Department of Health and Human Services July 29, 2008 – Federal Register Recent Federal Regulation Documents
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Food and Drug Administration Amendments Act of 2007; Prohibition Against Food to Which Drugs or Biological Products Have Been Added; Request for Comments
The Food and Drug Administration (FDA) is requesting comments relevant to the implementation of section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 912 of FDAAA establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act (the act), which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. FDA requests that interested persons submit data, information, and comments that will help provide a context for the agency's decisions on implementation of this provision. To encourage responsive comments, FDA is including a series of questions for interested persons to consider in preparing comments.
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 29th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting
This notice announces the 22nd meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards on Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft information sheet guidance entitled ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked QuestionsStatement of Investigator (Form FDA 1572).'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This draft information sheet guidance provides FDA's responses to the most frequently asked questions.
Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 15, 2008 (73 FR 40582). The document announced the determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. The document was published with an incorrect docket number. This document corrects that error.
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 19th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 28th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Developmental Disabilities Program
The Administration on Developmental Disabilities (ADD) reopens the public comment period on the proposed rule published in the Federal Register on April 10, 2008 (73 FR19708) to propose clarifications and new requirements to implement the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000). During the comment period there were instances when the electronic system was not available and individuals were having difficulties using the system. ADD is reopening the comment period of the NPRM to ensure that all individuals have an opportunity to comment on the proposed rule. Also, the submission of comments electronically will now be through the OMB regulations Web site, regulations.gov, rather than ACF's regulations Web site.
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