Global Implementation of the Veterinary Medicinal Products Guidelines, 61504-61505 [2010-24905]

Download as PDF mstockstill on DSKH9S0YB1PROD with NOTICES 61504 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, is the subject of ANDA 89–420, held by Schwarz Pharma, Inc., and initially approved on January 25, 1988. AZDONE is indicated for the relief of moderate to moderately severe pain. AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Lachman Consultant Services, Inc., submitted a citizen petition dated June 23, 2010 (Docket No. FDA–2010–P– 0338), under 21 CFR 10.30, requesting that the Agency determine whether AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records, FDA has determined under § 314.161 that AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg was not withdrawn for reasons of safety or effectiveness. The petitioner has VerDate Mar<15>2010 18:36 Oct 04, 2010 Jkt 223001 identified no data or other information suggesting that AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events and have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: September 29, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–24902 Filed 10–4–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0497] Global Implementation of the Veterinary Medicinal Products Guidelines AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for a cooperative agreement to the World Organization for Animal Health (OIE). The OIE is the intergovernmental organization responsible for improving animal health worldwide and is recognized by the World Trade Organization (WTO) as a reference for international sanitary SUMMARY: PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 rules, with 175 Member Countries and Territories. The purpose of this agreement is to continue outreach that began in fiscal year (FY) 2009 to expand capacity building to support OIE’s services and activities that are needed to carry out OIE’s Veterinary International Conference on Harmonization (VICH) Global Outreach to disseminate and implement VICH guidelines at the country level. FOR FURTHER INFORMATION CONTACT: Program Contact: Merton V. Smith, Center for Veterinary Medicine (HFV–1), Food and Drug Administration, 7519 Standish Pl., rm. 177, Rockville, MD 20855, 240– 276–9025, FAX: 240–276–9030, email: Merton.Smith@fda.hhs.gov. Management Contact: Katherine C. Bond, Office of the Commissioner, Food and Drug Administration, White Oak Bldg. 32, rm. 3300, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–8318, FAX: 301–595–5058, email: Katherine.Bond@fda.hhs.gov. Grants Contact: Kimberly Pendleton, Division of Acquisition and Grants (HFA–500), Food and Drug Administration, 5630 Fishers Lane, rm. 2104, Rockville, MD 20857, 301–827–9363, FAX: 301–827– 7101, email: kimberly.pendleton@fda.hhs.gov. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please contact Kimberly Pendleton. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description RFA–FD–10–010 Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov A. Background FDA announces its intention to accept and consider a single source application for award of a cooperative agreement to the OIE in support of international technical capacity building activities that help to assure that U.S. imports of veterinary medicinal products are safe, effective, and of high quality and that food from treated animals is safe and wholesome; to assist foreign regulators in developing and using rigorous safety standards; to develop and foster mutually beneficial regulatory partnerships; and to leverage resources for capacity building through appropriate training and other activities. B. Research Objectives • Promote and enhance in OIE Members good veterinary governance, which includes the compliance of Veterinary Services with OIE E:\FR\FM\05OCN1.SGM 05OCN1 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices international standards, as an instrumental and essential prerequisite to the establishment and effective implementation of adequate and appropriate legislation covering all aspects of products for veterinary use, including registration, quality control, distribution, monitoring of quantities and final use. • Develop and improve international and regional cooperation in the establishment and enforcement of legislation to harmonize the regulatory framework between OIE Member States so as to assist countries in need to effectively institute and maintain such mechanisms. • Encourage countries to allocate appropriate human and financial resources to veterinary services and laboratories to correctly implement the OIE standards and guidelines related to veterinary products and their control. • Enhance capacities of national focal points for OIE on matters related to veterinary products according to the suggested terms of reference and encourage his/her participation in training sessions and appropriate international gatherings and meetings. • Promote the responsible and prudent use of veterinary medicinal products, in particular of antimicrobials used in veterinary medicine, and the monitoring of the quantities used and potential existence or development of antimicrobial resistance in diseasecausing organisms affecting both humans and animals. • Actively encourage the recognition and application of the international recommendations, guidelines and tools developed by the OIE and adopted by the World Assembly of Delegates on veterinary products. C. Eligibility Information The following organizations/ institutions are eligible to apply: The OIE. II. Award Information/Funds Available mstockstill on DSKH9S0YB1PROD with NOTICES A. Award Amount FDA anticipates providing one award of $565,000 (total costs including indirect costs) in fiscal year (FY) 2010 in support of this project. Subject to the availability of funds and successful performance, 1 additional year of support up to $565,000 per year will be available. preceding year, receipt of a noncompeting continuation application and available Federal FY appropriations. Dated: September 29, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–24905 Filed 10–4–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Listing of Members of the National Institutes of Health’s Senior Executive Service 2010 Performance Review Board (PRB) The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health’s Senior Executive Service 2010 Performance Review Board. This action is being taken in accordance with Title 5, U.S.C., 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register. The following persons will serve on the NIH Performance Review Board, which oversees the evaluation of performance appraisals of NIH Senior Executive Service (SES) members: Ms. Colleen Barros (Chair), Dr. Michael Gottesman, Ms. Lenora Johnson, Ms. Robin Kawazoe, Dr. Sally Rockey, Dr. Lawrence Tabak, Dr. Samir Zakhari. For further information about the NIH Performance Review Board, contact the Office of Human Resources, Workforce Relations Division, National Institutes of Health, Building 31, Room B3C07, Bethesda, Maryland 20892, telephone 301–402–9203 (not a toll-free number). Dated: September 27, 2010. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2010–24929 Filed 10–4–10; 8:45 am] BILLING CODE 4140–01–P The support will be 1 year with the possibility of an additional year of noncompetitive support. Continuation beyond the first year will be based on satisfactory performance during the 18:36 Oct 04, 2010 Jkt 223001 PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)—Health Disparities Subcommittee (HDS) Correction: This notice was published in the Federal Register on September 1, 2010, Volume 75, Number 169, page 53703. A quorum of the subcommittee’s membership was not able to participate; therefore, the meeting was adjourned. The subcommittee will reconvene as follows: Time and Date: 2 p.m.–3 p.m., October 21, 2010. Place: Teleconference. Status: Open to the public. Teleconference access limited only by the availability of telephone ports. The public is welcome to participate during the public comment period, which is tentatively scheduled from 2:45 p.m. to 2:50 p.m. To participate in the teleconference please dial (877) 394– 7734 and enter conference code 9363147. Purpose: The Subcommittee will provide recommendations for consideration to the ACD on strategic and other broad issues facing CDC. Matters To Be Discussed: Policy brief on health equity and social determinants of health; update on collaboration with the CDC Health Equity Workgroup; CDC Director’s Annual Health Disparity Report; and briefing on the realignment of the CDC Office of Minority Health and Health Disparities. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Walter W. Williams, M.D., M.P.H., Designated Federal Officer, HDS, ACD, CDC, 1600 Clifton Road, NE., M/S E–67, Atlanta, Georgia 30333. Telephone (404) 498–2310, E-mail: https:// www1@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: September 29, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. B. Length of Support VerDate Mar<15>2010 61505 [FR Doc. 2010–24911 Filed 10–4–10; 8:45 am] BILLING CODE 4163–18–P Frm 00095 Fmt 4703 Sfmt 9990 E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61504-61505]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24905]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0497]


