Department of Health and Human Services November 17, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Prospective Grant of Exclusive License: Development of Cannabinoid(s) and Cannabidiol(s) Based Therapeutics To Treat Hepatic Encephalopathy in Humans.
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 invention embodied in U.S. Patent 6,630,507, entitled ``Cannabinoids as antioxidants and neuroprotectants'' and PCT Application Serial No. PCT/US99/08769 and foreign equivalents thereof, entitled ``Cannabinoids as antioxidants and neuroprotectants'' [HHS Ref. No. E-287-1997/2] to KannaLife Sciences Inc., which has offices in New York, U.S. This patent and its foreign counterparts have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
The Food and Drug Administration (FDA) is proposing to amend the Agency's regulations to allow the manufacturer of a cigarette or smokeless tobacco product with a trade or brand name that is also the trade or brand name of a nontobacco product to continue to use the name if the tobacco product was sold in the United States on or before June 22, 2009. FDA further proposes to amend the Agency's regulations to ensure that a manufacturer of a cigarette or smokeless tobacco product may continue to use its trade or brand name even if that name is subsequently registered with the United States Patent and Trademark Office (USPTO) or subsequently used for a nontobacco product.
Animal Food Labeling; Declaration of Certifiable Color Additives
The Food and Drug Administration (FDA) is amending its regulations regarding the declaration of certified color additives on the labels of animal food including animal feeds and pet foods. FDA is issuing a final regulation in response to the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by requiring, among other things, the listing on food labels of the common or usual names of all color additives required to be certified by FDA. An additional purpose of this final rule is to make these regulations consistent with the regulations regarding the declaration of certified color additives on the labels of human food. The final rule also suggests appropriate terminology for the declaration of certification-exempt color additives on the labels of animal food.
Public Meeting and Request for Information: Carcinogen and Recommended Exposure Limit (REL) Policy Assessment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces a public meeting to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. NIOSH requested initial input on these issues (including answers to five questions listed below under SUPPLEMENTARY INFORMATION), to be submitted to NIOSH Docket number 240. Written comments to this Docket will be accepted until December 30, 2011. Written comments submitted to the docket will be used to inform NIOSH with the review and revision of the carcinogen policy and the REL policy. NIOSH has also created a new NIOSH Cancer and REL Policy Web Topic Page [see https://www.cdc.gov/niosh/topics/ cancer/policy.html] to provide additional details about this effort and progress updates.
Patient Safety Organizations: Voluntary Relinquishment From Peminic Inc. dba The Peminic-Greeley PSO
AHRQ has accepted a notification of voluntary relinquishment from Peminic Inc. dba The Peminic-Greeley PSO of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
Patient Safety Organizations: Voluntary Relinquishment From Emergency Medicine Patient Safety Foundation
AHRQ has accepted a notification of voluntary relinquishment from Emergency Medicine Patient Safety Foundation of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
Patient Safety Organizations: Voluntary Relinquishment From Child Health Patient Safety Organization, Inc.
AHRQ has accepted a notification of voluntary relinquishment from Child Health Patient Safety Organization, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
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