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

Findings of Research Misconduct
Document Number: 2018-19019
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made on the part of Li Wang, Ph.D., Professor of Physiology and Neurobiology, University of Connecticut (UConn) (Respondent). Dr. Wang engaged in research misconduct in research included in National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant applications 1 R01 DK118645-01A1, 1 R01 DK116203-01, 1 R01 DK114804-01, and 2 R01 DK080440-09A1 and National Institute of General Medical Sciences (NIGMS), NIH, grant applications 1 R01 GM125140-01 and 1 R01 GM126685-01. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on August 14, 2018, and are detailed below.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-19014
Type: Notice
Date: 2018-08-31
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 Pregnancy Risk Assessment Monitoring System (PRAMS). PRAMS provides an important supplement to vital records data by providing state-specific information not available through birth certificate data on maternal behaviors and experiences before, during and after pregnancy on health conditions, prenatal care, postpartum care, access to care, and health insurance status.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-19013
Type: Notice
Date: 2018-08-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-19012
Type: Notice
Date: 2018-08-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-18973
Type: Notice
Date: 2018-08-31
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. 30-Day Public Comment Request
Document Number: 2018-18972
Type: Notice
Date: 2018-08-31
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; 30-Day Public Comment Request
Document Number: 2018-18971
Type: Notice
Date: 2018-08-31
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; 30-Day Public Comment Request
Document Number: 2018-18970
Type: Notice
Date: 2018-08-31
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. 30-Day Public Comment Request
Document Number: 2018-18965
Type: Notice
Date: 2018-08-31
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. 30-Day Public Comment Request
Document Number: 2018-18964
Type: Notice
Date: 2018-08-31
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. 30-Day Public Comment Request
Document Number: 2018-18963
Type: Notice
Date: 2018-08-31
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.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), September 26, 2018
Document Number: 2018-18961
Type: Notice
Date: 2018-08-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning CMS programs, initiatives and priorities. This meeting is open to the public.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-18906
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2018-18905
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-18904
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-18903
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-18902
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-18901
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-18900
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-18899
Type: Notice
Date: 2018-08-31
Agency: Department of Health and Human Services, National Institutes of Health
National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table
Document Number: 2018-18873
Type: Proposed Rule
Date: 2018-08-30
Agency: Department of Health and Human Services
This document announces a public hearing to receive information and comments regarding the notice of proposed rulemaking (NPRM) titled ``National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table.''
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2019
Document Number: 2018-18802
Type: Notice
Date: 2018-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2019 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.
Complex Innovative Designs Pilot Meeting Program
Document Number: 2018-18801
Type: Notice
Date: 2018-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI), incorporated as part of the FDA Reauthorization Act of 2017 (FDARA), highlights the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The Food and Drug Administration (FDA or Agency) is announcing a pilot meeting program that affords sponsors who are selected the opportunity to meet with Agency staff to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the pilot program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2018 to 2022. This pilot meeting program fulfills FDA's commitment under PDUFA VI. For each sponsor whose meeting request is granted as part of the pilot, FDA will grant two meetings between the sponsor and CDER or CBER that will provide an opportunity for medical product developers and FDA to discuss regulatory approaches for CID. To promote innovation in this area, trial designs developed through the pilot meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for drugs that have not yet been approved by FDA.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-18779
Type: Notice
Date: 2018-08-30
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 Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2018-18778
Type: Notice
Date: 2018-08-30
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is by webcast only and is open to the public. Registration is requested for oral comment and is required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of the Comment Period
Document Number: 2018-18775
Type: Notice
Date: 2018-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability for ``Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry,'' published in the Federal Register of June 1, 2018. The Agency has received a request for an extension of the comment period for the draft guidance.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-18773
Type: Notice
Date: 2018-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-18772
Type: Notice
Date: 2018-08-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-18769
Type: Notice
Date: 2018-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2018-18760
Type: Notice
Date: 2018-08-29
Agency: Department of Health and Human Services, Administration for Children and Families
DHL Laboratories Inc.; Proposal To Withdraw Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container; Opportunity for a Hearing
Document Number: 2018-18749
Type: Notice
Date: 2018-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of a new drug application (NDA) for Dextrose 5% Injection in Plastic Container, 5 grams (g)/100 milliliters (mL), held by DHL Laboratories Inc., 155 Medical Science Dr., Union, SC 23979, and is announcing an opportunity for the holder of the NDA to request a hearing on this proposal. The basis for the proposal is that the holder of the NDA has repeatedly failed to file required annual reports for the NDA.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-18699
Type: Notice
Date: 2018-08-29
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 Epidemiologic Study of Health Effects Associated With Low Pressure Events in Drinking Water Distribution Systems.
Center for Scientific Review; Notice of Meeting
Document Number: 2018-18654
Type: Notice
Date: 2018-08-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-18653
Type: Notice
Date: 2018-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-18652
Type: Notice
Date: 2018-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Interest Rate on Overdue Debts
Document Number: 2018-18648
Type: Notice
Date: 2018-08-28
Agency: Department of Health and Human Services, Office of the Secretary
List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2018-18614
Type: Notice
Date: 2018-08-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies three bulk drug substances that FDA has considered and is proposing not to include on the list: Bumetanide, nicardipine hydrochloride, and vasopressin. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-18589
Type: Notice
Date: 2018-08-28
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 CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for revision to the previously approved project used to monitor and evaluate performances and practices among national laboratories M. tuberculosis susceptibility testing.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-18588
Type: Notice
Date: 2018-08-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute Notice of Meeting
Document Number: 2018-18549
Type: Notice
Date: 2018-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2018-18548
Type: Notice
Date: 2018-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-18547
Type: Notice
Date: 2018-08-28
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: 2018-18546
Type: Notice
Date: 2018-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-18545
Type: Notice
Date: 2018-08-28
Agency: Department of Health and Human Services
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-18544
Type: Notice
Date: 2018-08-28
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 Activities: Proposed Collection; Comment Request
Document Number: 2018-18523
Type: Notice
Date: 2018-08-27
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 and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP
Document Number: 2018-18519
Type: Proposed Rule
Date: 2018-08-27
Agency: Department of Health and Human Services, Office of Inspector General
This request for information seeks input from the public on how to address any regulatory provisions that may act as barriers to coordinated care or value-based care.
Final National Occupational Research Agenda for Traumatic Injury Prevention
Document Number: 2018-18514
Type: Notice
Date: 2018-08-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Traumatic Injury Prevention.
Submission for OMB Review; Comment Request
Document Number: 2018-18495
Type: Notice
Date: 2018-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Document Number: 2018-18483
Type: Notice
Date: 2018-08-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website http://www.hhs.gov/ash/carb/ and must be completed by September 19, 2018; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at http://www.hhs.gov/ash/carb/ on the Meetings page.