Department of Health and Human Services July 15, 2016 – Federal Register Recent Federal Regulation Documents

Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education, Policy/Budget/Diabetes
Document Number: 2016-16824
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services, Indian Health Service
Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education II
Document Number: 2016-16819
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services, Indian Health Service
Medicare Program; Announcement of Requirements and Registration for the MIPS Mobile Challenge; Deadline Extension
Document Number: 2016-16808
Type: Notice
Date: 2016-07-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice launches a challenge related to the new Merit- based Incentive Payment System (MIPS) program, which will assist the Centers for Medicare & Medicaid Services (CMS) in accelerating the transition from the traditional fee-for-service payment model to a system that rewards health care providers for providing better care, not just more care. This challenge will address one of the most important aspects of our programs, which is educating and providing outreach to the potential hundreds of thousands of MIPS eligible clinicians.
Public Availability of the Department of Health and Human Services FY 2015 Service Contract Inventory
Document Number: 2016-16802
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2015 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that was awarded in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/ sites/default/files/omb/procurement/memo/service-contract-inv entories- guidance-11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: https:// www.hhs.gov/grants/contracts/get-ready-to-do-business/service -contract- inventory/.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-16797
Type: Notice
Date: 2016-07-15
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Council on Graduate Medical Education; Request for Nominations
Document Number: 2016-16751
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Council on Graduate Medical Education (COGME). COGME is authorized by Section 762 of the Public Health Service (PHS) Act (42 U.S.C. 294o), as amended. The Advisory Council is governed by the provisions of the Federal Advisory Act (FACA) (5 U.S.C. Appendix 2), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 762.
Request for Nominations on the Tobacco Products Scientific Advisory Committee
Document Number: 2016-16739
Type: Notice
Date: 2016-07-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products (CTP), notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee, and an alternate to this representative. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-16735
Type: Notice
Date: 2016-07-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.'' This draft guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. This draft guidance is also intended to assist FDA staff participating in the review of such IVD companion diagnostics or their associated therapeutic products. This draft guidance is not final nor is it in effect at this time.
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability
Document Number: 2016-16734
Type: Notice
Date: 2016-07-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.
Proposed Collection; 60-Day Comment Request; the Study of the Global Cancer Project Map (NCI)
Document Number: 2016-16707
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Kalina Duncan, Program Director, Center for Global Health, 9609 Medical Center Drive, 3W258, Rockville, MD 20850 or call non-toll-free number (240) 276-5804 or Email your request, including your address to: kalina.duncan@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Study of the Global Cancer Project Map, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a new information collection request for the Study of the Global Cancer Project Map (GCPM) for three years. Information will be collected from health care professionals and researchers in an effort to catalog international efforts related to cancer research, care, and outreach by integrating cancer control program and research project information from various organizations worldwide. The Global Cancer Project Map (GCPM) is a new, interactive, web- based tool that enables healthcare professionals and researchers to make informed decisions, initiate partnerships, and develop ideas for collaborations in cancer control. Its features allow people to (1) search for collaborators and projects by cancer type, project type, and country; (2) visualize information pertinent to each project on an interactive world map; (3) initiate contact with principal investigators and program directors; and (4) overlay heat maps of epidemiological measures that provide a representation of the burden of cancer by country. The primary goals of GCPM are to facilitate the building of collaborations across organizations; accelerate progress, ensure a balanced investment of resources, and align global cancer care and control efforts; and continue data collection from national and international organizations to develop the Map as a resource to view and better understand international efforts in cancer research and control. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 167.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2016-16706
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Refugee Microenterprise and Refugee Home-Based Child Care Microenterprise Development
Document Number: 2016-16700
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2016-16697
Type: Notice
Date: 2016-07-15
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Pricing Data Release; Medicare Advantage and Part D Medical Low Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model
Document Number: 2016-16097
Type: Proposed Rule
Date: 2016-07-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major proposed rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes proposals related to the Medicare Shared Saving Program, and the release of certain pricing data from Medicare Advantage bids and medical loss ratio reports from Medicare health and drug plans. In addition, this rule proposes to expand the Medicare Diabetes Prevention Program model.
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