Department of Health and Human Services April 2010 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 346
Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253
The Food and Drug Administration (FDA) has determined the regulatory review period for VIMPAT based on new drug application (NDA) 22-253 for VIMPAT TABLETS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extensions of patents which claim the human drug product, VIMPAT. The regulatory review period determination for VIMPAT Injection is publishing in this issue of the Federal Register.
Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254
The Food and Drug Administration (FDA) has determined the regulatory review period for VIMPAT based on new drug application (NDA) 22-254 for VIMPAT injection and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim the human drug product, VIMPAT. The regulatory review period determination for VIMPAT Tablets is publishing in this issue of the Federal Register.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Fiscal Year (FY) 2010 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $1,000,000 (total costs) for up to one year to the current grantee for the National Center for Child Traumatic Stress (NCCTS). This is not a formal request for applications. Assistance will be provided only to the current grantee for the National Center for Child Traumatic Stress based on the receipt of a satisfactory application that is approved by an independent review group.
North American Bioproducts Corp.; Filing of Food Additive Petition (Animal Use); Erythromycin Thiocyanate
The Food and Drug Administration (FDA) is announcing that North American Bioproducts Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of erythromycin thiocyanate as an antimicrobial processing aid in fuel- ethanol fermentations with respect to its consequent presence in by- product distiller grains used as an animal feed or feed ingredient.
Certain Other Dosage Form New Animal Drugs; Detomidine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation and restraint of horses.
Medicare Program; Ambulatory Surgical Centers, Conditions for Coverage
This proposed rule would revise one of the existing conditions for coverage (CfC) that ambulatory surgical centers (ASCs) must meet in order to participate in the Medicare program. The proposed revision would modify the current CfC for patient rights to include an exception that would allow an ASC to provide patients or the patients' representative or surrogate with required patient rights information on the day of the procedure when the procedure must, to safeguard the health of the patient, be performed on the same day as the physician's referral. In addition, we are proposing some other minor changes to the CfC for patient right requirements.
Medicare and Medicaid Programs; Waiver of Disapproval of Nurse Aide Training Program in Certain Cases
This final rule will permit a waiver of a nurse aide training disapproval as it applies to skilled nursing facilities, in the Medicare program, and nursing facilities, in the Medicaid program, that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. This is a statutory provision enacted by section 932 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003).
Medicaid Program; Final FY 2008, Revised Preliminary FY 2009, and Preliminary FY 2010 Disproportionate Share Hospital Allotments and Final FY 2008, Revised Preliminary FY 2009, and Preliminary FY 2010 Disproportionate Share Hospital Institutions for Mental Disease Limits
This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal FY (FY) 2008 and the preliminary Federal share DSH allotments for FY 2010. This notice also announces the final FY 2008 and the preliminary FY 2010 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. This notice also announces the revised preliminary Federal share DSH allotments for FY 2009 and the revised preliminary FY limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities to reflect the provisions of the American Reinvestment and Recovery Act of 2009 (the Recovery Act), enacted on February 17, 2009. This notice also includes background information describing the methodology for determining the amounts of States' FY DSH allotments.
Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2009 and Federal Fiscal Year 2010
This notice sets forth final allotments available to States to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the Federal fiscal year (FY) 2009 and the preliminary QI allotments for FY 2010. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations, as amended in the Federal Register published on November 24, 2008, and reflect funding for the QI program made available under recent legislation.
Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' This draft guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The draft guidance would provide even greater transparency to FDA's advisory committee process than current guidance. The draft guidance announced in this notice, when finalized, would replace guidance of the same title dated August 2008.
Health Center Program
The Health Resources and Services Administration (HRSA) will be transferring Health Center Program (section 330 of the Public Health Service Act) New Access Point (NAP), Increased Demand for Service (IDS), and Capital Improvement Program (CIP) funds originally awarded to Community Medical Services to Cornerstone Care, Inc. to ensure the provision of critical primary health care services to underserved populations in Fayette County, Pennsylvania.
New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The supplemental NADA provides for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, melengestrol, and monensin for heifers fed in confinement for slaughter.
Food Labeling; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Dallas District Office (DALDO), in collaboration with Oklahoma State University (OSU), Robert M. Kerr Food & Agricultural Products Center (FAPC), is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups.
Proposed Collection; Comment Request; Survey of Health Care Professionals' Awareness and Perceptions of the National Cancer Institute's Intramural Clinical Trials (NCI)
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
In March 2009, the NIH Office of Biotechnology Activities (OBA) published a proposal to revise the NIH Guidelines for Research
National Toxicology Program (NTP); Office of Liaison, Policy and Review Meeting of the NTP Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Center for Devices and Radiological Health; New Address Information
The Food and Drug Administration (FDA) is amending procedural regulations that pertain to obtaining, submitting, executing, and
Fiscal Year (FY) 2010 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $478,000 (total costs) for up to two years to Link2Health Solutions, Inc. This is not a formal request for applications. Assistance will be provided only to Link2Health Solutions, Inc. based on the receipt of a satisfactory application that is approved by an independent review group.
Guidance for Industry on Tobacco Health Document Submission; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Tobacco Health Document Submission.'' The guidance document is intended to assist persons making certain document submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
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