Department of Health and Human Services June 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-15564
Type: Notice
Date: 2016-06-30
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 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
Document Number: 2016-15549
Type: Notice
Date: 2016-06-30
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 (PRA), federal agencies are required to publish a 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.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-15523
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). 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 http:// www.samhsa.gov/workplace.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2016-15487
Type: Notice
Date: 2016-06-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
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; Extension of Comment Period
Document Number: 2016-15480
Type: Notice
Date: 2016-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice entitled ``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'' that appeared in the Federal Register of March 4, 2016. The notice requested scientific data, information, and comments that would assist in the development of a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). In the Federal Register notice of April 22, 2016, the comment period for this request was initially extended to July 5, 2016. We are taking this action due to maintenance on the Federal eRulemaking portal in early July 2016.
Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk Assessment: Report; Availability; Extension of the Comment Period
Document Number: 2016-15478
Type: Notice
Date: 2016-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice, published in the Federal Register of April 6, 2016 (81 FR 19976), announcing the availability of a draft guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action Level,'' a supporting document entitled ``Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants,'' and a risk assessment report entitled ``Arsenic in Rice and Rice Products Risk Assessment: Report.'' We are taking this action due to maintenance on the Federal eRulemaking portal in early July 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Extension of Comment Period
Document Number: 2016-15475
Type: Notice
Date: 2016-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of May 5, 2016. In the notice, FDA announced an opportunity for public comment on the proposed collection of certain information by the Agency. We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.
Society of the Plastics Industry, Inc.; Filing of Food Additive Petition
Document Number: 2016-15474
Type: Proposed Rule
Date: 2016-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Keller and Heckman LLP on behalf of the Society of the Plastics Industry, Inc. (Petitioner or SPI), requesting that we amend our food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because this use has been abandoned.
Delegation of Authority
Document Number: 2016-15470
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services, Office of the Secretary, Administration for Children and Families
Notice is hereby given that I delegate to the Assistant Secretary for the Administration for Children and Families (ACF) the following authorities vested in the Secretary of Health and Human Services under the Trafficking Victims Protection Act of 2000 (TVPA), Public Law 106-386, as amended. Authority under section 107(b)(1)(B)(i) of the TVPA (22 U.S.C. 7105(b)(1)(B)(i)) to expand benefits and services to victims of severe forms of trafficking in persons in the United States, without regard to immigration status. In the case of non-entitlement programs funded by the Secretary of Health and Human Services, such benefits and services may include services to assist potential victims of trafficking in achieving certification and to assist minor dependent children of victims of severe forms of trafficking in persons or potential victims of trafficking. Authority under section 107(b)(1)(B)(ii) of the TVPA (22 U.S.C. 7105(b)(1)(B)(ii)) to make grants for a national communication system to assist victims of severe forms of trafficking in persons in communicating with service providers. Authority under section 107(f) of the TVPA (22 U.S.C. 7105(f)) to establish a program to assist United States citizens and aliens lawfully admitted for permanent residence who are victims of severe forms of trafficking. In addition to the authority to provide such victims with specialized services, the program also has the authority to identify current providers and provide a means to make referrals to programs for which such victims are already eligible. In the course of exercising the authority to conduct activities, personnel in the Administration for Children and Families will consult with the Attorney General, the Secretary of Labor, and non-governmental organizations that provide services to victims of severe forms of trafficking in the United States. These authorities may be redelegated. These authorities shall be exercised under the Department's policy on regulations and the existing delegation of authority to approve and issue regulations. These delegations shall be exercised under financial and administrative requirements applicable to the Administration for Children and Families authorities. I hereby affirm and ratify any actions taken by the Assistant Secretary for Children and Families, or your subordinates, which involved the exercise of these authorities delegated herein prior to the effective date of this delegation. This delegation supersedes all existing delegations of these authorities.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Document Number: 2016-15469
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services
The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs.
Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; Correction
Document Number: 2016-15460
Type: Rule
Date: 2016-06-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule published in the Federal Register on May 4, 2016, entitled ``Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities.''
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-15447
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; Notice of Meeting
Document Number: 2016-15446
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2016-15445
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants
Document Number: 2016-15444
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-15443
Type: Notice
Date: 2016-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-15442
Type: Notice
Date: 2016-06-30
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. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-15441
Type: Notice
Date: 2016-06-30
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. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Annual Long-Term Care Ombudsman Report Amended Data Collection
Document Number: 2016-15433
Type: Notice
Date: 2016-06-30
Agency: Aging Administration, Department of Health and Human Services
The Administration on Community Living, Administration on Aging (ACL/AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 conflict of interest reporting per the Code of Federal Regulations and Older Americans Act Title VII.
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record
Document Number: 2016-15410
Type: Proposed Rule
Date: 2016-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective (GRAS/GRAE). In the 1994 TFM, certain antiseptic active ingredients were proposed as being GRAS for antiseptic rub use by consumers based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic rub active ingredients have in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model
Document Number: 2016-15188
Type: Proposed Rule
Date: 2016-06-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017 as well as proposing to implement policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also proposes to set forth requirements for the ESRD Quality Incentive Program, and proposes to establish and revise requirements for quality reporting and measurement, including the inclusion of new quality measures for payment year (PY) 2020 and beyond and updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also proposes to implement statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also proposes to expand suppliers' appeal rights in the event of a breach of contract action by CMS. In particular, this rule proposes a revision to current regulations to provide that the appeals process is applicable to all breach of contract actions taken by CMS, rather than just for the termination of a competitive bidding contract. It also proposes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from Competitive Bidding Programs and for submitting bids and establishing single payment amounts under the Competitive Bidding Programs for certain groupings of similar items with different features. Changes are also proposed to the methodology for establishing bid limits for items under the DMEPOS Competitive Bidding Programs. In addition, this rule also solicits comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule announces a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
National Institutes of Health, Precision Medicine Initiative® (PMI) Cohort Program; Notice of Meeting
Document Number: 2016-15395
Type: Notice
Date: 2016-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Institutes of Health (NIH), Precision Medicine Initiative[supreg] (PMI) Cohort Program will host two (2) teleconferences to enable public discussion of its proposal to align the authority and responsibility for the execution of PMI Cohort Program by establishing this program within the NIH Office of the Director, and reporting to the NIH Director.
