Department of Health and Human Services February 22, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for BREO ELLIPTA 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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 associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-194-1999/0, Collins et al., ``Production of Attenuated Respiratory Syncytial Virus Vaccines Involving Modification of M2 ORF2'', U.S. Provisional Patent Application Number 60/143,097, filed July 9, 1999, PCT Patent Application Number PCT/US2000/18534, filed July 7, 2000, U.S. Patent Application Number 09/611,829 (now U.S. Patent Number 6,713,066), and U.S. Patent Application Number 11/011,502 (now U.S. Patent Number 7,485,440), (2) E-135-2010/0, Collins et al., ``Genetically Stable Live Attenuated Vaccine for Respiratory Syncytial Virus (RSV) with an Attenuation and Temperature Sensitive Phenotype Conferred by an Amino Acid Deletion'', U.S. Provisional Patent Application Number 61/624,010, filed April 13, 2012, PCT Patent Application Number PCT/US2013/030836, filed March 13, 2013, United States Patent Application Number 14/ 394,226, filed October 13, 2014, European Patent Application Number 13712641.3, filed March 13, 2013, (3) E-216-2014/0, Collins et al., ``Versions of Respiratory Syncytial Virus (RSV) Vaccine Candidate LID Delta M2-2 with Increased Attenuation'', U.S. Provisional Patent Application Number 62/266,199, filed December 11, 2015, (4) E-241-2014/ 0, Collins et al., ``Improved RSV F Protein for Expression from a Heterologous Vector'', U.S. Provisional Patent Application Number 62/ 105,667, filed January 20, 2015, PCT Patent Application Number PCT/ US2016/014154, filed January 20, 2016, and (5) E-037-2016/0, Collins et al., ``Attenuated RSV Vaccine Strains in which the NS1 and/or NS2 Genes have been Shifted to Promoter-Distal Positions'', U.S. Provisional Patent Application Number 62/266,206, filed December 11, 2015, to Sanofi Pasteur, Inc., having a place of business in Swiftwater, Pennsylvania, U.S.A. The patent rights in this invention have been assigned to the United States of America.