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

Results 101 - 150 of 234
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2017-03245
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding a meeting to continue discussions and possibly develop recommendations regarding People Living with HIV/AIDS. The meeting will be open to the public.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-03235
Type: Notice
Date: 2017-02-17
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03234
Type: Notice
Date: 2017-02-17
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 (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 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 Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03190
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain
Document Number: 2017-03176
Type: Notice
Date: 2017-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials and industry experts.
Raymond Sean Brown: Debarment Order
Document Number: 2017-03173
Type: Notice
Date: 2017-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Dr. Raymond Sean Brown from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Brown was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Brown was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Brown failed to request a hearing. Dr. Brown's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Karis Copper Delong: Debarment Order
Document Number: 2017-03172
Type: Notice
Date: 2017-02-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Karis Copper Delong for a period of 12 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Delong was convicted of four misdemeanor counts under the FD&C Act for introducing, delivering for introduction, and causing the introduction and delivery for introduction of a misbranded drug into interstate commerce, which relates to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Ms. Delong was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Delong failed to request a hearing. Ms. Delong's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2017-03169
Type: Notice
Date: 2017-02-17
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: 2017-03168
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-03167
Type: Notice
Date: 2017-02-17
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: 2017-03166
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-03165
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03164
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03163
Type: Notice
Date: 2017-02-17
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: 2017-03162
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2017-03161
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services, National Institutes of Health
Patient Protection and Affordable Care Act; Market Stabilization
Document Number: 2017-03027
Type: Proposed Rule
Date: 2017-02-17
Agency: Department of Health and Human Services
This rule proposes changes that would help stabilize the individual and small group markets. This proposed rule would amend standards relating to special enrollment periods, guaranteed availability, and the timing of the annual open enrollment period in the individual market for the 2018 plan year; standards related to network adequacy and essential community providers for qualified health plans; and the rules around actuarial value requirements.
Confidentiality of Substance Use Disorder Patient Records; Delay of Effective Date
Document Number: 2017-03185
Type: Rule
Date: 2017-02-16
Agency: Department of Health and Human Services, Office of the Secretary
On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule on Confidentiality of Substance Use Disorder Patient Records. That rule is scheduled to take effect on February 17, 2017. In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' published in the Federal Register on January 24, 2017 (82 FR 8346), this action delays for 60 days from the date of the memorandum the effective date of the rule entitled ``Confidentiality of Substance Use Disorder Patient Records'' published in the Federal Register on January 18, 2017 (82 FR 6052).
Pediatric Advisory Committee; Amendment of Notice
Document Number: 2017-03144
Type: Notice
Date: 2017-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of January 5, 2017. The amendment is being made to reflect a change in the Center for Drug Evaluation and Research (CDER) products portion of the document. There are no other changes.
Proposed Collection; 60-Day Comment Request; Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health
Document Number: 2017-03137
Type: Notice
Date: 2017-02-16
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, the Office of Extramural Research (OER), the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-03135
Type: Notice
Date: 2017-02-16
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: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Use of the Term “Healthy” in the Labeling of Human Food Products; Public Meeting; Request for Comments
Document Number: 2017-03117
Type: Proposed Rule
Date: 2017-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``Use of the Term `Healthy' in the Labeling of Human Food Products.'' The purpose of the public meeting is to give interested persons an opportunity to discuss the use of the term ``healthy'' in the labeling of human food.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2017-03087
Type: Notice
Date: 2017-02-16
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2017-03081
Type: Notice
Date: 2017-02-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2017-03080
Type: Notice
Date: 2017-02-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03079
Type: Notice
Date: 2017-02-16
Agency: Department of Health and Human Services, National Institutes of Health
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review and Enhanced Biosafety Requirements; Delay of Effective Date
Document Number: 2017-03044
Type: Rule
Date: 2017-02-16
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a delay in the effective date of the final rule titled ``Possession, Use, and Transfer of Select Agents and Toxins, Biennial Review and Enhanced Biosafety Requirements'' that published on January 19, 2017. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) is making a parallel change in the effective date of their final rule. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled ``Regulatory Freeze Pending Review.''
Control of Communicable Diseases; Delay of Effective Date
Document Number: 2017-03042
Type: Rule
Date: 2017-02-15
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a change in the effective date of the final rule titled ``Control of Communicable Diseases'' that was published on January 19, 2017. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled ``Regulatory Freeze Pending Review.''
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
Document Number: 2017-03018
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a nonfederal public member on the Muscular Dystrophy Coordinating Committee.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-03017
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-03016
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-03015
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03014
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2017-03013
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2017-03012
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-02980
Type: Notice
Date: 2017-02-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2017-02979
Type: Notice
Date: 2017-02-15
Agency: Department of Health and Human Services, Administration for Children and Families
Bioequivalence Recommendations for Difluprednate; Revised Draft Guidance for Industry; Availability
Document Number: 2017-02972
Type: Notice
Date: 2017-02-15
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 revised draft guidance for industry on generic difluprednate emulsion, entitled ``Draft Guidance on Difluprednate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for difluprednate emulsion.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-02963
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-02962
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2017-02961
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Interest Rate on Overdue Debts
Document Number: 2017-02916
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, Office of the Secretary
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2017-02915
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2017-02914
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-02913
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-02912
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-02911
Type: Notice
Date: 2017-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-02893
Type: Notice
Date: 2017-02-13
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``The Re-Engineered Visit for Primary Care (AHRQ REV).'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-02880
Type: Notice
Date: 2017-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2017-02879
Type: Notice
Date: 2017-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services