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

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.

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.

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.

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.

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?

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).

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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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: ``TeamSTEPPS 2.0 Online Master Trainer Course.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on May 14th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, 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 April 9, 2013, page 19633 and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), 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.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014.''

The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.