Department of Health and Human Services June 22, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
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 procedure by which an applicant may obtain an assignment or designation determination.
Determination of Regulatory Review Period for Purposes of Patent Extension; CIALIS
The Food and Drug Administration (FDA) has determined the regulatory review period for CIALIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Sodium picosulfate, up to 10 milligrams (mg), as a laxative single active ingredient. FDA reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/E) for its proposed OTC use.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated in the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting is open to the public.
Solicitation of Nomination for Appointment to the Chronic Fatigue Syndrome Advisory Committee
The Office of Public Health and Science, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. The appointments of five Committee members are scheduled to end on September 30, 2006. Nominations of qualified candidates are being sought to fill these scheduled vacancies.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Generally Recognized as Safe: Notification Procedure
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Substances Generally Recognized as Safe: Notification Procedure'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006,'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; BONIVA
The Food and Drug Administration (FDA) has determined the regulatory review period for BONIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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 collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files
The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review.
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