Department of Health and Human Services October 24, 2011 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Health and Diet Survey
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Health and Diet Survey'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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 current burden hours on regulated industry of complying with the guidance underlying this collection of information.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Temporary Marketing Permit Applications
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Temporary Marketing Permit Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
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 requirements governing the registration of producers of drugs and listing of drugs in commercial distribution.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Evaluating the Safety of Flood-Affected Food Crops for Human Consumption.'' Flooding events can present a potentially hazardous public health risk. Flood waters may have been exposed to sewage, chemicals, heavy metals, pathogenic microorganisms, or other contaminants. The growers are responsible to ensure the safety of the flood-affected food crops. The guidance is intended to provide growers information on how to evaluate the safety of flood-affected food crops for human consumption.
Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated October 2011. The draft guidance document recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated August 2011, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with FDA's requirements and recommendations for collecting donor history information. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate.
Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction
This proposed rule identifies and proposes reforms in Medicare and Medicaid regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care. This is one of several rules that we are proposing to achieve regulatory reforms under Executive Order 13563 on Improving Regulation and Regulatory Review and the Department's Plan for Retrospective Review of Existing Rules.
Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation
This proposed rule would revise the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These proposed changes are an integral part of our efforts to reduce procedural burdens on providers. This proposed rule reflects the Centers for Medicare and Medicaid Services' (CMS') commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.''
Medicare Program; Changes to the Ambulatory Surgical Centers Patient Rights Conditions for Coverage
This final rule revises the ambulatory surgical centers (ASCs) conditions for coverage (CfC) to allow patient rights information to be provided to the patient, the patient's representative, or the patient's surrogate prior to the start of the surgical procedure. In addition, we made minor changes to the CfC for patient rights requirements, as specified in the proposed rule. This final rule reflects the Centers for Medicare and Medicaid Services' (CMS') commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.''
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