Department of Health and Human Services November 16, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Establishing a List of Qualifying Pathogens That Have the Potential To Pose a Serious Threat to Public Health; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on establishing a list of qualifying pathogens (i.e., those that have the potential to pose a serious threat to public health), as required under the Food and Drug Administration Safety and Innovation Act (FDASIA). This public hearing is being held to obtain comments from the public to determine the methodology that should be used in developing the list of qualifying pathogens, and to elicit suggestions for adding specific pathogens to the list.
Standard Test Procedures Approval Process for Respirators To Be Used in Wildland Fire-Fighting Operations; Standard Test Procedures for Composite Multi-Gas and Particulate Protection and Approval Process for Respirators To Be Used in Wildland Fire-Fighting Operations
The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) intends to employ existing provisions in 42 CFR Part 84 to test and approve air-purifying respirators (APRs) and powered air-purifying respirators (PAPRs) that provide composite multi-gas and particulate protection for inhalation hazards associated with wildland fire-fighting. NIOSH will evaluate candidate respirators for inhalation protections tailored against exposures identified in the National Fire Protection Association (NFPA) 1984 standard on respirators for wildland fire-fighting (WFF) operations. Under 42 CFR Part 84 requirements, NIOSH approval is necessary for the complete evaluation of WFF respirators pursuant to NFPA 1984 (2011).
Prospective Grant of Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking of giving a co-exclusive license in Africa, and an exclusive license in all territories other than Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Merial Limited, having a place of business in Duluth, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application(s) to be licensed are:
Prospective Grant of Co-Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a co-exclusive license in Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Deltamune Ltd., having a place of business in Centurion, South Africa. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are:
Prospective Grant of Exclusive License: Multiple-Valent Opsonophagocytic Assay Selection Panel Arrays
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a worldwide, exclusive license to practice the inventions listed in the patent referred to below to Flow Applications, Inc., having a place of business in Okawville, Illinois. The patent rights in these inventions have been assigned to the government of the United States of America. The patent to be licensed is:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
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 PRA).
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013
This major final rule with comment period addresses changes to the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also implements provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it implements statutory changes regarding the termination of non-random prepayment review. This final rule with comment period also includes a discussion in the Supplementary Information regarding various programs . (See the Table of Contents for a listing of the specific issues addressed in this final rule with comment period.)
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