Department of Health and Human Services June 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 346
Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates; Corrections
This document corrects technical and typographical errors in the proposed rule entitled ``Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates'' which appeared in the May 5, 2011, Federal Register.
Medicare Program; Pioneer Accountable Care Organization Model; Extension of the Submission Deadlines for the Letters of Intent and Applications
This notice extends the deadlines for the submission of the Pioneer Accountable Care Organization Model letters of intent to June 30, 2011 and the applications to August 19, 2011.
Notice of Hearing; Reconsideration of Disapproval of Colorado State Plan Amendments (SPA) 10-034
This notice announces an administrative hearing to be held on August 4, 2011, at the CMS Denver Regional Office, Colorado State Bank Building, 1600 Broadway, Suite 700, Denver, Colorado 80202-4367 to reconsider CMS' decision to disapprove Colorado SPA 10-034.
Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology''. This guidance is intended to provide industry with FDA's current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology. The points to consider are intended to be broadly applicable to all FDA-regulated products, with the understanding that additional guidance may be articulated for specific product areas, as appropriate in the future.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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 information collection for in vivo Radiopharmaceuticals Used for Diagnosis and Monitoring.
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
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 temporary marketing permit applications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Bioequivalence Data
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 requirement for an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
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 State petitions for exemption from preemption.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act'' 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; Data To Support Communications Usability Testing, as Used by the Food and Drug Administration
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance to collect information that will provide tools to test the usability of FDA communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Boards
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Institutional Review Boards'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer's Research, Care, and Services
The National Alzheimer's Project Act, Public Law 111-375 (42 U.S.C. 11225), requires that the Secretary of Health and Human Services (HHS) establish the Advisory Council on Alzheimer's Research, Care, and Services. The Advisory Council is governed by provisions of Public Law 92-463 (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. The Secretary of HHS has determined that establishment of the Advisory Council on Alzheimer's Research, Care, and Services is desirable to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for non-Federal members of the Advisory Council. Nominations should include the nominee's contact information (current mailing address, e-mail address, and telephone number) and a current curriculum vitae or resume.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Grand Junction Operations Office, Grand Junction, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Request for Information (RFI) To Identify and Obtain Relevant Information From Public or Private Entities With an Interest in Biovigilance; Extension
This extension of time to respond to the previously published Request For Information (RFI) seeks to provide additional opportunities for potential stakeholders to identify and obtain relevant information regarding the possible development of a public-private partnership (PPP) designed to facilitate the identification of risks and strategies to assure safety of the U.S. supply of blood and blood components, tissues, cells, and organs. The original RFI was published in the Federal Register in Vol. 76, No. 79 on Monday April 25, 2011, titled, ``Request for Information (RFI) to Identify and Obtain Relevant Information from Public or Private Entities with an Interest in Biovigilance.'' An extension is being provided to all who cannot make the original deadline of June 9, 2011. The extension is until June 30, 2011.
Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Oral Fluid Specimen for Drug Testing
This document is a request for information regarding specific aspects of the regulatory policies and standards that may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (oral fluid specimen).
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Norton Company, Worcester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Wah Chang facility, Albany, Oregon, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Vitro Manufacturing, Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Linde Ceramics Plant in Tonawanda, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 21, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
The U.S. Department of Health and Human Services (HHS) announces the next Federal advisory committee meeting regarding the national health promotion and disease prevention objectives for 2020. This meeting will be open to the public and will be held online via WebEx software. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will address efforts to implement the nation's health promotion and disease prevention objectives and strategies to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for implementing Healthy People 2020, the nation's health promotion and disease prevention goals and objectives, and provide recommendations for initiatives to occur during the implementation phase of the goals and objectives.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension of Certification of Maintenance of Effort for the Title III and Minor Revisions to the Certification of Long-Term Care Ombudsman Program Expenditures
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Findings of Misconduct in Science/Research Misconduct
Notice is hereby given that on May 16, 2011, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science and research misconduct findings of the Office of Research Integrity (ORI) in the following case: Philippe Bois, Ph.D., St. Jude Children's Research Hospital: Based on the findings of an investigation report by St. Jude Children's Research Hospital (St. Jude) and additional analysis conducted by ORI during its oversight review, ORI found that Philippe Bois, Ph.D., former postdoctoral fellow, Department of Biochemistry, St. Jude, engaged in misconduct in science and research misconduct in research funded by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM071596, and National Cancer Institute (NCI), NIH, grants P30 CA021765, P01 CA071907, R01 CA072996, and R01 CA100603. ORI found that the Respondent knowingly and intentionally falsified data reported in two (2) papers:
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