Department of Health and Human Services March 2016 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 353
Request for Information on NIOSH Center for Direct Reading and Sensor Technologies: Sensors for Emergency Response Activities; Extension of Comment Period
On January 19, 2016, the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [81 FR 2866] requesting information to enhance the value of the NIOSH Center for Direct Reading and Sensor Technologies entitled Request for Information on NIOSH Center for Direct Reading and Sensor Technologies: Sensors for Emergency Response Activities. Written comments were to be received by March 21, 2016. NIOSH is extending the public comment period until April 22, 2016.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017
This final rule sets forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also provides additional amendments regarding the annual open enrollment period for the individual market for the 2017 and 2018 benefit years; essential health benefits; cost sharing; qualified health plans; Exchange consumer assistance programs; network adequacy; patient safety; the Small Business Health Options Program; stand-alone dental plans; third-party payments to qualified health plans; the definitions of large employer and small employer; fair health insurance premiums; student health insurance coverage; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions and appeals; and other related topics.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.
Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled ``Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.'' The purposes of the workshop are to share current FDA experiences on the application of mechanism-based absorption modeling and simulation in regulatory activities; discuss current and future utility of mechanism-based absorption modeling and simulation in the development of bioequivalent oral drug products and regulatory reviews; obtain input from various stakeholders on when, where, and how to conduct mechanism-based absorption modeling and simulations in the context of bioequivalent product development; and request comments on these topics.
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity.'' It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for drug applications and certain supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA.
A Dietary Supplement Labeling Guide: Chapter II. Identity Statement; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``A Dietary Supplement Labeling Guide: Chapter II. Identity Statement.'' This guidance is part of a longer guidance entitled ``A Dietary Supplement Labeling Guide,'' which covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We are revising the guidance to correct an inaccurate statement.
Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Health (CDRH) developed this draft guidance to assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. This draft guidance is not final nor is it in effect at this time.
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' This guidance is intended to provide recommendations regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection).
New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations
The Food and Drug Administration (FDA) is removing regulations that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern, and the only remaining animal drug use listed in these regulations is now listed elsewhere in the new animal drug regulations.
Canned Tuna Deviating From Identity Standard: Temporary Permit for Market Testing
The Food and Drug Administration (FDA or we) is announcing the extension of temporary permits issued to Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company (the applicants) to market test products (designated as ``canned tuna'') that deviate from the U.S. standard of identity for canned tuna. The extension allows the applicants to continue to measure consumer acceptance of the products and assess the commercial feasibility of the products, in support of a petition to amend the standard of identity for canned tuna. We also invite other interested parties to participate in the market test.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee
The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. This action is being taken to reflect the change made to the charter for this advisory committee.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``DELTA FOCUS Program Evaluation.'' CDC will use the information collected to improve the national DELTA FOCUS program, and to develop strategy interactions to help the DELTA FOCUS program meet the requirements of the Funding Opportunity Announcement.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on An Assessment of the State Public Health Actions (``1305'') Program, a study to explore state-level partnerships and synergy among state health departments funded through the State Public Health Actions 1305 cooperative agreement.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection request Qualitative Information Collection on Emerging Diseases among the Foreign-born in the US that enables CDC improve the planning and implementation of disease prevention and control strategies targeting communicable diseases and other emerging health issues among high-risk foreign-born communities in specific and limited geographic areas in the United States where high numbers of those populations live.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Senior Medicare Patrol (SMP) Program Outcome Measurement
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evidence-Based Falls Prevention Program Standardized Data Collection
The Administration for Community Living (ACL), Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information. 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 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 relating to the Chronic Disease Self-Management Education Program.
Workshop on Shift Work at Night, Artificial Light at Night, and Circadian Disruption; Notice of Public Meeting; Registration Information; Amended Notice
This notice amends Federal Register notice 81 FR 7354 published February 11, 2016, announcing the public meeting and registration information for the Workshop on Shift Work at Night, Artificial Light at Night, and Circadian Disruption. Registration is available to attend the workshop in-person both March 10 and March 11 and will close prior to March 4 if space capacity at NIEHS is reached. Registration to view the webcast is requested, but not required. All other information in the original notice has not changed. Information on the workshop and registration is available at https:// ntp.niehs.nih.gov/go/workshop_ALAN.
Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.'' The guidance document provides establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for screening donors for evidence of, and risk factors for, infection with Zika virus (ZIKV). The guidance identifies ZIKV as a relevant communicable disease agent or disease (RCDAD) and adds to recommendations contained in the guidance entitled ``Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007.
Agency Information Collection Activities: Proposed Collection; 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 (the PRA), federal agencies are require; 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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Announcement of Requirements and Registration for the Opioid Overdose Prevention Challenge
In summarizing the challenge that will be issued by your agency, please answer the following four questions: (1) What action is being taken? The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a challenge to developers to help support patients in recovery who are receiving medication assisted treatment for opioid use disorder with an innovative app that provides features and information that support their recovery. (2) Why is this action necessary? Addressing the opioid epidemic is a top priority for the U.S. Department of Health and Human Services and the Secretary is committed to evidence-informed interventions to turn the tide against opioid drug-related overdose and misuse. To that end, Substance Abuse and Mental Health Services Administration (SAMHSA) is issuing a three-month challenge to spur developers to create an app that provides additional recovery support to patients receiving outpatient medication-assisted treatment for opioid use disorder. (3) What is the objective of the challenge? To provide support to people in recovery from opioid use disorder receiving medication assisted-treatment so that they can maintain treatment and achieve long-term recovery. (4) What is the intended effect of this action? An increase in the number of individuals with opioid use disorders maintaining recovery; and a reduction in the number of deaths from opioid overdose.
Intent to Review a Nonclinical Study Data Reviewer's Guide Template
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE Nonclinical SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of nonclinical study data. FDA is seeking public comment on the use of the PhUSE Nonclinical SDRG template for regulatory submissions.
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.'' This draft guidance addresses the inclusion of a boxed warning and a patient decision checklist in the product labeling for permanent hysteroscopically-placed tubal implants intended for female sterilization and as well as the content and format of those materials. This draft guidance is being issued in response to information provided to FDA, including in comments made at a 2015 Panel meeting and in comments submitted to the associated public docket, that women are not receiving or understanding information relating to the risks and benefits of this type of device. This draft guidance is not final nor is it in effect at this time.
Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; Corrections and Correcting Amendments
In the November 24, 2015 Federal Register (80 FR 73274), we published a final rule to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement (LEJR) or reattachment of a lower extremity. The effective date was January 15, 2016. This correcting amendment corrects a limited number of technical and typographical errors identified in the November 24, 2015 final rule.
Medicare and Medicaid Programs; Electronic Health Record Initiative Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting Amendment
This document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 3 and Modifications to Meaningful Use in 2015 through 2017.''
Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments
The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would assist the Agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). The risk assessment will evaluate and, if feasible, quantify the risk of human illness associated with consumption of produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin that are potentially contaminated with enteric pathogens, such as Escherichia coli O157:H7 or Salmonella. The risk assessment also will evaluate the impact of certain interventions, such as use of a time interval between application of the soil amendment and crop harvest, on the predicted risk. The risk assessment is intended to inform policy decisions with regard to produce safety.
Unique Device Identification System; Editorial Provisions; Technical Amendment
The Food and Drug Administration (FDA or Agency) is amending the Unique Device Identification (UDI) System regulation to make editorial changes. This technical amendment updates the email address associated with FDA's UDI system, which allows FDA to obtain information and offer support and assistance on medical devices through their distribution and use, ensuring consistency with the requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This change is necessary to ensure that the UDI team continues to maintain regular email communications with device labelers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments
The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices (hereafter termed ``third-party entity or entities''), including radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is taking this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments. We are seeking comments from the widest range of interested persons, including those who are engaged in one or more of the activities noted previously or who utilize refurbished, reconditioned, rebuilt, remarketed, remanufactured, or third-party serviced and repaired medical devices.
Privacy Act of 1974; Effective Date-April 2, 2016; Expiration Date-October 2, 2017
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the Department of Veterans Affairs, Veterans Health Administration (VHA).
Privacy Act of 1974; CMS Computer Match No. 2016-07; HHS Computer Match No. 1602; Effective Date-April 2, 2016; Expiration Date-October 2, 2017
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the Defense Enrollment Eligibility Reporting System (DEERS), Defense Manpower Data Center (DMDC), Department of Defense (DoD).
Privacy Act of 1974; CMS Computer Match No. 2016-11; HHS Computer Match No. 1601; Effective Date-April 2, 2016; Expiration Date-October 2, 2017
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the State-based Administering Entities.
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