Department of Health and Human Services May 2009 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 332
Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled ``Labeling OTC Human Drug Products; Small Entity Compliance Guide.'' FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand and comply with the agency's over- the-counter (OTC) labeling requirements and to prepare new labeling. This compliance guidance finalizes the draft compliance guidance published on December 9, 2004.
Agency Information Collection Activities: Proposed Collection; Conunent Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Health Literacy Item Set Supplemental to CAHPS Hospital SurveyPretest of Proposed Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Coordinating Care across Primary Care and Specialty Care Practices.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Public Meeting of the Federal Coordinating Council on Comparative Effectiveness Research
Authorized by the American Recovery and Reinvestment Act of 2009 (ARRA), the Federal Coordinating Council for Comparative Effectiveness Research will help coordinate research and guide investments in comparative effectiveness research funded by the Recovery Act. The Coordinating Council is holding this meeting to hear from the public about their views on the Council's activities.
National Biodefense Science Board; Notification of a Public Teleconference
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public teleconference. The meeting is open to the public.
Proposed Collection; Comment Request; CareerTrac
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 Fogarty International Center (FIC) and the National Institute of Environmental Health Sciences (NIEHS), 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.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2010; Minimum Data Set, Version 3.0 for Skilled Nursing Facilities and Medicaid Nursing Facilities
This proposed rule would update the payment rates used under the prospective payment system for skilled nursing facilities, for fiscal year 2010. In addition, it would recalibrate the case-mix indexes so that they more accurately reflect parity in expenditures related to the implementation of case-mix refinements in January 2006. It also discusses the results of our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification project, and proposes a new RUG-IV case-mix classification model that will use the updated Minimum Data Set (MDS) 3.0 resident assessment for case-mix classification. In addition, this proposed rule includes a request for public comment on a possible requirement for the quarterly reporting of nursing home staffing data, and would revise the regulations to incorporate certain technical corrections. Finally, this proposed rule includes a request for public comments on applying the quality monitoring mechanism in place for all other SNF PPS facilities to rural swing-bed hospitals.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
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.
New Animal Drugs; Trilostane
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of trilostane capsules in dogs for treatment of pituitary-dependent hyperadrenocorticism and for treatment of hyperadrenocorticism due to adrenocortical tumor.
New Animal Drugs; Carprofen
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the veterinary prescription use of carprofen caplets in dogs.
National Institute for Occupational Safety and Health; 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 at the Hood Building in Cambridge, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 31, 2009, 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:
Department of Health and Human Services Semiannual Regulatory Agenda
The Department's semiannual Agenda of Regulatory and Deregulatory Actions forecasts the rulemaking activities that we expect to undertake over the foreseeable future. We focus primarily on those areas of work anticipated to result in publication of Notices of Proposed Rulemaking or of Final Rules within the next 12 months. (Please note that the abstracts included below relate only to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities; the Regulatory Flexibility Act of 1980 requires dissemination of this information in the paper edition of the Federal Register. The complete HHS Agenda is accessible online at www.reginfo.gov.)
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 at Tyson Valley Powder Farm near Eureka, Missouri, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 31, 2009, 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 at Westinghouse Atomic Power Development Plant in East Pittsburgh, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 31, 2009, 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:
Determination of Regulatory Review Period for Purposes of Patent Extension; NEUPRO TRANSDERMAL SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for NEUPRO TRANSDERMAL SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”)
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; Investigational New Drug Regulations
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.
Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors; Request for Comments
On behalf of the Department of Health and Human Services (HHS) and the Public Health Service (PHS), a component of the HHS, the National Institutes of Health (NIH) seeks comments from the public on whether the HHS should amend its regulations on the responsibility of applicants for promoting objectivity in research for which phs funding is sought and on responsible prospective. We are interested particularly in receiving comments on the issues presented below from the general public, individual Investigators, scientific societies and associations, Members of Congress, other Federal agencies that support or conduct research, and institutions that receive PHS funds to conduct or support biomedical or behavioral research.
Tribal Management Grant Program
The Indian Health Service, HHS, published a document in the Federal Register Thursday, April 16, 2009. The document contained two errors.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.
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