Department of Health and Human Services September 2013 – Federal Register Recent Federal Regulation Documents
Results 251 - 284 of 284
Sole Source Cooperative Agreement Award to the National Association of County and City Health Officials (NACCHO)
ASPR requires collaboration with local health departments and officials to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems. This project aims to improve collaboration between ASPR and the local health departments (LHDs) to enhance national health security, foster community health resilience, and strengthen health care, public health, and emergency management systems. One of the overarching goals of both the National Health Security Strategy (2009) and the ASPR Strategic Plan 2011-2015 is to build community health resilience. ASPR seeks to partner with LHDs and health officials which play a critical role in building community health resilience by employing and evaluating localized public health strategies, such as preparing local communities to withstand and recover from public health emergencies and disasters, and engaging local health departments and health care organizations to build healthcare coalitions. The project will foster better approaches for building community health resilience. LHDs and health officials are intimately familiar with the communities and populations that they serve and are an essential partner in carrying out the mission of ASPR. ASPR seeks to engage LHDs and health officials as well as other appropriate local stakeholders in bi-directional communications to evaluate the effectiveness of, and ensure that, ASPR's strategies, policies, and programmatic activities are informed by and support the needs of local communities. The project will foster collaboration with local health officials to achieve, for example, national health security and strengthen local emergency preparedness, response, and recovery systems and capabilities, and build well-functioning healthcare coalitions, among other activities. ASPR seeks to partner with LHDs and local communities which frequently prepare for, respond to, and recover from localized emergency incidents and to identify valuable lessons and promising practices to collect and share these practices with other LHDs and communities. This project will capture lessons learned and promising practices from local communities and share them more widely. Justification: The National Association of County and City Health Officials (NACCHO) is the national nonprofit organization representing all local and tribal health officials from across the country. Members are elected by their peers, and include ex officio members representing the National Association of Counties, of which NACCHO is an affiliate, and the U.S. Conference of Mayors. NACCHO advocates on the behalf of county and city health departments by providing Congressional testimony, submitting letters to the Administration, and endorsing proposed legislation. NACCHO has demonstrated experience establishing partnerships with both traditional and non-traditional organizations to impact both county and city public health departments and the broader public health system. NACCHO's existing network of health officials will provide ASPR with the unique ability to collaborate on federal programs and actions that could impact the preparation for, response to or recovery from emergencies and disasters impacting public health and health care. Additional Information: The agency program contact is Lisa Kaplowitz, who can be contacted by phone at (202) 202-2882 or via email at Lisa.Kaplowitz@hhs.gov.
Sole Source Cooperative Agreement Award to the Association for State and Territorial Health Officials (ASTHO)
ASPR requires collaboration with state and territorial health departments and officials to ensure that state and local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems. This project aims to improve collaboration between ASPR and the state health departments (SHDs) to enhance national health security, foster community health resilience, and strengthen health care, public health, and emergency management systems. One of the overarching goals of both the National Health Security Strategy (2009) and the ASPR Strategic Plan 2011-2015 is to build community health resilience. ASPR seeks to partner with SHDs and territorial health officials, which play a critical role in building community health resilience by employing and evaluating public health strategies such as preparing local communities to withstand and recover from public health emergencies and disasters, and engaging health care organizations to build healthcare coalitions. The project will foster better approaches for building community health resilience. SHDs and territorial health officials are intimately familiar with the communities and populations that they serve and are an essential partner in carrying out the mission of ASPR. ASPR seeks to engage SHDs and health officials as well as other appropriate stakeholders in bi- directional communications to evaluate the effectiveness of, and ensure that, ASPR's strategies, policies, and programmatic activities are informed by and support the needs of states, territories, and local communities. The project will foster collaboration with state health officials to achieve, for example, national health security and strengthen emergency preparedness, response, and recovery systems and capabilities, and build well-functioning healthcare coalitions, among other activities. ASPR seeks to partner with SHDs and territorial health officials and local communities which frequently prepare for, respond to, and recover from emergency incidents and to identify valuable lessons learned and promising practices to collect and share these practices with other SHDs and communities. This project will capture lessons and promising practices and share them more widely. Justification: The Association for State and Territorial Health Officials (ASTHO) is the only national nonprofit membership organization that includes membership representation from every state and local public health agency in the United States (U.S.), the U.S. Territories, the District of Columbia, and over 100,000 public health professionals employed by these agencies. ASTHO members, the chief health officials of these jurisdictions, formulate and influence sound public health policy and ensure excellence in state-based public health practice. The ASTHO organization has the unique ability to represent the perspectives of all the state and territorial health officials across the nation. Additional Information: The agency program contact is Lisa Kaplowitz, who can be contacted by phone at (202) 202-2882 or via email at Lisa.Kaplowitz@hhs.gov.
Guidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled ``Tobacco Retailer Training Programs.'' The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) does not require retailers to implement retailer training programs. However, the Tobacco Control Act does provide for lower civil money penalties for violations of sale and distribution, including youth access, advertising, and promotion restrictions issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed by FDA for such programs. FDA intends to issue regulations establishing standards for approved retailer training programs. In the interim, this guidance document is intended to assist tobacco retailers who wish to implement training programs for employees.
Center for Devices and Radiological Health: Draft Standard Operating Procedure for Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues; Availability and Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of the Draft Standard Operating Procedure (SOP) for Level 1, Immediately in Effect (IIE) Guidance Documents on Premarket Data Issues. The SOP describes the Center for Devices and Radiological Health's (CDRH's or the Center's) draft process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect, data submitted as part of an Investigational Device Exemption (IDE) or premarket submission, including a Premarket Notification 510(k), a Premarket Approval (PMA), or a Humanitarian Device Exemption (HDE) that needs to be disseminated in a timely manner.
Fee for Using a Priority Review Voucher in Fiscal Year 2014
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2014.
Request for Information: Collection and Use of Nonfatal Workplace Violence Information from the National Crime Victimization Survey
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) and the Bureau of Justice Statistics (BJS) of the Office of Justice Programs, Department of Justice (DOJ), are collaborating to request public comments to inform BJS's approach in collecting and reporting data related to nonfatal workplace violence in the National Crime Victimization Survey (NCVS). NIOSH and BJS request input on these issues. The instructions for submitting comments can be found at www.regulations.gov. Written comments submitted to the Docket will be used to inform BJS with the planning and collection of workplace violence data in the NCVS. Dates: Public Comment Period: Comments must be received by November 27, 2013 to be considered by BJS and NIOSH. Addresses: Written comments: You may submit comments by any of the following methods: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226. Instructions: All submissions received must include the agency name and docket number [CDC-2013-0020; NIOSH-269]. All relevant comments, including any personal information provided, will be posted without change to https://www.regulations.gov. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
Solicitation of Written Comments on Draft National Action Plan for Adverse Drug Event Prevention
The Office of Disease Prevention and Health Promotion is soliciting public comment on the draft National Action Plan for Adverse Drug Event Prevention.
Development of Inward Leakage Standards for Half-Mask Air-Purifying Particulate Respirators
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting concerning inward leakage performance requirements for the class of NIOSH-certified non-powered air-purifying particulate respirators approved as half-facepiece respirators for protection from particulate-only hazards. The purpose of this meeting is to share information and to seek stakeholder feedback, in identified topic areas, concerning the development of inward leakage performance standards. Questions concerning the identified topics of specific interest are included in this document. Attendance at the public meeting is not required to submit written responses to the questions in this notice.
Availability of Draft National Toxicology Program Technical Reports; Request for Comments; Notice of Meeting
The National Toxicology Program (NTP) announces the availability of four draft NTP Technical Reports (TRs) scheduled for peer review: vinylidene chloride, cobalt metal dust, tetrabromobisphenol A (TBBPA), and glycidamide. The draft TRs should be available by September 20, 2013, at https://ntp.niehs.nih.gov/go/36051. The peer-review meeting is open to the public and preregistration is requested for both public attendance and comment. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/ 36051.
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 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 revision of the approved information collection assigned OMB control number 0945-0003 scheduled to expire on 12/31/2015. 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.
