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

Results 101 - 150 of 301
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-25338
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25337
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25336
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25335
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-25310
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2016-25307
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of two Committee members are scheduled to end during the 2016 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
Document Number: 2016-25232
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 requirements for premarket approval of medical devices.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-25231
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, Administration for Children and Families
Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket
Document Number: 2016-25223
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years.
Determination of Regulatory Review Period for Purposes of Patent Extension; PLEGRIDY
Document Number: 2016-25222
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for PLEGRIDY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; REPATHA
Document Number: 2016-25221
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for REPATHA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; PRILOSEC OTC
Document Number: 2016-25220
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for PRILOSEC OTC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-25215
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-25214
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions
Document Number: 2016-25118
Type: Notice
Date: 2016-10-19
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
ONC Health IT Certification Program: Enhanced Oversight and Accountability
Document Number: 2016-24908
Type: Rule
Date: 2016-10-19
Agency: Department of Health and Human Services, Office of the Secretary
This final rule finalizes modifications and new requirements under the ONC Health IT Certification Program (``Program''), including provisions related to the Office of the National Coordinator for Health Information Technology (ONC)'s role in the Program. The final rule creates a regulatory framework for ONC's direct review of health information technology (health IT) certified under the Program, including, when necessary, requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules. The final rule also sets forth processes for ONC to authorize and oversee accredited testing laboratories under the Program. In addition, it includes provisions for expanded public availability of certified health IT surveillance results.
Proposed Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines
Document Number: 2016-25144
Type: Notice
Date: 2016-10-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for MMR (measles, mumps, and rubella) and MMRV (measles, mumps, rubella, and varicella) vaccines.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-25120
Type: Notice
Date: 2016-10-18
Agency: Department of Health and Human Services, Administration for Children and Families
Performance Review Board Members
Document Number: 2016-25099
Type: Notice
Date: 2016-10-18
Agency: Department of Health and Human Services
Mallinckrodt Pharmaceuticals; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing
Document Number: 2016-25093
Type: Notice
Date: 2016-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.
Kremers Urban Pharmaceuticals Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing
Document Number: 2016-25092
Type: Notice
Date: 2016-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Practitioner Data Bank Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Certain Other Health Care Entities
Document Number: 2016-25074
Type: Notice
Date: 2016-10-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Office of The Director, Office of Science Policy, Office of Biotechnology Activities; Amended Notice of Meeting
Document Number: 2016-25072
Type: Notice
Date: 2016-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-25071
Type: Notice
Date: 2016-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2016-25070
Type: Notice
Date: 2016-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
Document Number: 2016-25005
Type: Proposed Rule
Date: 2016-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the proposed rule would add three entries to this list of drug products.
Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components
Document Number: 2016-25001
Type: Rule
Date: 2016-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2016-25069
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25068
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-25061
Type: Notice
Date: 2016-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
Document Number: 2016-25041
Type: Notice
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 recordkeeping requirements for manufacturers of medicated animal feeds.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Act Waivers and Reductions
Document Number: 2016-25040
Type: Notice
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 paperwork burden of requesting a waiver or reduction of fees under Animal Drug User Fee Act (ADUFA).
Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
Document Number: 2016-25037
Type: Notice
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``ANDA SubmissionsPrior Approval Supplements Under GDUFA.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to fund critical and measurable improvements to FDA's generic drugs program. This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA's performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to GDUFA performance metric goals. This guidance finalizes the draft guidance issued on July 11, 2014.
Electronic Submission of Labeling for Certain Home-Use Medical Devices
Document Number: 2016-25026
Type: Proposed Rule
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. FDA plans to make this device labeling available to the public through the Internet and would also provide search tools to facilitate locating information concerning a particular home-use device or a particular type of home-use device.
Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop
Document Number: 2016-25004
Type: Notice
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled ``Substitutability of Generic Drugs: Perceptions and Reality.'' The objective of this workshop is to discuss FDA and industry practices related to postmarket surveillance of generic drugs, postmarket generic drug research activities, public perceptions of generic drug quality and effectiveness, and verification of therapeutic equivalence of generic drugs. This workshop will also give stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public an opportunity to provide their insights on future research needs in postmarket surveillance of generic drugs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
Document Number: 2016-25003
Type: Notice
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 recordkeeping requirements for manufacturers of Type A medicated articles.
Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device
Document Number: 2016-25002
Type: Rule
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2016-24971
Type: Notice
Date: 2016-10-17
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. The theme of the October meeting will be on racial and ethnic disparities in research and care for dementia. Presentations will focus on general demographics, gaps and barriers that various groups face in obtaining services, and successful interventions to reduce these gaps. Additional presentations in the afternoon will include further discussion of the 2016 Update to the National Plan, updates on progress towards a Care and Services Summit, and federal workgroup updates.
Office of the Secretary; Notice of Meeting
Document Number: 2016-24954
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2016-24953
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-24952
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-24951
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-24950
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24949
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2016-24948
Type: Notice
Date: 2016-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2016-24947
Type: Notice
Date: 2016-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that EXONDYS 51 (eteplirsen), manufactured by Sarepta Therapeutics, meets the criteria for a priority review voucher.
Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings; Correction
Document Number: 2016-24917
Type: Rule
Date: 2016-10-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a technical error that appeared in the document published in the Federal Register on January 22, 2016 entitled ``Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-24910
Type: Notice
Date: 2016-10-14
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: 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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-24846
Type: Notice
Date: 2016-10-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services