Department of Health and Human Services January 2016 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 233
Proposed Collection; 60-Day Comment Request; Self-Affirmation Construct Validity (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, the 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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*: Rebecca Ferrer, Program Director, Basic Biobehavioral and Psychological Sciences Branch, Behavioral Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Dr., Rockville MD 20852. or call non-toll-free number (240) 276-6914 or Email your request, including your address to: ferrerra@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: Self-affirmation Construct Validity, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This information collection, seeks to refine a theory about how self-competence and values play a role in defensive responses to health communications. Although theoretically-driven research has shown that self- affirmationa process by which individuals reflect on values that are important to themcan improve responses to health and cancer communications, the ``active ingredient'' (or mechanisms underlying effectiveness) of self-affirmations is unknown. Self-affirmation is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. This research can inform NCI scientific priorities and investments in self-affirmation research. The results of the information collection will be used to further develop and improve self-affirmation theory. These findings may allow future researchers to develop and test cancer prevention interventions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 717.
Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Patient and Medical Professional Perspectives on the Return of Genetic Test Results.'' The purpose of this public workshop is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results. The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, with an emphasis on the type(s) and amount of evidence available to interpret the results for medical purposes, how those results should be returned, and what information is needed to understand the results in the event that they could effectively aid in medical decision making.
Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry.'' The guidance document provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations intended to minimize the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) from blood and blood products. The guidance amends the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010 (2010 guidance) by finalizing and incorporating the recommendations from the draft document entitled ``Draft Guidance for Industry: Amendment to 'Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products''' dated June 2012 (2012 draft guidance).
Clinical Outcome Assessment Compendium
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties (including academic institutions, regulated industry, and patient groups) on our pilot ``Clinical Outcome Assessment Compendium'' (COA Compendium). FDA has developed a Web site that describes the purpose of the pilot COA Compendium and provides background information. Comments received on the pilot COA Compendium during its pilot phase will help FDA determine its utility, and may assist FDA in developing future iterations of the COA Compendium and identifying best methods for conveying COA Compendium information on FDA's Web site.
Proposed Collection; 60-Day Comment Request; Cancer Genomics Cloud Pilots Survey (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, the 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 to address one or more of the following points: 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; 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; The quality, utility, and clarity of the information to be collected; and 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.
Meeting Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015
This notice announces the first meeting date for the Physician-Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') on Monday, February 1, 2016.
Proposed Collection; 60-Day Comment Request; Investigating Factors That Influence Career Choice Among Neuroscience Trainees NINDS
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 Institute of Neurological Disorders and Stroke (NINDS), the 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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: Paul A. Scott, Ph.D., Director, Office of Science Policy and Planning, National Institute of Neurological Disorders and Stroke, 31 Center Drive, Room 8A03, Bethesda, MD 20892-2540 or call non-toll-free number (301) 451- 7964 or Email your request, including your address to: NINDSWorkforceSurvey@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: Investigating Factors that Influence Career Choice Among Neuroscience Trainees NINDS, 0925-NEW, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH). Need and Use of Information Collection: In order to create and administer effective training programs for a diverse research workforce, NINDS needs information about the factors influencing career choice among different populations, particularly those underrepresented in the neuroscience workforce. Few studies have looked into factors influencing career choice among biomedical science trainees and how those career choices are influenced by social identity (race/ethnicity, gender, disability, disadvantaged background, and their intersection); none, to our knowledge, has reported this data specifically for neuroscientists. In pursuit of the training mission of NINDS, the Office of Training, Career Development, and Workforce Diversity (OTCDWD) administers programs to train the next generation of neuroscientists and to increase diversity of the neuroscience workforce. The information collected from this survey will help give NINDS a clearer picture of the environment and experiences of our trainee and potential trainee community. We are seeking a more accurate understanding of the career choices neuroscience trainees are making, and how well NINDS supports our trainees' needs and facilitates successful career trajectories. The survey will help improve our current programs, develop training opportunities, and provide programmatic support for current and future NINDS trainees. OMB approval is requested for 18 months. There are no costs to respondents other than their time. The total estimated annualized burden hours are 205.
Extension of Public Comment Period for the Request for Information (RFI): Soliciting Input for the National Center for Advancing Translational Sciences (NCATS) Strategic Planning Process
The National Center for Advancing Translational Sciences (NCATS) is extending the comment period for responses to its Request for Information (RFI), published in Vol. 80, No. 195, of the Federal Register on October 8, 2015. The response date has been extended from January 8, 2016, to February 8, 2016, to provide additional time for any and all interested parties to respond to this RFI. Comments must be submitted electronically using the web-based form available at https:// grants.nih.gov/grants/rfi/rfi.cfm?ID=50.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Next Generation Sequencing-Based Oncology Panels; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Next Generation Sequencing-Based Oncology Panels.'' The purpose of this workshop is to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)- based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for evaluation of NGS-based oncology panels in cancer patient management.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
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 regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting February 2-3, 2016. The meeting is open to the public. However, pre- registration is required for both public attendance and public comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac/ meetings/upcomingmeetings/. Participants may also register by emailing nvpo@hhs.gov or by calling 202-690-5566 and providing their name, organization, and email address.
HHS-Operated Risk Adjustment Methodology Meeting; March 25, 2016
This notice announces a meeting on the HHS-operated risk adjustment program, which is open to the public. The purpose of this stakeholder meeting is to solicit feedback on the HHS-operated risk adjustment methodology and to discuss potential improvements to the HHS risk adjustment methodology for the 2018 benefit year and beyond. This meeting, the ``HHS-operated Risk Adjustment Methodology Conference,'' will allow issuers, States, and other interested parties to discuss the contents of a White Paper to be published in advance of this meeting. This meeting will also provide an opportunity for participants to ask clarifying questions. The comments and information HHS obtains through this meeting may be used in future policy making for the HHS risk adjustment program.
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''
Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry.'' The draft guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The draft guidance, when finalized, is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).
Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Extension of Comment Period
The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled ``Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability'' that appeared in the Federal Register on November 23, 2015 (80 FR 72975). That notice announced the availability of a draft guidance for industry and requested comments to that draft guidance by January 22, 2016. FDA is extending the draft guidance's comment period by 30 days (to February 22, 2016) in response to a request for an extension to allow interested persons additional time to submit comments.
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
The Food and Drug Administration (FDA or Agency) is reopening the comment period for the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of November 7, 2013. The Agency is reopening the comment period to receive updated comments and any new information.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
