Department of Health and Human Services 2018 – Federal Register Recent Federal Regulation Documents

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Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-22409
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Privacy Act of 1974; Matching Program
Document Number: 2018-22405
Type: Notice
Date: 2018-10-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a re-established matching program between CMS and each State Based Administering Entity (AE), titled ``Determining Eligibility for Enrollment in Applicable State Health Subsidy Programs Under the Patient Protection and Affordable Care Act.''
Draft Guideline: Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services
Document Number: 2018-22377
Type: Notice
Date: 2018-10-15
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 (DHHS), announces the opening of a docket to obtain comment on the Draft Guideline: Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services (Draft Guideline). The Draft Guideline is an update of two sections of the Guideline for Infection Control in Healthcare Personnel, 1998: C. Infection Control Objectives for a Personnel Health Service and D. Elements of a Personnel Health Service for Infection Control. The updated recommendations in the Draft Guideline are intended to facilitate the provision of occupational infection prevention and control services to healthcare personnel and to prevent transmission of infections between healthcare personnel and others.
Pathogen Reduction Technologies for Blood Safety; Public Workshop; Correction
Document Number: 2018-22364
Type: Notice
Date: 2018-10-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a document that appeared in the Federal Register of September 17, 2018. The document announced a public workshop entitled ``Pathogen Reduction Technologies for Blood Safety; Public Workshop.'' The document was published with an error in the website address to register for the workshop. This document corrects that error.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22360
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22359
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-22358
Type: Notice
Date: 2018-10-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled One Health Harmful Algal Bloom System (OHHABS). The OHHABS is a voluntary reporting system available to state and territorial public health departments and their designated environmental health or animal health partners. It collects data on individual human and animal cases of illnesses from harmful algal bloom (HAB)-associated exposures, as well as environmental data about HABs.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-22344
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-22343
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-22342
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Submission for OMB Review; 30-Day Comment Request; Intramural Continuing Umbrella of Research Experiences (iCURE) Application-National Cancer Institute
Document Number: 2018-22319
Type: Notice
Date: 2018-10-15
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22318
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22317
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-22316
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-22315
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-22314
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-22313
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-22312
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-22311
Type: Notice
Date: 2018-10-15
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: 2018-22310
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-22309
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice to Close Meeting
Document Number: 2018-22308
Type: Notice
Date: 2018-10-15
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation for Nominations To Serve on the Advisory Council To Support Grandparents Raising Grandchildren
Document Number: 2018-22269
Type: Notice
Date: 2018-10-12
Agency: Department of Health and Human Services
The Secretary of Health & Human Services (Secretary) seeks nominations for grandparents who are raising grandchildren and older relatives who are caring for children to serve on the Advisory Council to Support Grandparents Raising Grandchildren.
Solicitation for Nominations To Serve on the Family Caregiving Advisory Council
Document Number: 2018-22268
Type: Notice
Date: 2018-10-12
Agency: Department of Health and Human Services
The Secretary of Health & Human Services (Secretary) seeks nominations for individuals to serve on the Family Caregiving Advisory Council.
Agency Information Collection Activity; Proposed Collection: Public Comment Request; One Protection and Advocacy Annual Program Performance Report
Document Number: 2018-22266
Type: Notice
Date: 2018-10-12
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed new data collection (ICR New) listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 seeks to collect comments on the proposed new data collection (ICR New), which will replace four existing Protection and Advocacy Program Performance Reports and other revisions. The four annual reports include the following: (1) Developmental Disabilities Protection and Advocacy Systems Program Performance Report (0985-0027), (2) Protection and Advocacy for Assistive Technology (PAAT) Program Performance Report (0985-0046); (3) Protection and Advocacy Voting Access Annual Report (Help America Vote Act) (HAVA) (0985-0028); and (4) Protection and Advocacy for Traumatic Brain Injury (PATBI) Program Performance Report (0985-0058). State Protection and Advocacy (P&A) Systems in each State and Territory provide individual legal advocacy, systemic advocacy, monitoring and investigations to protect and advance the rights of people with developmental disabilities, using funding administered by the Administration on Intellectual and Developmental Disabilities (AIDD), Administration on Disabilities, Administration for Community Living, HHS. To meet statutory reporting requirements, P&As have used four separate forms for submitting annual reports. It is proposed that the four forms be combined by creating the One Protection and Advocacy Annual Program Performance Report form. Once the four program performance reports are combined, the current OMB approval numbers for each report will be retired, and a new approval number will be created for the One Protection and Advocacy Program Performance Report.
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee, Renewal
Document Number: 2018-22183
Type: Notice
Date: 2018-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2020.
Charter Renewal of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2018-22167
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) is hereby giving notice that the charter for the Secretary's Advisory Committee on Human Research Protections (SACHRP) has been renewed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-22101
Type: Notice
Date: 2018-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal
Document Number: 2018-22098
Type: Notice
Date: 2018-10-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Antimicrobial Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2020.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-22091
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22090
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22089
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-22088
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-22087
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-22086
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-22085
Type: Notice
Date: 2018-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2018-22080
Type: Notice
Date: 2018-10-11
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: 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).