Department of Health and Human Services July 2009 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 344
Medicaid Program and Children's Health Insurance Program (CHIP); Revisions to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs
This proposed rule would implement provisions from the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) (Pub. L. 111-3) with regard to the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs. This proposed rule would also codify several procedural aspects of the process for estimating improper payments in Medicaid and the Children's Health Insurance Program (CHIP).
Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA's Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register.
Guidance for Institutional Review Boards, Frequently Asked Questions-Institutional Review Board Registration; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Institutional Review Boards (IRBs), Frequently Asked Questions IRB Registration.'' This guidance is intended to assist IRBs in complying with the new requirement for IRB registration. This new rule requires each IRB in the United States that reviews FDA-regulated research to register using an Internet-based registration system that is maintained by the Department of Health and Human Services (HHS). This registration system is a modification of the one currently used by the Office for Human Research Protections (OHRP) for registration of IRBs that are designated by institutions under Federalwide Assurances (FWAs). OHRP has issued a similar rule requiring IRBs designated by institutions under FWAs to register or update their registration information using this modified system.
Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The document provides guidance to the dietary supplement industry for complying with the serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA's Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
Dual Antiplatelet Therapy Trial: Research Project Grant (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Critical Path Programs (OCPP). The goal of the Dual Antiplatelet Therapy (DAPT) Trial is to solicit a sole source grant application from Harvard Clinical Research Institute (HCRI) that proposes to provide funding in support of a dual antiplatelet therapy clinical trial being conducted by HCRI.
Draft Guidance for Industry on “Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting,” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.'' This draft guidance provides recommendations to pharmaceutical manufacturers on design considerations for incorporating physical-chemical identifiers (PCIDs) into solid oral dosage forms (SODFs), supporting documentation to be submitted in new drug applications (NDAs) and abbreviated new drug
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 under the project: ``Evaluation of AHRQ's Effective Health Care Program.'' 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 for Healthcare Research and Quality
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: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component through 2012.'' 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.
Notice of Hearing: Reconsideration of Disapproval of Washington State Plan Amendment (SPA) 08-019
This notice announces an administrative hearing to be held on August 4, 2009 at the CMS Seattle Regional Office, 2201 Sixth Avenue, MS/RX-43, Seattle, Washington 98121, to reconsider CMS' decision to disapprove Washington SPA 08-019.
Possession, Use, and Transfer of Select Agents and Toxins; Proposed Addition of SARS-Associated Coronavirus (SARS-CoV)
The biological agents and toxins listed in Sec. 73.3 of Title 42 of the Code of Federal Regulations have been determined by the Secretary of the U.S. Department of Health and Human Services (HHS Secretary) to have the potential to pose a severe threat to public health and safety. We are now proposing to add SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We are proposing this action because (1) SARS-CoV can cause significant mortality, especially in the elderly; (2) the virus has the capability of easily being transmitted from human to human; (3) there is currently no vaccine or antiviral approved for the prevention or treatment of infections caused by the SARS-CoV virus; and (4) it has been documented that the virus may persist in the environment.
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010; Correction
This document corrects a technical error in the proposed rule entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010'' which appears elsewhere in this Federal Register.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches: Notice of Availability and Request for Public Comments
NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel (hereafter, Panel) on May 19-21, 2009, to evaluate test methods and approaches with the potential to reduce and refine the use of animals for ocular safety testing. These evaluations included the following:
Proposed Collection; Comment Request; The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer
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 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.
Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Office of the Commissioner (OC), is announcing a public workshop entitled ``Providing Effective Information to Consumers About Prescription Drug Risks and Benefits.'' This public workshop is intended to explore potential approaches that will result in written prescription drug information for consumers that is comprehensible, accurate, and easy to access.
Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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