Department of Health and Human Services September 2015 – Federal Register Recent Federal Regulation Documents

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Administration for Community Living proposes to submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

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 Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships. CDC will use the information to continue the ongoing longitudinal follow-up for CDC's teen dating violence (TDV) prevention initiative, Dating Matters[supreg]: Strategies to Promote Healthy Teen Relationships.

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.

The Food and Drug Administration (FDA) is classifying the oral electronic vision aid 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 oral electronic vision aid'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.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Healthcare Associated Venous Thromboembolism (HA-VTE) Prevention Challenge on November 2, 2015. The challenge will be open until January 10, 2016. Venous thromboembolism (VTE), blood clots occurring as deep vein thrombosis (DVT), pulmonary embolism (PE), or both, is an important and growing public health issue. Prevention of healthcare associated VTE (HA-VTE) is a national hospital safety priority. Many HA-VTEs can be prevented, but VTE prevention strategies and are still not being applied regularly or effectively across the United States. To support and promote HA-VTE prevention, HHS/CDC is announcing the 2015 HA-VTE Prevention Challenge. The challenge will bring prestige to organizations that invest in VTE prevention, improve understanding of successful implementation strategies at the health system level, and motivate health systems to strengthen their VTE prevention efforts. The top-judged organizations found to have implemented innovative and effective VTE prevention strategies will be recognized as HA-VTE Prevention Champions. HHS/CDC will document these successful strategies and highlight the systems, processes, and staffing that contributed to exceptional VTE prevention outcomes achieved by Champions. Champions will receive a cash prize (if eligible) and other forms of recognition.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of a draft strategic plan entitled NIOSH Oil and Gas Sector ProgramStrategic Plan for Research and Prevention, 2016-2025 for public comment. The document and instructions for submitting comments can be found at www.regulations.gov.

The 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. 552b(c)(4), and 5 U.S.C. 552b(c)(6).

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: ``Online Submission Form for Supplemental Evidence and Data for Systematic reviews for the Evidence-based Practice Center Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product- specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

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 proposed collection Active Monitoring of Travelers Coming from Ebola-affected Countries and Their Contacts Currently Residing in State, Territorial, and Local Jurisdictions.

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.

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Patient Engagement Advisory Committee (the Committee), Office of the Center Director, Center for Devices and Radiological Health. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is requesting industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Patient Engagement Advisory Committee (the Committee) for the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. This position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Committee. Nominations will be accepted for current vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.

The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS, to implement the Proposed Action, referred to as the Proposed Action in the Final EIS. This action is to install a Thermal Energy Storage System and an Industrial Water Storage System to provide sufficient storage capacity to meet two days of chilled water demand and two days of industrial water demand should an outside disturbance interrupt the water supply.

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, 2015, page 19090 and allowed 60-days for public comment. One comment was received. However, it was not applicable to this data collection. 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, OIRA_submission@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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0279, scheduled to expire on September 30, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.