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

Results 101 - 150 of 27,499
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2018-22079
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-22078
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-22077
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-22076
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-22075
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-22072
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Extension; DERT Extramural Grantee Data Collection (NIEHS)
Document Number: 2018-22038
Type: Notice
Date: 2018-10-11
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.
Annual Civil Monetary Penalties Inflation Adjustment
Document Number: 2018-22005
Type: Rule
Date: 2018-10-11
Agency: Department of Health and Human Services
The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
Children's Bureau; Proposed Information Collection Activity; Comment Request
Document Number: 2018-22020
Type: Notice
Date: 2018-10-10
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-22008
Type: Notice
Date: 2018-10-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-22007
Type: Notice
Date: 2018-10-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability
Document Number: 2018-21959
Type: Notice
Date: 2018-10-10
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 revised draft guidance for industry entitled ``Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.'' This revised draft guidance supersedes the draft guidance entitled ``Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs,'' which was announced in the Federal Register on June 1, 2016. This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or a topical delivery system (collectively referred to as TDS). Depending on the objectives of a TDS product development program, applicants may choose to evaluate TDS adhesion in clinical studies performed to evaluate TDS adhesion only or in clinical studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this revised draft guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA).
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
Document Number: 2018-21958
Type: Notice
Date: 2018-10-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.'' This draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this draft guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA).
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2018-21957
Type: Notice
Date: 2018-10-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plant and Resin; and Eight Additional Substances; Request for Comments
Document Number: 2018-21954
Type: Notice
Date: 2018-10-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 16 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).
Privacy Act of 1974; System of Records
Document Number: 2018-21899
Type: Notice
Date: 2018-10-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), is withdrawing the notice published on September 17, 2018 to modify system of records No. 09-70-0541, titled ``Medicaid Statistical Information System (MSIS).'' The notice was prematurely published. A revised version will be published at a later date.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21898
Type: Notice
Date: 2018-10-10
Agency: Department of Health and Human Services, National Institutes of Health
Charter Renewal for the Council on Graduate Medical Education
Document Number: 2018-21864
Type: Notice
Date: 2018-10-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
HHS is hereby giving notice that the Council on Graduate Medical Education (COGME) has been rechartered. The date the renewed charter took effect is September 30, 2018.
Performance Review Board Members
Document Number: 2018-21855
Type: Notice
Date: 2018-10-09
Agency: Department of Health and Human Services
Meeting of the National Clinical Care Commission
Document Number: 2018-21854
Type: Notice
Date: 2018-10-09
Agency: Department of Health and Human Services
The National Clinical Care Commission (the Commission) will conduct its inaugural meeting on October 31, 2018. The Commission will evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys (NLM)
Document Number: 2018-21818
Type: Notice
Date: 2018-10-09
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.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-21810
Type: Notice
Date: 2018-10-09
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 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-21809
Type: Notice
Date: 2018-10-09
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 Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Styrene
Document Number: 2018-21808
Type: Rule
Date: 2018-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned. We are taking this action in response to a food additive petition submitted by the Styrene Information and Research Center (SIRC).
Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants
Document Number: 2018-21807
Type: Rule
Date: 2018-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is partially granting a petition submitted by the Breast Cancer Fund (now known as the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids' Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff, by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. We are taking this action because, despite FDA's scientific analysis and determination that these substances do not pose a risk to public health under the conditions of their intended use, the petitioners provided data demonstrating that these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations. Because of evidence that benzophenone causes cancer in animals, FDA also is amending the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners' request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-21768
Type: Notice
Date: 2018-10-09
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: 2018-21767
Type: Notice
Date: 2018-10-09
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.
Submission for OMB Review; Comment Request
Document Number: 2018-21766
Type: Notice
Date: 2018-10-09
Agency: Department of Health and Human Services, Administration for Children and Families
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-21764
Type: Notice
Date: 2018-10-09
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: 2018-21762
Type: Notice
Date: 2018-10-09
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21754
Type: Notice
Date: 2018-10-05
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.
Medicare Program; Town Hall Meeting on the FY 2020 Applications for New Medical Services and Technologies Add-On Payments
Document Number: 2018-21753
Type: Notice
Date: 2018-10-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2020 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2020 new medical services and technologies applications meet the substantial clinical improvement criterion.
Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget
Document Number: 2018-21716
Type: Notice
Date: 2018-10-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR)
Document Number: 2018-21702
Type: Notice
Date: 2018-10-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by the space available. The meeting room accommodates up to 80 people. Public participants should pre-register for the meeting as described below. Members of the public that wish to attend this meeting in person should pre-register by submitting the following information by email, facsimile, or phone (see contact person for more information) no later than 12:00 noon (EDT) on Wednesday, October 22, 2018:
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2018-21701
Type: Notice
Date: 2018-10-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, is limited only by room seating available, (120). The public is also welcome to listen to the meeting via teleconference at 800-857- 9838, passcode: 5325685; 100 teleconference lines are available.
Notice of Closed Meeting
Document Number: 2018-21700
Type: Notice
Date: 2018-10-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-21688
Type: Notice
Date: 2018-10-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
Document Number: 2018-21682
Type: Notice
Date: 2018-10-05
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.
Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials; Draft Guidance for Industry; Availability; Correction
Document Number: 2018-21677
Type: Notice
Date: 2018-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is correcting a document that appeared in the Federal Register of September 7, 2018 (83 FR 45454). The document announced the draft guidance for industry entitled ``Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.'' The notice inadvertently contained the wrong docket number. This document corrects that error.
Delegation of Authority
Document Number: 2018-21672
Type: Notice
Date: 2018-10-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-21670
Type: Notice
Date: 2018-10-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21648
Type: Notice
Date: 2018-10-05
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: 2018-21647
Type: Notice
Date: 2018-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-21646
Type: Notice
Date: 2018-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21645
Type: Notice
Date: 2018-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21618
Type: Notice
Date: 2018-10-04
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 ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Database.'' This proposed information collection was previously published in the Federal Register on July 16th, 2018 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications
Document Number: 2018-21610
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.
Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
Document Number: 2018-21597
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of August 17, 2018. FDA requested comments on the draft guidance for industry and FDA staff entitled ``Process To Request a Review of FDA's Decision Not To Issue Certain Export Certificates for Devices.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2019 Proposed Guidance Development
Document Number: 2018-21596
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2019. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.
United States Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for Comments
Document Number: 2018-21594
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Charlotte, NC, scheduled for November 11 through 15, 2018. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Charlotte, NC.