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

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

This document announces changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent Hospital (MDH) Program under the hospital inpatient prospective payment systems (IPPS) for FY 2018 in accordance with sections 50204 and 50205, respectively, of the Bipartisan Budget Act of 2018.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit a Supplemental Information Request (SIR), described below, to the Office of Management and Budget (OMB). Prior to submitting the SIR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the SIR.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft research plan entitled Continuing To Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025 for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2018-0038 in the search field and click ``Search.''

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) and National Preparedness and Response Science Board (NPRSB) will hold a joint public teleconference on May 10, 2018.

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 National HIV Prevention Program Monitoring and Evaluation (NHM&E), which collects standardized HIV prevention program evaluation data from health departments and community-based organizations (CBOs) who receive federal funds for HIV prevention activities.

The Food and Drug Administration (FDA) is announcing the renewal of the Arthritis 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 Arthritis Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 5, 2020.

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.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) will hold a public meeting.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing.

In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects (hereafter the ``2018 Requirements''). The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). The departments and agencies listed in this document have also published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, to cover the time period of January 19, 2018 until July 19, 2018. As per the interim final rule, the effective date of the 2018 Requirements is now July 19, 2018. The departments and agencies listed in this document propose delaying the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. This proposed rule, if finalized, would require regulated entities to continue to comply with the requirements of the current Federal Policy for the Protection of Human Subjects (hereafter the ``pre-2018 Requirements'') until January 21, 2019. This proposal also takes comment on whether to permit institutions to implement, for certain research studies, the following provisions in the 2018 Requirements during the period from July 19, 2018, until January 21, 2019, that the general compliance date is delayed. Those three provisions, intended to reduce burdens on regulated entities, are the 2018 Requirements' definition of ``research,'' which deems certain activities not to be research, the allowance for no annual continuing review of certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications related to the research. The way that this option is proposed, regulated entities would be required to comply with all pre- 2018 Requirements during the period that the general compliance date is delayed, except for provisions substituted by the three burden-reducing provisions of the 2018 Requirements. As described in section III, below, this flexibility is proposed only for studies for which an institution makes a choice to transition to comply with the 2018 Requirements, beginning on July 19, 2018. In order to clearly describe this proposed flexibility, including how it would impact institutions choosing to transition research to comply with the 2018 Requirements, this document proposes a redrafted transition provision.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug ProductsQuality Considerations.'' The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers, or MDIs) and inhalation powders (also known as dry powder inhalers, or DPIs). Although not explicitly discussed, some of the principles and recommendations provided in this guidance may be applicable to nasal delivery products, as well. The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.

The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List, as well as any non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the National Priorities List. The agency will do so in order to ``. . . establish and maintain inventory of literature, research, and studies on the health effects of toxic substances'', to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.

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 ``Outcome Measure Repository (OMR).'' This proposed information collection was previously published in the Federal Register on January 29, 2018, and allowed 60 days for public comment. AHRQ received no substantive comments from the public. The purpose of this notice is to allow an additional 30 days for public comment.

This proposed notice acknowledges the receipt of an application from DNV GLHealthcare for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. The statute requires that we publish, within 60 days of receipt of an organization's complete application, a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

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.

The Food and Drug Administration (FDA, we, or Agency) 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.

This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally- facilitated Exchanges and State Exchanges on the Federal platform. It finalizes changes that provide additional flexibility to States to apply the definition of essential health benefits (EHB) to their markets, enhance the role of States regarding the certification of qualified health plans (QHPs); and provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Special Protocol Assessment.'' This guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research for special protocol assessment (SPA). This guidance is intended to improve the quality of requests for SPAs and accompanying submission materials, and the quality of the resulting interactions between sponsors and FDA. This guidance finalizes the draft guidance of the same name issued May 4, 2016, and replaces the guidance of the same name issued May 17, 2002.

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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and PreventionState, Tribal, Local and Territorial Subcommittee (ACD, CDC-STLT). This meeting is open to the public, limited only by the room seating, audio phone lines and net conference access available. The public is also welcome to listen to the meeting by dialing (877) 692-1879, entering participant code 57852858, with 100 ports available. The public comment period is from 2:00 p.m.-2:15 p.m. No advance registration is required.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Board on Radiation and Worker Health (ABRWH), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through March 22, 2020.

