Department of Health and Human Services March 13, 2015 – Federal Register Recent Federal Regulation Documents
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Solicitation of Nominations for Organizations To Serve as Non-Voting Liaison Representatives to the Chronic Fatigue Syndrome Advisory Committee (CFSAC)
The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is soliciting nominations from qualified organizations to be considered for non- voting liaison representative positions on the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The issues can include factors affecting access and care for persons with ME/CFS; the science and definition of ME/CFS; and broader public health, clinical, research, and educational issues related to ME/CFS. These three non- voting liaison representative positions will be occupied by individuals who are selected by their organizations to serve as representatives of organizations concerned with ME/CFS. Organizations will be designated to occupy the positions for a two-year term to commence during the 2015 calendar year. Nominations of qualified organizations are being sought for these three non-voting liaison representative positions. The organizations chosen for representation on CFSAC will be selected by the Designated Federal Officer (DFO) or designee during the 2015 calendar year. Details of nomination requirements are provided below.
Notice of the Establishment of the Disability, Independent Living and Rehabilitation Research Advisory Council (DILRRAC)
Pursuant to the Rehabilitation Act of 1973, Section 205(a), as amended (29 U.S.C. 765), Public Law 92-463 as amended (5 U.S.C., App) and the Federal Advisory Committee Act, the Administration for Community Living (ACL), announces the establishment of the Disability, Independent Living and Rehabilitation Research Advisory Council (DILRRAC). The DILRRAC will provide the following duties: (1) Advise the Director of the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) in the development, implementation and revision of the 5-year plan, ensuring priorities and activities are aligned with the tenets of the Plan; (2) provide input regarding the activities relative to the prioritization and integration of funding priorities, goals and timetables for implementation of activities to be conducted under Section 205 of the Rehabilitation Act; (3) ensure that the Director considers input of individuals with disabilities, organizations representing individuals with disabilities, providers of services furnished under this chapter, researchers in the rehabilitation field, and any other appropriate persons or entitles; (4) review accomplishments and results of covered activities, and recommend and facilitate strategies for widespread dissemination in accessible formats, to rehabilitation practitioners, providers of independent living and other community-based services, individuals with disabilities, and the individuals' representatives, and individuals with disabilities who are members of minority groups or of populations that are unserved or underserved by programs.
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 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.
Medicare Program; Quality Incentive Program; Correction
This document corrects technical errors that appeared in the final rule published in the Federal Register on November 6, 2014 entitled ``End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.''
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. 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.
Proposed Collection; 60 Day Comment Request; Assessment of NHLBI's Global Health Initiative Collaborating Centers of Excellence (NHLBI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Deshiree Belis, 6705 Rockledge Drive, Suite 6070, Bethesda, MD 20892, or call non-toll-free number (301)-435-1032, or Email your request to: deshiree.belis@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Assessment of NHLBI's Global Health Initiative Collaborating Centers of Excellence, 0925-New, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: This collection proposes to conduct a one-time outcome evaluation of the NHLBI Global Health Initiative Centers of Excellence (GHI COE) Program to examine the extent to which the program achieved its intended objectives in developing sustainable research and research training capacity, and advancing information about the prevention and treatment of chronic non-communicable chronic cardiovascular and pulmonary diseases (CVPD) in low- and middle-income country (LMIC) populations. The outcome evaluation will utilize a mixed-methods approach to comprehend each COE's processes, short term outcomes, and sustainability outcomes/ efforts. Specifically, the evaluation will involve triangulating quantitative data sources (e.g., archived systematic reporting data), and qualitative data sources (e.g., archival data and key informant interview data). Data collected will be used to develop a Case Study report for each COE outlining their experience with implementing their program as well as a comprehensive cross-site Lessons Learned Report describing knowledge and experiences from the overall program, including similarities and differences across a variety of project settings and conditions. Findings from interviews will be incorporated into the Case Studies report and Lessons Learned report, which will be used by CTRIS to inform NHLBI and NIH stakeholders about structural issues relevant to planning both global and domestic biomedical research and training programs with diverse operational conditions and challenges. Additionally, COEs may utilize the Case Studies report as a marketing tool to attract additional funding and media coverage. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 36.
Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period by 30 days to April 29, 2015, for the notice entitled ``Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,'' that appeared in the Federal Register of January 27, 2015 (80 FR 4280). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
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 invites comments on reporting requirements contained in existing FDA regulations governing State enforcement notifications.
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.
Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food EstablishmentsSmall Entity Compliance Guide''. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.''
Official Symbol, Logo and Seal
The U.S. Department of Health and Human Services (HHS) is adopting final regulations containing a description of its official symbol, logo, and seal.
Proposed priorities; National Institute on Disability, Independent Living, and Rehabilitation Research; Disability and Rehabilitation Research Projects Program
The Administrator of the Administration for Community Living proposes priorities for the Disability and Rehabilitation Research Projects (DRRPs) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes priorities for a Center on Knowledge Translation for Employment Research and Projects for Translating Disability and Rehabilitation Research into Practice. We take this action to focus research attention on areas of national need. We intend these priorities to contribute to improved outcomes for people with disabilities through improved uptake of research-based knowledge generated by NIDILRR-sponsored research.
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