Source: https://regulations.justia.com/regulations/fedreg/agencies/department-of-health-and-human-services/2008/09?registers=between&min-day=1&max-day=31
Timestamp: 2020-02-22 20:56:35
Document Index: 17904631

Matched Legal Cases: ['art 404', 'art 404', 'Application No. 60', 'Application No. 11', 'Application No. 06772641', 'Application No. 2006258035', 'Application No. 2008', 'Application No. 2609577']

Document Number: E8-22977
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22977.html
Document Number: E8-22976
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22976.html
Document Number: E8-22975
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22975.html
Document Number: E8-22921
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22921.html
Document Number: E8-22912
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22912.html
Document Number: E8-22911
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22911.html
Document Number: E8-22896
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22896.html
Document Number: E8-22895
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22895.html
Document Number: E8-22894
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22894.html
Prospective Grant of an Exclusive License: Therapeutics Based on Histone Deacetylase (HDAC) Inhibitors for the Prevention and Treatment of Central Nervous System (CNS) Metastases of Extra-CNS Origin Cancers
Document Number: E8-22893
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Application 60/891,856 filed February 27, 2007 (E-084-2007/0-US-01) and International Application PCT/US2008/055149 filed February 27, 2008 (E-084-2007/0- PCT-02), entitled ``Use of Histone Deacetylase Inhibitors for the Treatment of Central Nervous System Metastases,'' to Waypharm S.A.S. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be the United States and Europe, and the field of use may be limited to therapeutics based on CNS metastases of extra-CNS origin cancers.
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22893.html
Document Number: E8-22892
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22892.html
Document Number: E8-22889
https://regulations.justia.com/regulations/fedreg/2008/09/30/E8-22889.html
Document Number: E8-22833
https://regulations.justia.com/regulations/fedreg/2008/09/29/E8-22833.html
Document Number: E8-22829
https://regulations.justia.com/regulations/fedreg/2008/09/29/E8-22829.html
Document Number: E8-22731
https://regulations.justia.com/regulations/fedreg/2008/09/29/E8-22731.html
Document Number: E8-22730
https://regulations.justia.com/regulations/fedreg/2008/09/29/E8-22730.html
Document Number: E8-22585
https://regulations.justia.com/regulations/fedreg/2008/09/29/E8-22585.html
Document Number: E8-22698
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22698.html
Document Number: E8-22693
Section 1936 of the Social Security Act (the Act) (as added by section 6034 of the Deficit Reduction Act of 2005 (DRA) established the Medicaid Integrity Program to promote the integrity of the Medicaid program by requiring CMS to enter into contracts with eligible entities to: (1) Review the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of such plan approved under section 1115 of the Act; (2) audit claims for payment of items or services furnished, or administrative services rendered, under a State plan; (3) identify overpayments to individuals or entities receiving Federal funds; and (4) educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide requirements for an eligible entity to enter into a contract under the Medicaid integrity audit program. The final rule will also establish the contracting requirements for eligible entities. The requirements will include procedures for identifying, evaluating, and resolving organizational conflicts of interest that are generally applicable to Federal acquisition and procurement; competitive procedures to be used; and procedures under which a contract may be renewed.
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22693.html
Document Number: E8-22690
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22690.html
Document Number: E8-22669
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``End-of-Phase 2A Meetings.'' This draft guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs) who seek guidance on employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo) to design trials for better dose response estimation, dose selection, and other appropriate issues. This draft guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and to improve the quality of drug applications through early meetings with sponsors.
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22669.html
Document Number: E8-22668
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22668.html
Document Number: E8-22611
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. Patent Application No. 60/689,746, filed June 10, 2005, now abandoned [HHS Ref. No. E-089-2005/0-US-01]; PCT Patent Application No. PCT/ US2006/22401, filed June 7, 2006, now abandoned [HHS Ref. No. E-089- 2005/0-US-02]; U.S. Patent Application No. 11/917,036, filed December 10, 2007 [HHS Ref. No. E-089-2005/0-US-03]; European Patent Application No. 06772641.4, filed December 7, 2007, which published as 1888064 on February 20, 2008 [HHS Ref. No. E-089-2005/0-EP-04]; Australian Patent Application No. 2006258035, filed November 30, 2007 [HHS Ref. No. E- 089-2005/0-AU-05]; Japanese Patent Application No. 2008-515947, filed December 7, 2007 [HHS Ref. No. E-089-2005/0-JP-06]; and Canadian Patent Application No. 2609577, filed November 23, 2007 [HHS Ref. No. E-089- 2005/0-CA-07], all of which are entitled ``Benztropinamine Analogs as Dopamine Uptake Inhibitors'' (Inventors: Amy Newman and Jonathan Katz, NIDA) to Shire LLC, having an office in at least Basingstoke, United Kingdom. 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 the use of benztropinamine analogs, specifically, compounds derived from Formula I, wherein B is NR \4\ and wherein R \4\ is not CH3 (methyl group) to treat psychiatric and neurological disorders.
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22611.html
Document Number: E8-22610
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22610.html
Document Number: E8-22608
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22608.html
Document Number: E8-22607
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22607.html
Document Number: E8-22605
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22605.html
Document Number: E8-22604
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22604.html
Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes; Correcting Amendment
Document Number: E8-22592
In the December 5, 2007 issue of the Federal Register, we published a final rule finalizing the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D sponsors to complete corrective action plans. In that final rule, we also clarified the intermediate sanction and civil money penalty provisions that apply to MA organizations and Part D sponsors, modified elements of MA organizations and Part D sponsors' compliance plans, retained voluntary self-reporting for Part D sponsors, implemented voluntary self-reporting for MA organizations, and revised provisions to ensure HHS has access to the books and records of MA organizations and Part D sponsors' first tier, downstream, and related entities. This correcting amendment corrects a limited number of technical and typographical errors identified in the December 5, 2007 final rule.
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22592.html
Document Number: E8-22591
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, November 19, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of computed tomography colonography (CTC), also referred to as virtual colonoscopy, as a cancer screening test for average risk individuals (See section 1861(pp) of the Social Security Act (42 U.S.C. section 1395x(pp))). The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22591.html
Document Number: E8-22589
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22589.html
Document Number: E8-22584
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22584.html
Document Number: E8-22582
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22582.html
Document Number: E8-22307
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-22307.html
Document Number: E8-21910
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-21910.html
Document Number: E8-21909
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-21909.html
Document Number: E8-21594
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2008 through June 2008, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare- approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
https://regulations.justia.com/regulations/fedreg/2008/09/26/E8-21594.html
Document Number: E8-22636
https://regulations.justia.com/regulations/fedreg/2008/09/25/E8-22636.html
Document Number: E8-22594
https://regulations.justia.com/regulations/fedreg/2008/09/25/E8-22594.html
Document Number: E8-22580
https://regulations.justia.com/regulations/fedreg/2008/09/25/E8-22580.html
Document Number: E8-22577
https://regulations.justia.com/regulations/fedreg/2008/09/25/E8-22577.html