Department of Health and Human Services March 22, 2017 – Federal Register Recent Federal Regulation Documents
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Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the donor registration form in support of the project titled ``Acquisition of Freshly Drawn Whole Blood/Blood Products for Reference Diagnostic and Research Use.''
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; Corrections
This document corrects technical errors in the addenda to the final rule published in the November 15, 2016, Federal Register entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that a webinar meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place and will be open to the general public to listen in via a toll free number.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, 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 0955-0009 which expires on May 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Notice of Availability of the Draft Environmental Assessment and Public Meeting
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of the Draft Environmental Assessment (Draft EA) for the CDC Chamblee Campus 2025 Master Plan for public review and comment. This notice also announces the date, location and time for the public meeting. The Draft EA analyzes the potential impacts associated with the implementation of the CDC Chamblee Campus 2025 Master Plan (Master Plan) for HHS/CDC's Chamblee Campus located at 4770 Buford Highway, Chamblee, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500- 1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.
World Trade Center Health Program; Request for Nominations of Scientific Peer Reviewers of Proposed Additions to the List of WTC-Related Health Conditions
The CDC is soliciting nominations, including self-nominations, for scientific peer reviewers of proposed additions of conditions to the List of World Trade Center (WTC)-Related Health Conditions (List). Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, Public Law 111-347 (Jan. 2, 2011), amended by Public Law 114-113 (Dec. 18, 2015), added Title XXXIII to the Public Health Service Act (PHS Act), establishing the WTC Health Program within HHS (42 U.S.C. 300mm to 300mm-61). When the Administrator proposes to add a condition to the List, he must publish the proposed rule in accordance with the Administrative Procedure Act (5 U.S.C. 553). Additionally, as required by the James Zadroga 9/11 Health and Compensation Reauthorization Act in section 3312(a)(6)(F), prior to issuing a final rule to add a health condition to the List, the Administrator must provide for an independent peer review of the scientific and technical evidence that would be the basis for issuing such final rule.
Food and Drug Administration Center for Drug Evaluation and Research Small Business and Industry Assistance Regulatory Education for Industry Generic Drugs Forum; Public Conference
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is sponsoring a 2-day public conference entitled ``FDA CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Generic Drugs Forum.'' The goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of the generic drug development process. Our primary audience is that of small manufacturers within the generic drug industry. However, anyone involved in the pharmaceutical industry may attend.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces the cancellation of a meeting of the National Advisory Council for Healthcare Research and Quality.
Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of January 23, 2017. In the proposed rule, FDA requested comments on its proposal to establish a limit of N- nitrosonornicotine (NNN) in finished smokeless tobacco products. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. The Agency is also providing notice of a typographical error in a formula in the Laboratory Information Bulletin (LIB) titled, ``Determination of N-nitrosonornicotine (NNN) in Smokeless Tobacco and Tobacco Filler by HPLC-MS/MS'' (LIB No. 4620, January 2017). In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review'', the Agency is also taking this opportunity to provide notice that, as with all regulatory actions subject to such memorandum, this proposed rule is being reviewed consistent with the memorandum.
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