Advisory Council on Blood Stem Cell Transplantation; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations of qualified candidates to fill expected vacancies on the Advisory Council on Blood Stem Cell Transplantation (ACBSCT). The ACBSCT was established pursuant to Public Law 109-129 as amended by Public Law 111-264; 42 U.S.C. 274k; Section 379 of the Public Health Service Act. In accordance with Public Law 92-463, the ACBSCT was chartered on December 19, 2006.
HRSA's Bureau of Health Professions Advanced Education Nursing Traineeship Program
The Bureau of Health Professions (BHPr) is announcing a change to its Advanced Education Nursing Traineeship (AENT) program. Effective fiscal year (FY) 2014, AENT support for part-time students (trainees) will be limited to those students (trainees) who are enrolled within the last 12 months of study for their program. This change will apply to new part-time students (trainees) and will not affect part-time students (trainees) funded prior to FY 2014, who will continue to be supported throughout their advanced education primary care training. Support for full-time students (trainees) will continue without any changes. This change is being implemented to support part-time students (trainees) nearing graduation, in an effort to expeditiously meet the growing demand for primary care nurse practitioners and nurse midwives.
Single-Case Deviation From Competition Requirements: Maternal and Child Health (MCH) Bureau's Research Network on Pregnancy-Related Care Program
HRSA will be issuing a non-competitive program expansion supplement for the MCH Research Network on Pregnancy-related Care program. Approximately $200,000 in supplemental funding will be made available in the form of a cooperative agreement to the American College of Obstetricians and Gynecologists (ACOG), Washington, DC, Grant Number UA6MC19010, during the budget period of September 9, 2013, through August 31, 2014. The MCH Research Network on Pregnancy-related Care program (UA6MC 19010), CFDA No. 93.110, is authorized by Title V, Social Security Act, Section 501(a)(2); as amended (42 U.S.C. 701). The MCH Research Network on Pregnancy-related Care (Network) is the only existing national network of practicing obstetrician-gynecologists who have been recruited to participate in survey studies to examine physicians' clinical practice patterns, knowledge base, opinions, and educational needs with respect to maternal health, including pregnancy- related health and women's health across the lifespan. Now in its third year of a 5-year project period, the Network has successfully conducted numerous studies and boasts a very robust dissemination of critical information on its research findings including nearly 30 peer-reviewed publications since 2010. Types of studies conducted by the Network include the following: Core longitudinal studies that track physician knowledge and practice over time (e.g., Preterm birth, Diabetes during pregnancy, Obesity, Nausea and vomiting of pregnancy); Studies based on newly or soon-to-be published ACOG clinical practice guidelines (e.g., Thyroid disorders during pregnancy, Down syndrome); Studies that assess the maternal-child health workforce (e.g., Racial and gender differences in residents' perceptions of mentoring, Physician gender and practice satisfaction); and Topical studies to address the needs in the field (e.g., Oral health during pregnancy, Influenza vaccination during pregnancy).
Health Careers Opportunity Program
HRSA is issuing non-competitive program expansion supplements to all 17 fiscal year (FY) 2013 HCOP grantees to include interprofessional health educational activities focused on careers in behavioral health, such as a graduate degree in Clinical or Counseling Psychology, Clinical Social Work, and/or Marriage and Family Therapy. This expanded focus could be formed through collaboration with a Behavioral Health Department/School or Program that is within the current HCOP academic institution or accessible within the institution's geographic region. Approximately $1,900,000 will be available for this effort. HCOP grantees currently have the expertise, experience, and infrastructure to quickly and efficiently implement the behavioral health supplemental initiative within their existing educational programming. The program expansion supplements will allow the Bureau of Health Professions to consolidate resources and meet the growing need for and access to skilled and culturally competent behavioral health professionals within a currently existing grant program.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Alzheimer's Disease Supportive Services Program-Data Reporting Tool
The Administration on Aging (AoA), Administration for Community Living (ACL) is announcing the proposed continuation of the collection of information for the Alzheimer's Disease Supportive Services Program. The proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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