Department of Health and Human Services April 28, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Prospective Granting of an Exclusive License
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 of the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is contemplating granting a worldwide exclusive license to AES Raptor, LLC, located in North Kansas City, Missouri. Under this exclusive license, only AES Raptor, LLC would be permitted to commercialize the technology described in the patent applications listed below. CDC intends to grant rights to commercialize this invention to no other licensees. The patent rights in this invention have been assigned to the government of the United States of America. The invention to be licensed is: Title: Barricade System and Barricade Bracket for Use Therein, CDC Ref. : I-016-04, a safety rail system that provides protection to individuals working on inclined structures. The system is designed to prevent individuals from falls to a lower level. U.S. Patent No.: 7,509,702. U.S. Application No.: 11/257,472. Filing date: 10/24/2005. Canadian Application No.: 2,565,354. Filing date: October 23, 2006. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Online Direct-to-Consumer Prescription Drug Promotion
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a series of studies, Examination of Online Direct-to-Consumer Prescription Drug Promotion. These studies are designed to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug Web sites.
Guidance for Industry on Fish and Fishery Products Hazards and Controls, Fourth Edition; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition.'' The updated guidance supports and complements FDA's regulations for the safe and sanitary processing and importing of fish and fishery products using hazard analysis and critical control point (HACCP) methods.
Guidance for Industry: “Computer Crossmatch” (Computerized Analysis of the Compatibility Between the Donor's Cell Type and the Recipient's Serum or Plasma Type); Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: `Computer Crossmatch' (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)'' dated April 2011. The guidance document provides blood establishments that perform compatibility testing using a computer crossmatch system to perform computerized matching of blood with recommendations consistent with current good manufacturing practice (CGMP) requirements. Blood establishments are required to have standard operating procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type. The guidance describes practices that we believe satisfy those requirements to help ensure detection of an incompatible crossmatch when using a computerized system for matching a donor's cell type with a recipient's serum or plasma type. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: `Computer Crossmatch' (Electronic Based Testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)'' dated June 2007.
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