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

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Electronic Filing of Certain Import Data Into the Document Image System Through the Automated Commercial Environment
Document Number: 2016-31750
Type: Notice
Date: 2016-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Through publication of this notice, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces a new policy and guidance for the electronic submission of data related to the importation of CDC- regulated items in the International Trade Data System (ITDS). Certain data, forms, and documents required to be submitted to HHS/CDC will be submitted through the U.S. Customs and Border Protection (CBP)'s Automated Commercial Environment (ACE) system, using the Document Image System (DIS). This electronic process will replace certain paper-based processes in keeping with Federal policy and improve operations to further assist HHS/CDC's mission to protect public health.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-31740
Type: Notice
Date: 2016-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 revision of the information collection entitled ``Colorectal Cancer Control Program (CRCCP) Monitoring Activities.'' The change to the collection will include a redesigned survey and a redesigned clinic-level data collection template.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-31739
Type: Notice
Date: 2016-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 a proposed revision of the CDC information collection project entitled ``Possession, Use, and Transfer of Select Agents and Toxins.''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-31738
Type: Notice
Date: 2016-12-30
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Biomonitoring of Great Lakes Populations Program III.'' The purpose of the proposed study is to evaluate body burden levels of priority contaminants in Great Lakes residents, particularly those who are at high exposure risk, in the Milwaukee Bay Estuary Area of Concern (AOC) area that was not previously addressed in ATSDR's previous biomonitoring programs around the Great Lakes.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-31737
Type: Notice
Date: 2016-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 a proposed information collection project entitled ``Assessment of Interventions Intended to Protect Pregnant Women in Puerto Rico from Zika Infections.'' This project consists of telephone interviews with pregnant WIC participants in Puerto Rico.
Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period
Document Number: 2016-31734
Type: Proposed Rule
Date: 2016-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of the term ``healthy'' in the labeling of human food products. We established the docket through a notice that appeared in the Federal Register of September 28, 2016. In the notice, we requested comments on the term ``healthy'', generally, and as a nutrient content claim in the context of food labeling; we also requested comments on specific questions contained in the notice. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
Document Number: 2016-31733
Type: Notice
Date: 2016-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our food labeling regulations and on Form FDA 3570, Model Small Business Nutrition Labeling Exemption Notice, which small businesses may use to claim the small business exemption from nutrition labeling.
National Institutes of Health Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-31687
Type: Notice
Date: 2016-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
Document Number: 2016-31670
Type: Rule
Date: 2016-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device ``thoracolumbosacral pedicle screw systems''; reclassify dynamic stabilization systems, a subtype of pedicle screw systems regulated under product code NQP when used as an adjunct to fusion, into class II (special controls), renaming this device subtype ``semi-rigid systems''; and clarify the device identification of pedicle screw systems to more clearly delineate between rigid pedicle screw systems and semi-rigid systems. FDA is finalizing this action based on a reevaluation of information pertaining to the device type.
Medical Device Accessories-Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-31669
Type: Notice
Date: 2016-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Accessories Describing Accessories and Classification Pathways for New Accessory Types.'' This document provides guidance to industry and FDA staff about the regulation of accessories to medical devices. The guidance explains what devices FDA generally considers an ``accessory'' and encourages use of the de novo classification process under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to allow manufacturers and other parties to request risk- and regulatory control-based classification of accessories of a new type (i.e., accessories of a type that has not been previously classified under the FD&C Act, cleared for marketing under a 510(k) submission, or approved in an application for premarket approval (PMA)).
Novus International, Inc.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
Document Number: 2016-31606
Type: Proposed Rule
Date: 2016-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of petition, published in the Federal Register of November 8, 2016 (81 FR 78528), proposing that the food additive regulations be amended to provide for the safe use of poly (2- vinylpyridine-co-styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date
Document Number: 2016-31597
Type: Rule
Date: 2016-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014, and on May 5, 2016, we stated in the Federal Register that the enforcement of the final rule would begin on May 5, 2017. We are taking this action to clarify and confirm that the compliance date for the final rule is May 5, 2017.
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
Document Number: 2016-31649
Type: Rule
Date: 2016-12-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors that appeared in the final rule published in the November 15, 2016 Federal Register (81 FR 80170). That rule is 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.''
Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop
Document Number: 2016-31628
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.'' The purpose of the public workshop is to have a scientific discussion of the current methods available for identifying and characterizing infectious disease risks associated with human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Botanical Drug Development; Guidance for Industry; Availability
Document Number: 2016-31627
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Botanical Drug Development.'' This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations for submitting investigational new drug applications (INDs) to support future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This guidance replaces the guidance for industry entitled ``Botanical Drug Products'' issued in June 2004 and finalizes the August 2015 draft guidance entitled ``Botanical Drug Development.''
Providing Regulatory Submissions in Electronic Format-Submission of Manufacturing Establishment Information; Draft Guidance for Industry; Availability
Document Number: 2016-31626
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatSubmission of Manufacturing Establishment Information.'' This guidance discusses the requirements for a valid electronic submission of manufacturing establishment information (MEI) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action will streamline the review of all manufacturing establishments involved in the preparation of a drug or biological product by consolidating information in one location and eliminating the inclusion of erroneous and/or outdated information from other Agency files.
Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications
Document Number: 2016-31625
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of four new drug applications (NDAs) and two abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Office of the Director; Notice of Meeting
Document Number: 2016-31611
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-31610
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-31608
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Document Number: 2016-31607
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-31604
Type: Notice
Date: 2016-12-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 a proposed information collection entitled ``Test Predictability of Falls Screening Tools.'' CDC will use the information collected to evaluate current screening tools and potentially design a new screening tool for health care practitioners to identify community-dwelling adults 65 and older at risk for falls.
Listing of Ingredients in Tobacco Products; Revised Guidance for Industry; Availability
Document Number: 2016-31587
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). We received several comments to the draft guidance, and those comments were considered as the guidance was finalized.
Submission of Warning Plans for Cigars; Guidance for Industry; Availability
Document Number: 2016-31586
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submission of Warning Plans for Cigars.'' The guidance will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance reiterates the health warning statements and display and distribution requirements that should be provided in cigar warning plans and will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan.
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2016-31578
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-31571
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-31570
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-31569
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-31568
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-31567
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2016-31566
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-31565
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-31554
Type: Notice
Date: 2016-12-29
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Proposed Collection; 60-Day Comment Request; Continuation of Use of the Early Career Reviewer Program Online Application and Vetting System-Center for Scientific Review (CSR)
Document Number: 2016-31543
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, Center for Scientific Review, 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.
Meeting of the National Vaccine Advisory Committee
Document Number: 2016-31530
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT) (Previously Entitled: Alzheimer's Disease Supportive Services Program Data Reporting Tool (ADSSP-DRT) and Alzheimer's disease Initiative- Specialized Supportive Services (ADI- SSS) project))
Document Number: 2016-31528
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services
In compliance with 44 U.S.C. 3507, the Administration on Aging (AoA), Administration for Community Living (ACL), is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This notice collects comments on the information collection requirements relating to the continuation of an existing data collection for the Alzheimer's and Dementia Program Data Reporting Tool (ADP-PDR) and expansion of this collection to incorporate ACL grantees of the Alzheimer's Disease Initiative Specialized Supportive Services (ADI-SSS) project.
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability
Document Number: 2016-31513
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities.'' This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies and Federal facilities that are not registered as outsourcing facilities. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it does not intend to take action for violations of certain provisions of the FD&C Act when a State-licensed nuclear pharmacy or Federal facility compounds or repackages radiopharmaceuticals.
Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Draft Guidance for Industry; Availability
Document Number: 2016-31512
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' Specifically, this guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing facilities. This guidance describes how FDA intends to apply section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions under which FDA does not intend to take action for violations of certain provisions of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals.
Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability
Document Number: 2016-31511
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.'' This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Meeting of the Community Preventive Services Task Force (Task Force)
Document Number: 2016-31468
Type: Notice
Date: 2016-12-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars, and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research and practice-based evidence and issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when they are determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the evidence on which they are based, are compiled in the Guide to Community Preventive Services (The Community Guide).
Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Incorporating Chemical Information: Resources, Limitations, and Characterizing the Domain of Applicability for 21st Century Toxicity Testing; Notice of Public Webinar; Registration Information
Document Number: 2016-31439
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Incorporating Chemical Information: Resources, Limitations, and Characterizing the Domain of Applicability for 21st Century Toxicity Testing.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), National Institute of Environmental Health Sciences, and hosted by the U.S. Environmental Protection Agency's National Center for Computational Toxicology. Interested persons may participate via Adobe Connect. Time will be allotted for questions from the audience.
Using Informatics To Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish; Notice of Webinars; Registration Information
Document Number: 2016-31438
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences announces the webinar series, ``Using Informatics to Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish.'' The webinars will provide an overview of current issues that need to be addressed to facilitate the broader use of zebrafish for chemical safety screening studies and how data science can be applied to address some of those issues.
Prospective Grant of Exclusive Patent License: Development and Commercialization of Nitrite Salts for the Treatment, Amelioration, and Prevention by Any Route of Administration of Pulmonary Hypertension, Including All WHO Classifications of Pulmonary Hypertension, e.g., Groups 1-5
Document Number: 2016-31437
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to United Therapeutics Corporation (``United'') located in Silver Spring, MD and incorporated under the laws of Delaware.
National Institute on Aging; Notice of Closed Meetings
Document Number: 2016-31433
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-31432
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-31431
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services
National Center for Complementary and Integrative Health; Notice of Meeting
Document Number: 2016-31430
Type: Notice
Date: 2016-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
Document Number: 2016-31424
Type: Notice
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Refuse To Accept Procedures for Premarket Tobacco Product Submissions
Document Number: 2016-31370
Type: Rule
Date: 2016-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions.
Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration; Availability
Document Number: 2016-31406
Type: Notice
Date: 2016-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Postmarket Management of Cybersecurity in Medical Devices.'' FDA is issuing this guidance to inform industry and FDA staff of the Agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. The guidance clarifies FDA's postmarket recommendations with regards to addressing cybersecurity vulnerabilities and emphasizes that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of the postmarket management of their medical devices.