Department of Health and Human Services July 2009 – Federal Register Recent Federal Regulation Documents

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/850,132, filed October 6, 2006, now abandoned (HHS Ref. No. E-227-2006/0-US-01); U.S. Provisional Patent Application No. 60/864,153, filed November 02, 2006, now abandoned (HHS Ref. No. E-227-2006/1-US-01); U.S. Provisional Patent Application No. 60/888,754, filed February 07, 2007, now abandoned (HHS Ref. No. E-227-2006/2-US-01); U.S. Provisional Patent Application No. 60/910,549, filed April 06, 2007, now abandoned (HHS Ref. No. E-227- 2006/3-US-01); U.S. Provisional Patent Application No. 60/956,375, filed August 16, 2007, now abandoned (HHS Ref. No. E-227-2006/4-US-01); PCT Patent Application No. PCT/2007/080647, filed October 5, 2007, now abandoned (HHS Ref. No. E-227-2006/5-PCT-01); U.S. Patent Application No. 12/444,364, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-US- 02); Canadian Patent Application (not yet determined) (HHS Ref. No. E- 227-2006/5-CA-03); Australian Patent Application No. 2007319576, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-AU-04); and European Patent Application No. 07868382.8, filed October 5, 2007 (HHS Ref. No. E-227- 2006/5-EP-05), all of which are entitled ``Prevention of Tissue Ischemia, Related Methods and Compositions'', developed by Dr. David Roberts (NCI), Dr. Jeffrey Isenberg, and Dr. William Frazier. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to: (1) ``The use of antibodies including humanized antibodies reacting with CD47 or related antigens, precursors, or molecules, and isolated and/or recombinant fragments, and conjugates with an affinity for CD47 for the preservation or resuscitation of organs and tissues for transplantation''; (2) ``the use of antibodies including humanized antibodies reacting with CD47 or related antigens, precursors, or molecules, and isolated and/or recombinant fragments, and conjugates with an affinity for CD47 for treating or preventing vascular diseases, including but not limited to, pulmonary hypertension, sickle cell disease, myocardial infarction, stroke, and tissue ischemia resulting from trauma and surgical procedures''; (3) ``the use of antisense oligonucleotides or RNA formulations of stabilized composition to reduce expression of CD47 for treating wounds and/or burns and for use in reconstructive surgery''; and (4) ``use of small molecules antagonists of CD47 for treating or preventing vascular diseases including, but not limited to, thrombosis, hypertension, peripheral artery disease, renal artery disease, and ischemia resulting from atherosclerosis'' to Vasculox, Inc., having an office in at least St. Louis, Missouri, U.S.A. The patent rights in these inventions have been assigned to the United States of America.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 information collection provisions in FDA's food labeling regulations and on Form FDA 3570, ``Model Small Business Nutrition Labeling Exemption Notice,'' which small businesses may use to claim the small business exemption from nutrition labeling.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Studies and Clinical TrialsImplementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) authorizing FDA to require certain postmarketing studies and clinical trials for prescription drugs and biological products approved under the act or the Public Health Service Act (the PHS Act). This draft guidance provides information on the implementation of the new provisions and a description of the types of postmarketing studies and clinical trials that will generally be required under the new legislation (postmarketing requirements (PMRs)) and the types that will generally be agreed-upon commitments (postmarketing commitments (PMCs)) because they do not meet the new statutory criteria for required postmarketing studies and clinical trials.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of flunixin meglumine injectable solution in swine.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Alpharma Inc. The NADA provides for use of single-ingredient Type A medicated articles containing lasalocid and roxarsone to formulate two-way combination drug Type C medicated feeds for use in growing turkeys.