Department of Health and Human Services May 8, 2014 – Federal Register Recent Federal Regulation Documents
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Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Submission for OMB Review; 30-Day Comment Request; Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI)
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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 19, 2013, Vol. 78, page 36788 and allowed 60 days for public comment. Three public comments, questions, and requests for information were 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, 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.
Proposed Collection; 60-Day Comment Request; Evaluation of Center for Global Health's (CGH) Workshops (NCI)
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 Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted 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: Sudha Sivaram, Program Director, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W528, Rockville MD, 20850 or call non-toll-free number 240-276-5804 or Email your request, including your address to: sudha.sivaram@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment 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: Evaluation of Center for Global Health's (CGH) Workshops (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This submission is a request for OMB to approve the Evaluation of Center for Global Health's (CGH) Workshops for three years. These workshops are organized and funded by the National Cancer Institute's CGH in conjunction with various partners ranging from foreign Ministries of Health and research institutions, to international non-governmental organizations (NGOs) and U.S. academic institutions. The workshops to be evaluated are the Symposiums on Global Cancer Research, Workshops in Cancer Control Planning and Implementation, the Summer Curriculum in Cancer Prevention, Women's Empowerment Cancer Advisory Network Workshops (WE- CAN), Regional Grant Writing and Peer Review Workshops and other similar workshops. While these workshops differ in content and delivery style, their underlying goals are the same; they intend to initiate and enhance cancer control efforts, increase capacity for cancer research, foster new partnerships, and create research and cancer control networks. The proposed evaluation requests information about the outcomes of each of these workshops including (1) new cancer research partnerships and networks (2) cancer control partnerships and networks, (3) effects on cancer research, and (4) effect on cancer control planning and implementation efforts. The information will be collected 3-12 months after the workshops and is needed to evaluate the effectiveness of these workshops in order to inform future programming and funding decisions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 203.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Custom Device Exemption
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.
Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.'' The draft guidance, when finalized, will explain our current thinking on the preparation of regulatory submissions for obtaining exemptions for ingredients from the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) through submission of either a petition or a notification.
Meeting of the Community Preventive Services Task Force (Task Force)
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 are not mandates for compliance or spending. Instead, they 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).
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
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 https:// www.workplace.samhsa.gov.
Proposed Collection; 60-day Comment Request; NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer
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 Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted 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: Margaret Beckwith, International Cancer Research Databank Branch, Office of Communications and Education, 9609 Medical Center Drive, MSC 9776, Bethesda, MD 20892-9776 or call non-toll-free number 240-376-6593 or Email your request, including your address to: mbeckwit@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment 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: NCI Cancer Genetics Services Directory Web- Based Application and Update Mailer, 0925-0639, Date 08/31/2014, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Office of Communications and Education International Cancer Research Databank Branch has created the NCI Cancer Genetics Services Directory on NCI's Web site Cancer.gov. This directory is a searchable collection of information about professionals who provide services related to cancer genetics. These services include cancer risk assessment, genetic counseling, and genetic susceptibility testing. The professionals have applied to be in the directory using an online application form and have met basic criteria outlined on the form. There are currently 587 genetics professionals listed in the directory. Approximately 30-60 new professionals are added to the directory each year. The applicants are nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The information collected on the application form includes name, professional qualifications, practice locations, and the area of specialization. The information is updated annually using a Web-based update mailer that mirrors the application form. The NCI Cancer Genetics Services Directory is a unique resource for cancer patients and their families who are looking for information about their family risk of cancer and genetic counseling. Collecting applicant information and verifying it annually by using the NCI Cancer Genetics Services Directory Web-based Application Form and Update Mailer is important for providing this information to the public and for keeping it current. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 180.
Proposed Collection; 60-Day Comment Request; Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA-NCI)
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 Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted 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: Bradford W. Hesse, Ph.D., Health Communication and Informatics Research Branch, 9609 Medical Center Drive, MSC 9761, Room 3E610, Rockville, MD 20850 or call non-toll free number 240-276-6721 or Email your request, including your address, to hesseb@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment 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: Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA-NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This partnership between NCI and FDA will include assessing the public's knowledge of medical devices, communications related to product recalls, nutritional supplement labeling, and topics to inform FDA's regulatory authority over tobacco, such as risk perceptions about new tobacco products, product pack color gradations, perceptions of product harm, and tobacco product claims and labels. This NCI-FDA survey will couple knowledge- related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of FDA- regulated material. This survey will extend the information collected and priorities from the Health Information National Trends Survey (HINTS) which has been to provide a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,159.
Medicare Program; FY 2015 Hospice Wage Index and Payment Rate Update; Hospice Quality Reporting Requirements and Process and Appeals for Part D Payment for Drugs for Beneficiaries Enrolled in Hospice
This proposed rule would update the hospice payment rates and the wage index for fiscal year (FY) 2015 and continue the phase out of the wage index budget neutrality adjustment factor (BNAF). This rule provides an update on hospice payment reform analyses and solicits comments on ``terminal illness'' and ``related conditions'' definitions, and on a process and appeals for Part D payment for drugs, while beneficiaries are under a hospice election. Also, this rule proposes timeframes for filing the notice of election and the notice of termination/revocation; adding the attending physician to the hospice election form; a requirement that hospices complete their hospice inpatient and aggregate cap determinations within 5 months after the cap year ends, and remit any overpayments; and updates for the hospice quality reporting program. In addition, this rule would provide guidance on determining hospice eligibility, information on the delay in the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), and would further clarify how hospices are to report diagnoses on hospice claims. Finally, the rule proposes to make a technical regulatory text change.
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