Department of Health and Human Services June 2018 – Federal Register Recent Federal Regulation Documents
Results 251 - 280 of 280
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Office of the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311-Revision
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. This proposed information collection was previously published in the Federal Register on January 10, 2018 (83 FR 1264), and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. 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.
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC); Correction
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the space and ports available. The meeting room accommodates 70 participants and there will be 125 ports available. Due to the limited accommodations by phone ports and room size, we are encouraging the public to please register using the link https://www.surveymonkey.com/r/CMNSX73. There will be a public comment period from 11:10 a.m.-11:40 a.m., on June 19, 2018, and from 11:30 a.m.-11:45 a.m., on June 20, 2018. All public comments will be limited to two-minutes per speaker.
Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
This document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide.
Medical Devices; Exemptions From Premarket Notification: Class II Devices
The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Agency Information Collection Activities: Proposed Collection; Comment Request
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 ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.''
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of AHRQ to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' This proposed information collection was previously published in the Federal Register on February 26, 2018 and allowed 60 days for public comment. AHRQ did not receive any substantive comments.
Notice of Meeting
The Agency for Healthcare Research and Quality (AHRQ) announces the Special Emphasis Panel (SEP) meeting on AHRQ-HS-18-001, ``Patient Safety Learning Laboratories: Pursuing Safety in Diagnosis and Treatment at the Intersection of Design, Systems Engineering, and Health Services Research (R18).'' Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Radiology Devices; Reclassification of Medical Image Analyzers
The Food and Drug Administration (FDA or the Agency) is issuing this proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection as postamendments class III (premarket approval) devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient's radiology images by the clinician. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.'' The purpose of this draft guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this draft guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. The draft guidance focuses on appropriate criteria for inclusion in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical requirements.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), June 20, 2018
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Reallotment of Fiscal Year 2017 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2017 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, Tribes, and Tribal Organizations that received FY 2018 direct LIHEAP grants. No subgrantees or other entities may apply for these funds. Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), (42 U.S.C. 8626(b)(1)) requires that, if the Secretary of HHS determines that, as of September 1 of any fiscal year, an amount in excess of 10 percent of the amount awarded to a grantee for that fiscal year (excluding Leveraging and REACH funds) will not be used by the grantee during that fiscal year, then the Secretary must notify the grantee and publish a notice in the Federal Register that such funds may be reallotted to LIHEAP grantees during the following fiscal year. If reallotted, the LIHEAP block grant allocation formula will be used to distribute the funds. No funds may be allotted to entities that are not direct LIHEAP grantees during FY 2018.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
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 the information collection requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Evaluation of the Sodium Reduction in Communities Program (SRCP) to estimate the costs to SRCP partners of implementing sodium reduction strategies. The proposed data collection aims to understand the costs to SRCP partner of implementing sodium reduction strategies.
Waivers of the Single, Shared System Risk Evaluation and Mitigation Strategy Requirement; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Waivers of the Single, Shared System REMS Requirement.'' This guidance describes how FDA intends to consider granting a waiver of the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that the applicant for an abbreviated new drug application (ANDA) and its reference listed drug (RLD) use a single, shared system (SSS) for a required risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU).
Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of a Shared System REMS.'' This draft guidance provides recommendations on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products. This guidance describes some of the possible benefits of a shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs.
Meeting of the Pain Management Best Practices Inter-Agency Task Force; Amendment
A notice was published in the Federal Register on Thursday, May 3, 2018, to announce the inaugural meeting of the Pain Management Best Practices Inter-Agency Task Force (Task Force) and to invite the public to provide public comments. The period for written comments is currently scheduled to end close of business on May 25, 2018. The notice is being amended to extend the written public comment period for two weeks to allow more time for interested individuals to submit comments.
Compliance With Statutory Program Integrity Requirements
The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise its Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. In addition, OPA proposes amendments to the Title X regulations that would, among other things, clarify grantee responsibilities to provide a broad range of family planning methods; to require documented compliance with State and local laws requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, and human trafficking; to provide free or low cost access to family planning services for those women who are unable to obtain employer-sponsored insurance coverage for certain contraceptive services due to their employers' religious beliefs or moral convictions; to provide for the appropriate expenditure of federal Title X funds on family planning services, rather than on lobbying or related activities; and to appropriately encourage family participation in family planning decisions, all as required by Federal law.
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