Department of Health and Human Services July 2010 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 302
Solicitation of Nomination for Appointment to the Advisory Committee on Minority Health
The Department of Health and Human Service (HHS), Office of Public Health and Science (OPHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (ACMH). In accordance with Public Law 105- 392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health, on the development of goals and specific program activities of the Office of Minority Health (OMH) designed to improve the health of racial and ethnic minority groups. Nominations of qualified candidates are being sought to fill current and impending vacant positions on the Committee.
The Negotiated Rulemaking Committee on the Designation of Medically Underserved Populations and Health Professions Shortage Areas
Pursuant to Section 5602 of the ACA, HRSA plans to establish a comprehensive methodology and criteria for Designation of MUPs and Primary Care HPSAs [under Sections 330(b)(3) and 332 of the Public Health Service (PHS) Act, respectively], using a Negotiated Rulemaking process. To do this, HRSA announces the establishment of the Negotiated Rulemaking Committee on the Designation of Medically Underserved Populations and Health Professions Shortage Areas.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2011
This notice with comment period sets forth an update to the payment rates used under the prospective payment system for skilled nursing facilities for fiscal year 2011, and implements section 10325 of the Patient Protection and Affordable Care Act.
Medicare Program; Hospice Wage Index for Fiscal Year 2011
This notice with comment period announces the annual update to the hospice wage index for fiscal year 2011 and continues the phase out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2011 of 25 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2012 through FY 2016.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2011
This notice updates the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2011 (for discharges occurring on or after October 1, 2010 and on or before September 30, 2011) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Supplemental Form to the Financial Status Report for all AoA Title III Grantees
The Administration on Aging (AoA) 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 Supplemental Form to the Financial Status Report for all AoA Title III Grantees.
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 27 new drug applications (NDAs) and 58 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
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 provisions in the guidance document entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.''
Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors
The Department of Health and Human Services (HHS or the Department), including the HHS Public Health Service (PHS), is extending the comment period for a proposed rule that would amend the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors, and is clarifying certain elements of the proposed rule for which we are seeking additional comment. The proposed rule was published in the Federal Register on May 21, 2010 (75 FR 28688). The comment period is extended by 30 days and thus will end on August 19, 2010.
Office of Child Support Enforcement; Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Office of Child Support Enforcement (OCSE) is publishing notice of a new system of records, entitled ``Federal Parent Locator Service (FPLS) Child Support Services Portal,'' System No. 09-80-0387.
Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a) (the Bioterrorism Act) requires the biennial review and republication of the HHS list of select agents and toxins. Accordingly, we are soliciting public comment on the current HHS list of select agents and toxins, including whether any biological agent or toxin should be added to or removed from the list. We are also seeking comments as to whether we should ``tier'' the HHS select agent list based on the relative bioterrorism risk of each agent or toxin and possibly further ``stratify'' the security requirements for agents in the highest tier based on type of use or other factors.
Office of Biotechnology Activities; Recombinant DNA Research: Proposed Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Under the NIH Guidelines, experiments involving the generation of transgenic rodents by recombinant DNA technology must be registered with the Institutional Biosafety Committee (IBC). Specifically, Section
Memorandum of Understanding: Food and Drug Administration and the National Institutes of Health, National Institutes of Environmental Health Sciences, National Toxicology Program; and the National Institutes of Health, National Human Genome Research Institute, National Institutes of Health, Chemical Genomics Center; and the Environmental Protection Agency, Office of Research and Development
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Institutes of Health (NIH), National Institutes of Environmental Health Sciences (NIEHS), National Toxicology Program (NTP); and the NIH, National Human Genome Research Institute (NHGRI), NIH Chemical Genomics Center (NCGC); and the Environmental Protection Agency, Office of Research and Development.
Advancing the Development of Medical Products Used In the Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases; Public Hearing
The Food and Drug Administration (FDA) is announcing a public hearing to solicit general views and information from interested persons on issues related to advancing the development of medical products (drugs, biological products, and medical devices) used in the prevention, diagnosis, and treatment of neglected tropical diseases. In particular, FDA is seeking these views and information from interested persons on preclinical studies, trial design, regulatory approaches, and optimal solutions as they relate to the prevention, diagnosis, and treatment of neglected tropical diseases. To help solicit such views and information, FDA is seeking comments on specific issues (see section IV of this document).
International Conference on Harmonisation; Draft Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C: Impurities: Residual Solvents.'' The draft recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Withdrawal
The Food and Drug Administration (FDA) published in the Federal Register of April 1, 2010, a direct final rule that was intended to make noncontroversial amendments to existing regulations which would require the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
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 paperwork associated with designation under the Minor Use and Minor Species (MUMS) Animal Health Act of 2004.
Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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 reporting requirements contained in existing FDA regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients.
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