Global Implementation of the Veterinary Medicinal Products 
Guidelines

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces its intention 
to accept and consider a single source application for a cooperative 
agreement to the World Organization for Animal Health (OIE). The OIE is 
the intergovernmental organization responsible for improving animal 
health worldwide and is recognized by the World Trade Organization 
(WTO) as a reference for international sanitary rules, with 175 Member 
Countries and Territories. The purpose of this agreement is to continue 
outreach that began in fiscal year (FY) 2009 to expand capacity 
building to support OIE's services and activities that are needed to 
carry out OIE's Veterinary International Conference on Harmonization 
(VICH) Global Outreach to disseminate and implement VICH guidelines at 
the country level.

FOR FURTHER INFORMATION CONTACT:
    Program Contact: Merton V. Smith, Center for Veterinary Medicine 
(HFV-1), Food and Drug Administration, 7519 Standish Pl., rm. 177, 
Rockville, MD 20855, 240-276-9025, FAX: 240-276-9030, email: 
Merton.Smith@fda.hhs.gov.
    Management Contact: Katherine C. Bond, Office of the Commissioner, 
Food and Drug Administration, White Oak Bldg. 32, rm. 3300, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-8318, FAX: 301-595-
5058, email: Katherine.Bond@fda.hhs.gov.
    Grants Contact: Kimberly Pendleton, Division of Acquisition and 
Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm. 
2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, email: 
kimberly.pendleton@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please contact Kimberly Pendleton.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-10-010
Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov

A. Background

    FDA announces its intention to accept and consider a single source 
application for award of a cooperative agreement to the OIE in support 
of international technical capacity building activities that help to 
assure that U.S. imports of veterinary medicinal products are safe, 
effective, and of high quality and that food from treated animals is 
safe and wholesome; to assist foreign regulators in developing and 
using rigorous safety standards; to develop and foster mutually 
beneficial regulatory partnerships; and to leverage resources for 
capacity building through appropriate training and other activities.

B. Research Objectives

     Promote and enhance in OIE Members good veterinary 
governance, which includes the compliance of Veterinary Services with 
OIE

[[Page 61505]]

international standards, as an instrumental and essential prerequisite 
to the establishment and effective implementation of adequate and 
appropriate legislation covering all aspects of products for veterinary 
use, including registration, quality control, distribution, monitoring 
of quantities and final use.
     Develop and improve international and regional cooperation 
in the establishment and enforcement of legislation to harmonize the 
regulatory framework between OIE Member States so as to assist 
countries in need to effectively institute and maintain such 
mechanisms.
     Encourage countries to allocate appropriate human and 
financial resources to veterinary services and laboratories to 
correctly implement the OIE standards and guidelines related to 
veterinary products and their control.
     Enhance capacities of national focal points for OIE on 
matters related to veterinary products according to the suggested terms 
of reference and encourage his/her participation in training sessions 
and appropriate international gatherings and meetings.
     Promote the responsible and prudent use of veterinary 
medicinal products, in particular of antimicrobials used in veterinary 
medicine, and the monitoring of the quantities used and potential 
existence or development of antimicrobial resistance in disease-causing 
organisms affecting both humans and animals.
     Actively encourage the recognition and application of the 
international recommendations, guidelines and tools developed by the 
OIE and adopted by the World Assembly of Delegates on veterinary 
products.

C. Eligibility Information

    The following organizations/institutions are eligible to apply: The 
OIE.

II. Award Information/Funds Available

A. Award Amount

    FDA anticipates providing one award of $565,000 (total costs 
including indirect costs) in fiscal year (FY) 2010 in support of this 
project. Subject to the availability of funds and successful 
performance, 1 additional year of support up to $565,000 per year will 
be available.

B. Length of Support

    The support will be 1 year with the possibility of an additional 
year of noncompetitive support. Continuation beyond the first year will 
be based on satisfactory performance during the preceding year, receipt 
of a non-competing continuation application and available Federal FY 
appropriations.

    Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24905 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S

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