Department of Health and Human Services September 2014 – Federal Register Recent Federal Regulation Documents

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Submission for OMB Review; 30-day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NICHD)
Document Number: 2014-22867
Type: Notice
Date: 2014-09-25
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on Thursday, July 3, 2014, Vol. 79, No. 128, page 38047-38049 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. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2014-22813
Type: Notice
Date: 2014-09-25
Agency: Department of Health and Human Services, Office of the Secretary
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
Document Number: 2014-22808
Type: Notice
Date: 2014-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2014-22807
Type: Notice
Date: 2014-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Policy Clarification for Fluoroscopic Equipment Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-22806
Type: Notice
Date: 2014-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Policy Clarification for Fluoroscopic Equipment Requirements.'' This draft guidance describes FDA's intent to clarify the application of certain aspects of the performance standard requirements for fluoroscopic equipment when manufacturers comply with certain International Electrotechnical Commission (IEC) standards. This draft guidance is not final nor is it in effect at this time.
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-22763
Type: Notice
Date: 2014-09-25
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. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-22762
Type: Notice
Date: 2014-09-25
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-22752
Type: Notice
Date: 2014-09-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Meeting
Document Number: 2014-22704
Type: Notice
Date: 2014-09-25
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we announce an Agency for Healthcare Research and Quality Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-010, ``Disseminating and Implementing Evidence from Patient- Centered Outcomes Research in Clinical Practice Using Mobile Health Technology (R21).'' As with other SEP meetings, this meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meeting
Document Number: 2014-22703
Type: Notice
Date: 2014-09-25
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we announce an Agency for Healthcare Research and Quality Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-009, ``Evaluating AHRQ Initiative to Accelerate the Dissemination and Implementation of PCOR Finding in Primary Care (R01).'' As with other SEP meetings, this meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meeting
Document Number: 2014-22702
Type: Notice
Date: 2014-09-25
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), we announce an Agency for Healthcare Research and Quality Special Emphasis Panel (SEP) meeting on ``AHRQ RFA HS14-008 Accelerating the Dissemination and Implementation of PCOR Findings into Primary Care Practice (R18).'' As with other SEP meetings, this meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meetings
Document Number: 2014-22701
Type: Notice
Date: 2014-09-25
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The scientific peer review subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6).
Justification of a Single Source Cooperative Agreement Award for the World Health Organization
Document Number: 2014-22773
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to fund an unsolicited proposal submitted by the World Health Organization (WHO) to support work towards establishing a regulatory pathway at WHO for prequalification of medical countermeasures to be deployed internationally in an emergency, which includes supporting WHO and potential recipient countries to build regulatory capacity for the import, registration, and emergency use of medical countermeasures. The goals of this Cooperative Agreement are to: (1) Using smallpox vaccines as a case study, complete product review and prequalification of smallpox vaccines included in or pledged to the WHO Smallpox Vaccine Emergency Stockpile for emergency use; (2) Establish general regulatory pathways for emergency use authorization and/or a process for emergency prequalification of emergency medical countermeasures and; (3) Support potential recipient WHO member states in building capacities for the import, registration, and emergency use of medical countermeasures. This Cooperative Agreement directly supports several federal initiatives focused on strengthening national and international health security, including HHS's ongoing work within the Global Health Security Initiative (GHSI) to develop an operational framework for the international deployment of medical countermeasures which contemplates the legal, regulatory, and logistical issues to be considered during such a deployment as noted in the 2013 GHSI Ministerial communique.\1\ Additionally, it supports Objective 9 of the Global Health Security Agenda \2\ which calls for improving global access to medical and non- medical countermeasures during health emergencies and the improvement of international deployment capabilities. It also aligns with the HHS Global Health Strategy priority to ``develop policy frameworks, agreements and operational plans to facilitate HHS decision-making in response to both single and multiple international requests for emergency assistance, including for the deployment of medical countermeasures and HHS personnel.'' \3\
Performance Review Board Members
Document Number: 2014-22714
Type: Notice
Date: 2014-09-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2014.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-22691
Type: Notice
Date: 2014-09-24
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Custom Device Exemption; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-22683
Type: Notice
Date: 2014-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Custom Device Exemption.'' FDA has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act). The intent of this guidance is to define terms used in the custom device exemption, explain how to interpret the ``five units per year of a particular device type'' language contained in the FD&C Act, describe information that FDA proposes manufacturers should submit in the custom device annual report, and provide recommendations on how to submit an annual report for devices distributed under the custom device exemption.
Announcement of Requirements and Registration for the 2014 Food and Drug Administration Food Safety Challenge
Document Number: 2014-22682
Type: Notice
Date: 2014-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the 2014 FDA Food Safety Challenge, a prize competition under the America COMPETES Reauthorization Act of 2010. The 2014 FDA Food Safety Challenge is an effort to advance breakthroughs in foodborne pathogen detection, specifically with the goal of accelerating the detection of Salmonella in fresh produce. As FDA's food safety program incorporates preventive control measures through the implementation of the FDA Food Safety Modernization Act, quicker detection of these harmful bacteria will help to prevent foodborne illnesses.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL52); Draft Guidance for Industry on Bioequivalence: Blood Level Bioequivalence Study; Availability
Document Number: 2014-22681
Type: Notice
Date: 2014-09-24
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 for industry (GFI 224) entitled ``Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study'' (VICH GL52). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-22662
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2014-22661
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-22660
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2014-22659
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2014-22658
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2014-22657
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2014-22656
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2014-22655
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Meeting
Document Number: 2014-22654
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-22630
Type: Notice
Date: 2014-09-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medicare Program; Solicitation of Nominations to the Advisory Panel on Hospital Outpatient Payment
Document Number: 2014-22634
Type: Notice
Date: 2014-09-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice solicits nominations for up to four new members to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). There are vacancies on the Panel effective September 30, 2014. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and supervision of hospital outpatient services. The Secretary rechartered the Panel in 2012 for a 2-year period effective through November 19, 2014. CMS intends to recharter the Panel for another 2-year period prior to expiration of the current charter.
