Department of Health and Human Services November 2017 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 263
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance for Industry; Availability
Document Number: 2017-25457
Type: Notice
Date: 2017-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This draft guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be exempted, as grandfathered, from certain requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
Document Number: 2017-25456
Type: Notice
Date: 2017-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on export certificates for the export of FDA- regulated products.
Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop
Document Number: 2017-25454
Type: Notice
Date: 2017-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the public workshop entitled ``Safety Assessment for IND Safety Reporting.'' Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to ``Safety Assessment for Investigational New Drug (IND) Safety Reporting.'' This public workshop is organized in response to public comments received to Docket No. FDA-2015-D-4562 for the draft guidance ``Safety Assessment for IND Safety Reporting'' issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. The public workshop is intended to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Signatures
Document Number: 2017-25453
Type: Notice
Date: 2017-11-27
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2017-25452
Type: Notice
Date: 2017-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2017-25451
Type: Notice
Date: 2017-11-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2017-25450
Type: Notice
Date: 2017-11-27
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Meeting
Document Number: 2017-25449
Type: Notice
Date: 2017-11-27
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2017-25444
Type: Notice
Date: 2017-11-27
Agency: Department of Health and Human Services, Administration for Children and Families
Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)
Document Number: 2017-25440
Type: Notice
Date: 2017-11-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2019.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID); Notice of Charter Renewal
Document Number: 2017-25439
Type: Notice
Date: 2017-11-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through October 31, 2019.
Board of Scientific Counselors, BSC, NCIPC; Notice of Charter Renewal
Document Number: 2017-25438
Type: Notice
Date: 2017-11-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, BSC, NCIPC, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 3, 2019.
Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC); Correction
Document Number: 2017-25437
Type: Notice
Date: 2017-11-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Announcement of Meetings of the Tick-Borne Disease Working Group
Document Number: 2017-25425
Type: Notice
Date: 2017-11-24
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS), in accordance with Section 2062 of the 21st Century Cures Act, announces the inaugural meetings of the Tick-Borne Disease Working Group (Working Group). For these first meetings, Working Group members will focus on plans to submit a report to the Secretary of HHS and Congress that is due December 2018. The report will address a number of issues related to tick-borne diseases, including: Ongoing research; advances in research; Federal activities; gaps in research; the Working Group's meetings; and the comments received by the Working Group. The report will also include any recommendations to the Secretary of Health and Human Services. Planning will include developing plans to solicit stakeholder input and establish subcommittees. Working Group members will also determine how and when future meetings will be conducted.
Phase Four of the National Action Plan To Prevent Health Care-Associated Infections: Road Map to Elimination; Coordination Among Federal Partners To Leverage HAI Prevention and Antibiotic Stewardship
Document Number: 2017-25424
Type: Notice
Date: 2017-11-24
Agency: Department of Health and Human Services
The Office of Disease Prevention and Health Promotion and the Federal Steering Committee for the Prevention of HAIs have developed a new phase of the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination (HAI Action Plan). The first three phases of the HAI Action Plan meaningfully enhanced coordination of federal efforts to address HAIs by establishing a structure to regularly share best practices, resources, and lessons learned among federal partners. Given the pressing public health threat of antibiotic resistance and the need to maximize efficiency of federal activities, the Steering Committee recognized the opportunity to leverage this existing committee and network of participants to enhance the implementation of the CARB National Action Plan goal of slowing the emergence of antibiotic resistant bacteria and preventing the spread of resistant infections through antibiotic stewardship programs. Thus, Phase Four of the HAI Action Plan focuses on the importance of antibiotic stewardship to prevent HAIs, and specifically highlights the coordination between various health agencies. Recommendations within Phase Four align and reinforce the goals and objectives of the CARB National Action Plan. This update to the HAI Action Plan reaffirms a federal commitment to improving health care quality and protecting the health of all Americans. Phase Four is titled: Coordination among Federal Partners to Leverage HAI Prevention and Antibiotic Stewardship. The Steering Committee and the Office of Disease Prevention and Health Promotion invite public and private professionals, organizations, and consumer representatives to provide comments on the most recent draft of Phase Four.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-25339
Type: Notice
Date: 2017-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the National Preparedness and Response Science Board
Document Number: 2017-25336
Type: Notice
Date: 2017-11-24
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 the National Preparedness and Response Science Board (NPRSB) will hold a public teleconference on December 7, 2017.
NIH Pathways to Prevention Workshop: Methods for Evaluating Natural Experiments in Obesity
Document Number: 2017-25335
Type: Notice
Date: 2017-11-24
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) will host a workshop about Methods for Evaluating Natural Experiments in Obesity on December 5-6, 2017. The workshop is free and open to the public.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-25313
Type: Notice
Date: 2017-11-22
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-25295
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-25261
Type: Notice
Date: 2017-11-22
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Workplace Violence Prevention Programs in NJ Healthcare Facilities. Through nursing home administrator interviews, CDC seeks to continue measuring compliance to the state regulations for workplace violence prevention program: Violence prevention policies, reporting systems for violent events, violence prevention committee, written violence prevention plan, violence risk assessments, post incident response and violence prevention training.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-25260
Type: Notice
Date: 2017-11-22
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 the opportunity to comment on proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Monitoring Breastfeeding-Related Maternity CareUS hospitals. The Maternity Practices in Infant Nutrition and Care (mPINC) survey is a census of maternity care hospitals in the United States and Territories, that CDC has administered every other year since 2007 in order to monitor and examine changes in breastfeeding-related maternity care practices over time.
