Department of Health and Human Services June 5, 2013 – Federal Register Recent Federal Regulation Documents
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Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On May 29, 2013, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves Middle East respiratory syndrome coronavirus (MERS-CoV). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Middle East respiratory syndrome coronavirus (MERS-CoV) pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Request for Information: Solicits Public Input on the Renewal of “Combating the Silent Epidemic of Viral Hepatitis, Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis”
The Department of Health and Human Services (HHS) is seeking broad public input as it begins efforts to renew the 2011 Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis to include actions which can be undertaken over the course of the next three years, 2014-2016.
New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction
The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the Federal Register of April 30, 2013. FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations.
Request for Comments on Issues Related to Incidental Findings That Arise in the Clinical, Research, and Direct-To-Consumer Contexts
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical, legal, and social issues raised by incidental findings that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and direct-to-consumer contexts.
Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs for the treatment of HIV. This draft guidance revises the guidance for industry entitled ``Antiretroviral Drugs Using Plasma HIV RNA MeasurementsClinical Considerations for Accelerated and Traditional Approval'' issued in October 2002.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
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 information collection requirements relating to the reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue- based product (HCT/P) deviations, and Forms FDA 3486 and 3486A.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revision of the Requirements for Constituent Materials
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; Submission for Office of Management and Budget Review; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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.
Lung Cancer Patient-Focused Drug Development; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for lung cancer. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of lung cancer on daily life as well as the available therapies for lung cancer.
Announcement for the National Registry of Evidence-Based Programs and Practices (NREPP): Open Submission Period for Fiscal Year 2014
The mission of SAMHSA is to reduce the impact of substance abuse and mental illness on America's communities. Established in 1992, the Agency was directed by Congress to target effective substance abuse and mental health services to the people most in need and to translate research in these areas more effectively and more rapidly into the general health care system. NREPP is a key public resource SAMHSA has developed to help meet this directive. As of June 2013, approximately 290 interventions developed in the U.S. and abroad have been reviewed and added to the registry. This notice announces NREPP's open submission period for fiscal year 2014, during which program developers may submit a request to have their intervention reviewed. The notice provides information about the documentation that submissions must include to demonstrate that an intervention meets NREPP's minimum requirements; the responsibilities of the Principal during the review process; and the process for submitting materials for review during the open submission period.
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