Department of Health and Human Services September 23, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 29 of 29
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
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.
Solicitation of Written Comments on Draft Tier 2 Strategies/Modules for Inclusion in the “HHS Action Plan to Prevent Healthcare-Associated Infections”
The Office of Healthcare Quality is soliciting public comment on three new strategies or modules of the ``HHS Action Plan to Prevent Healthcare-Associated Infections.'' To further the HHS mission to protect the health and well-being of the nation, the HHS Steering Committee for the Prevention of Healthcare-Associated Infections has developed draft comprehensive strategies for preventing and reducing healthcare-associated infections in ambulatory surgical centers and end-stage renal disease facilities, as well as a strategy to increase influenza vaccination coverage among healthcare personnel. These Tier 2 modules build upon and are to be included in the existing ``HHS Action Plan to Prevent Healthcare-Associated Infections'' that focuses on reducing hospital-acquired infections (Tier 1).
Call for Comments on the Existing National Standards for the Culturally and Linguistically Appropriate Services in Health Care
The HHS Office of Minority Health (OMH) announces the launch of an enhancement initiative of the existing National Standards for Culturally and Linguistically Appropriate Services in Health Care (CLAS Standards). The public comment period will begin September 20, 2010 and conclude December 31, 2010. During this time three regional meetings on the standards will be held throughout the country. Individuals and organizations are encouraged to submit their comments on the 14 standards and their current application and use. The enhanced national standards, as revised in accordance with public comment and subject matter expertise, will be published for review in spring of 2011 with the final versions being published in fall of 2011.
Draft Revision of the Federalwide Assurance
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of the draft revised Federalwide Assurance (FWA) form and Terms of Assurance, and is seeking comment on these draft documents. OHRP is proposing several changes to simplify and shorten the FWA form and Terms of Assurance. Institutions engaged in non-exempt human subjects research conducted or supported by the Department of Health and Human Services (HHS) must hold an OHRP-approved FWA. The draft revised FWA form and Terms of Assurance, when finalized, will supersede the current FWA documents available on the OHRP Web site at http:[sol][sol]www.hhs.gov/ohrp/assurances/assurances_index.h tml. OHRP will consider comments received before implementing any revisions to the FWA documents.
Advisory Committee on Interdisciplinary, Community-Based Linkages Notice for Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill ten upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). Authority: 42 U.S.C. 294f, section 757 of the Public Health Service (PHS) Act, as amended by the Affordable Care Act. The ACICBL is governed by the Federal Advisory Committee Act, Public Law (Pub. L.) 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori.'' This draft guidance document provides industry and agency staff with updated recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Helicobacter pylori (H. pylori). This draft guidance is not final nor is it in effect at this time.
Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers
This proposed rule would implement provisions of the Affordable Care Act that establish: Procedures under which screening is conducted for providers of medical or other services and suppliers in the Medicare program, providers in the Medicaid program, and providers in the Children's Health Insurance Program (CHIP); an application fee to be imposed on providers and suppliers; temporary moratoria that may be imposed if necessary to prevent or combat fraud, waste, and abuse under the Medicare and Medicaid programs, and CHIP; guidance for States regarding termination of providers from Medicaid and CHIP if terminated by Medicare or another Medicaid State plan or CHIP; guidance regarding the termination of providers and suppliers from Medicare if terminated by a Medicaid State agency; and requirements for suspension of payments pending credible allegations of fraud in the Medicare and Medicaid programs. This proposed rule would also present an approach and request comments on the provisions of the Affordable Care Act that require providers of medical or other items or services or suppliers within a particular industry sector or category to establish compliance programs.
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