Tenth Annual Sentinel Initiative; Public Workshop
Document Number: 2017-25251
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Tenth Annual Sentinel Initiative Public Workshop.'' The purpose of this 2-day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions.
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products; Guidance for Industry; Availability
Document Number: 2017-25248
Type: Notice
Date: 2017-11-22
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 ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.'' This guidance is intended to assist a person who plans to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic version of a solid oral opioid drug product that references an opioid drug product with abuse- deterrent properties described in its labeling. The guidance recommends studies, including comparative in vitro and pharmacokinetic (PK) studies, that a potential ANDA applicant should conduct and submit to FDA to demonstrate that a generic solid oral opioid drug product is no less abuse deterrent than its reference listed drug (RLD) with respect to all potential routes of abuse.
Tobacco Product Manufacturing Practice; Request for Comments
Document Number: 2017-25245
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting public input on updated recommendations for regulations on good manufacturing practice for electronic nicotine delivery systems (ENDS) that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' ENDS recommendations). FDA is providing an opportunity for interested parties to comment on the tobacco companies' ENDS recommendations.
Modified Risk Tobacco Product Applications: Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Extension of Comment Period
Document Number: 2017-25224
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Philip Morris Products S.A. for its IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks.
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-25218
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Cancellation of Meeting
Document Number: 2017-25217
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2017-25216
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2017-25215
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Sanitary Transportation of Human and Animal Food: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
Document Number: 2017-25204
Type: Rule
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA RegulationSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Sanitary Transportation of Human and Animal Food.''
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2017-25192
Type: Notice
Date: 2017-11-21
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the next federal advisory committee meeting regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will advise the Secretary on the Healthy People 2030 mission, vision, framework, and organizational structure. The Committee will provide advice regarding criteria for identifying a more focused set of measurable, nationally representative objectives. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
Supplemental Award to the National Network for Oral Health Access
Document Number: 2017-25191
Type: Notice
Date: 2017-11-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement in the amount of $250,000 for a HRSA-funded cooperative agreement awarded to the National Network for Oral Health Access (NNOHA). The supplement, awarded on September 25, 2017, will fund demonstration projects to increase the integration of oral health and primary care practice through the adoption of HRSA's core clinical oral health competencies for non-dental health care providers in Health Center (HC) settings, focusing on services for pregnant women and children.
Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information
Document Number: 2017-25159
Type: Notice
Date: 2017-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 burden estimate for requests for a written statement from FDA regarding the classification and regulatory requirements that may be applicable to a particular device (513(g) requests).
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2017-25158
Type: Notice
Date: 2017-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on eligibility criteria and the process to be followed by establishments when notifying FDA of a manufacturer's intent to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the Accredited Persons (AP) Inspection Program.
Determination That TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-25156
Type: Notice
Date: 2017-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that TRINTELLIX (vortioxetine hydrobromide) oral tablet, equivalent to (EQ) 15 milligram (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for vortioxetine hydrobromide oral tablet, 15 mg base, if all other legal and regulatory requirements are met.
Medicare Program; CY 2018 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2017-24913
Type: Notice
Date: 2017-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2018 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2018, the inpatient hospital deductible will be $1,340. The daily coinsurance amounts for CY 2018 will be: $335 for the 61st through 90th day of hospitalization in a benefit period; $670 for lifetime reserve days; and $167.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; CY 2018 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2017-24912
Type: Notice
Date: 2017-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2018. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2018 for these individuals will be $422. The premium for certain other individuals as described in this notice will be $232.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2018
Document Number: 2017-24877
Type: Notice
Date: 2017-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2018. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2018, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2018 are $261.90 for aged enrollees and $295.00 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2018 is $134.00, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00. (The 2017 standard premium rate was $134.00, which included the $3.00 repayment amount.) The Part B deductible for 2018 is $183.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
Document Number: 2017-25070
Type: Notice
Date: 2017-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
Medical Devices; Exemption From Premarket Notification: Over-the-Counter Denture Repair Kits
Document Number: 2017-25065
Type: Notice
Date: 2017-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for over-the-counter (OTC) denture repair kits. These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Request for Public Comment: 60 Day Notice for Extension of the Indian Health Service Loan Repayment Program
Document Number: 2017-25049
Type: Notice
Date: 2017-11-20
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0014, titled, ``IHS Loan Repayment Program (LRP).'' This previously approved information collection project was last published in the Federal Register (80 FR 23558) on April 28, 2015, and allowed 60 and 30 days for public comment. No public comment was received in response to the notices. This notice announces our intent to submit this collection, which expires July 31, 2018, to OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-25044
Type: Notice
Date: 2017-11-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-25043
Type: Notice
Date: 2017-11-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences Notice of Organizational Change
Document Number: 2017-24853
Type: Notice
Date: 2017-11-20
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health (NIH) is seeking public comment regarding its proposal to reorganize and to rename its Center for Research Capacity Building to the Division for Research Capacity Building, and transfer the Office of Emergency Care Research to the National Institute of Neurological Disorders and Stroke.
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability
Document Number: 2017-25010
Type: Notice
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-25008
Type: Notice
Date: 2017-11-17
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-24992
Type: Notice
Date: 2017-11-17
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 ``Unique Device Identification: Direct Marking of Devices.'' This document is intended to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist industry and FDA staff in understanding direct marking requirements.
Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins
Document Number: 2017-24952
Type: Proposed Rule
Date: 2017-11-17
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2015 notice of proposed rulemaking (NPRM). The 2015 NPRM proposed to add certain influenza virus strains to the list of HHS select agents and toxins.