This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to further reduce the number of beneficiaries who may potentially misuse or overdose on opioids while still having access to important treatment options; implement certain provisions of the 21st Century Cures Act; support innovative approaches to improve program quality, accessibility, and affordability; offer beneficiaries more choices and better care; improve the CMS customer experience and maintain high beneficiary satisfaction; address program integrity policies related to payments based on prescriber, provider and supplier status in MA, Medicare cost plan, Medicare Part D and the PACE programs; provide an update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders and Food and Drug Administration Staff.'' FDA's vision is that NGS- based tests can be developed, validated, and offered for clinical use through a process that leverages appropriate standards, quality systems controls, and community assessment of clinical validity to streamline the premarket review process. This guidance provides recommendations for designing, developing, and establishing analytical performance for NGS-based tests used for whole exome human DNA sequencing (WES) or targeted human DNA sequencing intended to aid in the diagnosis of symptomatic individuals with suspected germline diseases or other conditions. These recommendations are based on FDA's understanding of the tools and processes needed to run an NGS-based test along with the design and analytical validation considerations appropriate for such tests.

The Food and Drug Administration (FDA or Agency) 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 ``Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance provides FDA's current thinking on expanding the abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the draft guidance is to describe an optional program for certain well understood device types, where a submitter could demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific, submitter-identified predicate device as part of a demonstration of substantial equivalence. This draft guidance is not final nor is it in effect at this time.

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 Evidence to Inform Standards that Ensure Turnout Gear Remains Protective Throughout Its Lifecycle that will provide data that links turnout gear use conditions to its resulting performance characteristics.

The Reagan-Udall Foundation (the Foundation) for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Administration Amendments Act of 2007, is announcing its annual public meeting. The Foundation will discuss its activities and how it supports FDA.

In accordance with the Federal Advisory Committee Act, notice is hereby given that a National Advisory Council on Migrant Health (NACMH) meeting has been scheduled. This meeting will be open to the public. The agenda for the NACMH meeting can be obtained by contacting the Designated Federal Officer (DFO) or accessing the NACMH website: https://bphc.hrsa.gov/qualityimprovement/strategicpartnership s/nacmh/ index.html.

Findings of research misconduct have been made on the part of Brandi M. Baughman, Ph.D., postdoctoral fellow in the Center for Integrative Chemical Biology and Drug Discovery, Division of Chemical Biology and Medicinal Chemistry, University of North Carolina at Chapel Hill (UNC). Dr. Baughman engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM100919. The administrative actions, including debarment for a period of two (2) years, were implemented beginning on March 19, 2018, and are detailed below.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) is announcing the renewal of the Bone, Reproductive and Urologic 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 Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2020.

The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-12 Meeting.'' The purpose of the public meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR-12 meeting that will be held July 10 to 12, 2018, in Tokyo, Japan.

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 five 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).

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or Agency) 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 reporting requirements contained in existing FDA regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients.

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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.'' This draft guidance addresses FDA's current thinking about the relevant age groups to study and how early in the drug development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD).

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.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board advises the Agency on keeping pace with technical and scientific developments, including in regulatory science; provides input into the Agency's research agenda; and advises on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public.

The Agency for Healthcare Research and Quality (AHRQ) announces the Special Emphasis Panel (SEP) meeting on Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute Learning Health Systems Mentored Career Development Program (K12). Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.

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; however, visitors must be processed in accordance with established federal policies and procedures. Attendance is limited only by room seating available, (add number of seats that will be available in the room). The public is also welcome to listen to the meeting via teleconference; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt of written public comment is May 3, 2018. All requests must contain the name, address, and organizational affiliation of the speaker, as well as the topic being addressed. Written comments should not exceed one single-spaced typed page in length and delivered in 3 minutes or less. Members of the public who wish to provide public comments should plan to attend the public comment session at the start time listed. Please note that the public comment period may end before the time indicated, following the last call for comments. Written comments received in advance of the meeting will be included in the official record of the meeting. Registration is required to attend in person or on the phone. Interested parties may register at www.cdc.gov/ hicpac.