Department of Health and Human Services September 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

Section 52.1(b) of the regulations governing grants for research projects, codified at 42 CFR part 52, authorizes the Secretary of Health and Human Services to publish periodically a list of all of the research project grant programs to which the research project grant regulations apply. This Notice provides the most recent list of the programs covered by the regulations and supersedes the prior Notice published on November 25, 2003 (68 FR 66114-66117).

The National Personal Protective Technology Laboratory (NPPTL), NIOSH, is conducting research to determine the reusability of filtering facepiece respirators (FFR) exposed to infectious aerosols. One aim of this research is to address whether NIOSH-certified FFR are suitable for reuse after decontamination. NIOSH proposes to study the effects of decontaminating a diverse array of FFR including NIOSH- certified N95, P100, and N95 filtering facepiece respirator/surgical mask. This project will also study the survivability of a simulant influenza virus on FFR. NIOSH plans to include in the research study some of the respirator models that have been stockpiled by the U.S government to be used in the event of an influenza pandemic. NIOSH also plans to include models that have head straps versus those that do not have head straps, as well as models with and without exhalation valves. Through this announcement, NIOSH is seeking to identify FFR products or prototypes that possess anti-viral or other novel technologies that disinfect or sterilize infectious aerosols (e.g., viruses) as part of their materials of construction. Program funding constraints may limit the number of candidate respirators that may be included in the research program. NIOSH will give consideration to the incorporation of novel anti-viral technologies into this research study using the following hierarchy for selection of candidate FFR products and prototypes: (1) The FFR proposed for consideration in this study are commercially available and are currently certified to meeting 42 CFR part 84 requirements, (2) the FFR proposed for consideration is in the process of being certified by NIOSH to meet 42 CFR part 84 requirements, (3) the FFR proposed for consideration are either a prototype or a commercially available product that has not been submitted to NIOSH for certification and the manufacturer submitting the letter of interest has received NIOSH certification for other respiratory protection products, and (4) the FFR prototype contains a unique technology for disinfecting or sterilizing infectious aerosol particles trapped on the exterior surface of the FFR and complements the diversity of technologies already considered in the research design. Candidate companies will be evaluated based on their capability to achieve the identified criteria in sufficient quantities for testing. Candidates selected could be requested to enter into a Cooperative Research and Development Agreement (CRADA). This announcement does not obligate NIOSH to enter into a contractual agreement with any respondents. NIOSH reserves the right to establish a partnership based on scientific analysis and capabilities found by way of this announcement or other searches, if determined to be in the best interest of the government.

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 extending OMB approval on the existing reporting and recordkeeping requirements for processors and importers of fish and fishery products.

The Food and Drug Administration (FDA) has determined the regulatory review period for KETEK 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 that claims that human drug product.

This notice announces the tenth meeting of the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4).'' The guidance responds to various questions raised about the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Persons covered by the regulation who employ 500 or more full-time equivalent employees (FTEs) had to be in compliance by December 9, 2005, and those who employ 11 to 499 FTEs had to be in compliance by June 9, 2006. Persons who employ 10 or fewer FTEs have until December 11, 2006, to be in compliance. ``Person'' includes an individual, partnership, corporation, and association.

The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or items that measure perceptions of patients and their informal caregivers regarding the quality of home health care these patients received from home health providers, health plans, other health care providers, stakeholders, vendors, researchers who include home health care as part of their research, and other interested parties. This initiative is in response to the need to develop a new CAHPs[reg] home health care survey. The Centers for Medicare & Medicaid Services is interested in incorporating this survey as part of its Home Health Quality Initiative which is intended to empower consumers with quality of care information to make more informed decisions about their health care while also encouraging Medicare certified home health agencies to improve the quality of care they deliver to all patients regardless of payer source. The survey is likely to assess the quality of care and services provided by nurses, therapists, home heath aides, medical social workers, and home health agency administrative staff. Based on the agency's prior consumer assessment of health care work, there are several functional areas that this instrument could assess such as: Communication; courtesy and respect; information provided and shared decision making; coordination/integration of care; time related issues (e.g., arrived and departed according to schedule, amount of time spent, visit frequency); competence: influence/control over care giver activities; unmet need issues, and customer service.

The Food and Drug Administration (FDA or we) is proposing to amend certain classification regulations to reflect the termination of certain device exemptions and the requirement to submit validation data for specific reprocessed single-use devices (SUDs), as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. This proposed rule will provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This proposed rule would codify actions taken in previous Federal Register notices in accordance with MDUFMA.

The Food and Drug Administration (FDA) has determined the regulatory review period for CLOLAR 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.

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.

This notice announces the seventh meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

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 estimated reporting and recordkeeping burden associated with the Mammography Quality Standards Act requirements.

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.

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.