Department of Health and Human Services December 30, 2015 – Federal Register Recent Federal Regulation Documents

Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2015-32890
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the January meeting, the Advisory Council will review the process for developing recommendations and developing the National Plan to Address Alzheimer's Disease, discuss updates to work on Goals 2 and 3 of the National Plan, and hear updates on a future summit on care.
Government-Owned Inventions; Availability for Licensing
Document Number: 2015-32879
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Government-Owned Inventions; Availability for Licensing and Co-Development
Document Number: 2015-32878
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2015-32877
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance
Document Number: 2015-32781
Type: Notice
Date: 2015-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a draft guidance for industry, entitled ``Draft Guidance for Industry: Acidified Foods.'' The draft guidance was intended to complement our regulations regarding acidified foods (including regulations for specific current good manufacturing practice, establishment registration, and process filing) by helping commercial food processors determine whether their food products are subject to these regulations by providing for voluntary submission of process filings by processors of non-acidified foods (e.g., some acid foods or fermented foods), and by helping processors of acidified foods in ensuring safe manufacturing, processing, and packing processes and in employing appropriate quality control procedures. We are withdrawing the draft guidance, in part, because many of the topics addressed in the draft guidance are now being addressed in other documents.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-32773
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-32772
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-32771
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2015-32770
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2015-32769
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; Amended Notice of Meeting
Document Number: 2015-32768
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-32767
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-32766
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2015-32765
Type: Notice
Date: 2015-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-32633
Type: Notice
Date: 2015-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
Document Number: 2015-32506
Type: Rule
Date: 2015-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule establishes a prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization. This rule defines unnecessary utilization and creates a new requirement that claims for certain DMEPOS items must have an associated provisional affirmed prior authorization decision as a condition of payment. This rule also adds the review contractor's decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.
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