Department of Health and Human Services December 16, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during the Federal Government Response Stages of an influenza pandemic. The agency makes recommendations to industry for focusing limited resources on reports related to influenza-related products and other specific types of reports indicated in the draft guidance.
Microbiological Testing for Contact Lens Care Products; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Microbiological Testing for Contact Lens Care Products.'' FDA is co-sponsoring the public workshop with the American Academy of Ophthalmology, the American Academy of Optometry, the American Optometric Association, and the Contact Lens Association of Ophthalmologists. The purpose of the public workshop is to discuss test method parameters for evaluating the activity of contact lens care products against Acanthamoeba and to discuss elements of microbiological test methods that simulate ``real world'' consumer use conditions. Date and Time: The public workshop will be held on January 22 and 23, 2009, from 8 a.m. to 5 p.m. Participants are encouraged to arrive by 7:30 a.m. to allow enough time for parking and security screening. Security Screening will begin at 7 a.m. Location: The public workshop will be held at the Food and Drug Administration, White Oak Conference Center, 10903 New Hampshire Ave., Bldg. 2 (Central Shared Use Building), Silver Spring, MD. Attendees should follow the directions provided in the Registration Information section of this document. Contact: Daryl L. Kaufman, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4200, FAX: 240-276-4234, e-mail: Daryl.Kaufman@fda.hhs.gov, or Marc Robboy, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4200, FAX: 240-276-4234, e-mail: Marc.Robboy@fda.hhs.gov. Agenda: The purpose of the conference is to discuss test methods for evaluating the anti-microbial activity of contact lens care products. On January 22, 2008, we hope to reach consensus on critical test method parameters for evaluating the activity of contact lens care products against Acanthamoeba. These parameters include organism species and strain, trophozoite culture and cyst production, microbial challenge level, and assay method for survivors. On January 23, 2008, we hope to present and discuss critical elements for new or modified disinfection efficacy test methods that simulate ``real world'' consumer use conditions. These elements include contact lens and lens case uptake of preservative and other solution ingredients, solution evaporation, minimal consumer compliance, biofilm formation and clinical isolates as challenge organisms. Background information on the public workshop, registration information, the agenda, information about lodging, and other relevant information will be posted on the Internet at www.jcahpo.org/clmw. Registration Information: Registration must be completed online at www.jcahpo.org/clmw. Please pre-register no later than January 8, 2009 (see instructions in this paragraph). There will be no onsite registration. Non-U.S. citizens are subject to additional security screening and should pre-register at least 3 weeks in advance. There is a registration fee of $250 for this workshop. Early registration is recommended because seating is limited. If you need special accommodations due to a disability, please contact Ms. Janice Prestwood at 800-284-3937, ext. 229 (toll free), 651-731-7229 (direct) or 651-731-0410 (fax) at least 7 days before the public workshop. Lodging, travel, and security clearance information are also available from the registration Web site. Persons without Internet access may contact Ms. Janice Prestwood for help in completing the registration form.
Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendation for Vancomycin HCl.'' The recommendation provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules.
Draft Guidance for Industry on Changes to Approved New Animal Drug Applications-New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 191 entitled ``Changes to Approved NADAsNew NADAs vs. Category II Supplemental NADAs''. This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM).
Guidance for Industry on Orally Disintegrating Tablets; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Orally Disintegrating Tablets.'' The guidance provides pharmaceutical manufacturers of new and generic products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate proposed products as ODTs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Advisory Committees; Filing of Closed Meeting Reports
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2008.
Draft Guidance for Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.'' This draft guidance is intended to inform pharmaceutical manufacturers of the agency's thinking regarding genotoxic and carcinogenic impurities in drug substances and drug products, including biologic products that are regulated by the Center for Drug Evaluation and Research (CDER), and to provide recommendations on how to evaluate the safety of these impurities during clinical development and for marketing applications. This draft guidance, when finalized, will clarify FDA's additional testing and exposure threshold recommendations for situations in which genotoxic or carcinogenic impurities are present. This draft guidance addresses synthetic impurities and degradants in drug substances, but does not otherwise address the genotoxicity or carcinogenicity of actual drug substances or intended drug product ingredients. This draft guidance also applies to known starting materials or anticipated reaction products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on postmarketing adverse drug experience reporting and recordkeeping requirements.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill four upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).
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