Department of Health and Human Services August 6, 2010 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This draft guidance document discusses information to be included in premarket notifications for lamotrigine or zonisamide assays. This draft guidance is not final nor is it in effect at this time.
Solicitation of Nomination for Appointment to the Advisory Committee on Minority Health; Correction
The Department of Health and Human Services published a document in the Federal Register on Thursday, July 22, 2010 soliciting nominations for appointment to the Advisory Committee on Minority Health. Within the FOR FURTHER INFORMATION CONTACT section, there was a
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting
The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August 26, 2010, is postponed. The meeting was announced in the Federal Register of June 24, 2010 (75 FR 36102). The meeting is postponed so that FDA can review and consider additional information that was submitted. A future meeting date will be announced in the Federal Register at a later date.
Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs). The guidance is structured to facilitate the preparation of applications submitted in Common Technical Document (CTD) format.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization
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; Generic Food and Drug Administration Rapid Response Surveys
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 the use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pretesting of Tobacco Communications
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.
Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of draft guidance documents for 11 neurological and physical medicine devices. The document was published with an inadvertent error. This document corrects that error.
Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition (or in the case of a vaccine or diagnostic, information to support the estimates of how many people will be administered the diagnostic or vaccine annually) and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Strategic Plan for Consumer Education via Cooperative Agreement (U18)
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application under a cooperative agreement grant (U18) in fiscal year (FY) 2010 to the Partnership for Food Safety Education (PFSE) located in Washington, DC. This cooperative agreement grant is being provided to facilitate a ``Strategic Plan for Consumer Education'' to determine future directions for PFSE in carrying out a nationwide food safety education program on safe handling practices to prevent foodborne illness. The goal of the cooperative agreement is to help strengthen PFSE, so that FDA's goal may be achieved in improving consumer food safety practices and in turn reduce the incidence of foodborne illness.
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