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

Results 51 - 100 of 323
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23141
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23140
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23139
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-23138
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-23136
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23135
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent License: Development of Adeno-Associated Virus-Based Vectors for the Treatment of Menkes Disease and Related Copper Transport Disorders
Document Number: 2016-23134
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
The Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Cyprium Therapeutics, Inc. (``Cyprium'') located in New York, NY, USA.
Generic Drug User Fees; Public Meeting; Request for Comments
Document Number: 2016-23111
Type: Notice
Date: 2016-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA), which authorizes FDA to collect fees and use them for the review of certain generic human drug applications and associated Type II active pharmaceutical ingredient (API) drug master files (DMFs), and for conducting associated inspections for fiscal years (FYs) 2018 through 2022. The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to present the recommendations to the relevant Congressional committees, publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket; Correction
Document Number: 2016-23106
Type: Notice
Date: 2016-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``A List of Biomarkers Used as Outcomes in Development of FDA- Approved New Molecular Entities and New Biological Therapeutics (October 2007 to December 2015); Establishment of a Public Docket'' that appeared in the Federal Register of September 19, 2016 (81 FR 64177). The document announced the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (such as academic researchers, regulated industries, consortia, and patient groups) on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities (NMEs) and New Biological Therapeutics from October 2007 to December 2015. The document was published without an active Web link. This document corrects that error.
Supplement for Zika Response, a Single-Award Deviation From Competition Requirements for the National Center for Medical Home Implementation Cooperative Agreement
Document Number: 2016-23096
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement in the amount of $350,000 for the National Center for Medical Home Implementation (NCMHI) cooperative agreement. The purpose of the NCMHI cooperative agreement is to support a national resource and assistance effort to implement and spread the medical home model to all children and youth, particularly children with special health care needs (CSHCN), children who are vulnerable and/or medically underserved, and pediatric populations served by state public health programs, the Maternal and Child Health Bureau (MCHB), and HRSA. The supplement will permit the American Academy of Pediatrics (AAP), the cooperative agreement awardee, during the budget period of July 1, 2016-June 30, 2017, to enhance their capacity to provide technical assistance and health professional education to increase the clinical expertise of pediatric health care professionals, including safety net providers, to more effectively serve as the medical home and provide family-centered, comprehensive, coordinated, and culturally-effective care for Zika- affected children and their families.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-23094
Type: Notice
Date: 2016-09-26
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 the ``ATSDR Communication Activities Survey (ACAS)'' which will be used to assess the effectiveness of ATSDR site team members as they engage and inform members of communities in providing effective, clear, and consistent communication and information about protecting communities from environmental hazards.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-23074
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-23073
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-23072
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2016-23058
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, Administration for Children and Families
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-23056
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-23055
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Notice of Charter Renewal
Document Number: 2016-23054
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices
Document Number: 2016-23053
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations of Candidates To Serve on the Advisory Council for the Elimination of Tuberculosis (ACET)
Document Number: 2016-23052
Type: Notice
Date: 2016-09-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Grant of Start-Up Exclusive Evaluation Patent License: Development of Autologous Tumor-reactive T Cells Isolated From Peripheral Blood for the Treatment of Metastatic Follicular Thyroid Cancer and Metastatic Soft Tissue Sarcomas
Document Number: 2016-23048
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-up Exclusive Evaluation Patent License to MedGene Therapeutics, Inc. (``MedGene'') located in Bethesda, MD to practice the inventions embodied in the patent applications listed Supplementary Information section of this notice.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2016-23042
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2016-23041
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2016-23040
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-23039
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute, Notice of Meeting
Document Number: 2016-23038
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2016-23037
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23036
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2017
Document Number: 2016-23002
Type: Notice
Date: 2016-09-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2017. The calendar year 2017 AIC threshold amounts are $160 for ALJ hearings and $1,560 for judicial review.
Submission for OMB Review; 30-Day Comment Request; Palliative Care: Conversations Matter® Phase Two Evaluation (National Institute of Nursing Research)
Document Number: 2016-22998
Type: Notice
Date: 2016-09-23
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 12, 2016, page 45169 (81 FR 45169) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-22967
Type: Notice
Date: 2016-09-23
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 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.
Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry; Availability
Document Number: 2016-22944
Type: Notice
Date: 2016-09-23
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 ``Self- Identification of Generic Drug Facilities, Sites, and Organizations.'' On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry to meet the self-identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.
Determination of Regulatory Review Period for Purposes of Patent Extension; BELVIQ
Document Number: 2016-22937
Type: Notice
Date: 2016-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for BELVIQ 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 drug product.
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff; Availability; Extension of Comment Period
Document Number: 2016-22936
Type: Notice
Date: 2016-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of June 29, 2016. In the notice, FDA requested comments on ``Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff'' and on whether FDA should request that each advisory committee member, who receives an authorization from FDA on an appearance issue so that they may participate in an advisory committee meeting, voluntarily publicly disclose the authorization. The Agency is taking this action due to errors displayed on the FDA Web site pertaining to this guidance.
Determination of Regulatory Review Period for Purposes of Patent Extension; MYALEPT
Document Number: 2016-22935
Type: Notice
Date: 2016-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for MYALEPT 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; FYCOMPA
Document Number: 2016-22933
Type: Notice
Date: 2016-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for FYCOMPA 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.
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2016-22925
Type: Notice
Date: 2016-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service; Extension of Comment Period
Document Number: 2016-22922
Type: Notice
Date: 2016-09-23
Agency: Department of Health and Human Services, Indian Health Service
This document extends the comment period in the Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service announcement that was published in the Federal Register on June 3, 2016.
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2016-22900
Type: Notice
Date: 2016-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-22899
Type: Notice
Date: 2016-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2016-22898
Type: Notice
Date: 2016-09-23
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Start-Up Exclusive License: Therapeutics for Frontotemporal Dementia, Alzheimer's Disease Excluding Intranasal Delivery, Neuronal Injury (Stroke, Traumatic Brain Injury (TBI) and Epilepsy), and Progressive Supranuclear Palsy
Document Number: 2016-22897
Type: Notice
Date: 2016-09-23
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to Cogentis Therapeutics, Inc. which is located in Maryland, to practice the inventions embodied in the following patents: U.S. Patent 8,597,660, issued December 3, 2013 (HHS reference E-144- 2010/0-US-02). The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive license territory may be worldwide and the field of use may be limited to Frontotemporal dementia, Alzheimer's disease excluding intranasal delivery, Neuronal injury (stroke, traumatic brain injury (TBI) and epilepsy), and Progressive Supranuclear Palsy.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-22896
Type: Notice
Date: 2016-09-23
Agency: Department of Health and Human Services, National Institutes of Health
Meeting Announcement for the Technical Advisory Panel on Medicare Trustee Reports
Document Number: 2016-22890
Type: Notice
Date: 2016-09-22
Agency: Department of Health and Human Services
This notice announces the meeting date for the second Technical Advisory Panel on Medicare Trustee Reports on Friday, September 30, 2016 in Washington, DC.
Agency Forms Undergoing Paperwork Reduction Acct Review
Document Number: 2016-22866
Type: Notice
Date: 2016-09-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 25, 2016 for public comment.
Renewal of Charter for the Advisory Committee on Organ Transplantation
Document Number: 2016-22858
Type: Notice
Date: 2016-09-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is giving notice that the Advisory Committee on Organ Transplantation (ACOT) has been rechartered. The effective date of the renewed charter is September 1, 2016.
Prospective Grant of Exclusive Patent License: Development of an Antibody-Drug Conjugate for Use in PhotoImmunoTherapy
Document Number: 2016-22820
Type: Notice
Date: 2016-09-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Summary Information section of this notice to Aspyrian Therapeutics, Inc. (``Aspyrian'') located in San Diego, California USA.
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-22819
Type: Notice
Date: 2016-09-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-22818
Type: Notice
Date: 2016-09-22
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2016-22817
Type: Notice
Date: 2016-09-22
Agency: Department of Health and Human Services, National Institutes of Health