Department of Health and Human Services March 6, 2014 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary, Department of Health and Human Services (HHS), announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0278, which expires on June 30, 2014. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition, Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. There were no comments received during the first public review of this ICR. OMB will accept further comments from the public on this ICR during the review and approval period.
Report to Congress; Report on the Food and Drug Administration's Policy To Be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices; Notice to Public of Web Site Location of Report to Congress
The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency has posted the report entitled ``Report to Congress; Report on FDA's Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices.'' In addition, FDA has established a docket where stakeholders may provide comments.
Prospective Grant of Start-Up Exclusive Evaluation License: Live Attenuated Codon-Deoptimized Respiratory Syncytial Virus Vaccines
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license to practice the inventions embodied in: HHS Ref. No. E-080-2013/0 and /1, ``Attenuation Of Human Respiratory Syncytial Virus By Genome Scale Codon-Pair Deoptimization,'' US Provisional Patent Applications 61/762,768 filed February 8, 2013 and 61/794,155 filed March 15, 2013, and PCT/US2014/ 015274 filed February 7, 2014, to Codagenix, Inc., having its principle place of business in Stony Brook, New York. The United States of America is an assignee to the patent rights of these inventions. The contemplated exclusive license may be limited to a live attenuated codon-deoptimized respiratory syncytial virus vaccine. Upon the expiration or termination of the start-up exclusive evaluation license, Codagenix will have the right to execute a start-up exclusive patent commercialization license with no greater field of use and territory than granted in the evaluation license.
Prospective Grant of Start-Up Exclusive Evaluation License: Caval-Aortic Devices for Aortic Valve Replacement
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license to practice the inventions embodied in: HHS Ref. No. E-553-2013/0, U.S. Provisional Patent Application No. 61/863,071, filed August 7, 2013; International Patent Application PCT/ US2013/072344 filed November 27, 2013 entitled ``Transvascular And Transcameral Device Access And Closure,'' to Mehr Medical LLC, having its principle place of business in Andover Massachusetts. The contemplated exclusive license may be limited to caval-aortic devices for aortic valve replacement. Upon the expiration or termination of the start-up exclusive evaluation license, Mehr will have the right to execute a start-up exclusive patent commercialization license with no greater field of use and territory than granted in the evaluation license.
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