Department of Health and Human Services August 29, 2006 – Federal Register Recent Federal Regulation Documents
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Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cardiovascular and Renal Drugs Advisory Committee. This meeting was originally announced in the Federal Register of August 1, 2006 (71 FR 43487). The amendment is being made to reflect changes in the Agenda portion of the document. The word ``TRASYOL'' should read ``TRASYLOL''. In the same paragraph, the word ``apportioning'' should read ``aprotinin''. There are no other changes.
Psychopharmacologic Drugs Advisory Committee; Cancellation
The meeting of the Psychopharmacologic Drugs Advisory Committee scheduled for September 7, 2006, is cancelled. This amended meeting was announced in the Federal Register of August 17, 2006 (71 FR 47502).
Notice of availability of Draft Policy Documents for Comment
This is a Notice of Availability and request for comments on certain draft policy documents prepared by HRSA's Bureau of Primary Health Care (BPHC). HRSA plans to periodically make some draft policy documents (including draft Program Information Notices (PINs)) available for public comment on the Internet at https://bphc.hrsa.gov. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
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 proposed collection of information that will permit an applicant to certify that it qualifies as a ``small business'' within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397
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.
Conduct of Emergency Clinical Research; Public Hearing
The Food and Drug Administration (FDA) is announcing a public hearing on emergency research conducted without informed consent under FDA's emergency research rule. The public hearing announced in this document is part of FDA's Human Subject Protection and Bioresearch Monitoring Initiative. We are particularly interested in hearing the views of individuals and groups who have encountered challenges in the conduct of emergency research in the absence of informed consent, including patient advocacy groups, individuals who have participated in clinical studies, institutional review board members (IRBs), sponsors, clinical investigators, medical societies, ethicists, and other interested parties. We are seeking input on a number of specific questions regarding aspects of emergency research and additional human subject protections. Elsewhere in this issue of the Federal Register, we are also issuing a draft guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.'' We will consider comments received on this draft guidance together with comments and suggestions received at the hearing to determine whether the current framework is adequate for the ethical conduct of emergency research, or whether modifications would be appropriate.
Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.'' This draft guidance, when finalized, is intended to assist Institutional Review Boards (IRBs), clinical investigators, and sponsors in the development and conduct of emergency research.The draft guidance also describes the additional specific human subject protection requirements for emergency research. Elsewhere in this issue of the Federal Register, FDA is announcing a public hearing on emergency research conducted without informed consent under FDA regulations.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
The Food and Drug Administration (FDA) is proposing to amend its regulations governing drug establishment registration and drug listing. The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products (including vaccines and allergenic products), and/ or human cells, tissues, and cellular and tissue-based products (HCT/ Ps), and animal drugs. The proposal describes when and how to register and list and what information must be submitted for registration and listing. In addition, the proposal would make certain changes to the National Drug Code (NDC) system and would require the appropriate NDC number to appear on the labels for drugs subject to the listing requirements. The proposed regulations generally would require the electronic submission of all registration and most listing information. We (FDA) rely on establishment registration and drug listing information for administering many of our programs, such as postmarketing surveillance (including FDA inspections), bioterrorism, drug shortages and availability, and user fee assessments. We are taking this action to use the latest technology to improve our registration and listing system, which would further our goal of protecting the public health. We also believe that the conversion to an electronic system would make the registration and listing processes more efficient and effective for industry and us. We are also taking this action to support the implementation of, for example, the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act, our rulemaking requiring a bar code on certain drug products, and the DailyMed initiative.
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