILLING CODE 4160-01-P

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