Medicare and Medicaid Program; Application From the Joint Commission for Continued Approval of Its Psychiatric Hospital Accreditation Program
Document Number: 2014-22632
Type: Notice
Date: 2014-09-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish 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.
Submission for OMB Review; Comment Request
Document Number: 2014-22598
Type: Notice
Date: 2014-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; 30-Day Comment Request: State and Community Tobacco Control Research Initiative Evaluation (NCI)
Document Number: 2014-22586
Type: Notice
Date: 2014-09-23
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 6, 2014 (79 FR 32742) and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-22533
Type: Notice
Date: 2014-09-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2014-22532
Type: Notice
Date: 2014-09-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR)
Document Number: 2014-22531
Type: Notice
Date: 2014-09-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services, Department of Health and Human Services (hhs)
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2014-22530
Type: Notice
Date: 2014-09-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2014-22529
Type: Notice
Date: 2014-09-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-State, Tribal, Local and Territorial (STLT) Subcommittee
Document Number: 2014-22528
Type: Notice
Date: 2014-09-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2014-22527
Type: Notice
Date: 2014-09-23
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Collaborative Approaches for Medical Device and Healthcare Cybersecurity; Public Workshop; Request for Comments
Document Number: 2014-22515
Type: Notice
Date: 2014-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications; Public Meeting
Document Number: 2014-22514
Type: Notice
Date: 2014-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA's approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties. FDA is seeking input on these issues from all stakeholders, including patients, health care providers, the pharmaceutical industry, patient advocates, academics, researchers, and other governmental entities.
Report on the Standardization of Risk Evaluation and Mitigation Strategies; Availability
Document Number: 2014-22513
Type: Notice
Date: 2014-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled ``Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)''. This report describes the Agency's findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into the existing and evolving health care system. FDA is publishing this report to allow the public to provide comment on the report as it relates to PDUFA.
Proposed National Total Worker HealthTM
Document Number: 2014-22465
Type: Notice
Date: 2014-09-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the opportunity for comment on the Proposed National Total Worker Health\TM\ Agenda. To view the Agenda and submit written comments, visit, www.regulations.gov, and enter CDC-2014-0014 in the search field and click ``Search.'' There is also an opportunity to submit oral comments at one of three town-hall sessions during the following two scientific meetings: The 1st International Symposium to Advance Total Worker Health\TM\ and The Healthier Federal Workers Conference. For information on how to register for the conferences and town-hall sessions see the Supplementary Section. All comments are welcome, but NIOSH specifically seeks those that address the following questions: Do you see your own organization's goals reflected in the Proposed National Total Worker Health\TM\ Agenda? What are the bridges between your own work and the Proposed National Total Worker Health\TM\ Agenda? Are there any missing components or gaps in the Proposed National Total Worker Health\TM\ Agenda?
Meeting of the Community Preventive Services Task Force (Task Force)
Document Number: 2014-22502
Type: Notice
Date: 2014-09-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. Task Force recommendations provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery
Document Number: 2014-22461
Type: Notice
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 (PRA).
First Annual Neonatal Scientific Workshop-Roadmap for Applying Regulatory Science to Neonates; Notice of Public Workshop
Document Number: 2014-22460
Type: Notice
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public scientific workshop to discuss the roadmap for applying regulatory science to neonates. This public scientific workshop is being co- sponsored with the FDA, the Critical Path Institute (C-Path) and the Burroughs Welcome Fund (BWF). The purpose of the public scientific workshop is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public to determine whether there is sufficient interest on the part of stakeholders to develop a neonatal consortium and to discuss potential working groups dedicated to the regulatory science required to develop neonatal therapeutics.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2014-22456
Type: Notice
Date: 2014-09-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2014-22455
Type: Notice
Date: 2014-09-22
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Direct Impact Corona Ionization Mass Spectrometry
Document Number: 2014-22454
Type: Notice
Date: 2014-09-22
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 Food and Drug Administration, an agency within the Department of Health and Human Services, through the National Institutes of Health Office of Technology Transfer is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in HHS Ref. No. E-258-2011/0, ``Direct Impact Corona Ionization (DICI) Mass Spectrometry;'' U.S. Patent 8,704,169, to Vivione Biosciences, Inc., a corporation incorporated under the laws of the State of Arkansas, having a principle place of business at 515 W. Matthews Ave., Jonesboro, AR 72401. The United States of America is the assignee of the patent rights pertaining to this invention. The exclusivity period of the contemplated license may be granted for no more than seven (7) years, may be territorially limited to the United States and may be limited to a field of use directed to direct impact corona ionization mass spectrometry pattern recognition devices and systems for detection of small molecules and microbiological agents.