Gifts to the Food and Drug Administration: Evaluation and Acceptance: Draft Guidance for the Public and Food and Drug Administration Staff; Availability
Document Number: 2016-15385
Type: Notice
Date: 2016-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for the public and FDA staff entitled ``Gifts to FDA: Evaluation and Acceptance.'' The Secretary of the Department of Health and Human Services (HHS) has the authority to accept conditional or unconditional gifts on behalf of the United States. The Secretary has delegated this gift authority to the Commissioner of Food and Drugs. This guidance provides the process and principles we will use in implementing this authority.
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff; Availability
Document Number: 2016-15384
Type: Notice
Date: 2016-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff.'' This draft guidance addresses FDA's process, under Government-wide Federal regulations, for evaluating whether an advisory committee member has an appearance issue that raises concerns about the member's participation in an advisory committee meeting and describes FDA's process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting. This draft guidance is not final nor is it in effect at this time. FDA is also requesting comment on whether FDA should request that each advisory committee member who has an appearance issue and who has received an authorization from FDA to participate in an advisory committee meeting voluntarily publicly disclose the authorization.
Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
Document Number: 2016-15381
Type: Rule
Date: 2016-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Microbiology Devices Panel of the Medical Devices
Document Number: 2016-15362
Type: Notice
Date: 2016-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2016-15361
Type: Notice
Date: 2016-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2016-15320
Type: Notice
Date: 2016-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Senior Medicare Patrol (SMP) Program National Beneficiary Survey
Document Number: 2016-15304
Type: Notice
Date: 2016-06-29
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from the public related to the Senior Medicare Patrol (SMP) Program. 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 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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-15321
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Federal Review of the Oklahoma Disability Law Center (ODLC)
Document Number: 2016-15313
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services
Representatives of the Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), will be conducting a federal review of the Oklahoma Disability Law Center (ODLC) on August 16-18, 2016. AIDD is soliciting comments from interested parties on your experiences with the work, program, and strategies employed by ODLC in meeting the needs of individuals with developmental disabilities and their families in Oklahoma. You are encouraged to share your experiences by way of any of the following methods: Email: Clare.Barnett@acl.hhs.gov. Telephone: 202-795-7301. Mail Comments to: Clare Barnett Huerta, Program Specialist, Administration on Intellectual and Developmental Disabilities, Administration for Community Living, 330 C Street SW., 1st Floor, Washington, DC 20201. Comments should be received by August 18, 2016 in order to be included in the final report.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; OAA Title III-E Evaluation
Document Number: 2016-15309
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services
The Administration for Community Living 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; Submission for OMB Review; Comment Request; State Health Insurance Assistance Program (SHIP) Client Contact Form, Public and Media Activity Report Form, and Resource Report Form
Document Number: 2016-15308
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services
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; Public Comment Request; State Health Insurance Assistance (SHIP) Program National Beneficiary Survey
Document Number: 2016-15307
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from the public related to the State Health Insurance Assistance (SHIP) Program. 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 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.
Patient Safety Organizations: Voluntary Relinquishment From the UM-JMH Center for Patient Safety PSO
Document Number: 2016-15226
Type: Notice
Date: 2016-06-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the UM-JMH Center for Patient Safety PSO of its status as a PSO, and has delisted the PSO accordingly.
Health Center Program
Document Number: 2016-15208
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Bureau of Primary Health Care has been granted class deviations.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2016-15207
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Meeting of the 2018 Physical Activity Guidelines Advisory Committee
Document Number: 2016-15206
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS) is hereby giving notice that a meeting of the 2018 Physical Activity Guidelines Advisory Committee (2018 PAGAC or Committee) will be held. This meeting will be open to the public.
Prospective Grant of Start-up Exclusive License: Premarket Approved Diagnostic for Identifying JC Virus
Document Number: 2016-15165
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to Pro Arc Diagnostics, Inc., which is located in Missouri, to practice the inventions embodied in the following patents: U.S. Patent Application 14/408,919, filed December 17, 2014 (HHS reference E-088-2012/0-US-03). The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive license territory may be worldwide and the field of use may be limited to FDA premarket approved (PMA) diagnostics for the detection of JC Virus.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2016-15164
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-15163
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-15162
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-15161
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-15160
Type: Notice
Date: 2016-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-15117
Type: Notice
Date: 2016-06-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-15116
Type: Notice
Date: 2016-06-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of Clinical and Preventive Services: National HIV Program; HIV/AIDS Prevention and Engagement in Care
Document Number: 2016-15115
Type: Notice
Date: 2016-06-27
Agency: Department of Health and Human Services, Indian Health Service
Special Protocol Assessment; Draft Guidance for Industry; Extension of the Comment Period
Document Number: 2016-15106
Type: Notice
Date: 2016-06-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability, published in the Federal Register of May 4, 2016 (81 FR 26799), announcing the draft guidance for industry entitled ``Special Protocol Assessment.'' We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.