Department of Health and Human Services January 2011 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 329
Notice of Revised Child Outcomes Framework
This notice announces and informs the public of the revised Head Start Child Outcomes Framework, renamed The Head Start Child Development and Learning Framework: Promoting Positive Outcomes in Early Childhood Programs Serving Children 3-5 Years Old. The Framework was revised to give more prominence to the information part of the initial document. The revisions do not create new requirements on Head Start and delegate agencies. The revised Framework continues to identify the developmental outcomes that Head Start and delegate agencies have been responsible for addressing in their Head Start preschool programs serving 3 to 5 year old children since the original was published in 2000.
Medicare Program; Amendment to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011
This amendment rescinds the addition and definition of voluntary advance care planning as a specified element of the annual wellness visit that was finalized in the ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011'' that appeared in the November 29, 2010 Federal Register.
Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The agency makes recommendations to industry for focusing limited resources on reports related to products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the draft guidance. This draft guidance is a revision of the draft guidance for industry of the same title published on December 16, 2008.
Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey
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 FDA's Health and Diet Survey.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
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.
Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It also describes FDA's recommended procedures for ensuring the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection.
Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Determination of System Attributes for the Tracking and Tracing of Prescription Drugs.'' This public workshop is intended to provide a forum for discussing potential approaches toward a track and trace system and obtaining input from supply chain partners on attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages, and to further the Agency's goal of protecting public health by securing the drug supply chain against the introduction of counterfeit and other substandard drugs.
FDA Transparency Initiative: Improving Transparency to Regulated Industry
As part of the third phase of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The report includes 19 action items and 5 draft proposals to improve transparency to regulated industry. FDA is seeking public comment on the content of the draft proposals, as well as on which draft proposals should be given priority.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.
Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Opportunity To Affirm Outstanding Hearing Requests; Final Resolution of Dockets
The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to Docket Nos. 81N-0391, 82N- 0078, and 82N-0311 have been withdrawn and therefore, shipment in interstate commerce of the products identified in those dockets, or any identical, related, or similar product that is not the subject of an approved new drug application (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice. FDA is also offering an opportunity to affirm outstanding hearing requests in Docket Nos. 81N- 0393, 81N-0396, 82N-0095, 82N-0096, and 83N-0095. FDA will assume that companies with outstanding hearing requests that do not respond to this notice are no longer interested in pursuing their requests, and will deem the requests withdrawn.
Establishment of the Permanent Certification Program for Health Information Technology
This final rule establishes a permanent certification program for the purpose of certifying health information technology (HIT). This final rule is issued pursuant to the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The permanent certification program will eventually replace the temporary certification program that was previously established by a final rule. The National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record (EHR) technology, such as Complete EHRs and/or EHR Modules. The permanent certification program could also be expanded to include the certification of other types of HIT.
Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.'' In general, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires a premarket application and market authorization order for new tobacco products before they may be marketed; alternatively, manufacturers may submit a 905(j) report intended to demonstrate substantial equivalence to a predicate tobacco product. The guidance provides recommendations on submitting information intended to demonstrate that a new tobacco product is substantially equivalent to a predicate tobacco product. Manufacturers of tobacco products first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, must submit a report no later than March 22, 2011, or the products can no longer be legally marketed. Manufacturers of a new tobacco product first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007 and before March 22, 2011, who submit a substantial equivalence report before March 23, 2011, may continue to market the tobacco product unless FDA issues an order finding that the product is not substantially equivalent. Because it is important that FDA's recommendations on submitting a substantial equivalence reports be available to assist new tobacco product manufacturers in preparing substantial equivalence reports in advance of March 23, 2011, this guidance document will be implemented immediately. This guidance, however, remains subject to comment in accordance with the Agency's good guidance practices (GGPs).
Tobacco Products, Exemptions From Substantial Equivalence Requirements
The Food and Drug Administration (FDA) is issuing this proposed rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The proposed rule would describe the process and statutory criteria for requesting an exemption and explain how FDA would review requests for exemptions. Once finalized, this regulation will satisfy the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.
Office of Planning, Research and Evaluation Advisory Committee on Head Start Research and Evaluation
This notice announces a forthcoming meeting of a public advisory committee of the Administration for Children and Families (ACF). The meeting will be open to the public. Name of Committee: Advisory Committee for Head Start Research and Evaluation. General Function of Committee: The Advisory Committee for Head Start Research and Evaluation will provide feedback on the published final report for the Head Start Impact Study, offering interpretations of the findings, discussing implications for practice and policy, and providing recommendations on follow-up research, including additional analysis of the Head Start Impact Study data. The Committee will also be asked to provide recommendations to the Secretary regarding how to improve Head Start and other early childhood programs by enhancing the use of research-informed practices in early childhood. Finally, the Committee will be asked to provide recommendations on the overall Head Start research agenda, includingbut not limited tohow the Head Start Impact Study fits within this agenda. The Committee will provide advice regarding future research efforts to inform HHS about how to guide the development and implementation of best practices in Head Start and other early childhood programs around the country.
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long- term rate of change in health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Dates: January 10, 2011, 9 a.m. to 6 p.m. and January 28, 2011, 9:30 a.m.-5 p.m. e.t.
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 that it will rescind a notice of a system of records entitled ``Location and Collection System,'' 09-90-0074, establish two new systems of records entitled ``OCSE National Directory of New Hires'' and ``OCSE Debtor File,'' and amend an existing system of records entitled ``OCSE Federal Case Registry of Child Support Orders.''
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia Burgdorferi; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease. This draft guidance is not final nor is it in effect at this time.
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